The Infant Heel Warmer™ Heel Snuggler® are instant warm packs intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, nontoxic, non-sterile, disposable device. The Infant Heel Warmer™, Heel Snuggle® have two configurations, the Heel Snuggler®, which is designed to conform to the shape of the infant's heel, and the standard Infant Heel Warmer™. The devices are primarily used in hospitals, Doctor's offices, and other healthcare settings.

Device Description

The Infant Heel Warmer™/Heel Snuggler® is a single use, disposable pouch that is filled with a super saturated solution of food grade sodium acetate and a catalyst disk. When the catalyst disk inside the packet is flexed by the user, the catalyst disk reacts with the non-toxic solution and initiates a chemical exothermic crystallization of the sodium acetate, generating heat. When activated at 75°F, both models will reach between 104-107°F and then gradually decrease in temperature over time.

The Heel Snuggler® is a butterfly shape with two straps and the Infant Heel Warmer™ is rectangular with one strap. Straps with adhesive ends are attached to the packet for securing the heel warmer to the infant's foot, if desired. Immediately following activation of the user rests the bottom of the infant's foot on one portion of the packet and holds the other portion of the packet to the ankle. The straps with adhesive tape on the end are then fitted across the infant's foot and ankle and secured to the opposite side of the adhesive portion of the strap is affixed to the packet only, not the infant's skin. The straps on the heel warmer are perforated, which enables the user to easily tear the straps and remove the heel warmer from the infant's foot after use.

AI/ML Overview

The provided text details a 510(k) summary for the Infant Heel Warmer™/Heel Snuggler®, arguing for its substantial equivalence to a predicate device. This submission primarily focuses on bench testing and comparison of technical specifications, not on an AI/ML-driven medical device that would involve a study of the type described in the request.

Therefore, many of the requested elements are not applicable to this document. The document describes a physical medical device (a warming pack), not a software or AI-based diagnostic tool.

However, I can extract the acceptance criteria and the "study" (bench testing) that was performed to demonstrate the device meets those criteria, as well as addressing the applicable parts of your request.

Here's a breakdown based on the provided text, with notes on what is not applicable:

Device: Infant Heel Warmer™; Heel Snuggler®

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the successful completion of specified tests. The performance is reported as meeting these implied criteria.

Acceptance Criterion (Implicit)	Reported Device Performance
Intended Use: Used on infant's heel to increase blood circulation to aid in blood drawing.	"Similar – ... doesn't introduce any new issues of safety and effectiveness." (Comparing to predicate with same intended use)
Device Configuration: Two configurations (Heel Snuggler® and standard Infant Heel Warmer™), conform to infant's heel.	"The Heel Snuggler® is a butterfly shape with two straps and the Infant Heel Warmer™ is rectangular with one strap." "The shape change allows the device to contour to the small patient foot."
Material: Non-toxic, disposable.	"Single use, nontoxic, non-sterile, disposable device." "Poly/nylon" pouch, "Sodium acetate (food grade) and water" solution.
Maximum Device Surface Temperature: Comparable to predicate.	104-107°F (matches predicate's 104°F, max peak 107°F).
Average Skin Surface Temperature: Acceptable for infant use.	102°F (Stated and deemed "in line with or slightly lower than the predicate for device surface temperature").
Temperature Duration: Adequate for intended use.	"gradually decrease in temperature over time" (implicit in "Temperature Profile Testing" passing).
Shelf Life: Stable for 24 months.	24 months confirmed by Stability Testing.
Burst Strength: Withstand pressure during use.	Successfully passed 200 lb compression for 10 seconds ("Burst testing to be safe and effective").
Biocompatibility: Safe for contact with skin.	Biocompatibility evaluation "leveraged from K936084" and considered in accordance with ISO-10993.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for bench tests (e.g., how many units were tested for temperature, burst, stability). It typically refers to a statistically significant number of units for product testing, but specific numbers are not provided in this summary.
Data Provenance: The testing was performed internally by International Biomedical. The location of the testing is not specified beyond "International Biomedical 8206 Cross Park Drive Austin, TX 78754 U.S.A." This is prospective testing of manufactured devices for performance and safety.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

N/A. This device is a physical warming pack, not an AI/ML-driven diagnostic tool that requires expert annotation for ground truth. Its performance is measured directly through physical tests (temperature, burst strength, stability).

