(147 days)
BI-MENTUM™ ALTRX® Dual Mobility System is indicated for total hip replacement in the following conditions: - Osteoarthritis - Femoral neck fracture - Dislocation risk - Osteonecrosis of the femoral head - Revision procedures where other treatments or devices have failed and if bone reconstruction so permits
BI-MENTUM™ ALTRX® Dual Mobility Liners are designed to provide additional stability where there is an unstable joint and are for use in total hip arthroplasty that is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation or a previously implanted prosthetic hip joint in patients where there is evidence of sufficient sound bone to seat and support the components.
The BI-MENTUM™ ALTRX® Dual Mobility Liners are intended for single use only.
BI-MENTUM™ ALTRX® Dual Mobility Liner is indicated for total hip replacement, which includes: - Osteoarthritis - Femoral neck fracture - Dislocation risk - Osteonecrosis of the femoral head - Revision procedures where other treatments or devices have failed are if bone reconstruction so permits
The BI-MENTUM™ ALTRX® Dual Mobility Liner is highly cross-linked ultra- high molecular weight polyethylene. The liner is mobile (free) in the metallic shell and retained on the prosthetic femoral head. The BI-MENTUM™ ALTRX® Dual Mobility Liner is compatible with all the stems listed on K181744 as well as all the BI-MENTUM™ cups cleared in K181744. The BI-MENTUM™ ALTRX® Dual Mobility Liner is also compatible with the PINNACLE® Dual Mobility Liner, cleared in K200854.
The provided text describes a 510(k) premarket notification for a medical device called the BI-MENTUM™ ALTRX® Dual Mobility Liner. This document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo performance criteria or conducting a clinical study with human patients and associated AI performance metrics.
Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, ground truth establishment, and training set details) are not applicable to this type of regulatory submission because the device is a mechanical implant, not an AI/software device.
The "acceptance criteria" in this context are the demonstration of mechanical and material properties that are substantially equivalent to predicate devices, ensuring safety and efficacy.
Here's the information that can be extracted:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria / Performance Aspect | Reported Device Performance (BI-MENTUM™ ALTRX® Dual Mobility Liner) | Comparison to Predicate (BI-MENTUM™ Dual Mobility System) / Reference (PINNACLE® ALTRX® Acetabular Liners) |
|---|---|---|
| Intended Use | Total Hip Arthroplasty | Same as predicate; Same as reference. |
| Liner Material | UHMWPE, GUR 1020 | Different from predicate (UHMWPE, GUR 1050); Same as reference. |
| Fixation | Uncemented | Same as predicate; Same as reference. |
| Dual Mobility | Yes | Same as predicate; Different from reference (No). |
| Dual Mobility Design | Monobloc dual articulation | Same as predicate. |
| Compatible Acetabular Shell Diameters | 41 - 69 mm | Same as predicate (41 - 69 mm); Different from reference (44 - 76 mm). |
| Internal Diameter of Dual Mobility Liner | 22.2 mm, 28 mm | Same as predicate; Different from reference (28, 32, 36, 40, 44, 48 mm). |
| Sterile Method | Gas Plasma | Different from predicate (Gamma); Same as reference. |
| Sterility Assurance Level | 10^-6 | Same as predicate; Same as reference. |
| Packaging | Double PETG blister with Tyvek peel lid | Different from predicate (Vacuum-packed in bags and sealed in blister packaging); Same as reference. |
| Shelf Life | 5 years | Same as predicate; Same as reference. |
| Product Compatibility | Verified | Demonstrated. |
| Standard Walking Wear Testing (ISO 14242-2) | Met requirements | Demonstrated. |
| Stem-Liner Range of Motion | Verified | Demonstrated. |
| Head Assembly and Retention Force (ASTM F1820-13) | Met requirements | Demonstrated. |
| Impingement Testing (ASTM F2582-20) after Accelerated Aging (ASTM F2003-02) | Met requirements | Demonstrated. |
| Post Impingement Testing Lever Out Testing (ASTM F1820-13) | Met requirements | Demonstrated. |
| Bacterial Endotoxin Testing | Met requirements | Demonstrated. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets its "acceptance criteria" (which in this context are the non-clinical performance standards to demonstrate substantial equivalence) consisted of a series of non-clinical tests as listed above.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as "sample size" in the context of patients or independent data points for an AI model. The tests were likely performed on a sufficient number of device units/specimens required by the respective ISO/ASTM standards.
