The BARRIER® EasyWarm® Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.

Device Description

The BARRIER® EasyWarm® Active Self-Warming Blanket is a disposable blanket 152 x 92 cm in size. The blanket contains warming pads (or heating elements) that are contained within sealed pouches that are advantageously positioned and sewn into the blanket's fabric for appropriate distribution of heat. The device is supplied in a vacuum sealed packaging. Once the blanket is removed from its' packaging, the blanket produces heat via an exothermic chemical reaction that takes place within the warming pads upon exposure to air.

AI/ML Overview

Here's the analysis of the BARRIER® EasyWarm® Active Self-Warming Blanket based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for BARRIER® EasyWarm® Active Self-Warming Blanket

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, side-by-side format. However, based on the Evaluation of Device Performance section, the implicit acceptance criteria and the device's reported performance can be inferred.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Study Goals)	Reported Device Performance
Temperature Characteristics:
Maximum temperature achieved (skin surface)	40° C
Minimum temperature achieved (skin surface)	35° C
Temperature range maintained (skin surface)	35-36° C
Temperature rise time to 40° C	Approximately 30 minutes
Duration of maintained temperatures	Up to 10 hours
Safety (risk of thermal injury)	Very minimal risks; skin temperatures not exceeding 43°C are generally considered safe.
Clinical Effectiveness (Core Body Temperature):
Higher perioperative core body temperature	Significantly higher perioperative core body temperature compared to control.
Lower incidence of hypothermia (pre-, intra-, post-operative)	Significantly lower incidence of hypothermia compared to control.
Safety (Adverse Events):
Absence of serious adverse events	No serious adverse events in the clinical investigation.
Biocompatibility:	Passed (Skin Irritation, Closed Patch Sensitization, Cytotoxicity)
Stability (Shelf-life):	Integrity maintained for labeled shelf-life.

2. Sample Size and Data Provenance for the Test Set

Clinical Study:
- Sample Size: Not explicitly stated for the test set. It mentions "Subjects in the BARRIER® EasyWarm® treatment arm" and "subjects in the control treatment arm," indicating a patient population, but the specific number is not provided.
- Data Provenance: The clinical study was described as a "prospective multi-center randomized controlled clinical study." This indicates that data was collected specifically for this study with a forward-looking design, and from multiple locations (centers). The country of origin is not specified.
Independent Non-Interventional Evaluation:
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated, but it's a separate evaluation.

3. Number of Experts and Qualifications for Ground Truth for the Test Set

The document does not mention the use of experts to establish a ground truth for the clinical study's primary outcomes (core body temperature, incidence of hypothermia, adverse events). These outcomes are typically measured directly or observed by medical staff involved in the study rather than being adjudicated by external experts in the way that, for example, imaging studies might require.
The independent non-interventional evaluation involved determining average and maximum skin temperatures, which would likely be measured by instruments. There is no mention of experts establishing ground truth for this.

4. Adjudication Method for the Test Set

No specific adjudication method (e.g., 2+1, 3+1) is mentioned. Given the nature of the primary endpoints (core body temperature, incidence of hypothermia, adverse events), these are typically direct measurements or clinician observations, rather than requiring expert adjudication of complex interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not explicitly done. The clinical study performed was a randomized controlled clinical study comparing the device (treatment arm) to a control arm to assess effectiveness in maintaining core body temperature and reducing hypothermia. This is a common and appropriate study design for medical devices that directly impact physiological parameters.
The concept of "human readers improving with AI vs. without AI assistance" is not applicable to this device, as it is a physical warming blanket, not an AI-assisted diagnostic or interpretative tool.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical active self-warming blanket. It does not employ an algorithm or AI that would have a "standalone" performance. Its performance is directly tied to its physical interaction with the patient.

7. Type of Ground Truth Used

For the clinical study, the ground truth was based on direct physiological measurements and clinical observations:
- Core body temperature: Measured directly.
- Incidence of hypothermia: Defined and observed based on measured core body temperatures.
- Adverse events: Clinically observed and reported.
For the independent non-interventional evaluation, the ground truth for skin temperature was based on direct temperature measurements.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve AI/machine learning algorithms that require a "training set" in the conventional sense. The "training" for such a device would be its design, manufacturing, and testing to meet performance specifications.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As mentioned above, there is no "training set" for this type of device. The extensive "bench testing" conducted (temperature characteristics, rise time, duration) characterizes the device's physical performance, similar to how a product's specifications are verified, but it's not a "training set" for an algorithm.

