(40 days)
The Volition Plating System is indication and fixation of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, including the toes, talus, and calcaneus; the distal fibula and tibia; as well as the fingers, hands, and wrists.
In addition, the non-locking screws and washers are in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
The Volition Plating System is a set of implantable metallic (Titanium Alloy) bone plates consisting of a series of tubular plates of varying lengths as well as anatomically contoured plates. The Volition Plating System plates are provided with locking and non-locking in Ø2.7mm, Ø3.5mm, & Ø4.0mm previously cleared under K202764. All implants are made from Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 and are provided non-sterile.
This is a 510(k) premarket notification for the Volition Plating System, a metallic bone fixation device. The document states that the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document describes a medical device called the "Volition Plating System" which is a metallic bone fixation device. The provided text is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. In such submissions, explicit "acceptance criteria" and "reported device performance" are typically framed in terms of equivalence to the predicate device through various tests and analyses.
Therefore, the "acceptance criteria" here is that the Volition Plating System demonstrates substantial equivalence to the predicate devices in terms of material, geometry, design, indications for use, and mechanical performance. The "reported device performance" is the conclusion that this equivalence has been demonstrated.
Since this is a substantial equivalence determination and not a performance claim against specific quantitative thresholds for a new function, a typical acceptance criteria table with numerical performance metrics isn't directly applicable in the same way it would be for, say, an AI diagnostic tool.
However, based on the "Performance Analysis" and "Conclusion" sections of the 510(k) summary, we can infer the following:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in material | The Volition Plating System uses Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136, which is stated to be substantially equivalent to the predicate devices. |
| Substantial equivalence in geometry | The Volition Plating System's plates consist of tubular plates of varying lengths and anatomically contoured plates, with locking and non-locking screws in Ø2.7mm, Ø3.5mm, & Ø4.0mm, which are stated to be substantially equivalent to the predicate devices. |
| Substantial equivalence in design | The design characteristics of the subject device do not raise new types of questions regarding safety or efficacy. |
| Substantial equivalence in indications for use | The Indications for Use for the Volition Plating System are the same as the predicate devices: stabilization and fixation of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, and fingers, hands, and wrists. Non-locking screws and washers are for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation. |
| Substantial equivalence in mechanical performance (e.g., bending strength) | Engineering analysis was employed to demonstrate that the Volition System bone plates are substantially equivalent to the predicate(s) with respect to bending strength performance. |
2. Sample size used for the test set and the data provenance
The document describes an engineering analysis and comparison to predicate devices. It does not describe a clinical study involving human subjects or a test set of data with a specified sample size. The provenance of such a "test set" is therefore not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, this is a 510(k) submission based on engineering analysis and comparison to predicate devices, not a study involving a "test set" with ground truth established by experts.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set or adjudication process.
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 MRMC comparative effectiveness study was done. This device is a bone fixation system, not an AI-powered diagnostic tool, so such a study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical bone fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As this is not a diagnostic device or a study requiring ground truth establishment, this information is not relevant to this 510(k) submission. The "ground truth" in this context is the performance of the legally marketed predicate devices, which the new device aims to be substantially equivalent to.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device. The "training" in this context would be the design and testing of the device to meet engineering specifications and ensure equivalence to predicates.
9. How the ground truth for the training set was established
Not applicable. As there is no training set discussed, this question is not relevant.
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April 13, 2021
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Ortho Solutions UK Ltd Andy Leither US Technical and Development Director West Station Business Park, Spital Road Maldon, CMF 6FF GBR
Re: K210658
Trade/Device Name: Volition Plating 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, HTN Dated: March 4. 2021 Received: March 4, 2021
Dear Andy Leither:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (08) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -S
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Volition Plating System
Indications for Use (Describe)
The Volition Plating System is indication and fixation of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, including the toes, talus, and calcaneus; the distal fibula and tibia; as well as the fingers, hands, and wrists.
In addition, the non-locking screws and washers are in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
| Type of Use (Select one or both, as applicable) | For Direct Use/Application (i.e. consumption of water) For Re-Circulation/Re-Use (i.e. cooling water) | For Direct Use/Application (i.e. consumption of water) | For Re-Circulation/Re-Use (i.e. cooling water) |
|---|---|---|---|
| For Direct Use/Application (i.e. consumption of water) | |||
| For Re-Circulation/Re-Use (i.e. cooling water) |
X 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 logo for OrthoS. The word "OrthoSolutions" is written in red font. Below the word "OrthoSolutions" is the word "Group" in a smaller, gray font. To the right of the text is a gray and red symbol that looks like the letter S.
K210658 - 510(k) SUMMARY
Submitter Information
| Submitters Name:Address: | Ortho Solutions UK LtdWest Station Business ParkSpital RoadEssex, CM9 6FFUnited Kingdom |
|---|---|
| Telephone Number:Fax Number:Prepared By:Contact Person:Date Prepared: | +44 1621 843 599+44 1621 858 953Andy LeitherAndy Leither09/16/2020 |
| Device Information | |
| Trade Name: | Volition Plating System |
| Common Name: | Plate, Fixation, BoneScrew, Fixation, BoneWasher, Bolt Nut |
| Device Classification: | Class II per 21 CFR 888.3030 (Primary)Single/multiple component metallic bone fixation appliances andaccessories.Panel: Orthopedic |
| Class II per 21 CFR 888.3040Smooth or threaded metallic bone fixation fastener.Panel: Orthopedic | |
| Class II per 21 CFR 888.3030Single/multiple component metallic bone fixation appliances andaccessories.Panel: Orthopedic | |
| Product Code: | HRS (Primary)HWCHTN |
| Material Composition: | Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 |
| Device Description: | The Volition Plating System is a set of implantable metallic (TitaniumAlloy) bone plates consisting of a series of tubular plates of varyinglengths as well as anatomically contoured plates. The Volition PlatingSystem plates are provided with locking and non-locking in Ø2.7mm,Ø3.5mm, & Ø4.0mm previously cleared under K202764. All implantsare made from Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 and areprovided non-sterile. |
| Primary Predicate Device: | Ortho Solutions Plating System, K202764 |
| Additional Predicate Devices: | Ortho Solutions Trauma Plates for Osteosynthesis, K120360 |
| Indications for Use: | The Ortho Solutions Plating System is indicated for use in stabilization andfixation of fractures or osteotomies, revision procedures, joint fusion, andreconstruction of small bones of the feet and ankles, including the toes,talus, and calcaneus; the distal fibula and tibia; as well as the fingers,hands, and wrists. |
| In addition, the non-locking screws and washers are indicated for use inbone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair,and fracture fixation, appropriate for the size of the device. | |
| Technological Characteristics: | The Volition Plating System is substantially equivalent in material,geometry, design, and indications to the predicate devices. |
| Performance Analysis: | Engineering analysis of the subject device was employed todemonstrate the Volition System bone plates are substantiallyequivalent to the predicate(s) with respect to bending strengthperformance. |
| Conclusion: | The Volition Plating System has been compared to the previouslycleared predicate devices with respect to indications for use, materials,mechanical performance, and technological characteristics. The designcharacteristics of the subject device do not raise new types of questionsregarding safety or efficacy. These comparisons demonstrate that theVolition Plating System is substantially equivalence to the predicatedevices. |
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Image /page/4/Picture/0 description: The image shows the logo for OrthoSolutions Group. The words "OrthoSolutions" are in red, with the word "Group" in gray underneath. To the right of the text is a stylized silver and red symbol that resembles the letter S.
§ 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.