HEATER COOLER UNIT, MODEL HCU 30

K031544 · Jostra AB · DWC · Aug 7, 2003 · Cardiovascular

Device Facts

• Record ID: K031544
• Device Name: HEATER COOLER UNIT, MODEL HCU 30
• Applicant: Jostra AB
• Product Code: DWC · Cardiovascular
• Decision Date: Aug 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jostra HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

Device Story

Jostra HCU 30 is a heater-cooler unit for hospital use during cardiopulmonary bypass. It circulates temperature-controlled water through heat exchange circuits for patient warming/cooling and cardioplegia. The device features a 26-liter tank, compressor for cooling/ice-making, and electrical heaters. It provides two independent circuits with separate temperature controls. A safety system monitors regulation to prevent temperatures exceeding 42°C. Operated by clinical staff in hospital settings, the device allows precise temperature adjustment (1°C to 41°C) via a graphic display. By maintaining patient temperature during bypass, it supports clinical management of patient thermal status.

Clinical Evidence

Bench testing only. Performance testing included heating and cooling mode tests, cleaning cycle validation, alarm function verification, interface testing with RCU30 and HL30, reliability testing, pressure regulation, and flow capacity testing. Constructional safety testing included electrical safety, electromagnetic compatibility (EMC), and package/transportation testing.

Technological Characteristics

Dual-circuit heater-cooler unit. Materials: 26L tank. Energy: Electrical heater (3180W at 230V/1800W at 115V) and compressor. Dimensions: 1060 x 465 x 525 mm. Control: 1°C-41°C range, 0.1°C resolution, ±0.3°C accuracy. Connectivity: Interface with RCU30 and HL30. Safety: Independent temperature monitoring, 42°C high-temp limit. Flow: Pressure pump system.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures lasting 6 hours or less, requiring temperature-controlled water for heat exchange circuits to warm or cool the patient.

Regulatory Classification

Identification

A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.

Predicate Devices

• Sarns temperature control and monitor system (TCM II) (K883603)

Submission Summary (Full Text)

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K03/544

### 510(k) Summary of Safety and Effectiveness

| Submitted by: | Jostra AB<br>Annedalsv\u00e4gen 2B<br>227 64 Lund, Sweden | | | AUG | 7 2003 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|-----|--------|
| Contact Person: | LeAnn Latham<br>Jostra Corp<br>2828 N. Crescent Ridge Dr.<br>The Woodlands, TX 77381<br>Phone: [phone]<br>Fax: [phone]<br>email: [e-mail] | | | | |
| Date prepared: | 2003-04-30 | | | | |
| Device Trade Name: | Jostra HCU 30 | | | | |
| Common/Usual Name: | Heater-Cooler Unit | | | | |
| Classification Names: | Controller, Temperature, Cardiopulmonary Bypass | | | | |
| Predicate Device: | Sarns temperature control and monitor system (TCM II)<br>K883603 | | | | |

#### Device Description:

The Jostra Heater-Cooler Unit HCU 30 supplies temperature-controlled water for cardioplegia heat exchangers, for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled.

The water temperature is adjustable from 1°C to 41°C. A 26 litre tank with ice and approx. 1ºC cold water assures quick cooling of the patient.

Two independent circuits with separate temperature controls can be attached (the main side has two connections).

A safety system monitors the regulation in order to prevent the temperature from rising above 42°C.

#### Indications for use:

The Jostra HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

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# Technical Characteristics Comparison:

