WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300

K020604 · Nellcor Puritan Bennett, Inc. · DWJ · Apr 23, 2002 · Cardiovascular

Device Facts

• Record ID: K020604
• Device Name: WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Apr 23, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WarmTouch Model 5300 Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, for example, with the surgical patient, the patient in the pre-operative holding area, the pregnant woman who shivers during epidural anesthesia due to hypothermia, or any patient who is uncomfortable anywhere in the cold critical care environment.

Device Story

WarmTouch Model 5300 is a convective air warming system; consists of a warming unit and specialized blankets (CareQuilt or CareDrape). Device warms air and delivers it into the blanket placed over or under the patient to transfer heat across the skin. Used in clinical settings (OR, pre-operative holding, critical care) to prevent or treat hypothermia. Operated by healthcare professionals. Modification from predicate involves updated temperature settings. Benefits include patient comfort and maintenance of normothermia.

Clinical Evidence

Bench testing only. Performance testing demonstrated safe maximum temperature compliance and conformity to ASTM standards for forced air patient temperature management devices. Electrical safety and EMC testing demonstrated compliance with UL544, IEC 60601-1-2, IEC 60601-2-35, and CAN/CSA C22.2 No. 125.

Technological Characteristics

Convective air warming system. Components: warming unit and blankets (CareQuilt/CareDrape). Standards: UL544, IEC 60601-1-2:1993, IEC 60601-2-35, CAN/CSA C22.2 No. 125, and draft ASTM Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices. Energy source: electrical. Form factor: warming unit with air-delivery blankets.

Indications for Use

Indicated for prevention and treatment of hypothermia in surgical patients, pre-operative patients, pregnant women shivering during epidural anesthesia, and patients in cold critical care environments.

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

• WarmTouch, Advanced Warming Systems, Inc. (K913016)

Submission Summary (Full Text)

{0}------------------------------------------------

K62004

280 Hacienda Dri Pleasanton, CA 9458

Tele: 925 463-4000 Fax: [phone]

# tuco Healthcare

Nellcor

# 510(k) Summary

APR 2 3 2002

| Submitted by: | Nellcor Puritan Bennett Incorporated<br>(A business unit of Mallinckrodt Inc.,<br>a division of Tyco Healthcare Group LP)<br>4280 Hacienda Drive<br>Pleasanton, CA 94588 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Gina To<br>Senior Regulatory Affairs Project Manager<br>[phone]<br>[phone] - FAX |
| Date Summary Prepared: | February 22, 2002 |
| Trade Name: | WarmTouch Model 5300 Patient Warming System |
| Common/Usual Name: | Convective Air Warming System |
| Classification Name: | Thermal Regulating System per 21 CFR §870.5900 |
| Product Code: | DWJ |
| Legally Marketed Predicate<br>Device (Unmodified): | WarmTouch, Advanced Warming Systems, Inc.,<br>510(k) #K913016 |

## Device Description

The WarmTouch Model 5300 Patient Warming System surrounds the patient with warm air and convectively transfers heat across the skin. With the WarmTouch Model 5300 Patient Warming System, air is warmed and delivered into a lightweight blanket (CareQuilt or CareDrape Blanket) that rests over or under the patient.

The modification to the WarmTouch Patient Warming Unit consists of design changes relating to temperature settings.

#### Intended Use

The WarmTouch Model 5300 Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, for example, with the surgical patient, the patient in the pre-operative holding area, the pregnant woman who shivers during epidural anesthesia due to hypothermia, or any patient who is uncomfortable anywhere in the cold critical care environment.

NPB CONFIDENTIAL

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# Summary of Technological Characteristics of the Device Compared to the Legally Marketed (Unmodified) Device

The WarmTouch Model 5300 Patient Warming System has the same technological characteristics as the above referenced predicate device. The only changes relate to temperature settings.

#### Testing

Performance testing of the WarmTouch Model 5300 with the CareQuilt and CareDrape Blankets demonstrated safe maximum temperature compliance.

Testing of the WarmTouch Model 5300 Patient Warming System for electrical safety and EMC testing demonstrated compliance to applicable sections in the November 1993 FDA Review Guidance document, UL544 Standard for Safety for Medical and Dental Equipment, IEC 60601-1-2:1993 1st Edition requirements, IEC 60601-2-35 Particular Standard for Patient Warming Systems, and CAN/CSA C22.2 No. 125 for Electromedical Equipment. Performance testing demonstrated conformity to the draft ASTM Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices.

#### Conclusions

The WarmTouch Model 5300 Patient Warming System and the results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2002

Ms. Gina To Senior Regulatory Affairs Project Manager Nellcor Puritan Bennett Incorporated 4280 Hacienda Drive Pleasanton, CA 94588

Re: K020604

Trade Name: WarmTouch Model 5300 Patient Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (two) Product Code: DNJ Dated: March 27, 2002 Received: March 28, 2002

Dear Ms. To:

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 - Ms. Gina To

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of acrease 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 or unf I vith 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 Of It Fart 6077, accems (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) rms letter will and in your e FDA finding of substantial equivalence of your device to a legally promance motification " 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 O invision of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Qarla Tull

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

WarmTouch Model 5300 Patient Warming System Device Name:

## Indications For Use:

The WarmTouch Model 5300 Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, for example, with the surgical patient, the patient in the pre-operative holding area, the pregnant woman who shivers during epidural anesthesia due to hypothermia, or any patient who is uncomfortable anywhere in the cold critical care environment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Division of Cardiovascular & Respiratory Devices**
510(k) Number

(Optional Format 3-10-98)

**Prescription Use**
(Per 21 CFR 801.109)