4. Adjudication Method for the Test Set

N/A. Not applicable to physical device bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

N/A. This is a physical device, not an AI/ML-driven diagnostic system. No human reader study or AI assistance is involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. Not an algorithm-driven device. Bench testing was performed on the physical device in a "standalone" manner (i.e., the device itself was tested, not in conjunction with a human operator as part of a performance study, though it is used by a human).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering and safety standards, and direct measurement of physical properties (e.g., temperature, burst strength, material properties) against predefined acceptance thresholds and comparison to a legally marketed predicate device's characteristics. There's no "expert consensus" on imaging or pathology results here.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

N/A. This is not an AI/ML device, so no ground truth for a training set was established.

Summary

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October 7, 2022

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

Re: K221154

Trade/Device Name: Infant Heel Warmer"]11; Heel Snuggler® Regulation Number: 21 CFR 890.5710 Regulation Name: Hot Or Cold Disposable Pack Regulatory Class: Class I, reserved Product Code: MPO Dated: September 6, 2022 Received: September 6, 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 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.

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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 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221154

Device Name Infant Heel Warmer™; Heel Snuggler®

Indications for Use (Describe)

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

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 7, 2022

Device Identification:

Trade Names: Infant Heel Warmer™; Heel Snuggler® Common Name: Infant Heel Warmer Regulatory Class: I Regulatory Name: Hot or cold disposable pack Regulatory Number: (21 CFR 890.5710) Product Code: MPO 510(k) number: K221154

Predicate Device:

CooperSurgical Inc. – Infant Heel Warmer (Model 24401), WarmGel® Infant Heel Warmer

(Model 20418)— K151845

Reference Device:

Omni Therm Inc.- Omni Warm Gel Packs - K936084

Device Description:

510(K) Summary

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rests the bottom of the infant's foot on one portion of the packet and holds the other portion of the packet to the ankle. The straps with adhesive tape on the end are then fitted across the infant's foot and ankle and secured to the opposite side of the adhesive portion of the strap is affixed to the packet only, not the infant's skin. The straps on the heel warmer are perforated, which enables the user to easily tear the straps and remove the heel warmer from the infant's foot after use.

Indications for Use:

The Infant Heel Warmer™; Heel Snuggler are instant warm packs intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, nontoxic, non-sterile, disposable device. The Infant Heel Warmer™, Heel Snuggler have two configurations, the Heel Snuggler , which is designed to conform to the shape of the infant's heel, and the standard Infant Heel Warmer". The devices are primarily used in hospitals, Doctor's offices, and other healthcare settings.

Substantial Equivalence:

The substantial equivalence of the International Biomedical Infant Heel Warmer™; Heel Snuggler 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.

