(42 days)
Not Found
No
The document describes a collagen matrix for soft tissue repair and does not mention any AI or ML components or functionalities.
No.
The device is described as a remodelable collagen matrix intended for reinforcement of soft tissues during tendon repair surgery, specifically stating it reinforces soft tissue and provides a remodelable scaffold, it is not intended to provide mechanical strength. This fits the definition of a regenerative medical device or implant, rather than a therapeutic device that actively treats a disease or condition.
No
The device description and intended use indicate that OrthoMend Soft Tissue Repair Matrix is a scaffold used to reinforce soft tissues during surgical repair, not to diagnose medical 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- OrthoMend's Function: OrthoMend is a physical matrix intended for surgical implantation to reinforce soft tissues within the body during tendon repair. It is a surgical implant, not a diagnostic test performed on a sample.
The description clearly states its use in surgery to reinforce tissues, which is a therapeutic or supportive function, not a diagnostic one.
N/A
Intended Use / Indications for Use
OrthoMend Soft Tissue Repair Matrix is intended for 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.
OrthoMend Soft Tissue Repair Matrix is not intended to replace normal body structure or provide the 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. OrthoMend Soft Tissue Repair Matrix reinforces soft tissues and provides a remodelable scaffold that is replaced by the patient’s own soft tissues.
Product codes
FTL
Device Description
OrthoMend is a remodelable collagen matrix used to reinforce soft tissues. OrthoMend 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, rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Prescription Use
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)
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
K051766 1/2
TEI BIOSCIENCES INC. June 29, 2005
AUG I 1 2005 Abbreviated 510(k) Premarket Notification
510(k) Summary
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. Senior Director of Product and Clinical Sciences
Date Prepared
June 29, 2005
Device Information
OrthoMend Proprietary name: Classification name: mesh, surgical, polymeric Device classification: Class II (21CFR878.3300)
Device Description
Description
OrthoMend is a remodelable collagen matrix used to reinforce soft tissues Of thoMend 15 a remodelable contage is supplied sterile and is provided in sheet whiche wouldess exises
form in a variety of sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs.
Intended Use
OrthoMend Soft Tissue Repair Matrix is intended for reinforcement of soft Orthomend Sort 1155de Repair many anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
OrthoMend Soft Tissue Repair Matrix is not intended to replace normal body Of thomend sore risous with mechanical strength to support tendon repair of structure of provide the Achilles, biceps, quadriceps or other tendons. che rocator carr, patchar, Aear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. cissue to the bothe price Repair Matrix reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient's own soft tissues.
1
KOS1766 2/2
Abbreviated 510(k) Premarket Notification
Legally Marketed Devices to which Equivalence is Being Claimed / Marketed Devices to which Equivalent in function and intended use to:
Predicate Devices | Manufacturer | 510(k) Number |
---|---|---|
OrthoMend | TEI Biosciences, Boston, MA | K031188 |
CuffPatch Surgical | ||
Mesh | Organogenesis, Canton, MA | K042809 |
Fortaflex Surgical | ||
Mesh (CuffPatch) | Organogenesis, Canton, MA | K020049 |
Summary of Technological Characteristics and Biocompatibility
al y of Technological Characterially equivalent to other surgical meshes with respect to of thomend is substancially bequence sheet which can be sutured to its design as a chin, Romana) 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 taboratory demonsticity, sensitization, intracutaneous reactivity, performed included. The occoxicity, intramuscular toxicity, hemolysis, and acute systemic toxicity, genocoing methods for OrthoMend were also tested by pyrogenient laboratory to assure safe levels of viral inactivation.
2
Image /page/2/Picture/1 description: The image contains the words "Public Health Service". The text is in a bold, sans-serif font. The words are stacked on top of each other.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.
AUG 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kenneth James, Ph.D. Sr. Director of Product and Clinical Sciences TEI Biosciences Inc. 7 Elkins Street Boston, Massachusetts 02127
Re: K051766
Trade/Device Name: OrthoMend Soft Tissue Repair Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 29, 2005 Received: June 30, 2005
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) rms letter witification. The FDA finding of substantial equivalence of your device to a legally premained noticate 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Barbara Bucher
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KOS1766
TEI BIOSCIENCES INC. June 29, 2005
OrthoMend™ Abbreviated 510(k) Premarket Notification
- Indications for Use
510(k) Number (if known):
OrthoMend Soft Tissue Repair Matrix Device Name:
Indications For Use:
OrthoMend Soft Tissue Repair Matrix is intended for reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery, including repulled by Jacares of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
OrthoMend Soft Tissue Repair Matrix is not intended to replace normal body structure Or chowend 50.1 Hissechanical strength to support tendon repair of the rotator cuff, or provide the ruti meenantear or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide cear and sucales of bono ar the tendon repair. OrthoMend Soft Tissue Repair Matrix bronfection of the ong not provides a remodelable scaffold that is replaced by the patient's own soft tissues.
Prescription Use X (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)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Ourbare buend for melkerson
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K051766