(73 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 technologies.
No
The device is a collagen matrix intended to reinforce soft tissue, not to provide therapy or treatment for a disease.
No
The device, OrthoMend, is described as a remodelable collagen matrix intended for surgical implantation to reinforce and repair soft tissue. Its use is therapeutic (reinforcement and repair), not for diagnosing conditions.
No
The device description clearly states that OrthoMend is a "remodelable collagen matrix" supplied in "sheet form," indicating it is a physical implantable 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 states that OrthoMend is for "surgical implantation to reinforce soft tissue" and "repair of damaged or ruptured soft tissue membranes." This describes a device used in vivo (within the body) for structural support and repair.
- Device Description: The description reinforces this by stating it's a "remodelable collagen matrix used to reinforce soft tissues" and is "supplied sterile and is provided in sheet form to be trimmed and sutured by the surgeon." This is consistent with a surgically implanted device.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or diagnostic purposes.
Therefore, OrthoMend is a surgically implanted medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
OrthoMend is intended for surgical implantation to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes. In addition, the device is intended to reinforce soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff surgery.
Product codes
FTL
Device Description
OrthoMend is a remodelable collagen matrix 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 tissue, supraspinatus
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 OrthoMend™. The tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity. The manufacturing methods for OrthoMend™ 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. JUN 2 7 2003 June 25, 2003
OrthoMend™
Abbreviated 510(k) Premarket Notification
K031188/P1/2
510(k) Summarv
This 510(k) summary for OrthoMend 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
June 25, 2003
Device Information
OrthoMend Proprietary name: Classification name: mesh, surgical, polymeric Device classification: Class II (21CFR878.3300)
Device Description
OrthoMend is a remodelable collagen matrix 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
OrthoMend is intended for surgical implantation to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes. In addition, the device is intended to reinforce soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff surgery.
Legally Marketed Devices to which Equivalence is Being Claimed
OrthoMend™ is substantially equivalent in function and intended use to:
| Predicate Devices | Manufacturer | 510(k) Number |
|---|---|---|
| TissueMend Soft | ||
| Tissue Repair Matrix | TEI Biosciences, Boston, MA | K020455 |
| Restore Orthobiologic | ||
| Soft Tissue Implant | DePuy, Warsaw, IN | K001738 |
1
TEI BIOSCIENCES INC. June 25, 2003
OrthoMend™
31188
Abbreviated 510(k) Premarket Notification
Summary of Technological Characteristics and Blocompatibility
OrthoMend™ 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 OrthoMend™. The tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity. The manufacturing methods for OrthoMend™ were also tested by an independent laboratory to assure safe levels of viral inactivation.
2
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 caduceus symbol, which is a staff with two snakes coiled around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2003
Kenneth James, Ph.D. Director of Product Development and Applied Research TEI Biosciences, Inc. 7 Elkins Street Boston, Massachusetts 02127
Re: K031188
Trade/Device Name: OrthoMend Regulation Number: 21 CFR 878.3300 Regulation Name: mesh, surgical, polymeric Regulatory Class: II Product Code: FTL Dated: April 8, 2003 Received: April 16, 2003
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 (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) you may obtain. 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,
Muram' C. Provost
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
TEI BIOSCIENCES INC. June 25, 2003
OrthoMend™ Abbreviated 510(k) Premarket Notification
2. Indications for Use of the Device
510(k) Number (if known):
OrthoMend Device Name:
Indications for Use: OrthoMend is intended for surgical implantation to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes. In addition, the device is intended to reinforce soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff surgery.
(Please do not write below this line-continue on another page if needed)
★ ★ ★ ★ . . . e ▲ t
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Or Over-the-Counter Use (Optional Format 1-2-96) (Per 21 CFR 801.109)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K'031188