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, non-sterile, disposable warmer.

Device Description

The CooperSurgical Infant Heel Warmer, which is available in both a liquid version (The Infant Heel Warmer, Model 24401) and a gel version (WarmGel® Infant Heel Warmer, Model 20418), is a non-sterile, single-use, disposable device comprised of a biaxially oriented nylon (BON)/polyethylene outer pouch filled with a supersaturated solution of food grade sodium acetate and water (liquid version), or food grade sodium acetate, water, and hydroxyethylcellulose, a common thickener (gel version). An adhesive tape is attached to the pouch, which can hold the warmer in place if desired. The pouch also contains a stainless steel disc that, when flexed, initiates an exothermic crystallization of the sodium acetate, generating heat. When activated at 75° + 1° F, the maximum peak temperature of the CooperSurgical Infant Heel Warmer is 107° F, which is reached in approximately 40 seconds and then gradually decreases over time.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the CooperSurgical Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418). This device is a hot or cold disposable pack and is classified as Class I. The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific numerical acceptance criteria for a novel AI/software medical device.

Therefore, many of the requested categories related to AI/software device studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this traditional medical device submission.

Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them, adapted to the context of this manual heating device:

Acceptance Criteria and Device Performance

The core "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to legally marketed predicate devices, particularly regarding safety and effectiveness for its intended use. The primary performance aspect evaluated is its temperature profile and its effect on infant skin.

Acceptance Criteria (Implicit from Substantial Equivalence Goal)	Reported Device Performance
Intended Use: Instant warm pack to increase blood circulation in infant's heel to aid blood drawing.	Device is an instant warm pack with this stated intended use.
Maximum Peak Temperature: Safe and comparable to predicates.	107°F (reported for subject device). Predicates: Rapid Aid (Unknown), DeRoyal (105°F average max temp).
Average Maximum Temperature: Safe and comparable to predicates.	104°F (reported for subject device). Predicates: Rapid Aid (104°F), DeRoyal (105°F).
Temperature Profile: Equivalent to predicate device.	Temperature profiles were "equivalent" between CooperSurgical Infant Heel Warmer and DeRoyal Infant Heel Warmer.
Biocompatibility: Patient-contacting parts conform to ISO standards.	Passed AAMI/ANSI/ISO 10993-5:2003 and AAMI/ANSI/ISO 10993-10:2010.
Shelf Life/Stability: Device maintains performance over time.	Stability testing was performed to confirm shelf life.
Skin Safety (Thermal Injury/Erythema): No evidence of thermal injury or significant erythema on application to skin.	No evidence of thermal injury; all but one animal received an erythema score of 0 (one received 1, barely perceptible).

Study Details

The primary "study" described is a combination of non-clinical performance testing and an animal study.

Sample Size used for the test set and the data provenance:
- Temperature Profile Testing: "For each sample, a calibrated thermocouple was attached to the center..." The exact number of samples tested for temperature profiling is not explicitly stated. It implies multiple samples were tested to establish the profile.
- Animal Study: 6 pigs (3 light-skinned, 3 dark-skinned), aged 3 to 3.5 weeks.
- Data Provenance: Not specified, but generally assumed to be internal laboratory testing by the manufacturer or contracted labs. The animal study involved "pigs."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the context of an AI/software device. For this device, "ground truth" for temperature was measured by calibrated thermocouples. For the animal study, grading of thermal insult and erythema was done against "established criteria," implying veterinary or pathology expertise, but the number and specific qualifications of graders are not provided.
Adjudication method for the test set:
- Not Applicable. This is not a human-reader-based diagnostic device.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI/software diagnostic device that involves human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical heating device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Temperature Profile: Objective measurements from calibrated thermocouples.
- Biocompatibility: Adherence to international standards (AAMI/ANSI/ISO 10993-5:2003, AAMI/ANSI/ISO 10993-10:2010), likely involving established lab tests for cytotoxicity and sensitization/irritation.
- Animal Study (Skin Safety): Visual grading against "established criteria" for thermal insult and erythema, which would typically involve macroscopic and potentially microscopic (pathology) assessment by trained personnel/veterinarians, but the specific detail is not explicitly provided.
The sample size for the training set:
- Not Applicable. This is not a device based on trained algorithms.
How the ground truth for the training set was established:
- Not Applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 18, 2016

CooperSurgical Inc. c/o Roaida Johnson Associate Director, New Product Development 95 Corporate Drive Trumbull, CT 06611

Re: K151845

Trade/Device Name: Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) Regulation Number: 21 CFR 890.5710 Regulation Name: Hot or cold disposable pack Regulatory Class: Class I Product Code: MPO Dated: February 16, 2016 Received: February 17, 2016

Dear Ms. Johnson:

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. 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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J.Hoffmann -A

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151845

Device Name Infant Heel Warmer (Model 24401) WarmGel® Infant Heel Warmer (Model 20418)

Indications for Use (Describe)

The device is primarily used in hospitals, doctor's offices, and other healthcare facilities.

