VYPRO Mesh is indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Description

VYPRO Mesh is constructed from approximately equal parts of absorbable polyglactin 910 multifilament fiber and non-absorbable polypropylene multifilament fiber. The purpose of the absorbable polyglactin component is to add firmness to the polypropylene structure and thus make intraoperative handling of the mesh easier. The mesh affords excellent strength, durability and surgical adaptability, with a porous structure to enable mesh incorporation into surrounding tissues. The polymer of the polypropylene fiber is identical to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). This material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.

The polyglactin fiber consists of a copolymer containing 90% glycolide and 10% lactide. This copolymer is identical in composition to that which has been found to be nonantigenic, nonpyrogenic and to elicit only a mild tissue reaction during absorption. The polyglactin component is absorbed within 56 to 70 days, leaving the polypropylene mesh structure that is able to withstand the physiological stresses to which the abdominal wall is subject.

AI/ML Overview

The provided document describes the predicate device information for the K002672 submission for VYPRO Mesh. It is not a study proving the device meets acceptance criteria but rather a declaration of substantial equivalence to predicate devices based on technological characteristics and a clinical study. Therefore, most of the requested information regarding acceptance criteria and study particulars cannot be fully extracted.

Here's what can be inferred from the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative table format with corresponding performance metrics that the device had to pass. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices (PROLENE Mesh, VICRYL Mesh, and MERSILENE Mesh) based on technological characteristics and a clinical comparison.

The "Performance Data" section indicates that certain characteristics were evaluated and compared to predicate devices:

Characteristic	VYPRO Mesh Performance (vs. Predicate Devices)
Thickness	Less than PROLENE Mesh, but greater than MERSILENE Mesh
Burst Strength	Less than PROLENE Mesh, but greater than MERSILENE Mesh; higher burst strength than MERSILENE Mesh
Flexural Rigidity	Less than PROLENE Mesh, but greater than MERSILENE Mesh
Tear Strength	Less than PROLENE Mesh, but greater than MERSILENE Mesh
Suture Pull-out	Less than PROLENE Mesh, but greater than MERSILENE Mesh
Tensile Strength	Less than PROLENE Mesh, but greater than MERSILENE Mesh
Pore Size	Larger pore size than PROLENE Mesh
Absorbable Component	Absorbable polyglactin component is absorbed within 56 to 70 days

Note: The phrasing "less than PROLENE Mesh, but greater than MERSILENE Mesh" appears to be a general comparison across all mechanical properties listed, followed by specific comparisons for burst strength and pore size. The document doesn't provide specific numerical values for these characteristics.

Study Information (as inferable from the document)

Sample size used for the test set and the data provenance:
- The document mentions "The results of a clinical study compared the use of VYPRO Mesh with MARLEX and ATRIUM Meshes." However, it does not provide the sample size for this clinical study.
- Data Provenance: Not specified (e.g., country of origin). The document only states "clinical study."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document, as it's a 510(k) summary focused on substantial equivalence rather than a detailed clinical trial report.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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, an MRMC study was not done. This device is a surgical mesh, not an AI diagnostic tool. The "clinical study" mentioned was a comparison of surgical mesh performance, not a reading task.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is a physical medical device (surgical mesh), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document states the clinical study "found VYPRO Mesh to be acceptable with regard to mechanical and therapeutic characteristics including some advantages in bench testing and clinical trials." This implies that clinical outcomes and possibly mechanical evaluations in a clinical setting served as the basis for "acceptability." Specific details on how ground truth was established (e.g., specific clinical endpoints, pathology confirmation, expert assessment of outcomes) are not provided.
The sample size for the training set:
- This information is not applicable as this is not an AI/ML device that requires a training set. If referring to experience with predicate devices or materials, it's not quantified in terms of a "training set."
How the ground truth for the training set was established:
- This information is not applicable as this is not an AI/ML device.

