THERMACYL BLOOD/FLUID WARMER

K953741 · Baxter Healthcare Corp · BSB · Jun 26, 1996 · Hematology

Device Facts

• Record ID: K953741
• Device Name: THERMACYL BLOOD/FLUID WARMER
• Applicant: Baxter Healthcare Corp
• Product Code: BSB · Hematology
• Decision Date: Jun 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.9205
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ThermaCyl™ blood/fluid warmer is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in clinical environments.

Device Story

ThermaCyl™ blood/fluid warmer warms blood products and IV fluids to 42°C. System comprises hardware warming unit and disposable warming cuff. Disposable cuff wraps around internal aluminum cylinder; cylinder heated via electrical resistance. Fluid flows through disposable bag in contact with heated cylinder. Device supports flow rates up to 500 mL/minute. Used by healthcare professionals in clinical settings. Electronics monitor temperature via thermistors (2 inlet, 2 outlet) to ensure safety; audible and visual alarms trigger if temperature exceeds 42°C or if thermistor pair temperatures differ by ±5°C. Benefits patient by preventing hypothermia during rapid fluid/blood administration.

Clinical Evidence

Bench testing only. Hemolysis study evaluated whole blood, packed red blood cells, and Adsol preserved red blood cells. Samples tested at flow rates <100 mL/minute and maximum device flow rates. Results showed minimal or no hemolysis across all tested blood types and flow variables.

Technological Characteristics

Heating method: electrical resistance heating of aluminum cylinder. Temperature control: 4 thermistors (2 inlet, 2 outlet). Flow rate: up to 500 mL/minute. Safety standards: UL 2601, CSA 601. Disposable: warming cuff for standard or mass infusion sets. No software used.

Indications for Use

Indicated for warming blood products and intravenous solutions prior to administration in clinical environments by healthcare professionals.

Regulatory Classification

Identification

A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.

Predicate Devices

• Pharmaseal DW 1000 Blood/Fluid Warmer (K770232)
• Alton Dean Blood Warmer (BK910033)

Submission Summary (Full Text)

{0}

U.S. Systems Division Regulatory Affairs
Baxter Healthcare Corporation
Route 120 &amp; Wilson Road
Round Lake, Illinois 60073-0490
708.546.6311
Fax: [phone]
K953741
JUN 26 1996
Baxter

510(k) Summary

Submitter
Baxter Healthcare Corporation
I. V. Systems Division
Route 120 and Wilson Road
Round Lake, IL 60073

Contact
Jody Ann Gould, Ph.D.
Phone: (708) 270 - 4014
Fax: (708) 270 - 4668

Date Prepared
June 26, 1995

Trade/Proprietary Name
ThermaCyl™ Blood/Fluid Warmer

Common/Usual Name
Blood/fluid warmer

Classification Name
Nonelectromagnetic blood or plasma warming device

Predicate Devices
Pharmaseal DW 1000 Blood/Fluid Warmer
Alton Dean Blood Warmer

Description of Device
The ThermaCyl™ blood/fluid warmer consists of a warming device (hardware) and a container (disposable) designed for use with the hardware. The device is capable of warming blood products or intravenous fluids, flowing at rates of up to 500 mL/minute, to temperatures of as high as and including 42°C (in accordance with American Association of Blood Banks (AABB) Standards for Blood Banks and Transfusion Services).

Two types of disposables are available. A standard blood/fluid warming cuff for use with standard administration sets and a high flow blood/fluid warming cuff for use with mass infusion sets. The disposables are composed of the same materials used in the current Pharmaseal blood warming device disposable. They are designed to surround the aluminum cylinder of the warming device. The disposable is in direct contact with the

CONFIDENTIAL
AUG 09 1995
23

{1}

.V. Systems Division Regulatory Affairs
Baxter Healthcare Corporation Route 120 &amp; Wilson Road Round Lake, Illinois 60073-0490
708.546.6311 Fax: [phone]

# Baxter

cylinder. The cylinder is heated by means of electrical resistance. Blood products or intravenous fluids are heated as they flow through the bag. The temperature of the cylinder is accurately controlled by the device's electronics. The electrical requirements are designed in accordance with UL 2601. The device also meets the requirements of CSA 601. No software is used.

## Statement of Intended Use

The ThermaCyl™ blood/fluid warmer is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in clinical environments.

## Comparison of the Technological Characteristics of the New Device and the Predicate Devices

The ThermaCyl™ blood/fluid warmer is substantially equivalent to the Pharmaseal blood/fluid warmer (found substantially equivalent under K770232) and the Alton Dean blood/fluid warmer (found substantially equivalent under BK910033). A comparison of technological features follows:

| FEATURE | ALTON DEAN BLOOD WARMER | BAXTER THERMACYL™ BLOOD/FLUID WARMER | PHARMASEAL BLOOD/FLUID WARMER (DW-1000D) |
| --- | --- | --- | --- |
| Maximum Flow Rate | >500 mL/minute | 500 mL/minute | 200 mL/minute |
| Heating Method | Metal plate heated by electrical resistance; disposable bag in direct contact with plate | Metal cylinder heated by electrical resistance; disposable bag in direct contact with cylinder | Metal cylinder heated by electrical resistance; disposable bag in direct contact with cylinder |
| Temperature Control | Adjustable set point; internal sensors | Thermistors (2 inlet; 2 outlet) | Three control thermostats |
| Alarm Description | Audible and visual alarms | Audible and visual alarms | Audible and visual alarms |
| Alarm Conditions | Temperature exceeds adjustable set point (up to 39.5°C) | Thermistor temperature exceeds 42°C; Thermistor pair's temperatures differ by ±5°C | Temperature reaches over-temperature thermostat range 41.7 - 44.7°C |
| Electronics | Microprocessor control | UL 2601 and CSA 601 | UL 551 |

## Discussion of NonClinical Studies

A study was conducted to evaluate the hemolytic effects of the redesigned blood/fluid warmer. Whole blood, packed red blood cells and Adsol preserved red blood cells near outdate were tested. Percent hemolysis was evaluated before and after flow through the blood warming device at less than 100 mL/minute and at the highest flow rate possible for each type of blood. There was minimal or no hemolysis for all bloods and variables tested.

CONFIDENTIAL
AUG 09 1995
24