(23 days)
PROGRIP™ Self-Gripping Polypropylene Mesh is intended for the reinforcement of tissue during surgical repair.
Parietene™ Flat Sheet Mesh is intended for the reinforcement of tissue during surgical repair.
PROGRIP™ Self-Gripping Polypropylene Mesh is indicated for inguinal and incisional hernia repair.
Parietene™ Flat Sheet Mesh is indicated for inguinal hernias, parietal reinforcement of tissues and abdominal wall hernia repair.
PROGRIP™ Self-Gripping Polypropylene Mesh: The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polypropylene with polylactic acid monofilament resorbable hooks on one of the sides. These hooks facilitate placing, positioning and temporary fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker is placed on the medial edge of the pre-cut mesh to help with orientation.
Parietene™ Flat Sheet Mesh: Parietene™ Flat Sheet Mesh is a Monofilament polypropylene mesh.
The provided text describes a 510(k) submission for two surgical mesh devices, PROGRIP™ Self-Gripping Polypropylene Mesh and Parietene™ Flat Sheet Mesh. The submission seeks to add a new formulation of raw material (polypropylene) from the same yarn supplier.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to predicate devices (K101197 and K991400) in: | Demonstrated through bench and preclinical tests. |
| - Indication | No changes to intended use or indications for use. |
| - Raw materials | New polypropylene formulation from the same yarn supplier. |
| - Performance characteristics | Evaluated by bench testing in accordance with FDA's March 2, 1999 Guidance for Surgical Mesh. |
| - Biocompatibility | Conducted in accordance with ISO 10993-1 for a permanent implant (FDA recognized standard #2-156). |
| - Stability | Stability studies conducted, and proposed devices' shelf life demonstrated. |
The document states, "The results of the bench and preclinical tests demonstrate that proposed devices are substantially equivalent to the predicates Parietene™ PROGRIP Mesh (K101197) and Parietene™ Polypropylene Mesh (K991400)." This implies that the device met the acceptance criteria by demonstrating substantial equivalence through various tests.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set of the performance studies. It mentions "bench testing" and "preclinical tests." The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies mentioned are bench and preclinical tests, which typically do not involve expert interpretation for ground truth in the same way clinical image analysis studies would.
4. Adjudication Method for the Test Set
This information is not provided as the studies are bench and preclinical tests, not clinical studies requiring adjudication of output.
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 mentioned. This submission is for a surgical mesh, not an AI-powered diagnostic or assistive device.
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 (surgical mesh), not an algorithm or AI system. The performance studies are focused on the material properties and biocompatibility of the mesh.
7. The Type of Ground Truth Used
For the bench testing, the ground truth would likely be established through standard engineering and materials science measurements, comparing the new material's performance to established specifications or the predicate devices' performance.
For biocompatibility, the ground truth would be established through standard cytotoxicity, sensitization, irritation, etc., testing as per ISO 10993-1, determining if the material elicits an unacceptable biological response.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical surgical mesh device.
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K140941 l of 4
510(k) SUMMARY
.
j
| Submitter InformationName: | Sofradim Production (subsidiary of Covidien LLC) |
|---|---|
| Address: | 116, avenue du formans01600 Trevoux, France |
| Phone number | +33 (0)4 74 08 90 00 |
| Fax number: | +33 (0) 4 74 08 90 02 |
| Establishment Registration: | 9615742 |
| Name of contact person: | Clare SantulliManager, Regulatory Affairs Covidien60 Middletown AvenueNorth Haven, CT 06473 |
| Phone: | 203-492-7635 |
| Date prepared: | April 11, 2014 |
| Name of device: | |
| Trade or proprietary name: | PROGRIP™ Self-Gripping Polypropylene MeshParietene™ Flat Sheet Mesh |
| Common or usual name: | Surgical Mesh |
| Classification name: | Mesh, Surgical, Polymeric |
| Classification panel: | General and Plastic Surgery (79) |
| Regulation: | 21 CFR 878.3300 |
| Product Code: | FTL |
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Legally marketed devices to which equivalence is claimed:
PARIETENE™ PROGRIP™ Mesh (K101197)
PARIETENE™ Polypropylene Mesh (K991400)
Reason for 510(k) Submission:
The purpose of this 510(k) is to notify the agency of the addition of another formulation of raw material, polypropylene, from the yarn supplier who manufactures the monofilament yarns used in the proposed devices. Eventually the current polypropylene will no longer be available by the supplier.
