CARBOMEDICS HANDLE

K962154 · Carbomedics, Inc. · DTJ · Aug 27, 1996 · Cardiovascular

Device Facts

• Record ID: K962154
• Device Name: CARBOMEDICS HANDLE
• Applicant: Carbomedics, Inc.
• Product Code: DTJ · Cardiovascular
• Decision Date: Aug 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3935
• Device Class: Class 1

Intended Use

The reusable CarboMedics Handle is intended for use with the CarboMedics Valve Holder (referred to herein as the "Valve Holder") for the purpose of assuring a firm grasp of the valve and to facilitate sewing ring exposure.

Device Story

Reusable, one-piece surgical instrument; consists of threaded polysulfone tip, bendable stainless steel shaft, and polysulfone handle. Used in clinical/OR settings by surgeons to grasp CarboMedics Valve Holder; facilitates sewing ring exposure during heart valve implantation. Device provides mechanical interface between surgeon and valve holder; ensures firm grip and positioning. Non-sterile; requires cleaning and sterilization before use. Benefits include improved handling and stability of prosthetic heart valves during surgical procedures.

Clinical Evidence

Bench testing only. Pull-out test (n=not specified) yielded average 75.2 lb_f (min 25 lb_f). Push-out test yielded average 113.5 lb_f (min 75 lb_f). Biocompatibility testing conducted per Tripartite Guidance and ISO 10993.

Technological Characteristics

Materials: Polysulfone (tip/handle), stainless steel (shaft). Construction: Injection molded. Form factor: One-piece, bendable shaft. Sterilization: Requires user-performed cleaning and sterilization. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for use by clinicians during cardiac surgery to assist in the manipulation and positioning of CarboMedics prosthetic heart valves via the CarboMedics Valve Holder.

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 Valve Holder Handle (VH-100) (K942736)

Reference Devices

• CarboMedics Prosthetic Heart Valve

Submission Summary (Full Text)

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AUG 27 1996
CarboMedics®
A company of SULZERmedica
1300 East Anderson Lane, Austin, Texas 78752-1793 ▼ 512 435 3200 ▼ 512 435 3350 FAX
K962154

# 510(k) SUMMARY CARBOMEDICS HANDLE

The reusable CarboMedics Handle is a one-piece, injection molded handle and is provided in one size only. The CarboMedics Handle is intended for use with the CarboMedics Valve Holder (referred to herein as the "Valve Holder") for the purpose of assuring a firm grasp of the valve and to facilitate sewing ring exposure. The threaded end of the CarboMedics Handle is inserted into the Valve Holder. The CarboMedics Handle consists of a threaded polysulfone tip injection molded to a bendable handle. The CarboMedics Handle is a reusable instrument. It is supplied non-sterile and must be cleaned and sterilized prior to initial use and each reuse.

The reusable CarboMedics Handle is manufactured using a polysulfone injection molding process. The CarboMedics Handle consists of a white polysulfone threaded tip injection molded onto a bendable stainless steel shaft, injection molded to a white polysulfone handle. Polysulfone has a history of use in medical device applications, including various instrumentation approved with the CarboMedics® Prosthetic Heart Valve. Biocompatibility tests were conducted on the white polysulfone in accordance with Tripartite Guidance and meets requirements of ISO 10993 for biomaterial testing. Acceptable results were obtained from all biocompatibility tests.

The one-piece injection molded handle is similar to handles used successfully with other CarboMedics instrumentation. The handle of a similar device has been tested to ensure that the handle exhibits torque and pull-out strengths that will exceed the requirements for the intended function. The purpose of the performance testing was to qualify the design and performance of this device. CarboMedics performed a pull-out test to determine the amount of force required to separate the molded tip from the steel shaft. Using a minimum failure load of 25 lb_f, the results were an average of 75.2 lb_f with a standard deviation of 19.9 lb_f. CarboMedics also performed a push-out test to determine the amount of force required to separate the steel shaft from the handle. Using a minimum push-out load of 75 lb_f, the results were an average of 113.5 lb_f with a standard deviation of 0.4 lb_f. This testing showed the design to be suitable for its intended use and capable of performing its function in a safe and effective manner.

CarboMedics considers the reusable CarboMedics Handle safe, effective, and substantially equivalent in intended use, design, and function to the CarboMedics Valve Holder Handle (VH-100), approved for market on July 6, 1994, 510(k) #K942736.

Common name of the device: Valve Holder Handle

Trade name or Proprietary name: CarboMedics Handle

Submitter and Contact person: Joy Fisher Shugart
Regulatory Affairs Specialist
1300 E. Anderson Lane
Austin, Texas 78752
Phone: [phone] Fax: [phone]

Submission Prepared/Submitted on: May 29, 1996

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