(45 days)
Not Found
No
The 510(k) summary describes a physical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to treat conditions such as rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post-fracture deformation or bone loss, which aligns with the definition of a therapeutic device.
No
The device is a prosthesis intended to replace a joint, which indicates a therapeutic or reconstructive purpose rather than a diagnostic one. Its function is to alleviate symptoms and improve function, not to identify or characterize a disease.
No
The device description clearly states it is a "single-use, spherical, interpositional prosthesis" fabricated from physical materials (pyrocarbon, graphite, tungsten). This indicates a physical implant, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Ascension PyroSphere is a surgical implant intended to replace a joint in the thumb. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The information clearly describes a medical device used for surgical intervention, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Ascension PyroSphere is intended to replace the joint between the first metacarpal and the trapezium in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as cither a painful, unstable thumb, or a thumb with limited range of motion.
Product codes
87 KYI
Device Description
The Ascension PyroSphere (PCS) is a single-use, spherical, interpositional prosthesis for the basal thumb joint. It is fabricated from a thick pyrocarbon layer encasing a graphites core that is impregnated with one-atomic percent tungsten so it is radiopaque. The device is avoilable 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
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)
Ceramic Zirconia Spherical CMC Implant (K960659), Ascension PyroHemiSphere (K041451)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Page 28 of 93
| DEC 1 3 2004 | 510(k) SUMMARY |
|---|---|
| SUBMITTER NAME: | Ascension Orthopedics, Inc. |
| 8200 Cameron Road, C-140 | |
| Austin, TX 78754-3832 | |
| CONTACT: | Peter Strzepa |
| Phone: (512) 836-5001 | |
| Fax: (512) 836-6933 | |
| DATE OF SUMMARY: | 28 September 2004 |
| TRADE NAME: | Ascension® PyroSphere® |
| COMMON NAME: | carpometacarpal (CMC) implant |
| CLASSIFICATION: | 21 CFR §888.3770 |
| PRODUCT CODE: | 87 KYI |
| PANEL: | Orthopedic and Rehabilitation Devices |
PREDICATE DEVICE:
Ceramic Zirconia Spherical CMC Implant (K960659) Ascension PyroHemiSphere (K041451)
DEVICE DESCRIPTION:
The Ascension PyroSphere (PCS) is a single-use, spherical, interpositional prosthesis for the basal thumb joint. It is fabricated from a thick pyrocarbon layer encasing a graphites core that is impregnated with one-atomic percent tungsten so it is radiopaque. The device is avoilable in five sizes and is provided sterile in packaging containing a single component.
INTENDED USE:
The Ascension PyroSphere is intended to replace the joint between the first metacarpal and the trapezium in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as cither 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 PyroSpherc is substantially equivalent to the predicate devices.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
DEC 1 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Peter Strzepa Vice President Science and Technology Ascension Orthopedics, Inc. 8200 Cameron Road, Suite C-140 Austin, Texas 78754
Re: K042690
Trade/Device Name: Ascension® PyroSphere® Regulation Numbers: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: KYI Dated: September 28, 2004 Received: September 29, 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.
2
Page 2 - Mr. Peter Strzepa
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 (240) 276-0120. 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.
Sincerely yours,
Mark N. Milleson
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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Indications For Use
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Ascension® PyroSphere® Device Name:
Indications for Use:
The Ascension® PyroSphere® is intended to replace the joint between the first metacarpal and the trapezium 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Milkerson
Restorative, and Neurological Devices
510(k) Number K042690