SAMS 8000 CARDIOPLEGIA MONITOR

K960916 · 3M Health Care, Sarns · DSJ · Jun 4, 1996 · Cardiovascular

Device Facts

• Record ID: K960916
• Device Name: SAMS 8000 CARDIOPLEGIA MONITOR
• Applicant: 3M Health Care, Sarns
• Product Code: DSJ · Cardiovascular
• Decision Date: Jun 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1100
• Device Class: Class 2

Indications for Use

The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit, either providing an alert or triggering an alarm which stops the cardioplegia pump only. The monitor also measures temperatures of the patient or extracorporeal circuit, counts the time during and between cardioplegia doses, and tracks the volume of cardioplegia delivered.

Device Story

Sarns 8000 Cardioplegia Monitor is a component of the Sarns 8000 Modular Perfusion System; used in clinical settings (OR) by perfusionists/clinicians. Inputs: pressure signals from extracorporeal lines, temperature from probes, and volume data from Sarns 8000 Roller Pump. Device processes inputs to display real-time pressure, temperature, dose timing, and cumulative cardioplegia volume. Features operator-set pressure alerts/alarms; communicates with Sarns 8000 Roller Pump to automatically stop cardioplegia delivery upon alarm trigger. Communicates with Sarns 8000 Data Communications Module for data acquisition. Output allows clinicians to monitor cardioplegia delivery parameters, ensuring safe pressure limits and accurate dosing during bypass procedures.

Clinical Evidence

No clinical data. Bench testing only; software functions validated against Software Requirements Specification.

Technological Characteristics

Modular perfusion system component; interfaces with Sarns 8000 Roller Pump and Data Communications Module. Measures pressure, temperature, and volume. Software-controlled monitoring and alarm system. No new technological characteristics compared to predicates.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass requiring cardioplegia delivery; measures extracorporeal line pressure, temperature, dose timing, and delivered volume.

Regulatory Classification

Identification

A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.

Predicate Devices

• Sarns 8000 Cardioplegia Monitor (K915183)
• Sarns 9000 Cardioplegia Control (K871131)

Submission Summary (Full Text)

{0}

3M Health Care
Cardiovascular Systems
Sarns™ and CDI™ Products
6200 Jackson Road
Ann Arbor, MI 48103-9300
USA
800 521 2818 Telephone
313 663 4145 Telephone
313 663 7981 Fax

JUN - 4 1996

# 3M

# K960916

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is ___________.

Submitter's Name: 3M Health Care
Submitter's Address: 6200 Jackson Road, Ann Arbor, Michigan, 48103
Contact Person: Cheryl Rosenberg
Phone Number: [phone]
FAX Number: [phone]
Summary Date: March 5, 1996

Device Trade Name:
Sarns 8000 Cardioplegia Monitor

Device Classification Names:
"Blood Pressure Alarm" (21 CFR 870.1100), and
"Blood Pressure Computer" (21 CFR 870.1110), and
Monitoring Accessory to a "Roller-type cardiopulmonary bypass blood pump" (21 CFR 870.4370).

Predicate Devices:
The new Sarns 8000 Cardioplegia Monitor is substantially equivalent to the existing Sarns 8000 Cardioplegia Monitor (K915183) and the Sarns 9000 Cardioplegia Control (K871131).

Device Description:
The Sarns 8000 Cardioplegia Monitor is only compatible with the Sarns 8000 Modular Perfusion System. The Sarns 8000 Cardioplegia Monitor can display two pressures and three temperatures from attached probes. The pressure has alert and alarm levels which are set by the operator. The Sarns 8000 Cardioplegia Monitor also has a timer for use in tracking the time during and between doses of cardioplegia. With the new added features, it also displays the volume of cardioplegia delivered to the patient. The Sarns 8000 Cardioplegia Monitor communicates with the Sarns 8000 Roller Pump for obtaining volume information and to stop the roller pump (designated for cardioplegia delivery) during a pressure alarm condition if set by the operator to do so. The Sarns 8000 Cardioplegia Monitor also communicates with the Sarns 8000 Data Communications Module for purposes of data acquisition.

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## Indications For Use:

The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit, either providing an alert or triggering an alarm which stops the cardioplegia pump only. The monitor also measures temperatures of the patient or extracorporeal circuit, counts the time during and between cardioplegia doses, and tracks the volume of cardioplegia delivered.

## Technological Characteristics:

Compared to the existing Sarns 8000 Cardioplegia Monitor, the software has undergone modifications to read and display volume information from the Sarns 8000 Roller Pump. The Sarns 9000 Cardioplegia Control, part of the Sarns 9000 Perfusion System, is also used as a predicate device since it has the same features which are being added to the Sarns 8000 Cardioplegia Monitor. The modified Sarns 8000 Cardioplegia Monitor has no new technological characteristics compared to the predicate devices.

## Nonclinical Performance:

The performance of the Sarns 8000 Cardioplegia Monitor and its interface with the Sarns 8000 Modular Perfusion System was exhaustively tested. All new and existing software functions as defined in the Software Requirements Specification were completely validated.

## Clinical Performance:

Clinical testing was not performed on the device.

## Conclusions from Nonclinical Tests:

The Sarns 8000 Cardioplegia Monitor performs as intended according to its performance specification. The Sarns 8000 Cardioplegia Monitor is substantially equivalent to the predicate devices.