(100 days)
The Orthofix Contours VPS III is intended for volar fixation of fractures and osteotomies involving the distal radius.
The Contours VPS is an anatomically contoured, delta-shaped plate intended for volar applications to the distal radius. The Contours VPS features an angled head with two rows of holes for placement of screws distally on the radius to secure bone fragments and provide stabilization. If a bone graft is required, access to the site is made possible by the opening in the plate that spans from the plate head to the distal portion of the shaft that may also be utilized for screw placement. The shaft of the Plate is placed proximally on the distal radius and offers a variety of K-wire and screw placement options for secure fixation to the external surface of the bone. The device provides the stabilization and fixation necessary in the treatment of distal radius fractures and osteotomies.
This document describes the Contours VPS III Volar Plating System, a bone plate intended for volar fixation of fractures and osteotomies involving the distal radius. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a bone plate for orthopedic fixation), the primary acceptance criteria revolve around biomechanical performance and material properties, demonstrating it is at least as safe and effective as a predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biomechanical Strength | The modified plates must meet or exceed the criteria for mechanical strength and stiffness of the predicate device when tested in uni-axial compression. (Implied: The device must be strong and stiff enough to stabilize distal radius fractures). | "The results of the testing demonstrated that the Contours VPS exceeded all mechanical testing criteria." (This explicitly states the device exceeded the criteria, implying successful meeting of acceptance standards). |
| Material Composition | The device material must be biocompatible and meet established standards for implantable titanium alloys. (Implied: Material should be safe and suitable for long-term implantation). | "The Contours VPS III plates and screws are made from titanium alloy, Ti6AL-4V ELI conforming to ASTM F136." (Conforming to ASTM F136 indicates it meets recognized material standards for medical implants). |
| Substantial Equivalence | Demonstrate substantial equivalence in design, function, and intended use to the predicate device (Orthofix Volar Distal Radial Plate, K042766). | The conclusion states: "Based upon the results of biomechanical testing, the modified Contours VPS III plates and expanded range of sizes is substantially equivalent to the Orthofix Volar Distal Radial Plate. The Contours VPS III has the mechanical properties needed to perform its indications for use and is considered to be substantially equivalent to the predicate device in design, intended use, material and function." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the test set: Not explicitly stated as a number of devices. The document mentions "the modified Contours VPS III plates." It refers to "testing" in the context of biomechanical properties. For mechanical testing, this typically involves a specified number of samples (e.g., n=5 or n=10) per test condition to achieve statistical significance. However, the exact count is not provided.
- Data Provenance: The study is reported internally by the manufacturer, Orthofix Inc. There's no mention of country of origin of the samples or if the data is retrospective or prospective, as it's a preclinical biomechanical testing study, not a clinical trial with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a biomechanical study comparing physical properties of a device, not a study evaluating human interpretation of medical data where expert radiologists or clinicians would establish ground truths. The "ground truth" here is the established mechanical properties and performance standards of the predicate device and relevant ASTM standards.
4. Adjudication Method for the Test Set
Not applicable for a biomechanical testing study. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers interpret data (e.g., imaging) and need a consensus to establish ground truth or resolve discrepancies.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a physical implant (bone plate), not an AI/software device that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this preclinical study is primarily based on:
- Established mechanical properties and performance of the predicate device: The Contours VPS III was tested against the "same criteria for mechanical strength and stiffness as the predicate device."
- Industry consensus standards: The material conformity to "ASTM F136" is a standard ground truth for implant materials.
8. The sample size for the training set
Not applicable. This is a biomechanical testing study for a physical device, not an AI/machine learning study that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of study.
