(37 days)
The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. The humeral component is fixated with a hollow screw and the glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.
The Arthrex Eclipse Titanium Humeral Head is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
The proposed Eclipse Titanium humeral head is manufactured from Ti-6Al-4V ELI per ASTM F136 and is offered in sizes ranging from 37-55mm with varying offsets of 16-23mm. The humeral head is placed on a trunnion, which is fixated to the proximal humerus by a hollow screw. The Titanium humeral heads are used with the existing trunnions and hollow screws cleared under the predicate.
This FDA 510(k) summary describes a medical device, the Arthrex Eclipse Titanium Humeral Head, which is a shoulder prosthesis. However, it does not contain information about the acceptance criteria and study proving a software or AI-based device's performance.
The document pertains to a physical orthopedic implant. The "Performance Data" section discusses:
- Fatigue testing and Pull Off testing: Evaluates the mechanical properties of the humeral head.
- Engineering analysis: Compares hardness, adhesion, surface roughness, scratch resistance, and Young's modulus to the predicate device.
- Bacterial endotoxin testing: Ensures pyrogen limits are met.
- MRI compatibility engineering analysis: Addresses MRI force, torque, and image artifact.
These are all standard tests for physical medical implants and not for software or AI performance. Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving the device (as in, a software or AI device) meets critical performance measures from the provided text.
{0}------------------------------------------------
November 20, 2020
Image /page/0/Picture/1 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Arthrex Inc. David Rogers Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945 USA
Re: K203100
Trade/Device Name: Arthrex Eclipse Titanium Humeral Head Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: QHQ, PKC Dated: October 12, 2020 Received: October 14, 2020
Dear David Rogers:
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 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
{1}------------------------------------------------
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 (QS) 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,
For Michael Owens 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K203100
Device Name Arthrex Eclipse Titanium Humeral Head
Indications for Use (Describe)
The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. The humeral component is fixated with a hollow screw and the glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.
The Arthrex Eclipse Titanium Humeral Head is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
| 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."
{3}------------------------------------------------
510(k) Summary
| Date Prepared | November 19, 2020 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | David L RogersSenior Manager, Regulatory Affairs1-239-643-5553david.rogers@arthrex.com |
| Name of Device | Arthrex Eclipse Titanium Humeral Head |
| Common Name | Shoulder Prosthesis |
| Product Code | PKC, QHQ |
| Classification Name | 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Regulatory Class | Class II |
| Predicate Device | K201542: Arthrex Eclipse Shoulder Prosthesis |
| Reference Device | K182799: Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsK183194: Arthrex Eclipse Shoulder Prosthesis |
| Device Description | The proposed Eclipse Titanium humeral head is manufactured from Ti-6Al-4V ELI perASTM F136 and is offered in sizes ranging from 37-55mm with varying offsets of 16-23mm. The humeral head is placed on a trunnion, which is fixated to the proximalhumerus by a hollow screw. The Titanium humeral heads are used with the existingtrunnions and hollow screws cleared under the predicate. |
| TechnologicalCharacteristics | The Arthrex Eclipse Titanium Humeral Head is a Titanium version of the Arthrex EclipseCobalt Chromium Humeral Head cleared under K201542/K183194. Compared to thepredicate, the proposed Titanium Humeral Heads have the same fundamental scientifictechnology, engineering design, sterilization, packaging configuration, and shelf-life.The size ranges of the subject device are the same as originally cleared underK201542/K183194. The difference is that the subject device is manufactured fromTitanium as opposed to Cobalt Chromium and the indications for use has been updatedto explain that the wear properties of Titanium and Titanium alloys are inferior to thatof cobalt alloy and that Titanium humeral heads are not recommended for patients wholack suspected material sensitivity to cobalt alloy. |
| Indications for Use | The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabledjoint resulting from osteoarthritis or traumatic arthritis. The humeral component isfixated with a hollow screw and the glenoid components are intended for cementedfixation in the joint and must only be used with appropriate bone cement.The Arthrex Eclipse Titanium Humeral Head is indicated for patients with suspectedcobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferiorto that of cobalt alloy. A Titanium humeral head is not recommended for patients wholack suspected material sensitivity to cobalt alloy. |
| Performance Data | Fatigue testing and Pull Off testing was performed to evaluate the fatigue properties ofthe Arthrex Eclipse Titanium Humeral Head. Additionally, an engineering analysis wasperformed to address the substantial equivalence of hardness, adhesion, surfaceroughness, scratch resistance, and young's modulus compared to the predicate device.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that thedevice meets pyrogen limit specifications.An engineering analysis was performed to ensure that the subject device is not a newworst-case regarding MRI force, torque, and image artifact and can be labeled MRConditional in accordance with the FDA guidance Testing and Labeling Medical Devicesin the Magnetic Resonance (MR) Environment |
| Conclusion | The Arthrex Eclipse Titanium Humeral Head has the same intended use and the samefundamental scientific technology as the Arthrex Eclipse Shoulder Prosthesis System. |
| Based on the non-clinical data presented in this 510(k), Arthrex concludes that theproposed device is substantially equivalent to the currently marketed predicate device. |
{4}------------------------------------------------
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”