(80 days)
No
The summary describes a physical medical device (acetabular components and bipolar prosthesis) and a sterilization process. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on wear reduction through material and sterilization process changes, not algorithmic performance.
Yes
The device is intended for the reconstruction of damaged hip joints and associated components, thereby treating conditions such as osteoarthritis and fractures.
No
Explanation: The device is an acetabular component and bipolar prosthesis intended for the reconstruction of hip joints, which is a therapeutic rather than a diagnostic function.
No
The device description clearly indicates it is a physical implant (acetabular components and bipolar prosthesis) made of UHMWPE, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the surgical reconstruction of hip joints due to various conditions like arthritis and fractures. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The description focuses on the materials and sterilization process of acetabular components and bipolar prostheses, which are physical implants.
- Performance Studies: The performance studies describe wear testing of the implants in a hip joint simulator, not diagnostic performance metrics like sensitivity or specificity.
- Anatomical Site: The anatomical sites mentioned are the acetabulum and femoral head, which are parts of the body where the implant is placed.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a condition, not to diagnose it.
N/A
Intended Use / Indications for Use
The Exeter All Plastic Acetabular Component (previously cleared in K936132) is intended to be used for primary and secondary reconstruction of the bearing surface of the acetabulum as a result of painful and/or severly disabled hip joints due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or revision of a failed acetabular component.
The Howmedica® Bipolar Prosthesis, Centrax® (previously cleared in K855231) is intended to be used in conjunction with a femoral stem component for the reconstruction of a femoral head damaged by fresh fracture, non-union, aseptic necrosis of the head and neck, or by osteoarthritis or post-traumatic arthritis.
Product codes
JDI, KWY
Device Description
This submission describes additional UHMWPE acetabular components that can be sterilized by the Duration® Stabilized process previously cleared in submission K934060, as an alternate to standard air irradiated gamma sterilization. The additional components are the Exeter All Plastic Acetabular Component (K936132) and the Howmedica® Bipolar Prosthesis, Centrax® (K855231). Corresponding wear claims, previously cleared in submission K 963612 and listed below, are also applicable to these additional components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabulum, femoral head
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
Howmedica's Duration® Stabilized UHMWPE, System 12®, size P4, neutral acetabular inserts, with an inner diameter of 32mm, a bearing thickness of 6.1 mm and aged for 6 months in an oxygen environment, showed a 36% reduction in volumetric wear versus the same cup conventionally gamma sterilized and aged for 6 months in an oxygen environment. Testing was performed in a multiaxial hip joint simulator for over 10 million cycles, using a 32mm CoCr Head articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
Howmedica's Duration® Stabilized UHMWPE, a hemispherical cup of generic design for hip simulator testing, with an inner diameter of 32 mm, and a bearing thickness of 8.4 mm, showed a 40% reduction in volumetric wear versus the same cup conventionally gamma sterilized. Testing was performed in a multiaxial hip joint wear simulator for over 5 million cycles, using a 32 mm diameter CoCr Head articulating counterface and tow calcium" containing bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
Howmedica's Duration® Stabilized UHMWPE, System 12® Neutral Acetabular Insert, size P4. with an inner diameter of 32mm, and a bearing thickness of 6.1 mm, showed a 40% reduction in volumetric wear versus the same cup conventionally gamma sterilized. Testing was performed in a hip joint wear simulator for over 5 million cycles, using a 32 mm CoCr Head articulating counterface and high calcium" containing bovine calf serum as a lubricant. The results of these in vitro tests have not been shown to correlate with clinical wear mechanisms or in vitro third body wear mechanisms involving fragments of bone cement, UHMWPE , metal, ceramic, etc.
