(296 days)
No
The description focuses on the mechanical components and materials of a bone screw system, with no mention of AI or ML capabilities.
No
The device is used to stabilize, fixate, and support bone filling materials and barrier membranes, which is a structural and supportive function rather than a direct therapeutic one. Its purpose is to facilitate bone regeneration, but it does not directly treat a disease or condition itself.
No
The device is used to stabilize, fixate, and/or support bone filling materials and barrier membranes, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "set of bone screws and instrumentation" made from titanium alloy, which are physical hardware components.
Based on the provided information, the Salvin Tenting Screw System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "stabilize, fixate, and/or support bone filling materials and /or barrier membranes used for regeneration of bone in the oral cavity." This describes a surgical device used directly on a patient's body for a therapeutic purpose (bone regeneration).
- Device Description: The device is a set of bone screws and instrumentation made from titanium alloy. This is consistent with a surgical implant and its associated tools.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. The Salvin Tenting Screw System is used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The Salvin Tenting Screw System is used to stabilize, fixate, and/or support bone filling materials and /or barrier membranes used for regeneration of bone in the oral cavity.
Product codes
DZL
Device Description
The Salvin Tenting Screw System is a set of bone screws and instrumentation. The system consists of a set of screws (one diameter and three lengths) and the driver used to implant these screws. The devices are delivered non-sterile. The screws are made from titanium alloy (Ti-6Al-4V ELI), as described by ASTM F136.
The screws come in one diameter – 1.5mm (5.0mm head diameter), and three lengths – 7mm, 8mm, and 9mm. The screws incorporate a 4mm thread length adjacent to a polished neck.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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
Bench testing including axial pullout and torque to failure, as well as geometric comparisons of the Salvin Tenting Screw device to the Osteogenics Pro-Fix™ device demonstrated substantial equivalence. The results for Sterile Validation met the acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other to create a sense of depth and unity.
Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2017
Salvin Dental Specialties % John Kapitan CEO Kapstone Medical, LLC Po Box 969 Leicester, North Carolina 28748
Re: K161857
Trade/Device Name: Salvin Tenting Screw System Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw Or Wire Regulatory Class: Class II Product Code: DZL Dated: March 30, 2017 Received: March 31, 2017
Dear John Kapitan:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - John Kapitan
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory,
Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
7. Indications for Use Statement
510(k) Number (if known): __ _________________________________________________________________________________________________________________________________________________
Device Name: Salvin Tenting Screw System
Indications for Use:
The Salvin Tenting Screw System is used to stabilize, fixate, and/or support bone filling materials and /or barrier membranes used for regeneration of bone in the oral cavity.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
1. Applicant
Salvin Dental Specialties, Inc. 3450 Latrobe Drive Charlotte, NC 28211
2. Official Correspondent
Kapstone Medical LLC PO Box 969 Leicester, NC 28748
Contact Person:
John Kapitan, CEO Tel: (704) 843-7852 Fax: (704) 831-5316 Email: jkapitan@kapstonemedical.com
3. Date Prepared:
March 30, 2017
4. Device Name
| Common/Usual Name: | Tenting Screw System |
|---|---|
| Classification Name: | Intraosseous Fixation Screw or Wire |
| Regulation Number: | 21CFR 872.4880 |
| Product Code: | DZL |
| Classification: | II |
| Panel: | Dental |
5. Predicate Devices
The Salvin Tenting Screw System is substantially equivalent to the Pro-Fix™ Tenting Screw produced by Osteogenics Biomedical. The Pro-Fix™ Tenting Screw is the Primary Predicate and the Salvin Fixation Screw System is a Reference Predicate.
| Predicate | 510(k) Number | Device | Manufacturer |
|---|---|---|---|
| Primary | K093719 | Pro-Fix™ Tenting Screw | Osteogenics Biomedical |
| Reference | K073342 | Salvin Dental Fixation Screw System | Salvin Dental Specialties |
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6. Description of the Device
The Salvin Tenting Screw System is a set of bone screws and instrumentation. The system consists of a set of screws (one diameter and three lengths) and the driver used to implant these screws. The devices are delivered non-sterile. The screws are made from titanium alloy (Ti-6Al-4V ELI), as described by ASTM F136.
