[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Rules and Regulations]
[Pages 64761-64763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22709]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2016-N-2562]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Magnetic Surgical Instrument System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
Magnetic Surgical Instrument System 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 magnetic 
surgical instrument system'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 September 21, 2016. The classification 
was applicable on June 13, 2016.

FOR FURTHER INFORMATION CONTACT: Varun Pattani, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G452, Silver Spring, MD, 20993-0002, 301-796-6368, 
[email protected].

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

[[Page 64762]]

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), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1) of 
the FD&C Act. Under the first procedure, the person submits a premarket 
notification under section 510(k) of the FD&C Act 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) of 
the FD&C Act, 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) of the FD&C Act 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) of the FD&C Act. 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 shall 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On February 9, 2015, Levita Magnetics International Corp., 
submitted a request for classification of the Levita Magnetic Surgical 
System under section 513(f)(2) of the FD&C Act.
    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, in addition to general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on June 13, 2016, FDA issued an order to the requestor 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 878.4815.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a magnetic 
surgical instrument system will need to comply with the special 
controls named in this final order. The device is assigned the generic 
name magnetic surgical instrument system, and it is identified as a 
prescription device used in laparoscopic surgical procedures consisting 
of several components, such as surgical instruments, and a magnetic 
controller. The magnetic controller is provided separately from the 
surgical instrument and is used outside the patient. The external 
magnetic controller is magnetically coupled with the internal surgical 
instrument(s) at the surgical site to grasp, hold, retract, mobilize, 
or manipulate soft tissue and organs.
    FDA has identified the following risks to health associated 
specifically with this type of device, as well as the mitigation 
measures required to mitigate these risks in table 1.

    Table 1--Magnetic Surgical Instrument System Risks and Mitigation
                                Measures
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               Identified risk                    Mitigation measures
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Tissue Damage................................  In vivo Performance
                                                Testing.
                                               Human Factors Testing and
                                                Analysis.
                                               Training.
                                               Labeling.
Need for Extended or Additional Surgery:       In vivo Performance
 Inability to couple the external       Testing.
 magnet with the internal surgical instrument  Non-clinical Performance
 Inability to retrieve or maneuver      Testing.
 device                                        Human Factors Testing and
 Inability to visualize critical        Analysis.
 anatomical structures                         Training.
                                               Labeling.
Abdominal Wall Injury........................  In vivo Performance
                                                Testing.
                                               Human Factors Testing and
                                                Analysis.
                                               Labeling.
Electromagnetic Field Incompatibility or       Non-clinical Performance
 Interference (including ferromagnetic          Testing.
 implants in users and patients,
 electrosurgical devices, etc.).
                                               Human Factors Testing and
                                                Analysis.
                                               Training.
                                               Labeling.
Adverse Tissue Reaction......................  Biocompatibility
                                                Evaluation.
Infection....................................  Sterilization Validation.
                                               Reprocessing Validation.
                                               Shelf Life Validation.
                                               Labeling.
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[[Page 64763]]

    FDA believes that the special controls, in addition to the general 
controls, address these risks to health and provide reasonable 
assurance of the safety and effectiveness.
    A magnetic surgical instrument system device is not safe for use 
except under the supervision of a practitioner licensed by law to 
direct the use of the device. As such, the device is a prescription 
device and must satisfy prescription labeling requirements (see 21 CFR 
801.109, Prescription devices).
    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 magnetic surgical instrument 
system 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.

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 part 878 continues to read as follows:

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


0
2. Add Sec.  878.4815 to subpart E to read as follows:


Sec.  878.4815  Magnetic surgical instrument system.

    (a) Identification. A magnetic surgical instrument system is a 
prescription device used in laparoscopic surgical procedures consisting 
of several components, such as surgical instruments, and a magnetic 
controller. The magnetic controller is provided separately from the 
surgical instrument and is used outside the patient. The external 
magnetic controller is magnetically coupled with the internal surgical 
instrument(s) at the surgical site to grasp, hold, retract, mobilize, 
or manipulate soft tissue and organs.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) In vivo performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. Testing must 
demonstrate the ability of the device to grasp, hold, retract, 
mobilize, or manipulate soft tissue and organs.
    (2) Non-clinical performance data must demonstrate that the system 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Magnetic field strength testing characterization to identify 
the distances from the magnet that are safe for patients and users with 
ferromagnetic implants, devices, or objects.
    (ii) Ability of the internal surgical instrument(s) to be coupled, 
de-coupled, and re-coupled with the external magnet over the external 
magnet use life.
    (3) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device 
components that are patient-contacting.
    (5) Methods and instructions for reprocessing reusable components 
must be validated.
    (6) Performance data must support shelf life by demonstrating 
continued sterility of the device or the sterile components and device 
functionality over the labeled shelf life.
    (7) Training must be developed and validated by human factors 
testing and analysis to ensure users can follow the instructions for 
use to allow safe use of the device.
    (8) Labeling must include:
    (i) Magnetic field safe zones.
    (ii) Instructions for proper device use.
    (iii) A screening checklist to ensure that all patients and 
operating staff are screened from bringing ferromagnetic implants, 
devices, or objects near the external magnet.
    (iv) Reprocessing instructions for any reusable components.
    (v) Shelf life.
    (vi) Use life.

    Dated: September 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22709 Filed 9-20-16; 8:45 am]
 BILLING CODE 4164-01-P