(51 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a collagen matrix, with no mention of AI or ML.
Yes
TissueMend™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes, which are therapeutic interventions.
No
This device is a soft tissue repair matrix used for surgical reinforcement and repair of weakened or damaged soft tissues. It is a treatment device, not one that identifies or diagnoses a condition.
No
The device description clearly states it is a "remodelable collagen matrix derived from bovine skin" and is supplied in "sheet form," indicating it is a physical, biological material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for surgical repair and reinforcement of soft tissues. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a collagen matrix derived from bovine skin, designed to be implanted surgically. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), using reagents, or providing diagnostic information based on laboratory tests.
The device is a surgical implant used to physically reinforce and repair tissue, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
TissueMend™ is intended for use as a soft tissue patch to reinforce soft tissues where weakness exists and for the surgical repair of damaged or ruptured softtissue membranes. Specifically the device is indicated for use in the surgical repair of hernias such as inguinal, femoral, umbilical, and incisional hernias; thoracic wall defects; urethral procedures and vaginal prolapse; muscle flap reinforcement; reconstruction of the pelvic floor and procedures such as sacrocolposuspension and urethral sling.
Product codes
FTM
Device Description
TissueMend™ Soft Tissue Repair Matrix is a remodelable collagen matrix derived from bovine skin to be used to reinforce soft tissues where weakness exists. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed and sutured 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 tissues, hernias such as inguinal, femoral, umbilical, and incisional hernias; thoracic wall defects; urethral procedures and vaginal prolapse; muscle flap; pelvic floor
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of TissueMend™. The tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity. The manufacturing methods for TissueMend™ were also tested by an independent laboratory to assure safe levels of viral inactivation.
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
TEI BIOSCIENCES INC.
February 8, 2002
TissueMend™ Soft Tissue Repair Matrix Abbreviated 510(k) Premarket Notification
APR 0 3 2002
510(k) Summary
This 510(k) summary for TissueMend™ Soft Tissue Repair Matrix 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. Director of Product Development and Applied Research
Date Prepared
February 8, 2002
Device Information
TissueMend™ Soft Tissue Repair Matrix Proprietary name: Classification name: mesh, surgical, polymeric Device classification: Class II (21CFR878.3300)
Device Description
TissueMend™ Soft Tissue Repair Matrix is a remodelable collagen matrix derived from bovine skin to be used to reinforce soft tissues where weakness exists. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs.
Intended Use
TissueMend™ is intended for use as a soft tissue patch to reinforce soft tissues where weakness exists and for the surgical repair of damaged or ruptured softtissue membranes. Specifically the device is indicated for use in the surgical repair of hernias such as inguinal, femoral, umbilical, and incisional hernias; thoracic wall defects; urethral procedures and vaginal prolapse; muscle flap reinforcement; reconstruction of the pelvic floor and procedures such as sacrocolposuspension and urethral sling.
Legally Marketed Devices to which Equivalence is Being Claimed
TissueMend™ is substantially equivalent in function and intended use to:
| Predicate Devices | Manufacturer | 510(k) Number |
|---|---|---|
| Permacol | Tissue Science Laboratories | K992556 |
| Surgisis | Cook Biotech | K980431 |
Summary of Technological Characteristics and Biocompatibility
1
TEI BIOSCIENCES INC. February 8, 2002
TissueMend™ Soft Tissue Repair Matrix Abbreviated 510(k) Premarket Notification
TissueMend™ is substantially equivalent to other surgical meshes with respect to its design as a thin, flexible, polymeric sheet which can be sutured to surrounding tissues to secure it in place. In addition, the device is fully resorbable over a period of months.
A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of TissueMend™. The tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity. The manufacturing methods for TissueMend™ were also tested by an independent laboratory to assure safe levels of viral inactivation.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kenneth James, Ph.D. Director of Product Development and Applied Research TEI Biosciences Inc. 7 Elkins Street Boston, Massachusetts 02127
APR 0 3 2002
Re: K020455
Trade/Device Name: TissueMend™ Soft Tissue Repair Matrix Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: February 8, 2002 Received: February 11, 2002
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO20455
TEI BIOSCIENCES INC. February 8, 2002
TissueMend™ Soft Tissue Repair Matrix Abbreviated 510(k) Premarket Notification
2. Indications for Use of the Device
510(k) Number (if known): KO20455
Device Name:
TissueMend™ Soft Tissue Repair Matrix
Indications for Use: TissueMend™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical, and incisional hernias: colon, rectal, urethral, and vaginal prolapse; muscle flap reinforcement; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.
(Please do not write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-the-Counter Use Prescription Use Or (Per 21 CFR 801.109) (Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number Kc20455