(92 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of bone screws, with no mention of AI or ML.
Yes
The device is intended to treat fractures of various bones, which is a therapeutic purpose.
No
Explanation: The device, SMV Scientific 4.5mm Bone Screws, is intended to treat fractures by fixing bones. It is a therapeutic device, not a diagnostic one, as it does not identify or detect conditions.
No
The device description clearly states the device is a physical bone screw made of stainless steel, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The SMV Scientific 4.5mm Bone Screws are described as physical implants used to treat bone fractures. They are surgically inserted into the body to stabilize broken bones.
- Lack of Specimen Analysis: There is no mention of this 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 4.5mm Bone Screws are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SMV Scientific 4.5mm Bone Screws are intended to treat fractures of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).
Product codes
HWC
Device Description
The SMV Scientific 4.5mm Solid Bone Screws consist of cortical screws in a variety of lengths to accommodate different anatomic sizes of patients. The screws are provided non-sterile and are self-tapping. 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
clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).
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 4.5mm 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 o
The results of this non-clinical testing show that the strength of the SMV Scientific 4.5mm 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2015
Summit MedVentures % Mr. Kenneth C. Maxwell II Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K150188
Trade/Device Name: SMV Scientific 4.5 mm 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: April 3, 2015 Received: April 6, 2015
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 C. Maxwell II
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
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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 ) | K150188 |
|---|---|
| Device Name | SMV Scientific 4.5mm Bone Screws |
| Indications for Use ( Describe ) | The SMV Scientific 4.5mm Bone Screws are intended to treat fractures of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges). |
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)
FORM FDA 3881 (9/13) PSC Publishing Services (301) 443-6740 EF
3
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 | 16 April 2015 |
| Trade or Proprietary Name | SMV Scientific 4.5mm 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 4.5mm Solid Bone Screws consist of cortical screws in a variety of lengths to accommodate different anatomic sizes of patients. The screws are provided non-sterile and are self-tapping. Screws are manufactured from stainless steel.
INDICATIONS FOR USE
The SMV Scientific 4.5mm Bone Screws are intended to treat fractures of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges). The indications for the 4.5mm Bone Screw is similar to that of the predicate devices.
TECHNOLOGICAL CHARACTERISTICS
The SMV Scientific 4.5mm Bone Screw is 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 identical between the subject and predicates:
- Indications for Use
- Materials
- Principles of Operation ●
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Table 5-1 Predicate Device
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K092889 | Osteo-Plate and Screw Fixation | Syntec | Primary |
PERFORMANCE DATA
The SMV Scientific 4.5mm 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 o
The results of this non-clinical testing show that the strength of the SMV Scientific 4.5mm 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 4.5mm Bone Screw is substantially equivalent to the predicate device.