(109 days)
Not Found
No
The summary describes a mechanical bone tack system and its associated instrumentation. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies are based on engineering review and inspection of parts, not data analysis or model training.
No.
The device is described as a system designed to stabilize a barrier membrane, which serves a structural rather than a therapeutic function.
No
The Salvin Bone Tack System is described as a device designed to stabilize a barrier membrane onto a region of cortical plate. Its function is clearly described as an active implant (a "tack") used for stabilization, not for identifying a condition or disease.
No
The device description explicitly states it consists of titanium bone tacks and associated instrumentation, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to stabilize a barrier membrane onto bone, which is a surgical procedure performed directly on the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The device consists of bone tacks and instrumentation, which are physical implants and tools used in surgery. IVDs are typically reagents, instruments, or systems used for testing specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests, or providing diagnostic information based on laboratory results.
Therefore, the Salvin Bone Tack System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial, maxillofacial, or mandibular bone
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)
Non-Clinical Testing: Analysis based on engineering review and inspection of actual parts
Clinical Testing: Not applicable to this device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K973180 – IMTEC Bone Tac
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 | Technological
Characteristics | As was established in this submission, the subject device
is substantially equivalent to other devices cleared by the
agency for commercial distribution in the United States. |
|---|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Engineering drawings, labeling, and detailed inspectional
analysis have demonstrated that the subject device is
substantially equivalent, if not identical, to its predicate
devices in terms of design, materials of composition,
indications for use, and such other characteristics as may
be associated with the manufacture of any medical device. |
| G | Non-Clinical Testing | Analysis based on engineering review and inspection of
actual parts |
| H | Clinical Testing | Not applicable to this device |
| I | Conclusions | Based on the 510(k) Summary and the information
provided herein, we conclude that the Salvin Bone Tack
System 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 - 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