(83 days)
Not Found
No
The summary describes a mechanical implant and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is a hemi-hip replacement component used to treat various hip conditions, which falls under the definition of a therapeutic device designed to restore function or provide treatment.
No
The device is an endoprosthesis system, a physical implant used for hip replacement, rather than a tool for diagnosis. Its intended use and indications describe treatment for conditions, not the identification or analysis of them.
No
The device description clearly states it is a "one-piece, hemi-hip replacement component" and is intended for "cemented use only," indicating it is a physical implant, not software.
Based on the provided information, 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 Osteo Austin Moore Endoprosthesis System is a physical implantable device (a hemi-hip replacement component) that is surgically placed inside the body.
- Intended Use: Its intended use is to replace a part of the hip joint, not to perform diagnostic tests on bodily samples.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Osteo Austin Moore Endoprosthesis System is a one-piece, hemi-hip replacement component. It is intended for cemented use only.
Indications
- Femoral head/neck fractures .
- Aseptic necrosis of the femoral head .
- Osteo-, rheumatoid, and post-traumatic arthitis of the hip with minimal acetabular . involvement.
Product codes
KWL
Device Description
The Osteo Austin Moore Endoprosthesis System comes in a range of sizes to address variations in patient anatomy, and is intended for hemi-hip replacement procedures. It is intended to articulate with the natural acetabulum, and is intended for cemented use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral head/neck, 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)
The Osteo Austin Moore Endoprosthesis System has been tested to ensure that the subject devices can withstand anticipated in-vivo loading conditions. All specimens successfully endured 10 million cycles of physiologically relevant loading.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Howmedica Austin Moore Endoprosthesis
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
MAR 1 6 1998
510(k) Summary
510(k) Summary Osteo Austin Moore Endoprosthesis System
Submission Information
Name and Address of the Sponsor:
Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
Regulatory Affairs Specialist
Name and Address of the Manufacturer:
Osteo AG Bohnackerweg 1 CH-2545 Selzach Switzerland
Terry Sheridan
December 22, 1997
Contact Person:
Date of Summary Preparation:
Device Identification
Proprietary Name:
Common Name:
Predicate Device Identification
Classification Name and Reference:
Osteo Austin Moore Endoprosthesis System
Artificial hemi-hip stem
888.3360:Hip joint femoral(hemi-hip) metallic cemented or uncemented prosthesis
Howmedica Austin Moore Endoprosthesis, Howmedica Inc.
Device Description
The Osteo Austin Moore Endoprosthesis System comes in a range of sizes to address variations in patient anatomy, and is intended for hemi-hip replacement procedures. It is intended to articulate with the natural acetabulum, and is intended for cemented use only.
1
Intended Use:
The Osteo Austin Moore Endoprosthesis System is a one-piece, hemi-hip replacement component. It is intended for cemented use only.
Indications
- Femoral head/neck fractures .
- Aseptic necrosis of the femoral head .
- Osteo-, rheumatoid, and post-traumatic arthitis of the hip with minimal acetabular . involvement.
Statement of Technological Comparison:
The substantial equivalence of the Osteo Austin Moore Endoprosthesis System is supported by a comparison of the subject device to the above-cited predicate devices with regard to intended use, materials, and design.
Intended Use
Both the subject devices and the predicate devices are intended for hemi-hip replacement for the specified indications, and are intended for cemented use.
Materials
The subject devices and predicate devices are both cast from cobalt chromium alloy.
Design
The subject and predicate devices both feature the classic Austin-Moore design. This design includes a fixed-head for articulation with the acetabulum, and fenestrations for cement interdigitation.
Performance Data:
The Osteo Austin Moore Endoprosthesis System has been tested to ensure that the subject devices can withstand anticipated in-vivo loading conditions. All specimens successfully endured 10 million cycles of physiologically relevant loading.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 1998
Robert A. Koch, J.D. Director, Requlatory Affairs Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
K974807 Re: Osteo Austin Moore Endoprosthesis System Trade Name: Regulatory Class: II Product Code: KWL December 22, 1997 Dated: December 23, 1997 Received:
Dear Mr. Koch:
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 reguirements 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 (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. A substantially equivalent determination assumes compliance with ...... the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 regulatory In addition, FDA may publish further announcements action. 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.
3
Page 2 - Robert A. Koch, J.D.
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,
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
4
510(k) Number (if known): K 9 7 4 & 2 7
Device Name: Osteo Austin Moore Endoprosthesis System
Indications For Use:
The subject devices are intended for hemi-hip replacement. They are intended for cemented use only.
Indications
- Femoral head/neck fractures .
- Aseptic necrosis of the femoral head .
- Osteo-, rheumatoid, and post-traumatic arthitis of the hip with minimal acetabular involvement. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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Division of Concrat Restorative Devices 97482
510(k) Number ...