(171 days)
The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware: fracture fixation (open and closed) pseudoarthrosis of long bones limb lengthening (epiphyseal or metaphyseal distraction) joint arthrodesis infected fractures or nonunions correction of bony or soft tissue deformities correction of segmental defects.
The DePuy Synthes MAXFRAME™ Multi-Axial Correction System, with adult and pediatric indications, is an external ring fixation system that is combined with web-based software in treatment of soft tissue and bone deformities. In the MAXFRAME system, implanted transfixion wires, Schanz screws and pins are attached to the rings and plates surrounding the deformity using bolts, nuts and connecting plates. Upper and lower rings are then connected to one another using six telescoping struts, creating a "Stewart Platform" type device. Adjusting the strut length allows for correction of length, rotation, and angular deformity at the same time. The modular nature of a ring fixation frame allows multiple frame options. A ring fixation frame is assembled individually by the surgeon to address the different characteristics of each case. The materials of construction for this system include aluminum, elgiloy, stainless steel and various polymeric materials. This system has been validated as MR Conditional.
The provided text describes the DePuy Synthes MAXFRAME™ Multi-Axial Correction System, a medical device, and its FDA 510(k) summary. However, it does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The device itself is a physical external ring fixation system combined with web-based software for treatment planning, not an AI diagnostic or predictive tool in the context of typical AI performance studies.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to AI, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI component.
The document discusses performance in terms of:
- Construct testing: ASTM 1541-02 (2011)
- Component testing: Static & Dynamic Compression testing, Static Torsion, Static Cantilever, Static and Dynamic Fatigue, Wire Slip and Ring to Wire Interface Testing
- System Validation
- Software Verification: In accordance with Special Controls & EN IEC 62304:2006-05 Medical device Software life cycle processes
- MR Conditional Technical Data: In accordance with FDA Guidance and ASTM F2503-13
- Reprocessing of SUD in accordance with Special Controls
The conclusion states that "The objective evidence presented demonstrates that the mechanical performance of the proposed device is comparable to that of the predicate device(s) and supports substantial equivalence for safety and effectiveness."
No clinical evaluation was deemed necessary for the determination of substantial equivalence for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2016
Synthes USA, LLC Stacey Bonnell Associate Director Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K161417
Trade/Device Name: DePuy Synthes MAXFRAME™ Multi-Axial Correction 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, OSN Dated: May 20, 2016 Received: May 23, 2016
Dear Ms. Bonnell:
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
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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 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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| PART NUMBER | DESCRIPTION |
|---|---|
| 03.312.813 | MAXFRAME Strut Long, Quick Adjust |
| 03.312.812 | MAXFRAME Strut Medium, Quick Adjust |
| 03.312.811 | MAXFRAME Strut Short, Quick Adjust |
| 03.312.810 | MAXFRAME Strut X-Short, Quick Adjust |
| 03.312.818 | MAXFRAME Strut Long, Standard |
| 03.312.817 | MAXFRAME Strut Medium, Standard |
| 03.312.816 | MAXFRAME Strut Short, Standard |
| 03.312.815 | MAXFRAME Strut X-Short, Standard |
| 03.312.814 | MAXFRAME Strut XX-Short, Standard |
| 03.312.090 | MAXFRAME full ring 90mm, Aluminum |
| 03.312.120 | MAXFRAME full ring 120mm, Aluminum |
| 03.312.150 | MAXFRAME full ring 150mm, Aluminum |
| 03.312.180 | MAXFRAME full ring 180mm, Aluminum |
| 03.312.210 | MAXFRAME full ring 210mm, Aluminum |
| 03.312.240 | MAXFRAME full ring 240mm, Aluminum |
| 03.312.270 | MAXFRAME full ring 270mm, Aluminum |
| 03.312.350 | MAXFRAME Bridging Plate for 5/8 ring 150mm, Aluminum |
| 03.312.380 | MAXFRAME Bridging Plate for 5/8 ring 180mm, Aluminum |
| 03.312.410 | MAXFRAME Bridging Plate for 5/8 ring 210mm, Aluminum |
| 03.312.440 | MAXFRAME Bridging Plate for 5/8 ring 240mm, Aluminum |
| 03.312.590 | MAXFRAME 5/8 ring 90mm, Aluminum |
| 03.312.620 | MAXFRAME 5/8 ring 120mm, Aluminum |
| 03.312.650 | MAXFRAME 5/8 ring 150mm, Aluminum |
| 03.312.680 | MAXFRAME 5/8 ring 180mm, Aluminum |
| 03.312.710 | MAXFRAME 5/8 ring 210mm, Aluminum |
| 03.312.740 | MAXFRAME 5/8 ring 240mm, Aluminum |
| 03.312.141 | MAXFRAME Foot Plate short 140mm, Aluminum |
| 03.312.161 | MAXFRAME Foot Plate short 160mm, Aluminum |
| 03.312.181 | MAXFRAME Foot Plate short 180mm, Aluminum |
| 03.312.201 | MAXFRAME Foot Plate short 210mm, Aluminum |
| 03.312.241 | MAXFRAME Foot Plate long 140mm, Aluminum |
| 03.312.261 | MAXFRAME Foot Plate long 160mm, Aluminum |
| 03.312.281 | MAXFRAME Foot Plate long 180mm, Aluminum |
| 03.312.301 | MAXFRAME Foot Plate long 210mm, Aluminum |
| 03.312.830 | MAXFRAME Shoulder Bolt for 8mm Rings |
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Indications for Use
510(k) Number (if known) K161417
Device Name
DePuy Synthes MAXFRAME™ Multi-Axial Correction System
Indications for Use (Describe)
The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware:
- · fracture fixation (open and closed)
- · pseudoarthrosis of long bones
- · limb lengthening (epiphyseal or metaphyseal distraction)
- · joint arthrodesis
- · infected fractures or nonunions
- · correction of bony or soft tissue deformities
- · correction of segmental defects.