Device description:
PROGRIP™ Self-Gripping Polypropylene Mesh
The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polypropylene with polylactic acid monofilament resorbable hooks on one of the sides. These hooks facilitate placing, positioning and temporary fixation of the overlapping flap and the mesh to the surrounding tissue.
A colored yarn marker is placed on the medial edge of the pre-cut mesh to help with orientation.
Parietene™ Flat Sheet Mesh
Parietene™ Flat Sheet Mesh is a Monofilament polypropylene mesh.
Intended use of the device:
PROGRIP™ Self-Gripping Polypropylene Mesh
PROGRIP™ Self-Gripping Polypropylene Mesh is intended for the reinforcement of tissue during surgical repair.
No changes to the intended use have been made in this submission.
Parietene™ Flat Sheet Mesh
Parietene™ Flat Sheet Mesh is intended for the reinforcement of tissue during surgical repair.
No changes to the intended use have been made in this submission
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Indications for use:
PROGRIP™ Self-Gripping Polypropylene Mesh
PROGRIP™ Self-Gripping Polypropylene Mesh is indicated for inguinal and incisional hernia repair.
No changes to the indication for use have been made in this submission
Parietene™ Flat Sheet Mesh
Parietene™ Flat Sheet Mesh is indicated for inguinal hernias, parietal reinforcement of tissues and abdominal wall hernia repair.
No changes to the indication for use have been made in this submission
Summary comparing the technological characteristics of the subject and predicate devices:
The proposed PROGRIP™ Self-Gripping Polypropylene Mesh and Parietene™ Flat Sheet Mesh manufactured with another formulation of raw material, polypropylene, from the same yarn supplier as the current polypropylene are equivalent to predicate Parietene™ PROGRIP Mesh (K101197) and Parietene™ Polypropylene Mesh (K991400) in terms of the following technological characteristics:
- Indication -
- Raw materials -
- Performance characteristics -
- -Biocompatibility
- Stability -
Performance data:
This change consists of the addition of another formulation of raw material, polypropylene, for the subject devices.
Bench testing has been conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of the proposed devices.
Stability Studies have been conducted and the proposed devices shelf life has been demonstrated.
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Biocompatibility studies have been conducted on the proposed polypropylene devices in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-156).
Conclusion:
The results of the bench and preclinical tests demonstrate that proposed devices are substantially equivalent to the predicates Parietene™ PROGRIP Mesh (K101197) and Parietene™ Polypropylene Mesh (K991400)
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and flow together, resembling a stylized representation of the human form.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 7, 2014
Sofradim Production % Ms. Clare Santulli Regulatory Affairs Manager, Covidien 60 Middleton Avenue North Haven, Connecticut 06473
Re: K140941
Trade/Device Name: PROGRIP" Self-Gripping Polypropylene Mesh, Parietene™ Flat Sheet Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: April 11, 2014 Received: April 14, 2014
Dear Ms. Santulli:
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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Page 2 - Ms. Clare Santulli
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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Binita S. Ashar 2014.05.07 17:12:16 -04'00'
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K 140941
Device Name
PROGRIP™ Self-Gripping Polypropylene Mesh
Parietene™ Flat Sheet Mesh
Indications for Use (Describe)
PROGRIP™ Self-Gripping Polypropylene Mesh is indicated for inguinal and incisional hernia repair.
Parietene™ Flat Sheet Mesh is inguinal hernias, parietal ereinforcement of tissue and abdominal wall hemai repair.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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§ 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.