(119 days)
The device is intended for use in internal fixation of small bones including the craniofacial and maxillofacial skeleton affected by trauma, or for reconstruction. Single patient use only
The Salvin Dental Specialties Titanium Fixation Screw System consists of 1.5mm and 2.0mm Titanium (Ti-6Al-4V) bone screws in lengths of 4, 6, 8, 10, 13 and 15mm. The 2.0mm diameter screws are “emergency” screws. The devices are provided non-sterile.
This document describes a 510(k) premarket notification for the "Salvin Dental Specialties, Inc. Titanium Fixation Screw System". The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through clinical studies. Therefore, many of the requested categories related to acceptance criteria, ground truth, and clinical study details are not directly applicable or available in this type of submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not define specific performance acceptance criteria in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) or statistical thresholds. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical testing.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Design: Substantially equivalent to predicate devices. | Engineering drawings reviewed, deemed substantially equivalent. |
| Materials of Composition: Substantially equivalent to predicate devices. | Titanium (Ti-6Al-4V) bone screws, deemed substantially equivalent. |
| Indications for Use: Same as predicate devices. | "internal fixation of small bones including the craniofacial and maxillofacial skeleton affected by trauma, or for reconstruction." - deemed substantially equivalent. |
| Mechanical Testing: Meets standards like ASTM F 543-02 for metallic bone screws. | Mechanical testing performed (referenced as "mechanical testing have demonstrated"), but specific results/metrics are not detailed in this summary. |
| Labeling: Consistent with predicate devices. | Labeling reviewed, deemed substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Directly applicable "test set" sample size for evaluating performance against clinical acceptance criteria is not mentioned because no clinical study with human subjects (patients) was conducted or referenced for this 510(k) submission.
- Data Provenance: Not applicable, as this submission relies on engineering design, material specifications, and non-clinical mechanical testing, rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts & Qualifications: Not applicable. No "ground truth" for a clinical test set was established in this context. The determination of substantial equivalence relies on regulatory review of technical documentation by FDA reviewers.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as there was no clinical test set requiring expert adjudication.
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
- MRMC Study: No MRMC comparative effectiveness study was conducted or referenced. This device is a mechanical fixation screw, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" in this context is the regulatory standard of "substantial equivalence" to legally marketed predicate devices, established through engineering specifications, material properties, intended use, and non-clinical mechanical testing (e.g., compliance with ASTM F 543-02). It is not based on expert consensus, pathology, or outcomes data from a clinical trial for this specific device.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a physical device, and the evaluation relies on established engineering principles and comparison to existing devices, not machine learning or AI models that require training data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model for this device.
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Image /page/0/Picture/1 description: The image shows the logo for "SALVIN Dental Specialties". The word "SALVIN" is in large, bold, black letters at the top of the logo. Below "SALVIN" is the phrase "Dental Specialties" in a smaller font, also in black. The registered trademark symbol is to the right of the word "SALVIN".
MAR 2 6 2008
Salvin Dental Specialties, Inc 3450 Latrobe Drive • Charlotte, NC 28211 • Phone 704-442-5400 • Fax 704-442-5424
510(k) Summary
| A | 510(k) Owner | Salvin Dental Specialties, Inc3450 Latrobe DriveCharlotte, NC 28211 |
|---|---|---|
| Contact | Robert SalvinCEOSalvin Dental Specialties, Inc.3450 Latrobe DriveCharlotte, NC 28211(704) 442-5400(704) 442-5424bobsalvin@salvin.com | |
| Preparation Date | November 23, 2007 | |
| B | Trade Name | Salvin Dental Specialties, Inc. Titanium Fixation ScrewSystem |
| Common Name | Fixation Screw | |
| Classification Name | Screw, Fixation, Bone(21 CFR 888.3040, Product code HWC) | |
| C | Predicate Device(s) | K023260 – Osteomed Auto-Drive Screw SystemK970912 - Leibinger Self-Drilling ScrewK050492 - Integra Bone Fixation SystemK040860 - Integra Bone Fixation System |
| D | Device Description | The Salvin Dental Specialties Titanium Fixation ScrewSystem consists of 1.5mm and 2.0mm Titanium (Ti-6Al-4V) bone screws in lengths of 4, 6, 8, 10, 13 and 15mm. |
| The 2.0mm diameter screws are “emergency” screws. | ||
| The devices are provided non-sterile. | ||
| E | Intended Use | The Salvin Dental Specialties, Inc. Titanium FixationScrew is intended for use in internal fixation of smallbones including the craniofacial and maxillofacialskeleton affected by trauma, or for reconstruction.Single patient use only. |
| F | TechnologicalCharacteristics | As was established in this submission, the subject deviceis substantially equivalent to other devices cleared by theagency for commercial distribution in the United States.Engineering drawings, labeling, and mechanical testinghave demonstrated that the subject device is substantiallyequivalent, if not identical, to its predicate devices interms of design, materials of composition, indications foruse, and such other characteristics as may be associatedwith the manufacture of any medical device. |
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- ASTM F 543-02 Standard Specification and Test Non-Clinical Testing G Methods for Metallic Medical Bone Screws
- Not applicable to this device Clinical Testing H
- Based on the 510(k) Summary and the information Conclusions I provided herein, we conclude that the Salvin Dental Specialties Titanium Fixation Screw is substantially equivalent to the existing legally marketed devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2008
Mr. Robert Salvin Chief Executive Officer Salvin Dental Specialties, Incorporated 3450 Latrobe Drive Charlotte, North Carolina 28211
Re: K073342
Trade/Device Name: Salvin Dental Specialties Fixation Screw Regulation Number: 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: March 13, 2008 Received: March 14, 2008
Dear Mr. Salvin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Salvin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sutte y. Michie Omd
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Salvin Dental Specialties Fixation Screw
Indications for Use:
The device is intended for use in internal fixation of small bones including the craniofacial and maxillofacial skeleton affected by trauma, or for reconstruction.
Single patient use only
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Rsi. Betz DDS for Dr. S. Ruminia
(Division Sign-Off) U Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K173342
§ 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.