(163 days)
The dETlogix annuloplasty ring, model 5100, is indicated for the correction of mitral valvular insufficiency where the lesions are not severe enough 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 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.
The dETlogix™ annuloplasty ring, model 5100, 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.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, or any studies conducted using AI or human readers. The document is a 510(k) summary for the Edwards™™ dETlogix™™ annuloplasty ring, focusing on its substantial equivalence to predicate devices and its indications for use. It primarily discusses design, materials, and functional/safety testing in a general manner, without providing specific performance data or details of clinical trials that would involve AI or human reader assessments.
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KO8319/
Image /page/0/Picture/1 description: The image shows a logo with the letter 'E' in a square grid pattern, with a circle behind the letter. Below the logo, the word 'Edwards' is printed in a serif font. The logo is simple and professional, likely representing a company or organization with the name Edwards.
APR 1 0 2009
510(k) Summary
| Submitter: | Edwards Lifesciences LLC |
|---|---|
| Contact Person: | Martin A. KaufmanDirector - Regulatory Affairsmartin_kaufman@edwards.com(ph) 949.250.2708(fax) 949.250.3630 |
| Date Prepared: | October 27, 2008 |
| Trade Name: | Edwards™™ dETlogix™™ annuloplasty ring |
| Classification Name: | Class II, CFR 870.3800 Annuloplasty Ring, KRH |
| Predicate Device(s): | GeoForm® annuloplasty ring (K032250)Carpentier-Edwards Physio® annuloplasty ring(K926138)Carpentier-Edwards Classic® annuloplasty ring(K831949) |
| Device Description: | The dETlogix™ annuloplasty ring, model 5100, isconstructed of titanium alloy and has a sewing ringmargin that consists of a layer of silicone rubber,covered with polyester velour cloth sewn with a singleseam. |
| Indications for Use: | The dETlogix annuloplasty ring, model 5100 isintended for the correction of mitral valvularinsufficiency where the lesions are not so severe as torequire total valve replacement. |
| Comparative Analysis: | It has been demonstrated that the dETlogixannuloplasty ring is comparable to the predicatedevices in design, intended use, materials, andprincipal of operation. |
| Functional/Safety Testing: | The dETlogix annuloplasty ring has successfullycompleted design verification testing. |
| Conclusion: | The dETlogix annuloplasty ring is substantiallyequivalent to the predicate devices. |
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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 stylized eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
APR 1 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Edwards Lifesciences, LLC. Martin A. Kaufman Director of Regulatory Affairs One Edwards Way Irvine CA 92614
Re: K083191
Trade/Device Name: dETlogix annuloplasty ring, model 5100 Regulation Number: 21 CFR 870.3800 Regulatory Class: Class II Product Code: KRH Dated: February 26, 2009 Received: March 2, 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, 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.
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): __K083191
Device Name: _dETlogix annuloplasty ring, Model 5100
Indications for Use:
The dETlogix annuloplasty ring, model 5100, is indicated for the correction of mitral valvular insufficiency where the lesions are not severe enough 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 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) | X | AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|---|---|
| ---------------------------------------------- | --- | -------- | --------------------------------------------- | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K083191 |
| Page 1 of 1 |
|---|
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§ 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.”