{0}------------------------------------------------
K10936
pg. 1/3
OCT 2 0 2010
SUMMARY OF SAFETY AND EFFECTIVENESS
Contours VPS III Volar Plating System
| Summary Date: | September 12, 2010 |
|---|---|
| 510(k) Submitter: | Mary E. Biggers, RAC / Orthofix Inc.1720 Bray Central DriveMcKinney, TX 75609972-824-4624 |
| Primary Contact: | Darla Chew / Directory, Regulatory Affairs/Orthofix Inc.Phone: 469-742-8824Fax: 469-742-2556darlachew@orthofix.com |
| Device Trade Name: | Contours VPS III Volar Plating System |
| Common Name: | bone plate |
| Regulation Name: | Single/multiple component metallic bone fixation appliances/accessories. |
| Classification Name: | Plate, fixation, bone (21 CFR Parts 888.3030) |
| Product Code: | HRS |
| Indications for Use: | The Orthofix Contours VPS III is intended for volar fixation of fracturesand osteotomies involving the distal radius. |
| Predicate Device: | The Orthofix Inc. Contours VPS III is substantially equivalent indesign, function, and intended use to the Orthofix Volar Distal RadialPlate. The Volar Distal Radial Plate, manufactured by Orthofix Inc. ofMcKinney, TX, was originally cleared by FDA under K042766 onNovember 16, 2004. |
| Device Description: | The Contours VPS is an anatomically contoured, delta-shaped plateintended for volar applications to the distal radius. The Contours VPSfeatures an angled head with two rows of holes for placement ofscrews distally on the radius to secure bone fragments and providestabilization. If a bone graft is required, access to the site is madepossible by the opening in the plate that spans from the plate head tothe distal portion of the shaft that may also be utilized for screwplacement. The shaft of the Plate is placed proximally on the distalradius and offers a variety of K-wire and screw placement options forsecure fixation to the external surface of the bone. The deviceprovides the stabilization and fixation necessary in the treatment ofdistal radius fractures and osteotomies. |
{1}------------------------------------------------
| Biomechanical | |
|---|---|
| Testing | The mechanical properties of the modified Contours VPS III plateswere tested in uni-axial compression to determine if the modifiedplates meet the same criteria for mechanical strength and stiffness asthe predicate device. The results of the testing demonstrated that theContours VPS exceeded all mechanical testing criteria. |
| Material: | The Contours VPS III plates and screws are made from titanium alloy,Ti6AL-4V ELI conforming to ASTM F136. |
| Sterilization: | The Contours VPS III is supplied NON-STERILE and requiressterilization prior to use. |
| Substantial | |
| Equivalence: | The Contours VPS III is substantially equivalent in design and functionto the Orthofix Inc. Volar Distal Radial Plate which received 510(k)clearance under K042766 on 11-16-04 |
| Features | Orthofix Volar Distal RadialPlate® | Contours VPS |
|---|---|---|
| Indications forUse | Intended for the volar fixation offractures and osteotomiesinvolving the distal radius. | Identical |
| Material | Implant grade Titanium(Ti6A14V ELI) | Identical |
| Fixation Method | Bone Screws | Identical |
| Overall Design | One-piece, low-profile, concaveplate with multiple screwattachment options in head andshaft. | Identical |
| Plate Features:- Graft/Screw Hole | Center hole(separate) | Merged center hole with oval holefor use as graft window or screwhole |
| - Screw Holes | Linear arrangement of screwholes | Non-linear arrangement of screwholes; addition of two metaphysealscrew holes |
| - Plate Thickness | 2.3mm-2.4mm | 3.4mm center plate thickness foradded strength |
| Plate Sizes | Left and right versions,Three widths: 0.7 - 1.2 in. rangeFive lengths: 2.0-4.0 in. range(all 5 lengths available in eachwidth) | Left and right versions;Three widths: 0.9 - 1.2 in. range(narrow, standard, wide)Three lengths: 2.0-4.3 in. range(Narrow/wide plates offered inshort and long lengths; standardwidth offered in short, long, &extra long) |
| Plate Geometry | Delta-shaped | Delta-shaped |
{2}------------------------------------------------
Conclusion:
Based upon the results of biomechanical testing, the modified Contours VPS III plates and expanded range of sizes is substantially equivalent to the Orthofix Volar Distal Radial Plate. The Contours VPS III has the mechanical properties needed to perform its indications for use and is considered to be substantially equivalent to the predicate device in design, intended use, material and function.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three stripes representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Orthofix, Inc. % Ms. Mary E. Biggers, RAC 1720 Bray Central Drive McKinney, Texas 75609
OCT 2 0 2010
Re: K101936
Trade/Device Name: Contours VPS III Volar Plating System (bone plate) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and appliances Regulatory Class: II Product Code: HRS, HWC Dated: September 12, 2010 Received: September 24, 2010
Dear Ms. Biggers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have deterniined 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. Ilsting 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
{4}------------------------------------------------
Page 2 - Ms. Mary E. Biggers, RAC
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
Sincerely yours,
[signature]
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
OCT 2 0 2010
INDICATION FOR USE STATEMENT
Page / of l
510(k) Number (if known): _K101936
Device Name:
Contours VPS III Volar Plating System (bone plate)
Indications for Use:
The Contours VPS III Volar Plating System is intended for the volar fixation of fractures and osteotomies involving the distal radius.
Prescription Use: _ X (Per 21 CFR 801.109)
Or
Over-The-Counter (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sonuta fer mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101936
§ 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.