(22 days)
Not Found
Not Found
No
The summary describes a mechanical implant system for soft tissue fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an implant system used for fixation during rotator cuff repair, which is a surgical procedure. While it aids in the healing process, it does not provide therapy in the sense of treating a disease or condition through non-surgical means or by actively changing the body's chemistry or function. Its primary role is mechanical support.
No
The device description and intended use clearly state that it is for "fixation of soft tissue to bone during rotator cuff repair," which is a treatment or surgical function, not a diagnostic one. There is no mention of identifying or characterizing a medical condition.
No
The device description explicitly states it includes a physical implant (Anchor) and an inserter, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the fixation of soft tissue to bone during rotator cuff repair." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is an "Implant System" consisting of "suture anchors." This is a physical device implanted into the body.
- 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. This device does not perform any such tests on samples.
The information provided clearly indicates this is a surgical implant used for mechanical fixation within the body, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The CINCHT™ Knotless Fixation Implant System is intended to be used for fixation of soft tissue to bone during rotator cuff repair.
The CINCH™ Knotless Fixation Implant System is intended for the fixation of soft tissue to bone during rotator cuff repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The CINCHT™ Knotless Fixation Implant includes single-use, sterile Anchor (3.5mm in diameter), which is preloaded onto a disposable anchor inserters.
The CINCH™ Knotless Fixation Implant System is comprised of nondegradable suture anchors each pre-loaded onto an inserter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue to bone
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™ Knotless Safety and Performance: Fixation Implant System meets its specifications and does not raise new issues of safety or effectiveness. In all instances, the CINCH™ Knotless Fixation Implant functioned as intended.
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.
Not Found
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
§ 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.
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DEC 0 7 2007
Page 1/2 510(k) Number K073226
510(k) Summary
| Trade Name: | CINCHT™ Knotless Fixation Implant System |
|---|---|
| Sponsor: | C2M Medical, Inc. |
| 3463 Magic Drive, Suite 320 | |
| San Antonio, Texas 78229 | |
| Telephone: 1-877-300-5010 | |
| Fax: 1-210-582-5811 | |
| Contact Person: Gabriele G. Niederauer, Ph.D. | |
| Date of Summary: | November 13, 2007 |
| Device Classification Name: | 21 CFR §888.3040 |
| Fastener, fixation, nondegradable, soft tissue | |
| Classification: | According to Section 13 of the Federal Food, Drug and |
| Cosmetic Act, the device classification is Class II, | |
| Performance Standards. | |
| Predicate Devices: | Original CINCHT™ Bone Anchor System |
| DePuy/Mitek Rotator Cuff QuickAnchor® Plus | |
| Device Description: | The CINCHT™ Knotless Fixation Implant includes single- |
| use, sterile Anchor (3.5mm in diameter), which is | |
| preloaded onto a disposable anchor inserters. | |
| Purpose of the | |
| Special 510(k) notice: | The CINCHT™ Knotless Fixation Implant System is a |
| modification to the original CINCHTM Bone Anchor | |
| System | |
| Indications for Use: | The CINCHT™ Knotless Fixation Implant System is |
| intended to be used for fixation of soft tissue to bone during | |
| rotator cuff repair. |
Results of bench testing demonstrate that the CINCH™ Knotless Safety and Performance: Fixation Implant System meets its specifications and does not raise new issues of safety or effectiveness. In all instances, the CINCH™ Knotless Fixation Implant functioned as intended.
Technological Characteristics
.
1
The CINCH™ Knotless Fixation Implant System is comprised of nondegradable suture anchors each pre-loaded onto an inserter.
Substantial Equivalence
The modified CINCH™ Knotless Fixation Implant System is substantially equivalent to the original CINCH™ Bone Anchor System and DePuy/Mitek Products' Rotator Cuff QuickAnchor® Plus. The CINCH™ Knotless Fixation Implant 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™ Knotless Fixation Implant System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the CINCH™ Knotless Fixation Implant System is as safe and effective as the predicate devices. Thus, the CINCH™ Knotless Fixation Implant System is substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a bird-like figure intertwined. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the logo.
DEC 0 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
C2M Medical, Inc. % Gabriele G. Niederauer, Ph.D. Vice President, Research and Development 3463 Magic Drive, Suite 320 San Antonio, Texas 78229
Re: K073226
Trade/Device Name: CINCH™ Knotless Fixation Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: November 14, 2007 Received: November 15, 2007
Dear Dr. Niederauer:
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 commence 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 r ca mayyuttors 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
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Page 2 - Gabriele G. Niederauer, Ph.D.
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 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 N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
M. Attachment 13 - Indications for Use Statement
Indications for Use Statement
K073226 510(k) Number (if known):
Device Name: CINCH™ Knotless Fixation Implant System
Indications for Use:
The CINCH™ Knotless Fixation Implant System is intended for the fixation of soft tissue to bone during rotator cuff repair.
Prescription Use _X (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use (Per 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 (Division Division of General, Restorat and Neurological Devices
510(k) Number