MYOCARDIAL PROTECTION SYSTEM

K953838 · Quest Medical, Inc. · DTR · Mar 6, 1996 · Cardiovascular

Device Facts

• Record ID: K953838
• Device Name: MYOCARDIAL PROTECTION SYSTEM
• Applicant: Quest Medical, Inc.
• Product Code: DTR · Cardiovascular
• Decision Date: Mar 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4240
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quest MPS consisting of a control unit, associated disposable cassette sets with a heat exchanger, additive cassettes, and extension sets used together are indicated for delivery of cardioplegic solutions to the heart during open heart surgery

Device Story

Quest MPS is a microprocessor-based system for monitoring and controlling cardioplegia solution delivery during open heart surgery. System components include a control unit, disposable cassette sets, heat exchanger with integral bubble trap, and extension sets. The device features a primary pump for mixing blood/crystalloid solutions at defined ratios and two secondary pumps for arresting agents and additives. A water circulation system regulates solution temperature. Operated by clinical staff in the OR, the device provides automated control of pumping, pressure, and temperature. Output allows clinicians to precisely manage myocardial protection via user-defined cardioplegia temperatures and additive concentrations. Benefits include improved control over pressure delivery and solution mixing compared to manual methods.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including leak testing, pull testing, package integrity (ASTM F1140-88), shipping simulation (ASTM D-775-80, D-999-75), accelerated aging, heat exchanger corrosion resistance, air in-line detection (100μL sensitivity), hemolytic characteristics, level sensing, and pressure control delivery. Functional testing verified pump performance at temperature extremes (95% mean accuracy), additive concentration delivery (±10%), blood/crystalloid ratio accuracy (<3%), and flow rate accuracy (AAMI 5% specification). Electrical safety met UL/CSA requirements.

Technological Characteristics

Microprocessor-based control unit; disposable cassettes; heat exchanger with integral bubble trap. Materials comply with ISO-10993. Sterilization: METHOD-1 Radiation (SAL 10⁶). Connectivity: Standalone system. Sensing: Pressure transducers, temperature sensors, air bubble detectors. Actuation: Peristaltic-style pumping for blood/crystalloid mixing and additive delivery. Dimensions/Form factor: Integrated console with disposable fluid path. Electrical: Meets UL/CSA safety standards. Luer connections meet ANSI/HIMA MD70.1-1983.

Indications for Use

Indicated for delivery of cardioplegic solutions to the heart during open heart surgery.

Regulatory Classification

Identification

A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

Predicate Devices

• Sarns' Integrated Cardioplegia Delivery System (ICDS) (K810079)
• Sarns Conducer Heat Exchanger (K923311)
• Avecor Heat Exchanger (K904171)
• Stockert-Shiley Low Level Detector Bubble Monitor (K864619)
• Shiley Temperature Monitor (802147)
• Stockert-Shiley Dual Pressure Control Module (K862836)

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS

## QUEST MYOCARDIAL PROTECTION SYSTEM

### I. General Information

A. Generic Name: Cardioplegia Delivery System
B. Trade Name of Device: Quest Myocardial Protection System
C. Applicant's Name and Address: Quest Medical, Inc. One Allentown Parkway Allen, Texas.
D. Pre-market Notification Number: Not assigned to date

### II. Indications For Use

The Quest MPS consisting of a control unit, associated disposable cassette sets with a heat exchanger, additive cassettes, and extension sets used together are indicated for delivery of cardioplegic solutions to the heart during open heart surgery

### III. Device Description

The Quest MPS device consists of a microprocessor based system for monitoring and controlling the mixing, pumping, pressure, and the heating and cooling of cardioplegia solutions. Sterile disposables are part of the system as well as pumping cassettes, and a heat exchanger with an integral bubble trap. The MPS includes a primary pump where blood crystalloid solutions are mixed at defined ratios, and two secondary pumps for the addition of an arresting agent and other physician-defined additives. The device also contains a water circulation system for supplying warm or cold water to the heat exchanger to achieve user-defined cardioplegia temperatures.

