(56 days)
The DePuy Synthes Variable Angle Locking Patella Plating System is indicated for the fixation and stabilization of patellar fractures in normal and osteopenic bone in skeletally mature patients.
The DePuy Synthes Variable Angle Locking Patella Plating System is comprised of single-use, sterile implants which will be placed on the lateral rim and on the anterior surface of the fractured patella to provide fixation during bone healing. The system offers both a small and a large plate to provide fixation for various patella fracture patterns. The subject plates are available sterile and are manufactured from implant grade stainless steel or titanium.
The system also consists of sterile, non-implantable templates that correspond to the implants. Templates are intended to help determine proper sizing and help predict contoured shape of the implant.
The provided text ("K210408") is a 510(k) premarket notification for a medical device: the DePuy Synthes Variable Angle Locking Patella Plating System. This type of FDA submission is for devices seeking substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning AI/ML performance metrics, sample sizes for test/training sets, expert adjudication, or MRMC studies.
The "Non-clinical performance data" section refers to:
- Mechanical testing: This is to demonstrate "substantially equivalent" performance to the predicate device under static and dynamic loading conditions. This is not a clinical study and doesn't involve "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for a diagnostic or AI-driven device.
- Magnetic Resonance compatibility testing: To establish MR Conditional parameters.
- Endotoxin testing: To meet specified endotoxin requirements.
The "Clinical performance data" section explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."
In summary, the provided document does not describe the kind of study and acceptance criteria you're asking about, which are typically associated with AI/ML-driven diagnostic or image analysis devices. This document is for a mechanical orthopedic implant demonstrating substantial equivalence based on engineering and material performance, not clinical outcome or algorithmic performance.
Therefore, I cannot populate the table or answer the specific questions about AI/ML study design and performance metrics based on the provided text.
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April 8, 2021
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Synthes (USA) Products, LLC Enrico Gindro Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K210408
Trade/Device Name: DePuy Synthes Variable Angle Locking Patella 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 Dated: February 10, 2021 Received: February 11, 2021
Dear Enrico Gindro:
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 (0S) 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, M.P.H. Assistant Director DHT6C: Division of Stereotaxic. Trauma and Restorative 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) K210408
Device Name
DePuy Synthes Variable Angle Locking Patella Plating System
Indications for Use (Describe)
The DePuy Synthes Variable Angle Locking Patella Plating System is indicated for the fixation and stabilization of patellar fractures in normal and osteopenic bone in skeletally mature patients.
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
| Sponsor | DePuy SynthesEnrico Gindro1301 Goshen ParkwayWest Chester, PA 19380Phone: +41 79 912 73 59 |
|---|---|
| Date prepared | February 10, 2021 |
| Proprietary name | DePuy Synthes Variable Angle Locking Patella Plating System |
| Classification name | Single/multiple component metallic bone fixation appliances andaccessories |
| Classification | Class II |
| Regulation Number: 21 CFR 888.3030 | |
| Product Code: HRS | |
| Primary predicatedevice | DePuy Synthes Variable Angle Locking Patella Plating System (K201578) |
| Reference device | Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot / Midfoot System(K100776) |
| Device description | The DePuy Synthes Variable Angle Locking Patella Plating System iscomprised of single-use, sterile implants which will be placed on thelateral rim and on the anterior surface of the fractured patella to providefixation during bone healing. The system offers both a small and a largeplate to provide fixation for various patella fracture patterns. The subjectplates are available sterile and are manufactured from implant gradestainless steel or titanium. |
| The system also consists of sterile, non-implantable templates thatcorrespond to the implants. Templates are intended to help determineproper sizing and help predict contoured shape of the implant. | |
| Indications for use | The DePuy Synthes Variable Angle Locking Patella Plating System isindicated for the fixation and stabilization of patellar fractures in normaland osteopenic bone in skeletally mature patients. |
| Contraindications | No contraindications specific to these devices. |
| Comparison topredicate | Intended use, indications for use, basic design features, technology,screw type compatibility, and sterility of the subject plates are identicalto the predicate cleared under K201578. |
| The subject device is placed along the lateral rim of the patella with aportion of the plate extending across the anterior surface of the patella,whereas the predicate is placed on the anterior surface of the patellawith a portion of the plate extending to the rim of the patella. Comparedto the predicate device the subject plates offer additional screw holes toprovide bi-cortical fixation along the lateral rim of the patella and fewerfixation points on the anterior portion of the plate. | |
| It can be concluded that features of the subject device are substantiallyequivalent to the predicate device based on the similarities in intendeduse and design. | |
| Non-clinicalperformance data | Mechanical testing of constructs (plate with screws) under static anddynamic loading conditions have been performed to demonstrate thatthe proposed DePuy Synthes Variable Angle Locking Patella PlatingSystem performs substantially equivalent to the predicate and referencedevice. |
| Magnetic Resonance compatibility testing has been performed toestablish MR Conditional parameters for the subject DePuy SynthesVariable Angle Locking Patella Plating System. | |
| Endotoxin testing has been performed using to the LAL test method toestablish that the subject DePuy Synthes Variable Angle Locking PatellaPlating System meet the specified endotoxin requirement of20 EU/device. | |
| Clinicalperformance data | Clinical testing was not necessary for the determination of substantialequivalence. |
| Substantialequivalence | The subject device has the same intended use compared to thepredicate device. |
| The non-clinical performance data as well as the comparison of designfeatures included in this premarket notification demonstrate that anydifferences in technological characteristics of the subject devicecompared to the predicate device do not raise any new questions ofsafety and effectiveness. | |
| Based on the indications for use, technological characteristics, and thesummary of data submitted, DePuy Synthes has determined that theproposed device is substantially equivalent to the currently marketedpredicate device. |
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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.