(139 days)
Not Found
No
The device description and intended use are for standard bone screws, and there is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is described as "Cannulated Bone Screws" intended for "fixation of fractures and non-unions" and "arthrodesis," which are therapeutic interventions.
No
This device, SMV Scientific Cannulated Bone Screws, is intended for the fixation of fractures and non-unions of bones and bone arthrodesis, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the device consists of "cannulated screws" made from Stainless Steel or Titanium, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes the SMV Scientific Cannulated Screws as implants used for the fixation of fractures and non-unions of bones. They are surgically inserted into the body.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens.
Therefore, based on the provided information, the SMV Scientific Cannulated Screws are not IVD devices. They are surgical implants.
N/A
Intended Use / Indications for Use
The SMV Scientific 2.4mm and 3.0mm Cannulated Screws are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies. The SMV Scientific 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation. The SMV Scientific 4.5mm Cannulated Screws is intended for fracture fixation of long bones and long bone fragments. The SMV Scientific 6.5mm and 7.3mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis.
Product codes
HWC
Device Description
The SMV Scientific Cannulated Bone Screws consist of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided non-sterile. Screws are manufactured from Stainless Steel per ASTM F138 or Titanium per ASTM F136 or F1295.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones, small bone fragments, long bones, long bone fragments, scaphoid, carpal, metacarpal, phalangeal, metatarsals, femoral neck, tibial plateau, ankle, intercondylar femur, subtalar.
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
Engineering analysis and dimensional comparison with the predicate devices supported substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K012945, K962823, K963192, K963172, K962011, K021932
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 shows the logo for the U.S. Department of Health and Human Services. The logo features the department's seal, which includes an abstract symbol of a human figure. The seal is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2017
SMV Scientific % Kenneth Maxwell Regulatory And Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K170021
Trade/Device Name: SMV Scientific Cannulated Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 20, 2017 Received: April 24, 2017
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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, Vincent J. Devlin -S for 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) K170021 Device Name SMV Scientific Cannulated Screws Indications for Use (Describe) The SMV Scientific 2.4mm and 3.0mm Cannulated Screws are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies. The SMV Scientific 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation. The SMV Scientific 4.5mm Cannulated Screws is intended for fracture fixation of long bones and long bone fragments. The SMV Scientific 6.5mm and 7.3mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis. Type of Use (Select one or both, as applicable) [ ] Over-The-Counter Use (21 CFR 801 Subpart C) > Prescription Use (Part 21 CFR 801 Subpart D) 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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| 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: | 15 May 2017 |
| Trade or Proprietary Name: | SMV Scientific Cannulated Screws |
| Common or Usual Name: | Smooth or threaded metallic bone fixation fastener |
| Classification: | Class II per 21 CFR §888.3040 |
| Product Code: | HWC |
| Classification Panel: | Division of Orthopedic Devices |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The SMV Scientific Cannulated Bone Screws consist of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided non-sterile. Screws are manufactured from Stainless Steel per ASTM F138 or Titanium per ASTM F136 or F1295.
INDICATIONS FOR USE
The SMV Scientific 2.4mm and 3.0mm Cannulated Screws are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
The SMV Scientific 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges. steochondritis dissecans, and ligament fixation.
The SMV Scientific 4.5mm Cannulated Screws is intended for fracture fixation of long bones and long bone fragments.
The SMV Scientific 6.5mm and 7.3mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis.
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TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Engineering analysis and dimensional comparison with the predicate devices supported substantial equivalence. Specifically the following characteristics are identical between the subject and predicates:
- Indications for Use ●
- Materials of manufacture ●
- Principles of operation ●
Table 5-1: Predicate Devices
| 510k
Number | Trade or Proprietary or Model
Name | Manufacturer | Predicate Type |
|--------------------|---------------------------------------|--------------|----------------|
| K012945 | 2.4mm Cannulated Screw | Synthes | Primary |
| K962823 | 3.0mm Cannulated Screw | Synthes | Additional |
| K963192 | 3.5mm & 4.0mm Cannulated Screw | Synthes | Additional |
| K963172 | 4.5mm Cannulated Screw | Synthes | Additional |
| K962011
K021932 | 6.5 & 7.3mm Cannulated Screw | Synthes | Additional |
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Cannulated Screws is substantially equivalent to the predicate device.