(88 days)
The Edwards MC3 Tricuspid annuloplasty ring, Model 4900, is intended for use in patients to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.
The Edwards MC3 Tricuspid annuloplasty ring, model 4900, consists of two primary components: the implantable annuloplasty ring and the template/ lanyard assembly (or holder). The implantable annuloplasty ring is constructed of titanium alloy and has a sewing ring margin that consists of a layer of silicone rubber, covered with polyester velour cloth sewn with a single seam.
The Edwards MC3 Tricuspid annuloplasty ring can be used in tricuspid valve repairs. The oval tricuspid ring conforms to the configuration of a normal tricuspid orifice. The ring has one rectilinear segment corresponding to the septal leaflet and one long curved segment corresponding to the anterior and posterior leaflets. The ring is open at the anteroseptal commissure. The annuloplasty ring is provided on an integral template which holds the ring during the plication to the annulus. A feature of the Edwards MC3 Tricuspid annuloplasty ring is that the rigid template is designed not to interfere with the tying of sutures and contains a retrieval system during the removal process. After implantation, this rigid template is removed.
The model 1150 handle may be utilized to facilitate ease of suture placement and annuloplasty ring implantation. The snap-fit assembly of the handle and template/lanyard assembly allows for connecting and disconnecting of the two components.
N/A
FDA 510(k) Clearance Letter - Edwards MC3 Tricuspid Annuloplasty Ring
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
September 23, 2025
Edwards Lifesciences LLC
Derrick Dukatz
Sr Manager, Regulatory Affairs
One Edwards Way
Irvine, California 92614
Re: K251982
Trade/Device Name: Edwards MC3 Tricuspid annuloplasty ring (4900)
Regulation Number: 21 CFR 870.3800
Regulation Name: Annuloplasty ring
Regulatory Class: Class II
Product Code: KRH
Dated: June 27, 2025
Received: June 27, 2025
Dear Derrick Dukatz:
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.
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"
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K251982 - Derrick Dukatz Page 2
(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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-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).
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K251982 - Derrick Dukatz Page 3
Sincerely,
JULIE B. MACKEL -S
For
Samuel Raben, PhD
Acting Assistant Director
DHT2B: Division of Circulatory Support,
Structural, and Vascular Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K251982
Device Name
Edwards MC3 Tricuspid annuloplasty ring (4900)
Indications for Use (Describe)
The Edwards MC3 Tricuspid annuloplasty ring, Model 4900, is intended for use in patients to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
Edwards Lifesciences LLC
Abbreviated 510(k) Premarket Notification
Edwards MC3 Tricuspid annuloplasty ring, Model 4900
Page 1 of 2
510(k) Summary
| Submitter: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614Derrick DukatzSenior Manager, Regulatory Affairs |
|---|---|
| Date Prepared: | June 30, 2025 |
| Device Name: | Edwards MC3 Tricuspid annuloplasty ring, Model 4900 |
| Classification Name: | Annuloplasty Ring21 CFR Part 870.3800, Product Code KRH, Class II(Special Controls) |
| Predicate Device: | K020864 Edwards MC3 Tricuspid annuloplasty ring,Model 4900 |
| Device Description: | The Edwards MC3 Tricuspid annuloplasty ring, model 4900, consists of two primary components: the implantable annuloplasty ring and the template/ lanyard assembly (or holder). The implantable annuloplasty ring is constructed of titanium alloy and has a sewing ring margin that consists of a layer of silicone rubber, covered with polyester velour cloth sewn with a single seam.The Edwards MC3 Tricuspid annuloplasty ring can be used in tricuspid valve repairs. The oval tricuspid ring conforms to the configuration of a normal tricuspid orifice. The ring has one rectilinear segment corresponding to the septal leaflet and one long curved segment corresponding to the anterior and posterior leaflets. The ring is open at the anteroseptal commissure. The annuloplasty ring is provided on an integral template which holds the ring during the plication to the annulus. A feature of the Edwards MC3 Tricuspid annuloplasty ring is that the rigid template is designed not to interfere with the tying of sutures and contains a retrieval system during the removal process. After implantation, this rigid template is removed.The model 1150 handle may be utilized to facilitate ease of suture placement and annuloplasty ring implantation. The snap-fit assembly of the handle and |
Page 6
Edwards Lifesciences LLC
Abbreviated 510(k) Premarket Notification
Edwards MC3 Tricuspid annuloplasty ring, Model 4900
Page 2 of 2
| template/lanyard assembly allows for connecting and disconnecting of the two components. | |
|---|---|
| Indications For Use: | The Edwards MC3 Tricuspid annuloplasty ring, Model 4900, is intended for use in patients to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.A comparison of the characteristics of the proposed device and the predicate devices shows the Edwards MC3 Tricuspid annuloplasty ring to have the same fundamental technological characteristics as the predicate device that has received 510(k) clearance. |
| Comparative Analysis: | Equivalence is based upon intended use, indications for use, principles of operation, and fundamental scientific technology. Both devices are intended to repair a malfunctioning heart valve.Both rings have identical structure, materials of composition, sterilization method, size range, sizing accessories, packaging, and site of application in the body.To verify that device design meets safety and performance requirements, representative samples of the devices underwent MRI testing in accordance with applicable standards and guidance. These data demonstrate substantial equivalence of the Edwards MC3 Tricuspid annuloplasty ring. |
| Functional / Safety Testing: | Performance testing was conducted to evaluate MRI compatibility |
| Conclusion: | Edwards MC3 Tricuspid annuloplasty ring is substantially equivalent to the named predicate device based on technological comparison, principle of operation, indications for use, and intended use. MRI testing was done to ensure substantially equivalent safety and effectiveness outcomes as compared to the predicate. |
§ 870.3800 Annuloplasty ring.
(a)
Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”