(83 days)
Total hip arthroplasty 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.
The EMPHASYS Acetabular Shell with RapiTite HA is intended for single use only.
INDICATIONS
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
EMPHASYS Acetabular Shells with RapiTite HA are indicated for cementless use only.
The EMPHASYS Acetabular Shell with RapiTite HA is a modular cementless porous-coated acetabular shell, with a hydroxyapatite (HA) coating applied conformally throughout the porous coating, offered in three configurations (No-Hole, 3-Hole, and Multi-Hole).
The provided text is a 510(k) summary for a medical device called "EMPHASYS Acetabular Shell with RapiTite HA". It details the device's purpose, indications, and comparison to predicate devices, and lists various tests conducted to demonstrate substantial equivalence.
However, the request asks for specific information regarding a study proving the device meets acceptance criteria and details about the data provenance, expert involvement, and ground truth establishment, often associated with a clinical or AI performance study.
The provided document does not contain information about a study that would require establishing ground truth with multiple experts, using a test set with specific data provenance, or performing MRMC comparative effectiveness studies. The "Animal & Performance Testing" section lists various mechanical, chemical, and biological tests that were performed (e.g., interfacial shear strength, fatigue testing, biocompatibility, bone ingrowth animal study), but these are primarily laboratory-based and do not involve human readers interpreting data or a "ground truth" derived from expert consensus in the way an AI/clinical performance study would.
Therefore, I cannot fulfill the request for information on the following points based on the provided text:
- A table of acceptance criteria and reported device performance related to a clinical/AI study. The document mentions acceptance criteria implicitly for the mechanical and biological tests (e.g., successfully passing ASTM standards), but not in the context of the requested AI/clinical performance study.
- Sample size for the test set and data provenance. The document mentions an "Animal Study" but no human test set.
- Number of experts and their qualifications for establishing ground truth. Not applicable to the studies described.
- Adjudication method for the test set. Not applicable.
- MRMC comparative effectiveness study and effect size. Not applicable.
- Standalone (algorithm only) performance. Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used. Not applicable in the requested context.
- Sample size for the training set. Not applicable.
- How ground truth for the training set was established. Not applicable.
The document primarily focuses on demonstrating the substantial equivalence of a physical medical implant (an acetabular shell) through engineering, material, and biocompatibility testing, rather than a clinical performance study involving human interpretation or an AI algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 7, 2024
DePuy Ireland UC Elaine Pears Regulatory Affairs Manager Loughbeg, Ringaskiddy Cork, Ireland
Re: K242084
Trade/Device Name: EMPHASYS Acetabular Shell with RapiTite HA 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: July 16, 2024 Received: September 12, 2024
Dear Elaine Pears:
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 (the 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/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.
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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
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).
Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
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assistance/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,
Image /page/2/Picture/3 description: The image shows the text "Limin Sun -S" in a large, sans-serif font. The text is black and is set against a white background. The words are arranged horizontally, with a hyphen separating "Sun" and "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
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Indications for Use
Submission Number (if known)
Device Name
EMPHASYS Acetabular Shell with RapiTite HA
Indications for Use (Describe)
Total hip arthroplasty 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.
The EMPHASYS Acetabular Shell with RapiTite HA is intended for single use only.
INDICATIONS
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis,
- or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head or neck.
-
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,
hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
EMPHASYS Acetabular Shell with RapiTite HA is indicated for cementless use only.
