(81 days)
Avanta Orthopaedics Finger Joint Prosthesis is intended for replacement of the Metacarpophalangeal joint of the hand which has been damaged by rheumatoid, osteo or post traumatic arthritis.
The finger joint prosthesis like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the MCP joint of the hand.
The provided text describes a 510(k) premarket notification for the Avanta Orthopaedics Finger Joint Prosthesis, which aims to demonstrate substantial equivalence to a predicate device, the Sutter Finger Joint Prosthesis. The information is primarily focused on comparing the new device to the predicate device in terms of design characteristics, materials, and indications for use.
Here's an analysis of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The provided document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The performance is assessed through a comparison of key characteristics and a specific test.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Design Characteristics: Similar design, materials, sizes, fixation, constraint. | The Avanta Product (Finger Joint Prosthesis) is compared to the Sutter Finger Joint Prosthesis across various items (Product Name, Use, Fixation, Constraint, Material, Sizes, Indications for use). All listed characteristics between the Avanta Product and the Sutter Biomedical predicate device are identical. |
| Intended Use: Identical indications for use. | Identical: "Avanta Orthopaedics Finger Joint Prosthesis is intended for replacement of the Metacarpophalangeal joint of the hand which has been damaged by rheumatoid, osteo or post traumatic arthritis." This matches the predicate device's indications precisely. |
| Functional Equivalence: Demonstrated through relevant testing. | "Flexion testing was performed on the Avanta Product to demonstrate substantial equivalence to the predicate device." No specific results or quantitative acceptance criteria for this testing are provided, only that it was performed to support equivalence. |
| Material Equivalence: Industry standard materials, no new materials introduced. | Identical: Both devices use Silicone and are described as using "industry standard materials. No new materials are introduced in either product." |
Study Details
The provided text describes the basis for a 510(k) submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than a comprehensive de novo clinical study with detailed performance metrics against quantitative acceptance criteria.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document mentions "Flexion testing was performed on the Avanta Product" but provides no details on the number of samples tested or the methodology.
- Data Provenance: Not specified. It cannot be determined if the data is retrospective or prospective, or the country of origin.
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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):
- Not applicable/Not specified. The study described is a bench test ("Flexion testing") for demonstrating mechanical equivalence, not a clinical trial requiring expert ground truth for diagnostic accuracy.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human interpretation or clinical outcomes requiring adjudication.
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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. This is not a study involving AI assistance or human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm or AI device. The "Flexion testing" could be considered a form of standalone mechanical performance assessment, but not in the context of an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not explicitly stated in terms of "ground truth" for a diagnostic or clinical outcome. The "ground truth" for the flexion testing would likely be the objective measurements of the device's mechanical properties and its comparison to the predicate device's known mechanical properties or performance standards.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that would have a training set.
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How the ground truth for the training set was established:
- Not applicable. See above.
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510 (k) Summary
JAN 2 5 2002
Page 1 of 2
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
January 16, 2001 Prepared:
Avanta Orthopaedics, Inc. Applicant: 9369 Carroll Park Drive, Suite A San Diego, CA 92121
858-452-8580 Telephone: 858-452-9945 Fax: Louise M. Focht Contact:
Prosthesis, Finger, Constrained, Polymer Device Name: Finger Joint Prosthesis Device Trade Name: Class II Device Classification: Orthopedic Reviewing Panel: 888.3230 Regulation Number 87 KYJ Product Code: Sutter Finger Joint Sutter Prosthesis Predicate Device: Corporation (K870200). 2030506 Registration Number: 9001389 Owner Operator Number:
Device Description:
The finger joint prosthesis like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the MCP joint of the hand.
Indications for Use:
Avanta Orthopaedics Finger Joint Prosthesis is intended for replacement of the Metacarpophalangeal joint of the hand which has been damaged by rheumatoid, osteo or post traumatic arthritis.
Comparison to Predicate Device:
The legally marketed predicate device to which this device is substantially equivalent is the Sutter Finger Joint Prosthesis.
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page 2 of 2
Regulatory Class: II 87 KYJ Product Code:
| Item | Avanta Product | Sutter Biomedical |
|---|---|---|
| Product Name | Finger Joint Prosthesis | Sutter Finger Joint Prosthesis |
| Use | Single use | Single use |
| Fixation | None | None |
| Constraint | Constrained | Constrained |
| Material | Silicone. | Silicone |
| Sizes | 7 sizes | 7 sizes |
| Indications for use | Avanta Orthopaedics Finger JointProsthesis is intended for replacementof the Metacarpophalangeal joint of thehand which has been damaged byrheumatoid, osteo or post traumaticarthritis. | Sutter Finger Joint Prosthesis isintended for replacement of theMetacarpophalangeal joint of the handwhich has been damaged byrheumatoid, osteo or post traumaticarthritis. |
| Item | Avanta Product | Sutter Biomedical |
| Product Name | Finger Joint Prosthesis | Sutter Finger Joint Prosthesis |
| Use | Single use | Single use |
| Fixation | stem in intramedulary canal | stem in intramedulary canal |
Similarities of the Avanta Orthopaedics Finger Joint Prosthesis and the Sutter Finger Joint Prosthesis 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 metacarpal and the proximal phalanx;
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.
Flexion testing was performed on the Avanta Product to demonstrate substantial equivalence to the predicate device.
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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized waves or lines, possibly representing the flow of health and human services. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Louise M. Focht Avanta Orthopaedics, Inc. 9369 Carroll Park Drive, Suite A San Diego, California 92121
JAN 2 5 2002
Re: K013629
Trade/Device Name: Finger Joint Prosthesis Regulation Number: 21 CFR 888.3230 Regulation Name: Finger Joint Polymer Constrained Prosthesis Regulatory Class: Class II Product Code: KYJ Dated: November 2, 2001 Received: November 5, 2001
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 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 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.
Sincerely yours,
Mark N Mulkersm
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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Page 1 of _ 1 .
510 (k) Number (If Known): Koi3629
Finger Joint Prosthesis Device Name:
Indications for Use:
Avanta Orthopaedics Finger Joint Prosthesis is intended for replacement of the Metacarpophalangeal joint of the hand which has been damaged by rheumatoid, osteo or post traumatic arthritis.
Mark n Milliken
rative
510(k) Number -
(Division Sign-Off)
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
013629
Prescription Use (Per 21 CFR § 801.109) OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)
§ 888.3230 Finger joint polymer constrained prosthesis.
(a)
Identification. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.(b)
Classification. Class II.