(76 days)
Not Found
No
The device description and intended use focus on a mechanical implant for soft tissue fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is intended for fixation of soft tissue to bone in various anatomical locations for repair and reconstruction, which directly addresses medical conditions and aims to restore normal function.
No
The device is described as an implant intended for fixation of soft tissue to bone, not for diagnosis.
No
The device description clearly outlines physical components like a bone anchor, inserter, suture, nitinol base, titanium rings, and a titanium cross pin. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "fixation of soft tissue to bone" for various surgical procedures. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a physical implant (bone anchor) and its insertion system. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biomarkers, detecting pathogens, or any other activity typically associated with in vitro diagnostics.
In vitro diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for structural repair.
N/A
Intended Use / Indications for Use
The Tornier CINCH™ Knotless Fixation Implant is intended for fixation of soft tissue to bone.
The CINCH™ Implant is intended for use in the following applications:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
- Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Illiotibial Band Tenodesis
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
Product codes
MBI
Device Description
The CINCH™ Knotless Fixation Implant System includes a 3.5 mm diameter bone anchor and a disposable preloaded anchor Inserter. The CINCH™ Knotless Fixation Implant is designed to secure soft tissue to bone using USP #2 high strength non-absorbable UHMWPE braided suture. The CINCH™ system includes a Suture Loading Assembly that is attached to the distal end of the Inserter Handle. The CINCH™ Bone Anchor is a knotless fixation device eliminating the need for surgical knots. The device is designed for inserting the implant directly into bone without a pre-drilled, punched, or tapped pilot hole.
The CINCH™ Anchor configuration is comprised of a curved nitinol base, a flared nitinol clip, two titanium rings and a titanium cross pin. The CINCH™ Anchor is 12.9 mm long from rings to tip and 3.5 mm in diameter prior to wing deployment and 7.4 mm wide with wings expanded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Hand/Wrist, Elbow, Pelvis
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)
K073226, K070227, K0061665, K002487
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K080335 (pg 1 of 3)
APR 2 3 2008 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
| Name: | Tornier, Inc. |
|---|---|
| Contact: | Howard Schrayer |
| Regulatory Affairs Consultant |
- 100 Cummings Center Address: Suite 444C Beverly, MA 01915
- Telephone: (978) 232 - 9997 (978) 232 — 9998 Fax:
- Date Prepared February 6, 2008
General Device Information
| Product Name: | CINCH™ Knotless Fixation Implant System |
|---|---|
| Classification: | "Non-degradable soft tissue fixation fastener" |
| Product code: MBI - Class II |
Predicate Device
| C2M Medical, Inc. | CINCH™ Knotless Fixation Implant System.
[510(k) Number K073226] |
|-------------------|---------------------------------------------------------------------|
| ArthroCare Corp. | Opus® Magnum™ PI Knotless Fixation Device
[510(k) K070227] |
| Arthrex, Inc. | Arthrex Corkscrew FT
[510(K) K0061665] |
| Mitek Products | Mini QuickAnchor® Plus
[510(K) K002487] |
1
K080 335 (pg. 2 of 3)
Description
The CINCH™ Knotless Fixation Implant System includes a 3.5 mm diameter bone anchor and a disposable preloaded anchor Inserter. The CINCH™ Knotless Fixation Implant is designed to secure soft tissue to bone using USP #2 high strength non-absorbable UHMWPE braided suture. The CINCH™ system includes a Suture Loading Assembly that is attached to the distal end of the Inserter Handle. The CINCH™ Bone Anchor is a knotless fixation device eliminating the need for surgical knots. The device is designed for inserting the implant directly into bone without a pre-drilled, punched, or tapped pilot hole.
The CINCH™ Anchor configuration is comprised of a curved nitinol base, a flared nitinol clip, two titanium rings and a titanium cross pin. The CINCH™ Anchor is 12.9 mm long from rings to tip and 3.5 mm in diameter prior to wing deployment and 7.4 mm wide with wings expanded.
Intended Use (Indications)
The Tornier CINCH™ Knotless Fixation Implant is intended for fixation of soft tissue to bone.
The CINCH™ Implant is intended for use in the following applications:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps . Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux . Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
- Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar . Tendon Repair, Posterior Oblique Ligament Repair. Illiotibial Band Tenodesis
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament . Reconstruction, Radial Collateral Ligament Reconstruction
- . Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral . hypermobility or intrinsic sphincter deficiency
2
K080335 (pg. 3 of 3)
Substantial Equivalence
This submission supports the position that the Tornier CINCH™ Knotless Fixation Implant System is substantially equivalent to a number of pre-enactment and previously cleared devices, including those listed above. A number of the referenced predicate devices list the same range of clinical uses.
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 CINCH™ Knotless Fixation Implant System. The materials from which the Tornier device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2008
Tornier, Inc. c/o Mr. Howard Schrayer 100 Cummings Center Suite 444C Beverly, MA 01915
K080335 Trade/Device Name: Tornier, CINCHTM Knotless Fixation Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 6, 2008 Received: February 7, 2008
Dear Mr. Schrayer:
Re:
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. Iisting 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.
4
Page 2 - Mr. Howard Schrayer
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KOBO335
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Tornier, CINCH™ Knotless Fixation Implant System
Indications For Use:
The Tornier CINCH™ Knotless Fixation Implant is intended for fixation of soft tissue to bone.
The CINCH™ Implant is intended for use in the following applications: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Illiotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil Re. Ogl for nxn
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number K080335