(179 days)
Avanta Orthopaedics Wrist implant is intended for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.
The wrist implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the wrist.
Here's an analysis of the provided text regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria or quantifiable performance metrics for the Avanta Orthopaedics Wrist implant. Instead, the "study" demonstrating the device meets "acceptance criteria" is a comparison to a predicate device and a general statement about fatigue and wear testing.
Therefore, the table would look like this:
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly defined as quantitative criteria, but implied by substantial equivalence to the predicate device. | - "Fatigue and wear testing have been performed" |
| - "Similar design characteristics and intended use" to predicate. | |
| - "Substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" or provide details about data provenance (e.g., country of origin, retrospective/prospective). The "study" mentioned is not a clinical trial with human subjects or a defined test set in the traditional sense of evaluating a diagnostic algorithm. It refers to non-clinical fatigue and wear testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes a medical device (wrist implant) for surgical replacement, not a diagnostic device or algorithm that requires a "ground truth" established by experts in a test set. The validation is based on engineering principles (fatigue, wear) and comparison to an existing predicate device.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. There is no mention of a test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not performed, or at least not mentioned. This type of study is typically used for diagnostic imaging devices or algorithms where human readers' performance is evaluated with and without AI assistance. The Avanta Orthopaedics Wrist implant is a physical implant.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not performed, or not applicable. This device is a physical implant, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the device's functionality is established by engineering tests (fatigue and wear) and comparison to the established performance and safety of the predicate device. There is no mention of pathology, outcomes data, or expert consensus in relation to a "ground truth" for a diagnostic evaluation.
8. Sample Size for the Training Set
There is no mention of a training set. This concept applies to machine learning algorithms. The development of the wrist implant would involve engineering design and material science, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no mention of a training set.
Summary of the Study:
The "study" referenced in the document is a regulatory submission process to demonstrate substantial equivalence to an already legally marketed predicate device (Universal Total Wrist System, KMI, K961051). The core of this demonstration relies on:
- Design Characteristics Comparison: Highlighting similarities in product name, use (single use), fixation method (stem in intramedullary canal, screw fixation distally), constraint (semi-constrained), material (Co-Cr/UHMWPE/CPTi), and sizes.
- Indications for Use Comparison: Showing that the Avanta implant has the same indications as the predicate: replacement of the painful wrist joint due to rheumatoid arthritis, osteoarthritis, or post-traumatic arthritis.
- Non-Clinical Testing: A general statement about "Fatigue and wear testing have been performed on this devices to demonstrate substantial equivalence."
Essentially, the "acceptance criteria" appear to be met by demonstrating that the new device is functionally, materially, and geometrically similar to a device already deemed safe and effective, and that it has undergone basic engineering tests (fatigue and wear) to support its durability. The document does not describe a typical clinical trial or a study evaluating diagnostic performance.
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K021859 Pge $\frac{1}{2}$
DEC 0 2 2002
510 (k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
| Prepared: | June 5, 2002 |
|---|---|
| Applicant: | Avanta Orthopaedics, Inc. |
| 9369 Carroll Park Drive, Suite A | |
| San Diego, CA 92121 | |
| Telephone: | 858-452-8580 |
| Fax: | 858-452-9945 |
| Contact: | Louise M. Focht |
| Device Name: | Wrist |
|---|---|
| Device Trade Name: | Wrist implant |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 888.3800 |
| Product Code: | JWJ |
| Predicate Device: | Universal Total Wrist System, KMI, K961051 |
| Registration Number: | 2030506 |
| Owner Operator Number: | 9001389 |
Device Description:
The wrist implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the wrist.
Indications for Use:
A vanta Orthopaedics Wrist implant is intended for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.
Comparison to Predicate Device:
The legally marketed predicate device to which this device is substantially equivalent is the Universal Total Wrist System, KMI, K961051.
Table. Comparison of Avanta Orthopaedics and KMI wrist.
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| page 3 of 2 | |
|---|---|
| KMI | |
| KMI Universal Total Wrist System | |
| Item | Avanta Product | KMI |
|---|---|---|
| Product Name | Wrist Implant | KMI Universal Total Wrist System |
| Use | Single use | Single use |
| Fixation | stem in intramedullary canal,proximallyScrew fixation distally | stem in intramedullary canal,proximallyScrew fixation distally |
| Constraint | Semi-constrained | Semi-constrained |
| Material | Co-Cr/UHMWPE/CPTi | Co-Cr/UHMWPE/CPTi |
| Sizes | 3 sizes small, medium, largeRight, Left | 3 sizes small, medium, largeRight, Left |
| Indications for use | Avanta Orthopaedics Wrist implant isintended for replacement of the painfulwrist joint due to:rheumatoid arthritis, oseto-arthritis, orpost-traumatic arthritis. | The KMI Universal Total Wrist Systemis indicated for:Intractable pain resulting fromtraumatic arthritis, osteo arthritis,rheumatoid arthritis, trauma inducedosteo arthritis of the radial/Carpal joint.To replace functionality of the joint dueto deformity of elements stated above. |
Similarities of the Avanta Orthopaedics wrist implant and the KMI Universal Total Wrist System 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 wrist joint;
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.
Fatigue and wear testing have been performed on this devices to demonstrate substantial equivalence.
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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 02 2002
Mr. H. Doug Plunkett General Manager Avanta Orthopaedics 8600 Evergreen Boulevard Minneapolis, Minnesota 55433
Re: K021859
Trade/Device Name: Wrist Implant Regulation Number: 21 CFR 888.3800 Regulation Name: Wrist Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWJ Dated: August 31, 2002 Received: September 5, 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.
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 – Mr. H. Doug Plunkett
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 (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 yours,
Miriam C. Provost
for 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
10 (k) Number (If Kno Device Name: Wrist
Comments of the country
Indications for Use:
Avanta Orthopaedics Wrist implant is intended for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.
(Division Sign-Off)
510(k) Number K021859
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
h is Prescription Use _ (Per 21 CFR § 801.109) OR
Over-the-Counter Use _ No (Optional Format 1-2-96)
isiam C. Provost
ு Olvision Sign-Off) Division of Genera and Neurological L. . vices
§ 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.