(83 days)
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 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.
Unfortunately, the provided text does not contain the specific details required to complete your request in full regarding acceptance criteria, study design, and performance metrics. The document is primarily a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results in the format you've requested for AI/ML device evaluations.
Here's a breakdown of what can be extracted and what is missing based on your criteria:
1. A table of acceptance criteria and the reported device performance
The document lists "Technical Characteristics Comparison" between the Jostra HCU 30 and the predicate device (Terumo TCM II). While it doesn't explicitly state "acceptance criteria," the comparison table implies that the performance of the Jostra device is deemed acceptable if it is comparable to or better than the predicate device's specifications for relevant parameters.
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Jostra HCU 30) |
|---|---|
| Temperature control range: 0°C - 42°C (main circuit), ice water only (cardioplegia) | 1°C - 41°C (both circuits) |
| Temperature setting resolution: 1°C | 0.1°C |
| Temperature measurement accuracy: ±0.3°C | ±0.3°C |
| Continuous cooling capacity: 4320 kJ/h (1200 W) | 4270 kJ/h (1186 W) |
| Heating Capacity: 1550 W (220 V), 2000 W (115 V) | 3180 W (230 V), 1800 W (115 V) |
| Flow capacity, patient circulation: 5.5 gal/min (21 l/min) | adjustable ca. 2.6-6.1 gal/min (10-23 l/min) |
| Flow capacity, cardioplegia circulation: 2.1 gal/min (7.8 l/min) | min. 1.8 gal/min (7.0 l/min) |
| Maximum pressure, patient circulation: ca. 15.0 psi (700 mmHg) | ca. 34.8 psi (1800 mmHg) |
| Maximum pressure, cardioplegia circulation: ca. 7.5 psi (386 mmHg) | ca. 13.1 psi (675 mmHg) |
Note on Interpretation: This table presents a comparison, and the "acceptance criteria" are implied by the performance of the legally marketed predicate device. The Jostra HCU 30 is considered acceptable if its performance is comparable and safe for its intended use. In many cases, the Jostra device meets or exceeds the predicate's specifications.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "Performance testing" and "Constructional Safety testing," but does not detail the nature of these tests in terms of sample size for a test set, data provenance, or whether they involved human subjects or real-world data in the context of an AI/ML device. For a physical device like a heater-cooler unit, these tests would likely involve bench testing and simulations rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. This concept of "ground truth" established by experts is typically relevant for diagnostic AI/ML devices where human interpretation is involved. For a physical device like a heater-cooler unit, ground truth would be established by objective measurements against known standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for subjective evaluations, often in clinical trials or image interpretation, where a consensus among experts is needed. This is not applicable to the type of device described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication of an MRMC study, nor is "AI assistance" relevant for this device. This is a physical medical device (heater-cooler unit), not a diagnostic AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the Jostra HCU 30. It is a physical device that performs a function (heating/cooling water) that is directly controlled by the device itself, not an "algorithm only" or an AI system that provides an output requiring human interpretation. Its performance is inherent to its design and operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the nature of the device (a heater-cooler unit), the "ground truth" would be objective physical measurements and engineering standards. For example:
- Temperature accuracy: Measured against calibrated thermometers.
- Flow capacity: Measured using flow meters.
- Pressure: Measured using pressure gauges.
- Safety features: Tested to ensure they activate at specified thresholds (e.g., temperature alarms, over-pressure relief).
The document mentions "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" and "Constructional Safety testing included: Electrical Safety, Electromagnetic compatibility EMC, Package and Transportation." These tests inherently involve measuring against defined physical and electrical standards, which serve as the "ground truth."
8. The sample size for the training set
This information is not provided and is not applicable. This device is not an AI/ML model that requires a "training set." Its design and performance are based on engineering principles and physical components, not machine learning.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as there is no training set for this type of device.
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K03/544
510(k) Summary of Safety and Effectiveness
| Submitted by: | Jostra ABAnnedalsv\u00e4gen 2B227 64 Lund, Sweden | AUG | 7 2003 | ||
|---|---|---|---|---|---|
| Contact Person: | LeAnn LathamJostra Corp2828 N. Crescent Ridge Dr.The Woodlands, TX 77381Phone: (281) 363-4949Fax: (281) 292-1269email: 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.
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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 (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
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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
§ 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).