(48 days)
Not Found
No
The document describes a bone plating system and its mechanical testing, with no mention of AI or ML.
Yes
This device is a plating system used for fracture fixation, arthrodesis, reconstruction, replantation, or reduction of bones, which are therapeutic medical interventions.
No.
The device is a plating system designed for fracture fixation, arthrodesis, reconstruction, replantation, or reduction of small bones and bone fragments, indicating a therapeutic or surgical purpose rather than a diagnostic one.
No
The device description and performance studies clearly indicate this is a physical bone plating system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures involving bone fixation, arthrodesis, reconstruction, replantation, and reduction. These are all procedures performed on the body, not in vitro (outside the body) testing of samples.
- Device Description: The description details bone plates and screws, which are implants used in surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
- Performance Studies: The performance studies described (finite element analysis, fatigue testing, bacterial endotoxin testing) are relevant to the mechanical and biological safety of an implantable device, not the analytical performance of a diagnostic test.
In summary, the VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are surgical implants, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12–18 years) and transitional adolescent (18–21 years) subpopulations and adults, as well as patients with osteopenic bone.
The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The subject VLP MINI-MOD 2.0mm Column Plates are line addition plates to the VLP MINI-MOD Small Bone Plating System. The VLP MINI-MOD Small Bone Plating System was initially cleared for market via K132886 as the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System. The proposed plates are intended to be used with the 2.0mm Locking and Cortex screws previously cleared via K132886.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones, long bones
Indicated Patient Age Range
adolescent (12–18 years) and transitional adolescent (18–21 years) subpopulations and adults
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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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 VLP MINI-MOD 2.0mm Column Plate to determine if it represented a new worst case compared against the existing MINI-MOD plates cleared via K132886. The subject plate did not represent a new worst case plate design.
- An engineering rationale was used to leverage the four-point bend fatigue testing that was previously conducted on the worst-case plate of the VLP MINI-MOD product family cleared via K132886. 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 when tested at the same bending moment. Due to the fact that the subject plate did not represent a new worst case, the testing was also applicable to the subject line addition plate.
- Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
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.
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.
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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
Smith & Nephew, Inc. Samantha Staubach Regulatory Affairs Specialist 1450 Brooks Rd Memphis. Tennessee 38116
Re: K163086
Trade/Device Name: VLP MINI-MOD 2.0 mm Column 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 Dated: November 2, 2016 Received: November 3, 2016
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 Part 801); medical device reporting (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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Indications for Use
510(k) Number (if known) K163086
Device Name VLP MINI-MOD 2.0mm Column Plates
Indications for Use (Describe)
The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone.
The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
| 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) |
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Image /page/3/Picture/0 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are" in gray, and "smith&nephew" in orange. The text is aligned horizontally, with the flower symbol slightly above the text.
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|
| Date of Summary: | December 21, 2016 |
| Contact Person and Address: | Samantha Staubach
Regulatory Affairs Specialist
T 901-399-6132
F 901-566-7596 |
| Name of Device: | VLP MINI-MOD 2.0mm Column Plates |
| Common Name: | Bone plates |
| Device Classification Name and
Reference: | 21CFR 888.3030 Single/multiple component metallic bone
fixation appliances and accessories |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HRS |
Predicates
Table 5-1: Substantially equivalent predicates
| Manufacturer | Description | Submission
Number | Clearance Date |
|----------------------|----------------------------------------------------------------------------------------------|----------------------|----------------|
| Smith & Nephew, Inc. | Smith & Nephew Variable-Angle
Locking Mini-Fragment Plating
System (Primary Predicate) | K132886 | 2/4/2014 |
| Smith & Nephew, Inc. | Smith & Nephew Bone Plate
System | K993106 | 12/9/1999 |
Device Description
The subject VLP MINI-MOD 2.0mm Column Plates are line addition plates to the VLP MINI-MOD Small Bone Plating System. The VLP MINI-MOD Small Bone Plating System was initially cleared for market via K132886 as the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System. The proposed plates are intended to be used with the 2.0mm Locking and Cortex screws previously cleared via K132886.
Indications for Use
The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12–18 years) and transitional adolescent (18–21 years) subpopulations and adults, as well as patients with osteopenic bone.
The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This
4
system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
Technological Characteristics
Device comparisons described in this premarket notification demonstrated that the proposed VLP MINI-MOD 2.0mm Column Plate is substantially equivalent to the legally marketed predicate devices described in Table 5-1 with regard to intended use, indications for use, and performance characteristics.
Summary of Pre-Clinical Testing
- Finite element analysis (FEA) was conducted on the proposed VLP MINI-MOD 2.0mm . Column Plate to determine if it represented a new worst case compared against the existing MINI-MOD plates cleared via K132886. The subject plate did not represent a new worst case plate design.
- An engineering rationale was used to leverage the four-point bend fatigue testing that was previously conducted on the worst-case plate of the VLP MINI-MOD product family cleared via K132886. 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 when tested at the same bending moment. Due to the fact that the subject plate did not represent a new worst case, the testing was also applicable to the subject line addition plate.
- . Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
Conclusion
This Traditional 510(k) premarket notification is being submitted to required clearance for the line addition VLP MINI-MOD 2.0mm Column Plate. Based on similarities to the predicate component and a review of the engineering rationale/mechanical testing previously conducted, the devices are substantially equivalent to the predicates described in Table 5-1.