The ALYTE™ Y-Mesh Graft is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy or laparoscopic approach) where surgical treatment for vaginal vault prolapse is warranted.

Device Description

The ALYTE™ Y-Mesh Graft is composed of lightweight/ultralight, non-absorbable, monofilament, polypropylene mesh. The Y configuration of the design provides two wide layers of mesh (A/P flaps) for anterior and posterior vaginal attachment that combine seamlessly into one double layer mesh (Sacral flap) for attachment to the anterior longitudinal ligament. The ALYTE™ Y-Mesh Graft contains a center line indicator created by knitting a blue polypropylene fiber in the mesh. The anterior and posterior flaps (A/P flaps) contain additional lateral indicator stripes also made from the same blue polypropylene fiber to provide guidance for placement. The graft is designed such that the surgeon will be able to alter/trim the graft to different sizes and lengths as required to fit each patient's anatomical requirements without unraveling.

AI/ML Overview

The provided text describes the ALYTE™ Y-Mesh Graft, a surgical mesh, and its substantial equivalence to predicate devices. However, it does not explicitly define "acceptance criteria" in a quantitative manner or provide a detailed study proving the device meets specific numerical acceptance criteria. Instead, the submission relies on demonstrating substantial equivalence to already cleared devices based on technological characteristics and a retrospective clinical survey.

Here's an attempt to extract the requested information, noting where specific details are not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Composition Equivalence: Material is non-absorbable, polymeric mesh.	The ALYTE™ Y-Mesh Graft is composed of a non-absorbable, polymeric mesh material, identical to the predicate Alyte Y-Mesh (K090739) and substantially equivalent to the Caldera Mesh device (K060004).
Design Equivalence (Y-configuration): The device has a Y configuration for vaginal and sacral attachment.	The design of the subject device is a Y configuration, which is identical to the predicate Alyte Y-Mesh (K090739) and similar to the AMS Sacral Colpopexy Sling (K010931).
Mechanical Performance: Equivalent to predicate devices.	Non-clinical performance characterized in accordance with FDA Guidance (March 22, 1999) to demonstrate substantial equivalence. Components have been subjected to mechanical testing and are identical to K090739 and substantially equivalent to K060004.
Stability (if changed from prior clearance): Device stability maintained.	The subject device is unchanged from the device cleared in K090739; therefore, stability testing was not repeated.
Biocompatibility (if changed from prior clearance): Device biocompatibility maintained.	The subject device is unchanged from the device cleared in K090739; therefore, biocompatibility testing was not repeated.
Effectiveness (correction of pelvic organ prolapse): Effectiveness shown in sacrocolpopexy.	Clinical survey reported median POP-Q stage at median follow-up of approximately 6 months was Stage 0-1 (implying correction). Supported by a review of peer-reviewed literature showing effectiveness of synthetic mesh in sacrocolpopexy to correct pelvic organ prolapse.
Vaginal Erosion Rate: Within a clinically acceptable range.	Clinical survey reported Rate of erosion of mesh in this survey was 2/69 (2.9%). The submission states Vaginal erosion was within a clinically acceptable range based on the literature review.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Survey): 69 sacrocolpopexy procedures.
Data Provenance: European retrospective survey.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: 17 surgeons.
Qualifications of Experts: Not explicitly stated beyond "surgeons." No specific experience level (e.g., "radiologist with 10 years of experience") is provided.

4. Adjudication Method for the Test Set

Not applicable. The data is from a retrospective survey of outcomes reported by individual surgeons, not a consensus-based adjudication process.

5. 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a surgical mesh, not an AI-driven interpretive tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a surgical mesh, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the clinical evaluation, the "ground truth" was based on patient outcomes data (POP-Q stage, mesh erosion rates) as reported by the surgeons in the retrospective survey and observed in the peer-reviewed medical literature. The POP-Q (Pelvic Organ Prolapse Quantification) system is a standardized assessment tool used by clinicians.

8. The Sample Size for the Training Set

Not applicable. This device is a physical surgical mesh, not an AI/ML algorithm that requires a "training set" in the computational sense. The "design" and "material composition" could be considered "trained" by prior predicate devices and general medical knowledge, but no explicit training set is mentioned.

9. How the Ground Truth for the Training Set was Established

Not applicable. (See #8).

