ULTRAPRO™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

ULTRAPRO ADVANCED™M Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

Device Description

ULTRAPRO™ Mesh is manufactured from approximately equal parts* of absorbable poliglecaprone-25 monofilament fiber and nonabsorbable polypropylene monofilament fiber. The polymer of the undyed and dyed polypropylene fiber (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 &-caprolactone; this copolymer is identical to the material used for MONOCRYL™ suture. After absorption of the poliglecaprone-25 component, only the polypropylene mesh remains. The structure and size of this remaining mesh are optimally designed for the physiological stresses of the abdominal wall.

ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh is a sterile, partially absorbable mesh*, designed for the repair of abdominal wall hernias and other abdominal wall deficiencies. The device is manufactured out of dyed (phtalocyanine blue) and undyed nonabsorbable polypropylene monofilaments (3.5 mil PROLENE™) as well as a twist, composed of dyed (phtalocyanine blue) and undyed non-absorbable polypropylene monofilaments (3.5 mil PROLENE™) and undyed absorbable poliglecaprone 25 monofilaments (5 mil MONOCRYL™). Blue stripes provide orientation.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to Ethicon Inc. regarding ULTRAPRO™ Mesh and ULTRAPRO ADVANCED™ for surgical mesh.

It primarily focuses on:

FDA's determination of substantial equivalence to previously marketed predicate devices (ULTRAPRO™ Mesh K033337 and ULTRAPRO ADVANCED K150906).
Device description: detailing the materials and composition of the mesh.
Indications for Use: for the repair of abdominal wall hernias and deficiencies.
Summary of Technological Characteristics: stating that the subject devices are identical to the predicate devices in terms of technology, materials, construction, manufacturing, and sterilization, with only labeling changes for clarity and regulatory expectations.
Conclusion: affirming substantial equivalence based on identical intended use and technological characteristics to the predicate devices.

There is no mention of:

Specific acceptance criteria (e.g., performance metrics, thresholds).
Details of any study conducted to demonstrate the device meets acceptance criteria.
Information regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC, standalone algorithm performance).

Therefore, I cannot fulfill your request to describe acceptance criteria and a corresponding study based on the provided text.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two main elements: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA acronym and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue.

Ethicon Inc % Ms. Melina Escobar Regulatory Affairs Specialist P.O. Box 151 U.S. Route 22 West Somerville, New Jersey 08876

July 2, 2018

Re: K180910

Trade/Device Name: ULTRAPRO™ Mesh and ULTRAPRO ADVANCED™ Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: April 5, 2018 Received: April 6, 2018

Dear Ms. Escobar:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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K180910

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K180910

Device Name ULTRAPRO™ Mesh ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh

Indications for Use (Describe)

ULTRAPRO™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is in large, red, sans-serif font. Below it, in a smaller, cursive font, is the text "a Johnson & Johnson company."

510(k) Summary

Submitter:	Ethicon, Inc. a Johnson & Johnson companyP.O. Box 151Route 22 WestSomerville, NJ 08876-0151
Contact Person:	Melina EscobarRegulatory Affairs SpecialistPhone: 908-218-2583Fax: 908-218-2595Email: mescob14@its.jnj.com
Date Prepared:	April 5, 2018
Device Trade Name:	ULTRAPRO™ MeshULTRAPRO ADVANCED™ Macroporous Partially AbsorbableMesh
Device Common Name:	ULTRAPRO™ MeshULTRAPRO ADVANCED™
Class:	Class II
Classification:	21 CFR 878.3300 – Surgical Mesh
Product Code:	FTL

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K180910 Page 2 of 4

Image /page/4/Picture/1 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif letters. Below the company name, in a smaller, cursive font, is the text "a Johnson & Johnson company". The logo is simple and clean, with a focus on the company name.

Predicate Device:

Device	Company	Product Code	510(k) Number	Predicate for
ULTRAPRO™Mesh	Ethicon, Inc.	FTL	K033337	Fundamental ScientificTechnology, Design,Intended Use, Materials,Construction, PerformanceCharacteristics
ULTRAPROADVANCED	Ethicon, Inc.	FTL	K150906	Fundamental ScientificTechnology, Design,Intended Use, Materials,Construction, PerformanceCharacteristics

Device Description:

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Image /page/5/Picture/0 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is written in large, red, serif font. Below it, in a smaller, cursive font, is the phrase "a Johnson & Johnson company."

Indications for Use:

ULTRAPRO™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

ULTRAPRO ADVANCED™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

Summary of Technological Characteristics:

ULTRAPRO Mesh is identical to the ULTRAPRO Mesh (K033337) marketed mesh with respect to technological characteristics. There are no material, construction, manufacturing or sterilization process changes to the currently marketed device differs only in the labeling which certain sections of the Instructions for Use of the subject device have been reworded/ reformatted for clarity to address evolving regulatory expectations and bring the contents of the Instructions for Use up to date.

ULTRAPRO ADVANCED is identical to the ULTRAPRO ADVANCED (K150906) marketed mesh with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed device. The device differs only in the labeling which has been revised to reworded/ reformatted most of the Instructions for Use sections for clarity to address evolving regulatory expectations and bring the contents of the Instructions for Use up to date.

Substantial Equivalence:

ULTRAPRO™ Mesh and ULTRAPRO ADVANCED are identical to the ULTRAPRO™ Mesh (K033337) and ULTRAPRO ADVANCED (K150906) marketed mesh with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices differ only in the labeling (Instructions for Use). Where several sections of the Instructions for Use of the subject devices have been reworded reformatted for clarity to address evolving regulatory expectations and bring the contents of the Instructions for Use up to date and aligned within the Mesh Harmonization project noted in the Cover Letter. The Indication statement of the subject meshes have been modified to add clarity. The Indication of the subject devices do not introduce any new indications or expand the patient population of the predicate meshes.

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Image /page/6/Picture/1 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif font. Below it, the phrase "a Johnson+Johnson company" is written in a smaller, cursive font.

Conclusion:

The subject mesh, ULTRAPRO™ Mesh and ULTRAPRO ADVANCED are identical to the predicate marketed meshes, ULTRAPRO™ Mesh (K033337) and ULTRAPRO ADVANCED (K150906) with respect to intended use, technological characteristics, material, construction, specification, manufacturing and sterilization. In conclusion, the subject ULTRAPRO™ Mesh and ULTRAPRO ADVANCED are substantially equivalent to the predicate meshes.

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.