(87 days)
Not Found
Not Found
No
The summary describes a physical surgical anchor and does not mention any software, algorithms, or AI/ML related terms.
No.
The device is a surgical anchor used for fixation of nonabsorbable sutures to bone, which is a structural component for surgical repair, not a device designed to provide therapy.
No
The device is described as a surgical suture anchor for fixation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states "Sherlock™ TiN Coated Threaded Suture Anchors," indicating a physical, hardware-based medical device (suture anchors). There is no mention of software as the primary or sole component.
Based on the provided information, the DRG Sherlock™ Threaded Anchor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of nonabsorbable braided polyester surgical suture to bone". This is a surgical procedure performed in vivo (within the body).
- Device Description: The description "Sherlock™ TiN Coated Threaded Suture Anchors" further reinforces that this is a physical implant used in surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Using reagents or assays
IVDs are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or screening purposes. The DRG Sherlock™ Threaded Anchor is a surgical implant used to physically attach suture to bone during a surgical procedure.
N/A
Intended Use / Indications for Use
The DRG Sherlock™ Threaded Anchor is for the fixation of nonabsorbable braided polyester surgical suture to bone for the indications listed below.
WRIST/HAND
Scapholunate ligament reconstruction
Thumb ulnar collateral ligament reconstruction
SKULL
Endoscopic Brow lifts
Product codes
MBI
Device Description
Sherlock™ Threaded Suture Anchor (TiN Coated)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
WRIST/HAND, SKULL
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)
Not Found
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
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUM." is arranged in a circular pattern around the left side of the eagle. The text "USA" is located on the upper right side of the eagle.
SEP 1 4 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard Deslauriers, M. D. President Doctor's Research Group, Inc. 143 Wolcott Road 06716 Wolcott, Connecticut
K982169 Re: Sherlock™ Threaded Suture Trade Name: Anchor (TiN Coated) Requlatory Class: II MBI Product Code: Dated: June 17, 1998 Received: June 19, 1998
Dear Dr. Deslauriers:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
1
Page 2 - Richard Deslauriers, M. D.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device; please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain-html".
Sincerely yours,
focolly
Ph.D., M.D. a M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
Doctor's Research Group, Inc. 143 Wolcott Road Wolcott, CT 06716 (203) 879-9422
Statement of indications for use:
510(k) Number (if Known): K982169
Device Name: Sherlock™ TiN Coated Threaded Suture Anchors
Indications for use:
The DRG Sherlock™ Threaded Anchor is for the fixation of nonabsorbable braided polyester surgical suture to bone for the indications listed below.
WRIST/HAND
Scapholunate ligament reconstruction Thumb ulnar collateral ligament reconstruction
SKULL Endoscopic Brow lifts
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRG, Office of Device Evaluation (ODE)
Division Sign-Off)
(Division Sign-Off) Division of General Restorative Devices 1982169 510(k) Number
Prescription Use ∑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use