(109 days)
The Salvin Bone Tack System is designed to stabilize a barrier membrane onto a region of cortical plate. This may be used in craniofacial, maxillofacial, or mandibular bone. Considerations such as quality of bone, bone type, functional loads exerted, general patient health and others should be carefully evaluated prior to use.
The Salvin Bone Tack System consists of 3mm and 5mm Titanium (Ti-6Al-4V) bone tacks and associated instrumentation. The devices are provided non-sterile.
This document describes a 510(k) premarket notification for the Salvin Dental Specialties Bone Tack System. A 510(k) submission seeks to demonstrate that a new device is "substantially equivalent" to one or more legally marketed predicate devices, rather than proving its safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on this substantial equivalence rather than explicit acceptance criteria and a study proving device performance against those criteria in the way one might see for a novel device.
Given the nature of a 510(k) for this type of device, the acceptance criteria are not explicitly numerical performance metrics but rather a demonstration of equivalence in design, materials, and intended use to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance (as per submission) |
|---|---|
| Substantial Equivalence to Predicate Device | Determined to be substantially equivalent to other devices cleared by the agency for commercial distribution. |
| Design Equivalence | Engineering drawings demonstrated substantial equivalence, if not identical, to predicate devices in terms of design. |
| Material Equivalence | Detailed inspectional analysis demonstrated substantial equivalence, if not identical, to predicate devices in terms of materials of composition (Titanium (Ti-6Al-4V)). |
| Indications for Use Equivalence | Demonstrated substantial equivalence, if not identical, to predicate devices in terms of indications for use (stabilize a barrier membrane onto a region of cortical plate in craniofacial, maxillofacial, or mandibular bone). |
| Associated Characteristics Equivalence | Demonstrated substantial equivalence, if not identical, to predicate devices in terms of other characteristics as may be associated with the manufacture of any medical device. |
| Non-Sterile Presentation | Devices are provided non-sterile. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. No "test set" in the traditional sense of a clinical or performance study was used. The submission relies on engineering equivalency and comparison to a predicate device.
- Data Provenance: Not applicable. The data primarily consists of engineering drawings and inspectional analysis of the device itself, compared to the known characteristics of the predicate device (IMTEC Bone Tac, K973180). This is internal manufacturer data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of clinical expert review is not relevant for this 510(k) submission, which relies on engineering and regulatory assessment of equivalence.
4. Adjudication method for the test set
Not applicable. There was no 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
Not applicable. This device is a bone tack system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
For a 510(k) submission for a device like this, the "ground truth" is established through:
- Reference to the predicate device's known characteristics and regulatory clearance.
- Engineering specifications and material science data for the proposed device, demonstrating it meets the same functional and safety profiles as the predicate.
- Intended Use statements that align with those of legally marketed predicate devices.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device submission.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for "SALVIN Dental Specialties". The word "SALVIN" is in large, bold, black letters, with a registered trademark symbol to the right of the "N". Below "SALVIN" is the phrase "Dental Specialties" in a smaller, sans-serif font, set against a black background.
MAY 1 0 2010
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, Inc 3450 Latrobe Drive Charlotte, NC 28211
Contact
Robert Salvin CEO Salvin Dental Specialties, Inc. 3450 Latrobe Drive Charlotte, NC 28211 (704) 442-5400 (704) 442-5424 bobsalvin@salvin.com
Preparation Date
B
C
December 22, 2009
Trade Name Salvin Dental Specialties, Inc. Bone Tack System
Membrane Fixation System
Screw, Fixation, Intraosseous
K973180 – IMTEC Bone Tac
Common Name
Classification Name
Predicate Device(s)
D Device Description The Salvin Bone Tack System consists of 3mm and 5mm Titanium (Ti-6Al-4V) bone tacks and associated instrumentation.
The devices are provided non-sterile.
(21 CFR 872.4880, Product code DZL)
E Intended Use The Salvin Bone Tack System is designed to stabilize a barrier membrane onto a region of cortical plate. This may be used in craniofacial, maxillofacial, or mandibular bone. Considerations such as quality of bone, bone type, functional loads exerted, general patient health and others should be carefully evaluated prior to use.
{1}------------------------------------------------
| 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 detailed inspectionalanalysis have demonstrated that the subject device issubstantially equivalent, if not identical, to its predicatedevices in terms of design, materials of composition,indications for use, and such other characteristics as maybe associated with the manufacture of any medical device. | ||
| G | Non-Clinical Testing | Analysis based on engineering review and inspection ofactual parts |
| H | Clinical Testing | Not applicable to this device |
| I | Conclusions | Based on the 510(k) Summary and the informationprovided herein, we conclude that the Salvin Bone TackSystem is substantially equivalent to the existing legallymarketed devices under the Federal Food, Drug andCosmetic Act. |
1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -
..
. .
. . . . .
.
。
:
:
.
t 1
.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 0 2010
Mr. Robert Salvin Chief Executive Office Salvin Dental Specialties, Incorporated 3450 Latrobe Drive Charlotte, North Carolina 28211
Re: K100182
Trade/Device Name: Salvin Dental Specialties Fixation Screw Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: April 2, 2010 Received: April 30, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your 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.
{3}------------------------------------------------
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucml 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Runyon
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): 1100182
Device Name: Salvin Dental Specialties Fixation Screw
Indications for Use:
The Salvin Bone Tack System is designed to stabilize a barrier membrane onto a region of cortical plate. This may be used in craniofacial, maxillofacial, or mandibular bone. Considerations such as quality of bone, bone type, functional loads exerted, general patient health and others should be carefully evaluated prior to use.
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)
Kei Mulaylian MSR
(Division Sign-Off)
Divisigont Anasthasiology GegarahHospital Intection Gootrol, Degran Dayiges
Page of
510(k) Number: K100182
§ 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.