(221 days)
Not Found
No
The summary describes a modification to the manufacturing process of a polyethylene material used in hip implants, focusing on material properties and wear performance. There is no mention of AI or ML in the device description, intended use, performance studies, or key metrics.
Yes
The device is a component of a total hip arthroplasty, which is used for the treatment of various joint diseases and deformities, indicating a direct therapeutic action in replacing a diseased joint.
No
The device description and intended use indicate that this is a material modification for polyethylene acetabular components used in total hip arthroplasty, not a tool for diagnosing medical conditions. The performance studies focus on wear rates and material properties, further confirming its non-diagnostic nature.
No
The device description clearly states it is a modification to the manufacturing process of UHMWPE used in the fabrication of polyethylene acetabular components, which are physical implants. The performance studies also focus on material properties and wear characteristics of this physical material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to treat various hip joint conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a component of a total hip arthroplasty (hip replacement), specifically a polyethylene acetabular component. This is a physical implant used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples (like blood or tissue), or provide information about a patient's health status through in vitro testing.
- Performance Studies: The performance studies focus on the material properties and wear characteristics of the polyethylene component, which are relevant to its function as an implant, not its diagnostic capability.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Indications For Use:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications
Product codes (comma separated list FDA assigned to the subject device)
JDI, LPH
Device Description
Biomet Manufacturing Corp. is modifying the manufacturing process of UHMWPE used in the fabrication of polyethylene acetabular components. The modified manufacturing process results in a higher cross-linked polyethylene, that Biomet will herein refer to as ArComXL™.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Hip Simulator Wear
A side by side hip simulator wear test of the two materials showed a 47% reduction in the volumetric wear rate (34.9 opposed to 65.8 mm³/10⁶ cycles) for ArComXL™ (EtO sterilized) when compared to the predicate device. Testing was performed under multiaxial hip joint simulation for five (5) million cycles. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.
Abrasive Hip Simulator Wear
Under abrasive conditions, the Biomet ArComXL™ (EtO sterilized) polyethylene acetabular insert (Part No.: XL-105933) showed a 64% reduction in volumetric wear rate (109.8 opposed to 309.0 mm³/10⁶ cycles) when compared to the same acetabular inserts fabricated from the predicate polyethylene (Part No.: 12-105893). Testing was performed under multiaxial hip joint simulation for two (2) million cycles. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.
Free Radicals
The Biomet ArComXL™ (Gas Plasma sterilized) material, showed a 94% reduction in the number of free radicals (0.22x10¹⁵ compared to 3.82x10¹⁵ spins/g) versus the predicate polyethylene material. Testing was performed by an independent laboratory using Electron Spin Resonance (ESR). Results of in vitro free radical testing have not been shown to quantitatively predict oxidation resistance.
Oxidative Stability
The Biomet ArComXL™ (Gas Plasma sterilized) material did not show any measurable oxidation by FTIR (oxidation index less than 0.4 throughout the sample) after accelerated aging per ASTM F2003-00. In contrast, when the predicate material was removed from inert packaging that was vacuum sealed after purging with argon), it did show measurable levels of oxidation after accelerated aging (oxidation index was greater than 1.1 at a depth of 1 mm). Further, after accelerated aging the average ultimate load for all three ArComXL™ axes (Gas Plasma Sterilized) remained higher than the peak load (31% higher; 91.8N vs. 70.2N); whereas the ultimate load for the isotropic predicate material was significantly less than the peak load (44% lower; 42.6N vs. 75.6N) as measured by small punch testing, ASTM F2183-02.
