(28 days)
Not Found
No
The device description details a chemical reaction for heat generation and does not mention any computational or learning components.
Yes
The device is described as "intended to help prevent hypothermia by providing warmth to the patient during the perioperative period," which falls under therapeutic use.
No
This device is a self-warming blanket intended to prevent hypothermia by providing warmth. It does not perform any diagnostic functions or analyze any physiological parameters for diagnostic purposes.
No
The device description clearly states it is a physical blanket containing warming pads with chemical components that produce heat through an exothermic reaction. This is a hardware device, not software.
Based on the provided information, the Barrier EasyWarm Active Self-Warming Blanket 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 blanket with warming pads that produce heat through a chemical reaction upon exposure to air. This is a physical process for external application.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The Barrier EasyWarm blanket does not interact with or analyze any biological specimens.
Therefore, the Barrier EasyWarm Active Self-Warming Blanket falls under the category of a medical device used for patient care, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Barrier EasyWarm 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 non-sterile, single use blanket that is intended to prevent hypothermia by providing warmth to the patient during the period. 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 warming pads contain iron, active coal, water, salt, clay with a sodium polyacrylate cover. 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. The chemical reaction results from the oxidation of iron.
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
Healthcare facilities
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
The subject devices were subjected to warmer/blanket performance testing (rise time, maintaining time, average temperature during 10 hours use, maximum temperature) to ensure performance according to specification.
In addition, the subject devices were subjected to thermal performance testing (skin temperature measurements via IR camera) in healthy human volunteers to demonstrate that the warming effect is safe and clinically effective.
Key Metrics
Ave. skin temperature reached: 34-39°C
Max skin temperature reached: 41°C
Useful life: 10 hours
Predicate Device(s)
Barrier EasyWarm Active Self-Warming Blanket (K132048)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 15, 2023
Molnlycke Health Care US, LLC Megan Bevill Regulatory Affairs Director, Americas and Antiseptics 5445 Triangle Parkway, Suite 400 Peachtree Corners, Georgia 30092
Re: K232508
Trade/Device Name: Barrier EasyWarm Active Self-Warming Blanket Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: August 16, 2023 Received: August 18, 2023
Dear Megan Bevill:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Eric E. Richardson - S
for Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Barrier EasyWarm Active Self-Warming Blanket
Indications for Use (Describe)
The Barrier EasyWarm Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) SUMMARY
This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| Date Prepared: | September 8, 2023 |
|---|---|
| Applicant: | Mölnlycke Health Care US, LLC |
| 5445 Triangle Parkway, Suite 400 | |
| Peachtree Corners, GA 30092 | |
| Registration number: 3004763499 | |
| Owner/Operator Number: 8030877 | |
| Official Correspondent: | Megan Bevill |
| Regulatory Affairs Director, Americas and Antiseptics | |
| Tel: 770-547-9196 | |
| email: megan.bevill@molnlycke.com | |
| Trade/Proprietary Names: | Barrier EasyWarm Active Self-Warming Blanket |
| Regulation Name: | Thermal regulating system |
| Device Class: | II |
| Regulation Number: | 21 CFR 870.5900 |
| Product Code: | DWJ |
| Predicate Device Name(s): | Barrier EasyWarm Active Self-Warming Blanket (K132048) |
Reason for 510(k) Submission:
This premarket notification is being submitted to obtain clearance for minor design and labeling modifications to the Barrier EasyWarm Active Self-Warming Blanket, originally cleared for market under premarket notification K132048. Minor design and labeling modifications include the following:
- Introduction of a two-piece design to the assortment ●
- . Changes to the warmers, resulting in a shift to a higher average temperature performance
- Upgrading of existing labeling statements to Contraindications
- Other minor labeling changes (e.g. administrative, formatting, and placement/presentation of ● information changes)
Description of Device:
The Barrier EasyWarm Active Self-Warming Blanket is a non-sterile, single use blanket that is intended to prevent hypothermia by providing warmth to the patient during the period. 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 warming pads contain iron, active coal, water, salt, clay with a sodium polyacrylate cover. 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. The chemical reaction results from the oxidation of iron.
