(203 days)
No
The summary describes a mechanical device (bone screws) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as intended for "internal fixation of small bones... secondary to trauma or for reconstruction," which implies treating or correcting a medical condition.
No
The device is a bone screw used for internal fixation, which is a treatment method, not a diagnostic one.
No
The device description clearly states it is a "self drilling bone screw," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "internal fixation of small bones... secondary to trauma or for reconstruction." This describes a surgical implant used within the body to stabilize bone fractures or defects.
- Device Description: The device is described as "self drilling bone screws." This further confirms its nature as a surgical implant.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with biological specimens.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.
Product codes
HWC
Device Description
This submission describes self drilling bone screws intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand, secondary to trauma or for reconstruction. The Self Drilling Screw is available in 1.2 and 1.7 mm diameters with lengths ranging from 4-7 mm and in a 2.0 mm diameter with lengths ranging from 5-8 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones including the craniomaxillofacial skeleton and hand
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)
K944565, K963739, K963740, K963741
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
510(k) Summary
OCT - 1 1997
Device Proprietary Name:
Device Common Name:
Classification Name:
Name of Submitter:
Contact Person:
Small Bone Screw Smooth or threaded metallic bone fixation fastener 21 CFR 888.3040
Howmedica Leibinger Inc.
Leibinger® Self-Drilling Screw
Kristyn R. Waski Quality Assurance/Regulatory Affairs Engineer Howmedica Leibinger Inc. 14540 Beltwood Pkwy., East Dallas, TX 75244 (972) 392-3636 x266 Telephone: (972) 392-7258 Fax:
| Date Prepared: |
|---|
| Date Revised: |
March 11, 1997 September 29, 1997
Summary:
This submission describes self drilling bone screws intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand, secondary to trauma or for reconstruction. The Self Drilling Screw is available in 1.2 and 1.7 mm diameters with lengths ranging from 4-7 mm and in a 2.0 mm diameter with lengths ranging from 5-8 mm.
Equivalence for this device is based on similanties in intended use, material, design and operational principle to the KLS Martin Centre-Drive Drill-Free™ Screw [K944565] and the Leibinger® Lubr Small Bone Screws [K963739, K963740 and K963741]. Each of the screw systems is intended for use in fixation of small bones secondary to trauma or for reconstruction. The Leibinger® Luhr Small Bone Screws and the Leibinger® Self Drilling Screws are intended for use in craniomaxillofacial and hand fixation. The KLS Martin Centre-Drive Drill-Free™ Screws and the Leibinger® Self Drilling Screws are both designed as self drilling screws intended for use in internal fixation of the craniomaxillofacial skeleton. Each of the screw systems is manufactured from titanium alloy. The basic operational principle is similar for each of the named screw systems. The Leibinger® Self Drilling and KLS Martin Centre-Drive Drill-Free™s are both self drilling and can be inserted in one step. Indications and contraindications are equivalent for each of the equivalent devices.
1
OCT - I
Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three heads, symbolizing service to the nation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kristyn R. Waski Quality Assurance/Regulatory Affairs Engineer Howmedica Inc. Pfizer Hospital Products Group 14540 Beltwood Parkway East Dallas, Texas 75244
Re: K970912 Leibinger® Self-Drilling Screw Trade Name: Requlatory Class: II Product Code: HWC July 2, 1997 Dated: Received: July 3, 1997
Dear Ms. Waski:
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. ਰ 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 requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 - Ms. Kristyn R. Waski
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.gov/cdrh/dsmamain.html".
Sincerely yours
a 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
510(k) Number (if known): UNKNOWN AT THIS TIME
Device Name: Leibinger® Self Drilling Screw
Indications for Use:
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
({
This device is intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K970912 |
Prescription Use
Over-The-Counter Use
(Optional Format 1-2-96)