(337 days)
The SURGIMESH®XD mesh is recommended for reinforcement of hernia defects. The hernia repair is for an inguinal hernia. The SURGIMESH®XD implant is indicated for use via an extraperitoneal approach either by open or laparoscopic surgery.
The SURGIMESH®XD consists of non-absorbable synthetic mesh, made of polypropylene. The SURGIMESH®XD has a 3D shape to fit the inguinal anatomy. In addition, two translucent windows are incorporated into the SURGIMESH®XD implant to allow proper positioning of the implant. The two windows allow the surgeon to place the implant in the correct anatomical location using the Cooper's ligament and the spermatic cord as anatomical guides in repairing a hernia defect. SURGIMESH®XD mesh is supplied sterile.
The provided text describes a 510(k) premarket notification for a surgical mesh device, SURGIMESH®XD. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study proving the device meets those criteria.
Therefore, much of the requested information regarding specific acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a study proving the device meets acceptance criteria cannot be extracted directly from this document. The document describes pre-clinical testing for safety and materials, which are typical for substantial equivalence claims.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Device is biocompatible per ISO 10993-1 standards. |
| Sterility | Device is sterile per ISO 10993-7, ISO 1137-1, ISO 14937, and USP 28 standards. |
| Product Packaging | Device packaging has appropriate sealing characteristics per ISO 11607. |
| Device Structure & Material Characterization (Mechanical/Material Characteristics) | SURGIMESH®XD specifications (ISO 5084, ISO 3801, ISO 9073-3, ISO 9073-4, ISO 9073-7, ISO 13934-1 and ISO 13938-1) are substantially similar to identified predicate device specifications. |
| Functionality | In all instances of preclinical testing, the SURGIMESH®XD functioned as intended. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The text refers to "preclinical testing" but does not specify sample sizes for these tests or the data provenance.
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):
This information is not provided. The document describes physical and material testing, not diagnostic or interpretive tasks that would require human expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided, as the testing described doesn't involve human interpretation requiring adjudication.
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:
An MRMC study was not conducted or described. This document pertains to a medical device (surgical mesh) that does not incorporate AI or require human interpretive reading in the way an AI-powered diagnostic tool would.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A "standalone" performance in the context of an algorithm is not applicable here, as the device is a physical surgical mesh and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests mentioned would be the defined standards themselves (e.g., ISO standards for biocompatibility or sterility, or the physical characteristics of the predicate devices for material characterization). For functionality, it would be the expected function of the device under test conditions.
8. The sample size for the training set:
This information is not applicable/not provided. The device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable/not provided. The device is not an AI algorithm that requires a training set.
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ASPIDE Médical
PREMARKET NOTIFICATION 510(k) SURGICAL MESH: SURGIMESH®XD
510(k) Summary
SURGIMESH®XD
JUN 2 5 2010
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
ASPIDE MEDICAL 246 allée Lavoisier 42350 LA TALAUDIERE (FRANCE) Tel: +33 4 77 53 16 59 Fax: +33 4 77 53 01 97
Contact Person: Mr. William Wiecek
Date Prepared: June 24, 2010
Name of Device and Name/Address of Sponsor
SURGIMESH®XD
ASPIDE MEDICAL 246 allée Lavoisier 42350 LA TALAUDIERE (FRANCE)
Common or Usual Name
Polymeric Surgical Mesh
Classification Name
Surgical Mesh
Predicate Devices
(1) ASPIDE MEDICAL's SURGIMESH WN (K061445);
Intended Use / Indications for Use
The SURGIMESH®XD mesh is recommended for reinforcement of hernia defects. The hernia repair is for an inguinal hernia. The SURGIMESH®XD implant is indicated for use via an extraperitoneal approach either by open or laparoscopic surgery,
Technological Characteristics
The SURGIMESH®XD consists of non-absorbable synthetic mesh, made of polypropylene. The SURGIMESH®XD has a 3D shape to fit the inguinal anatomy.
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Image /page/1/Picture/1 description: The image shows the logo for "ASPIDE Médical". The word "ASPIDE" is in a sans-serif font, with a line underneath it. Below that, the word "Médical" is in a cursive font. Above the word "ASPIDE" is a graphic of a series of dots that form a triangle.
PREMARKET NOTIFICATION 510(k) SURGICAL MESH: SURGIMESH®XD
In addition, two translucent windows are incorporated into the SURGIMESH®XD implant to allow proper positioning of the implant. The two windows allow the surgeon to place the implant in the correct anatomical location using the Cooper's ligament and the spermatic cord as anatomical guides in repairing a hernia defect.
SURGIMESH®XD mesh is supplied sterile.
Performance Data
Preclinical testing was conducted. Biocompatibility, product structure, and final product specifications were all tested. In all instances, the SURGIMESH®XD functioned as intended and the results observed were as expected. Specifically, the company conducted the following performance testing:
- Biocompatibility testing in accordance with ISO 10993-1 standards . were conducted and results demonstrated that the device is biocompatible per these standards;
- Sterilization validation testing in accordance with ISO 10993-7, ISO . I 137-1, ISO 14937, and USP 28 and results demonstrated that the device is sterile per these standards;
- . Product packaging testing in accordance with ISO 11607 and results demonstrated that the device packaging has the appropriate sealing characteristics:
- . The device structure and product characterization testing was performed in accordance with ISO 5084, ISO 3801, ISO 9073-3, ISO 9073-4, ISO 9073-7, ISO 13934-1 and ISO 13938-1 and results demonstrated the SURGIMESH®XD specifications are substantially similar to the identified predicate device specifications. Testing was also perform in accordance with FDA's Guidance Document entitled. Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 2, 1999).
Substantial Equivalence
The SURGIMESH®XD is substantially equivalent to: (1) ASPIDE MEDICAL's SURGIMESH WN (K061445); (2) BARD's 3D MAX (K081010); and (3) PROMEDON's SAFYRE SLING (K020007).
- The SURGIMESH®XD has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the SURGIMESH®XD and its predicate devices raise no new issues of safety or effectiveness. The SURGIMESH®XD mesh's mechanical and material characteristics are substantially equivalent to its predicate devices. Thus, the SURGIMESH®XD is substantially equivalent.
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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 with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 5 2010
Aspide Medical % Hogan & Hartson, LLP Mr. Howard M. Holstein Columbia Square 555 Thirteenth Street Northwest . Washington, District of Columbia 20004-1109
Re: K092233
Trade/Device Name: SURGIMESH®XD Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 14, 2010 Received: June 14, 2010
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. Iisting 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
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Page 2 - Mr. Howard M. Holstein
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/ucm1118001.html 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" (21CFF) 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 fre 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.
Sincerely yours,
For Peter D
Mark N. Melkerson
DEP Dir
Director Division of Surgical, Orthopedic · and Restorative 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):
Device Name: SURGIMESH®XD
Indications for Use:
The SURGIMESH®XD mesh is recommended for reinforcement of hemia defects. The hernia repair is for an inguinal hernia. The SURGIMESH®XD implant is indicated for use via an extraperitoneal approach either by open or laparoscopic surgery.
...
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Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (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 Device Evaluation (ODE)
David Kramerfullxiy
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K092233
§ 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.