K Number

Device Name

InfaTherm Disposable Infant Warming Mattress

Manufacturer

International Biomedical

Date Cleared

2022-10-06

(121 days)

Product Code

IMD

Regulation Number

890.5710

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K163295

Reference Devices

K936084

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a chemical reaction for heat generation and do not mention any AI or ML components.

Therapeutic

No.
The device provides warmth for transport but does not involve diagnosis, cure, mitigation, treatment, or prevention of disease.

Diagnostic

No
Explanation: The device is intended to provide warmth to infants during transport and does not perform any diagnostic function (e.g., detecting, identifying, or monitoring a disease or condition).

SaMD (Software as a Medical Device)

The device is a physical, disposable warming mattress that utilizes a chemical reaction to generate heat, with no mention of software components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to provide warmth to an infant during transport. This is a therapeutic or supportive function, not a diagnostic one.
Device Description: The device works by a chemical reaction to generate heat. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing any kind of diagnostic result.
Performance Studies: The performance studies focus on temperature profiles, stability, seal strength, and biocompatibility – all related to the physical function and safety of a warming device, not diagnostic accuracy.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 hospitals. It is recommended for full-term infants. It is a single use, nontoxic, non-sterile, disposable device.

Product codes

IMD

Device Description

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

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

full-term infants.

Intended User / Care Setting

within the hospital or between hospitals.

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

Bench Testing:

Temperature Profile Testing: Temperature profile testing, including skin contact temperature, was performed 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™ 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 (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. The burst and seal integrity testing are considered safe and effective.
Biocompatibility Testing: The biocompatibility evaluation for the International Biomedical InfaTherm™ 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".

Key Metrics

Not Found

Predicate Device(s)

K163295

Reference Device(s)

K936084

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 890.5710 Hot or cold disposable pack.

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," in a smaller font size.

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.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

Indications for Use

510(k) Number (if known)

K221653

Device Name

InfaTherm™ Disposable Infant Warming Mattress

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X 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 (512) 873-0033 - phone (512) 873-9090 - 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 rectangular in shape. Immediately following activation of the mattress, the user places the infant on the mattress.

Indications for Use:

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
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.	The Rapid Aid Infant
Transport Mattress Warmer
with Disc provides warmth
during transport of an infant
within the hospital or
between hospitals. It is
recommended for full-term
infants.	Same
Environment of
Use	Hospitals or between hospitals	Hospitals or between
hospitals	Same
Prescriptive	Yes	Yes	Same
Pouch Material	Polyethylene LLDPE with white
Polyester extrusion (PET)
material on bottom of bag	Polyethylene/60g polyamide
(PE/PA) with woven cloth
material on bottom outside
of bag	Similar – both devices utilize
polyethylene pouches with a cloth
material on the bottom. The
predicate device does not provide
enough detail on the cloth
material to claim a complete
match. Comparison between two
devices does not indicate a
material difference that would
introduce any new issues of safety
and effectiveness.
Solution Material	Sodium acetate (food grade),
water, activation disc;
supersaturated solution	Sodium acetate and water,
thickener, activation disc;
supersaturated solution	Similar – the subject device
omitted the thickening agent that
is used in the predicate. The
thickening agent only serves to
System
Specification	International Biomedical
InfaTherm™ Disposable Infant
Warming Mattress
Subject Device	Rapid Aid Corp
Infant Transport Mattress
Warmer with Disc K163295
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
Method	Activating Disc triggers the exothermic reaction	Activating Disc triggers the exothermic reaction	Same
Average
Device
Maximum
Surface
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
Surface
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