K Number
K101197
Device Name
PARIE TENE PROGRIP MESH
Date Cleared
2010-05-05

(7 days)

Product Code
Regulation Number
878.3300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PARIETENE PROGRIP™ Mesh is indicated for inguinal and incisional hernia repair.
Device Description
PARIETENE PROGRIP™ Mesh is available in 2 forms: • Pre-cut, elliptic slit mesh with self-gripping overlapping flap (right or left side) • Rectangular simple mesh These meshes and the overlapping flaps of the pre-cut versions are made of knitted monofilament polypropylene with polylactic acid (PLA) resorbable pins on one of the sides. The PLA pins facilitate placement, positioning and fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker on the medial edge of the pre-cut mesh helps orientation.
More Information

Not Found

No
The device description focuses on the material composition and physical design of a surgical mesh, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies described are bench tests comparing physical characteristics.

No
The device is a surgical mesh for hernia repair, not an active therapeutic device.

No
The device is a surgical mesh used for hernia repair, which is a therapeutic function, not diagnostic. Its description focuses on materials and structure for physical placement and repair, not on identifying a medical condition.

No

The device description clearly states it is a mesh made of physical materials (polypropylene and polylactic acid) with resorbable pins, indicating it is a physical medical device, not software.

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

Here's why:

  • Intended Use: The intended use is for "inguinal and incisional hernia repair." This is a surgical procedure performed directly on the patient's body.
  • Device Description: The device is a mesh made of polypropylene and PLA with pins, designed for physical implantation to repair hernias.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.

IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to repair a physical defect.

N/A

Intended Use / Indications for Use

PARIETENE PROGRIP™ Mesh is indicated for inguinal and incisional hernia repair.

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

FTL

Device Description

PARIETENE PROGRIP™ Mesh is available in 2 forms:
• Pre-cut, elliptic slit mesh with self-gripping overlapping flap
(right or left side)
• Rectangular simple mesh
These meshes and the overlapping flaps of the pre-cut versions
are made of knitted monofilament polypropylene with polylactic
acid (PLA) resorbable pins on one of the sides. The PLA pins
facilitate placement, positioning and fixation of the overlapping
flap and the mesh to the surrounding tissue. A colored yarn
marker on the medial edge of the pre-cut mesh helps orientation.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Inguinal, incisional hernia

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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)

Bench testing has been conducted to evaluate the performance characteristics of PARIETENE PROGRIP™. Testing has shown that the PARIETENE PROGRIP™ is equivalent in performance characteristics to the predicate PARIETEX PROGRIP™.

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.

PARIETEX Progrip™ Mesh (K081050), PARIETENE™ Mesh (K991400), PARIETEX™ TET Mesh (K003990)

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

§ 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.

0

Special 510(k) - PARIETENE PROGRIP™ MESH

1 1 1 1 1 1 1

· ·

510(k) Summary of Safety and Effectiveness

| SUBMITTER: | Sofradim Production
116, avenue du formans
01600 Trevoux, France
Phone: 33 04 74 08 90 00 | K101197 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Sharon Alexander
Associate Manager, Regulatory Affairs
Covidien
60 Middletown Avenue
North Haven, CT 06473 USA
Phone: (203) 492-6060 | MAY - 5 2010 |
| DATE PREPARED: | April 26, 2010 | |
| TRADE/PROPRIETARY NAME: | PARIETENE PROGRIP™ Mesh | |
| COMMON/USUAL NAME: | Surgical Mesh | |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric | |
| PREDICATE DEVICE(S): | PARIETEX Progrip™ Mesh (K081050)
PARIETENE™ Mesh (K991400)
PARIETEX™ TET Mesh (K003990) | |
| DEVICE DESCRIPTION: | PARIETENE PROGRIP™ Mesh is available in 2 forms:
• Pre-cut, elliptic slit mesh with self-gripping overlapping flap
(right or left side)
• Rectangular simple mesh
These meshes and the overlapping flaps of the pre-cut versions
are made of knitted monofilament polypropylene with polylactic
acid (PLA) resorbable pins on one of the sides. The PLA pins
facilitate placement, positioning and fixation of the overlapping
flap and the mesh to the surrounding tissue. A colored yarn
marker on the medial edge of the pre-cut mesh helps orientation. | |
| INDICATION: | PARIETENE PROGRIP™ Mesh is indicated for inguinal and
incisional hernia repair. | |
| TECHNOLOGICAL
CHARACTERISTICS: | PARIETENE PROGRIP™ meshes are made with knitted
monofilament polypropylene and monofilament polylactic acid
resorbable pins. The intended use and fundamental technology of
PARIETENE PROGRIP™ Mesh are equivalent to that of the
predicate PARIETEX PROGRIP™. | |
| MATERIALS: | PARIETENE PROGRIP™ Mesh is comprised of biocompatible
materials that are in compliance with ISO 10993-1 and/or USP
standards. | |
| PERFORMANCE DATA: | Bench testing has been conducted to evaluate the performance
characteristics of PARIETENE PROGRIP™. Testing has shown
that the PARIETENE PROGRIP™ is equivalent in performance
characteristics to the predicate PARIETEX PROGRIP™. | |

:

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Sofradim Production % Covidien - Div. of Tyco Healthcare Group LP Ms. Sharon Alexander Associate Manager, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

MAY - 5 2010

Re: K101197

Trade/Device Name: Parietene Progrip Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: April 28, 2010 Received: April 28, 2010

Dear Ms. Alexander:

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

2

Page 2 - Ms. Sharon Alexander

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 (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.

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" (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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

Indications for Use

KIQULS 510(k) Number (if known):

Device Name:

PARIETENE PROGRIP™ Mesh is indicated for inguinal and incisional hernia repair.

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause for MXM

(Divisi Division of Surgical, Orthope and Restorative Device

Page 1 of _

510(k) Number K101147