The ChillBuster® Model 8002 has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition. Use is limited to whole-body warming in adult humans, free of skin conditions or other impairments where distributed heat application is deemed contraindicated by the responsible physician.

Device Description

The ChillBuster® Model 8002 Portable Electric Blanket System features a special electrical resistively heated Blanket, a Controller to manage power and device function, a rechargeable Battery, special cabling, and means to connect to external DC or AC power for recharging the Battery and, at the option of the user, operating the Blanket. During therapy, the Blanket is encased in a Sterile, Single-Use Blanket Cover to prevent cross-contamination of successive patients and to prevent soiling. The device can perform therapy at virtually any interval in the following activities or activity chains: a) initial patient preparation and transport in the field, and at any stage of ER, surgery, and ICU or post-op care for injury victims from the field; b) pre-op, surgery, ICU or post-op care of in-facility patients; and c) special situations involving potential or actual hypothermia (e.g. hemodialysis; peritoneal dialysis; plasmapheresis; patient warming during transport from point to point, etc.).

AI/ML Overview

This is a 510(k) summary for a portable electric blanket, not an AI device. As such, the requested information regarding AI device acceptance criteria, study details, ground truth, and expert involvement is not applicable or available in the provided text.

Here's an overview of the non-clinical performance data provided, which serves as the acceptance criteria for this non-AI medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standards Met/Performance Goal)	Reported Device Performance
Compliance with Consensus Standards:
IEC/EN 60601-1 (General Medical Safety)	Device has been tested to currently valid versions of this standard.
EN/JEC 60601-1-2 (Electromagnetic Compatibility)	Device has been tested to currently valid versions of this standard.
IEC 60601-2-35 (Heating Pads and Blankets)	Device has been tested to currently valid versions of this standard. The safety cutoff temperature is 41 ± 1℃, which is the same as specified in IEC 60601-2-35 for maximum safety.
ISO 14971 (Application of Risk Management)	Device has been tested to currently valid versions of this standard.
CAN/CSA C22.2 No. 601.1-M90 (Canadian General Medical Safety)	Device has been tested to currently valid versions of this standard.
Durability (Washing/Drying Cycles):	Blanket subjected to 50 washing/drying cycles using household detergent and machines. No sign of wear or deterioration. Function demonstrated to be normal in five sessions of heating performance tests.
Water Resistance/Functionality:	Demonstrated to function normally even when completely submerged (except for the Blanket Connector).
Heat Density Comparison:	Analytical calculations showed higher heat density at the actively heated surface compared to the ChillBuster® predicate, but a small percentage of the Life-Air predicate.
Temperature Safety Limit:	Blanket limit is 41 ± 1℃. This is within the maximum safety cutoff temperature specified in International Standard IEC 60601-2-35 and lower than the Life-Air predicate's 43 ± 3℃.
Operational Modes:	Can operate the Blanket while connected to the AC line (a significant difference from the predicate).
Power Output:	Higher power output to the Blanket compared to the predicate (but still low compared to the Life-Air Predicate).
Temperature Monitoring/Distribution:	Improved Blanket temperature monitoring and assurance of even heat distribution (compared to the predicate).

2. Sample size used for the test set and the data provenance:

Test Set Sample Size:
- Washing/Drying: 1 blanket (subjected to 50 cycles).
- Heating Performance: 1 blanket (tested across 5 sessions).
- Submersion: 1 blanket.
Data Provenance: Not explicitly stated, but the tests were conducted as non-clinical performance data studies, likely by the manufacturer. No country of origin for "data" in the context of patient data is relevant here, as this is a physical device testing. The studies are prospective in nature, as they involve actively testing the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a medical device (electric blanket) undergoing engineering and safety testing against established standards, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is the pass/fail criteria of the tests and compliance with regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks in AI studies. For this device, performance is evaluated against predefined engineering standards and test protocols.

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:

Not applicable. This is not an AI device, and therefore, no MRMC study involving human readers and AI assistance was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm. The "standalone performance" refers to the device's functional and safety performance as described in point 1 above.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is established by international and national consensus standards for medical device safety and performance (e.g., IEC/EN 60601-1, IEC 60601-2-35, ISO 14971, CAN/CSA C22.2 No. 601.1-M90) and the physical attributes and intended function of the device. For example, the maximum temperature cutoff of 41 ± 1℃ is a safety standard specified in IEC 60601-2-35.

8. The sample size for the training set:

Not applicable. This is not an AI device, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for it.

