(70 days)
None
No
The document describes bone screws and their mechanical properties, with no mention of AI or ML.
Yes
The device, bone screws, is used for the fixation of fractures, osteotomies, and non-unions, which are all therapeutic interventions for the human body.
No
The device is a bone screw, which is an implant used for fixation of fractures and osteotomies, not for diagnosing medical conditions.
No
The device description explicitly states the device consists of "cortical screws" manufactured from "stainless steel," which are physical hardware components. The performance studies also describe testing of these physical screws.
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 Bone Screws as implants used for the fixation of bones during surgical procedures. They are physical devices inserted into the body to provide structural support.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the SMV Scientific Bone Screws are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The SMV Scientific 2.0mm and 2.4mm Bone Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The SMV Scientific 2.7mm Bone Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The SMV Scientific 3.5mm and 4.0mm Bone Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The SMV Scientific 4.5mm Bone Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
Product codes
HWC
Device Description
The SMV Scientific Bone Screws consist of cortical screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided both sterile and non-sterile. Screws are manufactured from stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand, wrist, and other small bones and bone fragments; foot, ankle, and hand; clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur and fibula; humerus, femur and tibia.
Indicated Patient Age Range
Adults and in both children (2-12 years) and adolescents (12-21 years)
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 Bone Screw has been tested in the following test modes:
- Static Torsion per ASTM F543
- Driving Torque per ASTM F543
- Pullout Testing per ASTM F543
- Removal Torque per ASTM F543
The results of this non-clinical testing show that the strength of the SMV Scientific Bone 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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2015
SMV Scientific Mr. Nephi Zufelt Chief Technology Officer 111 Sandra Muraida Way, Unit 18A Austin, Texas 78703
Re: K150981
Trade/Device Name: SMV Scientific Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 30, 2015 Received: May 1, 2015
Dear Mr. Zufelt:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Nephi Zufelt
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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 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) | |
| K150981 | |
| Device Name | |
| SMV Scientific Bone Screws | |
| Indications for Use (Describe) | |
| The SMV Scientific 2.0mm and 2.4mm Bone Screws are intended for use in trauma procedures, | |
| reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bone | |
| fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth | |
| plates have fused or in which growth plates will not be crossed by screw fixation. | |
| The SMV Scientific 2.7mm Bone Screw is intended for fractures and osteotomies of small bones and | |
| bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and | |
| adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be | |
| crossed by screw fixation. | |
| The SMV Scientific 3.5mm and 4.0mm Bone Screws are intended for fixation of fractures, osteotomies | |
| and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, | |
| femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which | |
| growth plates have fused or in which growth plates will not be crossed by screw fixation. | |
| The SMV Scientific 4.5mm Bone Screw is intended for fixation of various long bones, such as the | |
| humerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults and in both | |
| children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which | |
| growth plates will not be crossed by screw fixation. | |
| 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) |
PSC Publishing Services (301) 443-6740 EF
3
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 | |
| Date Summary was | |
| Prepared | 12 June 2015 |
| Trade or Proprietary Name | SMV Scientific Bone Screw |
| Common or Usual Name | Screw, Fixation, Bone |
| 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:
The SMV Scientific Bone Screws consist of cortical screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided both sterile and non-sterile. Screws are manufactured from stainless steel.
INDICATIONS FOR USE
The SMV Scientific 2.0mm and 2.4mm Bone Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The SMV Scientific 2.7mm Bone Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The SMV Scientific 3.5mm and 4.0mm Bone Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle. scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The SMV Scientific 4.5mm Bone Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults
4
and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The indications for use for the SMV Scientific Bone Screw is similar to that of the predicate devices.
TECHNOLOGICAL CHARACTERISTICS
SMV Scientific Bone Screws are made from stainless steel that conforms to ASTM F138. The subject and predicate device have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are similar between the subject and predicates:
- . Indications for Use
- Materials ●
- Principles of Operation ●
Table 5-1 Predicate Device
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K112583 | Cortical Screws | Synthes | Primary |
PERFORMANCE DATA
The SMV Scientific Bone Screw has been tested in the following test modes:
- Static Torsion per ASTM F543
- Driving Torque per ASTM F543 ●
- Pullout Testing per ASTM F543
- . Removal Torque per ASTM F543
The results of this non-clinical testing show that the strength of the SMV Scientific Bone 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 Bone Screw is substantially equivalent to the predicate device.