(119 days)
No
The summary describes a physical medical device (acetabular insert) with improved material properties due to a new manufacturing process. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is an acetabular insert intended for total hip arthroplasty, which is a surgical procedure to replace a damaged hip joint, addressing conditions like noninflammatory degenerative joint disease, inflammatory joint disease, and failed previous surgeries. This replacement aims to alleviate pain, correct deformity, and restore function, thereby treating a medical condition and improving health.
No
The device is an acetabular insert for total hip arthroplasty, and while the "Diagnostic indications for use" section lists patient conditions, these are conditions for which the device can be used to treat, not conditions the device diagnoses. The device itself is a prosthetic component, not a tool for diagnosis.
No
The device is a physical implant (acetabular insert) made of UHMWPE, not software. The submission describes a manufacturing process change for this physical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "replace the acetabulum during total hip arthroplasty." This is a surgical procedure to replace a joint, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant (acetabular insert) made of polyethylene. It's designed to be surgically implanted.
- Diagnostic Indications: While the text lists "Diagnostic indications for use," these are actually patient conditions for which the device is indicated for treatment (e.g., osteoarthritis, rheumatoid arthritis). They are not diagnostic tests performed by the device itself.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, analysis of biological samples (blood, urine, tissue), or diagnostic results.
The device is a medical device intended for surgical implantation to treat specific joint conditions.
N/A
Intended Use / Indications for Use
The DURASUL acetabular insert is a snap-in acetabular shell liner that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The insert is available in three styles and is intended to be used in conjunction with an Inter-Op acetabular shell to replace the acetabulum during total hip arthroplasty. Inter-Op acetabular components (shell/insert combination) may be implanted with or without bone cement.
Diagnostic indications for use of this device include:
- patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- . those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- revision of a previously failed arthroplasty. .
Product codes
JDI, LPH
Device Description
Sulzer Orthopedics currently markets a polyethylene shell liner (insert) in conjunction with its Inter-Op Acetabular System. The UHMWPE insert was originally cleared via 510(k) K955033 and is available in three styles, all of which mate with various shell designs in the system.
The purpose of this submission is to describe a different UHMWPE treatment process that was developed and patented by Massachusetts General Hospital (MGH) and Massachusetts Institute of Technology (MIT). This treatment produces a highly cross-linked polyethylene and reduces free radicals that can lead to oxidative degradation. This in turn provides a highly wear resistant surface which has been demonstrated through hip simulation.
Sulzer Orthopedics has licensed this process for use in the manufacture of Inter-Op acetabular inserts. Sulzer Orthopedics does not intend to change the intended use of this device, nor do we intend to alter the basic geometrical design of the three insert styles. Moreover, while there is a change in process to enhance the wear properties of UHMWPE, there is no change to the raw material (GUR 1150/1050 conforming to ASTM F 648).
Sulzer Orthopedics intends to make marketing claims with regard to wear properties based on improved performance demonstrated by comparative hip simulator test results. DURASUL inserts were tested under identical conditions and compared to inserts manufactured and treated according to current processes (CONTROL). Undetectable wear was noted over 5 million cycles as compared to a steady average wear rate of approximately 12 mg/million cycles for the CONTROL inserts. The results of in vitro wear tests have not been shown to correlate with clinical wear mechanisms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabulum (hip joint)
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)
Sulzer Orthopedics intends to make marketing claims with regard to wear properties based on improved performance demonstrated by comparative hip simulator test results. DURASUL inserts were tested under identical conditions and compared to inserts manufactured and treated according to current processes (CONTROL). Undetectable wear was noted over 5 million cycles as compared to a steady average wear rate of approximately 12 mg/million cycles for the CONTROL inserts. The results of in vitro wear tests have not been shown to correlate with clinical wear mechanisms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
FEB 3 1039
510(k) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Inter-Op™ DURASUL™ Acetabular Insert.
| Submitter: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | February 3, 1999 |
| Contact Person: | Mitchell Dhority, RAC
Manager, Regulatory Affairs |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous coated
uncemented prosthesis, 21 CFR 888.3358 |
| Common/Usual Name: | Total Hip Prosthesis, Semi-constrained |
| Trade/Proprietary Name: | Sulzer Orthopedics Inter-Op™ DURASUL™ Acetabular Insert |
PRODUCT DESCRIPTION
Sulzer Orthopedics currently markets a polyethylene shell liner (insert) in conjunction with its Inter-Op Acetabular System. The UHMWPE insert was originally cleared via 510(k) K955033 and is available in three styles, all of which mate with various shell designs in the system.
