(63 days)
Not Found
Not Found
No
The summary does not contain any keywords or descriptions related to AI or ML.
Yes
The 'Intended Use / Indications for Use' section lists medical conditions like Rheumatoid arthritis, Traumatic arthritis, Osteoarthritis, and Post Fracture deformation or bone loss, which are typically addressed by therapeutic devices designed to treat or manage these conditions.
Yes
The "Intended Use / Indications for Use" section lists specific medical conditions (rheumatoid arthritis, traumatic arthritis, osteoarthritis, post-fracture deformation or bone loss), which are conditions that would require diagnosis. The device is intended for "Prescription Use," implying it is used in a medical context, likely for identifying or characterizing these conditions.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to ascertain if the device includes any hardware components or relies solely on software for its intended use.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (Rheumatoid arthritis, Traumatic arthritis, Osteoarthritis, Post Fracture deformation or bone loss) are all related to diagnosing or managing conditions within the human body, not analyzing samples in vitro (outside the body).
- Device Description: While the device description is "Not Found," the intended uses strongly suggest a device that interacts with the patient directly, likely for imaging, physical therapy, or some other form of treatment or assessment.
- No mention of analyzing biological samples: IVDs are designed to analyze biological samples like blood, urine, tissue, etc. There is no indication of this type of analysis in the provided text.
Therefore, based on the available information, this device appears to be a medical device intended for use in vivo (within the body) or on the body, rather than an IVD.
N/A
Intended Use / Indications for Use
- Rheumatoid arthritis
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- Traumatic arthritis
-
- Osteoarthritis
-
- Post Fracture deformation or bone loss
Product codes
KYI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the eagle in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 20 2006
Mr. David Mrak Director of Product Development BioPro, Inc. 17 Seventeenth Street Port Huron, Michigan 48060
Re: K061089
Trade/Device Name: Modular Thumb Implant Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: Class II Product Code: KYI Dated: June 15, 2006 Received: June 16, 2006
Dear Mr. Mrak:
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 net
1
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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Meller, M.S.
ark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): KO61089
Device Name: Biopro Modular Thumb
Indications For Use:
- Rheumatoid arthritis
-
- Traumatic arthritis
-
- Osteoarthritis
-
- Post Fracture deformation or bone loss
Prescription Use xxxxx (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulu Lenuw
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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510(k) Number Lo bl089