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SystemSpecification	International Biomedical InfantHeel WarmerTM; Heel Snuggler®	CooperSurgical Inc.Infant Heel Warmer(Model 24401)WarmGel® InfantHeel Warmer(Model20418)K151845	Comparison
Indications forUse	The Infant Heel WarmerTM; HeelSnuggler® are instant warm packsintended to be used on an infant'sheel to increase blood circulationto the area to aid in the drawing ofblood for analysis. It is a singleuse, nontoxic, non-sterile,disposable device. The Infant HeelWarmerTM; Heel Snuggler® havetwo configurations, the HeelSnuggler®, which is designed toconform to the shape of theinfant's heel, and the standardInfant Heel WarmerTM. Thedevices are primarily used inhospitals, Doctor's offices, andother healthcare settings.K221154Subject Device	An instant warm packintended to be used on aninfant's heel to increaseblood circulation to the areato aid in the drawing ofblood for analysis. It is asingle use, non-toxic,disposable warmer.The device is primarily usedin hospitals, doctor's offices,and other healthcarefacilities.Predicate Device	Similar – The subject device hastwo different shapes. The SlightHour-glass shape of the subjectdevice reduces the overall volumeof the device, but the temperaturecharacteristics are unaffected.The shape change allows thedevice to contour to the smallpatient foot. Therefore, the slightshape difference does notintroduce any new issues of safetyand effectiveness.
Environment ofUse	Hospitals, doctor's offices andother healthcare settings.	Hospitals, doctor's offices,and other healthcarefacilities.	Same
Prescriptive	Yes	Yes	Same
Pouch Material	Poly/nylon	Poly/nylon	Same
SolutionMaterial	Sodium acetate (food grade) andwater	Liquid version – Sodiumacetate (food grade) andwaterGel Version - SodiumAcetate (food grade), water,and hydroxyethylcellulose	Same (for the liquid version). Thesubject device does not offer a"Gel Version" like the predicate.Only offering the liquid versiondoes not introduce any new issuesof safety and effectiveness as it ismerely reducing the number ofproducts offered.
ActivationMethod	Flexing Disc	Flexing metal Disc	Same
AverageMaximum DeviceSurfaceTemperature andMaximum Device	104-107°F	104°F, maximum peak 107°F	Same
surface PeakTemperature
Average SkinSurfaceTemperature	102°F	Not publicly Available	Similar – The predicate devicedoes not publish the skin surfacetemperature, but the subjectdevice temperature is in line withor slightly lower than thepredicate for device surfacetemperature and there is a strongcorrelation in this type of productbetween the device surfacetemperature and the skin surfacetemperature. Therefore thestated skin surface temperature ofthe subject device doesn'tintroduce any new issues of safetyand effectiveness.
Size of Pouch	5.5″ × 3.5″	5″ × 3.5″	Similar – subject device is 0.5"larger. Slight change in size doesnot introduce any new issues ofsafety and effectiveness.
Shape of Pouch(Heel Warmer)	Rectangular (Heel Warmer)Rectangular with Hour-glass cutout in center (Heel Snuggler)	Not Publicly Available	Similar - The Slight Hour-glassshape of the subject devicereduces the overall volume of thedevice, but the temperaturecharacteristics are unaffected.The shape change allows thedevice to contour to the smallpatient foot. Therefore, the slightshape difference does notintroduce any new issues of safetyand effectiveness.
Method ofAttachment toHeel	Adhesive Strap	Adhesive Strap	Same
Sterility, Numberof Uses	Non-sterile, Single Use,Disposable	Non-sterile, Single Use,Disposable	Same

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Image /page/6/Picture/0 description: The image shows the logo for International Biomedical. The logo consists of a stylized letter "B" with a swirl at the top left, followed by the words "international" in a smaller font size. Below "international" is the word "BIOMEDICAL" in a larger, bolder font, with the registered trademark symbol to the right.

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Bench Testing:

The following tests/evaluations were performed

Temperature Profile Testing .
- Temperature profile testing was performed on the International Biomedical O Infant Heel Warmer™; Heel Snuggler and compared to the data from the predicate device. Testing included activation temperature testing, surface temperature, temperature duration testing and skin temperature. All tests were a pass.
Stability Testing ●
- o Stability Testing was performed on the International Biomedical Infant Heel Warmer™; Heel Snuggler in conjunction with the temperature profile testing to confirm its shelf life of 24 months.
Burst Testing ●
- o The Subject device has been evaluated for burst strength testing by using a 200 lb compression for 10 seconds. We consider the burst testing to be safe and effective.
Biocompatibility Testing ●
- The biocompatibility evaluation for the International Biomedical Infant Heel o Warmer™; Heel Snuggler 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 Infant Heel Warmer™ ; Heel Snuggler® has been shown to be substantially equivalent to the predicate device identified, and does not present any new issues of safety or effectiveness.

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.