(128 days)
No
The device description and performance studies focus on the mechanical properties and structural integrity of bone plates and screws, with no mention of AI or ML technologies.
Yes
The device is intended for fixation of fractures, osteotomies, and non-unions, which are restorative actions to treat medical conditions.
No
Explanation: The device is a bone plate and screw system intended for fixation of fractures, osteotomies, and non-unions, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of implants (plates and screws) and instruments, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula." This describes a surgical implant used in vivo (within the body) to stabilize bones.
- Device Description: The description details implants (plates and screws) and instruments for surgical procedures. This aligns with a medical device used for treatment, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SMV Bone Plate and Screw System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, periarticular and intraarticular fractures.
Product codes
HRS, HWC
Device Description
The SMV Bone Plate and Screw System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features nineteen (19) types of plates, bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F138), and offered in various widths and lengths. Plates and screws are provided non-sterile. The implants in this submission can be used with the screws cleared in K150981 and K150188.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula
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
The SMV Scientific Bone Plate and Screw System has been tested in the following test modes:
- Static Four-point Bending per ASTM F382
- Dynamic Four-point Bending ASTM F382
The results of this non-clinical testing show that the strength of the Bone Plate and Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K001945, K011335, K020872, K082807
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol 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
November 25, 2015
SMV Scientific % Mr. Kenneth Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K152000
Trade/Device Name: SMV Bone Plate and Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 28, 2015 Received: October 30, 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 Parts 801); medical device 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/ResourcesforYou/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) | K152000 |
| Device Name | SMV Bone Plate and Screw System |
| Indications for Use (Describe) | The SMV Bone Plate and Screw System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, periarticular and intraarticular fractures. |
| 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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This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services
Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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: | 12 November 2015 |
| Trade or Proprietary Name: | SMV Bone Plate and Screw System |
| Common or Usual Name: | Plate, Fixation, Bone |
| Screw, Fixation, Bone | |
| Classification: | Class II per 21 CFR §888.3030 & §888.3040 |
| Product Code: | HRS, HWC |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The SMV Bone Plate and Screw System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features nineteen (19) types of plates, bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F138), and offered in various widths and lengths. Plates and screws are provided non-sterile. The implants in this submission can be used with the screws cleared in K150981 and K150188.
INDICATIONS FOR USE
The SMV Bone Plate and Screw System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, periarticular and intraarticular fractures.
The indications for use for the Bone Plate and Screw System is similar to that of the predicate devices listed in Table 5-1: Predicate Devices.
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. Specifically the following characteristics are identical between the subject and predicates:
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- . 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 |
|---|---|---|---|
| K092609 | 3.5mm and 4.5mm Curved Narrow and Broad Locking Compression Plates (LCP), Straight Compression, Straight Reconstruction Bone Plates | Synthes | Primary |
| K001945 | Medial Distal Tibia Plates | Synthes | Reference |
| K011335 | One-Third Tubular DCL Plate, One-Third Tubular | Synthes | Reference |
| K020872 | 3.5 mm Broad LC-DCP Plates | Synthes | Reference |
| K082807 | 3.5mm and 4.5mm Locking Compression Plate (LCP) System | Synthes | Reference |
Performance Data
The SMV Scientific Bone Plate and Screw System has been tested in the following test modes:
- Static Four-point Bending per ASTM F382 ●
- . Dynamic Four-point Bending ASTM F382
The results of this non-clinical testing show that the strength of the Bone Plate and Screw System 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 Bone Plate and Screw System is substantially equivalent to the predicate device.