(170 days)
The Terumo® HX2™ Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
The Terumo® HX2™ Temperature Management System provides temperature control of two independent water circuits that directly control the temperature of patient blood and cardioplegia solution during cardiovascular bypass surgery.
The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right).
The system will have the capacity to circulate water at least 6.5 gal/min (25 L/min) with no load connected.
The system is capable of heating and cooling for a single channel or for both channels.
Channels are configurable such that different waterlice mixture ratios can be obtained. Manually added ice is the only means of obtaining the cool water supply. If a channel should fail during use, the user may switch the water hose connections to the other channel allowing the user to be operational in less than or equal to a minute.
Software is used to adjust and display channel set temperatures, acquire and display actual temperatures, automatically regulate temperatures to the entered setpoint, perform system diagnostics, and present visual and audible indications of faults that may occur.
The provided text describes a 510(k) premarket notification for the Terumo® HX2™ Temperature Management System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria, sample sizes, and expert ground truth establishment for AI/Machine Learning performance.
Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics (like MRMC or standalone performance, training data, etc.) is not applicable to this traditional 510(k) submission as it is not an AI/ML device.
The document states that the device's performance was "exhaustively tested and compared with the performance characteristics of the currently marketed Sarns™ Dual Cooler/Heater and the Sarns™ Temperature Control and Monitor System (TCM II)." It also concludes that "The Terumo® HX2 ™ Temperature Management System performed as intended according to its performance specifications." However, the specific acceptance criteria and the detailed results of these tests (e.g., in a table format) are not provided in this summary.
General Summary of the Device and its Testing as per the Document:
- Device: Terumo® HX2™ Temperature Management System
- Indication for Use: To supply temperature regulated water to heat exchangers during open heart surgery.
- Legal Basis: 510(k) premarket notification, demonstrating substantial equivalence to predicate devices (Sarns™ Dual Cooler/Heater and Sarns™ Temperature Control and Monitor System (TCM II)).
- Performance Evaluation: Non-clinical performance testing was conducted where the HX2™ system's characteristics were compared to its predicate devices.
- Conclusion: The device performed as intended based on its performance specifications and was found to be substantially equivalent to its predicate devices.
Specific answers to the requested points, based only on the provided text:
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in a quantitative table. The general acceptance criterion is that the device "performed as intended according to its performance specifications" and its characteristics were successfully "compared with the performance characteristics" of the predicate devices.
- Reported Device Performance:
- Circulate water at least 6.5 gal/min (25 L/min) with no load.
- Capable of heating and cooling for a single channel or both channels.
- User can switch water hose connections to the other channel allowing operation in ≤ 1 minute if a channel fails.
- Automated control for both heating and cooling.
- Improvements to priming and draining.
- Range of user temperature setpoints for both channels (compared to 4 hardware-limited setpoints of predicate).
- New system diagnostics display error codes.
- Temperature display accuracy "better than analog temperature display on Dual Cooler Heater."
- Operation within 10° to 40°C, < 75% relative humidity, non-condensing.
- Storage within -30° to 54°C, < 95% relative humidity, non-condensing.
- Transportable up to 15 degrees incline without tipping.
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Sample size used for the test set and the data provenance: Not mentioned. The testing described is non-clinical performance testing of a mechanical/electrical system, not typically involving human test sets or data provenance in the way AI studies do.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable. This is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML ground truth. The "ground truth" for this device's performance would be engineering specifications and validated measurements against those specifications and comparison to the predicate devices.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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NOV 2 1 2007
Image /page/0/Picture/2 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter "T" inside, followed by the word "TERUMO" in bold, sans-serif font. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in a smaller, sans-serif font. The logo is black and white.
510(k) SMDA Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) Number is
| Submitters Name: | Terumo Cardiovascular Systems Corporation |
|---|---|
| Submitters Address: | 6200 Jackson Road, Ann Arbor, Michigan 48103-9300 |
| Contact Person: | Mark A. Bur |
| Phone Number: | (734) 741-6117 |
| FAX Number: | (734) 663-5062 |
| Summary Date: | May 30, 2007 |
Device Trade Name: Terumo® HX2™ Temperature Management System
Common Name: Temperature Management System (TMS)
Device Classification Name: Cardiopulmonary Bypass Temperature Controller (21 CFR 870.4250)
Legally Marketed Predicate Device: Sarns TM Dual Cooler/Heater (Preamendment) Sarns ™ Temperature Control and Monitor System (TCM II) (K883603)
Indications for Use:
The Terumo® HX2™ Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
| Operation | 10° to 40°C, less than 75% relative humidity, non condensing |
|---|---|
| Storage | Ventilated area, -30° to 54° C (-22 to 130°F), less than 95% relativehumidity, non-condensing. |
| Transporting | Units may be transported up or down an incline up to 15 degreeswithout tipping. |
Device Description:
The Terumo® HX2™ Temperature Management System provides temperature control of two independent water circuits that directly control the temperature of patient blood and cardioplegia solution during cardiovascular bypass surgery.