Summary

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K071918

510(k) SUMMARY

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

510(k) Summary of Safety and Effectiveness

Submitter Information

ThermoGear™ Inc. (contact: Wayne Fields, PhD) 16337 SW Bryant Rd (PO Box 1545) NOV 0 9 2007 Lake Oswego, OR 97035 (Phone): 503.697.1900; (FAX): 503.697.1907

NOV 0 9 2007

Date Summary Prepared: June 1, 2007 (Rev. A)

Device Information

ChillBuster® Model 8002 Portable Electric Blanket, with CDRH formal identity:

Device Group:	System, Thermal Regulating
Medical Specialty:	Cardiovascular
Product Code:	DWJ
Device Class:	2
Regulation No.:	870.5900

Predicate Devices

#K991684 ChillBuster® Model 8001 Portable Electric Blanket, CDRH formal identity:

Device Group:	System, Thermal Regulating
Medical Specialty:	Cardiovascular
Product Code:	DWJ
Device Class:	2
Regulation No.:	870.5900

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#K952329 Life-Air 1000® Hypothermic Therapy System. Its CDRH formal identity is:

Device Group:	System, Thermal Regulating
Medical Specialty:	Cardiovascular
Product Code:	DWJ
Device Class:	2
Regulation No.:	870.5900

Device Description

Intended Use

The ChillBuster® Model 8002 Portable Electric Blanket has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition. This is the same as that of the ChillBuster® predicate and the Life-Air predicate.

For both the ChillBuster® proposed and predicate devices, use is limited to wholebody warming in adult humans, free of skin conditions or other impairments where distributed heat application is deemed contraindicated by the responsible physician. In turn, the Life-Air predicate can also treat younger and pediatric patients.

Technological Characteristics

The proposed device is largely the same as the ChillBuster® predicate device. The significant differences are that the proposed device can operate the Blanket while connected to the AC line, and the power output to the Blanket is higher in the proposed versus predicate device (but still low compared to the Life-Air Predicate), and the proposed device has improved Blanket temperature monitoring and assurance of even heat distribution.

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Non-Clinical Performance Data

The proposed device has been tested to currently valid versions of the following Consensus Standards and other Standards that include:

IEC/EN 60601-1, General Medical Safety; EN/JEC 60601-1-2, Electromagnetic Compatibility; IEC 60601-2-35. Heating Pads and Blankets; ISO 14971, Application of Risk Management to Medical Devices; CAN/CSA C22.2 No. 601.1-M90, Canadian General Medical Safety.

The proposed device Blanket was subjected to 50 washing/drying cycles using household detergent and machines, with no sign of wear or deterioration, and function was demonstrated to be normal in the five sessions in which Blanket heating performance was tested. In separate tests, it was demonstrated that the Blanket functions normally even when completely submerged (except for the Blanket Connector that connects the Blanket to a cable from the Controller).

Analytical calculations were carried out to show that the heat density at the actively heated surface of the ChillBuster® proposed device Blanket was higher than that of the ChillBuster® predicate but only a small percentage of that of the actively heated surface of the Life-Air predicate patient cover. Importantly, the Life-Air predicate specifies a safety cutoff temperature of 43 ± 3℃, whereas the ChillBuster® proposed device Blanket limit is 41 ± 1℃. The latter is the same as that specified for maximum safety cutoff temperature in the International Standard IEC 60601-2-35.

Conclusion

The ChillBuster® proposed device is substantially equivalent to the ChillBuster® predicate device in terms of System general structure, arrangement, function, and temperature tolerance, and to the Life-Air Predicate device in terms of operation from the AC line, temperature safety limits, and output power to the patient therapy component (blanket or cover). The proposed device and both predicates have the same basic Intended Use and Indications for Use. The Predicate 8001 and the proposed device place qualifications on patient age and condition.

(4)

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a series of interconnected shapes, possibly representing people or services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

ThermoGear Inc. c/o Mr. Gregor Dzialas Responsible Third Party Official 12 Commerce Road Newtown, CT 06470

Re: K071918

ChillBuster® Model 8002 Portable Electric Blanket Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (Two) Product Code: DWJ Dated: July 10, 2007 Received: October 24, 2007

Dear Mr. Dzialas:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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. Gregor Dzialas

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Dma R. Vachner

A 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

K07 19 | 8 510(k) Number (if known):

Devicc Name:

ChillBuster® Model 8002 Portable Electric Blanket

Indications for Use: The ChillBuster® Model 8002 has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition. Use is limited to whole-body warming in adult humans, free of skin conditions or other impairments where distributed heat application is deemed contraindicated by the responsible physician.

Prescription Use	X (Part 21 CFR 801 Subpart D)
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AND/OR

Over-The-Counter Use	(Part 21 CFR 801 Subpart D)
----------------------	-----------------------------

Anna B. Vachon

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number: K071918

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).