(31 days)
Rapid Aid Infant Heel Warmer is primarily used in hospitals, Doctor's offices, and other healthcare facilities. It is 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 Rapid Aid Infant Heel Warmer is a self contained unit comprised of a flexible, poly/nylon outer pouch containing:
- a) A flexible, perforated, polyethylene/polyester inner pouch that holds the liquid solution.
- b) Liquid solution of food grade sodium acetate and water contained in a).
- c) Minute crystals of sodium acetate.
An adhesive tape is attached to the top of the unit. The unit is activated by squeezing firmly on the inner fluid pouch, this will cause the inner perforated pouch to activate. Rapid crystallization occurs when the liquid contents are exposed to the minute crystals of sodium acetate contained within the poly/nylon outer pouch. This exothermic reaction causes the unit to heat up to 105 degrees F. The adhesive tape strip is used to hold the warmer in place on the infant's heel.
This 510(k) summary does not contain sufficient detail to fully answer all aspects of the request, particularly regarding specific numerical acceptance criteria and a detailed study design for device performance. However, based on the provided text, here's an analysis of the acceptance criteria and the study conducted for the Rapid Aid Infant Heel Warmer:
The primary "acceptance criterion" for this device, as presented in the 510(k), is substantial equivalence to predicate devices, specifically concerning temperature characteristics and intended use. The study focuses on demonstrating that the Rapid Aid Infant Heel Warmer performs "very similarly" to and is "substantially equivalent" to predicate infant heel warmers.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state numerical acceptance criteria for temperature output beyond "within the range of the predicate devices" and "reaching a maximum temperature around 105 F."
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate devices (aid in drawing blood from infant heel) | "intended use is the same" |
| Performance Attributes | Same as predicate devices | "performance attributes are the same" |
| Temperature Output | Within the range of predicate devices; reach max ~105°F | "temperature output... is within the range of the predicate devices"; "performed very similarly with temperatures within the same ranges, reaching a maximum temperature around 105 F within the first minutes and then steadily decreasing in temperature." |
| Chemical Composition | Primarily food-grade sodium acetate and water, same as predicate | "chemical composition is primarily the same... food grade sodium acetate and water" |
| Material Safety | Latex-free, non-sensitizing, non-toxic, food-grade chemicals | "outer poly/nylon pouch material... is latex free and non-sensitizing"; "sodium acetate... is a nontoxic, food grade chemical and has been found to be toxicologically acceptable for it's intended use." |
| Physical Properties | Meets ASTM thickness, tensile strength, seal width, seal/burst integrity | "tested for: thickness following ASTM D1203, tensile strength following ASTM D-882 and seal width"; "subject to incoming inspection for width/length, scal integrity and burst strength." |
| Peak Temperature | Consistent with production batch results and predicate performance | "Summary of peak temperature from batch production results is attached [not provided in extract]"; performs "very similarly" to predicates reaching ~105°F. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance testing against predicate devices. It refers to "batch production results" for peak temperature but does not specify how many units or batches were tested.
- Sample Size: Not specified.
- Data Provenance: Not explicitly stated, but assumed to be internal testing by Rapid Aid Ltd. There is no mention of country of origin for data or whether it was retrospective or prospective, although performance testing is generally prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (a simple warming pack) does not typically require expert-established ground truth in the way diagnostic or prognostic AI devices do. The "truth" here is objective physical measurements of temperature and material properties. Therefore:
- Number of Experts: Not applicable/not specified for ground truth establishment.
- Qualifications of Experts: N/A. The "ground truth" is based on instrumental measurements and adherence to ASTM standards.
4. Adjudication Method for the Test Set
Not applicable. This device does not involve subjective interpretations requiring adjudication (e.g., medical image reading). Performance is evaluated through objective measurements and comparisons to predicate device characteristics.
5. 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 a physical medical device (an infant heel warmer), not an AI diagnostic or prognostic tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on:
- Objective Physical Measurements: Temperature (peak and duration), material properties (thickness, tensile strength, seal integrity, burst strength), and chemical composition analysis.
- Predicate Device Performance: The primary "ground truth" for comparison is the established performance characteristics and safety profile of the legally marketed predicate infant heel warmers.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set." The device's function is based on a chemical reaction, not a learned algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.