(301 days)
The SURGIMESH®XB is intended to be used for the reinforcement of tissues during surgical repair.
The SURGIMESH®XB is indicated for use in: the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera.
The SURGIMESH®XB surgical mesh is a non-absorbable synthetic mesh, made of nonknitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The SURGIMESH®XB mesh is supplied sterile and is available in anatomic forms in order to meet the individual patient's surgical needs. The use of SURGIMESH®XB mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera.
This 510(k) summary is for a medical device (SURGIMESH®XB surgical mesh) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics in the way a diagnostic AI device submission would.
Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory document.
Here's an attempt to address the points based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present:
Acceptance Criteria and Study for SURGIMESH®XB
The submission for SURGIMESH®XB is a 510(k) premarket notification, which establishes substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. It does not typically involve defining specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) in the same way an AI diagnostic algorithm would, nor does it present a clinical trial with a test set, ground truth experts, or MRMC studies.
Therefore, the "acceptance criteria" for a device like SURGIMESH®XB are implicitly tied to demonstrating that its mechanical, material, and biocompatibility characteristics are "substantially equivalent" to predicate devices, which are themselves deemed safe and effective.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-toxic and non-sensitizing | "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." |
| Mechanical/Material Characteristics: Substantially equivalent to predicate devices | "The SURGIMESH®XB mesh's mechanical and material characteristics are substantially equivalent to its predicate devices." |
| Intended Use: Reinforcement of tissues during surgical repair for hernias and soft tissue deficiencies; temporary bridging of fascial defects; silicone layer minimizes tissue attachment to viscera. | "The SURGIMESH®XB has the same intended uses and similar indications... as its predicate device." |
| Technological Characteristics: Non-absorbable synthetic mesh, non-knitted, non-woven polypropylene fibers, one surface coated with silicone, supplied sterile, available in anatomic forms. | "The SURGIMESH®XB has... similar technological characteristics, and principles of operation as its predicate device." |
| Safety and Effectiveness: As safe and effective as predicate devices. | "Performance data demonstrate that the SURGIMESH®XB is as safe and effective as [listing 6 predicate devices]." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not Applicable. This submission does not describe a clinical "test set" in the context of diagnostic performance. The evaluation is based on material testing and comparison to predicates.
- Data Provenance: Not Applicable. No patient data or clinical study dataset is described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not Applicable. No ground truth establishment by experts is described for this type of device submission.
- Qualifications of Experts: Not Applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not Applicable. No test set requiring expert adjudication 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
- MRMC Study: No. This is a surgical mesh, not an AI diagnostic device for human readers.
- Effect Size: Not Applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not Applicable. This is a surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not Applicable. The "ground truth" concept for a surgical mesh revolves around proven safety and effectiveness of similar devices and the demonstration of equivalent physical, mechanical, and biological properties. It's not based on case-level diagnoses or outcomes in a study, but rather on material science and biocompatibility testing.
8. The Sample Size for the Training Set
- Sample Size: Not Applicable. This is a surgical mesh, not an AI device that uses a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not Applicable.
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K072974
pg 1082
510(k) SUMMARY
Aspide Medical's SURGIMESH®XB
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
ASPIDE MEDICAL Impasse George SAND 246 Allée LAVOISIER 42350 LA TALAUDIERE (FRANCE)
Phone: +33 4 77 53 16 59 Facsimile: +33 4 77 53 01 97
Contact Person: Mr. William WIECEK
Date Prepared: August 8, 2008
Name of Device and Name/Address of Sponsor
SURGIMESH®XB
ASPIDE MEDICAL Impasse George SAND 246 Allée LA VOISIER 42350 LA TALAUDIERE (FRANCE)
Common or Usual Name
Polymeric Surgical Mesh
Classification Name
Surgical Mesh Product Code: FTL Regulation Number: 21 C.F.R. 878.3300
Predicate Devices
- (1) ASPIDE MEDICAL SURGIMESH®WN (K061445)
- (2) Sofradim Production's Parietex Composite mesh (K040998)
- (3) AMS triangle silicone-coated sling (K002721)
- (4) Gore-Tex® DualMesh® PLUS Biomaterial with Holes (K010228)
- (5) Davol Inc., Bard® Soft Mesh (K033814)
- (6) Davol Inc., Bard Composix® L/P Mesh (K061754)
1
\\DC - 024886/000001 - 2767007 v1
AUG 1 8 2008
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Intended Use / Indications for Use
The SURGIMESH®XB is intended to be used for the reinforcement of tissues during surgical repair.
The SURGIMESH®XB is indicated for use in: the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera.
Technological Characteristics
The SURGIMESH®XB surgical mesh is a non-absorbable synthetic mesh, made of nonknitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The SURGIMESH®XB mesh is supplied sterile and is available in anatomic forms in order to meet the individual patient's surgical needs. The use of SURGIMESH®XB mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Performance Data
The SURGIMESH®XB 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
Substantial Equivalence
The SURGIMESH®XB is as safe and effective as the (1) the ASPIDE MEDICAL SURGIMESH®WN; (2) the Sofradim Production's Parietex Composite mesh; (3) the AMS triangle silicone-coated sling; (4) the Gore-Tex® DualMesh® PLUS Biomaterial with Holes; (5) the Davol Inc., Bard® Soft Mesh; and (6) the Duvol Inc., Bard® Composix® L/P Mesh. The SURGIMESH®XB 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®XB and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the SURGIMESH®XB is as safe and effective as (1) the ASPIDE MEDICAL SURGIMESH®WN; (2) the Sofradim Production's Parietex Composite mesh; (3) the AMS triangle silicone-coated sling; (4) the Gore-Tex® DualMesh® PLUS Biomaterial with Holes; (5) the Davol Inc., Bard® Soft Mesh; and (6) the Davol Inc., Bard® Composix® L/P Mesh. Thus, the SURGIMESH®XB is substantially equivalent.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aspide Meccal % Hogan & Hartson, LLP Mr. Howard M. Holstein, Esq. Columbia Square 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
AUG 1 8 2008
Re: K072974
Trade/Device Name: SURGIMESH®XB Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 8, 2008 Received: August 8, 2008
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
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and a ribbon flowing beneath it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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Page 2 - Mr. Howard M. Holstein, Esq.
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. Mulkerson
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):
Device Name: SURGIMESH®XB
Indications for Use:
The SURGIMESH®XB is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera.
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)
Mark A. Malkuss
Division of Ge and New 510(k) Number
§ 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.