(335 days)
Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
- Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:
- Pain and weakness of the wrist joint not improved by non-operative treatment
- Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint
- Failed ulnar head resection; eg. Darrach resection
- Primary replacement after fracture of the ulnar head or neck.
- Revision following failed ulnar head arthroplasty.
The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.
This 510(k) summary describes a medical device, the Aptis Medical Distal Radio-Ulnar Joint Implant, seeking substantial equivalence to a predicate device. As such, the documentation provided does not include acceptance criteria for standalone device performance, nor details of a study demonstrating such performance in the way a clinical trial for a novel AI device would.
Instead, the "acceptance criteria" here are based on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. The study proving this involves a comparison of design characteristics and intended use.
Here's an breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device "Performance" (Comparison to Predicate) |
|---|---|
| Primary Goal: Substantial Equivalence to WMT Modular Ulnar Head Implant in terms of safety and effectiveness. This is assessed by comparing: | |
| Intended Use: Device must have the same indications for use as the predicate. | Identical Indications for Use: Both the Aptis Medical Distal Radio-Ulnar Joint Implant and the WMT Modular Ulnar Head Implant are intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty for rheumatoid, degenerative, or post-traumatic arthritis (pain/weakness, instability, failed ulnar head resection), primary replacement after ulnar head/neck fracture, and revision following failed ulnar head arthroplasty. |
| Technological Characteristics (similar design, materials, etc.): | Similar Design Characteristics: Both are single-use devices, intended for surgical implantation longer than 30 days, placed into the intramedullary canal of the distal ulna, and made of industry-standard materials (Co-Cr, UHMWPe, CPTi for Aptis; Co-Cr, Titanium Alloy, Plasma Spray for WMT). The Aptis device also has screw fixation to the distal radius, which is a difference, but not deemed to preclude substantial equivalence in this context. Comparable Size: Both devices offer various sizes (Aptis: 2 sizes; WMT: 8 heads, 6 stems). Fixation: Aptis has a stem in the intramedullary canal and screw fixation to the distal radius; WMT has a stem in the intramedullary canal. Constraint: Aptis is Semi constrained; WMT is non-constrained. These differences are implicitly deemed acceptable for substantial equivalence based on the positive FDA determination. |
| Performance Data (e.g., mechanical testing, biocompatibility): | While not explicitly detailed as "acceptance criteria" in this summary, the basis for substantial equivalence typically includes supporting studies like mechanical testing (fatigue, wear, tensile strength) to demonstrate that the new device performs comparably to the predicate device and meets established standards for implantable devices. The summary states "The device and the predicate device have similar design characteristics and intended use," implying such underlying testing supported this conclusion. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a 510(k) submission for a medical implant, not an AI/software device. Therefore, the concept of a "test set" in the context of machine learning (i.e., a dataset used to evaluate an algorithm's performance) is not applicable here. The "test" is a comparison of the device's characteristics and intended use against a legally marketed predicate device.
- Test Set Sample Size: Not applicable in the context of an AI device's performance evaluation. The "sample" here refers to the characteristics of the device itself and its comparison to the predicate.
- Data Provenance: Not applicable for an AI device. The "data" are the specifications and indications for use of the proposed and predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. "Ground truth" in an AI/imaging context refers to definitive labels or diagnoses. For a device like this, the "ground truth" is established by regulatory standards, engineering specifications, and clinical consensus on indications for use.
- Qualifications of Experts: The review was conducted by the FDA, specifically the Division of General, Restorative and Neurological Devices at the Office of Device Evaluation, Center for Devices and Radiological Health. The Director at the time was Celia M. Witten, Ph.D., M.D. This implies review by medical and regulatory experts involved in orthopedic devices.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the context of an AI device's performance evaluation. The "adjudication" in this regulatory context is the FDA's decision-making process based on the submitted application and comparison to the predicate device.
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
- MRMC Study: No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical medical implant like a joint prosthesis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: No, a standalone study was not done. This concept is specific to AI algorithms.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the FDA's regulatory framework and the established safety and effectiveness of the legally marketed predicate device. This involves:
- Predicate Device's Known Performance: The WMT Modular Ulnar Head, having been legally marketed, is accepted as safe and effective for its indicated uses.
