SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR

K974648 · Sulzer Carbomedics, Inc. · MOP · Aug 4, 1998 · Cardiovascular

Device Facts

• Record ID: K974648
• Device Name: SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
• Applicant: Sulzer Carbomedics, Inc.
• Product Code: MOP · Cardiovascular
• Decision Date: Aug 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3935
• Device Class: Class 1

Intended Use

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 Story

The Sulzer Carbomedics Low Profile Mitral Rotator is a sterile, single-use surgical instrument designed for intraoperative use by surgeons. It features a socket mechanism that locks onto the CPHV™ (CarboMedics Prosthetic Heart Valve) mitral valve. By inserting the valve into the rotator, the surgeon can adjust the orientation of the prosthetic valve in situ to prevent anatomical obstruction. The device is available in sizes corresponding to the CPHV™ Mitral 700 valve series. It serves as a mechanical tool to optimize valve positioning during cardiac surgery, potentially improving patient outcomes by ensuring proper valve fit and function within the mitral annulus.

Clinical Evidence

Bench testing only.

Technological Characteristics

Constructed from polyetherimide; mechanical socket-and-lock design; manual operation; sterile, single-use; available in multiple sizes corresponding to CPHV™ Mitral 700 valve series.

Indications for Use

Indicated for use in patients undergoing mitral valve replacement with the CPHV™ Mitral 700 valve series, specifically to facilitate intraoperative rotation of the prosthetic valve to avoid anatomical obstruction.

Regulatory Classification

Identification

A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.

Predicate Devices

• Sulzer Carbomedics Extended Mitral Rotator (K951368)

Submission Summary (Full Text)

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# EDICA

#### Sulzer Carbomedics Inc.

1300 East Anderson Lane Austin, Texas 78752-1793

Phone [phone] FAX [phone] WATS [phone] (US and Canada)

### 510(k) SUMMARY SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR

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. 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. Newton<br>Sr. Regulatory Affairs Specialist<br>1300 E. Anderson Lane<br>Austin, Texas 78752<br>Phone: [phone]<br>Fax: [phone] |
| Submission Submitted on: | June 29, 1998 |

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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.

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#### 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 [phone]. 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 [phone] or [phone] 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

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## 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 is<br>intended for use in rotating the CPHV™ mitral valve in<br><i>situ</i> when necessary to avoid anatomical obstruction. |

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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

OR

Over-the-Counter Use

(Optional Format 1-2-96)