MODIFICATION TO: MINIMESH POLYPROPYLENE MESH by MPATHY MEDICAL DEVICES, LTD.

MINIMESH® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, uterological prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

Device Description

Minimesh® is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene. Minimesh® polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling. Minimesh® polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability. These properties permit the correct adaptation to the various stresses encountered in the body. The device is supplied sterile.

AI/ML Overview

Here's an analysis of the provided text regarding the Minimesh® polypropylene mesh, focusing on acceptance criteria and study details.

Based on the provided documents (K053361), this submission is a 510(k) for a modification to an existing device (K041632 Minimesh® polypropylene mesh). The nature of the modification is not explicitly detailed in the provided excerpts, but the summary primarily focuses on the device description, indications for use, and stability testing.

Analysis of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This document does not describe an acceptance criteria or a study with specific performance metrics for the device's clinical efficacy or diagnostic accuracy. This is typical for a 510(k) submission for a surgical mesh, especially a modification, where the primary focus is on demonstrating substantial equivalence to a predicate device through material properties, manufacturing processes, and safety, rather than a clinical performance study with defined acceptance criteria for outcomes like diagnostic accuracy.

The "TESTING" section almost exclusively discusses stability studies and not clinical performance.

Here's the information extracted / inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Expected / Implied from Text)	Reported Device Performance (from Text)
Expiration Date / Stability	Support a three-year expiration date.	"Accelerated and real time stability studies have been conducted and support use of a three year expiration date for the product. The results... demonstrate that Minimesh® polypropylene mesh... can be used safely and effectively throughout this dating period."
Functional Properties (Implied - for substantial equivalence)	Necessary strength, flexibility, durability, and surgical adaptability.	"Minimesh® polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability. These properties permit the correct adaptation to the various stresses encountered in the body." (This is a descriptive statement, not a performance metric from a study.)
Biocompatibility (Implied - for substantial equivalence)	Safe for implantation.	(Not explicitly detailed in provided text, but assumed to be demonstrated for substantial equivalence to predicate)
Sterility (Implied)	Device supplied sterile.	"The device is supplied sterile."
Unraveling (Implied)	Mesh can be cut without unraveling.	"Permits the mesh to be cut into any desired shape or size without unraveling." (Descriptive, not a study outcome.)

2. Sample size used for the test set and the data provenance

None provided for a clinical or performance study with a test set of patients/cases. The stability studies would have involved material samples, but the sample size is not specified.
Data Provenance: Not applicable for a clinical test set. The stability studies would be лабораторные (lab-based) rather than human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set requiring expert ground truth was described.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication was described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a surgical mesh device, not an AI/imaging diagnostic device. An MRMC study is not relevant to this type of medical device submission.

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

Not applicable. This is a surgical mesh device, not an algorithm.

7. The type of ground truth used

For the stability studies, the "ground truth" would be laboratory measurements (e.g., tensile strength, degradation rates) against established specifications for material properties to determine shelf life.
For the overall device, substantial equivalence relies on comparison to a predicate device (K041632) which would have already established its safety and efficacy for the intended use.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this surgical mesh device.

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

Not applicable.

Summary of Device and Evidence Type:

The submission for Minimesh® polypropylene mesh (K053361) is a 510(k) for a modification. The evidence presented in these excerpts focuses on:

Substantial Equivalence: By describing the device properties and indications for use as similar to a legally marketed predicate device (K041632).
Product Stability/Shelf-Life: Via accelerated and real-time stability studies conducted to support a three-year expiration date. These are lab-based technical tests, not clinical performance studies.

There are no clinical performance studies with specific patient-oriented acceptance criteria or detailed methodologies involving a test set of patients/cases, human readers, or AI algorithms described in the provided documents.

Summary

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K053361
Page 1 of 2
FEB 6 2006

MPATHY MEDICAL DEVICE:5 L. D. SPECIAL 5 : O(K) 05 336 1 : Modificiation

510(k) SUMMARY OF SAFETY & EFFECTIVENESS

SUBMITTER	Mpathy Medical Devices, Ltd.6.05 Kelvin CampusWest of Scotland Science ParkGlasgow G20 OSPU.K.
CONTACT PERSON	Louis J. Mazzarese(U.S. Agent for Mpathy Medical Devices Ltd.)
DATE PREPARED	January 30, 2006
CLASSIFICATION	Polymeric Surgical Mesh (Product Code OTO) is a Class II deviceper 21 CFR 878.3300
COMMON NAME	Polymeric Surgical Mesh
PROPRIETARY NAME	Minimesh® polypropylene mesh
PREDICATE DEVICES	K041632 Minimesh® polypropylene mesh
DEVICE DESCRIPTION	Minimesh® is a non-absorbable polypropylene mesh constructedfrom knitted monofilaments of extruded polypropylene.
	Minimesh® polypropylene mesh is constructed using a warp-knitprocess to a unique design that permits the mesh to be cut into anydesired shape or size without unraveling.
	Minimesh® polypropylene mesh has the necessary strength,flexibility, durability and surgical adaptability. These propertiespermit the correct adaptation to the various stresses encountered inthe body.
	The device is supplied sterile.
INDICATIONS FOR USE	Minimesh® polypropylene mesh may be used for the repair ofabdominal wall hernia, including inguinal, femoral, and incisional,uterological prolapse and other fascial deficiencies that requiresupport material. It may be used in open or laparoscopicabdominal procedures or for repair by the vaginal route.

Replacement Page 16 of 18 January 30, 2006

MINIME SHO®

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K053361
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MPATHY MEDICAL DEVICES I... D SPECIAL 5 1 O(K) 05:3361 : Modification

510(k) SUMMARY OF SAFETY & EFFECTIVENESS (Cont'd.)

TESTING

Accelerated and real time stability studies have been conducted and support use of a three year expiration date for the product. The results of these studies demonstrate that Minimesh® polypropylene mesh, when stored under the conditions specified in the product labeling, can be used safely and effectively throughout this dating period (see Addendum A).

Additional Page 16A of 18 January 30, 2006

MINIME SHI®

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are rendered in a thick, black line. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

Mpathy Medical Devices Ltd. % Mr. Louis J. Mazzarese Designated U.S. Agent 150 Aran Hill Road FAIRFIELD CT 06824

SEP 2 8 2012

K053361 Re: Trade/Device Name: Minimesh® polypropylene mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO, OTP Dated: January 5, 2006 Received: January 10, 2006

Dear Mr. Mazzarese:

This letter corrects our substantially equivalent letter of February 6, 2006.

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 (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 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

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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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Benjamin R. Perkins

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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MPATHY MEDICAL. DEVICES LTD. SPECIAL 510(K): MODIFICATION

Indications for Use

210(k) Number: ان جي جي جي جي

Device Name: Mpathy Medical Devices Ltd Minimesh® polypropylene mesh

Indications for Use:

Prescription Use	X
(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 OF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number	K053361

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MINIMESH®

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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.