(228 days)
Not Found
No
The 510(k) summary describes a synthetic absorbable surgical mesh for soft tissue reinforcement and does not mention any AI or ML components or functionalities.
Yes
The device is intended to reinforce soft tissues and repair fascial defects, which are therapeutic actions to treat a medical condition.
No
Explanation: The "Intended Use / Indications for Use" section describes the device as a "Scaffold" or "reinforcing or bridging material" for soft tissue repair, and the "Device Description" states it is a "synthetic absorbable reinforced woven fabric." These descriptions clearly indicate it is a therapeutic device used for structural support, not for diagnosing a condition.
No
The device description clearly states it is a "bi-layer, synthetic absorbable reinforced woven fabric made from poly(4-hydroxybutyrate) fibers," which is a physical material, not software.
Based on the provided information, the Tornier® BioFiber Scaffold is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Tornier® BioFiber Scaffold's Intended Use: The intended use clearly states that the device is for "temporary wound support to reinforce soft tissues" and "reinforcement of soft tissues... during tendon repair surgery." This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details a "bi-layer, synthetic absorbable reinforced woven fabric" made from poly(4-hydroxybutyrate) fibers. This is a material designed for implantation, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or any other activities associated with in vitro diagnostics.
Therefore, the Tornier® BioFiber Scaffold is a surgical implant device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Tornier® BioFiber Scaffold is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Tornier® BioFiber Scaffold is intended for reinforcement of soft tissues, in conjunction with sutures and/or suture anchors during tendon repair surgery; including the reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps tendons.
Tornier® BioFiber Scaffold is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
Tornier® BioFiber Scaffold is a bi-layer, synthetic absorbable reinforced woven fabric made from poly(4-hydroxybutyrate) fibers. The construction permits the mesh to be cut into anv desired shape or size without unraveling. The device is supplied sterile, for sinqle-patient use for the reinforcement of soft tissue where weakness exists.
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 and quadriceps 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.
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.
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510(k) SUMMARY (Per 21 CFR 807.92)
.
General Company Information
MAY 1 0 2011
Tornier, Inc. Name:
Lael J. Pickett Contact: Director Regulatory and Clinical Affairs Tornier, Inc.
Office: 952-426-7641 Cell: 612-219-7350 Fax: 952-426-7601 Email: Ipickett@tornier.com
Date Prepared April 15, 2010
General Device Information
- Product Name: Tornier® BioFiber Scaffold
- "Absorbable Surgical Mesh" Classification: Product code: FTL - Class II
Predicate Device
Tepha, Inc. | TephaFLEX™ Surgical Mesh |
---|---|
[510(k) Number K070894] |
Tornier, Inc. | Tornier ® Surgical Mesh |
---|---|
[510(k) Number K093799] |
1
Description
Tornier® BioFiber Scaffold is a bi-layer, synthetic absorbable reinforced woven fabric made from poly(4-hydroxybutyrate) fibers. The construction permits the mesh to be cut into anv desired shape or size without unraveling. The device is supplied sterile, for sinqle-patient use for the reinforcement of soft tissue where weakness exists.
Intended Use (Indications)
Tornier® BioFiber Scaffold is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Tornier® BioFiber Scaffold is intended for reinforcement of soft tissues, in conjunction with sutures and/or suture anchors during tendon repair surgery; including the reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps tendons.
Tornier® Surgical Mesh is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.
Substantial Equivalence
This submission supports the position that the Tornier™ BioFiber Scaffold is substantially equivalent to previously cleared devices, including those listed above. A number of predicate devices list the same range of clinical uses. Scientific evidence of substantial equivalence has been previously submitted to FDA. The device that is the subject of this submission is exactly the same device as the Tornier predicate device.
Conclusions
Tornier, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Tornier® Surgical Mesh. The materials from which the Tornier device is fabricated have an established history of use, and the device has been tested in accordance with applicable FDA guidelines.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an emblem that resembles a stylized eagle or bird-like figure, composed of three curved lines that suggest wings and a body. The emblem is black, and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Tornier, Inc. % Mr. Howard L. Schraver 100 Cummings Center - Suite 444C Beverly, Massachusetts 015
MAY 1 0 2011
Re: K102788
Trade/Device Name: Tornier® BioFiber Scaffold Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 15, 2011 Received: April 18, 2011
Dear Mr. Schrayer:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Mr. Howard L. Schrayer
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, Part , 807,97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/McdicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Tornier® BioFiber Scaffold
Indications For Use:
Tornier® BioFiber Scaffold is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Tornier® BioFiber Scaffold is intended for reinforcement of soft tissues, in conjunction with sutures and/or suture anchors during tendon repair surgery; including the reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps tendons.
Tornier® BioFiber Scaffold is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical 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)
Daniel Krumlauf MXM
(Division Sign. Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number