[Federal Register Volume 89, Number 159 (Friday, August 16, 2024)]
[Rules and Regulations]
[Pages 66558-66560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18267]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. FDA-2024-N-3356]


Medical Devices; General Hospital and Personal Use Devices; 
Classification of the Intravenous Catheter Force-Activated Separation 
Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the intravenous catheter force-activated separation device 
into class II (special controls). The special controls that apply to 
the device type are identified in this order and will be part of the 
codified language for the intravenous catheter force-activated 
separation device's classification. We are taking this action because 
we have determined that classifying the device into class II (special 
controls) will provide a reasonable assurance of safety and 
effectiveness of the device. We believe this action will also enhance 
patients' access to beneficial innovative devices.

DATES: This order is effective August 16, 2024. The classification was 
applicable on May 27, 2021.

FOR FURTHER INFORMATION CONTACT: Florencia Wilson, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2458, Silver Spring,

[[Page 66559]]

MD 20993-0002, 240-402-9978, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the intravenous catheter force-
activated separation device as class II (special controls), which we 
have determined will provide a reasonable assurance of safety and 
effectiveness. In addition, we believe this action will enhance 
patients' access to beneficial innovation, in part by placing the 
device into a lower device class than the automatic class III 
assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device 
that does not require premarket approval. We determine whether a new 
device is substantially equivalent to a predicate device by means of 
the procedures for premarket notification under section 510(k) of the 
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) established the first procedure for De 
Novo classification. Section 607 of the Food and Drug Administration 
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo 
application process by adding a second procedure. A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo 
process, the device can serve as a predicate for future devices of that 
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C 
Act). As a result, other device sponsors do not have to submit a De 
Novo request or premarket approval application to market a 
substantially equivalent device (see section 513(i) of the FD&C Act, 
defining ``substantial equivalence''). Instead, sponsors can use the 
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On September 18, 2019, FDA received Site Saver, Inc. d/b/a Lineus 
Medical's request for De Novo classification of the SafeBreak Vascular. 
FDA reviewed the request to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the FD&C Act.
    We classify 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 that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the 
information submitted in the request, we determined that the device can 
be classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on May 27, 2021, FDA issued an order to the requester 
classifying the device into class II. In this final order, FDA is 
codifying the classification of the device by adding 21 CFR 
880.5220.\1\ We have named the generic type of device intravenous 
catheter force-activated separation device and it is identified as a 
device placed in-line with an intravenous (IV) catheter and an 
intravascular administration set, including any administration set 
accessories. It separates into two parts when a specified force is 
applied. The device is intended to reduce the risk of IV catheter 
failure(s) requiring IV catheter replacement.
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    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1.

  Table 1--Intravenous Catheter Force-Activated Separation Device Risks
                         and Mitigation Measures
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       Identified risks to health              Mitigation measures
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Delays of therapy due to failure of      Performance data, Non-clinical
 device to function as expected (e.g.,    performance testing, and
 if separation force too low).            Labeling.
Mechanical complications (e.g., IV       Performance data, Non-clinical
 dislodgement, IV infiltration,           performance testing, and
 occlusion, and phlebitis events          Labeling.
 requiring IV replacement) due to
 failure of device to function as
 expected (e.g., if separation force
 too high).
Infection..............................  Sterilization validation, Shelf
                                          life testing, Non-clinical
                                          performance testing, and
                                          Labeling.
Air embolism...........................  Non-clinical performance
                                          testing, and Labeling.

[[Page 66560]]

 
Adverse tissue reaction................  Biocompatibility evaluation,
                                          Pyrogenicity testing, and Non-
                                          clinical performance testing.
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    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. For a device to fall within this 
classification, and thus avoid automatic classification in class III, 
it would have to comply with the special controls named in this final 
order. The necessary special controls appear in the regulation codified 
by this order. This device is subject to premarket notification 
requirements under section 510(k) of the FD&C Act.

III. Analysis of 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations and guidance. 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. 3501-3521). The collections 
of information in 21 CFR part 860, subpart D, regarding De Novo 
classification have been approved under OMB control number 0910-0844; 
the collections of information in 21 CFR part 814, subparts A through 
E, regarding premarket approval, have been approved under OMB control 
number 0910-0231; the collections of information in part 807, subpart 
E, regarding premarket notification submissions, have been approved 
under OMB control number 0910-0120; the collections of information in 
21 CFR part 820, regarding quality system regulation, have been 
approved under OMB control number 0910-0073; 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 880

    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 
880 is amended as follows:

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
1. The authority citation for part 880 continues to read as follows:

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


0
2. Add Sec.  880.5220 to read as follows:


Sec.  880.5220  Intravenous catheter force-activated separation device.

    (a) Identification. An intravenous catheter force-activated 
separation device is placed in-line with an intravenous (IV) catheter 
and an intravascular administration set, including any administration 
set accessories. It separates into two parts when a specified force is 
applied. The device is intended to reduce the risk of IV catheter 
failure(s) requiring IV catheter replacement.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Performance data must be provided to demonstrate clinically 
acceptable performance for the intended use of the device.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Separation force testing;
    (ii) Validation of anti-reconnect features;
    (iii) Air and liquid leakage testing, both before and after 
separation;
    (iv) Luer connection testing;
    (v) Flow rate testing;
    (vi) Particulate testing; and
    (vii) Microbial ingress testing.
    (3) The device must be demonstrated to be biocompatible.
    (4) Performance testing must demonstrate that the device is sterile 
and non-pyrogenic.
    (5) Performance testing must support the shelf life of the device 
by demonstrating continued sterility and device functionality over the 
identified shelf life.
    (6) Device labeling must include:
    (i) Instructions for use; and
    (ii) A discussion of catheter dressings intended to be used with 
the device.

    Dated: August 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18267 Filed 8-15-24; 8:45 am]
BILLING CODE 4164-01-P