(255 days)
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.
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.
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.
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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."
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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.
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Adjudication method for the test set:
- Not Applicable. This is not a human-reader-based diagnostic device.
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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.
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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.
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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.
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The sample size for the training set:
- Not Applicable. This is not a device based on trained algorithms.
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How the ground truth for the training set was established:
- Not Applicable.
§ 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.