(169 days)
No
The device description and performance studies focus on the chemical and physical properties of a heat pack, with no mention of AI or ML.
No.
The device is intended to increase blood circulation to aid in drawing blood for analysis, which is a diagnostic aid, not a therapeutic treatment for a medical condition.
No
The device is a heel warmer intended to increase blood circulation to aid in blood drawing, not to diagnose a condition.
No
The device is a physical product (pouch with solution and catalyst disk) that generates heat through a chemical reaction. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "increase blood circulation to the area to aid in the drawing of blood for analysis." While it aids in the process of obtaining a sample for analysis, the device itself does not perform any diagnostic testing in vitro (outside of the body).
- Device Description: The device is a heat pack that works through a chemical reaction to generate warmth. It does not contain reagents, calibrators, controls, or other components typically associated with IVD devices that are used to examine specimens from the human body.
- Performance Studies: The performance studies focus on the physical properties of the device (temperature, stability, burst strength, biocompatibility) and its ability to warm the heel, not on its ability to diagnose or detect specific substances in a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is a medical device that facilitates a medical procedure (blood draw), but it does not perform an in vitro diagnostic test.
N/A
Intended 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MPO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Infant's heel
Indicated Patient Age Range
Infant
Intended User / Care Setting
Hospitals, Doctor's offices, and other healthcare settings.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- Temperature Profile Testing: Temperature profile testing was performed on the International Biomedical 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: 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: 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 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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
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.
1
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)
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.
| 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:
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
510(K) Summary
4
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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| System
Specification | International Biomedical Infant
Heel WarmerTM; Heel Snuggler® | CooperSurgical Inc.
Infant Heel Warmer
(Model 24401)
WarmGel® Infant
Heel Warmer
(Model
20418)K151845 | Comparison |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Infant Heel WarmerTM; 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
WarmerTM; 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 WarmerTM. The
devices are primarily used in
hospitals, Doctor's offices, and
other healthcare settings.
K221154
Subject Device | An instant warm pack
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, non-toxic,
disposable warmer.
The device is primarily used
in hospitals, doctor's offices,
and other healthcare
facilities.
Predicate Device | Similar – The subject device has
two different shapes. The Slight
Hour-glass shape of the subject
device reduces the overall volume
of the device, but the temperature
characteristics are unaffected.
The shape change allows the
device to contour to the small
patient foot. Therefore, the slight
shape difference does not
introduce any new issues of safety
and effectiveness. |
| Environment of
Use | Hospitals, doctor's offices and
other healthcare settings. | Hospitals, doctor's offices,
and other healthcare
facilities. | Same |
| Prescriptive | Yes | Yes | Same |
| Pouch Material | Poly/nylon | Poly/nylon | Same |
| Solution
Material | Sodium acetate (food grade) and
water | Liquid version – Sodium
acetate (food grade) and
water
Gel Version - Sodium
Acetate (food grade), water,
and hydroxyethylcellulose | Same (for the liquid version). The
subject device does not offer a
"Gel Version" like the predicate.
Only offering the liquid version
does not introduce any new issues
of safety and effectiveness as it is
merely reducing the number of
products offered. |
| Activation
Method | Flexing Disc | Flexing metal Disc | Same |
| Average
Maximum Device
Surface
Temperature and
Maximum Device | 104-107°F | 104°F, maximum peak 107°F | Same |
| surface Peak
Temperature | | | |
| Average Skin
Surface
Temperature | 102°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 | 5.5″ × 3.5″ | 5″ × 3.5″ | Similar – subject device is 0.5"
larger. Slight change in size does
not introduce any new issues of
safety and effectiveness. |
| Shape of Pouch
(Heel Warmer) | Rectangular (Heel Warmer)
Rectangular with Hour-glass cut
out in center (Heel Snuggler) | Not Publicly Available | Similar - The Slight Hour-glass
shape of the subject device
reduces the overall volume of the
device, but the temperature
characteristics are unaffected.
The shape change allows the
device to contour to the small
patient foot. Therefore, the slight
shape difference does not
introduce any new issues of safety
and effectiveness. |
| Method of
Attachment to
Heel | Adhesive Strap | Adhesive Strap | Same |
| Sterility, Number
of 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.