ULTRAPRO ADVANCED™ Mesh may be used for the repair of abdominal fascial deficiencies, such as hernias, that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Description

ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh is a sterile, partially absorbable mesh device designed for the repair of hernias and other fascial defects. The implant device is composed of a macroporous mesh, manufactured out of dyed (phtalocyanine blue) and undyed non absorbable polypropylene monofilaments (3.5 mil PROLENE™) as well as a twist yarn, composed of dyed (phtalocyanine blue) and undyed non absorbable polypropylene monofilaments (3.5 mil PROLENE™) and undyed absorbable poliglecaprone 25 monofilaments (5 mil MONOCRYL™). The mesh provides blue stripes for orientation.

AI/ML Overview

This document is a 510(k) premarket notification for the ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving acceptance criteria for a novel AI/software device.

Therefore, most of the requested information for an AI/software device, such as acceptance criteria tables, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone performance, is not applicable or available in this document.

However, I can extract the information relevant to the safety and performance testing that was conducted to demonstrate substantial equivalence:

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

The document does not provide a table with explicit numerical acceptance criteria and corresponding reported device performance values. Instead, it describes general categories of testing and concludes that the device "meets the requirements as defined in user specifications, performs as intended, and is substantially equivalent to the predicate device."

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

Bench Testing: No specific sample sizes are provided for the bench top tests. The provenance is not explicitly stated, but it's implied to be within the manufacturing/testing process of the applicant/manufacturer.
Animal Testing:
- Pilot Study: One 28-day pilot study was performed. The sample size (number of animals) is not specified.
- Definitive Study: One 28-day and one 91-day definitive study were performed. The sample size (number of animals) is not specified.
Data Provenance: Not explicitly stated, but these studies would be prospective controlled animal studies.

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 is not applicable as the studies described are animal and bench tests, not human reader studies requiring expert ground truth establishment in the context of diagnostic interpretation.

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

Not applicable, as this refers to human reader studies, which were not conducted for this device.

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

No such study was conducted or is mentioned, as this is a physical medical device (surgical mesh), not an AI/software device intended to assist human readers.

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

Not applicable, as this is a physical medical device, not an algorithm.

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

For the animal studies, the "ground truth" would be established through histological analysis (tissue integration, tissue reaction) and potentially gross anatomical assessment, typically performed by veterinarians or pathologists specializing in animal studies. For bench tests, the "ground truth" is derived from measured physical properties against established engineering standards or predicate device performance.

8. The sample size for the training set

Not applicable, as this is a physical medical device and does not involve machine learning algorithms with training sets.

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing right, layered on top of each other. The profiles are depicted in a flowing, wave-like design.

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

Ethicon Incorporated Ms. Susan Lin Manager Regulatory Affairs Route 22 West, P.O. Box 151 Somerville, New Jersey 08876

July 24, 2015

Re: K150906

Trade/Device Name: ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: June 26, 2015 Received: June 26, 2015

Dear Ms. Lin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 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

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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Mipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150906

Device Name

ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Applicant:	Ethicon Inc.P.O. Box 151Route 22 WestSomerville, NJ 08876USAPhone: +1-908-218-2256Fax: +1-908-218-2595
Date:	March 31st, 2015
Contact Person:	Thomas Greiner
Proprietary Device Name:	ULTRAPRO ADVANCED™ Macroporous Partially AbsorbableMesh
Common Device Name:	Surgical Mesh
Classification:	Class II21 CFR 878.3300 – Surgical Mesh, polymeric;Product Code: FTL
Predicate Device:	ETHICON Ultrapro™ Mesh - (K033337)
Manufacturer:	Johnson & Johnson MEDICAL GmbHRobert-Koch-Strasse 122851 NorderstedtGermany

Description of the Device Subject to Premarket Notification:

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Indications for Use:

ULTRAPRO ADVANCED™ Mesh may be used for the repair of abdominal fascial deficiencies. such as hernias, that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Summary of Characteristics of New Device to Predicate Devices:

The principle of operation and fundamental scientific technology of the new device are equivalent to the predicate device. The ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh and its predicate device function in the same manner - they are designed as prosthetic material for the repair of hernias and other fascial deficiencies by providing reinforcement or acting as bridging materials.

The technological characteristics of the new device are similar to the predicate device. Similar to ETHICON Ultrapro Mesh™, the new device is composed of a macroporous partially absorbable mesh.

Performance Data:

ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh underwent an extensive safety and performance testing program, including bench and animal testing, to demonstrate that the device meets the requirements as defined in user specifications, performs as intended, and is substantially equivalent to the predicate device. The tests conducted include:

Biocompatibility testing in accordance to the tests recommended in the ISO 10993-1 ● standard was conducted. The results indicate that the device is biocompatible per this standard.
Bench top testing was performed to assess the physical/performance characteristics of the ● new device. In accordance with FDA's "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh" (March 2, 1999), the bench top testing evaluated physical characteristics of mesh including mesh knitting pattern, mesh pore size/porosity, mesh density, mesh thickness, and mesh stiffness as well as mesh performance testing including mesh burst strength and suture pullout strength.
Pre-clinical efficacy studies were performed including a 28 day pilot study of ULTRAPRO ● ADVANCED™ Mesh designed to evaluate tissue integration, tissue reaction and mesh compression and a 28 and 91 day definitive study of ULTRAPRO ADVANCED™ Mesh designed to evaluate tissue integration and tissue reaction.

Conclusion

The ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh has the same intended use and fundamental scientific technology as its predicate device. Performance data demonstrates that the device is as safe and as effective as the predicate device for the intended use. Thus we conclude that the proposed device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act.

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.