(35 days)
Not Found
No
The device description and intended use focus on a biological tissue matrix for soft tissue repair and reinforcement. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies are related to biocompatibility and viral inactivation, not algorithmic performance.
Yes.
The device is intended to reinforce and repair damaged or weakened soft tissues, which is a therapeutic function.
No
The device description and intended use indicate that SurgiMend is an implant to reinforce soft tissue, not a tool for diagnosing medical conditions.
No
The device description clearly states that SurgiMend is an acellular dermal tissue matrix derived from fetal bovine dermis, which is a physical material intended for implantation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- SurgiMend's Intended Use: SurgiMend is intended for implantation to reinforce and repair soft tissue within the body. It is a surgical implant, not a device used to test specimens outside the body.
- Device Description: The description confirms it is an acellular dermal tissue matrix for implantation.
- Lack of Diagnostic Information: The intended use and description do not mention any diagnostic purpose or the analysis of biological specimens.
Therefore, SurgiMend falls under the category of a surgical implant or medical device for tissue repair, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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, . diaphragmatic, scrotal, umbilical, and incisional hernias
- Reinforcement of soft tissues repaired by sutures or suture . anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. SurgiMend is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
SurgiMend is an acellular dermal tissue matrix derived from fetal 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, muscle flap, abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, incisional hernias, rotator cuff, patellar, Achilles, biceps, quadriceps, other tendons
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K051766, K060829, K020455, K071065
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
TEI BIOSCIENCES INC.
8/2/2007
510(k) Premarket Notification
1/2
AUG -6 2007
510(k) Summary
This 510(k) summary for SurgiMend 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 Regulatory 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 fetal 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, inguinal, femoral, . diaphragmatic, scrotal, umbilical, and incisional hernias
- Reinforcement of soft tissues repaired by sutures or sutures . anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. SurgiMend is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles,
1
KC718C7
TEI BIOSCIENCES INC. 8/2/2007
SurgiMend 510(k) Premarket Notification
biceps, quadriceps or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
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 |
|---|---|---|
| OrthoMend | TEI Biosciences | K051766 |
| CosMatrix | TEI Biosciences | K060829 |
| TissueMend | TEI Biosciences | K020455 |
| OrthADAPT | Pegasus Biologics | K071065 |
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 toxicity, hemolysis, and pyrogenicity. The manufacturing methods for SurgiMend have also been tested by an independent laboratory to assure appropriate levels of viral inactivation.
2
Public Health Service
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.
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
AUG - 6 2007
Re: K071807
Trade/Device Name: SurgiMed Collagen Matrix for Soft Tissue Reconstruction Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: June 26, 2007 Received: July 9, 2007
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 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 - Kenneth James, Ph.D.
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 A. Milkeren
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
TEI BIOSCIENCES INC. 8/2/2007
SuraiMend 510(k) Premarket Notification
Indications for Use
510(k) Number (if known):
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 ruptured soft tissue membranes.
SurgiMend is specifically indicated for:
- Plastic and reconstructive surgery .
- Muscle flap reinforcement .
- Hernia repair including abdominal, inquinal, femoral, . diaphragmatic, scrotal, umbilical, and incisional hernias
- Reinforcement of soft tissues repaired by sutures or suture . anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. SurgiMend is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
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)
Mark A. Mcllhenny
(Division Sign-Of Division of General, Restorative,
510(k) Number
- 13 -