(21 days)
No
The summary describes a mechanical implant (a fusion plate and screws) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is a fusion plate used to treat pain and loss of function due to various conditions affecting the carpal bones, which qualifies it as a therapeutic device.
No
The device is a fusion plate designed to treat carpal bone issues, not to diagnose them.
No
The device description clearly states it is a physical plate and screws fabricated from implantable grade stainless steel, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Avanta carpal fusion plate is a physical implant designed to be surgically placed inside the body to fuse bones. It is a surgical device, not a diagnostic test.
- Intended Use: The intended use is for the surgical treatment of conditions affecting the carpal bones, not for performing diagnostic tests on samples.
Therefore, based on the provided information, the Avanta carpal fusion plate is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Avanta carpal fusion plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, and triquetrum. The fusion plate is intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.
Product codes
HRS
Device Description
The Avanta carpal fusion plate is a low profile single piece construct designed to fit over the dorsal aspect of the carpal bones in the hand. The plate has spherical holes or slots that accommodate screws for fixation. The plate and screws are fabricated from implantable grade stainless steel. Appendix 3 contains engineering drawings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carpal bones of the hand including; capitate, hamate, and triquetrum.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KMI Wrist Fusion System (K991873), Acumed Wrist Fusion Plate (K021321)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K030881
page 1 of 2
510 (k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
Prepared: March 19, 2003
Applicant: Avanta Orthopaedics, Inc. 9369 Carroll Park Drive, Suite A San Diego, CA 92121
- H. Doug Plunkett Contact: Avanta Orthopaedics, Inc. 8600 Evergreen Blvd. Minneapolis, MN 55433
- Telephone: 763-783-5017 Fax: 763-783-5073 Email dplunkett@machine.com
| Device Name: | Single/Multiple Component Metallic
Bone Fixation Appliance and
Accessories |
|------------------------|----------------------------------------------------------------------------------|
| Device Trade Name: | Avanta Carpal Fusion Plating System |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopaedic |
| Regulation Number | 888.3030 |
| Product Code: | HRS |
| Predicate Device: | KMI Wrist Fusion System (K991873)
Acumed Wrist Fusion Plate (K021321) |
Device Description:
The Avanta carpal fusion plate is a low profile single piece construct designed to fit over the dorsal aspect of the carpal bones in the hand. The plate has spherical holes or slots that accommodate screws for fixation. The plate and screws are fabricated from implantable grade stainless steel. Appendix 3 contains engineering drawings.
Intended Use:
The Avanta carpal fusion plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, and triquetrum. The fusion plate is intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic
1
K030881
page 2 of 2
arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.
Comparison to Predicate Device: (Appendix 4 contains predicate device literature.)
The table below summarizes similarities and differences between the Avanta, KMI, and Acumed plates.
| Item | Avanta | KMI | Acumed |
|---|---|---|---|
| Product | |||
| Name | Carpal Fusion Plate | KMI Wrist | |
| Fusion System | Acumed Wrist | ||
| Fusion Plate | |||
| Use | Single use | Single use | Single use |
| Fixation | Bone screw | Bone screw | Bone screw |
| Material | Stainless steel | Stainless steel | Titanium |
| Indications | |||
| for use | Intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. | Same indications | Same indications |
Summary:
The Avanta device and the predicate devices studied have similar design characteristics and intended use. The safety and effectiveness of the Avanta Carpal Fusion Plate is substantially equivalent to the predicate devices mentioned above.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines above a shape that resembles a caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2003
Mr. H. Doug Plunkett Director Avanta Orthopaedics, Inc. 8600 Evergreen Boulevard Minneapolis, Minnesota 55433
Re: K030881
Trade Name: Avanta Carpal Fusion Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliance and Accessories Regulatory Class: II Product Code: HRS Dated: March 19, 2003 Received: March 20, 2003
Dear Mr. Plunkett:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
3
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. 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,
for Mark N. Milkman
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
4
510 (k) Number (If Known): K030881 Device Name: Carpal Fusion Plating System
Indications for Use:
The Avanta carpal fusion plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, lunate, and triquetrum. The fusion plate is intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over the Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number
K030881