(253 days)
Not Found
No
The summary describes a physical surgical mesh implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a surgical mesh primarily used for structural reinforcement of hernia defects and is not described as directly administering therapy or having a therapeutic effect beyond its supportive function.
No
The device, SURGIMESH®WN, is indicated for the reinforcement of hernia defects as an implant, not for diagnosis. Its description and intended use clearly state it is a surgical mesh for repair.
No
The device description explicitly states it is a "non-absorbable synthetic mesh, made of nonknitted, non-woven fibers of polypropylene," which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SURGIMESH®WN Function: The SURGIMESH®WN is a surgical implant used to physically reinforce hernia defects. It is placed within the body during surgery.
- Lack of Specimen Analysis: The description clearly states the device is a mesh implant and does not mention any analysis of biological specimens.
Therefore, based on the provided information, the SURGIMESH®WN is a surgical implant, not an In Vitro Diagnostic device.
N/A
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.
Product codes
FTL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for "ASPIDE Médical". The word "ASPIDE" is in a large, bold font, with a line underneath it. Above the word "ASPIDE" is a graphic of small squares arranged in a diagonal line. Below the word "ASPIDE" is the word "Médical" in a smaller font.
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.
1
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
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.
3
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
4
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 _