The ULTRAPRO* Hernia System is intended for use in open repairs of abdominal wall hemia defects. This product is indicated for open repair of abdominal wall hernia defects

Device Description

The proposed ULTRAPRO* Hernia System (UHS) is a sterile, pre-shaped, three-dimensional device constructed of an undyed onlay patch connected by a mesh cylinder to an underlay patch which is reinforced by a flat undyed absorbable film of Poliglecaprone-25 (MONOCRYL*). The underlay patch is marked with dyed polypropylene fibers to be clearly distinguishable from the onlay patch. The onlay patch, connector and underlay patch are manufactured from approximately equal parts of absorbable Poliglecaprone-25 monofilament fiber and non-absorbable polypropylene monofilament fiber. The polymer of the undyed and dyed polypropylene fibers (phthalocyanine blue, Color Index No. 74160) is identical to the material used for dyed/undyed PROLENE* suture material. Poliglecaprone-25 fiber consists of a copolymer containing glycolide and e-caprolactone. This copolymer is also used for MONOCRYL* suture material. After absorption of the Poliglecaprone-25 components only the polypropylene mesh remains. The structure and size of this remaining mesh are designed for the physiological stresses to which the abdominal wall is subject. The UHS is available in different sizes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ULTRAPRO* Hernia System, a Class II surgical mesh. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, performance studies, expert involvement, and ground truth establishment is not present in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or specific quantitative performance metrics reported in this document. The submission is focused on demonstrating substantial equivalence to predicate devices. The performance data section broadly states:

Acceptance Criteria Mentioned: N/A (not applicable in this type of submission for specific performance targets)
Reported Device Performance:
- "Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, with results demonstrating that the materials are acceptable for the intended use."
- "Results of functional performance testing (bench and animal testing) indicate that the proposed device meets or exceeds all functional requirements."

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

Sample Size for Test Set: Not applicable. This submission does not include a test set in the sense of a clinical or analytical performance study with a defined sample size for comparison against a ground truth. The "performance data" refers to biological and functional testing, not a dataset for evaluating an algorithm or diagnostic accuracy.
Data Provenance: The document mentions "bench and animal testing," indicating experimental data, but does not provide specifics on the origin (e.g., country) for these tests.

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

Not applicable. This device is a surgical mesh; it does not involve establishing ground truth by expert review in the context of diagnostic or interpretive performance.

4. Adjudication Method for the Test Set:

Not applicable.

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 not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used:

Not applicable in the context of diagnostic accuracy. However, for the "biological reactivity" and "functional performance testing," the "ground truth" would be established by validated test methods (e.g., ISO standards, engineering specifications for functional requirements).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

In summary, the provided document is a 510(k) submission for a surgical mesh and therefore primarily relies on demonstrating equivalence to predicate devices and adherence to established material/functional testing standards rather than presenting data from clinical performance studies with specific acceptance criteria as would be seen for diagnostic or AI-powered devices.

Summary

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JUN - 5 2007

PMN-2007-001

K071249

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:

Patrice Napoda Manager Regulatory Affairs 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:

ULTRAPRO* Hernia System

Predicate Devices:

PROLENE* Hernia System ULTRAPRO* Mesh

Statement of Intended Use:

The ULTRAPRO* Hernia System is intended for use in open repairs of abdominal wall hemia defects.

Device Description:

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Summary of Technological Characteristics of New Device to Predicate Devices:

The modified device has similar technological characteristics to those of the predicate devices. Like the currently marketed PROLENE Hernia System, the ULTRAPRO Hernia System is a sterile, pre-shaped three-dimensional device constructed of an onlay patch connected by a mesh cylinder to an oval or circular underlay patch. The ULTRAPRO Hernia System is composed of approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non-absorbable polypropylene monofilament fiber, a material identical to the currently marketed ULTRAPRO Mesh. After absorption of the poliglecaprone-25 materials, the remaining polypropylene mesh provides the long-term tissue support, similar to the PROLENE Hernia System.

Performance Data:

Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, with results demonstrating that the materials are acceptable for the 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 device, 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 with its wings spread, and three bars extending from the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ethicon, Inc % Ms. Patrice Napoda Manager, Regulatory Affairs PO Box 151, Route 22 West Somerville, New Jersey 08876

JUN - 5 2007

Re: K071249

Trade/Device Name: ULTRAPRO Hernia System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: May 03, 2007 Received: May 04, 2007

Dear Ms. Napoda:

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. Iisting 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 - Ms. Patrice Napoda

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 Pete

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):

Device Name: ULTRAPRO* Hernia System

Indications for Use:

This product is indicated for open repair of abdominal wall hernia defects

*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)

Pedr
me

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number 1671245

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.