PROCEED Ventral Patch is intended for the repair of hernias or other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

PROCEED Ventral Patch is also indicated for the repair of tissue deficiencies caused by trocar use.

Device Description

The proposed PROCEED* Ventral Patch (PVP) is a self-expanding, partially absorbable, laminate mesh device that is designed for the repair of hernias and other fascial deficiencies such as those caused by trocar use. The mesh device is comprised of several layers: an absorbable fabric of oxidized regenerated cellulose (ORC), PROLENE* Soft Mesh, two absorbable polydioxanone polymer rings, VICRYL* Mesh, polydioxanone polymer film, and polyester suture.

AI/ML Overview

This submission, K061533, describes the PROCEED Ventral Patch, a surgical mesh device. The review of the provided text reveals that the submission focuses on substantial equivalence to predicate devices rather than establishing novel performance criteria through extensive clinical studies with specific acceptance criteria and ground truth.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not applicable in this context. The provided information centers on demonstrating that the new device has similar technological characteristics and performs comparably to already marketed devices.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

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

Acceptance Criteria	Reported Device Performance
Biological Reactivity (Biocompatibility): Acceptable for intended use as per ISO Standard 10993-1.	Acceptable: "Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, and the material was found to be acceptable for its intended use."
Functional Performance (Bench and Animal Testing): Meets or exceeds all functional requirements.	Meets or Exceeds: "Results of functional performance testing (bench and animal testing) indicate that the proposed device meets or exceeds all functional requirements."
Substantial Equivalence to Predicate Devices: Similar technological characteristics and intended use.	Substantially Equivalent: "Based on the similarities to the predicate devices identified in this submission, we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act."

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

Not explicitly stated for functional or biological testing. The text only mentions "bench and animal testing" and assessment using "ISO Standard 10993-1." Specific sample sizes, details of animal models, or the location/type of these tests are not provided. This suggests standard-based testing rather than a large-scale clinical trial with a defined "test set" in the context of AI/diagnostic device evaluation.

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. This submission does not involve expert-adjudicated ground truth as would be relevant for a diagnostic or AI-driven device. The "ground truth" for this surgical mesh is established through compliance with biological and functional standards, and comparison to predicate devices, rather than expert consensus on diagnostic images or clinical outcomes in a comparative trial setting.

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

Not applicable. There is no "adjudication method" in the sense of resolving discrepancies among experts for a test set, as this is not a diagnostic device relying on human interpretation of complex data for ground truth establishment.

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. An MRMC comparative effectiveness study is relevant for diagnostic devices, particularly those involving AI assistance to human readers (e.g., radiologists interpreting images). This submission is for a surgical mesh, which is a physical implant, not a diagnostic or AI-assisted tool.

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

Not applicable. This question pertains to AI algorithms or diagnostic systems. The PROCEED Ventral Patch is a surgical implant and does not operate as a standalone algorithm.

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

The "ground truth" for this device's performance and safety is established through:
- Compliance with ISO Standard 10993-1 for biological reactivity.
- Meeting/exceeding functional requirements as determined by "bench and animal testing."
- Comparison of technological characteristics and intended use to predicate devices to establish substantial equivalence.
- Safety track record of the materials (PROLENE, VICRYL, ORC, polydioxanone polymer) which are identical to those in currently marketed devices.

8. The sample size for the training set

Not applicable. A "training set" is a concept used in machine learning for AI model development. This submission is for a medical device (surgical mesh) and does not involve AI.

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

Not applicable. As there is no AI component, there is no training set or ground truth established in that context.

Summary

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KU61533

Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.

Submitted by:

Bryan A. Lisa Sr. Regulatory Affairs Associate Ethicon, Inc., A Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876

Name/Classification of Device:

Class II in 21 CFR § 878.3300, Surgical Mesh (FTL)

Trade Name:

PROCEED* Ventral Patch

Predicate Devices:

PROLENE* Soft Mesh PROCEED* Mesh BARD Ventralex & Small Ventralex Hernia Patch VICRYL* Mesh ETHIBOND* Polyester Suture

Statement of Intended Use:

PROCEED Ventral Patch is intended for the repair of hernias or other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

PROCEED Ventral Patch is also indicated for the repair of tissue deficiencies caused by trocar use.

Device Description:

The proposed PROCEED Ventral Patch (PVP) is a self-expanding, partially absorbable, laminate mesh device that is designed for the repair of hernias and other fascial deficiencies such as those caused by trocar use. The mesh device is comprised of several layers: an absorbable fabric of oxidized regenerated cellulose (ORC), PROLENE* Soft Mesh, two absorbable polydioxanone polymer rings, VICRYL* Mesh, polydioxanone polymer film, and polyester suture.

Summary of Technological Characteristics of New Device to Predicate Devices:

The modified device has similar technological characteristics as the predicate devices. Like currently marketed devices, it is a sterile, mesh implant intended for the repair of hernias or abdominal fascial defects. Like several

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of the currently marketed devices, the proposed device is made of nonabsorbable and absorbable polymers. The polymers used are identical to those found in PROCEED Mesh and VICRYL Mesh, currently marketed by Ethicon, Inc.

K061533

2/2

Performance Data:

Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing (bench and animal testing) indicate that the proposed device meets or exceeds all functional requirements.

Conclusions:

Based on the similarities to the predicate devices identified in this submission, we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.

Trademark of Ethicon, Inc.

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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 consists of a stylized eagle or bird-like figure with its wings spread, positioned to the right of a circular border. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ethicon, Inc. % Mr. Bryan A. Lisa Senior Regulatory Affairs Associate Route 22 West, P.O. Box 151 Somerville, New Jersey 08876

Re: K061533

Trade/Device Name: PROCEED Ventral Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: November 21, 2006 Received: November 22, 2006

Dear Mr. Lisa:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

OEC I 1 2006

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Page 2 - Mr. Bryan A. Lisa

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

for
Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K06 / 533

Device Name: PROCEED* Ventral Patch

Indications for Use:

PROCEED Ventral Patch is intended for the repair of hernias or other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

PROCEED Ventral Patch is also indicated for the repair of tissue deficiencies caused by trocar use.

*Trademark.

(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Division of General, Restorative, and Neurological Devices

510(k) Number L061532

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.