CARBOMEDICS MITRAL ROTATOR

K960923 · Carbomedics, Inc. · MOP · Apr 29, 1996 · Cardiovascular

Device Facts

• Record ID: K960923
• Device Name: CARBOMEDICS MITRAL ROTATOR
• Applicant: Carbomedics, Inc.
• Product Code: MOP · Cardiovascular
• Decision Date: Apr 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3935
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The reusable CarboMedics Mitral Rotators are intended for use in rotating the CarboMedics mitral heart valves (Model 700 and S700) in situ when necessary to avoid anatomical obstruction.

Device Story

Hand-held, one-piece surgical instrument; used by surgeons in OR to rotate CarboMedics mitral heart valves (Model 700/S700) in situ; prevents anatomical obstruction; device is non-sterile, requires cleaning/sterilization before use; manufactured from blue polysulfone or polyetherimide; manual operation.

Clinical Evidence

Clinical usage data since 1986, including application under IDE G880074, supports safety and effectiveness. No specific clinical trial metrics provided.

Technological Characteristics

One-piece, hand-held instrument; materials: blue polysulfone or blue polyetherimide; biocompatibility per ISO 10993; non-sterile, reusable; requires manual cleaning and sterilization.

Indications for Use

Indicated for patients undergoing mitral heart valve replacement requiring intraoperative or postoperative rotation of CarboMedics Model 700 and S700 prosthetic valves to prevent 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

• CarboMedics Extended Mitral Rotator heads (K951368)

Reference Devices

• CarboMedics Prosthetic Heart Valve

Submission Summary (Full Text)

{0}

04/26/96 09:26 512 435 3350 CARBOMEDICS ---> CDRH ODE 002

# CarboMedics
*A company of BULGERMEDICS*

1300 East Anderson Lane, Austin, Texas 78752-1793 ▼ 512 435 3200 ▼ 512 435 3350 FAX

APR 29 1996

**510(k) K960923 SUMMARY**
**CARBOMEDICS MITRAL ROTATOR**

The reusable CarboMedics Mitral Rotators are intended for use in rotating the CarboMedics mitral heart valves (Model 700 and S700) in situ when necessary to avoid anatomical obstruction. The CarboMedics Mitral Rotator is a one-piece, injection modeled rotator, manufactured from either blue polysulfone or blue polyetherimide. The CarboMedics Mitral Rotators are supplied non-sterile and must be cleaned and sterilized prior to initial use and each reuse.

The reusable CarboMedics Mitral Rotators are manufactured using a polysulfone or polyetherimide injection molding process. The CarboMedics Mitral Rotators are one-piece, hand-held instruments. Polysulfone and polyetherimide have a history of use in medical device applications, including various instrumentation approved with the CarboMedics® Prosthetic Heart Valve. Biocompatibility tests were conducted on the blue polysulfone and blue polyetherimide in accordance with Tripartite Guidance and meet requirements of ISO 10993 for biomaterial testing. Acceptable results were obtained from all biocompatibility tests.

The hand-held CarboMedics Mitral Rotators have been used in clinical applications since 1986. CarboMedics purports that based on the clinical usage of this device, including its clinical application under IDE G880074, the CarboMedics Mitral Rotators are capable of performing their function in a safe and effective manner.

CarboMedics considers the reusable CarboMedics Mitral Rotators safe, effective, and substantially equivalent in intended use, design, composition (polysulfone and polyetherimide) and function to the CarboMedics Extended Mitral Rotator heads approved for market on June 20, 1995, 510(k) #K951368.

Common name of the device: Valve Rotator
Trade Name or Proprietary Name: CarboMedics Mitral Rotator
Submitter and Contact person: Joy Fisher Shugart
Regulatory Affairs Specialist
1300 E. Anderson Lane
Austin, Tx 78752
Phone: [phone]
Fax: [phone]
Submission Prepared/Submitted on: March 5, 1996

CarboMedics Prosthetic Heart Valve - Celebrating a Decade of Clinical Performance - 2 -