(116 days)
Not Found
Not Found
No
The summary describes a physical annuloplasty ring and its implantation system, with no mention of software, algorithms, or any AI/ML related terms or concepts.
Yes
The device is an annuloplasty ring used to repair the human cardiac mitral valve, which is a therapeutic intervention.
No.
The device, AnnuloFlex annuloplasty ring, is indicated as a reinforcement for repair of the human cardiac mitral valve, which is a therapeutic intervention, not a diagnostic one. It is an implantable device used to treat a condition rather than to identify or characterize a disease.
No
The device description clearly states it is an annuloplasty ring, which is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reinforce or replace a damaged mitral valve in the human heart. This is a surgical implant used in vivo (within the body) for structural repair.
- Device Description: The device is an annuloplasty ring, a physical implant.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The information clearly describes a surgical implant for cardiac repair, which falls under the category of medical devices used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The AnnuloFlex™ System is intended for use in the repair of the human cardiac mitral valve.
The AnnuloFlex 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.
Product codes (comma separated list FDA assigned to the subject device)
74 KRH
Device Description
The AnnuloFlex™ Annuloplasty System consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral 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 valve
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)
Material biocompatibility testing has been completed that 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 mitral valve.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Sulzer Carbomedics® AnnuloFlo™ Annuloplasty Ring, Medtronic Duran Flexible Ring, Baxter Cosgrove-Edwards Ring
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/0 description: The image shows the text "SULZER MEDICA" in a bold, sans-serif font. Above the text, there is a handwritten number "1992056". The text is the name of a company in the medical field. The image is likely a logo or a document header.
OCT 1 2 1999
Sulzer Carbomedics Inc.
1300 East Anderson Lane Austin, Texas 78752-1793
Phone (512) 435-3200 FAX (512) 435-3350 WATS (800) 648-1579 (US and Canada)
510(k) SUMMARY
per 21 CFR §807.92
| Submitter | Contact |
|---|---|
| Sulzer Carbomedics Inc. | Robert M. Wolfarth, CQA |
| 1300 East Anderson Lane | Regulatory Affairs Specialist |
| Austin, Texas 78752-1793 | Telephone: (512) 435-3467 |
| Facsimile: (512) 435-3350 | |
| E-mail: rwolfarth@carbomedics.com |
| Date of Summary: | May 28, 1999 |
|---|---|
| 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 position. A complete set of instrumentation is available separately to properly size the annulus and implant the annuloplasty ring.
Statement of Intended Use: The AnnuloFlex™ System is intended for use in the repair of the human cardiac mitral valve.
Technological Comparison: The AnnuloFlex™ Annuloplasty Ring is a flexible annuloplasty ring which 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® AnnuloFlo™ Annuloplasty Ring: rigid ring with nearly 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: Material biocompatibility testing has been completed that 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 mitral valve.
1
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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
OCT 1 2 1999
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert M. Wolfarth Regualtroy Affairs Specialist Sulzer Medica Sulzer Carbomedics, Inc. 1300 East Anderson Lane Austin, TX 78752-1793
Re: K992056 Sulzer Cardomedics® AnnuloFlex™ Annuloplasty System Requlatory Class: III (Three) Product Code: 74 KRH Dated: June 17, 1999 Received: June 18, 1999
Dear Mr. Wolfarth:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval) , 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Robert M. Wolfarth
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
510(k) Number:
· Device Name:
AnnuloFlex System
Indications for Use:
The AnnuloFlex 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.
Beete L. Campbell
Division Sign Off
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K992056
(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
(Optional Format 1-2-96)