(60 days)
The Carpentier-Edwards Physio II Annuloplasty Ring is intended for the correction of mitral valve Insufficiency, or mixed mitral insufficiency and stenosis, where treatment does not necessitate a replacement of the natural mitral valve.
The Carpentier-Edwards Physio if Annuloplasty Ring is intended to meet the challenges of modern valvuloplasty by maintaining the physiologic annular shape and motion The annuloplasty ring is designed to follow the functional changes which occur during the cardiac cycle, thereby maintaining coaptation and valve integrity in systole while permitting good hemodynamics in diastole.
The decision to undertake annuloplasty can be made only after visual analysis of the lesion present The most favorable conditions for annuloplasty using a prosthetic ring are a combination of the distended natural valve ring associated with supple valve cusps and normal chordae tendineae.
The remodeling annuloplasty technique with a Carpentier-Edwards Physio II Annuloplasty Ring, Model 5200, may be used in all acqured or congental mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus, with the exception of severe congenital malformations (e g , AV canal or hypoplastic commissures) or severe degenerative valvular diseases where there is considerable excess tissue.
For Type I mitral insufficiencies with no subvalvular lesions and normal vaivular movements, this ring technique used alone is sufficient However, the ring technique must be associated with mitral valvuloplasty repar in Type II insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae or papillary muscle and in Type III imitation of valvular movements due to fusion of the commissures or chordae, or chordal hypertrophy.
The Carpentier-Edwards Physio II annuloplasty ring, model 5200, is constructed of cobalt-chromium alloy/polyester film bands with a silicone sewing ring margin covered with a polyester cloth
The provided text is a 510(k) Summary for the Carpentier-Edwards Physio II™ Annuloplasty Ring, Model 5200. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance results as one might find for a novel AI/medical imaging device.
Therefore, the specific information requested in the prompt (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training data details, etc.) is not available in the provided text.
Based on the document, here's what can be inferred about the "acceptance criteria" and "study" in the context of this 510(k) submission:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" in this context are implicitly that the Carpentier-Edwards Physio II Annuloplasty Ring, Model 5200, is comparable to its predicate device in design, intended use, materials, and principal of operation, and that it has successfully completed design verification testing.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Comparability in design, intended use, materials, and principal of operation to the predicate device (Carpentier-Edwards Physio™ Annuloplasty Ring, K926138) | "It has been demonstrated that the Carpentier-Edwards Physio II annuloplasty ring, model 5200, is comparable to its predicate device in design, intended use, materials, and principal of operation." |
| Successful completion of design verification testing | "The Carpentier-Edwards Physio II annuloplasty ring, model 5200, has successfully completed design verification testing." |
| Substantial equivalence to the predicate device | "The Carpentier-Edwards Physio II annuloplasty ring, model 5200, is substantially equivalent to its predicate device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. "Design verification testing" typically involves various engineering tests, but the document does not specify the sample sizes of devices tested or the provenance of any data beyond a general statement of successful completion.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. This device is an annuloplasty ring, not an AI/diagnostic device that would involve expert interpretation for ground truth establishment in a clinical study. The "testing" referred to is likely engineering and bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. This is not an AI-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a medical device like an annuloplasty ring, "ground truth" would be related to its physical properties, biocompatibility, mechanical performance, and clinical function. The document generally states "design verification testing" was successful, implying that physical and performance specifications were met. No specific "ground truth" establishment method like expert consensus or pathology for a test set is discussed, as this is not a diagnostic device.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This is not an AI/machine learning device.
In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for a medical implant (annuloplasty ring). It relies on comparability to a predicate device and successful completion of design verification testing, rather than the types of clinical performance studies with acceptance criteria, expert involvement, and data sets typically associated with AI or diagnostic devices.
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Image /page/0/Picture/0 description: The image shows a logo with the letter 'E' in a stylized font, superimposed on a background of circles and squares. The letter 'E' is white, while the background is black. Below the logo, the word 'Edwards' is written in a serif font.
