(129 days)
Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation visible on x-ray; and/or resistance to conservative treatment. Primary replacement after fracture of the radial head. Symptomatic sequelae after radial head resection. Revision following failed radial head arthroplasty.
This document is regarding the DePuy Synthes Radial Head Replacement System-MR Conditional. The Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 –24mm in length. The Radial Head is manufactured from wrought CoCrMo alloy. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone. The devices in scope of the subject submission are being reviewed for MR Conditional labeling in addition to the previously cleared indications for use.
Please find the information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria below:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Magnetically Induced Displacement Force (ASTM F2052-15) | Not explicitly stated, but generally implies forces should be within safe limits for patient use. | The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no different questions of safety or effectiveness. |
| Magnetically Induced Torque (ASTM F2213-17) | Not explicitly stated, but generally implies torque should be within safe limits for patient use. | The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no different questions of safety or effectiveness. |
| Radio Frequency (RF) Heating (ASTM F2182-11a) | Not explicitly stated, but generally implies heating should be within safe limits for patient use. | The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no different questions of safety or effectiveness. |
| Image Artifacts (ASTM F2119-07 (2013)) | Not explicitly stated, but generally implies artifacts should be acceptable and not obscure critical information for diagnosis. | The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no different questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the test set or the data provenance for the non-clinical performance data. It refers to "non-clinical testing" conducted to support the conditional safety of the implants in the MR environment. This type of testing typically involves testing physical samples of the device and not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The studies conducted were non-clinical performance tests on the device itself, not studies involving human subjects with clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The studies conducted were non-clinical performance tests on the device itself, not studies involving human subjects requiring adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical implant (Radial Head Replacement System), not an algorithm or AI system. The testing performed was related to its performance in an MR environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance data, the "ground truth" would be the established safety standards and measurement methodologies outlined in the ASTM standards (F2052-15, F2213-17, F2182-11a, F2119-07 (2013)). These standards define the acceptable limits and procedures for testing device performance under specific conditions.
8. The sample size for the training set
This information is not applicable as the device is a physical medical implant, not an AI or algorithm-based system that requires training data.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical medical implant, not an AI or algorithm-based system that requires training data and ground truth establishment for a training set.
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March 18, 2022
DePuy Synthes Quinn Mccarthy Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester. Pennsylvania 19380
Re: K213563
Trade/Device Name: DePuy Synthes Radial Head Replacement System Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow Joint Radial (Hemi-Elbow) Polymer Prosthesis Regulatory Class: Class II Product Code: KWI Dated: January 28, 2022 Received: January 31, 2022
Dear Quinn Mccarthy:
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.
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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 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 medical devices and radiation-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.
Lixin Liu, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty 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) K213563
Device Name
DePuy Synthes Radial Head Replacement System
Indications for Use (Describe)
•Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
o joint destruction and/or subluxation visible on x-ray; and/or
- o resistance to conservative treatment.
- · Primary replacement after fracture of the radial head.
- · Symptomatic sequelae after radial head resection.
- · Revision following failed radial head arthroplasty.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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/1 description: The image is a logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red graphic element on the left, followed by the company name in gray. Below the company name, it says "THE ORTHOPAEDICS COMPANY OF Johnson & Johnson" in smaller letters, with "Johnson & Johnson" in red.
510(k) Summary
| Sponsor | DePuy SynthesQuinn McCarthy1301 Goshen ParkwayWest Chester, PA 19380Phone: (732) 947 2251 |
|---|---|
| Date Prepared | March 04, 2022 |
| Proprietary Name | DePuy Synthes Radial Head Replacement System – MR Conditional |
| Classification Name | Elbow joint radial (hemi elbow) polymer prosthesis |
| Classification | Class IIRegulation Number: 21 CFR §888.3170Product Code: KWI |
| Predicate Device | Revolution Radial Head - K183618 |
| Device Description | This document is regarding the DePuy Synthes Radial HeadReplacement System-MR Conditional. The Radial Head ReplacementSystem Implant is a one-piece, stemmed radial head replacement. Theradial head is available in diameters of 19, 22 and 25mm. The radialstems range from 5.5 to 8.5mm in diameter and from 21 –24mm inlength. The Radial Head is manufactured from wrought CoCrMo alloy.The system is provided with a set of accessory instruments designed forpreparation of the implant site and insertion of the implants into bone.The devices in scope of the subject submission are being reviewed forMR Conditional labeling in addition to the previously clearedindications for use. |
| Indications for Use | Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, anddecreased motion at the radio-humeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation visible on x-ray; and/or resistance to conservative treatment. Primary replacement after fracture of the radial head. Symptomatic sequelae after radial head resection. |
| Image: THE ORTHOPAEDICS COMPANY OF Johnson & Johnson | |
| Contraindications | Absolute contraindications include: Infection, sepsis, osteomyelitis.Relative contraindications include: Uncooperative patient or patientwith neurologic disorders who are incapable of following directions,osteoporosis, metabolic disorders which may impair bone formation,osteomalacia, distant foci of infections which may spread to theimplant site, rapid joint destruction, marked bone loss or boneresorption apparent on roentgenogram |
| Comparison toPredicate | The purpose of this submission is to add MR Conditional information tothe device labeling for the DePuy Synthes Radial Head ReplacementSystem - MR Conditional, K183618. The intended use andtechnological characteristics of the devices remains unchanged. Thedevice name has been updated to reflect the current company name,DePuy Synthes, previously cleared as the Revolution Radial Head andnow renamed to the DePuy Synthes Radial Head Replacement System -MR Conditional.The materials of the devices remain unchanged from K183618 (CoCrMoalloy conforming to ASTM F1537).The technical characteristics of the device remain unchanged from thepredicate K183618:One-piece Head diameters of 19, 22 and 25mm Head Heights of 9-15, 10-16, 11-17mm Stem diameters 5.5 – 8.5mm Stem lengths 21-24mm Radial head thickness 9 – 17mm Articular depth 1.6 – 2.6mm |
| Non-ClinicalPerformance Data | This submission includes non-clinical testing to support the conditionalsafety of the DePuy Synthes Radial Head Implants in the Radial HeadReplacement System in the MR environment. The testing includesmagnetically induced displacement force (ASTM F2052-15) and torque(ASTM F2213-17), radio frequency (RF) heating (ASTM F2182-11a), andimage artifacts (ASTM F2119-07 (2013)). The non-clinical performancedata demonstrate that the subject devices, when exposed to the MRenvironment under specific MR conditions of use, raise no differentquestions of safety or effectiveness. |
| 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 technological characteristics of the device remainunchanged. |
| It is concluded that the information provided herein supportssubstantial equivalence of the subject devices to the predicate device,K183618. |
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Image /page/5/Picture/1 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red symbol on the left, followed by the company name in gray. Below the company name, it says "THE ORTHOPAEDICS COMPANY OF Johnson & Johnson" in a smaller font.
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.