Barrier EasyWarm Active Self-Warming Blanket

K232508 · Molnlycke Health Care Us, LLC · DWJ · Sep 15, 2023 · Cardiovascular

Device Facts

• Record ID: K232508
• Device Name: Barrier EasyWarm Active Self-Warming Blanket
• Applicant: Molnlycke Health Care Us, LLC
• Product Code: DWJ · Cardiovascular
• Decision Date: Sep 15, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Barrier EasyWarm Active Self-Warming Blanket is a non-sterile, single-use thermal regulating device; prevents hypothermia during perioperative period. Device consists of polypropylene blanket containing sealed warming pads; pads contain iron, active coal, water, salt, and clay with sodium polyacrylate cover. Operation relies on exothermic chemical reaction (oxidation of iron) triggered by exposure to air upon removal from vacuum-sealed packaging. Available in one-piece or two-piece configurations; two-piece design uses polyamide hook-and-loop closures for flexible positioning. Used in healthcare facilities; operated by clinical staff. Provides passive/active warming to patient skin; average temperature 34-39°C; maximum 41°C. Benefits patient by maintaining normothermia during surgery.

Clinical Evidence

Bench testing performed for rise time, maintenance time, and temperature specifications. Clinical thermal performance testing conducted on healthy human volunteers using IR camera measurements to confirm safety and effectiveness of the warming effect.

Technological Characteristics

Thermal regulating system; non-sterile; single-use. Materials: polypropylene blanket, polyester thread, polyamide hook-and-loop closure. Warming pads: iron, activated charcoal, clay, water, salt, sodium polyacrylate. Exothermic oxidation principle. Dimensions: 92x152cm (one-piece); 110/150x200cm (two-piece). Shelf life: 2 years. Performance: 34-39°C average skin temperature; 41°C max; 10-hour duration.

Indications for Use

Indicated for patients during the perioperative period to help prevent hypothermia.

Regulatory Classification

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.

Predicate Devices

• Barrier EasyWarm Active Self-Warming Blanket (K132048)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

K232508

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)

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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<br>5445 Triangle Parkway, Suite 400<br>Peachtree Corners, GA 30092<br>Registration number: 3004763499<br>Owner/Operator Number: 8030877 |
| Official Correspondent: | Megan Bevill<br>Regulatory Affairs Director, Americas and Antiseptics<br>Tel: [phone]<br>email: [e-mail] |
| 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-<br>Warming Blanket | Barrier EasyWarm Active Self-<br>Warming Blanket | Substantial Equivalence Comments |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>clearance | Subject of submission | K132048 | NA |
| Rationale for<br>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<br>use/Intended<br>use | The Barrier EasyWarm Active Self-<br>Warming Blanket is intended to help<br>prevent hypothermia by providing<br>warmth to the patient during the<br>perioperative period. | The Barrier EasyWarm Active Self-<br>Warming Blanket is intended to help<br>prevent hypothermia by providing<br>warmth to the patient during the<br>perioperative period. | Same indications for use/intended use<br>as predicate |
| Use<br>environment | Healthcare facilities | Healthcare facilities | Same use environment as predicate |
| Presentation | One piece blanket (92 x 152 cm) with 12<br>warmers<br>Two piece blanket (110/150 x 200 cm,<br>assembled) with 12 warmers | One piece blanket (92 x 152 cm) with 12<br>warmers | The introduction of the new two-piece<br>blanket style does not impact safety or<br>effectiveness of the Barrier EasyWarm<br>Self-Warming Blanket. The overall<br>design, materials of construction, and<br>warmer technology are the same. The<br>two piece design allows the blanket to<br>be separated for upper and lower body<br>coverage in different surgical positions.<br>The two pieces can be connected via a<br>hook and loop closure. |
| Sterility | Non-sterile | Non-sterile | Same |
| Shelf Life | 2 years | 3 years | Based on real-time stability data<br>available for the modified design |
| Materials of<br>construction | Polypropylene blanket (blue for one-<br>piece blanket, blue topside and white<br>underside for two-piece blanket)<br>Polyester sewing thread<br>Polypropylene hem | Polypropylene blanket (blue)<br>Polyester sewing thread<br>Polypropylene hem | The materials of construction are the<br>same for the subject and predicate<br>devices, with the following exceptions: |
| | Polyamide hook and loop closure (two<br>piece design only)<br>Warmer containing activated charcoal,<br>clay, iron, water, salt, and sodium<br>polyacrylate | Warmer containing activated charcoal,<br>clay, iron, water, salt, and sodium<br>polyacrylate | • Use of white polypropylene on<br>one side of two-piece blanket;<br>the white polypropylene is<br>identical to the blue<br>polypropylene cleared under<br>K132048 but with a white<br>pigment instead of blue<br>• Addition of polyamide hook and<br>loop closure on the two-piece<br>blanket<br>Replacement of the color pigment in a<br>portion of the blanket and addition of a<br>hook and loop closure do not impact<br>safety or effectiveness of the device. |
| Performance<br>specification | Ave. skin temperature reached: 34-39°C<br>Max skin temperature reached: 41°C<br>Useful life: 10 hours | Ave. skin temperature reached: 35-36°C<br>Max skin temperature reached: 40°C<br>Useful life: 10 hours | The average temperature performance<br>specification has been shifted higher<br>while maintaining the same specification<br>for maximum skin temperature reached.<br>As the maximum skin temperature<br>reached is still below the original limit of<br>42°C, there are no new issues of safety<br>or effectiveness. |

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#### 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.