(22 days)
The AnnuloFlo® System is intended for use in the repair of the human cardiac valve.
The AnnuloFlo® annuloplasty ring is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.
The AnnuloFlo® System consists of an annuloplasty ring, and a prosthesis of instrumentation provided in a tray to properly size the annulus and implant the annuloplasty ring. The annuloplasty ring is designed to reinforce the native annulus while retaining the native valve apparatus.
The AnnuloFlo® annuloplasty ring employs materials with a long and satisfactory history of use in cardiovascular applications. All materials are non-ferrous, have extensive history in implants and do not present a significant risk during Magnetic Resonance Imaging (MRI). The annuloplasty ring consists of a titanium stiffener ring enclosed in a sewing ring of silicone and knitted polyester fabric.
The mitral AnnuloFlo® annuloplasty ring is kidney shaped. The curved posterior segment of the ring corresponds to the native posterior leaflet. The open segment of the ring corresponds to the anterior leaflet.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any specific criteria. The text is a 510(k) summary and an FDA clearance letter for the AnnuloFlo® Annuloplasty System. It focuses on the device's description, intended use, indications for use, and a comparison to a predicate device for the purpose of demonstrating substantial equivalence for FDA clearance.
The document does not contain details regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training data was established.
Therefore, I cannot fulfill your request with the given input.
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APR 2 3 2002
Summary of Safety and Effectiveness per SMDA 1990 and 21 CFR 807.92 AnnuloFlo® Annuloplasty System
| Submitter: | Sulzer Carbomedics, Inc.1300 East Anderson LaneAustin, Texas 78752U.S.A. | Contact: | Teffany HankinsonRegulatory Affairs AssociateTelephone: (512) 435-3202Facsimile: (512) 435-3350 |
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Classification Name: Annuloplasty Ring Date of Summary: March 27, 2002 Proprietary Name: AnnuloFlo® System Common Name: Annuloplasty Ring
Predicate Device: AnnuloFlex™ Annuloplasty System
Statement of Intended Use: The AnnuloFlo® System is intended for use in the repair of the human cardiac valve.
Statement of Indications for Use: The AnnuloFlo® annuloplasty ring is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital Itimoreement for topen of the a previously implanted annuloplasty ring. The annuloplasty ring dibouse, or as a repidentifical inspection confirms that the valve is repairable and does not require replacement.
Description of Device: The AnnuloFlo® System consists of an annuloplasty ring, and a Doserproasis of instrumentation provided in a tray to properly size the annulus and implant the annuloplasty ring. The annuloplasty ring is designed to reinforce the native annulus while retaining the native valve apparatus.
The AnnuloFlo® annuloplasty ring employs materials with a long and satisfactory history of use in cardiovascular applications. All materials are non-ferrous, have extensive history in implants and do not present a significant risk during Magnetic Resonance Imaging (MRJ). The annulonlasty ring consists of a titanium stiffener ring enclosed in a sewing ring of silicone and knitted polyester fabric.
The mitral AnnuloFlo® annuloplasty ring is kidney shaped. The curved posterior segment of the ring corresponds to the native posterior leaflet. The open segment of the ring corresponds to the anterior leaflet.
Technological Comparison: The sewing cuff material of the AnnuloFlo® annuloplasty ring is similar to the sewing cuff material used in the AnnuloFlex™ annuloplasty ring.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2002
Sulzer Carbomedics, Inc. c/o Teffany Hankinson Regulatory Affairs Associate 1300 East Anderson Lane Austin, TX 78752
Re: K021051
Trade/Device Name: AnnuloFlo® System, Mitral AR-700 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 28, 2002 Received: April 1, 2002
Dear Ms. Hankinson:
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
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Page 2 – Ms. Teffany Hankinson
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of 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 Division 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,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
K970375 510(K) Number:
Device Name:
. ..
AnnuloFlo® System
Indications for Use:
The AnnuloFlo® annuloplasty ring is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
Division of Cardiovascular & Respiratory Devices
510(k) Number K021051
§ 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.”