(174 days)
Not Found
No
The 510(k) summary describes a simple mechanical device (wires) for bone fixation and guidance, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The S-Wire is intended for temporary fixation and stabilization of bone fractures, which is a therapeutic function.
No
The device is described as a temporary fixation and stabilization unit for bone fractures and for guiding implant insertion, not for diagnosing medical conditions.
No
The device description explicitly states the device is composed of physical wires made from stainless steel and nitinol, which are hardware components.
Based on the provided information, the S-Wire is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use of the S-Wire is for temporary fixation and stabilization of bone fractures and as guidance for implant insertion into the skeletal system. This is a surgical/interventional use, not a diagnostic use performed in vitro (outside the body).
- Device Description: The device is a physical wire made of stainless steel and nitinol, designed to be inserted into the body. This aligns with a surgical tool, not a diagnostic test kit or instrument that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The S-Wire does not fit this description.
N/A
Intended Use / Indications for Use
The S-Wire is intended to perform as temporary fixation and stabilization unit of bone fractures and as guidance at insertion of implants into the skeletal system.
Product codes
HTY, JDW
Device Description
The S-Wire is composed of wires manufactured from stainless steel per ASTM F138 and nitinol per ASTM F2063. The wires are available in lengths of 150-550mm and diameters of .7-1.6mm. The S-wire is available with the following tip styles: Diamond Smooth, Diamond Threaded, Round Smooth, Round Threaded, Trocar Smooth, Trocar Threaded, and Diamond Suture Passer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Spinal Resources, Incorporated % Mr. Kenneth Maxwell Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K152662
Trade/Device Name: S-Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, JDW Dated: January 29, 2016 Received: February 1, 2016
Dear Mr. Maxwell:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Kenneth Maxwell
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 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/Resourcesfor You/Industry/default.htm. 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/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 yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| See PRA Statement on last page. |
Indications for Use
| 510(k) Number (if known) | K152662 |
|---|---|
| Device Name | S-Wire |
| Indications for Use (Describe) | The S-Wire is intended to perform as temporary fixation and stabilization unit of bone fractures and as guidance at insertion of implants into the skeletal system. |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
3
510(K) SUMMARY
| Submitter's Name: | Spinal Resources, Inc. |
|---|---|
| Submitter's Address: | 274 E Eau Gallie Blvd Unit 303 |
| Indian Harbour Beach FL 32937 | |
| Submitter's Telephone: | 904-540-9049 |
| Contact Person: | Kenneth C. Maxwell II |
| Empirical Testing Corp. |
- 291.6874 |
| Date Summary was Prepared: | 07 March 2016 |
| Trade or Proprietary Name: | S-Wire |
| Common or Usual Name: | Pin, Fixation, Smooth
Pin, Fixation, Threaded |
| Classification: | Class II per 21 CFR §888.3040 |
| Product Code: | HTY and JDW |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The S-Wire is composed of wires manufactured from stainless steel per ASTM F138 and nitinol per ASTM F2063. The wires are available in lengths of 150-550mm and diameters of .7-1.6mm. The S-wire is available with the following tip styles: Diamond Smooth, Diamond Threaded, Round Smooth, Round Threaded, Trocar Smooth, Trocar Threaded, and Diamond Suture Passer.
Indications for Use
The S-Wire is intended to perform as temporary fixation and stabilization unit of bone fractures and as guidance at insertion of implants into the skeletal system.
The indications for use for the S-wire is similar to that of the predicate device.
Table 5-1 Predicate Device
| 510k
Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate
Type |
|----------------|---------------------------------------|----------------------------|-------------------|
| K060654 | DSI Pins and Wires | Delta Surgical Instruments | Primary |
CONCLUSION
The overall technology characteristics and the geometrical analysis comparing the devices leads to the conclusion that the S-wire is substantially equivalent to the predicate device.