(113 days)
PREVADH™ mesh is indicated for use when a temporary wound support is required in abdominopelvic surgery. The resorbable hydrophilic film minimizes tissue attachment to the mesh in the case of direct contact with the viscera.
PREVADH™ Mesh is sterile and can be anchored. It has three component layers: one porous side made of lyophilized porcine collagen; one non-porous smooth side made of porcine collagen, polyethylene glycol and glycerol; and a multifilament polylactic acid mesh inserted between the two collagen layers. The porous side is soft and hydrophilic, and combined with the highly porous mesh, allows for fast tissue in-growth. The nonporous smooth side minimizes visceral attachment. The entire PREVADH™ Mesh device resorbs. The porous side is resorbed in less than 1 week and the non-porous smooth side is resorbed in approximately 3 weeks. The multifilament polylactic acid mesh is bioresorbable and offers significant mechanical strength during at least 12 weeks to maintain support throughout the critical healing period.
This submission describes the PREVADH™ Mesh, a resorbable surgical mesh indicated for temporary wound support in abdominopelvic surgery. The device consists of three layers: a porous porcine collagen side, a non-porous layer of porcine collagen, polyethylene glycol, and glycerol, and a multifilament polylactic acid mesh inserted between the collagen layers.
Here's an analysis of the provided information regarding acceptance criteria and supportive studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (materials) | "Comprised of biocompatible materials that are in compliance with ISO 10993-1 and/or USP standards." |
| Mechanical Properties | "Results of mechanical properties testing show that PREVADH™ Mesh has similar performance characteristics to the predicate VICRYL Mesh." |
| Porosity for fast tissue in-growth | "PREVADH™ Mesh is knitted in a design with large pores that allow fast tissue in-growth." |
| Minimization of visceral attachment | "The non-porous smooth side minimizes visceral attachment." and "the hydrophilic collagen film serves to temporarily separate the mesh from adjacent organs to minimize visceral attachment to the mesh which may occur during the healing process." |
| Resorption Profile (Porous side) | "The porous side is resorbed in less than 1 week." |
| Resorption Profile (Non-porous side) | "the non-porous smooth side is resorbed in approximately 3 weeks." |
| Resorption Profile (Polylactic acid mesh) | "The multifilament polylactic acid mesh is bioresorbable and offers significant mechanical strength during at least 12 weeks to maintain support throughout the critical healing period." |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Bench and animal testing has been conducted to evaluate the performance characteristics of PREVADH™ Mesh."
- Sample Size for Test Set: Not specified. The document only mentions "Bench and animal testing."
- Data Provenance: Not specified. It's common for animal studies for device clearance to be conducted in-house or by contract research organizations, but the specific origins are not detailed. These studies are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
No mention of human experts establishing ground truth for the "Bench and animal testing." The evaluations appear to be objective measurements (e.g., mechanical properties, resorption rates, tissue response in animals).
4. Adjudication Method for the Test Set:
Not applicable, as there's no mention of human-involved assessment in the "Bench and animal testing" that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The device is a surgical mesh, and its evaluation focuses on material properties, biocompatibility, and animal efficacy, not interpretation of medical images by multiple readers.
6. Standalone (Algorithm only without human-in-the-loop performance) Study:
Not applicable. This is a medical device (surgical mesh), not an algorithm or AI system.
7. Type of Ground Truth Used:
The ground truth for the performance claims appears to be based on:
- Objective Measurements: Mechanical property tests, resorption rate measurements.
- Animal Observations: Assessment of tissue in-growth, visceral attachment minimization, and overall biological response in animal models.
- Material Standards: Compliance with ISO 10993-1 and/or USP standards for biocompatibility.
8. Sample Size for the Training Set:
Not applicable, as this is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is not an AI/ML device requiring a training set.
Summary of Study and Justification for Equivalence:
The 510(k) submission for PREVADH™ Mesh relies on demonstrating substantial equivalence to legally marketed predicate devices: PARIETEX™ COMPOSITE (PCO) Mesh (K040998), Ethicon, Inc. VICRYL Mesh (K810428), and UGYTEX™ Mesh (K033376).
The studies conducted to support this claim include:
- Bench Testing: To evaluate mechanical properties and similarity to predicate VICRYL Mesh.