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

Bard Medical Division Sponsor: C.R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014

Scott R. Robirds Contact: Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014 Ph: 770-784-6722 Fax: 770-385-4706 E-mail: scott.robirds@crbard.com
Date of Submission: March 31, 2011

ALYTE™ Y-Mesh Graft Proprietary Name:

Common Name: Surgical Mesh

21 CFR 878.3300 Requiation:

Regulatory Class: =

OTO - Mesh, Surgical, Gynocological, For Apical Vaginal Prolapse, Product Codes: Transabdominally Placed

Predicate Device(s): ALYTE™ Y-Mesh Graft (BARD Graft), CR BARD, K090739 Caldera Mesh, Caldera Medical, K060004 AMS Sacral Colpopexy Sling, American Medical Systems, K010931

Device Description: The ALYTE™ Y-Mesh Graft is composed of lightweight/ultralight, non-absorbable, monofilament, polypropylene mesh. The Y configuration of the design provides two wide layers of mesh (A/P flaps) for anterior and posterior vaginal attachment that combine seamlessly into one double layer mesh (Sacral flap) for attachment to the anterior longitudinal ligament. The ALYTE™ Y-Mesh Graft contains a center line indicator created by knitting a blue polypropylene fiber in the mesh. The anterior and posterior flaps (A/P flaps) contain additional lateral indicator stripes also made from the same blue polypropylene fiber to provide guidance for placement. The graft is designed such that the surgeon will be able to alter/trim the graft to lefferent sizes and lengths as required to fit each patient's anatomical requirements without unraveling.

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K101722

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Indications for Use: The ALYTE Y-Mesh Graft is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy or laparoscopic approach) where surgical treatment for vaginal vault prolapsed is warranted.

Technological Characteristics Summary: The ALYTE™ Y-Mesh Graft is composed of a non-absorbable, polymeric mesh material which is the same technology used in each of the selected predicates. The design of the subject device is a Y configuration, which is identical to the predicate Alyte Y-Mesh (K090739) and similar to the AMS Sacral Colpopexy Sling (K010931).

Non Clinical Testing: Non-clinical performance of the subject device was characterized in accordance with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999) to demonstrate substantial equivalence to the predicate device for the intended use of sacrocolposuspension. The components of the subject device have been subjected to mechanical testing and are identical to the predicate Alyte Y-Mesh (K090739) and substantially equivalent to the Caldera Mesh device (K060004). The subject device is unchanged from the device cleared in K090739; therefore stability and biocompatibility testing was not repeated.

Clinical Testing: Data were provided from a 2010 European retrospective survey of 17 surgeons who reported outcomes following 69 sacrocolpopexy procedures (approximately 2/3 laparoscopic, 1/3 laparotomy) in women with POP -Q stage >/= Stage 2 using the Alyte Y -mesh graft. Median POP-Q stage at median follow-up of approximately 6 months was Stage 0-1. Rate of erosion of mesh in this survey was 2/69 (2.9%). The 510(k) was also supported by a review of clinical studies described in the peer-review medical literature comparing different graft materials used in the pelvic floor space. Six of the studies evaluated synthetic mesh for sacrocolpopexy. Although different graft materials were compared, all studies showed effectiveness of synthetic mesh in sacrocolpopexy to correct pelvic organ prolapse. Vaginal erosion was within a clinically acceptable range.

Conclusions: The data provided in this submission demonstrate that the Alyte Y-Mesh Graft is substantially equivalent to the predicate devices for the proposed indications for use, i.e for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy or laparoscopic approach) where surgical treatment for vaginal vault prolapse is warranted.

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APR

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

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

Mr. Scott Robirds Vice President, Regulatory and Clinical Affairs Bard Medical Division C.R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014

K101722 Trade/Device Name: Alyte™ Y-Mesh Graft Regulation Number: 21 CFR §878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTO Dated: January 26, 2011 Received: January 27, 2011

Dear Mr. Robirds:

Re:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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 of medical device-related

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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/CDRHQffices/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" (21CFR 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/ReportalProblem/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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Stuker Lemur MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K101722 ·

Device Name: ALYTE™ Y-Mesh Graft

Indications for Use:

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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)

Norm M Whay

of Reproductive. Gastro-Renal, and 510/k) Numbe

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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.