The screws come in one diameter – 1.5mm (5.0mm head diameter), and three lengths – 7mm, 8mm, and 9mm. The screws incorporate a 4mm thread length adjacent to a polished neck.
7. Indications for Use
The Salvin Tenting Screw System is used to stabilize, fixate, and/or support bone grafts, bone filling materials and /or barrier membranes used for regeneration of bone in the oral cavity.
8. Summary of Technological Similarities and Differences
The Salvin Tenting Screw is substantially equivalent to the primary predicate – the Osteogenics Pro-Fix™ Tenting Screw in terms of material, geometry, and mechanical performance. The Salvin Fixation Screw is a reference predicate with technological similarities in terms of material, geometry, and manufacturing processing.
| Applicant | Salvin Dental | Osteogenics | Salvin Dental |
|---|---|---|---|
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | |
| Product Name | Tenting Screw | Pro-Fix™ | Fixation Screw |
| 510(k) Number | K161857 | K093719 | K073342 |
| Product Code | DZL | DZL | HWC |
| Regulation # | 21CFR 872.4880 | 21CFR 872.4880 | 21CFR 888.3040 |
| Class | II | II | II |
| Prescription or O- | |||
| T-C? | Prescription | Prescription | Prescription |
| Provided Sterile or | |||
| Non-sterile? | Non-sterile | Non-sterile | Non-sterile |
| Indications for Use | The Salvin Tenting Screw | ||
| is used to stabilize, fixate, | |||
| and/or support bone | |||
| grafts, bone filling | |||
| materials and /or barrier | |||
| membranes used for | |||
| regeneration of bone in | |||
| the oral cavity. | The Pro-Fix™ Precision | ||
| Fixation System is used to | |||
| stabilize, fixate, and/or | |||
| support bone grafts, bone | |||
| filling materials and /or | |||
| barrier membranes used for | |||
| regeneration of bone in the | |||
| oral cavity. | The Salvin Fixation | ||
| Screw is intended for | |||
| use in internal fixation | |||
| of small bones including | |||
| the craniofacial and | |||
| maxillofacial skeleton | |||
| affected by trauma, or | |||
| for reconstruction. | |||
| Components and | |||
| Size(s) | Diameter: 1.5mm | ||
| Lengths: 7, 8, and 9mm | Diameter: 1.5mm | ||
| Lengths: 7, 8, and 9mm | Diameters: 1.5 and | ||
| 2.0mm | |||
| Lengths: 4, 6, 8, 10, 13, | |||
| 15, 17mm |
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| Applicant | Salvin Dental | Osteogenics | Salvin Dental |
|---|---|---|---|
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | |
| Product Name | Tenting Screw | Pro-Fix™ | Fixation Screw |
| Device/Implant | |||
| Materials | Ti-6Al-4V ELI per ASTM | ||
| F136 | Ti-6Al-4V ELI per ASTM | ||
| F136 | Ti-6Al-4V ELI per ASTM | ||
| F136 | |||
| Manufacturing & | |||
| Cleaning | Proprietary Process | ||
| Shared with Salvin | |||
| Fixation Screw | Unknown | Proprietary Process | |
| Shared with Salvin | |||
| Tenting Screw | |||
| Sterilization | |||
| Methodology | Steam | Steam | Steam |
9. Summary of Performance Data
Specific Tests Performed:
- · ASTM F543-13
- ଚ୍ଚ Torsional Properties
-
Drive Torque
- ► Axial Pullout
-
Self-Tapping Force
- Sterilization Validation
Bench testing including axial pullout and torque to failure, as well as geometric comparisons of the Salvin Tenting Screw device to the Osteogenics Pro-Fix™ device demonstrated substantial equivalence. The results for Sterile Validation met the acceptance criteria.
10. Conclusion
The Salvin Tenting Screw is substantially equivalent to the Osteogenics Pro-Fix™ predicate device (Primary Predicate - K093719). In addition to conclusions from performance testing and geometric comparisons, the devices have the same "Indications for Use," are available by prescription only, utilize Ti-6Al-4V ELI material, and are provided non-sterile for single-use only. It can be concluded that the Salvin Tenting Screw is substantially equivalent to the predicate device.