(35 days)
Not Found
No
The summary describes a mechanical implant (bone plates) and mentions only standard engineering analyses (FEA, fatigue testing) and packaging tests. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of AI/ML.
Yes
Explanation: The device is indicated for fracture fixation, reconstruction, or arthrodesis of small bones, which are therapeutic interventions.
No
The device is a talus plate for fracture fixation, reconstruction, or arthrodesis, which is a therapeutic device, not a diagnostic one.
No
The device is a physical implant (talus plates) made of titanium alloy, not software. The description clearly details the material and manufacturing of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended for fracture fixation, reconstruction, or arthrodesis of small bones in the foot. This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a bone plate made of titanium alloy, designed for surgical implantation. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- No mention of biological samples: The description does not mention the use of blood, tissue, or any other biological sample.
- Performance Studies: The performance studies described are related to the mechanical properties and packaging of the implant, not the analysis of biological samples.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to fix bones.
N/A
Intended Use / Indications for Use
The VLP Mini-Mod Talus Plates can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP Mini-Mod Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The subject premarket notification describes talus plate line additions to the VLP Mini-Mod Small Bone Plating System. Subject plates consist of several varieties of medial and lateral talus plates in left and right designs. All described implant devices are manufactured from implant-grade titanium alloy material (Ti-6Al-4V) and designed for single-use. They will be provided in a sterile-packaged option and will be sterilized via Gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forefoot, midfoot and hindfoot
Indicated Patient Age Range
adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults
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)
- Finite element analysis (FEA) was conducted on the proposed talus plate designs to evaluate the effect of the material change from Stainless Steel to Ti-6Al-4V. This testing was used to determine the worst case plate as well as the high stress region of the plates.
- Four-point bend fatigue testing was conducted on worst-case examples of the proposed bone plates, as identified through FEA testing. Results of the testing concluded that the number of log cycles to failure achieved by the proposed bone plates met the acceptance criteria in that they were found to be non-inferior to the fatigue log cycles to failure of a previously cleared predicate.
- Engineering analysis based on the device geometry and nominal material properties.
- Packaging testing consisting of post-sterilization visual inspection, a package challenge test, post package challenge test visual inspection, and seal integrity bubble emission testing showed that the product will not be damaged during shipping and will maintain sterility post-shipping.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K110670, K132886, K071264, K993106
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2015
Smith & Nephew, Incorporated Ms. Samantha Staubach Regulatory Affairs Specialist I 1450 East Brooks Road Memphis, Tennessee 38116
Re: K152976 Trade/Device Name: VLP Mini-Mod Talus Plates 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 6, 2015 Received: October 8, 2015
Dear Ms. Staubach:
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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152976
Device Name VLP Mini-Mod Talus Plates
Indications for Use (Describe)
The VLP Mini-Mod Talus Plates can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP Mini-Mod Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, in the forefoot, midfoot and hindfoot.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
We are smith&nephew
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | November 10, 2015 |
| Contact Person and Address: | Samantha Staubach
Regulatory Affairs Specialist I
T 901-399-6132
F 901-566-7596 |
| Name of Device: | VLP Mini-Mod Talus Plates |
| Common Name: | Bone plates |
| Device Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple component metallic bone
fixation appliances and accessories
21 CFR 888.3040 Smooth or threaded metallic bone fixation
fastener |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HRS, HWC |
Predicates
| Manufacturer | Description | Submission
Number | Clearance
Date |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------|-------------------|
| Smith & Nephew,
Inc. | VLP FOOT Plating System and PERI-LOC
Ankle Fusion Plating System - Locking Bone
Plates and Screws (Primary Predicate) | K110670 | 7/12/11 |
| Smith & Nephew,
Inc. | Smith & Nephew Variable-Angle Locking
Mini-Fragment Plating System | K132886 | 2/4/14 |
| Synthes (USA) | Synthes (USA) 2.4/2.7mm Locking Foot
Module | K071264 | 7/9/2007 |
| Smith & Nephew,
Inc. | Smith & Nephew Bone Plate System (Bone
Plates, Bone Screws, and Accessories) | K993106 | 12/9/1999 |
Device Description
The subject premarket notification describes talus plate line additions to the VLP Mini-Mod Small Bone Plating System. Subject plates consist of several varieties of medial and lateral talus plates in left and right designs. All described implant devices are manufactured from implant-grade titanium alloy material (Ti-6Al-4V) and designed for single-use. They will be provided in a sterile-packaged option and will be sterilized via Gamma irradiation.
Indications for Use
The VLP Mini-Mod Talus Plates can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic
4
bone. The VLP Mini-Mod Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.
Technological Characteristics
Device comparisons described in this premarket notification demonstrated that the proposed talus plates are substantially equivalent to the legally marketed primary predicate devices cleared in K110670 with regard to intended use, indications for use, and performance characteristics.
The subject VLP Mini-Mod Talus Plates feature characteristics very similar to the VLP FOOT Plating System talus plates cleared via K110670 with the primary differences being the material selection, the addition of device-specific bone template instrumentation and different packaging configuration. The subject plates feature identical indications for use and intended use as the talus plates offered in K110670 and the same plate design options from K110670 will be available with the VLP Mini-Mod system.
Summary of Pre-Clinical Testing
- Finite element analysis (FEA) was conducted on the proposed talus plate designs to . evaluate the effect of the material change from Stainless Steel to Ti-6Al-4V. This testing was used to determine the worst case plate as well as the high stress region of the plates.
- . Four-point bend fatigue testing was conducted on worst-case examples of the proposed bone plates, as identified through FEA testing. Results of the testing concluded that the number of log cycles to failure achieved by the proposed bone plates met the acceptance criteria in that they were found to be non-inferior to the fatigue log cycles to failure of a previously cleared predicate.
- Engineering analysis based on the device geometry and nominal material properties. .
- . Packaging testing consisting of post-sterilization visual inspection, a package challenge test, post package challenge test visual inspection, and seal integrity bubble emission testing showed that the product will not be damaged during shipping and will maintain sterility post-shipping.
Conclusion
This Special 510(k) premarket notification is being submitted to request clearance for the VLP Mini-Mod Talus Plates. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the predicate talus plates.