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.

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.

AI/ML Overview

This document is a 510(k) summary for the Sulzer Carbomedics AnnuloFlex™ Annuloplasty System. This device is a medical implant, not an AI or software device, so the typical acceptance criteria and study designs associated with AI performance metrics (like sensitivity, specificity, F1-score, sample sizes for test/training sets, expert adjudication, MRMC studies) are not applicable.

Instead, the "acceptance criteria" for such a device are based on demonstrating substantial equivalence to legally marketed predicate devices, supported by biocompatibility and mechanical efficacy testing.

Here's an breakdown of the information provided in the context of a medical device submission:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Testing Results)
Material Biocompatibility: Materials used must be non-toxic, non-hemolytic, and non-pyrogenic.	Completed. Testing supports that "the materials used in the manufacture of the AnnuloFlex™ are non-toxic, non-hemolytic, and non-pyrogenic."
Mechanical Efficacy: The device must withstand forces and demonstrate comparable performance to predicate devices in terms of its intended function.	Suture Retention Testing: Demonstrated that "the sewing ring fabric is comparable to fabrics used in vascular prostheses." Overall Mechanical Testing: Testing "demonstrated that the AnnuloFlex™ Annuloplasty Ring is substantially equivalent to the predicate devices for repair of the mitral valve" in terms of function, materials, and manufacturing processes where applicable. The predatory devices are: * Sulzer Carbomedics® AnnuloFlo™ Annuloplasty Ring (rigid, nearly identical materials, identical manufacturing process, identical function) * Medtronic Duran Flexible Ring (flexible complete ring with identical function) * Baxter Cosgrove-Edwards Ring (flexible partial ring with identical function)
Intended Use: The device must be suitable for its stated intended use.	The AnnuloFlex™ System is intended for use in the repair of the human cardiac mitral valve, specifically 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. It should be used only if the valve is repairable and not requiring replacement.
Technological Characteristics: Comparable to predicate devices in design and function.	Described as a flexible annuloplasty ring that can be implanted as a partial or complete ring. Compared against predicate devices for being flexible/rigid, complete/partial rings, with comparable materials, manufacturing processes, and identical function.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable in the context of this device. The testing described (biocompatibility, mechanical suture retention) are laboratory-based tests on the device materials and components, not a "test set" of patient data or images.
Data Provenance: Not applicable. The testing represents lab-generated data from material and mechanical assessments of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth for AI software involves expert labels of data. For a hardware medical device like this, "truth" is established through engineering specifications, material science, and mechanical testing standards.

4. Adjudication method for the test set:

Not applicable. There is no expert adjudication of a "test set" in the sense of AI performance evaluation. The data is physical test results against pre-defined engineering and safety standards.

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:

No, an MRMC study was not done. This device is an implanted annuloplasty ring, not an AI or imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For this device, the "ground truth" (or functional equivalent for a hardware device) is based on established biocompatibility standards (e.g., ISO 10993 for non-toxicity, non-hemolysis, non-pyrogenicity) and mechanical engineering standards for durability, suture retention, and performance under simulated physiological conditions. It also relies heavily on the documented performance and safety profiles of the predicate devices to which it claims substantial equivalence.

8. The sample size for the training set:

Not applicable. There is no "training set" for physical medical device testing in the AI sense.

9. How the ground truth for the training set was established:

Not applicable.

Summary

{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:

K992056

· Device Name:

AnnuloFlex System

Indications for Use:

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)

Regulation Number and Section

§ 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.”