InfaTherm Disposable Infant Warming Mattress

K221653 · International Biomedical · IMD · Oct 6, 2022 · Physical Medicine

Device Facts

• Record ID: K221653
• Device Name: InfaTherm Disposable Infant Warming Mattress
• Applicant: International Biomedical
• Product Code: IMD · Physical Medicine
• Decision Date: Oct 6, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5710
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The InfaTherm™ Disposable Infant Warming Mattress is an instant warm pack intended to provide warmth during transport of an infant within the hospital or between hospitals. It is recommended for full-term infants. It is a single use, nontoxic, non-sterile, disposable device.

Device Story

InfaTherm™ is a single-use, disposable, non-sterile infant warming mattress. Device consists of a rectangular pouch containing a supersaturated solution of food-grade sodium acetate, water, and a metal catalyst disk. Operation: user flexes the internal catalyst disk to initiate an exothermic crystallization reaction, generating heat. The mattress reaches 100-102°F when activated at 75°F, providing warmth to the infant during transport. Used in hospital settings or during patient transfer; operated by clinical staff. Output is passive thermal energy. Benefits include maintenance of infant body temperature during transport, reducing risk of hypothermia.

Clinical Evidence

Bench testing only. Testing included temperature profile analysis (activation, surface, duration, and skin contact temperatures), shelf-life stability (20 months), seal strength (80 psi cross seal/50 psi inline seal), and burst testing (40 lbs for 15 minutes). Biocompatibility evaluation leveraged from K936084 per ISO-10993 standards.

Technological Characteristics

Materials: Polyethylene LLDPE pouch with polyester (PET) bottom. Principle: Exothermic chemical crystallization of supersaturated sodium acetate solution triggered by a metal catalyst disk. Dimensions: ~10" x 16". Single-use, non-sterile. No electronics, software, or external energy source.

Indications for Use

Indicated for full-term infants requiring warmth during hospital or inter-hospital transport.

Regulatory Classification

Identification

A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

Predicate Devices

• Rapid Aid Corp. – Infant Transport Mattress Warmer with Disc (K163295)

Reference Devices

• Omni Therm Inc.- Omni Warm Gel Packs (K936084)

Submission Summary (Full Text)

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October 6, 2022

International Biomedical Amy Pieper Director of Regulatory Affairs 8206 Cross Park Drive Austin, Texas 78754

Re: K221653

Trade/Device Name: InfaTherm™ Disposable Infant Warming Mattress Regulation Number: 21 CFR 890.5710 Regulation Name: Hot Or Cold Disposable Pack Regulatory Class: Class I, reserved Product Code: IMD Dated: June 7, 2022 Received: June 7, 2022

Dear Amy Pieper:

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 mav, 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.

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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 809); 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 mediation-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.

Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### K221653

Device Name

InfaTherm™ Disposable Infant Warming Mattress

Indications for Use (Describe)

The InfaTherm™ Disposable Infant Warming Mattress is an instant warm pack intended to provide warmth during transport of an infant within the hospitals. It is recommended for full-term infants. It is a single use, nontoxic, non-sterile, disposable device.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) SUMMARY

### Submitter Information:

### Regulatory Affairs Contact:

International Biomedical 8206 Cross Park Drive Austin, TX 78754 U.S.A.

Amy Pieper Director of Regulatory Affairs [phone] - phone [phone] - fax

Date Summary Prepared: October 6, 2022

### Device Identification:

Trade Names: InfaTherm™ Disposable Infant Warming Mattress Common Name: Infant Warming Mattress Regulatory Class: I Regulatory Name: Hot or cold disposable pack Regulatory Number: (21 CFR 890.5710) Product Code: IMD 510(k) number: K221653

## Predicate Device:

Rapid Aid Corp. – Infant Transport Mattress Warmer with Disc – K163295

## Reference Device:

Omni Therm Inc.- Omni Warm Gel Packs - K936084

## Device Description:

The InfaTherm™ Disposable Infant Warming Mattress is a single use, disposable pouch that is filled with a super saturated solution of food grade sodium acetate and water and a catalyst disk. When the catalyst disk inside the packet is flexed by the user, the catalyst disk reacts with the nontoxic solution and initiates a chemical exothermic crystallization of the sodium acetate, generating heat. When activated at 75°F, the Infant warming mattress will reach between 100-102°F and then gradually decrease in temperature over time.

The InfaTherm™ Disposable Infant Warming Mattress is rectangular in shape. Immediately following activation of the mattress, the user places the infant on the mattress.

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# Indications for Use:

The InfaTherm™ Disposable Infant Warming Mattress is an instant warm pack intended to provide warmth during transport of an infant within the hospital or between hospitals. It is recommended for full-term infants. It is a single use, nontoxic, non-sterile, disposable device.

