MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002

K083135 · Thermogear, Inc. · DWJ · Oct 31, 2008 · Cardiovascular

Device Facts

• Record ID: K083135
• Device Name: MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002
• Applicant: Thermogear, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Oct 31, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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. For both the Modified and Predicate devices, 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 Story

Portable electric blanket system for whole-body warming; used to treat or prevent hypothermia during surgical procedures or medical crises. Device consists of heating unit and blanket cover; requires practitioner decision on use of sterile vs. non-sterile cover based on clinical environment and patient condition. Operated by healthcare professionals in clinical settings. Provides thermal regulation to patient; helps maintain normothermia; improves patient outcomes by mitigating hypothermic trauma. Modification involves updated labeling regarding sterile cover requirements; no changes to device design or heating technology.

Clinical Evidence

No clinical data provided. Bench testing not required for labeling modification.

Technological Characteristics

Portable electric thermal regulating system. Consists of heating unit and single-use blanket covers (sterile or non-sterile). No changes to materials or energy source from predicate. Class II device (21 CFR 870.5900).

Indications for Use

Indicated for whole-body warming in adult humans to reduce hypothermia effects during surgical trauma or medical crisis. Contraindicated for patients with skin conditions or impairments where distributed heat application is deemed inappropriate by a physician.

Regulatory Classification

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.

Predicate Devices

• ChillBuster® Model 8002 Portable Electric Blanket (K071918)
• DM-EMG Hypothermic Therapy System (K072513)

Submission Summary (Full Text)

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1083135

4

OCT 3 1 2008

# 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness is provided as part of a 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.

#### Submitter Information

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

Date Summary Prepared: June 27, 2008

### Device Information

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

Device Group: Medical Specialty: Product Code: Device Class: Regulation No:

System, Thermal Regulating Cardiovascular DWJ 2 870.5900

#### Predicate Devices

#K071918 ChillBuster® Model 8002 Portable Electric Blanket; ThermoGear Inc; #K072513 DM-EMG Hypothermic Therapy System; Medvation LLC.

#### Device Description

This device, as now cleared, permits use with either a sterile or a non-sterile blanket cover, as necessary, upon the determination by a health care practitioner. Most intended use does not involve surgery. Also, even during surgery, only those interventions where the blanket cover would threaten a sterile operating field actually require a sterile blanket cover to achieve intended function.

The present design modification involves no change to intended use, indications for use, technological basis, device design, or substantial equivalence. And both the ChiliBuster® Predicate and Modified devices require use of a blanket cover with every therapy session. For ThermoGear's ChillBuster® product, the only Predicate/Modified device difference lies in labeling that addresses when to use a sterile versus non-sterile blanket cover.

ThermoGear Inc.

Confidential & Proprietary

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While the Predicate 8002 requires use of a sterile blanket cover for every therapy, the Modified 8002 "requires the decision to use a sterile or a non-sterile blanket the woulded by a medical practitioner, familiar with the patient's condition and circumstance." This improves practicality, while not sacrificing device safety and effectiveness.

#### Intended Use

There is no difference in intended use of the Modified versus Predicate devices.

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.

For both the Modified and Predicate devices, 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.

#### Technological Characteristics

The elements of the ChillBuster® system that comprise the current subject, sterile and non-sterile blanket covers, are exactly the same in both the Modified and Predicate devices. The only difference is in labeling related to when to use sterile covers compared to non-sterile ones. The latter is treated in prior discussion.

#### Non-Clinical Performance Data

Clearance of the subject of this submittal, requirements of when to use a sterile or non-sterile blanket cover, does not require performance data. The two cover types are the same in every way, save the state of sterility. Practitioners can be expected to know the functional properties of sterile versus non-sterile single-use products. The present design change merely replaces an overly restrictive requirement for sterile cover use with one that is practical in the real world.

#### Conclusion

The ChillBuster® Modified 8002 is substantially equivalent to the ChillBuster® Predicate 8002 at all levels of system design. The subject here is an upgrade of labeling, to render required use of a sterile blanket cover only when the attending practitioner judges such protection is needed. This provides better clarity to assure safer and more effective use.

Confidential & Proprietary

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 2008

Microtek Medical, Inc. c/o Mr. Tamas Borsai TUV Rheinland of North America, Inc. 12 Commerce Road Newton, CT 06470

Rc: K083135

ChillBuster Portable Electric Blanket, Model 8002 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: October 2, 2008 Received: October 23, 2008

Dear Mr. Borsai:

We have reviewed your Section 510(k) premarket notification of intent to market the device w only reveal 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 for use stated in the encreated)76 the enactment date of the Medical Device Amendments, or to continer of they 20, 2018 10:11 accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, merelore, manes of the Act include requirements for annual registration, listing of general connects provision practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device 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. Tamas Borsai

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 rcquirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice rcquirements 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 Scction 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 [phone]. 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 Biometrics' (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-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

#### K08 313 5 510(k) Number (if known):

#### ChillBuster® Model 8002 Portable Electric Blanket Device Name:

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 | <b>X</b> | AND/OR | Over-The-Counter Use | _ |
|-----------------------------|----------|--------|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | | | (Part 21 CFR 801 Subpart D) | |

(Division/Sign-Off)

Division of Cardiovascular Devices

| ThermoGear Inc. | 510(k) Number | K083135 | Confidential & Proprietary |
|-----------------|---------------|---------|----------------------------|
|-----------------|---------------|---------|----------------------------|