(84 days)
Not Found
No
The document describes a mechanical annuloplasty ring and its associated instrumentation, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is an annuloplasty ring used to repair cardiac mitral and tricuspid valves, which is a therapeutic intervention.
No
The device is an annuloplasty ring system used for the repair or replacement of damaged cardiac valves, not for diagnosing conditions.
No
The device description clearly states that the system consists of an annuloplasty ring mounted on a holder assembly, which are physical hardware components. The summary also mentions mechanical testing and biocompatibility testing, which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "reinforcement for repair of the human cardiac mitral and tricuspid valves" and a "replacement for a previously implanted annuloplasty ring." This describes a device used in vivo (within the body) for surgical repair.
- Device Description: The description details an "annuloplasty ring mounted on a holder assembly for implantation." This further confirms its use as an implantable medical device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens in vitro.
Therefore, the Sulzer Carbomedics AnnuloFlex™ Annuloplasty System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Sulzer Carbomedics Annuloplasty System is indicated as a reinforcement for repair of the human cardiac mitral and tricuspid valves 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.
Product codes
74 KRH
Device Description
The AnnuloFlex™ Annuloplasty System consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral or tricuspid position. A complete set of instrumentation is available separately to properly size the annulus and implant the annuloplasty ring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human cardiac mitral and tricuspid valves
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)
Results of biocompatibility testing supports that the materials used in the manufacture of the AnnuloFlex" are non-toxic, non-hemolytic, and non-pyrogenic. Mechanical testing for the AnnuloFlex™ annuloplasty ring includes suture retention testing and demonstrated that the sewing ring, fabric is comparable to fabrics used in vascular prostheses. Testing demonstrated that the AnnuloFlex Annuloplasty Ring is substantially equivalent to the predicate devices for repair of the mittal or tricuspid valve.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
5185
DEC 1 7 2002
Summary of Safety and Effectiveness per SMDA 1990 and 21 CFR 807.92 AnnuloFlex™ Annuloplasty System
| Submitter: | Sulzer Carbomedics, Inc.
1300 East Anderson Lane
Austin, Texas 78752
U.S.A. | Contact: | Teffany Hankinson
Regulatory Affairs Specialist
Telephone: (512) 435-3202
Facsimile: (512) 435-3350 |
|-------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Date of Summary: September 19, 2002 | | Classification Name: Annuloplasty Ring | |
| Common Name: Annuloplasty Ring | | Proprietary Name: AnnuloFlex™ Annuloplasty System | |
Description of Device: The AnnuloFlex™ Annuloplasty System consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral or tricuspid position. A complete set of instrumentation is available separately to properly size the annulus and implant the annuloplasty ring.
Statement of Intended Use: The Sulzer Carbomedics Annuloplasty System is indicated as a reinforcement for repair of the human cardiac mitral and tricuspid valves 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.
Technological Comparison: The AnnuloFlex™ Annuloplasty Ring is a flexible annuloplasty ring that can be implanted either as a partial or complete ring, according to the surgeon's preference and/or patient condition. For purposes of this submission, the AnnuloFlex " Annuloplasty Ring was compared to the following predicate devices:
- Sulzer Carbomedics® AnnuloFlex™ Annuloplasty Ring: flexible complete or partial ring with � identical materials, identical manufacturing process, and identical function
- Medtronic Duran Flexible Ring: flexible complete ring with identical function �
- � Baxter Cosgrove-Edwards Ring: flexible partial ring with identical function
Testing: Results of biocompatibility testing supports that the materials used in the manufacture of the AnnuloFlex" are non-toxic, non-hemolytic, and non-pyrogenic. Mechanical testing for the AnnuloFlex™ annuloplasty ring includes suture retention testing and demonstrated that the sewing ring, fabric is comparable to fabrics used in vascular prostheses. Testing demonstrated that the AnnuloFlex Annuloplasty Ring is substantially equivalent to the predicate devices for repair of the mittal or tricuspid valve.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 2002
Sulzer Carbomedics Inc. c/o Ms. Teffany Hankinson 1300 East Anderson Lane Austin, TX 78752-1793
Re: K023185
AnnuloFlex™ Annuloplasty System Regulation Number: 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: 74 KRH Dated: September 19, 2002 Received: September 24, 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 10 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
2
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 Office of Compliance at (301) 594-4646. 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
C. Tiller
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 STATEMENT
| 510(K) Number: | K |
|---|---|
| Device Name: | AnnuloFlex™ Annuloplasty System |
Indications for Use: The Sulzer Carbomedics AnnuloFlex™ Annuloplasty System is indicated
as a reinforcement for repair of the human cardiac mitral and tricuspid
valves 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
C.K.Tir
sion Sign-Off) Division of Cardiovascular Devices
510(k) Number K003185