(209 days)
The device is designed for press-fitting into the human femurs for total hip replacement. This hip is indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprosthesis and/or total hip components in the affected extremity; patients with acute femoral neck fractures.
The device is identical to the predicate hip of Zimmer LFIC Hip Prosthesis, Zimmer Inc., , P.O. Box 708, Warsaw, Indiana 46581-0708, (K952776). It is intended for pressfit use into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum. These stems are made of Tivanium Ti-6A1-4V Alloy and anatomic in shape.
Lateral Flare Internal Collar (LFIC), (proportional sizes). These stems are made of Tivanium Ti-6A1-4V Alloy and anatomic in shape.
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Lateral Flare Internal Collar (LFIC)," an internal hip prosthesis. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/ML device performance or clinical studies with quantifiable metrics.
The FDA 510(k) clearance process primarily establishes "substantial equivalence" to a predicate device. This often involves demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a legally marketed predicate device. While testing (e.g., mechanical, biocompatibility) is usually performed for such devices, the level of detail regarding specific performance metrics and studies is not typically included in the summary provided in the 510(k) clearance letter itself.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be stated based on the provided text:
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Device Name: Lateral Flare Internal Collar (LFIC)
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Intended Use: The device is designed for press-fitting into the human femurs for total hip replacement. It is indicated for patients suffering from severe hip pain and disability due to various conditions such as rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprosthesis and/or total hip components in the affected extremity; and patients with acute femoral neck fractures.
The document explicitly states: "The device is identical to the predicate hip of Zimmer LFIC Hip Prosthesis, Zimmer Inc., P.O. Box 708, Warsaw, Indiana 46581-0708, (K952776). It is intended for pressfit use into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum. These stems are made of Tivanium Ti-6A1-4V Alloy and anatomic in shape."
Based on the provided text, I cannot answer the following points as they are not present in the document:
- A table of acceptance criteria and the reported device performance.
- Sample sized used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance. (This is a traditional medical device, not an AI/ML device).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. (This is a traditional medical device, not an AI/ML device).
- The type of ground truth used.
- The sample size for the training set. (This is a traditional medical device, not an AI/ML device).
- How the ground truth for the training set was established. (This is a traditional medical device, not an AI/ML device).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, placed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1997
Irving L. Wiesen, Esq. Representing Pro-Lfic LLC 500 West Putnam Avenue, Third Floor Greenwich, Connecticut 06830
Re: K971900 Lateral Flare Internal Collar (LFIC), (proportional sizes) Regulatory Class: II Product Code: LWJ September 24, 1997 Dated: Received: September 29, 1997
Dear Mr. Wiesen:
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, good manufacturing practice, labeling, and prohibitions aqainst 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. ਸ 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 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 requlations.
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Page 2 - Irving L. Wiesen, Esq.
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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1997
Irving L. Wiesen, Esq. Representing Pro-Lfic LLC 500 West Putnam Avenue, Third Floor Greenwich, Connecticut 06830
Re: K971900 Lateral Flare Internal Collar (LFIC), (proportional sizes) Regulatory Class: II Product Code: LWJ September 24, 1997 Dated: Received: September 29, 1997
Dear Mr. Wiesen:
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, good manufacturing practice, labeling, and prohibitions aqainst 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. ਸ 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 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 requlations.
{3}------------------------------------------------
Page 2 - Irving L. Wiesen, Esq.
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
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510(k) Number (if known):
Device Name: Lateral Flare Internal Collar (LFIC)
Indications For Use:
The device is designed for press-fitting into the human femurs for total hip replacement. This hip is indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprosthesis and/or total hip components in the affected extremity; patients with acute femoral neck fractures.
The device is identical to the predicate hip of Zimmer LFIC Hip Prosthesis, Zimmer Inc., , P.O. Box 708, Warsaw, Indiana 46581-0708, (K952776). It is intended for pressfit use into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum. These stems are made of Tivanium Ti-6A1-4V Alloy and anatomic in shape.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tcoles
Division of General Restorative Devices
510(k) Number
.
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.