In an independent laboratory test on Howmedica's Duration® Stabilized UHMWPE, a hemispherical cup of generic design for hip simulator testing, with an inner diameter of 32 mm, a bearing thickness of 8.4 mm, and having undergone 11 days of heating in air to simulate 5 years "aging", showed a 27% reduction in volumetric wear versus the same cup conventionally gamma sterilized, having undergone 11 days of heating in air to simulate 5 years "aging". Testing was performed in a multiaxial hip joint wear simulator over 10 million cycles, using a 32 mm CoCr Head articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
Key Metrics
Reduction in volumetric wear: 36%, 40%, 40%, 27%
Predicate Device(s)
Not Found
Reference Device(s)
K934060, K936132, K855231, K963612
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k) Summary
Proprietary Name: Duration® Stabilized UHMWPE Acetabular Components
Common Name: UHMWPE Acetabular Components
21 CFR 888.3358 Classification Name and Reference:
Proposed Requlatory Class: Class II Device Product Code: JDI
:
For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 Fax: (201) 507-6870 Date Summary Prepared: 7-25-97
This submission describes additional UHMWPE acetabular components that can be sterilized by the Duration® Stabilized process previously cleared in submission K934060, as an alternate to standard air irradiated gamma sterilization. The additional components are the Exeter All Plastic Acetabular Component (K936132) and the Howmedica® Bipolar Prosthesis, Centrax® (K855231). Corresponding wear claims, previously cleared in submission K 963612 and listed below, are also applicable to these additional components.
Howmedica's Duration® Stabilized UHMWPE, System 12®, size P4, neutral acetabular inserts, with an inner diameter of 32mm, a bearing thickness of 6.1 mm and aged for 6 months in an oxygen environment, showed a 36% reduction in volumetric wear versus the same cup conventionally gamma sterilized and aged for 6 months in an oxygen environment. Testing was performed in a multiaxial hip joint simulator for over 10 million cycles, using a 32mm CoCr Head articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
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Howmedica's Duration® Stabilized UHMWPE, a hemispherical cup of generic design for hip simulator testing, with an inner diameter of 32 mm, and a bearing thickness of 8.4 mm, showed a 40% reduction in volumetric wear versus the same cup conventionally gamma sterilized. Testing was performed in a multiaxial hip joint wear simulator for over 5 million cycles, using a 32 mm diameter CoCr Head articulating counterface and tow calcium" containing bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
Howmedica's Duration® Stabilized UHMWPE, System 12® Neutral Acetabular Insert, size P4. with an inner diameter of 32mm, and a bearing thickness of 6.1 mm, showed a 40% reduction in volumetric wear versus the same cup conventionally gamma sterilized. Testing was performed in a hip joint wear simulator for over 5 million cycles, using a 32 mm CoCr Head articulating counterface and high calcium" containing bovine calf serum as a lubricant. The results of these in vitro tests have not been shown to correlate with clinical wear mechanisms or in vitro third body wear mechanisms involving fragments of bone cement, UHMWPE , metal, ceramic, etc.
In an independent laboratory test on Howmedica's Duration® Stabilized UHMWPE, a hemispherical cup of generic design for hip simulator testing, with an inner diameter of 32 mm, a bearing thickness of 8.4 mm, and having undergone 11 days of heating in air to simulate 5 years "aging", showed a 27% reduction in volumetric wear versus the same cup conventionally gamma sterilized, having undergone 11 days of heating in air to simulate 5 years "aging". Testing was performed in a multiaxial hip joint wear simulator over 10 million cycles, using a 32 mm CoCr Head articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human profile, composed of three curved lines. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Maas .Manager, Requlatory Affairs Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070
OCT 1 6 1997
Re: K972792 Duration Stabilized UHMWPE Exeter All Trade Name: Plastic Acetabular Component and Centrex® Bipolar Component Regulatory Class: II Product Codes: JDI and KWY Dated: July 25, 1997 Received: July 28, 1997
Dear Mr. Maas:
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. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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:
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Page 2 - Mr. Frank Maas
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 enrough on or or on 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 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.qov/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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ications for Use
510(k) Number (if known):
Device Name: Duration® Stabilized UHMWPE Acetabular Components
Indications for Use:
The Exeter All Plastic Acetabular Component (previously cleared in K936132) is intended to be used for primary and secondary reconstruction of the bearing surface of the acetabulum as a result of painful and/or severly disabled hip joints due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or revision of a failed acetabular component.
The Howmedica® Bipolar Prosthesis, Centrax® (previously cleared in K855231) is intended to be used in conjunction with a femoral stem component for the reconstruction of a femoral head damaged by fresh fracture, non-union, aseptic necrosis of the head and neck, or by osteoarthritis or post-traumatic arthritis.
SEE NEXT PAGE FOR DURATION® WEAR CLAIMS
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
D - General Restorative Devices
510(k) K972792 (Optional Format 1-2-96)