(265 days)
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint (typically due to non-inflammatory degenerative joint disease).
- Failed previous hip surgery.
- Dislocation risks.
EMPHASYS Dual Mobility Liners and Mobile Bearing Heads are intended for cementless applications.
The EMPHASYS Dual Mobility System includes Co-Cr-Mo Dual Mobility Liners and AOX Polyethylene Mobile Bearing Heads as well as other previously cleared compatible components.
This is a 510(k) summary for a medical device called the EMPHASYS™ Dual Mobility System, specifically for hip replacement. The document does not describe a study involving an algorithm or AI, but rather a series of physical performance tests conducted on the device itself to demonstrate its substantial equivalence to existing predicate devices.
Therefore, many of the requested categories related to AI model evaluation, such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, and training set details, are not applicable to this type of device clearance submission.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets in a table alongside reported performance results in an easy-to-digest format. Instead, it lists various performance tests conducted to demonstrate substantial equivalence to predicate devices. The implicit acceptance criteria are that the device performs "as well as" or equivalently to the predicate devices under these tests.
No direct table of acceptance criteria vs. reported performance is provided in the document. The document states: "Results of performance testing and analyses demonstrate that the EMPHASYS Dual Mobility System performs as well as the predicate devices."
The tests conducted are:
- EMPHASYS Mobile Bearing Head Thickness Assessment
- EMPHASYS Dual Mobility Liner Thickness Assessment
- Range of Motion Analysis- ISO 21535:2007
- EMPHASYS Mobile Bearing Head Impingement-ASTM F2582-20
- EMPHASYS Dual Mobility Impingement Testing to ASTM F2582-20
- EMPHASYS Dual Mobility Liner Push-Out- ASTM F1820-22
- EMPHASYS Dual Mobility Liner Offset Pull-Out- ASTM F1820-22
- EMPHASYS Dual Mobility Liner Torque-Out- ASTM F1820-22
- EMPHASYS Mobile Bearing Head Lever-Out
- EMPHASYS Dual Mobility ASTM F1875 Method I Test
- EMPHASYS Dual Mobility Non-Aged Standard Walking Wear Test- ISO 14242-1:2014 and ISO 14242-2:2016.
- EMPHASYS Dual Mobility Standard Walking with Mode 3 Third Body Abrasive Wear Test - ISO 14242-1:2014, ISO 14242-1 AMD 1:2018, ISO 14242-2:2016 and ISO 14242-4:2018.
- EMPHASYS Dual Mobility High Angle Standard Walking Wear Test- ISO 14242-1:2014, ISO 14242-2:2016 and ISO 14242-4:2018.
- EMPHASYS Dual Mobility Worst Case Outer Bearing Wear of EMSYS DM under Standard Walking Wear- ISO 14242-1:2014 and ISO 14242-2:2016
- EMPHASYS Dual Mobility Friction Test- ASTM F3143-20
- MRI Safety Evaluation Testing of Total Hip Systems- ASTM F2503-23, ASTM F2182 -19e2, ASTM F2052-21, ASTM F2213-17, and ASTM F2119-07
2. Sample size used for the test set and the data provenance
Not applicable. This pertains to physical device testing rather than a software or AI evaluation with patient data. The "test set" would be the physical devices and components manufactured for testing. The document does not specify the number of individual devices or components tested for each category.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for these physical tests is established by recognized engineering standards (e.g., ISO, ASTM) and comparative performance against predicate devices, not by expert medical interpretation of data.
4. Adjudication method for the test set
Not applicable. This applies to medical imaging or diagnostic studies, not physical device performance testing against engineering standards.
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 hardware device (hip prosthesis) clearance, not an AI software clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware device clearance.
7. The type of ground truth used
The "ground truth" in this context refers to the established performance requirements and benchmarks defined by international and national engineering standards (ISO and ASTM) and the performance characteristics of previously cleared predicate devices. The device must demonstrate that its performance meets these standards and is equivalent to the predicate.
8. The sample size for the training set
Not applicable. This is a hardware device clearance, not an AI software clearance.
9. How the ground truth for the training set was established
Not applicable. This is a hardware device clearance, not an AI software clearance.
{0}------------------------------------------------
Image /page/0/Picture/0 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 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.
February 15, 2024
DePuy Ireland UC Farah Valli Project lead Regulatory Affairs Loughbeg, Ringaskiddy Co. Cork Ireland
Re: K231522
Trade/Device Name: EMPHASYS™ Dual Mobility System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, LZO Dated: January 19, 2024 Received: January 19, 2024
Dear Farah Valli:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
{2}------------------------------------------------
Sincerely,
Limin Sun -S
Limin Sun, Ph.D. 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
{3}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
EMPHASYS™ Dual Mobility System
Indications for Use (Describe)
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint (typically due to non-inflammatory
degenerative joint disease).
-
Failed previous hip surgery.
-
Dislocation risks.
