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 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.

AI/ML Overview

The provided 510(k) summary for the WarmTouch Model 5300 Patient Warming System does not contain detailed acceptance criteria and a specific study proving the device meets those criteria in the typical format seen for AI/ML medical devices. This submission pertains to a re-submission of a Convective Air Warming System with minor changes relating to temperature settings, which falls under a different regulatory pathway than novel AI/ML devices.

However, based on the information provided, we can infer some aspects related to acceptance criteria and performance testing:

Inferred Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance
Safe Maximum Temperature Compliance	Performance testing of the WarmTouch Model 5300 with the CareQuilt and CareDrape Blankets demonstrated safe maximum temperature compliance.
Electrical Safety	Testing demonstrated compliance to applicable sections of UL544 Standard for Safety for Medical and Dental Equipment, IEC 60601-1-2:1993, and CAN/CSA C22.2 No. 125 for Electromedical Equipment.
Electromagnetic Compatibility (EMC)	Testing demonstrated compliance to applicable sections of IEC 60601-1-2:1993 1st Edition requirements.
Patient Warming System Specific Standards	Testing demonstrated compliance to IEC 60601-2-35 Particular Standard for Patient Warming Systems.
Circulating Liquid and Forced Air Patient Temperature Management Devices	Performance testing demonstrated conformity to the draft ASTM Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices.

Information Not Present or Applicable to this Submission Type:

The following information is typically relevant for AI/ML device submissions, but is not provided or applicable in this 510(k) for a hardware-based patient warming system with minor modifications:

Sample size used for the test set and the data provenance: Not provided. The performance testing described suggests engineering and safety verification rather than a clinical trial with a "test set" as understood for AI/ML.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a patient warming device would be based on validated instrumentation for temperature measurement and safety standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This device is not designed to assist human readers in interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for a patient warming device's performance would be established through objective measurements of temperature outputs, electrical safety, and electromagnetic compatibility against industry standards.
The sample size for the training set: Not applicable for this type of device.
How the ground truth for the training set was established: Not applicable for this type of device.

Summary of the Study Proving Acceptance Criteria:

The "study" or rather, the verification and validation process, involved several types of performance and safety testing:

Safe Maximum Temperature Compliance Testing: This likely involved measuring the maximum temperature achievable by the device under various operating conditions to ensure it remains within safe limits for patient contact, using both the CareQuilt and CareDrape Blankets. The criteria for "safe" maximum temperature would be defined by relevant standards and clinical understanding of thermal injury thresholds.
Electrical Safety Testing: This encompassed tests to ensure the device poses no electrical hazard, complying with:
- UL544 Standard for Safety for Medical and Dental Equipment
- IEC 60601-1-2:1993 1st Edition requirements (likely referring to general requirements for electrical safety and electromagnetic compatibility)
- CAN/CSA C22.2 No. 125 for Electromedical Equipment
Electromagnetic Compatibility (EMC) Testing: This testing ensures the device does not interfere with other electronic equipment and is not adversely affected by electromagnetic fields, specifically complying with IEC 60601-1-2:1993 1st Edition requirements.
Patient Warming System Specific Standard Compliance: The device demonstrated compliance with IEC 60601-2-35 Particular Standard for Patient Warming Systems, which sets specific requirements for the safety and essential performance of patient warming systems.
ASTM Standard Conformity: The performance testing also showed conformity to a draft ASTM Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices.

Conclusion stated in the 510(k) Summary:

The manufacturer concluded that "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." This indicates that the purpose of the testing was to demonstrate that the changes in temperature settings did not negatively impact the safety or effectiveness previously established for the predicate device, and that the updated device continues to meet established industry and regulatory standards.

Summary

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K62004

280 Hacienda Dri Pleasanton, CA 9458

Tele: 925 463-4000 Fax: 925 463-4020

tuco Healthcare

Nellcor

510(k) Summary

APR 2 3 2002

Submitted by:	Nellcor Puritan Bennett Incorporated(A business unit of Mallinckrodt Inc.,a division of Tyco Healthcare Group LP)4280 Hacienda DrivePleasanton, CA 94588
Company Contact:	Gina ToSenior Regulatory Affairs Project Manager(925) 463-4427(925) 463-4020 - 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 PredicateDevice (Unmodified):	WarmTouch, Advanced Warming Systems, Inc.,510(k) #K913016

Device Description

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

Intended Use

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 (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 O invision 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 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:

(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)

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).