Summary

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Traditional 510(k) Premarket Notification

K132048

510(k) SUMMARY

BARRIER® EasyWarm® Active Self-Warming Blanket

This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Date Prepared:	October 15, 2013	NOV 06 2013
Applicant:	Mölnlycke Health Care US, LLC5550 Peachtree Parkway, Suite 500Norcross, GA 30092Registration number: 3004763499Owner/Operator Number: 8030877
Official Correspondent:	Curtis TruesdaleDirector, Regulatory Affairs for the AmericasTel: 678-250-7928Fax: 678-245-7746e-mail: curtis.truesdale@molnlycke.com
Trade/Proprietary Name:	BARRIER® Easy Warm® Active Self-Warming Blanket
Common Name:	Warming Blanket
Regulation Name:	Thermal Regulating System
Device Class:	Class II
Regulation Number:	21 CFR 870.5900
Product Code:	DWJ
Predicate Device Name(s):	HotDog Patient Warming System (K112488)

Description of Device:

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The BARRIER® EasyWarm® Active Self-Warming Blanket is intended to be used in the pre-, intra- and post-operative phases of a patient's surgical experience to maintain normothermia. The blanket provides continuous thermal coverage, affording the patient active warming up to 10 hours. The blanket is removed from packaging at least 30 minutes prior to use to initiate the warming of blanket. The blanket reaches 40 ℃ in approximately 30 minutes. Once the blanket is placed on the patient, it helps prevent the patient from cooling during the perioperative period. The blanket is designed to help patients maintain body temperature by decreasing cutaneous heat loss. The maintenance of normothermia is accomplished through safe administration of skin surface warming facilitated by the active self-warming blanket.

Intended Use/Indication for Use:

The BARRIER® Easy Warm® Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.

Technological Characteristics:

The BARRIER® EasyWarm® Active Self-Warming Blanket and HotDog Patient Warming System (K112488) device have similar principles of operation - to prevent or maintain normothermia.

The differences in these two products are the mechanism used to provide the heat through the blanket. The BARRIER® EasyWarm® Active Self-Warming Blanket is a disposable 152 x 92 cm blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron. The chemicals are securely contained in 12 individually sealed pockets, strategically placed to provide heat to the subject for optimal thermal warming. The components of the warmers are -activated coal, clay, iron, water, salt and sodium polyacrylate.

BARRIER® EasyWarm® has no external attachments, requires no power source, is quiet, and carries no risk of "hosing" or blowing pathogens. It is available in one design with three cut-outs positioned to provide the ability to position the blanket longwise on the patient. Turning the blanket 90 degrees will allow exposure of abdomen and legs if the surgical procedure warrants this.

There is asymmetry of the heating pads to allow the blanket to provide access to one extremity while maintaining coverage of the rest of the patient. The blanket should be placed with the heating pads away from the patient.

The Active Self-Warming Blanket does not contain any novel features. Non-warming blankets of the same material have been used for more than three years and this material has been used by Mölnlycke Health Care for other applications such as surgical drapes and surgical gowns.

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Evaluation of Device Performance

Bench testing:

A series of tests and evaluations were conducted in support of the device design verification activities were completed to characterize the device with respect to the temperature achieved (maximum and minimums), temperature rise time, duration of temperatures are maintained.

Biocompatibility Evaluation:

A biocompatibility assessment was completed for the device per ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, which included the following studies:

Skin Irritation;
Closed Patch Sensitization
Cytotoxity .

Stability (Shelf-life) Testing:

Stability testing was conducted to demonstrate that the integrity of the device is maintained for the labeled shelf-life period.

Clinical Testing:

The results of from a prospective multi-center randomized controlled clinical study. conducted for the BARRIER® EasyWarm® Active Self-Warming Blanket, demonstrated that skin temperatures reached with the use of the device were safety and clinically effective at maintaining core body temperatures. The following is a summary of the primary endpoint results:

Subjects in the BARRIER® EasyWarm® treatment arm had significantly higher . perioperative core body temperature, relative to subjects in the control treatment arm;
Subjects in the BARRIER® EasyWarm® treatment arm had a significantly lower . incidence of hypothermia preoperatively, intraoperatively, and postoperatively compared with the subjects in the control treatment arm: and
. There were no serious adverse events in this clinical investigation.

In addition to the aforementioned clinical study, an independent non-interventional evaluation was performed to determine the average skin temperature range and maximum skin temperatures reached with the warming blanket. The average skin temperature range and the maximum skin temperature achieved with the use of the device are 35-36° C and 40° C respectively. The skin temperatures achieved with the BARRIER® EasyWarm® Active Self-Warming Blanket have been shown to be effective at maintaining core body temperature, with very minimal risks of causing thermal injury to the skin. Skin

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temperatures not exceeding 43° C are generally considered safe for skin surface warming. The reduction in cutaneous heat loss via active skin warming techniques is the scientific principle behind the maintenance and/or management of core body temperature; most of metabolic heat is lost the through skin.

Conclusion:

Based on the performance.testing, it can be.concluded that the BARRIER® Easy Warm® Active Self-Warming Blanket is substantially equivalent to the HotDog Patient Warming System (KI12488) predicate.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 14, 2014

Mölnlycke Health Care US, LLC Curtis Truesdale, Director, Regulatory Affairs for the Americas 5550 Peachtree Parkway Suite 500 Norcross, GA 30092

Re: K132048 Trade/Device Name: BARRIER® EasyWarm® Active Self-Warming Blanket Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: II Product Code: DWJ Dated: October 15, 2013 Received: October 17, 2013

Dear Mr. Truesdale:

This letter corrects our substantially equivalent letter of November 06, 2013.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical

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Page 2 - Mr. Curtis Truesdale

device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Willhemen

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

Enclosure

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INDICATONS FOR USE

510(k) Number (if known): K132048

Device Name: BARRIER® EasyWarm® Active Self-Warming Blanket

The BARRIER® EasyWarm® Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.

Prescription Use X (21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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M. A. Wilhelmen

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).