(203 days)
This device is intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.
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.
The provided document is a 510(k) summary for the Leibinger® Self-Drilling Screw and the FDA's response letter indicating substantial equivalence. This type of submission is for medical devices and focuses on demonstrating equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a standalone study.
Therefore, the information typically requested for AI/device performance studies (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document. The document highlights the device's intended use, materials, design, and operational principle to establish similarity with predicate devices.
Here's why the requested information isn't available and what the document does provide:
- Acceptance Criteria & Reported Performance: This document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present a study comparing the device's performance against such criteria. The "performance" being evaluated here is primarily whether the new device is substantially equivalent to existing legally marketed devices based on its characteristics.
- Study Details (Sample Size, Data Provenance, Ground Truth, Adjudication, MRMC, Standalone): These are all elements of a clinical or technical performance study, which is not described. The 510(k) pathway often relies on bench testing, material characterization, and comparison to predicate devices rather than de novo clinical performance trials, especially for low-to-moderate risk devices like bone screws, if substantial equivalence can be shown.
- Training Set Information: This product is a physical medical device (a screw), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
Based on the provided text, here is what can be extracted, acknowledging that most of the requested fields are not applicable to this type of regulatory submission:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as numerical performance metrics. The underlying "acceptance criteria" for a 510(k) submission are met if the FDA determines the device is substantially equivalent to a predicate device. This is based on similarities in intended use, materials, design, and operational principles, and that it doesn't raise different questions of safety and effectiveness.
- Reported Device Performance: The document states that "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® Luhr Small Bone Screws [K963739, K963740 and K963741]. This is the "performance" shown: it is sufficiently similar to devices already on the market.
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document does not describe a "test set" in the context of performance evaluation for an AI or diagnostic device. The evaluation is based on device specifications and comparison to predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth establishment by experts is described for a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a physical bone screw, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical bone screw, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. There is no "ground truth" established for performance evaluation in a clinical study detailed in this document. The "truth" in this context is the FDA's regulatory determination of substantial equivalence based on the provided technical information and comparison to predicate devices.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. This is a physical medical device, not an AI algorithm.
Summary of what the document does provide:
- Device Name: Leibinger® Self-Drilling Screw
- Intended Use: Internal fixation of small bones including the craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.
- Device Description: Available in 1.2, 1.7, and 2.0 mm diameters with various lengths. Manufactured from titanium alloy. Self-drilling, one-step insertion.
- Predicate Devices: KLS Martin Centre-Drive Drill-Free™ Screw [K944565] and Leibinger® Luhr Small Bone Screws [K963739, K963740, K963741].
- Basis for Equivalence: Similarities in intended use, material, design, and operational principle.
- Regulatory Outcome: FDA found the device "substantially equivalent" to predicate devices, allowing it to be marketed.
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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.
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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.
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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
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510(k) Number (if known): UNKNOWN AT THIS TIME
Device Name: Leibinger® Self Drilling Screw
Indications for Use:
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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)
§ 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.