BioArc TO Subfascial Hammock is intended for the placement of a suburethral graft for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and / or intrinsic sphincter deficiency.

The BioArc SP Sling Kit is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and / or intrinsic sphincter deficiency.

Device Description

The BioArc TO Subfascial Hammock is a suburethral sling procedure that uses a transobturator surgical approach to treat stress urinary incontinence. It is a sterile, single transobare kit consisting of two stainless steel helical shaped needle passers and a mesh sling assembly to which graft material is attached.

AI/ML Overview

The provided text is a 510(k) summary for the BioArc TO™ Subfascial Hammock. It describes the device, its indications for use, and its comparison to predicate devices, ultimately concluding substantial equivalence. However, the document explicitly states that it is a Special 510(k) application and that "the risk analysis and the verification / validation activities reported in this Special 510(k) application substantiate equivalence to the predicate devices and did not raise any new questions of safety or efficacy." This means that a full clinical study with specific acceptance criteria and detailed performance reporting, as you've requested, was not conducted or reported in this specific submission for the BioArc TO device.

Instead, the submission relies on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices (BioArc SP™ Sling Kit and MONARC™ subfascial hammock) based on similar indications for use, fundamental scientific technology, surgical approach, sling placement, and materials.

Therefore, I cannot provide the detailed information you requested about acceptance criteria and study data for the BioArc TO device from this document. The information you are asking for typically comes from a full clinical trial or a more extensive performance study, which is not summarized here for a Special 510(k) such as this.

If the BioArc SP Sling Kit is considered a predicate, the "Indications For Use" statement from page 3, which is for the BioArc SP Sling Kit alone, would be relevant to understand the clinical context for which the predicate (and by extension the new device) is intended.

Since the document does not present a standalone study with acceptance criteria and a performance table for the BioArc TO, I will state that such information is not available in the provided text.

Information Not Available in the Provided Text:

A table of acceptance criteria and the reported device performance: This information is not provided because the submission relies on substantial equivalence to predicate devices, rather than presenting a de novo performance study for the BioArc TO.
Sample size used for the test set and the data provenance: No new test set data is presented for the BioArc TO device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new test set data is presented.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a surgical mesh, not an AI or imaging device. Therefore, an MRMC study is not relevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no new clinical performance data is presented.
The sample size for the training set: Not applicable, as no algorithm or AI is involved.
How the ground truth for the training set was established: Not applicable, as no algorithm or AI is involved.

Summary

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MAR 1 7 2004

Kψ4ψ538

2.6	510(k) Summary
Submitter:	American Medical Systems10700 Bren Road WestMinnetonka, MN 55343Phone: 952-933-4666Fax: 952-930-6496
Contact Person:	Denise Thompson
Date Summary Prepared:	February 27, 2004
Device Common Name:	Urethral Sling, Surgical Mesh
Device Trade Name:	BioArc TO™ Subfascial Hammock
Device Classification Name:	Surgical Mesh, polymeric
Predicate Device:	BioArc SP™ Sling Kit, K030123MONARC™ subfascial hammock, K023516

Device Description:

Indications for Use:

Comparison to Predicate Device:

The BioArc TO brings two currently marketed AMS technologies, the BioArc SP Sling Kit and the Monarc subfascial hammock, together into one procedure.

The Indications for Use, fundamental scientific technology, surgical approach, sling placement, and materials are all the same as one of the two predicates.

Supporting Information:

The risk analysis and the verification / validation activities reported in this Special 510(k) application substantiate equivalence to the predicate devices and did not raise any new questions of safety or efficacy.

Conclusion:

The BioArc TO Subfascial Hammock is substantially equivalent to its predicates with respect to intended use, technological characteristics, and performance.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings outstretched, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle, emphasizing the department's name and national affiliation. The overall design is simple and professional, conveying a sense of authority and trustworthiness.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Denise Thompson Regulatory Specialist American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343

SEP 28 2022

Re: K040538 Trade/Device Name: AMS BioArc™ TO Subfascial Hammock AMS BioArc™ SP Sling Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN, PAG Dated: March 1, 2004 Received: March 2, 2004

Dear Ms. Thompson:

This letter corrects our substantially equivalent letter of March 17, 2004.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 -

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Benjamin R. Fuchs

Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1.4

INDICATIONS FOR USE STATEMENT

<44 4538

510(k) Number (if known):

Device Name: AMS BioArc™ SP Sling Kit

Indications For Use:

The BioArc SP Sling Kit is intended for the placement of a pubourethral sling for the The BloArc St. Sling Ni. Is Intended for the pre (SUI) resulting from urethral hypermobility and / or intrinsic sphincter deficiency.

× Prescription Use_ (Per 21 CFR 801 Subpan D) AND/OR

Over-The Counter Use_ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of 2

510(k) Number K040538

Page 12 of 28

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.