The WarmTouch Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia and/or shivering in the critical care environment.

Device Description

The Warm Touch® CareDrape™ Cardiac Blanket is similar to the CareDrape™ Lower Body Blanket in use, as both are used in the operating room to help manage the patient's body temperature. The WarmTouch® CareDrape™ Cardiac Blanket is similar to the CareQuilt™ Full Body/ Multi-Access Warming Blanket, as both are equipped with slits, which can be opened for access to the patient through the blanket. The kev difference between the Cardiac Blanket and all earlier WarmTouch® blankets is that the Cardiac Blanket is sterile permitting use of the blanket within the sterile field.

AI/ML Overview

The provided text describes performance testing for a medical device (WarmTouch® CareDrape™ Cardiac Blanket) to demonstrate its substantial equivalence. The document is a 510(k) summary, which focuses on device-specific physical and functional characteristics rather than clinical AI algorithm performance. Therefore, many of the requested categories related to AI performance, such as human experts, ground truth establishment, training sets, and AI assistance effect sizes, are not applicable to this submission.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Maximum Temperature delivered to patient	Maintained a maximum temperature of 40.5°C
Temperature Range across blanket area	Temperature difference of <5°C across its area
Burst Pressure - Pre/post sterilization and aging	Met the same robustness requirements as predicate blankets
Tape Strength - Pre/post sterilization and aging	Tensile strength of tape bond was measured after accelerated aging (2-year equivalent) and after levels of radiation; these levels bracket typical expected effects on the tape adhesive.

Details Not Applicable to AI Performance Studies

The following information is not present in the provided 510(k) summary because this document describes a physical medical device (a warming blanket) and its engineering performance, not an AI-powered diagnostic or therapeutic system. Therefore, concepts like "experts to establish ground truth," "adjudication," "MRMC study," "standalone algorithm performance," "training set," and "ground truth for training set" are not relevant to this submission.

Sample size used for the test set and the data provenance: Not explicitly stated as "test set" in the context of an AI algorithm. The tests described are engineering/physical performance tests of the blanket itself. For example, "blankets were tested" for temperature, burst pressure, and tape strength. The number of blankets or specific test iterations isn't provided, but it's implied that sufficient testing was done to meet the stated criteria. Data provenance for such tests is typically from internal lab testing by the manufacturer.
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 warming blanket's performance involves direct physical measurements (temperature, pressure, strength), not expert clinical interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are for resolving discrepancies in expert interpretations, which is not relevant for physical product testing.
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 is a physical device, not an AI system assisting human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the physical performance tests are the direct physical measurements taken (e.g., thermometer readings for temperature, pressure gauges for burst pressure, tensile testers for tape strength).
The sample size for the training set: Not applicable. There is no AI model being trained.
How the ground truth for the training set was established: Not applicable. There is no AI model being trained.

Summary

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JAN 1 1 2002

K014121

510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter's Name: Nellcor Puritan Bennett, Inc.

Submitter's Address: 4280 Hacienda Drive Pleasanton, CA 94588-8604

Contact Person: Anthony Mullin Phone Number: 314-654-3049 FAX Number: 314-654-3344 Summary Date: December 5, 2001

Device Trade Name: WarmTouch® CareQuilt™ Cardiac Blanket

Common Name: Convective Air Warming Blanket

Device Classification Names: The FDA has classified Thermal Regulation Systems as Class II devices under CFR Title 21, Section 870-5900. The product code is DWJ
Predicate Devices: CareDrape™ Lower Body Blanket, Cat #503-0830 CareQuilt™ Full Body/ Multi-Access Warming Blanket, Cat #503-0810.

Device Description: The Warm Touch® CareDrape™ Cardiac Blanket is similar to the CareDrape™ Lower Body Blanket in use, as both are used in the operating room to help manage the patient's body temperature. The WarmTouch® CareDrape™ Cardiac Blanket is similar to the CareQuilt™ Full Body/ Multi-Access Warming Blanket, as both are equipped with slits, which can be opened for access to the patient through the blanket. The kev difference between the Cardiac Blanket and all earlier WarmTouch® blankets is that the Cardiac Blanket is sterile permitting use of the blanket within the sterile field.

Indications For Use: The WarmTouch Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia and/or shivering in the critical care environment.
Contraindications: There are no contraindications for the use of this device

Summary of Performance Testing:

Maximum Temperature delivered to the patient �

The blankets were tested according to the draft ASTM standard Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices. This testing vertfied that the blanket maintained a maximum temperature of 40.5℃. This maximum temperature is located immediately in front of the nozzle tube.

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Temperature range .

i emperature range The blankels were tosted docoraing to the nemerature Management Devices. This testing Cilculaung Liquid and I olecu Air Patche Formprature difference of <5°C across its area.

Burst Pressure -- Pre/post sterilization and aging .

Burst Pressure of the blankets was tested in the same way as the currently marketed The Durst 1 the blankets are inflated until they burst, and the burst pressure wan i r ouch blankets . The blankets met the same robustness requirements as do the predicate blankets.

Tape strength – pre/post sterilization and aging .

Tape Strength of the tape bond was measured before and after accelerated aging (2 The tentile strength of the tape Dond was mousures . These levels bracket the typical year equivalent) and aller of levels of Rudition expective effects on the tape adhesive.

Conclusions:

The WarmTouch® CareDrape™ Cardiac Blanket performs as intended according to its The Wallin Ouch® CareDrape - Garaldo Liamist persone™ Cardiac Blanket is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 11 2002

Mr. Anthony M. Mullin Assistant Director, Regulatory and Clinical Affairs Nellcor Puritan Bennett, Inc. 4280 Hacienda Drive Pleasanton, CA 94588

Re: K014121

Trade Name: WarmTouch® CareDrape™ Cardiac Blanket Regulation Number: 21 CFR 870.5900 Regulation Name: Convective Air Warming Blanket Regulatory Class: Class II (two) Product Code: DWJ Dated: December 6, 2001 Received: December 17, 2001

Dear Mr. Mullin:

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. Anthony M. Mullin

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 (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 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 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 yours,

A. Dattell

Bram D. Zuckerman, M.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):

K014121

Device-Name:

WarmTouch® CareDrape™ Cardiae Blanket

Indications for Use:

The WarmTouch Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia and/or shivering in the critical care environment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oella Tell
Division of Cardiovascular & Respiratory Devices
510(k) Number K014121

Prescription Use ✓

OR Over-the-Counter 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).