(60 days)
The MAVERICK External Fixation System is intended to be used for temporary stabilization of the long bones, feet, and pelvis.
The indications for the Smith & Nephew MAVERICK External Fixation System are the following:
- Open and closed fracture fixation
- Bony or soft tissue deformities
The subject of this premarket notification is the MAVERICK External Fixation System. The system is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application.
The provided text is a 510(k) Premarket Notification from the U.S. FDA for the MAVERICK External Fixation System. It details the device's intended use, regulatory classification, and comparisons to predicate devices. However, the document does not contain information about a study proving the device meets acceptance criteria related to AI/Machine Learning performance, diagnostic accuracy, or human reader improvement with AI assistance.
The performance testing section (on page 4) exclusively describes mechanical bench testing of the device's components and full constructs, such as grip strength, resistance to slip, and cyclic testing of frames. This type of testing is standard for orthopedic devices to demonstrate structural integrity and durability, not diagnostic accuracy or AI performance.
Therefore, I cannot fulfill the request as the provided text does not contain the necessary information regarding:
- A table of acceptance criteria and the reported device performance for an AI/diagnostic device. The provided "Device Testing" table lists mechanical tests, not diagnostic performance metrics.
- Sample size used for the test set and data provenance: No such data is mentioned.
- Number of experts used to establish ground truth and their qualifications: Not applicable to mechanical testing.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
The document is about a Class II medical device for temporary stabilization of bones, and the "study" described is entirely focused on mechanical performance and biocompatibility, not on diagnostic accuracy or AI-powered assistance.
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February 11, 2022
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Smith & Nephew, Inc. Brad Sheals Senior Regulatory Affairs Manager 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K213874
Trade/Device Name: MAVERICK External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JDW Dated: December 10, 2021 Received: December 13, 2021
Dear Brad Sheals:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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,
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name MAVERICK External Fixation System
Indications for Use (Describe)
The MAVERICK External Fixation System is intended to be used for temporary stabilization of the long bones, feet, and pelvis.
The indications for the Smith & Nephew MAVERICK External Fixation System are the following:
-
- Open and closed fracture fixation
- Bony or soft tissue deformities
| 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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-We are smith&nephew
| Submitted by: | Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116 |
|---|---|
| Date of Summary: | December 10, 2021 |
| Mr. Brad Sheals, MSSenior Regulatory Affairs ManagerT 901-288-7141F 901-566-7911 | |
| Name of Device: | MAVERICK External Fixation System |
| Common Name: | Multi-lateral Fixators and Accessories |
| Device Classification Name andReference: | 21 CFR 888.3030 Single/multiple component metallicbone fixation appliances and accessories |
| 21 CFR 888.3040 Smooth or threaded metallic bonefixation fastener | |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | KTT, JDW |
Predicates
| Manufacturer | Description | SubmissionNumber | Clearance Date |
|---|---|---|---|
| Smith & Nephew,Inc. | Jet-X Bar System Clamps,Bars and Posts – MR Safe(Primary Predicate) | K072212 | March 7, 2008 |
| Austin MillerTrauma LLC | Austin Miller Large ExternalFixation System | K181528 | February 28,2019 |
| Smith & Nephew,Inc. | Smith & Nephew ExternalFixation System (Jet-X) | K994143 | February 18,2000 |
Device Description
The subject of this premarket notification is the MAVERICK External Fixation System. The system is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application.
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Indications for Use
The MAVERICK External Fixation System is intended to be used for temporary stabilization of the long bones, feet, and pelvis.
The indications for the Smith & Nephew MAVERICK External Fixation System are the following:
- Open and closed fracture fixation .
- Bony or soft tissue deformities
Technological Characteristics
The principle of operation for the subject and the predicate devices is stabilization of bones through fixation with pins clamped to an external fixation frame built with composite bars. The MAVERICK External Fixation System is similar to legally marketed predicate devices in that they are manufactured from similar materials, are of structurally similar size, strength and stiffness, and incorporate similar methods of assembly and adjustment.
Performance Testing
To further support a determination of substantial equivalence, Mechanical testing and/or assessments were utilized. A review of the data indicates that the subject MAVERICK External Fixation System is substantially equivalent to one or more of the previously cleared predicate devices listed above. The following overall bench performance strategy was used as a basis for the determination of substantial equivalence.
| Device Testing | |
|---|---|
| Subject Pin Testing | Axial Grip Strength of ClampsTorsional Grip Strength of ClampsPin Insertion ForcePin Pullout |
| Subject Clamps Testing | Torsional Grip Strength of PinsResistance to Slip at InternalSwivelJunctionAxial Grip Strength of BarsTorsional Grip Strength of BarsAxial Grip Strength with Pins |
| Subject Clamps/Post Testing | Axial Grip Strength of ClampsTorsional Grip Strength of Clamps |
| Testing of Interconnections in Full Constructs | Cyclic Testing of Pelvic FramesCyclic Testing of Joint Spanning StyleFrames |
| Rigidity Testing to Failure of Full Constructs | Load to Failure of Pelvic FramesLoad to Failure of Joint Spanning StyleFrames |
Overall Bench Performance Testing Strategy
A biocompatibility assessment was completed. A MRI justification was utilized in lieu of testing.
Conclusion
Based on similarities to the predicate multi-lateral external fixation systems and a review of testing performed, the subject MAVERICK External Fixation System is substantially equivalent to the commercially available predicate devices.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.