(153 days)
No
The description focuses on the mechanical design and materials of the bone anchor system, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a fixation anchor for soft tissue to bone during surgical repair, not as a device that delivers therapy.
No
The device is described as a fixation anchor for soft tissue to bone during rotator cuff repair, focusing on mechanical fixation and surgical technique, not diagnosis.
No
The device description explicitly details physical components made of PEEK and nitinol, preloaded in a delivery instrument, and intended for physical implantation during surgery. There is no mention of software as a component or function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fixation of soft tissue to bone during rotator cuff repair." This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a physical implant (bone anchor) used to secure tissue. It does not involve testing samples of bodily fluids or tissues in vitro (outside the living body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The CINCH Bone Anchor System is a surgical implant used for mechanical fixation during a surgical procedure.
N/A
Intended Use / Indications for Use
The CINCH Bone Anchor System is intended to be used for fixation of soft tissue to bone during rotator cuff repair.
Product codes
MBI
Device Description
The CINCH Bone Anchor System provides surgeons with a fixation anchor that can be used during arthroscopic shoulder procedures. The device is available in two configurations, the CINCH WRC Anchor and the CINCH RRC Anchor. Both configurations are provided pre-loaded in a delivery instrument.
The CINCH WRC Anchor configuration is comprised of a curved PEEK base, a flared nitinol clip, two nitinol laser cut rings and a nitinol anchor pin. The device is preloaded in the CINCH Inserter
The CINCH RRC Anchor, is comprised of a machine molded cylindrical PEEK base, two nitinol laser cut rings and a nitinol anchor pin This device is also preloaded in a CINCH Inserter.
The design of the CINCH Bone Anchors is intended to permit surgeons to have direct tactile feedback of the tension in the suture between the tissue and the bone. Additionally, the CINCH Anchors are designed to allow the two ends of a suture to be individually adjusted. This permits the surgeon to fine-tune the placement of the tissue with respect to the bone, and then secure the suture without tying a knot.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue to bone during rotator cuff repair
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)
Results of bench testing demonstrate that the CINCH Bone Anchor System meets its specifications and does not raise new issues of safety or effectiveness. In all instances, the CINCH Bone Anchor functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DePuy/Mitek Products, Rotator Cuff QuickAnchor® Plus, K062739
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
510(k) SUMMARY
SAPPHIRE MEDICAL, INC. CINCH™ BONE ANCHOR SYSTEM
FEB 1 3 2007
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Sapphire Medical, Inc 690 Oak Grove Avenue Menlo Park, CA 94025
Phone: 650-322-3544 Facsimile: 650-322-3546
Contact Person: Brooke Campbell
Date Prepared: September 13, 2006
Name of Device and Name/Address of Sponsor
CINCH Bone Anchor System
Sapphire Medical, Inc 690 Oak Grove Avenue Menlo Park, CA 94025
Common or Usual Name
Bone Anchor
Classification Name
Class II Classification: Classification Name: Fastener, fixation, nondegradable, soft tissue.
Predicate Devices
- DePuy/Mitek Products, Rotator Cuff QuickAnchor® Plus .
- Linvatec Corporation, UltraFix® RC .
- ArthroCare Corporation, Opus® Magnum .
- Arthrex, Inc., PEEK Corkscrew FT ●
- Smith & Nephew, Inc., BioRaptor 2.9 Suture Anchor .
1
Intended Use / Indications for Use
The CINCH Bone Anchor System is intended to be used for fixation of soft tissue to bone during rotator cuff repair.
Device Description
The CINCH Bone Anchor System provides surgeons with a fixation anchor that can be used during arthroscopic shoulder procedures. The device is available in two configurations, the CINCH WRC Anchor and the CINCH RRC Anchor. Both configurations are provided pre-loaded in a delivery instrument.
The CINCH WRC Anchor configuration is comprised of a curved PEEK base, a flared nitinol clip, two nitinol laser cut rings and a nitinol anchor pin. The device is preloaded in the CINCH Inserter
The CINCH RRC Anchor, is comprised of a machine molded cylindrical PEEK base, two nitinol laser cut rings and a nitinol anchor pin This device is also preloaded in a CINCH Inserter.
The design of the CINCH Bone Anchors is intended to permit surgeons to have direct tactile feedback of the tension in the suture between the tissue and the bone. Additionally, the CINCH Anchors are designed to allow the two ends of a suture to be individually adjusted. This permits the surgeon to fine-tune the placement of the tissue with respect to the bone, and then secure the suture without tying a knot.
Performance Data
Results of bench testing demonstrate that the CINCH Bone Anchor System meets its specifications and does not raise new issues of safety or effectiveness. In all instances, the CINCH Bone Anchor functioned as intended.
Biocompatibility Data
The materials used in the CINCH Bone Anchor System are biocompatible. The same materials are commonly used in similar medical devices.
Substantial Equivalence
The CINCH Bone Anchor System is substantially equivalent to the DePuy/Mitek Products' Rotator Cuff QuickAnchor® Plus, Arthrex, Inc.'s PEEK Corkscrew FT, Smith & Nephew, Inc.'s BioRaptor 2.9 Suture Anchor, and Linvatec Corporation's UltraFix® RC. The CINCH Bone Anchor System has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the CINCH Bone Anchor System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the CINCH Bone Anchor System is as safe and effective as the predicate devices. Thus, the CINCH Bone Anchor System is substantially equivalent.
2
Summary
1 1 1
Based on the intended use, technological characteristics, and performance information Based on this notification, the subject device has been shown to be substantially provided in this nothriouncil, the such predicate devices.
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 or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sapphire Medical, Inc. % Janice M. Hogan, Esq. Partner Hogan & Hartson, L.L.P. 1835 Market Street, 28th Floor Philadelphia, Pennsylvania 19103
FEB 1 3 2007
Re: K062739
Trade/Device Name: CINCH Bone Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 26, 2007 Received: January 26, 2007
Dear Ms. Hogan:
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.
4
Page 2 - Janice M. Hogan, Esq.
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. 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Budara Muehlus
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: CINCH Bone Anchor System
Indications for Use:
The CINCH Bone Anchor System is intended for the fixation of soft tissue to bone during rotator cuff repair.
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oalbara Barehn
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K062739
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