- Engineering Standards and Biocompatibility Data: Although not explicitly detailed in the summary, implantable devices are subject to rigorous testing against international and national standards for materials, mechanical properties, and biocompatibility. The "industry standard materials" and the comparison of fixation methods suggest adherence to these established engineering principles.
- Clinical Consensus on Indications for Use: The listed indications are based on established medical practice for orthopedic surgery.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI model.
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JAN 2 6 2005
510 (k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
February 25, 2004 Prepared:
Applicant: Aptis Medical, LLC 5 River Hill Road Louisville, KY 40207
| Device Name: | Wrist joint ulnar (hemi-wrist) prosthesis |
|---|---|
| Device Trade Name: | Distal Radio-Ulnar Joint Implant |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 888.3810 |
| Product Code: | 87 KXE |
| Predicate Device: | WMT Modular Ulnar Head, WrightMedical Technology, Inc. |
Owner Operator Number:
9054354
Device Description:
The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.
Indications for Use:
Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
- Replacement of the distal ulnar head for rheumatoid, degenerative, or post-. traumatic arthritis presenting with the following findings:
- . Pain and weakness of the wrist joint not improved by non-operative treatment
- Instability of the ulnar head with radiographic evidence of dislocation . or erosive changes of the distal radioulnar joint
- . Failed ulnar head resection; eg. Darrach resection
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- Primary replacement after fracture of the ulnar head or neck. ●
- Revision following failed ulnar head arthroplasty. .
Comparison to Predicate Device:
The legally marketed predicate device to which this device is substantially equivalent is the Wright Medical Technologies Modular Ulnar Head Implant.
Regulatory Class: II Product Code: 87 KXE
| Item | Aptis Product | Wright Medical Technologies |
|---|---|---|
| Product Name | Distal Radioulnar Joint Implant | WMT Modular Ulnar Head Implant |
| Use | Single use | Single use |
| Fixation | stem in intramedulary canal, screw fixation to the distal radius | stem in intramedulary canal |
| Constraint | Semi constrained | non constrained |
| Material | Co-Cr, UHMWPe, CPTi | Co-Cr, Titanium Alloy, Plasma Spray |
| Sizes | 2 sizes, 1, 2 | 8 heads, 6 stems |
| Indications for use | Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:Pain and weakness of the wrist joint not improved by non-operative treatmentInstability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar jointFailed ulnar head resection; eg. Darrach resectionPrimary replacement after fracture of the ulnar head or neck.Revision following failed ulnar head arthroplasty | WMT Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:Pain and weakness of the wrist joint not improved by non-operative treatmentInstability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar jointFailed ulnar head resection; eg. Darrach resectionPrimary replacement after fracture of the ulnar head or neck.Revision following failed ulnar head arthroplasty |
Table 1. Comparison of Aptis and WMT ulnar head.
Similarities of the Aptis Medical, LLC and WMT Modular Ulnar Head Implant include:
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Both devices are: intended for single use only; intended for surgical implantation longer than 30 days; placed into the intramedullary canal of the distal ulna; made of industry standard materials; comparable in size; and have the same indications for use.
Summary:
The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 6 2005
Aptis Medical, LLC C/o Ms. Louise M. Focht P.O. Box 249 Del Mar, California 92014
Re: K040497
Trade/Device Name: Distal Radio-Ulnar Joint Implant Regulation Numbers: 21 CFR 888.3810 Regulation Names: Wrist joint ulnar (hemi-wrist) polymer prosthesis Product Code: KXE Dated: November 22, 2004 Received: November 23, 2004
Dear Ms. Focht:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Louise M. Focht
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K040497, Device Name: Distal Radio-Ulnar Joint Implant Indications for Use:
Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
- Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic . arthritis presenting with the following findings:
- Pain and weakness of the wrist joint not improved by non-operative treatment .
- Instability of the ulnar head with radiographic evidence of dislocation or erosive . changes of the distal radiouinar joint
- Failed ulnar head resection; eg. Darrach resection .
- Primary replacement after fracture of the ulnar head or neck. .
- Revision following failed ulnar head arthroplasty. .
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Mark A. Millhause
Division of General, Restorative, and Neurological Devices
Page of
K040497 510(k) Number_
§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
(a)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.(b)
Classification. Class II.