(28 days)
PROGRIP™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach.
The PROGRIP™ Laparoscopic Self-Fixating Mesh is available in anatomical and rectangular shapes. The mesh is made of knitted monofilament polyester with monofilament polylactic acid resorbable grips on one side and a resorbable collagen film on the other side. The film is made up of collagen from porcine origin and glycerol. The grips allow positioning and fixation of mesh to the surrounding tissue, while the collagen film facilitates mesh handling and deployment. The mesh presents a green band that facilitates mesh orientation No changes to product have been made in this submission.
This 510(k) submission (K123479) for the PROGRIP™ Laparoscopic Self-Fixating Mesh is not a study that proves the device meets specific acceptance criteria through clinical trials or performance testing as would be described for an AI/ML device.
Instead, this submission is a request to the FDA to remove a specific final product specification (lower specification of extractible pH) for an already legally marketed device (PROGRIP™ Laparoscopic Self-Fixating Mesh, K120897). The core assertion is that this change does not impact the device's intended use, does not alter its fundamental scientific technology, and does not require additional performance data.
Therefore, many of the requested elements for an AI/ML device study (like sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) are not applicable and not present in this document.
Here's an breakdown based on the provided text, focusing on what is relevant to a 510(k) submission for a modification to a predicate device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table with typical performance metrics (like sensitivity, specificity, AUC) for a new device. Instead, it discusses the impact of a specification change on the effectiveness for intended use.
| Acceptance Criteria (Conceptual, based on the submission) | Reported Device Performance (Argument for Equivalence) |
|---|---|
| Original Device Performance: Maintained despite specification change. The product must continue to be "effective for intended use" (reinforcement of tissues during surgical repair, specifically inguinal hernia). | The submission argues that "The removal of the collagen film lower specification of extractible pH, as a final product specification, does not affect the product performance." It further states that "The combination of the upper extractible pH and the lot release final product specification (gripping point test) ensure the product effectiveness for intended use." No quantitative performance data is provided as it's a change to a predicate. |
| Technological Characteristics: Remain substantially equivalent to the predicate device. | "The subject PROGRIP™ Laparoscopic Self-Fixating Mesh is identical to the predicate device PROGRIP™ Laparoscopic Self-Fixating Mesh (K120897) in terms of its physical, technological characteristics and performance characteristics." |
| Safety: No new safety concerns introduced by the specification change. | Implied by the lack of new performance data requirement and the assertion that "This change does not impact the intended use and does not alter the fundamental scientific technology of the device." |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission is for a modification to a previously cleared medical device, not a new device requiring a clinical performance study with a test set. The justification relies on the existing predicate device's performance and the argument that the change is minor.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No expert review panel or ground truth establishment for a test set is mentioned, as this is not a study evaluating diagnostic or predictive performance.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is described.
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:
- Not applicable. This device is a surgical mesh, not an AI/ML diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- Not applicable. As there is no "test set" in the context of an AI/ML study, there is no discussion of ground truth derived from pathology, outcomes data, or expert consensus. The "ground truth" for this submission is implicitly the established safety and efficacy profile of the predicate device (K120897), which this modified device claims to be substantially equivalent to, despite a minor change in a manufacturing specification.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set mentioned.
9. How the ground truth for the training set was established:
- Not applicable. No training set exists for this device.
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PROGRIP™ Laparoscopic Self-fixating Mesh
Covidien
DEC 1 1 2012
、510(K) SUMMARY
This 510(k) summary of information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98.
Submitter Information .
| Name: | Sofradim Production |
|---|---|
| Address: | 116, avenue du formans |
| 01600 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: | James McMahon (US Agent) |
| Associate Director, Regulatory Affairs | |
| Covidien | |
| 15 Hampshire Street | |
| Mansfield, MA 02048 USA | |
| Phone: 508-452-1545 | |
| Date prepared: | December 4, 2012 |
| Name of device | |
| Trade or proprietary name: | PROGRIP™ Laparoscopic Self-fixating 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 |
Page 1 of 3
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Covidien
PROGRIP™ Laparoscopic Self-fixating Mesh
Legally marketed devices to
which equivalence is claimed: PROGRIP™ Laparoscopic Self-Fixating Mesh (K120897)
Reason for 510(k) Submission:
To propose the removal of a final product specification (lower specification of extractible pH). This change is supported by a final product specification (gripping points test). The combination of the upper extractible pH and the lot release final product specification (gripping point test) ensure the product effectiveness for intended use. This change does not impact the intended use and does not alter the fundamental scientific technology of the device.
Device description:
The PROGRIP™ Laparoscopic Self-Fixating Mesh is available in anatomical and rectangular shapes.
The mesh is made of knitted monofilament polyester with monofilament polylactic acid resorbable grips on one side and a resorbable collagen film on the other side. The film is made up of collagen from porcine origin and glycerol. The grips allow positioning and fixation of mesh to the surrounding tissue, while the collagen film facilitates mesh handling and deployment. The mesh presents a green band that facilitates mesh orientation No changes to product have been made in this submission.
Intended use of the device:
The PROGRIP™ Laparoscopic Self-Fixating Mesh is used for the reinforcement of tissues during surgical repair. No changes to the intended use have been made in this submission
Indications for use:
PROGRIP™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach. No changes to the indication for use have been made in this submission
Page 2 of 3
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Covidien
PROGRIP™ Laparoscopic Self-fixating Mesh
Summary comparing the technological characteristics
of the subject and predicate
devices:
The subject PROGRIP™ Laparoscopic Self-Fixating Mesh is identical to the predicate device PROGRIP™ Laparoscopic Self-Fixating Mesh (K120897) in terms of its physical, technological characteristics and performance characteristics.
and predicate (K120897) PROGRIP™ proposed The Laparoscopic Self-Fixating Mesh is a monofilament polyester knit with monofilament polylactic acid resorbable grips on one of the sides. The grips allow positioning and fixation of the mesh to surrounding tissue.
Performance data:
The removal of the collagen film lower specification of extractible pH, as a final product specification, does not affect the product performance. The combination of the upper extractible pH and the lot release final product specification (gripping point test) ensure the product effectiveness for intended use.
The change in specification does not alter the performance specifications of the PROGRIP™ Laparoscopic Self-Fixating Mesh (K120897) and does not require additional performance data.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the symbol in a circular fashion. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Sofradim Production % Covidien LLC, Soft Tissue Implants Mr. James McMahon Associate Director, Regulatory Affairs 15 Crosby Drive Bedford, Massachusetts 01730
December 11, 2012
Re: K123479
Trade/Device Name: PROGRIP™ Laparoscopic Self-Fixating Mesh
· Regulation Number: 21 CFR 878.3300
Regulation Name: Surgical mesh
Regulatory Class: II Product Code: FTL Dated: November 09, 2012 Received: November 19, 2012
Dear Mr. McMahon:
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
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Page 2 - Mr. James McMahon
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 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" (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 vours.
Peter D. Rumm -S
- Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
510(k) Number (if known):
Device Name: PROGRIP™ Laparoscopic Self-Fixating Mesh
Indications for Use:
PROGRIP™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach.
Prescription Use_ X (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
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123479
§ 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.