(253 days)
The SURGIMESH®WN implant is recommended for reinforcement of hernia defects. The hernia repair could be, for example, inguinal hernia, femoral or crural hernia or ventral hernia. The SURGIMESH®WN implant is indicated for use via an extraperitoneal approach either by open or laproscopic surgery.
The SURGIMESH®WN consists of non-absorbable synthetic mesh, made of nonknitted, non-woven fibers of polypropylene. SURGIMESH®WN mesh is supplied sterile and is available in rectangular and anatomic forms in order to meet the individual patient's surgical needs.
The provided text describes the regulatory clearance of a surgical mesh device, SURGIMESH®WN, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed results from a study proving those criteria, or information on AI performance or ground truth generation methods.
The "Performance Data" section states: "Pre-clinical and clinical performance testing was conducted. Tissue integration, biocompatibility, product structure, and final product specifications were all tested, in addition to two clinical studies that were performed. In all instances, the SURGIMESH®WN functioned as intended and the results observed were as expected."
This general statement indicates that studies were performed and that the device met its intended function, but it lacks the quantitative details required to fill out the requested table and answer the specific questions about acceptance criteria and study design.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated in text) | Reported Device Performance (General Statement in text) |
|---|---|
| Not available in the provided text. | "In all instances, the SURGIMESH®WN functioned as intended and the results observed were as expected." (P. 1, "Performance Data" section) |
| Tissue integration standards (e.g., degree of fibroblast infiltration, inflammatory response) | "Tissue integration... were all tested" (P. 1) |
| Biocompatibility standards (e.g., cytotoxicity, sensitization) | "Biocompatibility... were all tested" (P. 1) |
| Product structure specifications (e.g., tensile strength, pore size, material composition) | "Product structure... were all tested" (P. 1) |
| Final product specifications (e.g., sterilization effectiveness, dimensional stability) | "Final product specifications were all tested" (P. 1) |
| Clinical outcome measures (e.g., hernia recurrence rates, infection rates) | "two clinical studies that were performed" (P. 1) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The text mentions "two clinical studies," but no sample sizes are given for these studies.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as the device is a surgical mesh, not an AI device requiring expert ground truth for image interpretation or similar tasks. The evaluations would typically be based on objective measures, clinical outcomes, and histological analysis rather than expert consensus on interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. This typically applies to studies requiring expert review or interpretation, which is not described for this device.
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. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Based on the description of "Tissue integration, biocompatibility, product structure, and final product specifications," the ground truth likely involved:
- Histopathology/Pathology: For tissue integration and biocompatibility (e.g., microscopic examination of tissue response).
- Physical and Mechanical Testing: For product structure and final product specifications (e.g., tensile strength testing, pore size measurement).
- Clinical Outcomes Data: For the "two clinical studies" (e.g., hernia recurrence, complications, patient satisfaction).
8. The sample size for the training set
- Not applicable. This is not an AI device that uses a "training set" in the machine learning sense. The "training set" in the context of a medical device development would refer to data used for initial R&D and optimization, which is not detailed here.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI device.
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III 510(k) Summary
SURGIMESH®WN
1/2
FEB - 1 2007
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
ASPIDE MEDICAL Zone Industrielle La Chazotte Allée Joseph Cugnot 42350 LA TALAUDIERE (FRANCE) Tel: +33 4 77 53 16 59 Fax: +33 4 77 53 04 92
Contact Person: Mr William WIECEK
Date Prepared: January 23, 2007
Name of Device and Name/Address of Sponsor
SURGIMESH®WN
ASPIDE MEDICAL Zone Industrielle La Chazotte Allée Joseph Cugnot 42350 LA TALAUDIERE (FRANCE)
Common or Usual Name
Polymeric Surgical Mesh
Classification Name
Surgical Mesh
Predicate Devices
(1) Tissue Science Laboratories' Permacol synthetic mesh (K992556)
Intended Use / Indications for Use
The SURGIMESH®WN implant is recommended for reinforcement of hernia defects. The hernia repair could be, for example, inguinal hernia, femoral or crural hernia or ventral hernia. The SURGIMESH®WN implant is indicated for use via an extraperitoneal approach either by open or laproscopic surgery.
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Image /page/1/Picture/0 description: The image shows the logo for Aspide Medical. The logo consists of the word "ASPIDE" in a bold, sans-serif font, with the word "Medical" in a smaller font below it. There is a graphic above the word "ASPIDE" that appears to be a stylized representation of a medical symbol.
PREMARKET NOTIFICATION 510(k) SURGICAL MESH: SURGIMESH®WN
Technological Characteristics
The SURGIMESH®WN consists of non-absorbable synthetic mesh, made of nonknitted, non-woven fibers of polypropylene. SURGIMESH®WN mesh is supplied sterile and is available in rectangular and anatomic forms in order to meet the individual patient's surgical needs.
KO6144
2
Performance Data
Pre-clinical and clinical performance testing was conducted. Tissue integration, biocompatibility, product structure, and final product specifications were all tested, in addition to two clinical studies that were performed. In all instances, the SURGIMESH®WN functioned as intended and the results observed were as expected.
Substantial Equivalence
The SURGIMESH®WN is as safe and effective as: (1) Tissue Science Laboratories' Permacol synthetic mesh (K992556); (2) Davol, Inc.'s Bard Mesh (K033814); and (3) Mentor Corp.'s Obtape Mesh (K031767).
The SURGIMESH®WN has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the SURGIMESH®WN and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the SURGIMESH®WN is as safe and effective as: (1) Tissue Science Laboratories' Permacol synthetic mesh (K992556); (2) Davol, Inc.'s Bard Mesh (K033814); and (3) Mentor Corp.'s Obtape Mesh (K031767). The SURGIMESH®WN mesh's mechanical and material characteristics are substantially equivalent to its predicate devices. The biocompatibility results show that the material used in the design and manufacture of the device is non-toxic and non-sensitizing to biological tissues when used as intended. Thus, the SURGIMESH®WN is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aspide Medical % Hogan & Hartson LLP Mr. Howard M. Holstein Partner Columbia Square 555 Thirteenth Street, NW Washington, District of Columbia 20004-1109
FEB - 1 2007
Re: K061445
Trade/Device Name: SURGIMESH® WN Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: November 30, 2006 Received: November 30, 2006
Dear Mr. Holstein:
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 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.
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Page 2 - Mr. Howard M. Holstein
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 Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 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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Indications for Use Statement
510(k) Number (if known): K061445
Device Name: SURGIMESH® WN
Indications for Use:
The SURGIMESH®WN implant is recommended for reinforcement of hernia defects. The hernia repair could be, for example, inguinal hernia, femoral or crural hernia or ventral hernia. The SURGIMESH®WN implant is indicated for use via an extraperitoneal approach either by open or laproscopic surgery.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter
(21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Cevice Evaluation (ODE) (Division Sign-O Division of General, Restorative, and Ne .. Hogical Devices
510(k) ber 461445 Page _ of _
§ 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.