(127 days)
Not Found
No
The device description and performance studies focus on a chemical reaction for warming and clinical effectiveness, with no mention of AI or ML.
Yes
The device is intended to prevent hypothermia by providing warmth, which is a therapeutic effect on the patient's body. The clinical study also demonstrates its effectiveness in maintaining core body temperatures and reducing the incidence of hypothermia.
No
The device is intended to prevent hypothermia by providing warmth, not to diagnose a condition.
No
The device description clearly states it is a disposable blanket containing warming pads that produce heat via an exothermic chemical reaction, indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "help prevent hypothermia by providing warmth to the patient during the perioperative period." This is a therapeutic and supportive function applied directly to the patient's body.
- Device Description: The description details a physical blanket with warming pads that generate heat through a chemical reaction. This is a physical device for external application.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any bodily specimens.
The information provided clearly describes a device used for external patient warming, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications 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.
Product codes
DWJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average skin temperature range: 35-36° C
Maximum skin temperature achieved: 40° C
Predicate Device(s)
HotDog Patient Warming System (K112488)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Traditional 510(k) Premarket Notification
:
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, LLC | |
| 5550 Peachtree Parkway, Suite 500 | ||
| Norcross, GA 30092 | ||
| Registration number: 3004763499 | ||
| Owner/Operator Number: 8030877 | ||
| Official Correspondent: | Curtis Truesdale | |
| Director, Regulatory Affairs for the Americas | ||
| Tel: 678-250-7928 | ||
| Fax: 678-245-7746 | ||
| e-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:
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.
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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
3
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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
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
5
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