(128 days)
The Carpentier-McCarthy-Adams IMR ETlogix Mitral Annuloplasty Ring is indicated for the correction of mitral valvular insufficiency where the lesions are not so severe as to require total valve replacement.
The decision to undertake valvuloplasty can be made only after visual analysis of the lesion present. The most favorable conditions for valvuloplasty using an annuloplasty ring are a combination of a distended natural valve ring associated with supple valve cusps and normal chordae tendineae.
The remodeling valvuloplasty technique with a prosthetic ring may be used in all acquired or congenital mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus.
For Type I mitral insufficiencies with no subvalvular lesions and normal valvular movements, this ring technique used alone is sufficient. However, the ring technique must be associated with mitral valvuloplasty repair in Type II insufficiencies with prolapsed valve due to elongation or rupture of the chordae tendineae and in Type III insufficiencies with limitation of valvular movements due to fusion of the commissures of chordae tendineae, or chordal hypertrophy.
The Carpentier-McCarthy-Adams IMR ETlogix annuloplasty ring, model 4100 (IMR ETlogix) is constructed of titanium alloy and has a sewing ring margin that consists of a layer of silicone rubber covered with a woven polyester cloth.
This 510(k) premarket notification for the Carpentier-McCarthy-Adams IMR ETlogix Mitral Annuloplasty Ring, model 4100, does not contain information about specific acceptance criteria, a formal study demonstrating the device meets those criteria, or details regarding diagnostic performance.
The document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against pre-defined acceptance criteria. The key sections stating this are:
- Comparative Analysis: "It has been demonstrated that the Carpentier-McCarthy-Adams IMR ETlogix mitral annuloplasty ring is comparable to the predicate devices in design, intended use, materials, and principal of operation."
- Functional/Safety Testing: "The Carpentier-McCarthy-Adams IMR ETlogix mitral annuloplasty ring has successfully completed design verification testing."
- Conclusion: "The Carpentier-McCarthy-Adams IMR ETlogix mitral annuloplasty ring is substantially equivalent to the predicate devices."
Therefore, I cannot populate the table and answer your specific questions about acceptance criteria, study details, and performance metrics as they are not present in the provided text. The document does not describe a study involving diagnostic performance, human readers, or ground truth establishment.
A 510(k) submission typically aims to show that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove novel performance against specific quantitative criteria, especially for Class II devices like this annuloplasty ring. The "design verification testing" mentioned would primarily ensure the device meets its own internal design specifications and safety requirements, rather than a diagnostic performance study.
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Image /page/0/Picture/1 description: The image shows a logo with the word "Edwards" written below it. The logo is a square grid with a stylized letter "E" in the center. The letter "E" is surrounded by circular shapes and lines, creating a complex and abstract design.
510(k) Summary
APR ] 5 2009
| Submitter: | Edwards Lifesciences LLC |
|---|---|
| Contact Person: | Martin A. KaufmanDirector - Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614martin_kaufman@edwards.com(ph) 949.250.2708(fax) 949.250.3630 |
| Date Prepared: | December 3, 2008 |
| Trade Name: | Carpentier-McCarthy-Adams IMR ETlogix™ Mitral Annuloplasty Ring, or IMR ETlogix™Mitral Annuloplasty Ring |
| Classification Name: | Class II, CFR 870.3800 Annuloplasty Ring, KRH |
| Predicate Device(s): | Carpentier-Edwards Classic® ring (K912554)Carpentier-Edwards Physio® annuloplasty ring (K926138)GeoForm® annuloplasty ring (K032250) |
| Device Description: | The Carpentier-McCarthy-Adams IMR ETlogix annuloplasty ring, model 4100 (IMRETlogix) is constructed of titanium alloy and has a sewing ring margin that consists of alayer of silicone rubber covered with a woven polyester cloth. |
| Indications for Use: | The IMR ETlogix Annuloplasty Ring is indicated for the correction of mitral valvularinsufficiency where the lesions are not so severe as to require total valve replacement. |
| The decision to undertake valvuloplasty can be made only after visual analysis of thelesion present. The most favorable conditions for valvuloplasty using an annuloplastyring are a combination of a distended natural valve ring associated with supple valvecusps and normal chordae tendineae. | |
| The remodeling valvuloplasty technique with a prosthetic ring may be used in allacquired or congenital mitral insufficiencies with dilatation and deformation of thefibrous mitral annulus. | |
| For Type I mitral insufficiencies with no subvalvular lesions and normal valvularmovements, this ring technique used alone is sufficient. However, the ring techniquemust be associated with mitral valvuloplasty repair in Type II insufficiencies withprolapsed valve due to elongation or rupture of the chordae tendineae and in Type IIIinsufficiencies with limitation of valvular movements due to fusion of the commissuresof chordae tendineae, or chordal hypertrophy. | |
| Comparative Analysis: | It has been demonstrated that the Carpentier-McCarthy-Adams IMR ETlogix mitralannuloplasty ring is comparable to the predicate devices in design, intended use,materials, and principal of operation. |
| Functional/Safety Testing: | The Carpentier-McCarthy-Adams IMR ETlogix mitral annuloplasty ring has successfullycompleted design verification testing. |
| Conclusion: | The Carpentier-McCarthy-Adams IMR ETlogix mitral annuloplasty ring is substantiallyequivalent to the predicate devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird-like figure with three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 2009
Edwards Lifesciences, LLC. Martin A. Kaufman Director of Regulatory Affairs One Edwards Way Irvine CA 92614
Re: K083623
Trade/Device Name: IMR ETlogix annuloplasty ring, model 4100 Regulation Number: 21 CFR 870.3800 Regulatory Class: Class II Product Code: KRH Dated: March 13, 2009 Received: March 16, 2009
Dear Mr. Kaufman:
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, Trug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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.
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 803); good manufacturing practice requirements as set forth in the quality systems (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.
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Mr. Kaufman - Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K083623
Device Name: Carpentier-McCarthy-Adams IMR ETlogix™ annuloplasty ring, model 4100, or IMR ETlogix™ annuloplasty ring, model 4100
Indications for Use:
The Carpentier-McCarthy-Adams IMR ETlogix Mitral Annuloplasty Ring is indicated for the correction of mitral valve insufficiency where the lesions are not so severe as to require total valve replacement.
The decision to undertake valvuloplasty can be made only after visual analysis of the lesion present. The most favorable conditions for valvuloplasty using an annuloplasty ring are a combination of a distended natural valve ring associated with supple valve cusps and normal chordae tendinae.
The remodeling valvuloplasty technique with a prosthetic ring may be used in all acquired or congenital mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus.
For Type I mitral insufficiencies with no subvalvular lesions and normal valvular movements, this ring technique used alone is sufficient. However, the ring technique must be associated with mitral valvuloplasty repair in Type II insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae and in Type III insufficiencies with limitation of valvular movements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
(Division Sign-Off)
Vision of Cardiovascular Devices
10(k) Number ko 83623
Page of
§ 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.”