(26 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a physical screw for fracture fixation, with no mention of AI or ML.
No.
The device is an orthopedic implant (Schanz Screws) used for external fixation, which falls under surgical or structural devices, not therapeutic devices (which would typically involve delivering therapy, such as drugs, radiation, or electrical stimulation).
No
The device is described as an external fixation device for fracture fixation and other orthopedic corrections, not for diagnosing medical conditions.
No
The device description explicitly states it is a physical medical device ("manufactured from medical grade stainless steel") and the performance studies are based on mechanical testing of the hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as external fixation for various orthopedic procedures (fracture fixation, limb lengthening, deformity correction, etc.). This is a surgical implant/device used directly on the patient's body.
- Device Description: The description confirms it's a physical screw made of stainless steel, designed to provide mechanical fixation.
- 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. This device does not interact with biological samples for diagnostic purposes.
The information provided aligns with a device used in surgical procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SMV Scientific Schanz Screws are intended for use as external fixation for fracture fixation (open and closed); pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.
Product codes
HWC
Device Description
SMV Scientific Schanz Screws are manufactured from medical grade stainless steel. SMV Scientific Schanz Screws are offered in various diameters and lengths. SMV Scientific Schanz Screws are intended to provide fracture fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The SMV Scientific Schanz Screw has been tested in the following test modes:
- Static Four-point Bending per ASTM F1541-02
- o Static Torsion per ASTM F1541-02
The results of this non-clinical testing show that the strength of the SMV Scientific Schanz Screw is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2016
SMV Scientific % Mr. Kenneth Maxwell Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K160603
Trade/Device Name: SMV Scientific Schanz Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 29, 2016 Received: March 2, 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 | ||
| Indications for Use | Expiration Date: January 31, 2017 | |
| See PRA Statement on last page. |
| 510(k) Number (if known) | K160603 |
|---|---|
| Device Name | SMV Scientific Schanz Screws |
| Indications for Use (Describe) | The SMV Scientific Schanz Screws are intended for use as external fixation for fracture fixation (open and closed); pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis. |
| 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) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
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5.510(K) SUMMARY
| Submitter's Name: | SMV Scientific |
|---|---|
| Submitter's Address: | 111 Sandra Muraida Way |
| Unit 18A | |
| Austin, TX 78703 | |
| Submitter Contact Person: | Nephi Zufelt |
| Chief Technology Officer | |
| 512-750-8622 | |
| Empirical Consulting Contact | |
| Person: | Kenneth C. Maxwell II |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| Date Summary was Prepared: | 29 February 2016 |
| Trade or Proprietary Name: | SMV Scientific Schanz Screws |
| Common or Usual Name: | Smooth or threaded metallic bone fixation fastener. |
| Classification: | Class II per 21 CFR §888.3040 Device Classification |
| Product Code: | HWC |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
SMV Scientific Schanz Screws are manufactured from medical grade stainless steel. SMV Scientific Schanz Screws are offered in various diameters and lengths. SMV Scientific Schanz Screws are intended to provide fracture fixation.
Indications for Use
The SMV Scientific Schanz Screws are intended for use as external fixation for fracture fixation (open and closed); pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.
The indications for use for the SMV Scientific Schanz Screw is similar to that of the predicate devices in Table 5-1 below.
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or Model
Name | Manufacturer | Predicate
Type |
|-------------|---------------------------------------|--------------|-------------------|
| K040701 | Self-Drilling Schanz Screws | Synthes | Primary |
PERFORMANCE DATA
The SMV Scientific Schanz Screw has been tested in the following test modes:
- Static Four-point Bending per ASTM F1541-02
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- o Static Torsion per ASTM F1541-02
The results of this non-clinical testing show that the strength of the SMV Scientific Schanz Screw is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the SMV Scientific Schanz Screw is substantially equivalent to the predicate device.