- Animal Testing: To assess performance characteristics such as tissue in-growth and minimization of visceral attachment, which are key functions of the device, particularly the hydrophilic film (similar to the PCO Mesh predicate).
- Biocompatibility Testing: Materials shown to be in compliance with ISO 10993-1 and/or USP standards.
The acceptance criteria are implied by the desired functional characteristics of a surgical mesh (biocompatibility, appropriate mechanical strength, desirable resorption profile, and minimization of adhesions), and the performance data presented aims to show that the PREVADH™ Mesh meets these characteristics and performs similarly to its predicate devices. The submission concludes that the technological characteristics are similar to the predicate devices, thereby supporting substantial equivalence for its intended use.
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K073287
(1+1=2)
MAR J 3 2008 510(k) Summary of Safety and Effectiveness
- SUBMITTER: Sofradim Production 116, avenue du formans 01600 Trevoux, France Phone: 33 0 4 74 08 90 00 CONTACT PERSON: Sharon Alexander Senior Associate, Regulatory Affairs Covidien 60 Middletown Avenue North Haven, CT 06473 USA Phone: (203) 492-6060 DATE PREPARED: November 20, 2007 TRADE/PROPRIETARY NAME: PREVADH™ Mesh COMMON/USUAL NAME: Surgical Mesh CLASSIFICATION NAME: Mesh, Surgical, Polymeric PREDICATE DEVICE(S): PARIETEX™ COMPOSITE (PCO) Mesh (K040998) Ethicon, Inc. VICRYL Mesh (K810428) UGYTEX™ Mesh (K033376) DEVICE DESCRIPTION: PREVADH™ Mesh is sterile and can be anchored. It has three component layers: one porous side made of lyophilized porcine collagen; one non-porous smooth side made of porcine collagen, polyethylene glycol and glycerol; and a multifilament polylactic acid mesh inserted between the two collagen layers. The porous side is soft and hydrophilic, and combined with the highly porous mesh, allows for fast tissue in-growth. The nonporous smooth side minimizes visceral attachment. The entire PREVADH™ Mesh device resorbs. The porous side is resorbed in less than 1 week and the non-porous smooth side is resorbed in approximately 3 weeks. The multifilament polylactic acid mesh is bioresorbable and offers significant mechanical strength during at least 12 weeks to maintain support throughout the critical healing period. INTENDED USE: PREVADH™ mesh is indicated for use when a temporary wound support is required in abdominopelvic surgery. The resorbable hydrophilic film minimizes tissue attachment to the mesh in the case of direct contact with the viscera. TECHNOLOGICAL CHARACTERISTICS: The technological characteristics of PREVADH™ Mesh are similar to those of the predicate devices. PREVADH™ Mesh is manufactured from three resorbable components: porous collagen foam, polylactic acid mesh, and a hydrophilic collagen
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PREVADH™ Mesh
film. PREVADH™ Mesh is knitted in a design with large pores that allow fast tissue in-growth. The collagen-based components of PREVADH™ Mesh are derived from a porcine source already cleared by FDA for predicate PARIETEX™ COMPOSITE (PCO) Mesh (K040998). As with this predicate PCO Mesh, the hydrophilic collagen film serves to temporarily separate the mesh from adjacent organs to minimize visceral attachment to the mesh which may occur during the healing process.
MATERIALS: PREVADH™ Mesh is comprised of biocompatible materials that are in compliance with ISO 10993-1 and/or USP standards.
- PERFORMANCE DATA: Bench and animal testing has been conducted to evaluate the performance characteristics of PREVADH™ Mesh. Results of mechanical properties testing show that PREVADH™ Mesh has similar performance characteristics to the predicate VICRYL Mesh.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2008
Sofradim Production % Covidien Ms. Sharon Alexander Senior Associate, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K073287
Trade/Device Name: PREVADH™ Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 15, 2008 Received: February 19, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Ms. Sharon Alexander
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PREVADH™ Mesh
Indications For Use
510(k) Number (if known): {_c 7 328
Device Name: PREVADH™ Mesh
Indications For Use:
PREVADH™ mesh is indicated for use when a temporary wound support is required in abdominopelvic surgery. The resorbable hydrophilic film minimizes tissue attachment to the mesh in the case of direct contact with the viscera.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
RH, Office of Device Evaluation (ODE) Concurre (Division Sign-Off Division of General, Restorative.
and Neurological Devices
510(k) Number K073287
§ 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.