ChillBuster™ Portable Electric Blanket is to be used 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.

Device Description

The ChillBuster™ Portable Electric Blanket System is made up of six major components: Blanket, Control Module, Cabling, Battery, AC adapter, Carrying Bag.

AI/ML Overview

This document appears to be a 510(k) Pre-market Notification Summary for a medical device called the "ChillBuster™ Portable Electric Blanket." It primarily serves to establish substantial equivalence to a legally marketed predicate device, rather than providing extensive details about a study demonstrating performance against specific acceptance criteria.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not provided in this type of submission.

Here's the breakdown based on the provided text, indicating where information is present versus where it's absent or not relevant for this document type:

Acceptance Criteria and Device Performance Study Details (K022903)

This 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards, rather than presenting a performance study with explicit acceptance criteria. The "acceptance criteria" here implicitly refer to meeting the requirements of the standards listed and performing equivalently to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied from Standards & Predicate Equivalence)	Reported Device Performance (Summary from 510k)
Safety:	Compliance:
• IEC 601-1: 1998; Amd. 1: 1991; Amd. 2: 1995 (General Medical Safety)	Unit was tested using these standards.
• UL 2601-1 (General Medical Safety)	Unit was tested using these standards.
Electromagnetic Compatibility (EMC):	Compliance:
• IEC 601-1-2	Unit was tested using this standard.
Functional Equivalence:	Substantial Equivalence:
• Perform equivalently to ChillBuster™ (ThermoGear K991684)	Stated as substantially equivalent.
• Perform equivalently to Life-Air 1000 (Progressive Dynamics Inc.)	Stated as substantially equivalent.
Intended Use:	Met:
• Reduce effects of hypothermia during surgical procedures or other medical crises.	Indications for Use statement confirms this.
Device Characteristics:	Description Provided:
• Blanket size, materials, thermal wire array, control module components, battery, AC adapter, carrying bag.	Detailed component descriptions provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable / Not provided. This document does not detail a specific performance study with a test set of data points or patients. The testing referenced is related to compliance with electrical and safety standards for the device itself, not a clinical data set.

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):

Not applicable / Not provided. No ground truth establishment for a test set is discussed in this 510(k) summary.

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

Not applicable / Not provided. No test set or related adjudication method is mentioned.

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 device is a portable electric blanket, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

Not applicable / Not provided. No ground truth for a performance study is mentioned. The "ground truth" for this submission is implicitly the established safety and performance benchmarks of the predicate devices and the requirements of the cited industry standards.

8. The sample size for the training set:

Not applicable / Not provided. This is not an AI/algorithm device, so there is no training set in the typical sense.

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

Not applicable / Not provided. (See #8).

Summary

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K022903

Premarket (510k) Summary

Submitter Information

NOV 2 7 2002

Microtek Medical, Inc. 512 Lehmberg Road Columbus, Mississippi 39702 662-327-1863 Contact person: Thomas Bonner Date prepared: August 15, 2002

Device Name

Proprietary name: ChillBuster™ Portable Electric Blanket Common name: Hypothermic Therapy System. CDRH Product Regulation: Thermal Regulation System (21 CFR, 870,5900)

Establishment Registration Number: 1043582 (Microtek Medical, Inc.)

Classification: II (74 DWJ)

Statement of Substantial Equivalence

ChillBuster™ Portable Electric Blanket is equivalent to:

1. ChillBuster™ (ThermoGear K991684)
1. Life-Air 1000 (Progressive Dynamics Inc., Marshall, MI)

Description of Device

The ChillBuster™ Portable Electric Blanket System is made up of six major components:

Blanket. The main functional system element is 40"X 60" in area, featuring an oxford nylon outer layer and an inner layer of knapped acrylic blanket fabric. The unique ChillBuster™ array of special thermal wire resides between the two layers, thermal wire extensions and electrical data relative to blanket temperature exiting the blanket through a special interface and connector at one blanket corner. The latter blanket connector extends a few inches from the blanket corner, and mates with the blanket cable from the control module. The blanket can be machine washed and dried.

Control Module. Five key sub-units form this component: 1) one electric circuit board (ECB) where all control and electronics reside; 2) one user interface panel, providing information and controls; 3) Interconnect wiring to the user interface panel and to the battery; 4) a molded chassis that forms the base for the other components, along with a recessed compartment accepting two sizes of battery (see below); and 5) the blanket cable, hard wired to the ECB, and exiting the control module through the user interface panel (see cabling below);

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Cabling. There are two cables associated with the system. One is the blanket cable, hard wired to the ECB, exiting the control module through the interface panel, and extending approximately six feet to a terminal connector at the blanket end of the cable. The latter connector mates with a corresponding connector that terminates a short (few inches long) pigtail cable protruding from the corner of the blanket. The other cable is an optional cigarette lighter cable, to allow system charging and/or operation using power from any vehicle cigarette lighter socket that supplies 12 volts;

Battery. The 8000 series employs a 12 volt, sealed lead acid, rechargeable battery. The control module will accept two different battery configurations, of 7 amp-hour and 4 amp-hour capacity, respectively. The purchaser specifies the desired battery capacity at the time of purchase.

AC adapter. All 8000 series systems include and standard, U2601-1 approved, AC-to-DC adapter properly matched to the voltage, current and interconnect requirements of other system components applicable to local AC line power.

Carrying Bag. ChillBuster™ systems include a custom carrying bag with several important features, including; a suitcase type carrying handle; a shoulder strap; and an internal shelf in the bag that separates the upper two thirds of the bag cavity as a blanket and cable storage compartment, leaving the lower one-third for the control module with attached battery. Removal of the blanket and cables from the carrying bag permits user access to the user interface panel on the control module.

Standards. The following standards were used in the testing of this unit:

General Medical Safety: IEC 601-1: 1998; Amd. 1: 1991; Amd. 2: 1995 UL 2601-1

EMC IEC 601-1-2

Intended Use

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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms, composed of three curved lines.

Public Health Service

9200 Corporate Boulevard Rockville MD 20850

NOV 27 2002

Microtek Medical, Inc. c/o Mr. Thomas B. Bonner, Jr. Vice President, Regulatory Affairs/Quality Assurance 512 Lehmberg Road Columbus, MS 39702

Re: K022903

Trade Name: ChillBuster™ Portable Electric Blanket Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (two) Product Code: DWJ Dated: August 15, 2002 Received: September 3, 2002

Dear Mr. Bonner:

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. Thomas B. Bonner, Jr.

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 (OS) 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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.

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 Statement

510(k) Number

Device Name: Microtek Medical, Inc. ChillBuster™ Portable Electric Blanket

Indications for Use Statement:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

V. Deluca

(Division Sign-Off) Division of Cardiovascular, Respiratory, And Neurological Devices

140 28403 510(k) Number

Prescription Use
(per 21CFR 801.109)

Over-The-Counter Use

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).