(265 days)
No
The summary describes a mechanical implant system and the performance studies are focused on mechanical properties and wear testing, with no mention of AI/ML or related concepts.
Yes
The device, a total hip replacement system, is indicated for conditions like severe joint pain due to degenerative joint disease. This explicitly states its role in treating a medical condition, making it a therapeutic device.
No
The document describes the EMPHASYS Dual Mobility System, which consists of liners and mobile bearing heads intended for total hip replacement, a surgical procedure. Its intended use is to replace a joint, not to diagnose a condition. The performance studies mentioned are related to the mechanical properties and wear performance of the device, not its ability to detect or identify diseases or conditions.
No
The device description explicitly states it includes physical components (Co-Cr-Mo Dual Mobility Liners and AOX Polyethylene Mobile Bearing Heads) and the performance studies involve physical testing of these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total hip replacement, which is a surgical procedure to replace a damaged hip joint. This is a therapeutic intervention performed on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant (liners and heads) designed to be surgically placed in the hip joint.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly a surgical implant used for treatment, not a diagnostic tool.
N/A
# Intended Use / Indications for Use
Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint (typically due to non-inflammatory
degenerative joint disease).
2. Failed previous hip surgery.
3. Dislocation risks.
EMPHASYS Dual Mobility Liners and Mobile Bearing Heads are intended for cementless applications.
# Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO
# Device Description
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.
# 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)
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-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. Results of performance testing and analyses demonstrate that the EMPHASYS Dual Mobility System performs as well as the predicate devices.
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# 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.
[K200854](https://510k.innolitics.com/search/K200854), [K181744](https://510k.innolitics.com/search/K181744)
# 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.
[K103233](https://510k.innolitics.com/search/K103233), [K150522](https://510k.innolitics.com/search/K150522), [K231873](https://510k.innolitics.com/search/K231873), [K221636](https://510k.innolitics.com/search/K221636), [K232667](https://510k.innolitics.com/search/K232667)
# 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
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)
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510(K) SUMMARY
(As required by 21 CFR 807.87(h))
| Submitter Information | |
|---|---|
| Name | DePuy Ireland UC |
| Address | Loughbeg, Ringaskiddy |
| Co. 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 or | |
| proprietary | |
| name | EMPHASYST™ Dual Mobility System |
| Common or | |
| usual name | Total Hip Arthroplasty Prosthesis |
| Classification | |
| name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous |
| Uncemented; | |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, | |
| Cemented Or Non-Porous, Uncemented | |
| Class | II |
| Classification | |
| panel | 87 Orthopedics |
| Regulation | 888.3358; 888.3353 |
| Product | |
| Code(s) | LPH; LZO |
5
| Legally
marketed
device(s) to
which
equivalence is
claimed | Subject
Device:
EMPHASYS
Dual Mobility
Liners | Predicate
Device:
DePuy
PINNACLE
Dual Mobility
Liners
(K200854) | Reference Devices:
Stryker MDM Acetabular
System (K103233)
Zimmer Biomet G7 Dual
Mobility (K150522)
DePuy SUMMIT Porocoat
Hip Prosthesis - MR
Conditional, DePuy SUMMIT
DuoFix Hip Prosthesis – MR
Conditional, DePuy SUMMIT
Cemented Hip Prosthesis -
MR Conditional, DePuy
SUMMIT FX Cemented Hip
Prosthesis - MR Conditional,
DePuy SUMMIT Basic Press-
Fit Hip Prosthesis – MR
Conditional (K231873) |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject
Device:
EMPHASYS
Mobile
Bearing
Heads | Predicate
Device:
BI-MENTUM
Dual Mobility
System
(K181744) | Reference Devices:
EMPHASYS Acetabular
AOX Liners (K221636)
Zimmer Biomet G7 Dual
Mobility (K150522)
Smith & Nephew OR3O
(K232667)
DePuy SUMMIT Porocoat
Hip Prosthesis - MR
Conditional, DePuy SUMMIT
DuoFix Hip Prosthesis – MR
Conditional, DePuy SUMMIT
Cemented Hip Prosthesis -
MR Conditional, DePuy
SUMMIT FX Cemented Hip
Prosthesis - MR Conditional,
DePuy SUMMIT Basic Press-
Fit Hip Prosthesis - MR
Conditional (K231873) |
| Reason for
510(k)
submission | The purpose of this 510(k) submission is to obtain market
clearance for the DePuy EMPHASYS Dual Mobility System. | | |
| Device
description | 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. | | |
| Intended use
of the device | The EMPHASYS Dual Mobility System is designed to provide
additional stability where there is an unstable joint and is for use in
total hip arthroplasty, which is intended to provide increased
patient mobility and reduce pain by replacing the damaged hip
joint articulation in patients where there is evidence of sufficient
sound bone to seat and support the components. | | |
6
| Indications for
use | 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 EMPHASYS Mobile
Bearing Heads are intended for cementless applications. |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
Technological
Characteristics | The EMPHASYS Dual Mobility System proposes no new
applications, intended use, or indications relative to the predicate devices. The material of construction of the EMPHASYS Dual
Mobility Liners is identical to that of the predicate (Cobalt-
chromium-molybdenum alloy (CoCrMo) conforming to ASTM
F1537). The EMPHASYS Mobile Bearing Heads are
manufactured from AOX Polyethylene, identical to the reference device (EMPHASYS Acetabular AOX Liners (K221636)). While
there are minor differences in design between the subject devices and the predicate/reference devices, DePuy has provided
comparative testing to demonstrate equivalence with existing products. |
| Performance
Testing | 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-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 |
| Substantial
Equivalence | The EMPHASYS Dual Mobility System is substantially equivalent
to the identified predicates with respect to intended use,
indications, materials, geometry, and method of fixation. Results of
performance testing and analyses demonstrate that the
EMPHASYS Dual Mobility System performs as well as the
predicate devices. |
7