Mechanical Strength
The Biomet ArComXL™ (EtO sterilized) material showed a 30% increase in ultimate tensile strength (from 47 MPa to 61 MPa) in the longitudinal axis versus the predicate polyethylene material. The tensile testing was performed per ASTM standard D638-02a using Type 5 tensile specimens.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Volumetric wear rate reduction: 47% (Hip Simulator Wear), 64% (Abrasive Hip Simulator Wear)
Reduction in free radicals: 94%
Oxidation index: less than 0.4 (ArComXL), greater than 1.1 (Predicate)
Ultimate load increase: 31% (ArComXL)
Ultimate tensile strength increase: 30%
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
p.1/3
BIOMET
MAR 8 - 2005
510(k) Summary
| NATA |
|---|
Sponsor: Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Contact Person: Tracy Bickel Johnson, RAC ArComXL™ Polyethylene Liners Proprietary Name: Common Name; UHMWPE Classification Name: - hip jolnt metal/polymer/metal semi-constralned porous coated uncemented prosthesis (888.3358) - hip joint metal/polymer semi-constrained cemented prosthesis (888.3350) Substantlally Equivalent Devices: -ArCom® Polyethylene Liners and Components (K023357) -RingLoc® 36mm Liners (K032396) Device Description: Biomet Manufacturing Corp. is modifying the manufacturing process of UHMWPE used in the fabrication of polyethylene acetabular components. The modified manufacturing process results in a higher cross-linked polyethylene, that Biomet will herein refer to as ArComXL™. Indications for Use: 1) Non-inflammatory degenerative ioint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity 4) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) Revision of previously failed total hip arthroplasty. Cemented and Uncemented Applications. Summary of Technologies: The intended use, indications, contraindications, and design specifications of the subject components remain identical to their predicate component counterparts. The raw material being utilized in the manufacture of both the subject and the predicate devices remains a ultra-high molecular weight polyethylene (UHMWPE) per ASTM F-648. The modifications to the manufacturing process of this polyethylene will be Introduced in order to create a higher crosslinked polyethylene. The safety and effectiveness of this crosslinked polyethylene in acetabular applications, as well as the proposed wear claims, are adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notlfication.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
1
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
1
OFFICE 574.267.6639
ドヘメ 574.267.8137
E-MAIL hiomet@blomet.com
1
042051
510(k) Summary- Page 2 of 3 ArComXL™ Polyethylene Liners
Claims:
Hip Simulator Wear
The Biomet ArComXL™ polyethylene acetabular inserts (Part No.: XL-105933) tested are isostatically compression molded highly crosslinked components (50kGy gamma irradiated under argon) that are sterilized in alr by either gas plasma or ethylene oxide. ArComXL™ was compared to identical predicate polyethylene liners (Part No.: 12-105893) that were machined from isostatically molded polyethylene that was subsequently gamma sterilized (25-40kGy) in argon. A side by side hip simulator wear test of the two materials showed a 47% reduction in the volumetric wear rate (34.9 opposed to 65.8 mm³/10° cycles) for ArComXL™ (EtO sterilized) when compared to the predicate device. All inserts In this study mate with either a 50 or 52mm acetabular shell, have a standard rim, a 32 mm inner dlameter, and a 4.75 mm bearing thickness. Testing was performed under multiaxial hip joint simulation for five (5) million cycles, using a Paul Hip load profile with a maximum load of 2.4kN, 32 mm CoCr articulating heads, and a bovine calf servim lubricant. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.
Abrasive Hip Simulator Wear
The Biomet ArComXL™ polyethylene acetabular inserts (Part No.: XL-105933) tested are isostatically compression molded highly crosslinked components (50kGy gamma irradiated under argon) that are sterilized in air by either gas plasma or ethylene oxide. ArComXL™ was compared to Identical predicate polyethylene liners (Part No.: 12-105893) that were machined from isostatically moded polyethylene that was subsequently gamma sterilized (25-40kGy) in argon. After 5 million cycles of hip simulator wear with no additives, bone cement particulate was added to simulate abrasive conditions for two (2) million cycles. Under abrasive conditions, the Biomet ArComXL™ (EtO sterilized) polyethylene acetabular insert (Part No.: XL-105933) showed a 64% reduction In volumetric wear rate (109.8 opposed to 309.0 mm /10 cycles) when compared to the same acetabular inserts fabricated from the predicate polyethylene (Part No .: 12-105893). These Inserts mate with either a 50 or 52mm acetabular shell, have a standard rim, a 32mm inner diameter, and a 4.75 mm bearing thickness. Testing was performed under multiaxial hip joint slawlation for two (2) million cycles, using a Paul Hip load profile with a maximum load of 2.4kN, 32 mm CoCr articulating heads, and bovine calf serum lubricant. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.
