(86 days)
The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.
The Paragon 28 Laser Alignment Guide is a line extension to the APEX 3D Total Ankle Replacement System instrumentation (K192994). The Paragon 28® APEX 3D™ Total Ankle Replacement System Laser Alignment Guide is designed to provide a visual guide to verify alignment of the instrumentation associated with the APEX 3D™ Total Ankle Replacement System. Once inserted into the proper instrumentation, the Laser projects a line onto the patient to be used by surgeons as a visual reference for alignment. The Laser Alignment Guide is a singleuse electrical device.
This document describes the APEX 3D Total Ankle Replacement System Laser Alignment Guide, a line extension to the APEX 3D Total Ankle Replacement System instrumentation. The information provided is sufficient to answer some, but not all, of your questions regarding acceptance criteria and the study proving device performance, especially concerning clinical study details, as this submission primarily focuses on substantial equivalence based on non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on the Laser Alignment Guide specifically and its substantial equivalence to predicate devices, rather than establishing new performance criteria or providing a direct table of acceptance criteria and performance for the overall APEX 3D Total Ankle Replacement System itself. The "acceptance criteria" for the Laser Alignment Guide are inferred from the non-clinical tests performed to demonstrate its intended function and safety.
| Acceptance Criteria (Inferred for Laser Alignment Guide) | Reported Device Performance (Summary from Non-Clinical Testing) |
|---|---|
| Laser line projection efficacy (e.g., clear, visible, accurate projection of a line onto the patient for alignment) | Cadaveric design evaluation of the Laser line demonstrated it performs as intended. |
| Stability of the Laser Alignment Guide (e.g., secure attachment to instrumentation, does not obstruct procedures) | Stability assessment demonstrated it performs as intended. |
| Electrical Safety (e.g., compliance with electrical safety standards, safe operation as an electrical device) | Electrical safety testing demonstrated it performs as intended. |
| Material/Chemical Composition/Energy Source Similarities to Predicate Devices | The Laser Alignment Guide possesses similar technological characteristics as the predicate devices, including design, material, chemical composition, and energy source. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "a cadaveric design evaluation" and "stability assessment" but does not specify the sample size (e.g., number of cadavers, number of stability tests).
- Data Provenance: The cadaveric study would imply human anatomical data. The provenance (e.g., country of origin) is not specified.
- Retrospective or Prospective: These non-clinical tests would be considered prospective in nature, as they were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The cadaveric design evaluation and stability assessment would likely involve technical and possibly surgical experts, but their numbers and qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the non-clinical tests (cadaveric evaluation, stability, electrical safety), a formal "adjudication method" in the sense of consensus among multiple human readers of medical images is unlikely to apply directly. The "assessment" mentioned suggests an evaluation against pre-defined criteria, but the specific method is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission for the Laser Alignment Guide is based on substantial equivalence demonstrated through non-clinical testing. It does not involve a study comparing human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The Laser Alignment Guide is a physical medical device that provides a visual guide for human surgeons. It is not an algorithm or an AI system, so the concept of "standalone performance" for an algorithm does not apply. Its function is inherently "human-in-the-loop" as it assists a surgeon.
7. The Type of Ground Truth Used
For the non-clinical tests mentioned:
- Cadaveric Design Evaluation: The "ground truth" would be the anatomical landmarks and the intended alignment as determined by surgical principles. The laser's projection would be evaluated against this anatomical reality.
- Stability Assessment: The "ground truth" would be the engineering specifications for stability and secure attachment.
- Electrical Safety Testing: The "ground truth" would be the applicable electrical safety standards and regulations.
8. The Sample Size for the Training Set
The Laser Alignment Guide is a hardware device, not an AI/ML system that utilizes a "training set." Therefore, discussions of a training set sample size are not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this hardware device, this question is not applicable.
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November 13, 2020
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Paragon 28, Inc. % Dave McGurl Director, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001
Re: K202373
Trade/Device Name: APEX 3D Total Ankle Replacement System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN Dated: September 18, 2020 Received: September 18, 2020
Dear Dave McGurl:
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 (OS) 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,
for 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) K202373
Device Name APEX 3D Total Ankle Replacement System
Indications for Use (Describe)
The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended use only.
| 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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510(k) Summary
| 510(k) Number: | K202373 |
|---|---|
| Manufacturer: | Paragon 28, Inc.14445 Grasslands Dr.,Englewood, CO 80112 |
| Contact: | Ms. Haylie HertzRegulatory Affairs SpecialistPhone: 855-786-2828hhertz@paragon28.com |
| Correspondent: | Musculoskeletal Clinical Regulatory Advisers, LLC1050 K Street, NW, Suite 1000Washington, DC 20001Phone: 202.552.5800 |
| Date Prepared: | August 21, 2020 |
| Device Trade Name: | APEX 3D Total Ankle Replacement System |
| Device Common Name: | Total Ankle Prosthesis |
| Classification: | 21 CFR 888.3110Class II |
| Product Codes: | HSN |
Indications for Use:
The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.
Device Description:
The Paragon 28 Laser Alignment Guide is a line extension to the APEX 3D Total Ankle Replacement System instrumentation (K192994). The Paragon 28® APEX 3D™ Total Ankle
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Replacement System Laser Alignment Guide is designed to provide a visual guide to verify alignment of the instrumentation associated with the APEX 3D™ Total Ankle Replacement System. Once inserted into the proper instrumentation, the Laser projects a line onto the patient to be used by surgeons as a visual reference for alignment. The Laser Alignment Guide is a singleuse electrical device.
Predicate Devices:
The Paragon 28 Laser Alignment Guide is substantially equivalent to the APEX 3D Total Ankle Replacement System Instrumentation (K192994) and the Corin Optimized Positioning System (K152893). The OEC Elite (K192819) is considered a reference device.
Substantial Equivalence:
The subject Laser Alignment Guide is substantially equivalent to the predicate systems with respect to intended use, indications, and design. The subject Laser Alignment Guide possesses similar technological characteristics as the predicate devices, including design, material, chemical composition, and energy source. Non-clinical testing performed included a cadaveric design evaluation of the Laser line, a stability assessment, and electrical safety testing. The results of this testing demonstrate that the subject system performs as intended.
Conclusion:
The APEX 3D Total Ankle Replacement System Laser Alignment Guide possesses the same intended use and technological characteristics as the predicate devices. Therefore, the Laser Alignment Guide is substantially equivalent for its intended use.
N/A