- Data Provenance: Not applicable as this is a mechanical device, not an AI/software device using medical image data from specific countries or patients. The data is generated from laboratory testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context refers to established engineering specifications and successful performance against industry standards (ISO, ASTM). The "experts" would be the engineers and scientists conducting and analyzing the mechanical tests, ensuring adherence to the standard methodologies.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods are used for human review of data, typically in diagnostic or clinical settings. Mechanical tests have objective pass/fail criteria based on measured values against specified thresholds.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a hip implant, not an AI-powered diagnostic device that would assist human readers in interpreting medical data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Expert Consensus / Industry Standards: The "ground truth" for the device's performance is defined by established international and American standards for orthopedic implants, specifically ISO 14242-2 (for wear testing) and ASTM F1820-13, ASTM F2582-20, ASTM F2003-02 (for mechanical properties like head assembly, retention force, impingement, and accelerated aging). These standards represent accumulated expert consensus on what constitutes safe and effective performance for such devices.
8. The sample size for the training set:
- Not applicable. This is a physical medical device. There is no "training set" in the machine learning sense. The device itself is manufactured following standardized designs and processes, and then tested.
9. How the ground truth for the training set was established:
- Not applicable. As there's no training set, there's no ground truth to establish for it in the context of an AI model. The "ground truth" for the design and manufacturing of such a device is derived from extensive biomechanical research, clinical experience with previous generations of implants, and compliance with material and engineering standards.
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April 28, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Depuy Ireland UC Floriane Heinrich Regulatory Affairs Project Leader Loughbeg Ringaskiddy Co. Cork. Ireland
Re: K203532
Trade/Device Name: BI-MENTUM™ ALTRX® Dual Mobility Liner Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, MEH Dated: April 1, 2021 Received: April 2, 2021
Dear Floriane Heinrich:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
BI-MENTUM™ ALTRX® Dual Mobility Liner
Indications for Use (Describe)
BI-MENTUM™ ALTRX® Dual Mobility System is indicated for total hip replacement in the following conditions: - Osteoarthritis
-
Femoral neck fracture
-
Dislocation risk
-
Osteonecrosis of the femoral head
-
Revision procedures where other treatments or devices have failed and if bone reconstruction so permits
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
(As required by 21 CFR 807.92)
| Submitter Information | |
|---|---|
| Name | DePuy Ireland UC |
| Address | LoughbegRingaskiddyCo. Cork, Ireland |
| Phone number | +334 72792851 |
| Establishment RegistrationNumber | 3015516266 |
| Name of contact person | Floriane Heinrich |
| Date prepared | November 30, 2020 |
| Name of device | |
| Trade or proprietaryname | BI-MENTUM™ ALTRX® Dual Mobility Liner |
| Common or usual name | Total hip prosthesis - Acetabular component |
| Classification name | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3353 |
| Product Code(s) | LZO, MEH |
| Legally marketeddevice(s) to whichequivalence is claimed | BI-MENTUM™ Dual Mobility System (K181744, cleared December 11, 2018)Reference device: PINNACLE® ALTRX® insert (K072963, cleared January 8,2008 and K132959, cleared March 10, 2014) |
| Reason for 510(k)submission | Line extension - The subject device is dual mobility liner ALTRX® (ultra-highmolecular weight polyethylene) manufactured from DePuy. |
