(30 days)
Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:
- Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
- joint destruction or subluxation visible on x-ray .
- resistance to conservative treatment .
- Primary replacement after fracture of the radial head .
- Symptomatic sequelae after radial head resection .
The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.
The provided text is a 510(k) Summary for a Radial Head Implant (K023604). This document focuses on demonstrating substantial equivalence to a predicate device through comparison of design characteristics, intended use, and materials, rather than establishing acceptance criteria or reporting performance metrics from a clinical study as would be typical for artificial intelligence/machine learning (AI/ML) devices.
Therefore, the requested information, which is highly relevant to AI/ML device performance and testing, cannot be extracted from this document. This document describes a traditional medical device (implant) and its clearance process, which relies on a comparison to an already-marketed device and mechanical testing, not a study evaluating algorithm performance.
Specifically:
- No acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) are present because this is a physical implant, not an AI/ML diagnostic tool. The "performance" discussed is in terms of material properties and mechanical strength, which are assessed through bench testing.
- No sample size for test set or data provenance is mentioned, as there is no "test set" of clinical cases for an algorithm.
- No number or qualifications of experts for ground truth, adjudication method, MRMC study, or standalone performance study is mentioned. These are all concepts related to evaluating diagnostic algorithms.
- No type of ground truth, training set size, or method for establishing training set ground truth is mentioned. Again, these are AI/ML specific details not applicable to this device submission.
The document indicates "Mechanical testing has been performed to demonstrate substantial equivalence." (p.2/2), implying the device's physical properties are comparable to the predicate. However, it does not detail the nature of this testing, specific metrics, or any defined acceptance criteria for these mechanical tests.
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NOV 2 7 2002
510 (k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
| Prepared: | October 23, 2002 |
|---|---|
| Applicant: | Avanta Orthopaedics, Inc.9369 Carroll Park Drive, Suite ASan Diego, CA 92121 |
| Telephone: | 858-452-8580 |
| Fax: | 858-452-9945 |
| Contact: | |
| Device Name: | Radial Head Implant |
| Device Trade Name: | Radial head implant |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 888.3170 |
| Product Code: | 87 KWI |
| Original Predicate Device: | Original 510k application Avanta Orthopaedics (K982288, K002644). |
| Registration Number: | 2030506 |
| Owner Operator Number: | 9001389 |
Device Description:
The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.
Indications for Use:
Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:
- Replacement of the radial head for degenerative, or post-traumatic disabilities . presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
- joint destruction or subluxation visible on x-ray .
- resistance to conservative treatment .
- Primary replacement after fracture of the radial head .
- Symptomatic sequelae after radial head resection .
pi/2
{1}------------------------------------------------
KOZ3604
Comparison to the Original Predicate Device:
The legally marketed predicate device to which this device is substantially equivalent is the Avanta Radial Head Implant.
Regulatory Class: II Product Code: 87 KWI
| Item | Original Avanta Product | Proposed product configuration |
|---|---|---|
| Product Name | Radial Head Implant | Radial Head Implant |
| Use | Single use | Single use |
| Fixation | stem in intramedulary canal | stem in intramedulary canal |
| Constraint | non constrained | non constrained |
| Material | Co-Cr/CpTi | Co-Cr/CpTi/UHMWPE |
| Sizes | 4 sizes, 2, 3,4N,4 | 4 sizes, 2, 3,4N,4 |
| Indications for use | Avanta Orthopaedics Radial Headimplant is intended for replacement ofthe proximal end of the radius:Replacement of the radial head fordegenerative, or post-traumaticdisabilities presenting pain, crepitationand decreased motion at the radio-humeral and/or proximal radio-ulnarjoint with :joint destruction or subluxation visible on x-ray resistance to conservative treatment Primary replacement after fracture ofthe radial headSymptomatic sequelae after radial headresection | Avanta Orthopaedics Radial Headimplant is intended for replacement ofthe proximal end of the radius:Replacement of the radial head fordegenerative, or post-traumaticdisabilities presenting pain, crepitationand decreased motion at the radio-humeral and/or proximal radio-ulnarjoint with :joint destruction or subluxation visible on x-ray resistance to conservative treatment Primary replacement after fracture ofthe radial headSymptomatic sequelae after radial headresection |
Table 2. Comparison of the Avanta Radial Head Implants
Similarities of the Avanta Orthopaedics Radial Head Implant and the Avanta Predicate Radial Head Implant include; Both devices are intended for single use only; Both devices are intended for surgical implantation longer than 30 days; Both devices are placed into the intramedullary canal of the proximal end of the radius; Both devices are made of industry standard materials. No new materials are introduced in either product; Both devices are comparably sized; Both devices 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.
Mechanical testing has been performed to demonstrate substantial equivalence.
p2/2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows a black and white logo. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, depicted in a minimalist, abstract style.
Food and Drug. Administration 200 Corporate Boulevard Rockville MD 20850
Mr. Doug Plunkett Avanta Orthopedics, Inc. 9639 Carroll Park Drive, Suite A San Diego, California 92121
Re: K023604
Trade/Device Name: Radial Head Implant Regulation Number: 21 CFR §888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: Class II Product Code: KWI Dated: October 23, 2002 Received: October 28, 2002
Dear Mr. Plunkett;
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.
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Page 2 – Mr. Mr. Doug Plunkett
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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Mark M Mcherson
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
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Page Joof |
510 (k) Number (If Known): Device Name: Radial Head
Indications for Use:
Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:
- Replacement of the radial head for degenerative, or post-traumatic disabilities ● presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
- joint destruction or subluxation visible on x-ray .
- resistance to conservative treatment .
- Primary replacement after fracture of the radial head .
- Symptomatic sequelae after radial head resection .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| for (Division Sign-Off, Division of General and Neurological Administrative) | |
| Prescription Use | OR |
| (Per 21 CFR 801.109) | |
| 510(k) Number | K023604 |
| Over the Counter Use | |
| (Optional Format 1-2-96) |
§ 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.