## Substantial Equivalence:

The substantial equivalence of the International Biomedical InfaTherm™ Disposable Infant Warming Mattress to the predicate is shown by similarity in intended use, indications for use, materials and performance. The table below provides a comparison of the technological characteristics of the subject device to the predicate.

| System | International Biomedical | Rapid Aid Corp | Comparison |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specification | InfaTherm™ Disposable Infant | Infant Transport Mattress | |
| | Warming Mattress | Warmer with Disc k163295 | |
| | Subject Device | Predicate Device | |
| Indications for<br>Use | The InfaTherm™ Disposable<br>Infant Warming Mattress is an<br>instant warm pack intended to<br>provide warmth during<br>transport of an infant within the<br>hospital or between hospitals. It<br>is recommended for full-term<br>infants. It is a single use,<br>nontoxic, non-sterile, disposable<br>device. | The Rapid Aid Infant<br>Transport Mattress Warmer<br>with Disc provides warmth<br>during transport of an infant<br>within the hospital or<br>between hospitals. It is<br>recommended for full-term<br>infants. | Same |
| Environment of<br>Use | Hospitals or between hospitals | Hospitals or between<br>hospitals | Same |
| Prescriptive | Yes | Yes | Same |
| Pouch Material | Polyethylene LLDPE with white<br>Polyester extrusion (PET)<br>material on bottom of bag | Polyethylene/60g polyamide<br>(PE/PA) with woven cloth<br>material on bottom outside<br>of bag | Similar – both devices utilize<br>polyethylene pouches with a cloth<br>material on the bottom. The<br>predicate device does not provide<br>enough detail on the cloth<br>material to claim a complete<br>match. Comparison between two<br>devices does not indicate a<br>material difference that would<br>introduce any new issues of safety<br>and effectiveness. |
| Solution Material | Sodium acetate (food grade),<br>water, activation disc;<br>supersaturated solution | Sodium acetate and water,<br>thickener, activation disc;<br>supersaturated solution | Similar – the subject device<br>omitted the thickening agent that<br>is used in the predicate. The<br>thickening agent only serves to |
| System<br>Specification | International Biomedical<br>InfaTherm™ Disposable Infant<br>Warming Mattress<br>Subject Device | Rapid Aid Corp<br>Infant Transport Mattress<br>Warmer with Disc k163295<br>Predicate Device | Comparison |
| | | | make the gel more viscous when activated. Upon activation, the liquid becomes viscous by nature of the chemical reaction, a thickening agent is redundant. Omitting the thickening agent doesn't introduce any new issues of safety and effectiveness. |
| Activation<br>Method | Activating Disc triggers the exothermic reaction | Activating Disc triggers the exothermic reaction | Same |
| Average<br>Device<br>Maximum<br>Surface<br>Temperature | 100-102°F | 101-104°F | Similar - Subject Device average temperature has a slightly lower peak temperature. Lower peak temperature doesn't introduce any new issues of safety and effectiveness. |
| Average Skin<br>Surface<br>Temperature | 101°F | Not Publicly Available | Similar – The predicate device does not publish the skin surface temperature, but the subject device temperature is in line with or slightly lower than the predicate for device surface temperature and there is a strong correlation in this type of product between the device surface temperature and the skin surface temperature. Therefore the stated skin surface temperature of the subject device doesn't introduce any new issues of safety and effectiveness. |
| Size of Pouch | Approximately 10" x 16" (160 sq in) | 15.7" x 9.6" (151 sq in) | Similar - subject device is <0.5" larger. Slight change in size does not introduce any new issues of safety and effectiveness. |
| Sterility, Number<br>of Uses | Non-sterile, Single Use, Disposable | Non-sterile, Single Use, Disposable | Same |

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Image /page/5/Picture/0 description: The image shows the logo for International Biomedical. The logo consists of a stylized symbol resembling a plant or abstract figure on the left, followed by the words "international" in a smaller font size above the word "BIOMEDICAL" in a larger font size. A registered trademark symbol is placed to the right of the word "BIOMEDICAL".

#### Bench Testing:

The following tests/evaluations were performed

- Temperature Profile Testing

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- Temperature profile testing, including skin contact temperature, was performed O on the International Biomedical InfaTherm™ Disposable Infant Warming Mattress and compared to the date from the predicate device. Testing included activation temperature testing, surface temperature, temperature duration testing and skin temperature. All tests were a pass.
- Stability Testing ●
- Stability Testing was performed on the International Biomedical InfaTherm™ o Disposable Infant Warming Mattress in conjunction with the temperature profile testing to confirm its shelf life of 20 months.
- Seal Strength Testing ●
- The Subject device has been evaluated for seal strength testing of 80 psi pressure O (pull test) for a cross seal and 50 Psi Pressure for an inline seal by the pouch manufacturer. The filled and sealed pouch is then subjected to a 40 pound for 15 minute burst test. We consider the burst and seal integrity testing to be safe and effective.
- Biocompatibility Testing ●
- The biocompatibility evaluation for the International Biomedical InfaTherm™ O Disposable Infant Warming Mattress was leveraged from k936084. Therefore, the evaluation is considered to be in accordance with the FDA guidance on Biocompatibility on the International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".

# Conclusion:

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate, the International Biomedical InfaTherm™ Disposable Infant Warming Mattress has been shown to be substantially equivalent to the predicate device identified, and does not present any new issues of safety or effectiveness