[Federal Register Volume 79, Number 46 (Monday, March 10, 2014)]
[Rules and Regulations]
[Pages 13218-13220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05061]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2014-N-0107]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Absorbable Lung Biopsy Plug

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
absorbable lung biopsy plug into class II (special controls). The 
special controls that will apply to the device are identified in this 
order, and will be part of the codified language for the absorbable 
lung biopsy plug's classification. The Agency is classifying the device 
into class II (special controls) in order to provide a reasonable 
assurance of safety and effectiveness of the device.

DATES: This order is effective April 9, 2014. The classification was 
effective on December 19, 2012.

FOR FURTHER INFORMATION CONTACT: Neel Patel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2532, Silver Spring, MD 20993-0002, 301-796-6274.

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i), to a predicate device that does not 
require premarket approval. The Agency determines whether new devices 
are substantially equivalent to predicate devices by means of premarket 
notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144, July 9, 2012, 126 Stat. 1054), provides two procedures by which a 
person may request FDA to classify a device under the criteria set 
forth in section 513(a)(1). Under the first procedure, the person 
submits a premarket notification under section 510(k) for a device that 
has not previously been classified and, within 30 days of receiving an 
order classifying the device into class III under section 513(f)(1), 
the person requests a classification under section 513(f)(2). Under the 
second procedure, rather than first submitting a premarket notification 
under section 510(k) and then a request for classification under the 
first procedure, the person determines that there is no legally 
marketed device upon which to base a determination of substantial 
equivalence and requests a classification under section 513(f)(2). If 
the person submits a request to classify the device under this second 
procedure, FDA may decline to undertake the classification request if 
FDA identifies a legally marketed device that could provide a 
reasonable basis for review of substantial equivalence with the device 
or if FDA determines that the device submitted is not of ``low-moderate 
risk'' or that general controls would be inadequate to control the 
risks and special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an 
order on March 19, 2009, classifying the Bio-Seal Lung Biopsy Tract 
Plug System into class III, because it was not substantially equivalent 
to a device that was introduced or delivered for introduction into 
interstate commerce for commercial distribution before May 28, 1976, or 
a device which was subsequently reclassified into class I or class II. 
On April 16, 2009, Angiotech submitted a request for classification of 
the Bio-Seal Lung Biopsy Tract Plug System under section 513(f)(2) of 
the FD&C Act. The manufacturer recommended that the device be 
classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the FD&C Act. FDA 
classifies devices into class II if general controls by themselves are 
insufficient to provide reasonable assurance of safety and 
effectiveness but there is sufficient information to establish special 
controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use. After review of the 
information submitted in the request, FDA determined that the device 
can be classified into class II with the establishment of special 
controls. FDA believes these special controls will provide reasonable 
assurance of the safety and effectiveness of the device.
    Therefore, on December 19, 2012, FDA issued an order to the 
requester classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 878.4755.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for an absorbable 
lung biopsy plug will need to comply with the special controls named in 
this final order.
    The device is assigned the generic name Absorbable Lung Biopsy 
Plug, and it is identified as a preformed (polymerized) absorbable lung 
biopsy plug intended to provide accuracy in marking a biopsy location 
for visualization during surgical resection and closure of pleural 
punctures associated with percutaneous, transthoracic needle lung 
biopsies. Upon deployment into the biopsy tract, the plug expands to 
fill the biopsy void and remains in place until resorbed.
    FDA has identified the following risks to health associated 
specifically with this type of device, as well as the mitigation 
measures.

[[Page 13219]]



------------------------------------------------------------------------
       Identified potential risk          Recommended mitigation measure
------------------------------------------------------------------------
Inability to deploy plug...............  Design and Material
                                          Characterization
                                         Bench Testing
                                         In Vivo Evaluation
                                         Labeling
Delayed plug expansion.................  Design and Material
                                          Characterization
                                         Bench Testing
                                         In Vivo Evaluation
                                         Labeling
Leakage around plug....................  Design and Material
                                          Characterization
                                         Bench Testing
                                         In Vivo Evaluation
                                         Labeling
Plug migration (whole plug and/or        Design and Material
 fragments).                              Characterization
                                         Bench Testing
                                         In Vivo Evaluation
                                         Labeling
Procedural complications...............  In Vivo Evaluation
                                         Labeling
Adverse tissue reaction................  Biocompatibility
                                         In Vivo Evaluation
Infection..............................  Biocompatibility
                                         Sterility
                                         Shelf-Life Testing
Use error..............................  Labeling
------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to 
the general controls, address these risks to health and provide 
reasonable assurance of the safety and effectiveness:
    (1) The design characteristics of the device must ensure that the 
geometry and material composition are consistent with the intended use.
    (2) Performance testing must demonstrate deployment as indicated in 
the accompanying labeling, including the indicated introducer needles, 
and demonstrate expansion and resorption characteristics in a 
clinically relevant environment.
    (3) In vivo evaluation must demonstrate performance characteristics 
of the device including the ability of the plug to not prematurely 
resorb or migrate and the rate of pneumothorax.
    (4) Sterility testing must demonstrate the sterility of the device 
and the effects of the sterilization process on the physical 
characteristics of the plug.
    (5) Shelf-life testing must demonstrate the shelf-life of the 
device including the physical characteristics of the plug.
    (6) The device must be demonstrated to be biocompatible.
    (7) Labeling must include a detailed summary of the device-related 
and procedure-related complications pertinent to the use of the device 
and appropriate warnings. Labeling must include identification of 
compatible introducer needles.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act if FDA determines that premarket notification is 
not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this device type is not exempt from premarket notification 
requirements. Persons who intend to market this type of device must 
submit to FDA a premarket notification, prior to marketing the device, 
which contains information about the absorbable lung biopsy plug they 
intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 
part 807, subpart E regarding premarket notification submissions have 
been approved under OMB control number 0910-0120, and the collections 
of information in 21 CFR part 801, regarding labeling have been 
approved under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and is available electronically at http://www.regulations.gov.

    1. Request from Angiotech, dated April 16, 2009.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Section 878.4755 is added to subpart E to read as follows:


Sec.  878.4755  Absorbable Lung Biopsy Plug.

    (a) Identification. A preformed (polymerized) absorbable lung 
biopsy plug is intended to provide accuracy in marking a biopsy 
location for visualization during surgical resection and closure of 
pleural punctures associated with percutaneous, transthoracic needle 
lung biopsies. Upon deployment into the biopsy tract,

[[Page 13220]]

the plug expands to fill the biopsy void and remains in place until 
resorbed.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The design characteristics of the device must ensure that the 
geometry and material composition are consistent with the intended use.
    (2) Performance testing must demonstrate deployment as indicated in 
the accompanying labeling, including the indicated introducer needles, 
and demonstrate expansion and resorption characteristics in a 
clinically relevant environment.
    (3) In vivo evaluation must demonstrate performance characteristics 
of the device, including the ability of the plug to not prematurely 
resorb or migrate and the rate of pneumothorax.
    (4) Sterility testing must demonstrate the sterility of the device 
and the effects of the sterilization process on the physical 
characteristics of the plug.
    (5) Shelf-life testing must demonstrate the shelf-life of the 
device including the physical characteristics of the plug.
    (6) The device must be demonstrated to be biocompatible.
    (7) Labeling must include a detailed summary of the device-related 
and procedure-related complications pertinent to the use of the device 
and appropriate warnings. Labeling must include identification of 
compatible introducer needles.

    Dated: February 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05061 Filed 3-7-14; 8:45 am]
BILLING CODE 4160-01-P