| Device description | The BI-MENTUM™ ALTRX® Dual Mobility Liner is highly cross-linked ultra-high molecular weight polyethylene. The liner is mobile (free) in the metallicshell and retained on the prosthetic femoral head.The BI-MENTUM™ ALTRX® Dual Mobility Liner is compatible with all thestems listed on K181744 as well as all the BI-MENTUM™ cups cleared inK181744. The BI-MENTUM™ ALTRX® Dual Mobility Liner is alsocompatible with the PINNACLE® Dual Mobility Liner, cleared in K200854. |
| Intended use of the device | BI-MENTUM™ ALTRX® Dual Mobility Liners are designed to provideadditional stability where there is an unstable joint and are for use in total hip |
| arthroplasty that is intended to provide increased patient mobility and reduce painby replacing the damaged hip joint articulation or a previously implanted prosthetichip joint in patients where there is evidence of sufficient sound bone to seat andsupport the components. | |
| The BI-MENTUM™ ALTRX® Dual Mobility Liners are intended for single useonly. | |
| Indications for use | BI-MENTUM™ ALTRX® Dual Mobility Liner is indicated for total hipreplacement, which includes:- Osteoarthritis- Femoral neck fracture- Dislocation risk- Osteonecrosis of the femoral head- Revision procedures where other treatments or devices have failed are ifbone reconstruction so permits |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE | |||
|---|---|---|---|
| Characteristics | Subject Device:BI-MENTUM™ ALTRX® DualMobility Liner | Predicate Device:SERF BI-MENTUM™ DualMobility System (K181744) | Reference Device:DePuy PINNACLE® ALTRX®Acetabular Liners (K072963,K132959) |
| Intended Use | Total Hip Arthroplasty | Same | Same |
| Liner Material | UHMWPE, GUR 1020 | UHMWPE, GUR 1050 | UHMWPE, GUR 1020 |
| Fixation | Uncemented | Same | Same |
| Dual Mobility | Yes | Yes | No |
| Dual MobilityDesign | Monobloc dual articulation | Monobloc dual articulation | N/A |
| CompatibleAcetabular ShellDiameters | 41 - 69 mm | Same | 44 - 76 mm |
| Internal Diameterof Dual MobilityLiner | 22.2 mm, 28 mm | Same | 28, 32, 36, 40, 44 and 48 mm |
| Sterile Method | Gas Plasma | Gamma | Gas Plasma |
| Sterility AssuranceLevel | 10-6 | 10-6 | 10-6 |
| Packaging | Double PETG blister with Tyvek peellid | Vacuum-packed in bags and sealed inblister packaging | Double PETG blister with Tyvekpeel lid |
| Shelf Life | 5 years | Same | Same |
| The subject BI-MENTUM™ ALTRX® Dual Mobility Liner has the same intended use and fixation as the predicate BI-MENTUM™ DualMobility System (K181744). The subject device is intended for total hip arthroplasty; is a dual mobility construct and is available in the samesize range as the predicate device. The subject BI-MENTUM™ ALTRX® Dual Mobility Liner has the same intended use and the same materia(UHMWPE GUR 1020) as the reference device DePuy PINNACLE® ALTRX® Acetabular Liners (K072963, K132959). |
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PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed on the BI-MENTUM™ ALTRX® Dual Mobility Liner to demonstrate of safety and efficacy with the predicate devices:
- . Verification of product compatibility
- Standard walking wear testing (per ISO 14242-2) .
- Stem-Liner Range of Motion .
- Head assembly and retention force (per ASTM F1820-13) .
- Impingement testing (per ASTM F2582-20) after accelerated aging (per ASTM F2003-02) .
- Post impingement testing lever out testing (per ASTM F1820-13) .
- The proposed devices also meet the requirement of bacterial endotoxin testing .
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIV ALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests were conducted to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject BI-MENTUM™ ALTRX® Dual Mobility Liner is substantially equivalent to the predicate BI-MENTUM™ Dual Mobility System.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.