(121 days)
Not Found
None
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description and intended use are consistent with a traditional orthopedic implant.
Yes
The device is intended to treat various conditions of the hip and proximal femur, such as fractures, non-unions, aseptic necrosis, and arthritis, indicating a therapeutic purpose.
No
The device, "ARGOMEDICAL Biopolar Hip System," is indicated for treating conditions like fractures, non-unions, aseptic necrosis, and arthritis of the hip, as well as for salvaging failed arthroplasty. These are all therapeutic or reconstructive uses, not diagnostic.
No
The 510(k) summary describes a "Biopolar Hip System," which is a physical implant used in hip replacement surgery. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information describes a surgical implant (ARGOMEDICAL Biopolar Hip System) used to treat conditions affecting the hip and femur. It is implanted directly into the body to replace or support damaged bone and joints.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any specimens taken from the body. Its function is mechanical and structural within the body.
Therefore, based on the provided information, the ARGOMEDICAL Biopolar Hip System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
-
- Fractures of the proximal femur.
-
- Non-unions of proximal femoral neck fractures.
-
- Aseptic necrosis of the femoral head.
-
- Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum.
-
- Salvage of failed total hip arthroplasty.
Product codes
KWL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur, femoral neck, femoral head, hip, acetabulum
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.
AUG 2 1 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Donald A. Stevens President StelKast Company 800 Vinial Street, Suite B-210 Pittsburgh, Pennsylvania 15212
K981451 Re: ARGOMEDICAL Biopolar Hip System Regulatory Class: II Product Code: KWL Dated: July 21, 1998 Received: July 22, 1998
Dear Mr. Stevens:
We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), 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 895. ದ್ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Donald A. Stevens
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Russell W. Ayres
Celia M. Witten, Ph. D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
981451 510(K) Number (if known):
Device Name: StelKast Company - ARGOMEDICAL Bipolar System
Indications For Use:
-
- Fractures of the proximal femur.
-
- Non-unions of proximal femoral neck fractures.
-
- Aseptic necrosis of the femoral head.
-
- Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum.
-
- Salvage of failed total hip arthroplasty.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thurber Lyman Brewer
(Division Sinn. Division of General Restor 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)