(120 days)
No
The summary describes a portable electric blanket system with a controller for managing power and function. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies. The performance studies focus on electrical safety, washing cycles, and heat density, not algorithmic performance.
Yes
The device is intended to "reduce the effects of hypothermia," which is a medical condition, making it a therapeutic device.
No
Explanation: The device description states its purpose is to "reduce the effects of hypothermia" and "perform therapy." It is a warming device, not one used to identify or diagnose a medical condition.
No
The device description explicitly lists hardware components such as an electrical resistively heated Blanket, a Controller, a rechargeable Battery, special cabling, and means to connect to external power. This indicates it is a hardware device with potentially embedded software, not a software-only medical device.
Based on the provided information, the ChillBuster® Model 8002 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is 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 describes a therapeutic intervention applied directly to the patient's body.
- Device Description: The device is a "Portable Electric Blanket System" that provides "whole-body warming." This is a physical treatment applied externally to the patient.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are used to perform tests in vitro (in glass, or outside the living organism).
The ChillBuster® Model 8002 is a therapeutic medical device used for patient warming, not for diagnosing a condition.
N/A
Intended Use / Indications for 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.
Product codes
DWJ
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.).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
whole-body
Indicated Patient Age Range
adult humans
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 |
1
#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
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.).
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.
2
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)
3
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.
4
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
5
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) |
|---|---|
| ------------------ | -------------------------------------- |
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