Free Radicals
The Biomet ArComXL™ polyethylene material tested is isostatically compression molded, highly crosslinked (50kGy gamma irradiated under argon), and sterilized in air by either gas plasma or ethylene oxlde. ArComXL™ was compared to predicate polyethylene material that was machined from isostatically molded polyethylene that was subsequently gamma sterllized (25-40kGy) in argon. The Biomet ArComXL™ (Gas Plasma sterflized) material, showed a 94% reduction in the number of free radicals (0.22x1055 compared to 3.82x1045 spins/g) versus the predicate polyethylene material. Testing was performed by an independent laboratory using Electron Spin Resonance (ESR). Results of in vitro free radical testing have not been shown to quantitatively predict oxldation resistance.
OxIdative Stability
The Biomet ArComXL™ polyethylene material tested is isostatically compression molded, highly crosslinked (50kGy gamma irradlated under argon), and sterilized in air by elther gas plasma or ethylene oxide, ArComXL™ was compared to predicate polyethylene material that was machined from isostatically molded polyethylene that was subsequently gamma sterilized (25-40KGy) in argon.
2
042051
510(k) Summary- Page 3 of 3 ArComXL™ Polyethylene Liners
The Biomet ArComXL™ (Gas Plasma sterlized) material did not show any measurable oxidation by FTIR (oxidation index less than 0.4 throughout the sample) after accelerated aging per ASTM F2003-00, which is designed to simulate several years of shelf-aging in air. In contrast, when the predicate material was removed from inert packaging that was vacuum sealed after purging with argon), it did show measurable levels of oxidation after accelerated aging (oxidation index was greater than 1.1 at a depth of 1 mm). Further, after accelerated aging the average ultimate load for all three ArComXL™ axes (Gas Plasma Sterilized) remained higher than the peak load (31% higher; 91.8N vs. 70.2N); whereas the uttimate load for the isotropic predicate material was significantly less than the peak load (44% lower; 42.6N) as measured by small punch testing, ASTM F2183-02.
Mechanical Strength
The Biomet ArComXL™ polyethylene material tested is isostatically compression molded, highly crosslinked (50kGy gamma irradiated under argon), and sterilized in air by either gas plasma or ethylene oxide. ArComXL™ was compared to predicate polyethylene material that was machined from isostatically molded polyethylene that was subsequently gamma sterilized (25-40kGy) in argon. The Biomet ArComXL™ (EtO sterilized) material showed a 30% increase in ultimate tensile strength (from 47 MPa to 61 MPa) in the longitudinal axis versus the predicate polyethylene material. The tensile testing was performed per ASTM standard D638-02a using Type 5 tensile specimens.
Non-Clinical Testing: Verification activities were performed on ArComXL. Met or exceeded current standards or guidelines.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles a stylized caduceus, with three lines representing snakes intertwined around a staff.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 8 - 2005
Ms. Tracy Bickel Johnson, RAC Regulatory Associate Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K042051
Trade Name: ArComXL™ Polyethylene Liners -Regulation Number: 21 CFR 888.3350, 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II
Product Code: JDI, LPH Dated: December 6, 2004 Received: December 8, 2004
Dear Ms. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA`s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21
4
Page 2 - Ms. Tracy Bickel Johnson, RAC
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mb loter vill and wy of substantial equivalence of your device of your device to a legally premaince hodicate 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), please n you attire office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Economic and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Muriaml Provert
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K042051
Device Name: ArComXL™ Polyethylene Liners
Indications For Use:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mariam C. Parrott
(Division Sign-6 Division of General, Restorative, and Neurological Devices
Page 1 of 3
510(k) Number K072051
6
Claim Statements:
Hip Simulator Wear
The Biomet ArComXL™ polyethylene acetabular inserts (Part No.: XL-105933) tested are lsostatically compression molded highly crosslinked components (50kGy gamma irradlated under argon) that are sterilized in alr by either gas plasma or ethylene oxide. ArComXL™ was compared to Identical predicate polyethylene liners (Part No .: 12-105893) that were machined from isostatically molded polyethylene that was subsequently gamma sterlilized (25-40kGy) in argon, A side by side hip simulator wear test of the two materials showed a 47% reduction In the volumetric wear rate (34.9 opposed to 65,8 mm²/10° cycles) for ArComXL™ (EtO sterilized) when compared to the predicate device. All inserts in this study mate with either a 50 or 52mm acetabular shell, have a standard rim, a 32 mm inner diameter, and a 4.75 mm bearing thickness. Testing was performed under multiaxial hip Joint simulation for five (5) million cycles, using a Paul Hip load profile with a maximum load of 2.4kN, 32 mm CoCr articulating heads, and a bovine calf serum lubricant. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.