The purpose of this submission is to describe a different UHMWPE treatment process that was developed and patented by Massachusetts General Hospital (MGH) and Massachusetts Institute of Technology (MIT). This treatment produces a highly cross-linked polyethylene and reduces free radicals that can lead to oxidative degradation. This in turn provides a highly wear resistant surface which has been demonstrated through hip simulation.
Sulzer Orthopedics has licensed this process for use in the manufacture of Inter-Op acetabular inserts. Sulzer Orthopedics does not intend to change the intended use of this device, nor do we intend to alter the basic geometrical design of the three insert styles. Moreover, while there is a change in process to enhance the wear properties of UHMWPE, there is no change to the raw material (GUR 1150/1050 conforming to ASTM F 648).
Sulzer Orthopedics intends to make marketing claims with regard to wear properties based on improved performance demonstrated by comparative hip simulator test results. DURASUL inserts were tested under identical conditions and compared to inserts manufactured and treated according to current processes (CONTROL). Undetectable wear was noted over 5 million cycles as compared to a steady average wear rate of approximately 12 mg/million cycles for the CONTROL inserts. The results of in vitro wear tests have not been shown to correlate with clinical wear mechanisms.
1
SPECIFIC DIAGNOSTIC INDICATIONS
The DURASUL acetabular insert is a snap-in acetabular shell liner that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The insert is available in three styles and is intended to be used in conjunction with an Inter-Op acetabular shell to replace the acetabulum during total hip arthroplasty. Inter-Op acetabular components (shell/insert combination) may be implanted with or without bone cement.
Diagnostic indications for use of this device include:
- patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- . those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- revision of a previously failed arthroplasty. .
SUBSTANTIAL EQUIVALENCE
The Inter-Op DURASUL acetabular insert is substantially equivalent in function, material and overall design to most currently marketed shell liners. It is a modular component that is manufactured from cross-linked polyethylene and is used to resurface the acetabulum during total hip arthroplasty. The major difference between the DURASUL insert and other commercially available designs is that it is cross-linked by electron beam radiation under melling conditions rather than gamma radiation. It is also irradiated at a slightly higher effective dose than the typical sterilization dose used in the industry.
Sulzer Orthopedics is unaware of any other orthopedic manufacturer that uses this process for their polyethylene components. Therefore, substantial equivalence is based upon comparison of the DURASUL acetabular insert to Sulzer Orthopedics' currently available Inter-Op design. The following summarizes the similarities between the two:
- . The DURASUL acetabular insert (manufactured using the WIAM process) has the same intended use as Sulzer Orthopedics currently available acetabular inserts (manufactured using standard polyethylene).
- . The geomerical design of the DURASUL acetabular insert is essentially the same as the currently available Inter-Op insert.
- . The DURASUL insert and the currently available insert are both manufactured from UHMWPE that is subsequently cross-linked by irradiation. Both the standard and WIAM treated material conform to ASTM F 648, even after cross-linking. They both also conform to the FDA draft guidance document.
- Both the standard and WIAM material exhibit similar networks. The cross-link . densities are also similar: 0.13mol/dm2 for the standard gamma irradiated material as opposed to 0.18mol/dm3 for the WIAM material.
- . Although the wear performance of the WIAM processed material is much improved over the standard material, other performance characteristics are essentially the same. Neither the WIAM nor standard process compromised the fatigue or creep behavior of the inserts under physiological testing. Likewise, the locking strength of the shell/liner interface was the same for the DURASUL insert as compared to the currently available device.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 1999
Ms. Shavawn Evans Parduhn Requlatory Affairs Specialist Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
K983509 Re: Inter-Op™ Acetabular System, Durasul™ Trade Name: ・ Acetabular Insert Regulatory Class: II Product Codes: JDI and LPH Dated: January 4, 1999 Received: January 5, 1999
Dear Ms. Parduhn:
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 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 requlation (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.
3
Page 2 - Ms. Shavawn Evans Parduhn
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,
Nunn C. Fager
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
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Inter-Op DURASUL Acetabular Insert
Indications For Use:
The DURASUL acetabular insert is a snap-in acetabular shell liner that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The insert is available in three styles and is intended to be used in conjunction with an Inter-Op acetabular shell to replace the acetabulum during total hip arthroplasty. Inter-Op acetabular components (shell/insert combination) may be implanted with or without bone cement.
Diagnostic indications for use of this device include:
- patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- those patients with failed previous surgery where pain, deformity, or dysfunction persists. .
- revision of previously failed hip arthroplasty. ●
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR
Over-The-Counter Use
(Optional Format 1-2-96)
Russell J. Wagner /in CHK
(Division Sign-Off)
Division of General Restorative Devices 510(k) Number . 78 3509