### IV. Device Classification: Class II.

**Classification:**

Myocardial Management System™ (MPS) with Heat Exchanger are reviewed by the FDA Cardiovascular (CV) and (HO) General Hospital Classification Panels. The Product Classification Codes and Panel Codes for this device and predicate devices are:

80 DWK Pump, Infusion, Cardiovascular
74 DTR Cardiopulmonary Bypass, Heat Exchanger
74 DXS Gauge, Pressure, Coronary Cardiopulmonary Bypass
74 KRL Cardiopulmonary, Bypass Bubble Detector
74 DRS Transducer, Blood-Pressure, Extravascular
74 DWF Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing

QUEST Medical, Inc.
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# SUMMARY OF SAFETY AND EFFECTIVENESS

## V. Safety and Effectiveness

Substantial Equivalence:

The device has been shown to be substantially equivalent to the Sarns' Integrated Cardioplegia Delivery System (ICDS) #K810079, Sarns Conducer Heat Exchanger # K923311, Avecor Heat Exchanger # K904171, Stockert-Shiley Low Level Detector Bubble Monitor # K864619, Shiley Temperature Monitor # 802147 and the Stockert-Shiley Dual Pressure Control Module # K862836.

## VI. Other Safety and Effectiveness Data:

Materials: Fluid contact materials of construction comply with ISO-10993 " Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing" for short term devices.

Sterilization: Validated METHOD-1 Radiation Sterilization SAL 10⁶

Pyrogenicity: Non-Pyrogenic per USP Pyrogen test (LAL)

## Functional Testing

Leak Test Requirements: No leaks at 15 psi.

Pull Test Requirements: No leaks at 5 lbs for small bore and 10 psi for large bore tubing.

Luer Connections: Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Taper Fittings.

Package Integrity: Tyvek/Polystyrene tray and Tyvek/Polymylar pouches passed burst test with in accordance with ASTM F1140-88.

Shipping and Distribution Testing: Passed Distribution Simulation Test I/NSTA Project 1A. ASTM D-775-80 and D-999-75.

Accelerated Aging: One (1) year with no effects on performance characteristics.

Heat Exchanger Corrosion Test: Resists corrosion for periods of up to 72 hours.

Air In-line Detection: Detects 100μL size air bubbles in blood and saline.

Hemolytic Characteristics: MPS disposable and instrument lower than predicate devices.

Level Sensing and Autoventing: Meets performance specifications for venting and is equivalent to the predicate device for level sensing.

Pressure Control Delivery: Allows greater control of pressure than does the predicate device.

QUEST Medical, Inc

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| Pressure Alarm Verification | Operates within predicate device's alarm range of 0% to ± 10% of preset value. Allows ability to set lower pressure limits. |
| --- | --- |
| Pressure Sensor Accuracy | Equivalent to predicate device specification of ± 5 mmHg |
| Pump Performance at Temperature Extremes | MPS has a mean accuracy of 95% of the flow rates (50, 150, 500 ml/minute) delivered at 36°C and 5°C. |
| Use with Crystalloid Filter | Pressure cuffs allow MPS to provide maximum settable flow rate with the use of a crystalloid filter. |
| Arrest Agent/Additive Concentration Delivery | Adjustable from 4-40 mEq/L and delivers within ± 10% of desired concentration. |
| Blood/Crystalloid Ratio Accuracy | Less than 3% of each components required proportion |
| Delivery Rate Accuracy | Meets AAMI recommended 5% accuracy specification for infusion pumps. |
| Pump Output Flow Profile | Depicts a more linear flow rate than the predicate device at 50, 300, 500 ml/minute. |
| Environmental Tests | Meets temperature, humidity specification requirements and UL External Surface Temperature Safety requirements. |
| Electrical Safety | Meets UL/CSA requirements for electrical safety |
| Temperature Sensor Accuracy | Meets temperature sensor accuracy specifications of 5% of the reading. |
| Warm and Cold Temperature Control | Heat and cools cardioplegia solution within operating flow rate ranges. |

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