(119 days)
Not Found
No
The description focuses on mechanical components (screws) and their materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a titanium screw system for internal fixation of bones, which is a structural component for trauma or reconstruction, not a device that itself provides therapy.
No
The device is described as a titanium fixation screw system for internal fixation of small bones, indicating a therapeutic or reconstructive purpose rather than diagnosing a condition.
No
The device description explicitly states it consists of titanium bone screws, which are physical 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 "for use in internal fixation of small bones including the craniofacial and maxillofacial skeleton affected by trauma, or for reconstruction." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "Titanium Fixation Screw System" consisting of bone screws. These are implants used to physically stabilize bone.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of samples or analysis of biological material.
Therefore, this device falls under the category of a surgical implant or fixation device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Salvin Dental Specialties, Inc. Titanium Fixation Screw 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.
Product codes (comma separated list FDA assigned to the subject device)
HWC, DZL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial and maxillofacial skeleton
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)
Engineering drawings, labeling, and mechanical testing 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K023260, K970912, K050492, K040860
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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, 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 | November 23, 2007 |
| B | Trade Name | Salvin Dental Specialties, Inc. Titanium Fixation Screw
System |
| | 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 System
K970912 - Leibinger Self-Drilling Screw
K050492 - Integra Bone Fixation System
K040860 - Integra Bone Fixation System |
| D | Device Description | 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. |
| E | Intended Use | The Salvin Dental Specialties, Inc. Titanium Fixation
Screw 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. |
| 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 mechanical testing
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. |
1
- 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.
2
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.
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); 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
4
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
Page / of /
510(k) Number: K173342