(30 days)
Not Found
No
The summary describes a mechanical annuloplasty ring and its delivery system, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is intended to correct annular dilatation and increase leaflet coaptation, which are therapeutic actions.
No
This device is an annuloplasty system, which is a surgical implant used to correct and reinforce a heart valve annulus. Its intended use is for treatment (correcting dilatation, increasing coaptation, reinforcing suture lines, preventing further dilatation), not for diagnosing a condition.
No
The device description explicitly states it consists of an implantable annuloplasty ring made of titanium alloy and a template/lanyard assembly, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus in patients. This describes a surgical implant used in vivo (within the body) to treat a structural issue.
- Device Description: The device is an implantable annuloplasty ring made of titanium alloy and silicone rubber, designed to be surgically placed around the tricuspid annulus. This is a physical implant, not a reagent or instrument used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and structural.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Edwards® MC3 Tricuspid Annuloplasty System is intended for use in patients to correct annular dilatation, increase leaftet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.
Product codes (comma separated list FDA assigned to the subject device)
KRH
Device Description
The Edwards MC3 Tricuspid Annuloplasty System, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Edwards MC3 Tricuspid Annuloplasty System has successfully completed design verification testing.
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.
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.
Not Found
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
§ 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.”
0
510(k) Summary
| Submitter: | Edwards Lifesciences LLC |
|---|---|
| Contact Person: | Susan Reynolds, Regulatory Affairs Associate |
| Date Prepared: | March 15, 2002 |
| Trade Name: | Edwards MC3 Tricuspid Annulplasty System |
| Classification Name: | Class II, CFR 870.3800 Annuloplasty Ring, 74 KRH |
| Predicate Device: | Cosgrove-Edwards™ Annuloplasty System (K923367) |
| Device Description: | The Edwards MC3 Tricuspid Annuloplasty System, |
| 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. | |
| Indications for Use: | The Edwards MC3 Tricuspid Annuloplasty System, is |
| intended for use in patients to correct annular dilatation, | |
| increase leaflet coaptation, reinforce annular suture | |
| lines, and prevent further dilatation of the annulus. | |
| Comparative Analysis: | It has been demonstrated that the Edwards MC3 |
| Tricuspid Annuloplasty System is comparable to the | |
| predicate device in design, intended use, materials, and | |
| principal of operation. | |
| Functional/Safety Testing: | The Edwards MC3 Tricuspid Annuloplasty System has |
| successfully completed design verification testing. | |
| Conclusion: | The Edwards MC3 Tricuspid Annuloplasty System is |
| substantially equivalent to the predicate device. |
1
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Edwards Lifesciences, LLC c/o Ms. Susan Reynolds Regulatory Affairs Associate One Edwards Way Irvine. CA 92614
APR 1 7 2002
Re: K020864
Trade/Device Name: Edwards® MC3 Tricuspid Annuloplasty System, Model 4900, sizes 26, 28, 30, 32, 34, and 36 mm Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty ring Regulatory Class: Class II Product Code: KRH Dated: March 15, 2002 Received: March 18, 2002
Dear Ms. Reynolds:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
2
Page 2 - Ms. Susan Reynolds
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fat 007), accesses (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) rms loket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 01 - 11 - 11 - 11 - 11 - 11 - 10 - 11 - 10 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oivision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dea Tell
onna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
of Page |
510(k) Number (if known):
Device Name:
Edwards MC3 Tricuspid Annuloplasty System
Indications for Use:
The Edwards® MC3 Tricuspid Annuloplasty System is intended for use in patients to correct annular dilatation, increase leaftet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020564