(37 days)
SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Plastic and reconstructive surgery Muscle flap reinforcement Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias
SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
This document is a 510(k) Premarket Notification for a medical device called SurgiMend Collagen Matrix for Soft Tissue Reconstruction. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text.
The document primarily states:
- Device Description: SurgiMend is an acellular dermal tissue matrix derived from bovine dermis for soft tissue reinforcement and repair.
- Intended Use: Plastic and reconstructive surgery, muscle flap reinforcement, and hernia repair.
- Predicate Devices: SurgiMend (K071807) and TissueMend (K020488) from TEI Biosciences.
- Technological Characteristics: Substantially equivalent to other surgical meshes.
- Biocompatibility: A rigorous assessment by an independent laboratory demonstrated biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular implantation, hemolysis, and pyrogenicity). Viral inactivation methods were also tested.
Essentially, this submission asserts that the new SurgiMend device is safe and effective because it is fundamentally the same as devices already on the market, which presumably had their safety and effectiveness established through other means (e.g., prior clinical data for older predicate devices, or through general knowledge of the safety of collagen matrix materials). There is no "study that proves the device meets the acceptance criteria" in the format of specific performance metrics against pre-defined thresholds.
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TEI BIOSCIENCES INC.
1/23/2008
SurgiMend Special 510(k) Premarket Notification
K08 3898
510(k) Summary
K08 3878
1/2
FEB - 4 2009
This 510(k) summary for SurqiMend is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitted by
TEI Biosciences Inc. 7 Elkins Street Boston, MA 02127 (617) 268-1616 (617) 268-3282 (fax)
Contact Person
Kenneth James, Ph.D. Vice President, Product Sciences and Requlatory Affairs
Date Prepared
July 31, 2007
Device Information
Proprietary name: SurgiMend Collagen Matrix for Soft Tissue Reconstruction Classification name: Surgical Mesh Device classification: Class II
Device Description
SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
Intended Use
SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
SurgiMend is specifically indicated for:
- Plastic and reconstructive surgery
- Muscle flap reinforcement
- Hernia repair including abdominal, inquinal, femoral, diaphraqmatic, scrotal, umbilical, and incisional hernias
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Legally Marketed Devices to which Equivalence is Being Claimed
SurgiMend is substantially equivalent in function and intended use to:
| Predicate Device | Manufacturer | 510(k) Number |
|---|---|---|
| SurgiMend | TEI Biosciences | K071807 |
| TissueMend | TEI Biosciences | K020488 |
Summary of Technological Characteristics and Biocompatibility
SurgiMend is substantially equivalent to other surgical meshes with respect to its design and intended use.
A rigorous biocompatibility assessment performed by an independent laboratory demonstrated the biocompatibility of SurgiMend. The tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular implantation, hemolysis, and pyrogenicity. The manufacturing methods for SurgiMend have also been tested by an independent laboratory to assure appropriate levels of viral inactivation.
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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 with three stripes forming its wing and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
FEB - 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TEI Biosciences, Inc. % Kenneth James, Ph.D. VP, Product Sciences and Regulatory Affairs 7 Elkins Street Boston, Massachusetts 02127
Re: K083898
Trade/Device Name: SurgiMend Collagen Matrix for Soft Tissue Reconstruction Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: January 23, 2009 Received: January 26, 2009
Dear Dr. James:
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 - Kenneth James, Ph.D.
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 Pestmarket, 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 vours.
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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SurqiMend Special 510(k) Premarket Notification
Ka 83898
Indications for Use
510(k) Number (if known): K083898
Device Name: SurgiMend Collagen Matrix for Soft Tissue Reconstruction
Indications for Use:
SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptwred soft tissue membranes.
SurgiMend is specifically indicated for:
- Plastic and reconstructive surgery .
- Muscle flap reinforcement
- Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias
Prescription Use | (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off Division of General, Restorative, and Neurological Devices
§ 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.