EMPHASYS Dual Mobility Liners and Mobile Bearing Heads are intended for cementless applications.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(K) SUMMARY
(As required by 21 CFR 807.87(h))
| Submitter Information | |
|---|---|
| Name | DePuy Ireland UC |
| Address | Loughbeg, RingaskiddyCo. Cork, IRELAND |
| Phone number | 574-372-7211 |
| Fax number | 574-371-4987 |
| Establishment Registration Number | 3015516266 |
| Name of contact person | Farah Valli |
| Date prepared | 15 Feb 2024 |
| Name of device | |
| Trade orproprietaryname | EMPHASYST™ Dual Mobility System |
| Common orusual name | Total Hip Arthroplasty Prosthesis |
| Classificationname | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, PorousUncemented;Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,Cemented Or Non-Porous, Uncemented |
| Class | II |
| Classificationpanel | 87 Orthopedics |
| Regulation | 888.3358; 888.3353 |
| ProductCode(s) | LPH; LZO |
{5}------------------------------------------------
| Legallymarketeddevice(s) towhichequivalence isclaimed | SubjectDevice:EMPHASYSDual MobilityLiners | PredicateDevice:DePuyPINNACLEDual MobilityLiners(K200854) | Reference Devices:Stryker MDM AcetabularSystem (K103233)Zimmer Biomet G7 DualMobility (K150522)DePuy SUMMIT PorocoatHip Prosthesis - MRConditional, DePuy SUMMITDuoFix Hip Prosthesis – MRConditional, DePuy SUMMITCemented Hip Prosthesis -MR Conditional, DePuySUMMIT FX Cemented HipProsthesis - MR Conditional,DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MRConditional (K231873) |
|---|---|---|---|
| SubjectDevice:EMPHASYSMobileBearingHeads | PredicateDevice:BI-MENTUMDual MobilitySystem(K181744) | Reference Devices:EMPHASYS AcetabularAOX Liners (K221636)Zimmer Biomet G7 DualMobility (K150522)Smith & Nephew OR3O(K232667)DePuy SUMMIT PorocoatHip Prosthesis - MRConditional, DePuy SUMMITDuoFix Hip Prosthesis – MRConditional, DePuy SUMMITCemented Hip Prosthesis -MR Conditional, DePuySUMMIT FX Cemented HipProsthesis - MR Conditional,DePuy SUMMIT Basic Press-Fit Hip Prosthesis - MRConditional (K231873) | |
| Reason for510(k)submission | The purpose of this 510(k) submission is to obtain marketclearance for the DePuy EMPHASYS Dual Mobility System. | ||
| Devicedescription | The EMPHASYS Dual Mobility System includes Co-Cr-Mo DualMobility Liners and AOX Polyethylene Mobile Bearing Heads aswell as other previously cleared compatible components. | ||
| Intended useof the device | The EMPHASYS Dual Mobility System is designed to provideadditional stability where there is an unstable joint and is for use intotal hip arthroplasty, which is intended to provide increasedpatient mobility and reduce pain by replacing the damaged hipjoint articulation in patients where there is evidence of sufficientsound bone to seat and support the components. |
{6}------------------------------------------------
| Indications foruse | Total hip replacement is indicated in the following conditions:A severely painful and/or disabled joint (typically due tonon-inflammatory degenerative joint disease). Failed previous hip surgery. Dislocation risks. EMPHASYS Dual Mobility Liners and EMPHASYS MobileBearing Heads are intended for cementless applications. |
|---|---|
| Comparison ofTechnologicalCharacteristics | The EMPHASYS Dual Mobility System proposes no newapplications, intended use, or indications relative to the predicate devices. The material of construction of the EMPHASYS DualMobility Liners is identical to that of the predicate (Cobalt-chromium-molybdenum alloy (CoCrMo) conforming to ASTMF1537). The EMPHASYS Mobile Bearing Heads aremanufactured from AOX Polyethylene, identical to the reference device (EMPHASYS Acetabular AOX Liners (K221636)). Whilethere are minor differences in design between the subject devices and the predicate/reference devices, DePuy has providedcomparative testing to demonstrate equivalence with existing products. |
| PerformanceTesting | The EMPHASYS Dual Mobility System was tested to demonstrate its substantial equivalence to the identified predicate devices.Testing and analyses included: EMPHASYS Mobile Bearing Head Thickness Assessment EMPHASYS Dual Mobility Liner Thickness Assessment Range of Motion Analysis- ISO 21535:2007 EMPHASYS Mobile Bearing Head Impingement-ASTMF2582-20 EMPHASYS Dual Mobility Impingement Testing toASTM F2582-20 EMPHASYS Dual Mobility Liner Push-Out- ASTMF1820-22 EMPHASYS Dual Mobility Liner Offset Pull-Out- ASTMF1820-22 EMPHASYS Dual Mobility Liner Torque-Out- ASTMF1820-22 EMPHASYS Mobile Bearing Head Lever-Out EMPHASYS Dual Mobility ASTM F1875 Method I Test EMPHASYS Dual Mobility Non-Aged Standard WalkingWear Test- ISO 14242-1:2014 and ISO 14242-2:2016. EMPHASYS Dual Mobility Standard Walking with Mode3 Third Body Abrasive Wear Test - ISO 14242-1:2014,ISO 14242-1 AMD 1:2018, ISO 14242-2:2016 and ISO14242-4:2018. |
| EMPHASYS Dual Mobility High Angle Standard WalkingWear Test- ISO 14242-1:2014, ISO 14242-2:2016 and ISO14242-4:2018. EMPHASYS Dual Mobility Worst Case Outer BearingWear of EMSYS DM under Standard Walking Wear- ISO14242-1:2014 and ISO 14242-2:2016 EMPHASYS Dual Mobility Friction Test- ASTMF3143-20 MRI Safety Evaluation Testing of Total Hip Systems-ASTM F2503-23, ASTM F2182 -19e2, ASTM F2052-21,ASTM F2213-17, and ASTM F2119-07 | |
| SubstantialEquivalence | The EMPHASYS Dual Mobility System is substantially equivalentto the identified predicates with respect to intended use,indications, materials, geometry, and method of fixation. Results ofperformance testing and analyses demonstrate that theEMPHASYS Dual Mobility System performs as well as thepredicate devices. |
{7}------------------------------------------------
§ 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.