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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510(k) Summary
| Date Prepared: | November 3, 2016 |
|---|---|
| Submitter: | DePuy Synthes |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 - United States of America | |
| Primary Contact: | Stacey Bonnell |
| Associate Director, Regulatory Affairs - DePuy Synthes | |
| (610) 719-5895sbonnell@its.jnj.com | |
| DEVICE NAME | DePuy Synthes MAXFRAME™ Multi-Axial Correction System |
| Classification Name: | Single/multiple component metallic bone fixation appliances |
| Regulatory Class: | II |
| Product Code(s): | KTT (Appliance, fixation, nail/blade/plate combination, multiple |
| components) | |
| OSN (Software for diagnosis/treatment) | |
| PREDICATE DEVICE(S) | Smith & Nephew Circular Fixation System (rebranded as Taylor |
| Spatial Frame or TSF) – K093047 | |
| Synthes Distraction Osteogenesis (DO) System - K092190 | |
| DEVICE DESCRIPTION | The DePuy Synthes MAXFRAME™ Multi-Axial Correction |
| System, with adult and pediatric indications, is an external ring | |
| fixation system that is combined with web-based software in | |
| treatment of soft tissue and bone deformities. In the | |
| MAXFRAME system, implanted transfixion wires, Schanz screws | |
| and pins are attached to the rings and plates surrounding the | |
| deformity using bolts, nuts and connecting plates. Upper and | |
| lower rings are then connected to one another using six | |
| telescoping struts, creating a "Stewart Platform" type device. | |
| Adjusting the strut length allows for correction of length, | |
| rotation, and angular deformity at the same time. The modular | |
| nature of a ring fixation frame allows multiple frame options. Aring fixation frame is assembled individually by the surgeon to | |
| address the different characteristics of each case. The materials | |
| of construction for this system include aluminum, elgiloy, | |
| stainless steel and various polymeric materials. This system has | |
| been validated as MR Conditional. | |
| INTENDED USE | The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is intended for external fixation of fractured long bones and bones of the foot, limb lengthening, and deformity correction in adult, children* (3-12), and adolescent* (12-21) patient populations. The DePuy Synthes MAXFRAME™ Multi-Axial Correction System utilizes software for assisting surgeons in treatment planning.*in which the growth plates have fused or will not be crossed. |
| INDICATIONS FOR USE | The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware: fracture fixation (open and closed) pseudoarthrosis of long bones limb lengthening (epiphyseal or metaphyseal distraction) joint arthrodesis infected fractures or nonunions correction of bony or soft tissue deformities correction of segmental defects. |
| COMPARISON OFTECHNOLOGICALCHARACTERISTICSWITH THE PREDICATEDEVICES | The DePuy Synthes MAXFRAME™ Multi-Axial Correction System has similar intended use, indications, design characteristics, functionality, materials, and performance characteristics in comparison to the predicate devices. The following assessments have been completed to demonstrate substantial equivalence performance specifications: Construct testing (ASTM 1541-02 2011) and component testing including Static & Dynamic Compression testing, Static Torsion, Static Cantilever, Static and Dynamic Fatigue, Wire Slip and Ring to Wire Interface Testing System Validation Software Verification (in accordance with Special Controls & EN IEC 62304:2006-05 Medical device Software life cycle processes) MR Conditional Technical Data (in accordance with FDA Guidance and ASTM F2503-13) Reprocessing of SUD in accordance with Special Controls |
| CLINICAL EVAL | Clinical testing was not necessary for the determination of substantial equivalence. |
| CONCLUSION | The objective evidence presented demonstrates that the mechanical performance of the proposed device is comparable to that of the predicate device(s) and supports substantial equivalence for safety and effectiveness. The proposed device has a similar intended use, indications for use, and |
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§ 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.