(86 days)
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Not Found
No
The summary describes a mechanical implant (acetabular cup) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an acetabular cup system used in total hip arthroplasty to restore the acetabular cavity, which is a therapeutic intervention for conditions like arthritis.
No
Explanation: The device is an acetabular cup system used as a pelvic component in total hip arthroplasty to restore the acetabular cavity, not to diagnose a condition.
No
The device description clearly states "Rim-Fix, Acetabular Cup," which is a physical implantable 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 describes the device as a surgical implant used in total hip arthroplasty to restore the acetabular cavity. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as an "Acetabular Cup," which is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
IVDs are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The Rim-Fix, acetabular cup system is intended to be used as the pelvic component of a total hip arthroplasty. It can be implanted either as a press fit cup or cemented into the cavity. The acetabular cup is used to restore the acetabular cavity in a total joint arthroplasty and is used in conjunction with a metal femoral hip stem. The indications for use of the Rim-Fix cup system are as follows: Osteoarthritis, rheumatoid arthritis, posttraumatic arthritis or arthritis secondary to a variety of diseases or anomalies, or revision from a failed arthroplasty.
Product codes
JDI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
pelvic component; acetabular cavity
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2000
Mr. Douglas W. Stuart President Surgical Implants, Inc. 962 South Tamiami Trail Suite 203 Sarasota, Florida 34326
Re: K993713
Trade Name: Rim-Fix, Acetabular Cup Regulatory Class: II Product Code: JDI Dated: October 20, 1999 Received: November 3, 1999
Dear Mr. Stuart:
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 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 (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 Regulation (OS) 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 regulation may result in regulatory 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.
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
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Page 2 - Mr. Douglas W. Stuart
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) 594-4595. 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 J. Wagner
Su James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Exhibit 8
Statement of Intended Use
Unknown_ K993713 510(K) Number: __ Rim-Fix Acetabular Cup System Device Name:
Intended Use
Indicated Use:
The Rim-Fix, acetabular cup system is intended to be used as the pelvic component of a total hip arthroplasty. It can be implanted either as a press fit cup or cemented into the cavity. The acetabular cup is used to restore the acetabular cavity in a total joint arthroplasty and is used in conjunction with a metal femoral hip stem. The indications for use of the Rim-Fix cup system are as follows: Osteoarthritis, rheumatoid arthritis, posttraumatic arthritis or arthritis secondary to a variety of diseases or anomalies, or revision from a failed arthroplasty.
| Signed: | Diostunt |
|---|---|
| --------- | ---------- |
(Please do not write below this line - continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| (Division Sign-Off) | |||
| Division of General Restorative Devices | |||
| 510(k) Number K99 3717 | |||
| Prescription Use ✓ | OR | Over The Counter Use __ | |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |