(188 days)
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Not Found
No
The 510(k) summary describes bone screws and does not mention any software, image processing, AI, or ML capabilities.
Yes
The device, a bone screw, is intended for craniofacial and mandibular trauma and reconstruction, which are medical treatments or interventions, thus qualifying it as a therapeutic device.
No
Explanation: The device is a bone screw used for reconstruction and trauma, which is a therapeutic rather than a diagnostic function.
No
The device description clearly indicates it is a physical bone screw made of Cocrmo and Ti Alloy, which are hardware materials.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the DRG Sherlock™ MF Bone Screws are intended for use in craniofacial and mandibular trauma and reconstruction. This involves implanting the screws within the body to fix bones.
- Lack of IVD Characteristics: The provided information does not mention any testing of bodily specimens, analysis of biological markers, or any other activity typically associated with IVDs.
Therefore, based on the provided information, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The DRG Sherlock™ MF Self-Tapping and Self-Tapping/Self-Drilling Bone Screws are intended for craniofacial and mandibular trauma and reconstruction.
Product codes
DZL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
craniofacial and mandibular
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three overlapping profiles, symbolizing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the figure.
DEC - 2 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard J. Deslauriers, M.D. President Doctor's Research Group, Incorporated 143 Wolcott Road Wolcott, Connecticut 06716
Re : K981881 DRG Sherlock™ MF Bone Screw, Cocrmo Self-Trade Name: Tapping, Ti Alloy Regulatory Class: II Product Code: DZL September 15, 1998 Dated: Received: September 15, 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 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). 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Dr. Deslauriers
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4692. 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" (21CFR 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.gov/cdrh/dsma/dsmamajn.html" .
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological 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): 五月号 | 828
Device Name: Sherlock™ MF Bone Screws
Indications for use:
The DRG Sherlock™ MF Self-Tapping and Self-Tapping/Self-Drilling Bone Screws are intended for craniofacial and mandibular trauma and reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEE Concurrence of CDRG, Office of Device Evaluation (ODE)
Sandra L. Shire, DMD for USR
(Division Sign-Off)
n of Dental, Infection Control, d General Hospital De 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use