Summary

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K002672

NOV 2 2 2000

SECTION 7

SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) 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. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

MODIFIED DEVICE NAME: VYPRO* Mesh

PREDICATE DEVICE NAME: PROLENE* (Polypropylene) Mesh and VICRYL* (Polyglactin 910) Mesh for materials and indications and MERSILENE* Polyester Mesh for Indications For Use.

510(k) SUMMARY

...

Device Description

Continued on next page

VYPRO* Mesh ETHICON, Inc.

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

...

510(k) SUMMARY, Continued

Description (continued)

Intended Use

Indications Statement

Technological Characteristics

Performance Data

The polyglactin fiber consists of a copolymer containing 90% The polygiaoun 10% lactide. This copolymer is identical in gryconde and 107at used in VICRYL* (polyglactin 910) synthetic composition to that which has been found to be nonantigenic, absorbacts batand to elicit only a mild tissue reaction during nonpyrogeme and to enortial component is absorbed within 56 to absorption. The poryglacem on polypropylene mesh structure that 70 days, leaving the physiological stresses to which the abdominal wall is subject.

This mesh is intended for the repair of hernia or other fascial 1 mo most require the addition of a reinforcing or bridging material to obtain the desired surgical result.

This mesh is used for the repair of hernia or other fascial defects 1 mis mosil is aboution of a reinforcing or bridging material to obtain the desired surgical result.

The technological characteristics that were evaluated for VYPRO Mesh include: thickness, burst strength, flexural rigidity, tear strength, suture pull-out and tensile strength. The values strongin, sutters proPRO Mesh are less than those for PROLENE Mesh, but greater than MERSILENE Mesh. VYPRO Mesh has a NICSII, but grouter than ility and thickness than PROLENE Mesh, iarger porce bize, frigher burst strength than MERSILENE Mesh.

Nonclinical laboratory testing was not performed as there is no Nonemarous the clinical intended use as compared to the predicate devices. Sufficient bench testing was conducted in accordance with devices: Suitting document ""Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."

Continued on next page

VYPRO* Mesh ETHICON, Inc.

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

Performance Data (continued)

The results of a clinical study compared the use of VYPRO Mesh with MARLEX and ATRIUM Meshes. This study has found WYPRO Mesh to be acceptable with regard to mechanical and v ITTC Mosil to stics including some advantages in bench testing and clinical trials.

Conclusions

Based on the 510(k) summaries and 510(k) statements (21 CFR Dasod on the orrormation provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act.

Contact

Gregory R. Jones Director, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151

Date

August 25, 2000

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2000

Mr. Gregory R. Jones Director, Regulatory Affairs Ethicon, Inc. Route 22 West P.O. Box 151 Somerville, New Jersey 08876

K002672 Re:

Trade Name: VYPRO Mesh VICRYL-PROLENE Partially Absorbable Synthetic Surgical Mesh

Regulatory Class: II Product Code: FTL Dated: August 25, 2000 Received: August 28, 2000

Dear Mr. Jones:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Gregory R. Jones

This letter will allow you to begin marketing your device as described in your 510(k) rins letter will anow yourse obgan finding of substantial equivalence of your device to a premaince notification. - In 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of and additionally 60911594-4595. Additionally, for questions on the promotion and Compliance at (301) vice, please contact the Office of Compliance at (301) 594-4639. advortibing or your aregulation entitled, "Misbranding by reference to premarket Also, prease flore the regal 97). Other general information on your responsibilities under the nother (21) OF IC or the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

/ Mark McMullan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K002672

INDICATION FOR USE

510(k) Number (if known):

. , :

Device Name:

Indications for Use:

VYPRO* Mesh VICRYL*-PROLENE* Partially Absorbable Synthetic Surgical Mesh

VYPRO Mesh is indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	X
	OR
Over-The Counter Use
	for Mark N Millhiser(Division Sign-Off)Division of General Restorative Devices
510(k) Number	K002672 (Optional Format 1-2-9G)

VYPRO* Mesh ETHICON, Inc.

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.