Is for the "repair of hemias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result."

Device Description

ULTRAPRO* Mesh is a sterile partially absorbable composite mesh designed for the repair of hernias and other abdominal fascia deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

ULTRAPRO Mesh is manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non absorbable polypropylene monofilament fiber.

AI/ML Overview

The provided text describes the ULTRAPRO* Mesh device, a sterile, partially absorbable composite mesh for repairing hernias and other abdominal fascia deficiencies. The document is a 510(k) summary for the device, seeking substantial equivalence to predicate devices.

Here's an analysis of the requested information based on the provided text:

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

Acceptance Criteria (Technological Characteristics of Predicate Devices)	Reported Device Performance (ULTRAPRO* Mesh)
Thickness	Similar to predicate devices
Burst strength	Similar to predicate devices
Flexural rigidity	Similar to predicate devices
Tear strength	Similar to predicate devices
Tensile strength	Similar to predicate devices
Porosity	Similar to predicate devices
Suture pull-out strength	Similar to predicate devices
Clinical performance (indicated for hernia repair and other fascial deficiencies)	Equivalency in clinical performance to other commercialized surgical meshes; achieved good tissue ingrowth in animal testing.

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

The document does not specify a separate "test set" in the context of a clinical study with human patients. The performance data section mentions "Non-clinical laboratory testing" and "animal testing." No details on the sample sizes for these tests (e.g., number of animals, number of mesh samples for lab tests) are provided, nor is the country of origin of the data mentioned. The data is non-clinical and animal-based, not involving human patients in a retrospective or prospective manner as would be typical for medical device performance studies involving patient outcomes.

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)

This information is not applicable and not provided. The study presented is a non-clinical and animal study, not a human clinical trial where expert consensus on "ground truth" for patient outcomes would typically be established.

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

This information is not applicable and not provided. As noted above, there is no human "test set" or clinical trial described that would necessitate an adjudication method for establishing ground truth from multiple expert readings.

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

An MRMC comparative effectiveness study was not done. This device is a surgical mesh, not a diagnostic or AI-powered device that involves human "readers" or an AI component.

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

A standalone performance study was not done. This device is a physical surgical mesh, not an algorithm.

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

For the non-clinical laboratory testing, the "ground truth" would be objective measurements against established engineering and material science standards for surgical meshes.

For the animal testing, the "ground truth" regarding "good tissue ingrowth" would likely be based on histological examination and macroscopic assessment by veterinary pathologists or other trained professionals, comparing the tissue response to existing accepted benchmarks for similar devices. This is a form of biological outcome data.

8. The sample size for the training set

This information is not applicable and not provided. This device is a physical surgical mesh, not an AI model that requires a training set.

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

This information is not applicable and not provided.

Summary

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K03337

SECTION 8 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.NEW DEVICE NAME: ULTRAPRO* MeshPREDICATE DEVICES NAME: VYPRO Mesh, PROLENE Polypropylene Mesh, MERSILENE Mesh
Device Description	ULTRAPRO* Mesh is a sterile partially absorbable composite mesh designed for the repair of hernias and other abdominal fascia deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.ULTRAPRO Mesh is manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non absorbable polypropylene monofilament fiber.
Intended Use	ULTRAPRO Mesh may be used for the repair of hernias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Indications Statement	ULTRAPRO Mesh may be used for the repair of hernias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
TechnologicalCharacteristics		ULTRAPRO has similar technological characteristics as thepredicate devices. The characteristics evaluated include thickness,burst strength, flexural rigidity, tear strength, tensile strength,porosity, and suture pull-out strength. Comparison to othercommercialized surgical meshes indicates equivalency in clinicalperformance.
Performance Data		Non-clinical laboratory testing was performed demonstrating thatthe device is comparable to standard surgical mesh devices that areindicated for hernia repair and other fascial deficiencies thatrequire the addition of a reinforcing or bridging material to obtainthat desired surgical result. Additionally, animal testingdemonstrated that ULTRAPRO would achieve good tissueingrowth.
Conclusions		Based on the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that themodified device is substantially equivalent to the Predicate Devicesunder the Federal Food, Drug, and Cosmetic Act.
Contact		Rey LibrojoSenior Project Manager, Regulatory AffairsETHICON ProductsETHICON, Inc.Rt. #22, WestSomerville, NJ 08876-0151
Date		October 14, 2003

Trademark ULTRAPRO Mesh ETHICON, Inc.

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Trademark ULTRAPRO Mesh ETHICON, Inc.

K03337

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 1 2004

Mr. Ray Librojo Senior Project Manager Ethicon. Inc. Rt. #22, West Somerville, New Jersey 08876-0151

Re: K033337

Trade/Device Name: ULTRAPRO Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: January 8, 2004 Received: January 13, 2004

Dear Mr. Librojo:

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.

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Page 2 - Mr. Ray Librojo

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 vour 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

(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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510(k) Number (if known): K033337

Device Name: ULTRAPRO Mesh

Indications For Use. Is for the "repair of hemias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result."

Prescription Use (Part 21 CFR 801 Subpart 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

510(k) Number_K633337

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.