(157 days)
Not Found
No
The summary describes a physical implant made of stainless steel for surgical repair and contains no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an implant used for rotator cuff repair in shoulder surgery, which indicates a therapeutic purpose.
No
The device is described as an implant used for rotator cuff repair, which is a treatment, not a diagnostic procedure.
No
The device is described as an implant made of 316L stainless steel, which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is an "implant used for rotator cuff repair in shoulder surgery." This is a surgical device used in vivo (within the body) for treatment.
- Device Description: The description confirms it is an "implant" made of stainless steel, further supporting its use as a surgical device.
- 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 for diagnosis, monitoring, or screening. This device does not perform any such tests on biological samples.
Therefore, based on the provided information, the ADHOC® CLAW is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADHOC® CLAW is an implant used for rotator cuff repair in shoulder surgery.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The ADHOC® CLAW is an implant used for rotator cuff repair in shoulder surgery. The ADHOC® CLAW is made of 316L stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder
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
§ 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 FOR SOFT TISSUE FIXATOR
510k #: K023963
| Owner / Operator: | Future Medical Systems, SA. | 510K #: K023963 |
|---|---|---|
| Address: | 265 Route de la Baronne, ST. Jeannet 06640 France | MAY 0 5 2003 |
| Phone: | 011-33-4-92-12-32-56 | |
| Fax: | 011-33-4-92-12-04-75 | |
| Contact: | Patrick Janin (US Native/ English speaker) | |
| Official correspondent: | ||
| Company: | Future Medical Systems, Inc. | |
| Address: | 504 McCormick Drive, Glen Burnie, MD 21061 | |
| Phone: | 410 761 9411 ext. 11 | |
| Fax: | 410 760 9422 | |
| Contact: | Mr. Steve Janin | |
| Date of submission: | November 26th 2002 | |
| Name of device: | ADHOC® CLAW | |
| Common name: | Soft tissue fixator | |
| Classification: | 87 MBI, Class II, 21 CFR 888.3040 |
Predicate device:
K953877: MITEK GII (Mitek Surgical Products now Ethicon J&J) K884565: ACUFEX MICROSURGICAL (now SMITH & NEPHEW). K896310: ACUFEX MICROSURGICAL (now SMITH & NEPHEW).
Device intended use, description and substantial equivalence:
The ADHOC® CLAW is an implant used for rotator cuff repair in shoulder surgery. The ADHOC® CLAW is made of 316L stainless steel.
The ADHOC® CLAW and the predicate devices have the same final function. In addition, the small differences in design do not affect the use, safety and effectiveness, between the device and the predicate devices.
Based on these similarities and equivalences we believe the ADHOC® CLAW is substantially equivalent to the MITEK GII and the Acufex Fixation Button.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing the wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 5 2003
Mr. Steven Janin Future Medical System, Inc. 504 McCormick Drive, Suite T Glen Burnie, MD 21061
Re: K023963
Trade/Device Name: ADHOC® CLAW Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: March 25, 2003 Received: March 28, 2003
Dear Mr. Janin:
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.
2
Part 2 - Mr. Steven Janin
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 (301) 594-4659. 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,
Mark A. Millenn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510 K Number: K023963
Page 1 of 1
Device name: ADHOC® CLAW soft tissue fixator
INDICATIONS FOR USE:
The ADHOC® CLAW is an implant used for rotator cuff repair in shoulder surgery.
Mark N. Melhus
(Division Sign-Off) Division of General. Restorative and Neurological Devices 023963
510(k) Number ________________________________________________________________________________________________________________________________________________________________
(Please do not write below this Line-Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1)