(83 days)
Not Found
No
The description focuses on standard temperature control and safety mechanisms, with no mention of AI or ML.
Yes
The device is intended to warm or cool a patient during medical procedures, which directly impacts the patient's physiological state.
No
Explanation: The device is a heater-cooler unit used to warm or cool a patient during medical procedures by circulating temperature-controlled water. It is a therapeutic device that manages patient temperature, not a diagnostic device that identifies or characterizes a disease or condition.
No
The device description clearly outlines a physical hardware device (Heater-Cooler Unit) with components like a tank, circuits, and temperature controls, not solely software.
Based on the provided information, the Jostra HCU 30 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to circulate water through heat exchange circuits to warm or cool a patient during cardiopulmonary bypass procedures. This is a direct interaction with the patient's body for therapeutic temperature management.
- Device Description: The device description confirms it supplies temperature-controlled water for use with heat exchangers and blankets applied to the patient.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide diagnostic information. IVD devices are used to test blood, urine, tissue, etc., to diagnose diseases or conditions.
The Jostra HCU 30 is a medical device used for patient temperature management during surgery, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing included:
- Heating mode test
- Cooling mode test
- Cleaning cycle test
- Alarm function test
- Interface test with RCU30 and HL30
- Reliability test
- Pressure regulation test
- Flow capacity test
Constructional Safety testing included:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4250 Cardiopulmonary bypass temperature controller.
(a)
Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.(b)
Classification. Class II (performance standards).
0
K03/544
510(k) Summary of Safety and Effectiveness
| Submitted by: | Jostra AB
Annedalsv\u00e4gen 2B
227 64 Lund, Sweden | | | AUG | 7 2003 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|-----|--------|
| Contact Person: | LeAnn Latham
Jostra Corp
2828 N. Crescent Ridge Dr.
The Woodlands, TX 77381
Phone: (281) 363-4949
Fax: (281) 292-1269
email: leann.latham@jostra.us | | | | |
| 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)
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.
1
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) |
2
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.
3
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.
4
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
5
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