Abrasiye Hip Simulator Wear
The Blomet ArComXL™ polyethylene acetabular inserts (Part No .: XL-105933) tested are Isostatically compression molded highly crosslinked components (50kGy gamma irradiated under argon) that are sterilized in air by either gas plasma or ethylene oxide. ArComXL™ was compared to identical predicate polyethylene liners (Part No .: 12-105893) that were machined from isostatically molded polyethylene that was subsequently gamma sterlized (25-40kGy) in argon. After 5 million cycles of hip simulator wear with no additives, bone cement particulate was added to simulate abrasive conditions for two (2) million cycles. Under abrasive conditions, the Blomet. ArComXL™ (EtO sterllized) polyethylene acetabular insert (Part No.: XL-105933) showed a 64% reduction in volumetric wear rate (109.8 opposed to 309.0 mm²/10° cycles) when compared to the same acetabular inserts fabricated from the predicate polyethylene (Part No.; 12-105893). These inserts mate with either a 50 or 52mm acetabular shell, have a standard rim, a 32mm Inner diameter, and a 4.75 mm bearing thickness. Testing was performed under multlaxial hip joint simulation for two (2) million cycles, using a Paul Hip load profile with a maxlmum foad of 2.4kN, 32 mm CoCr articulating heads, and bovine calf serum lubricant. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.
Free Radicals
The Blomet ArComXL™ polyethylene material tested is isostatically compression molded, highly crosslinked (50kGy gamma irradiated under argon), and sterilized in air by either gas plasma or ethylene oxide. ArComXL™ was compared to predicate polyethylene material that was machined from isostatically molded polyethylene that was subsequently gamma sterflized (25-40kGy) in argon. The Blomet ArComXL™ (Gas Plasma sterilized) material, showed a 94% reduction in the number of free radicals (0.22x1055 compared to 3.82x1015 spins/g) versus the predicate polyethylene material. Testing was performed by an Independent laboratory using Electron Spin Resonance (ESR). Results of In vitro free radical testing have not been shown to quantitatively predict oxidation resistance.
Oxidative Stablilty
The Biomet ArComXL™ polyethylene material tested is isostatically compression molded, highly crosslinked (50kGy gamma irradiated under argon), and sterilized in air by elther gas plasma or ethylene oxide. ArComXL™ was compared to predicate polyethylene material that was machined from isostatically molded polyethylene that was subsequently gamma sterilized (25-40KGy) In argon. The Biomet ArComXL™ (Gas Plasma sterllized) material did not show any measurable Page 2 of 3
7
oxidation by FTIR (oxidation index less than 0.4 throughout the sample) after accelerated aging per ASTM F2003-00, which is designed to simulate several years of shelf-aging in alr. In contrast, when the predicate material was removed from inert packaging that was vacuum sealed after purging with argon), it did show measurable levels of oxIdation after accelerated aging (oxidation Index was greater than 1.1 at a depth of 1 mm), Further, after accelerated aging the average ultimate load for all three ArComXL™ axes (Gas Plasma Sterilized) remalned higher than the peak load (31% higher; 91.8N vs. 70.2N); whereas the ultimate load for the isotropic predicate material was significantly less than the peak load (44% lower; 42.6N vs. 75.6N) as measured by small punch testing, ASTM F2183-02.
Mechanical Strength
The Biomet ArComXL To polyethylene material tested is isostatically compression molded, highly crosslinked (50kGy gamma irradlated under argon), and sterilized in air by either gas plasma or ethylene oxide. ArComXL™ was compared to predicate polyethylene material that was machined from isostatically molded polyethylene that was subsequently gamma sterilized (25-40KGy) in argon. The Biomet ArComXL™ (EtO sterilized) material showed a 30% increase in ultimate tensile strength (from 47 MPa) in the longitudinal axis versus the predicate polyethylene material. The tensile testing was performed per ASTM standard D638-02a using Type 5 tensile specimens.