The Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CPHV™ mitral valve in situ when necessary to avoid anatomical obstruction.

Device Description

The sterile, single use Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CarboMedics® Prosthetic Heart Valve (CPHV™) mitral valve in situ when necessary to avoid anatomical obstruction. The Sulzer Carbomedics Low Profile Mitral Rotator design includes a socket that the bendable is inserted into and locked in place. This allows the surgeon to orient the valve into the position of greatest advantage for each patient. The Low Profile Mitral Rotator with the corresponding CPHV size on the rotator. The Low Profile Mitral Rotator will be made available in sizes corresponding with previously approved CPHV™ sizes. The Low Profile Valve Rotators are intended for use with the CPHV™ Mitral 700 valve series. The Sulzer Carbomedics Low Profile Mitral Rotator will be manufactured from polyetherimide previously used with instrumentation approved with the CPHV". Polyetherimide has a history of use in medical device applications.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Sulzer Carbomedics Low Profile Mitral Rotator. It's an application for clearance to market an equivalent device, not a study reporting on the performance of an AI/ML system. Therefore, most of the requested information regarding AI/ML performance metrics, studies, and ground truth establishment is not applicable to this document.

However, I can extract information related to the device's intended use and equivalence claim, which can be seen as meeting its "acceptance criteria" for market clearance based on substantial equivalence.

Here's the breakdown of what can be extracted or inferred from the provided text:

Acceptance Criteria and Device Performance (in the context of 510(k) substantial equivalence):

For a 510(k) submission, the primary "acceptance criterion" is to demonstrate substantial equivalence to a previously legally marketed predicate device. This involves showing similar intended use, technological characteristics, and safety and effectiveness.

Acceptance Criterion (for 510(k) clearance)	Reported Device Performance (as claimed in 510(k))
Intended Use Equivalence:	The Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CPHV™ mitral valve in situ when necessary to avoid anatomical obstruction. This is stated to be equivalent to the predicate device, the Sulzer Carbomedics Extended Mitral Rotator (K951368, June 20, 1995), which performs the same function.
Technological Characteristics Equivalence:	Manufactured from polyetherimide, a material previously used in approved CPHV™ instrumentation and with a history of use in medical device applications. The design includes a socket for inserting and locking a bendable component to orient the valve. This implies that the materials and basic function are comparable to the predicate device. The document explicitly states the "results indicate that the Sulzer Carbomedics Low Profile Mitral Rotator is substantially equivalent to the Sulzer Carbomedics Extended Mitral Rotator."
Safety and Effectiveness Equivalence:	The submission asserts that the device is substantially equivalent to the predicate device. In a 510(k), this typically means that any differences in technological characteristics do not raise new questions of safety or effectiveness. The FDA's clearance letter confirms this by stating "we have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the device is deemed as safe and effective as the predicate.
Product Code and Regulatory Class:	Product Code: MOP. Regulatory Class: unclassified. (This is a classification assigned by the FDA based on the equivalence determination, not an acceptance criterion per se, but an outcome of meeting the criteria).

Since this is a 510(k) submission for a non-AI/ML medical device, the following points are not applicable:

Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not a diagnostic or AI system. Testing would typically involve mechanical bench testing or biocompatibility assessments, not a "test set" of patient data in the AI sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the AI sense is established.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary from the provided text:

The document describes a 510(k) premarket notification for a mechanical medical device, the Sulzer Carbomedics Low Profile Mitral Rotator. The primary study and "acceptance criteria" focus on demonstrating substantial equivalence to an existing predicate device (Sulzer Carbomedics Extended Mitral Rotator, K951368). The equivalence is based on similar intended use and technological characteristics (e.g., material, function). The FDA's letter (K974648) confirms that the device was deemed substantially equivalent, allowing its marketing. No AI/ML-specific performance metrics or studies are mentioned in this submission.

Summary

{0}------------------------------------------------

EDICA

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 SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR

The Sulzer Carbomedics Low Profile Mitral Rotator design includes a socket that the bendable is inserted into and locked in place. This allows the surgeon to orient the valve into the position of greatest advantage for each patient. The Low Profile Mitral Rotator with the corresponding CPHV size on the rotator. The Low Profile Mitral Rotator will be made available in sizes corresponding with previously approved CPHV™ sizes. The Low Profile Valve Rotators are intended for use with the CPHV™ Mitral 700 valve series.

The Sulzer Carbomedics Low Profile Mitral Rotator will be manufactured from polyetherimide previously used with instrumentation approved with the CPHV". Polyetherimide has a history of use in medical device applications. The Sulzer Carbomedics Low Profile Mitral Rotator has been tested and compared to the predicate device, the Sulzer Carbomedics Extended Mitral Rotator (K951368, June 20, 1995). The results indicate that the Sulzer Carbomedics Low Profile Mitral Rotator is substanially equivalent to the Sulzer Carbomedics Extended Mitral Rotator.

Common name of the Device:	Valve Rotator
Trade name of Proprietary Name:	Sulzer Carbomedics Low Profile Mitral Rotator
Submitter and Contact Person:	Edward E. NewtonSr. Regulatory Affairs Specialist1300 E. Anderson LaneAustin, Texas 78752Phone: (512) 435-3407Fax: (512) 435-3351
Submission Submitted on:	June 29, 1998

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are all capitalized and evenly spaced.

Image /page/1/Picture/1 description: The image shows the words "HUMAN SERVI" in a bold, sans-serif font. The text appears to be part of a larger phrase or title, but only these two words are visible in the image. The letters are black against a white background.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 1998

Mr. Edward E. Newton Sr. Regulatory Affairs Specialist Sulzer Carbomedics, Inc. 1300 East Anderson Lane Austin, TX 78752-1793

Re: K974648 Sulzer Carbomedics Low Profile Mitral Rotator Regulatory Class: unclassified Product Code: MOP Dated: June 29, 1998 Received: June 30, 1998

Dear Mr. Newton:

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, qood 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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. Edward E. Newton

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), promotion, or advertising, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation 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. Callahan

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 STATEMENT

510(K) Number (if known):	Unknown
Device Name:	Sulzer Carbomedics Low Profile Mitral Rotator
Indications for Use:	The Sulzer Carbomedics Low Profile Mitral Rotator isintended for use in rotating the CPHV™ mitral valve insitu when necessary to avoid anatomical obstruction.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bee & Lempersle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K974648

Prescription Use X

Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.3935 Prosthetic heart valve holder.

(a)
Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.