- Certain cases of ankylosis.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY – EMPHASYS ACETABULAR SHELL WITH RAPITITE HA
(As required by 21 CFR 807.87(h))
| Submitter Information | ||
|---|---|---|
| Name | DePuy Ireland UC | |
| Address | Loughbeg, RingaskiddyCo. Cork, IRELAND | |
| Establishment Registration Number | 3015516266 | |
| Submission Prepared by | Elaine Pears | |
| e-mail address | epears@its.jnj.comDePuySynthesJointsRegulatoryAffairs@its.jnj.com | |
| Work mobile | +44 (0)7876 217532 | |
| Alternative Contact Person | Clare Hill | |
| e-mail address | chill7@its.jnj.com | |
| Work mobile | +44 7795 389956 | |
| Date prepared | 16 July 2024 | |
| Name of device | ||
| Trade or proprietary name | EMPHASYS Acetabular Shell with RapiTite HA | |
| Common or usual name | Total Hip Arthroplasty Prosthesis | |
| Classification name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, PorousUncementedProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,Cemented Or Non-Porous, Uncemented | |
| Class | II | |
| Classification panel | 87 Orthopedics | |
| Regulation | 21 CFR 888.3358; 21 CFR 888.3353 | |
| Product Codes | LPH; LZO | |
| Legally marketed devicesto which equivalence isclaimed | Predicate Devices | Reference Device |
| DePuy EMPHASYS AcetabularSystem (K221636/K231873)(primary predicate) | ||
| DePuy Pinnacle Duofix HAAcetabular Cup (K031495) | Stryker Tritanium® Peri-Apatite™ Acetabular ShellSystem (K101072) | |
| DePuy Pinnacle with GriptionAcetabular Cups(K090998/K093646) | ||
| Reason for 510(k)submission | The purpose of this 510(k) submission is to obtain market clearancefor the DePuy EMPHASYS Acetabular Shell with RapiTite HA. | |
| Device description | The EMPHASYS Acetabular Shell with RapiTite HA is a modularcementless porous-coated acetabular shell, with a hydroxyapatite (HA)coating applied conformally throughout the porous coating, offered inthree configurations (No-Hole, 3-Hole, and Multi-Hole). | |
| Intended use of the device | Total hip arthroplasty is intended to provide increased patient mobility andreduce pain by replacing the damaged hip joint articulation in patientswhere there is evidence of sufficient sound bone to seat and support thecomponents.The EMPHASYS Acetabular Shell with RapiTite HA is intended forsingle use only. | |
| Indications for use | Total hip replacement is indicated in the following conditions:1. A severely painful and/or disabled joint from osteoarthritis,traumatic arthritis, rheumatoid arthritis, or congenital hipdysplasia.2. Avascular necrosis of the femoral head.3. Acute traumatic fracture of the femoral head or neck.4. Failed previous hip surgery including joint reconstruction,internal fixation, arthrodesis, hemiarthroplasty, surfacereplacement arthroplasty, or total hip replacement.5. Certain cases of ankylosis.EMPHASYS Acetabular Shells with RapiTite HA are indicated forcementless use only. | |
| Comparison ofTechnologicalCharacteristics withpredicate devices | The EMPHASYS Acetabular Shell with RapiTite HA is identical to theacetabular shells in the primary predicate EMPHASYS AcetabularSystem in terms of intended use, indications, design and materials ofconstruction, with the only exception being that the subject devices havean additional layer of HA coating. The HA coating is equivalent instructure and composition to that used in the secondary predicate (DePuyPinnacle Duofix HA Acetabular Cup), and is applied in a way similarto that used for the reference device (Stryker Tritanium® Peri-Apatite™ Acetabular Shell System). | |
| Animal & PerformanceTesting | The EMPHASYS Acetabular Shell with RapiTite HA was tested todemonstrate its substantial equivalence to the identified predicatedevices. Testing and analyses included: | |
| Chemical Analysis (per ASTM F1609-08(2014) & ISO 13779-3:2018) Dissolution (per ASTM F1926-14) Solubility (per ISO 13779-6:2015) SEM Morphological Characterization Abraded Particle Characterization FTIR Analysis XRD Analysis (per ISO 13779-3:2018) Static interfacial shear strength (per ASTM F1044-05(2017)e1 Static interfacial tensile strength (per ASTM F1147-05(2017)e1) Interfacial shear fatigue (per ASTM F1160-14 (2017)e1) Stereological evaluation (per ASTM F1854-15) Static friction testing (per ASTM D4518-91) Fatigue testing (per ASTM F3090-20) Biocompatibility (per ISO 10993-1:2018) Bone Ingrowth Animal Study Characterization of the Physical and Mechanical Properties ofthe HA coated porous surface per FDA guidance documents“Guidance Document for Testing Orthopedic Implants WithModified Metallic Surfaces Apposing Bone Or Bone Cement”(Apr. 1994) and “510(K) Information Needed forHydroxyapatite Coated Orthopedic Implants (Feb 1997)” MRI Safety Evaluation Testing of Total Hip Systems - ASTME2503-23, ASTM E2182 -19e2, ASTM E2052-21, ASTM | ||
| Substantial Equivalence | The EMPHASYS Acetabular Shell with RapiTite HA is substantiallyequivalent to the identified predicate devices with respect to intendeduse, indications, materials of construction, geometry, range of sizes,and method of fixation. Results of animal and performance testingand analyses demonstrate that the EMPHASYS Acetabular Shell withRapiTite HA performs as well as the predicate devices. |
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§ 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.