(70 days)
Not Found
Not Found
No
The summary describes a mechanical implant (acetabular cup) and does not mention any software, algorithms, or data processing that would suggest AI/ML.
Yes
The device is described as an "acetabular cup system" used as the "pelvic component of a total hip arthroplasty," which is a medical procedure to replace parts of the hip joint, indicating its therapeutic intent.
No
Explanation: The device is an acetabular cup system, which is an implant used in total hip arthroplasty, not a tool for diagnosis.
No
The device description clearly indicates a physical implant (acetabular cup system) used in surgery, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "pelvic component of a total hip arthoplasty." This describes a surgical implant used in vivo (within the body) to replace a joint.
- IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform such tests.
- Lack of IVD-related information: The provided text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the Groupe Lepine B2C Espace, revision acetabular cup system is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Groupe Lepine B2C Espace, revision acetabular cup system is intended to be used as the pelvic component of a total hip arthoplasty. The acetabular component geometry has been designed to fill large acetabular defects in the floor and superior aspects of the acetabular cavity. It can be implanted either as a press fit cup with bone screw fixation or cemented into the cavity.
Product codes
LPH, 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 of a total hip arthoplasty, acetabular cavity
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an abstract caduceus symbol, which is often associated with healthcare and medicine. The caduceus is depicted with a staff and intertwined snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1999
Mr. Douglas W. Stuart Surgical Implants, Inc. 962 South Tamiami Trail Suite 203 Sarasota, Florida 34326
K990523 Re: B2C, "Espace" Revision Cup System Trade Name: Regulatory Class: II Product Codes: LPH and JDI February 12, 1999 Dated: Received: February 19, 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 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 Requlations, 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 (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 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.
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Page 2 - Mr. Douglas W. Stuart
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 requlation (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 che regulation chercred) hrobididing by 2018.000 eral 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
2
EXHIBIT 6
A Statement of intended Use
510(K) Number Device Name: B2C Revision C
Statement of Intended Use
Indications For Use:
The Groupe Lepine B2C Espace, revision acetabular cup system is intended to be used as the pelvic component of a total hip arthoplasty. The acetabular component geometry has been designed to fill large acetabular defects in the floor and superior aspects of the acetabular cavity. It can be implanted either as a press fit cup with bone screw fixation or cemented into the cavity.
Signed: Dwstiant
(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 K990523
510(k) Number
| Labels | Values |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | Yes |
| Over The Counter Use (Optional Format 1-2-96) | No |