Intended Use/Indication for Use:
The Barrier EasyWarm Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.
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Technological Characteristics:
| Feature | Barrier EasyWarm Active Self-
Warming Blanket | Barrier EasyWarm Active Self-
Warming Blanket | Substantial Equivalence Comments |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
clearance | Subject of submission | K132048 | NA |
| Rationale for
inclusion | Subject of submission | Predicate device | NA |
| Manufacturer | Mölnlycke Health Care | Mölnlycke Health Care | NA |
| Regulation | 21 CFR 870.5900 | 21 CFR 870.5900 | Same regulation as predicate |
| Class name | Thermal regulating system | Thermal regulating system | Same classification as predicate |
| Class | II | II | Same classification as predicate |
| Product code | DWJ | DWJ | Same product code as predicate |
| Indication for
use/Intended
use | The Barrier EasyWarm Active Self-
Warming Blanket is intended to help
prevent hypothermia by providing
warmth to the patient during the
perioperative period. | The Barrier EasyWarm Active Self-
Warming Blanket is intended to help
prevent hypothermia by providing
warmth to the patient during the
perioperative period. | Same indications for use/intended use
as predicate |
| Use
environment | Healthcare facilities | Healthcare facilities | Same use environment as predicate |
| Presentation | One piece blanket (92 x 152 cm) with 12
warmers
Two piece blanket (110/150 x 200 cm,
assembled) with 12 warmers | One piece blanket (92 x 152 cm) with 12
warmers | The introduction of the new two-piece
blanket style does not impact safety or
effectiveness of the Barrier EasyWarm
Self-Warming Blanket. The overall
design, materials of construction, and
warmer technology are the same. The
two piece design allows the blanket to
be separated for upper and lower body
coverage in different surgical positions.
The two pieces can be connected via a
hook and loop closure. |
| Sterility | Non-sterile | Non-sterile | Same |
| Shelf Life | 2 years | 3 years | Based on real-time stability data
available for the modified design |
| Materials of
construction | Polypropylene blanket (blue for one-
piece blanket, blue topside and white
underside for two-piece blanket)
Polyester sewing thread
Polypropylene hem | Polypropylene blanket (blue)
Polyester sewing thread
Polypropylene hem | The materials of construction are the
same for the subject and predicate
devices, with the following exceptions: |
| | Polyamide hook and loop closure (two
piece design only)
Warmer containing activated charcoal,
clay, iron, water, salt, and sodium
polyacrylate | Warmer containing activated charcoal,
clay, iron, water, salt, and sodium
polyacrylate | • Use of white polypropylene on
one side of two-piece blanket;
the white polypropylene is
identical to the blue
polypropylene cleared under
K132048 but with a white
pigment instead of blue
• Addition of polyamide hook and
loop closure on the two-piece
blanket
Replacement of the color pigment in a
portion of the blanket and addition of a
hook and loop closure do not impact
safety or effectiveness of the device. |
| Performance
specification | Ave. skin temperature reached: 34-39°C
Max skin temperature reached: 41°C
Useful life: 10 hours | Ave. skin temperature reached: 35-36°C
Max skin temperature reached: 40°C
Useful life: 10 hours | The average temperature performance
specification has been shifted higher
while maintaining the same specification
for maximum skin temperature reached.
As the maximum skin temperature
reached is still below the original limit of
42°C, there are no new issues of safety
or effectiveness. |
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6
Performance Testing:
The subject devices were subjected to warmer/blanket performance testing (rise time, maintaining time, average temperature during 10 hours use, maximum temperature) to ensure performance according to specification.
In addition, the subject devices were subjected to thermal performance testing (skin temperature measurements via IR camera) in healthy human volunteers to demonstrate that the warming effect is safe and clinically effective.
Conclusion:
Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics as well as performance testing. The subject EasyWarm Active Self-Warming Blanket is at least as safe and effective, and performs at least as well as the predicate device, Easy Warm Active Self-Warming Blanket cleared under K132048.