K Number
K092207
Device Name
RESTORELLE POLYPROPYLENE MESH
Date Cleared
2009-08-04

(13 days)

Product Code
Regulation Number
884.5980
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RESTORELLE™ polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal 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
Restorelle™ is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene. Restorelle™ 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. It maintains excellent isotropic properties arising from its knitted construction. Restorelle™ polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability properties which permit the correct adaptation to the various stresses encountered in the body. The device is supplied sterile.
More Information

Not Found

No
The device description and summary of performance studies focus on the material properties and mechanical performance of a polypropylene mesh, with no mention of AI or ML technologies.

No
The device, a polypropylene mesh, is used for the repair of hernias and prolapses by providing support, not for active treatment or diagnosis of a disease.

No
This device is a surgical mesh used for the repair of hernias and prolapse, not for diagnosing medical conditions.

No

The device description clearly states it is a polypropylene mesh, which is a physical, non-software component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the repair of hernias and uterovaginal prolapse, which are surgical procedures performed directly on the patient's body.
  • Device Description: The device is a surgical mesh made of polypropylene, designed to provide structural support within the body.
  • Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of samples or diagnostic purposes.

Therefore, the Restorelle™ polypropylene mesh is a surgical implant, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

RESTORELLE™ polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal 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.

Product codes (comma separated list FDA assigned to the subject device)

OTP, OTO

Device Description

Restorelle™ is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene.

Restorelle™ 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.

It maintains excellent isotropic properties arising from its knitted construction.

Restorelle™ polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability properties which permit the correct adaptation to the various stresses encountered in the body.

The device is supplied sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

abdominal wall, uterovaginal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

licensed physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The components of the Restorelle™ device have been subjected to biocompatibility and mechanical testing and are substantially equivalent to the predicate Minimesh device (K041632 & K053361).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K041632 & K053361, K010931, K071512

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.

(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.

0

K09 2207
page 1 of 2

AUG 0 4 2009

MPATHY MEDICAL DEVICES, LED. RESTORELLE POLYPROFYLENE MESH SPECIAL 510(K) NOTIFICATION

15. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

SUBMITTER Ms Melissa Peloquin Director of Office Administration Mpathy Medical Devices Inc. 175 Paramount Drive Raynham, MA 02767

CONTACT PERSON Dr Caroline Stretton Quality & Regulatory Affairs Director Mpathy Medical Devices, Ltd. 208 Wright Business Centre Lonmay Road Glasgow G33 4EL (United Kingdom)

DATE PREPARED 15 July 2009

CLASSIFICATION Polymeric Surgical Mesh (Product Code OTP, is a Class II device per 21 CFR 878.3300

COMMON NAME Polymeric Surgical Mesh

Restorelle™ polypropylene mesh

PROPRIETARY NAME

PREDICATE DEVICE

  • . K041632 & K053361 - Minimesh (Mpathy Medical Ltd)
  • K010931 Straight In sacral colpopexy mesh . (American Medical Systems)
  • K071512 Gynecare Prolift (Ethicon) .

DEVICE DESCRIPTION Restorelle™ is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene.

Restorelle™ 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.

It maintains excellent isotropic properties arising from its knitted construction.

Restorelle™ polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability

PAGE 34 OF 56

1

K09 2207
page 2 of 2

MPATITY MEDICAL DEVICES, LTD. RESTORELLE POLYPROPYLENE MESH SPECIAL 510(K) NOTIFICATION

properties which permit the correct adaptation to the various stresses encountered in the body.

The device is supplied sterile.

INDICATIONS

Restorelle™ polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal 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.

Restorelle™ polypropylene mesh is a prescriptive device and should only be used by a licensed physician.

Restorelle™ polypropylene mesh has the same indications as a combination of the predicate devices.

TESTING

The components of the Restorelle™ device have been subjected to biocompatibility and mechanical testing and are substantially equivalent to the predicate Minimesh device (K041632 & K053361).

TECHNOLOGICAL Restorelle™ polypropylene mesh has the same CHARACTERISTICS use, general design, material intended and fundamental scientific technology as the predicate Restorelle™ polypropylene mesh device.

2

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Mpathy Medical Devices Ltd. % Mpathy Medical Devices, Inc. Ms. Melissa Peloquin Director of Office Administration 175 Paramount Drive RAYNHAM MA 02767

SEP 2 8 2012

Re: K092207 Trade/Device Name: Restorelle polypropylene mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, OTO Dated: July 15, 2009 Received: July 22, 2009

Dear Ms. Peloquin:

This letter corrects our substantially equivalent letter of August 4, 2009.

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

3

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/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

4

MPATHY MEDICAL DEVICES, LTD. RESTORELLE POLYPROPYLENE MESH SPECIAL 510(K) NOTIFICATION

14. STATEMENT FOR INDICATIONS FOR USE

K092207 510(k) Number: _

Device Name: Restorelle polypropylene mesh

Indications for Use:

RESTORELLE™ polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal 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.

Prescription Use: Yes

DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation

Daniel Keane Hansen

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number: K092207

PAGE 33 OF 56