| Name of Product | Jostra HCU 30 | Terumo TCM II |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Applications | Total-body heating cooling,, independent cardioplegia (Dual hyper-hypothermia system) | Total-body heating cooling,, independent cardioplegia (Dual hyper-hypothermia system) |
| Intended use | The Jostra HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less. | The Sarns TCM II is indicated for controlling and monitoring patient temperature. |
| Where used | Hospital | Hospital |
| Physical Dimensions | | |
| Dimensions (HxWxD) | 42 x 18 x 21 in. (1060 x 465 x 525 mm) | 34 x 20 x 30 in. (876 x 508 x 749 mm) |
| Floor space | 380 sqin. (0.24 sqm) | 600 sqin. (0.28 sqm) |
| Weight | ca. 267 lbs (121 kg) full ca. 209 lbs (95 kg) empty | ca. 368 lbs (175 kg) full ca. 294 lbs (133 kg) empty |
| Temperature control | | |
| Display | Full graphic display | Seven segment displays |
| Control range | 1°C - 41°C (both circuits) | 0°C - 42°C (for the main circuit), cardioplegia circuit: ice water only |
| Setting resolution | 0,1°C | 1°C |
| Measurement accuracy | ±0.3°C | ±0.3°C |
| Cooling system | | |
| Method | Compressor, ice-making | Compressor, ice-making |
| Tank volume | 7 gal. (26 litres) | 9 gal. (34 I) main tank 1.2 gal. (4.5 I) cplg tank not specified |
| Initial cooling capacity | 6250 kJ/h | not specified |
| Continuous cooling capacity | 4270 kJ/h (1186 W) | 4320 kJ/h (1200 W) |
| Max cooling capacity | 10520 kJ/h | not specified |
| | | |
| Heating System | | |
| Method | Electrical heater (2 units) | Electrical heater (2 units) |
| Capacity | 3180 W (230 V) 1800 W (115 V) | 1550 W (220 V) 2000 W (115 V) |
| Circulation | | |
| Method | Pressure pump (2 units) | Pressure pump (2 units) |
| Number of connectors | 6 (Two patient circuits with the same temperature and one independent cardioplegia circuit) | 6 (Two patient circuits with the same temperature and one independent cardioplegia circuit) |
| Flow capacity, patient circulation | adjustable ca. 2.6-6.1 gal/min (10-23 l/min ) | 5.5 gal/min (21 l/min ) |
| Flow capacity, cardioplegia circulation | min. 1.8 gal/min (7.0 l/min) | 2.1 gal/min (7.8 l/min) |
| Maximum pressure, patient circulation | ca. 34.8 psi (1800 mmHg) | ca. 15.0 psi (700 mmHg) |
| Maximum pressure, cardioplegia circulation | ca. 13.1 psi (675 mmHg) | ca. 7.5 psi (386 mmHg) |

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#### Performance testing included:

The following performance tests were done in order to demonstrate that the requirements in the Requirement Specification were met.

- Heating mode test .
- Cooling mode test t
- . Cleaning cycle test
- Alarm function test .
- . Interface test with RCU30 and HL30
- . Reliability test
- . Pressure regulation test
- . Flow capacity test

## Constructional Safety testing included:

The following tests were done in order to demonstrate that the legal requirements in the Requirement Specification were met.

- . Electrical Safety
- . Electromagnetic compatibility EMC
- . Package and Transportation

#### Conclusion:

Performance and functional testing demonstrate that the Jostra HCU-30 is substantially equivalent to the claimed predicate devices in intended use, principles of operation, materials, design, and performance.

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Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 2003

Jostra Corp. c/o Ms. LeAnn Latham 2828 N. Crescent Ridge Drive The Woodlands, TX 77381

Re: K031544

Heater Cooler Unit HCU-30 Regulation Number: 870.4250 Regulation Name: Temperature Controller Regulatory Class: Class II (two) Product Code: DWC Dated: April 30, 2003 Received: May 16, 2003

Dear Ms. Latham:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. LeAnn Latham

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

Bram D. Zuckerman, M.D.

ram D. Z man, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification Jostra AB – HCU 30

# Indications for Use Statement

Page 1 of 1

510(k) Number (if known):

not assigned

Device Name:

Jostra Heater Cooler Unit HCU 30

#### Indications for Use:

The Jostra HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient duration cardiopulmonary bypass procedures lasting 6 hours or less.

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

X. De Geeter

(Optional Format 3-10-98)

# Prescription Use Only

Prepared by Jostra AB, Lund, Sweden

FDA Submission Page 4