Document ID: FDA-2019-D-5606-0001
Agency: fda
Document Type: Notice
Title: Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use— Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2020-01-28T05:00Z

[Federal Register Volume 85, Number 18 (Tuesday, January 28, 2020)]
[Notices]
[Pages 4997-4999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01342]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5606]

Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use--
Premarket Notification (510(k)) Submissions; Draft Guidance for 
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Arthroscopy Pump 
Tubing Sets Intended for Multiple Patient Use--Premarket Notification 
(510(k)) Submissions.'' FDA has developed this draft guidance document 
to assist in the preparation of premarket notification submissions 
(510(k)) for arthroscopy pump tubing sets intended for multiple patient 
use. This draft guidance outlines the device design considerations, 
risk mitigation strategies, and testing recommendations for arthroscopy 
pump tubing sets intended for multiple patient use. This draft guidance 
document also clarifies the terminology used to describe arthroscopy 
pump tubing sets intended for multiple patient use. This draft guidance 
is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by March 30, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

[[Page 4998]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-5606 for ``Arthroscopy Pump Tubing Sets Intended for 
Multiple Patient Use--Premarket Notification (510(k)) Submissions.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use--
Premarket Notification (510(k)) Submissions'' to the Office of Policy, 
Guidance and Policy Development, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Cal Rabang, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4633, Silver Spring, MD 20993-0002, 301-796-6412.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Arthroscopy Pump Tubing Sets Intended for 
Multiple Patient Use--Premarket Notification (510(k)) Submissions.'' 
FDA has developed this draft guidance document to assist in the 
preparation of premarket notification submissions (510(k)) for 
arthroscopy pump tubing sets intended for multiple patient use. These 
devices are designed to deliver irrigation fluid to the surgical site, 
such as knee, shoulder, hip, elbow, ankle, and wrist joint cavities, 
during arthroscopic procedures. In arthroscopic procedures, clinicians 
often use a single source of irrigation fluid for multiple patients 
without replacing the source of irrigation fluid or replacing/
reprocessing the irrigation tubing system between patients. This 
practice may increase the risk of cross-contamination between patients 
and subsequent iatrogenic infection because the irrigation system can 
become contaminated with patient fluids that travel back through the 
irrigation tubing (``backflow''). FDA has received reports of backflow 
of patient fluids, which raises the question of potential for disease 
transmission when using irrigation and tubing systems in such a manner 
on multiple patients.
    When finalized, this guidance is intended to provide 
recommendations for information to include in premarket notifications 
(510(k)s) for arthroscopy pump tubing sets intended for multiple 
patient use. This guidance will outline device design considerations, 
risk mitigation strategies, and testing recommendations for these 
devices, and will also clarify the terminology used to describe 
arthroscopy pump tubing sets intended for multiple patient use.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Arthroscopy 
Pump Tubing Sets Intended for Multiple Patient Use--Premarket 
Notification (510(k)) Submissions.'' It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov. Persons unable to download an 
electronic copy of ``Arthroscopy Pump Tubing Sets Intended for Multiple 
Patient Use--Premarket Notification (510(k)) Submissions'' may send an 
email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 1500066 to 
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in 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. 3501-3521). The 
collections of information in the following FDA

[[Page 4999]]

regulations have been approved by OMB as listed in the following table:

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                                                            OMB control
          21 CFR part                     Topic                 No.
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807, subpart E.................  Premarket Notification.       0910-0120
801............................  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
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    Dated: January 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01342 Filed 1-27-20; 8:45 am]
 BILLING CODE 4164-01-P