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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K151845

Image /page/3/Picture/1 description: The image shows the logo for CooperSurgical. The logo is in black and features the company name in a stylized font. The 'C' in Cooper is stylized with two concentric circles.

510(k) Summary WarmGel® Infant Heel Warmer (Model 20418) Infant Heel Warmer (Model 24401)

Submitter Information

Company Name:	CooperSurgical Inc.
Company Address:	95 Corporate DriveTrumbull, CT 06611
Telephone:	203-601-5200
Fax:	203-601-9870

Contact Person:	Roaida Johnson
Date Prepared:	March 17, 2016

Device Information

Trade Names:	The Infant Heel Warmer (Model 24401)WarmGel® Infant Heel Warmer (Model 20418)
Common Name:	Infant Heel Warmer
Classification:	Class I per 21 CFR 890.5710
Classification Name:	Hot or cold disposable pack
Product Code:	MPO

Predicate Device Information

The CooperSurgical Infant Heel Warmer is substantially equivalent to the following predicates:

Primary Predicate: Rapid Aid Instant Disposable Infant Heel Warmer - Disc (K150627) Additional Predicate: DeRoyal Industries Infant Heel Warmer (K954716)

Device Description

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Indications for Use

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.

Substantial Equivalence Analysis

The substantial equivalence of the CooperSurgical Infant Heel Warmer to the predicates 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 predicates.

Property	Subject DeviceCooperSurgicalInfant Heel Warmer	PrimaryPredicateInstantDisposableInfant HeelWarmer - Disc	AdditionalPredicateInfant HeelWarmer	Comparison
Manufacturer	CooperSurgical Inc.	Rapid Aid Corp.	DeRoyalIndustries	---
510(k)Number	K151845	K150627	K954716	---
PouchMaterial	Poly/nylon	Poly/nylon	Unknown	Same as primarypredicate
SolutionMaterial	Liquid version -Sodium acetate (foodgrade) and waterGel version - Sodiumacetate (food grade),water, andhydroxyethylcellulose	Sodium acetate(food grade) andwater	Unknown	Thehydroxyethylcelluloseis a non-toxicthickening agent. Theaddition of the materialdoes not raise newissues of safety andeffectiveness.
ActivationMethod	Flexing metal disc	Flexing metaldisc	Squeeze to burstinner pouch	Same as primarypredicate
AverageMaximumTemperature	104° F	104° F	105° F	Same as primarypredicate
MaximumPeakTemperature	107° F	Unknown	Unknown	An animal study wasperformed to confirmno new issues of safetyand effectiveness.
Size of Pouch	5" x 3.5"	5.5" x 3.75"	5" x 3.5"	Same as secondarypredicate
Method ofAttachment toHeel	Adhesive strap	Adhesive strap	Adhesive strap	Same as bothpredicates
Sterility.Number ofUses	Non-sterile, SingleUse, Disposable	Non-sterile,Single Use,Disposable	Non-sterile,Single Use,Disposable	Same as bothpredicates

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Non-Clinical Performance Testing

Temperature profile testing was performed on the CooperSurgical Infant Heel Warmer and on the predicate DeRoyal Infant Heel Warmer, and the results of this testing were used to determine the substantial equivalence of the Infant Heel Warmer to the predicate. For each sample, a calibrated thermocouple was attached to the center, the device was activated to allow the exothermic reaction to begin, and temperature readings were taken at 5 second intervals for 30 minutes. The samples were activated at a temperature of 75° + 1° F. The temperature profiles were compared between the CooperSurgical Infant Heel Warmer and the predicate DeRoyal Infant Heel Warmer, and were found to be equivalent.

Stability testing was also performed on the CooperSurgical Infant Heel Warmer to confirm its shelf life. Biocompatibility was performed on the patient-contacting components of the device (outer pouch and adhesive tape) per AAMI/ANSI/ISO 10993-5:2003, and AAMI/ANSI/ISO 10993-10:2010.

An animal study was performed to determine the temperature of the skin after application of the device. The study consisted of three light-skinned and three dark-skinned pigs, aged 3 to 3.5 weeks. A WarmGel Infant Heel Warmer was placed on one side of the animal while the opposite side served as a control. Temperatures were measured using thermocouples adhered to the animal, one under the heel warmer and one on the control side, at 1-minute intervals for a total of 22 minutes. The animals were then graded against established criteria for both thermal insult and erythema. There was no evidence of thermal injury in any of the animals, and all but one animal received an erythema score of 0, with the one animal receiving a score of 1, which is barely perceptible.

Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, the CooperSurgical Infant Heel Warmer has been shown to be substantially equivalent to the predicate devices 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.