(85 days)
Not Found
No
The summary describes a passive, mechanical implant and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended to replace parts of the thumb to address conditions like rheumatoid arthritis, traumatic arthritis, and osteoarthritis, which are therapeutic interventions.
No
The device is described as a prosthesis intended to replace a part of the thumb, not to diagnose a condition.
No
The device description clearly states it is a physical prosthesis fabricated from pyrocarbon and graphite, intended to be implanted in the basal thumb joint. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a prosthesis intended to replace a part of the thumb joint. This is a surgical implant used in vivo (within the body) for treatment.
- Device Description: The description details a physical implant made of pyrocarbon and graphite, designed to be surgically placed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first mctacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Product codes (comma separated list FDA assigned to the subject device)
87 KYI
Device Description
The Ascension PyroHemiSphere (PHS) is single-use, uncemented, onc-component prosthesis for the basal thumb joint. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The device is available in five sizes and is provided sterile in packaging containing a single component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
basal thumb joint / proximal end of the first metacarpal
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.
(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.
0
| AUG 2 5 2004 | 510(k) SUMMARY | page 1 |
|---|---|---|
| SUBMITTER NAME: | Ascension Orthopedics, Inc. | |
| 8200 Cameron Road, C-140 | ||
| Austin, TX 78754-3832 | K04145 | |
| CONTACT: | Peter Strzepa | |
| Phone: (512) 836-5001 | ||
| Fax: (512) 836-6933 | ||
| DATE OF SUMMARY: | 28 May 2004 | |
| TRADE NAME: | Ascension® PyroHemiSphereTM | |
| COMMON NAME: | carpometacarpal (CMC) implant | |
| CLASSIFICATION: | 21 CFR §888.3770 | |
| PRODUCT CODE: | 87 KYI | |
| PANEL: | Orthopedic and Rehabilitation Devices |
PREDICATE DEVICE:
Swanson Titanium Basal Thumb (K864488) Ceramic Zirconia Spherical CMC Implant (K960659) Biopro Cobalt Trapeziometacarpal Replacement (K964472)
DEVICE DESCRIPTION:
The Ascension PyroHemiSphere (PHS) is single-use, uncemented, onc-component prosthesis for the basal thumb joint. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The device is available in five sizes and is provided sterile in packaging containing a single component.
INTENDED USE:
The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first mctacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
BASIS OF SUBSTANTIAL EQUIVALENCE:
A comparison of the design features as well as performance tests demonstrate that the Ascension PyroHemiSphere is substantially equivalent to the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2004
Mr. Peter Strzepa Vice President Science and Technology Ascension Orthopedics, Inc. 8200 Cameron Road, Suite C-140 Austin, Texas 78754
Re: K041451
Trade/Device Name: Ascension PyroHemiSphere Regulation Numbers: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: KYI Dated: May 28, 2004 Received: June 1, 2004
Dear Mr. Strzepa:
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. 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.
2
Page 2 -- Mr. Peter Strzepa
Page 2 - Mr. Peter Strzepa
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,
L. Mark A. Milkins
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
3
Indications For Use
Kodines I 510(K) Number:
Ascension® PyroHemiSphere Device Name:
Indications for Use:
The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Prescription Use (Part 21 CFR 801 Subpart D
AND/OR
Over-The-Counter Use (21 CFR 807 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. Milkers
I. Restorative, Division of Ge and Neurological Devices
510(k) I