(86 days)
Not Found
No
The summary describes bone screws and does not mention any AI or ML capabilities.
No
The device is a bone screw used for fixation after trauma or reconstruction. While it aids in the healing process, it is a medical device for structural support rather than a therapeutic device that directly treats a disease or condition (e.g., drug, therapy, or treatment of a disease).
No
Explanation: The device is described as a bone screw for fixation, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states "The Auto-Drive™ bone screws are available in 1.6 mm and 2.0 mm diameters with lengths ranging from 4 mm to 8 mm," indicating a physical hardware component (bone screws).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a bone screw used for fixation of the craniofacial and maxillofacial skeleton and bones of the hand. This is a surgical implant used directly on the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The information provided does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes.
Therefore, the Auto-Drive™ bone screw is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand
Product codes
HWC
Device Description
This submission describes the Auto-Drive™ bone screws intended for use in internal fixation of small bones including the cranifacial and maxillofacial skeleton and hand, secondary to trauma or for reconstruction. The Auto-Drive™ bone screws are available in 1.6 mm and 2.0 mm diameters with lengths ranging from 4 mm to 8 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones including the cranifacial and maxillofacial skeleton and hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
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
MAR 18 1998
Device Proprietary Name:
Device Common Name:
Classification Name:
Name of Submitter:
Contact Person:
510(k) Summary
OsteoMed Auto-Drive Bone Screw
Small Bone Screw
Smooth or threaded metallic bone fixation fastener 21 CFR 888.3040
OsteoMed Corporation
Bruce Horowitz Manager, Regulatory Affairs/Quality OsteoMed Corp. 3750 Realty Road Dallas, TX 75244 Telephone: (972) 241-3401 FAX: (972) 241-3507
12/19/97
Date Prepared:
Summary:
This submission describes the Auto-Drive™ bone screws intended for use in internal fixation of small bones including the cranifacial and maxillofacial skeleton and hand, secondary to trauma or for reconstruction. The Auto-Drive™ bone screws are available in 1.6 mm and 2.0 mm diameters with lengths ranging from 4 mm to 8 mm.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS Martin Centre-Drive Drill-free™ Screw (K944565) and the Leibinger® Self-Drilling Screw (K970912). All of the screw systems are intended for use in internal fixation of small bones including the cranifacial and maxillofacial skeleton and hand, secondary to trauma or for reconstruction. All of the screws are self drilling and manufactured from Titanium alloy. The basic operational principle is the same for all three screws, e.g., they are self drilling and can be inserted in one step. Indications are also equivalent for each of the devices.
1
Image /page/1/Picture/2 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 symbol, with three distinct head profiles overlapping each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
MAR 1 8 1998
Mr. Bruce R. Horowitz Manager, Requlatory Affairs/Quality Assurance OsteoMed Corporation 3750 Realty Road Dallas, Texas 75244
K974785 Re: Auto-Drive Bone Screw Trade Name: Regulatory Class: II Product Code: HWC Dated: December 19, 1997 December 22, 1997 Received:
Dear Mr. Horowitz:
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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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. ਜੋ 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 action. In addition, FDA may publish further announcements 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 regulations.
2
Page 2 - Mr. Bruce R. Horowitz
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acbeirbed in your alence of your device to a legally marketed predicate device results in a classification for your marketed predicate acits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (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 ocalpiration 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Nussell J. Ryan
A Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
OSTEOMED "Indications for Use" Submission
510(k) Number:
. .
| Device Name: | Osteomed Auto-Drive Bone Screw
Smooth or threaded metallic bone fixation
fastener |
|---------------------|------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use: | Fixation secondary to trauma or
reconstruction of the craniofacial and
maxillofacial skeleton and bones of the
hand |
Prescription Use
(Per 21 CFR 801.109)
Thurrell P. Tyson
(Division Sign-Off)
fir ﮨﺮﮮ Division of General Restorative Devices 1974785 510(k) Number .