K083470 JAN 2 3 2009
510(k) Summary
| Submitter | Edwards Lifesciences LLC |
|---|---|
| Contact Person | Erica A WaltersRegulatory Affairs Associateerica_walters@edwards.com(ph) 949-250-2438(fax) 949-250-3630 |
| Date Prepared | November 20, 2008 |
| Trade Name | Carpentier-Edwards Physio II™ Annuloplasty Ring,Model 5200 |
| Classification Name | Class II, CFR 870 3800 Annuloplasty Ring, KRH |
| Predicate Device(s) | Carpentier-Edwards Physio™ Annuloplasty Ring(K926138) |
| Device Description | The Carpentier-Edwards Physio II annuloplasty ring,model 5200, is constructed of cobalt-chromiumalloy/polyester film bands with a silicone sewing ringmargin covered with a polyester cloth |
| Indications for Use | The Carpentier-Edwards Physio II annuloplasty ring,model 5200, is intended for the correction of mitralvalvular insufficiency where the lesions are not so severeas to require total valve replacement |
| Comparative Analysis | It has been demonstrated that the Carpentier-Edwards ,Physio II annuloplasty ring, model 5200, is comparable toits predicate device in design, intended use, materials,and principal of operation |
| Functional/Safety Testing | The Carpentier-Edwards Physio II annuloplasty ring,model 5200, has successfully completed designverification testing |
| Conclusion. | The Carpentier-Edwards Physio II annuloplasty ring,model 5200, is substantially equivalent to its predicatedevice |
ﻟﺴﻴﺎﺭ ﺍ
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Edwards Lifesciences, LLC Erica A Walters Regulatory Affairs Associate One Edwards Way Irvine CA 92614
JAN 23 2009
Re K083470
Trade/Device Name Carpentier-Edwards Physio II annuloplasty ring, model 5200 Regulation Number 21 CFR 870 3800 Regulation Name Annuloplasty ring Regulatory Class Class II Product Code KRH Dated November 20, 2008 Received November 24, 2008
t,
Dear Ms Walters
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 adulteratıon
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
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comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807), labeling (21 CFR Part 801), 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 This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification The FDA finding of substantial equivalence of your device to a legally marketed 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), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 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,
R buhner
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)
Carpentier-Edwards Physio II Annuloplasty Ring, Model 5200 Device Name
Indications For Use
The Carpentier-Edwards Physio II Annuloplasty Ring is intended for the correction of mitral valve Insufficiency, or mixed mitral insufficiency and stenosis, where treatment does not necessitate a replacement of the natural mitral valve
The Carpentier-Edwards Physio if Annuloplasty Ring is intended to meet the challenges of modern valvuloplasty by maintaining the physiologic annular shape and motion The annuloplasty ring is designed to follow the functional changes which occur during the cardiac cycle, thereby maintaining coaptation and valve integrity in systole while permitting good hemodynamics in diastole
The decision to undertake annuloplasty can be made only after visual analysis of the lesion present The most favorable conditions for annuloplasty using a prosthetic ring are a combination of the distended natural valve ring associated with supple valve cusps and normal chordae tendineae
The remodeling annuloplasty technique with a Carpentier-Edwards Physio II Annuloplasty Ring, Model 5200, may be used in all acqured or congental mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus, with the exception of severe congenital malformations (e g , AV canal or hypoplastic commissures) or severe degenerative valvular diseases where there is considerable excess tissue
For Type I mitral insufficiencies with no subvalvular lesions and normal vaivular movements, this ring technique used alone is sufficient However, the ring technique must be associated with mitral valvuloplasty repar in Type II insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae or papillary muscle and in Type III imitation of valvular movements due to fusion of the commissures or chordae, 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)
R. Holmes
(Division Sign-Off)
Division of Cardiovascular Devices
umber K083470
Page 1 of 1
§ 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.”