AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM by C.R. BARD, INC.

The Avaulta™ Support System is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.

Device Description

The Avaulta™ Support System includes a sterile, single use, permanent implant that provides long term reinforcement to support structures in the correction of anterior or posterior vaginal wall prolapse. The central soft knit section provides compliant organ support while the strong knit arms provide improved strength for tension free fixation of the implant. The Avaulta Plus™ Biosynthetic Support System and Avaulta Solo™ support system both utilize a nonabsorbable monofilament, polypropylene mesh to provide long-term reinforcement for support structures. The Avaulta Plus ™ Biosynthetic Support System adds a porous, acellular, ultrathin sheet of crosslinked collagen attached to the polypropylene mesh which serves to establish a protective barrier between mucosal tissue and the polypropylene mesh and contains apertures uniformly sized to allow for ingrowth of host tissue and capillary vessels.

AI/ML Overview

The provided text is a 510(k) summary for the Avaulta™ Support System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance through clinical trials and specific acceptance criteria. Therefore, the document does not contain the detailed information requested in the prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Here's a breakdown of what can be extracted and why the other information is missing:

1. A table of acceptance criteria and the reported device performance

Not Available. The 510(k) summary states, "The appropriate testing to determine substantial equivalence was completed. This includes testing in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999)." This refers to non-clinical testing (e.g., biocompatibility, mechanical properties) to show the new device is similar to the predicate. It does not include performance metrics against pre-defined clinical acceptance criteria like sensitivity/specificity or other efficacy measures expected for AI or diagnostic devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable/Available. There is no mention of a "test set" in the context of clinical performance evaluation, as this 510(k) focuses on substantial equivalence rather than a new clinical claim. The testing mentioned is for substantial equivalence, likely bench or animal studies, not human clinical data with a test set in the conventional sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Available. No clinical test set requiring expert-established ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable/Available. No clinical test set requiring adjudication is described.

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

Not Applicable. This is a medical device (surgical mesh), not an AI-based diagnostic tool. Therefore, MRMC studies involving AI assistance are not relevant to this submission.

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

Not Applicable. This is a surgical mesh, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable/Available. No clinical ground truth is discussed in this regulatory summary. The "ground truth" for a 510(k) is typically the established safety and effectiveness profile of the predicate device, against which the new device is compared regarding its material, design, and intended use.

8. The sample size for the training set

Not Applicable/Available. No "training set" in the context of machine learning is discussed.

9. How the ground truth for the training set was established

Not Applicable/Available. No "training set" or corresponding ground truth establishment is discussed.

Summary of available relevant information from the document:

Device Name: Avaulta™ Solo Support System, Avaulta™ Plus Biosynthetic Support System; Common Name: Surgical Mesh
Predicate Device: Avaulta Solo™ Support System, Avaulta Plus™ Biosynthetic Support System (K063712 and K082571) - Note: The document lists the predicate devices with very similar names, suggesting this 510(k) might be an updated version or specific modification of previously cleared devices, or a consolidation.
Intended Use: "The Avaulta™ Support System is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect."
Performance Data Summary: "The appropriate testing to determine substantial equivalence was completed. This includes testing in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999)." This indicates that the device underwent non-clinical testing (e.g., biocompatibility per ISO standards, mechanical strength, material characterization) to demonstrate similar performance and safety characteristics to its predicate device, as required for a 510(k) submission for a surgical mesh. It does not involve clinical performance criteria or studies in the sense of AI or diagnostic device evaluation.

Summary

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t083859
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JAN 1 5 2009

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

A. SUBMITTER INFORMATION:
Submitter's Name: C. R. Bard, Inc. Bard Urological Division Address: 13183 Harland Drive Covington, GA 30014

Contact Person: Terri Morris Contact Person's Telephone Number: 678-342-4922 Contact Person's Fax: 770-788-5605

B. DEVICE NAME:

Trade Name(s):	Avaulta™ Solo Support SystemAvaulta™ Plus Biosynthetic Support System
Common/Usual Name:	Surgical Mesh
Classification Names:	79 - Mesh, Surgical, Polymeric (OTP, PAI)
CFR Reference:	21 CFR 878.3300
Classification Panel:	General and Plastic Surgery

C. PREDICATE DEVICE NAME:

Trade Names:

Avaulta Solo™ Support System Avaulta Plus™ Biosynthetic Support System K063712 and K082571

D. Device Description:

.. .

The Avaulta Plus™ Biosynthetic Support System and Avaulta Solo™ support system both utilize a nonabsorbable monofilament, polypropylene mesh to provide long-term reinforcement for support structures. The Avaulta Plus ™ Biosynthetic Support System adds a porous, acellular, ultrathin sheet of crosslinked collagen attached to the polypropylene mesh which serves to establish a protective barrier between mucosal tissue and

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the polypropylene mesh and contains apertures uniformly sized to allow for ingrowth of host tissue and capillary vessels.

E. Intended Use:
The Avaulta™ Support System is indicated for tissue reinforcement and longlasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.
F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:
The subject Avaulta™ Support System has the same intended use, general design and fundamental scientific technology as the predicate device.
G. Performance Data Summary:
The appropriate testing to determine substantial equivalence was completed. This includes testing in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999).

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

C.R. Bard, Inc. % Mr. Terri Morris Regulatory Affairs Specialist II 13183 Harland Drive COVINGTON GA 30014

SEP 2 8 2012

Re: K083839 Trade/Device Name: Avaulta™ Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, PAI Dated: December 16, 2008 Received: December 23, 2008

Dear Mr. Morris:

This letter corrects our substantially equivalent letter of January 15, 2009.

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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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/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.

Sincerely yours,

Benjamin R. Perkins

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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C R Bard, Inc Bard Urological Division Avaulta™ Support System Premarket Notification [510(k)]

1.4 Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

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

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Nil R.P. Oplem Surimxn

(Division Sign-6 Division of General. Restorative, and Neurological Devices

510(k) Number_K083839

(Recommended Format 11/13/2003)

Regulation Number and Section

§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.

(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.