The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right).
The system will have the capacity to circulate water at least 6.5 gal/min (25 L/min) with no load connected.
The system is capable of heating and cooling for a single channel or for both channels.
Traditional 510(k) Terumo® HX2™ Temperature Management System Terumo Cardiovascular Systems Corporation
Section 03:
Page 03-1
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Image /page/1/Picture/1 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter "T" inside, followed by the word "TERUMO" in bold, sans-serif font. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in a smaller font. The logo is black and white.
Channels are configurable such that different waterlice mixture ratios can be obtained. Manually added ice is the only means of obtaining the cool water supply. If a channel should fail during use, the user may switch the water hose connections to the other channel allowing the user to be operational in less than or equal to a minute.
Software is used to adjust and display channel set temperatures, acquire and display actual temperatures, automatically regulate temperatures to the entered setpoint, perform system diagnostics, and present visual and audible indications of faults that may occur.
Technological Characteristics:
The Terumo® HX2™ Temperature Management System is a combination of the technologies from the current legally marked devices, Sarns™ Dual Cooler/Heater and the Sams™ Temperature Control and Monitor System (TCM II) and the present day technologies and a computer. The main differences between the predicate devices, Sarns™ Dual Cooler/Heater and the Sarns™ Temperature Control and Monitor System (TCM II) and the Terumo® HX2 ™ Temperature Management System are:
- · old Hg-added switches used in predicates replaced with thermosistors and rtd temperature sensors,
- · old single channel of Dual Cooler Heater and 2 dependent channels of TCM II compared to 2 independent channels with equal capability.
- · automated control of the new system for both heating and cooling compared to predicates manual control.
- · improvements to the priming and draining of the new system compared to both predicates,
- · range of user temperature setpoints for both channels compared to predicate (4) hardware limited setpoints,
- · new system diagnostics will display error codes compared to no indications for the Dual Cooler Heater and only LED visual indicators on the TCM II,
- · temperature display accuracy better than analog temperature display on Dual Cooler Heater.
Non-clinical Performance:
The performance characteristics of the Terumo® HX2 ™ Temperature Management System were exhaustively tested and compared with the performance characteristics of the currently marketed Sarns™ Dual Cooler/Heater and the Sarns™ Temperature Control and Monitor System (TCM II). All new and existing performance characteristics of the Terumo® HX2™ Temperature Management System have been validated.
Conclusion from Conducted Testing:
The Terumo® HX2 ™ Temperature Management System performed as intended according to its performance specifications. The Terumo® HX2™ Temperature Management System is substantially equivalent to its predicate devices.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.
NOV 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Terumo Cardiovascular Systems Corp. c/o Mr. Mark A. Bur 6200 Jackson Rd. Ann Arbor, MI 48103
Re: K071521
Terumo HX2 Temperature Management System Regulation Number: 21 CFR 870.4250 Regulation Name: Cardiopulmonary bypass temperature controller Regulatory Class: Class II (two) Product Code: DWC Dated: November 8, 2007 Received: November 9, 2007
Dear Mr. Bur:
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, listing 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 - Mr. Mark Bur
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K271521 |
|---|---|
| --------------------------- | --------- |
Terumo® HX2™ Temperature Management System Device Name:
Indications For Use:
The Terumo® HX2™ Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
10° to 40°C, less than 75% relative humidity, non-condensing. Operation
Ventilated area, -30° to 54°C (-22 to 130°F), less than 95% Storage relative humidity, non-condensing.
Transporting Units may be transported up or down an incline of up to 15 degrees without tipping.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
QgmQ
diovascular Devices
K011521 510(k) Number.
Traditional 510(k) -Terumo® HX2™ Temperature Management System Terumo Cardiovascular Systems Corporation
Section 02: Page 02 - 1
§ 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).