(302 days)
The Infant Heel Warmer by Intco is a single use, non-toxic, non-sterile, disposable device. It is an instant warm pack intended to be used on an infant's heel to aid in the drawing of blood for analysis. The device is to be limited to use in hospitals, doctors' offices, and other healthcare facilities that administer health care services to newborns and infants. Prescription Use Only. The Indication for use of the Infant Heel Warmer by Intco is the same to the Rapid Aid Infant Heel Warmer, a legally marketed predicate device.
- Classified by FDA's Physical Medicine Device Panel as Class I, 21 CFR 890.5710, Pack, Hot or Cold disposable, MPO, and meets all requirements of ISO 7176 and EN 1021.
- The Infant Heel Warmer by Intco is a self contained unit comprised of a flexible, poly/nylon outer pouch containing: I) A flexible, perforated, polyethylene/polyester inner pouch that holds the liquid solution. II) Liquid solution of food grade sodium acetate and water contained in I). III) 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 102 degree F. The adhesive tape strip is used to hold the warmer in place on the infant's heel.
The provided document describes the acceptance criteria and a study for the "Infant Heel Warmer by Intco." However, this is a Class I medical device (Hot or cold disposable pack) which typically relies on substantial equivalence to a predicate device rather than extensive clinical studies with complex acceptance criteria like those for higher-risk devices or AI-powered diagnostics.
Based on the provided text, the device's performance is measured against that of a predicate device, focusing on fundamental physical characteristics rather than diagnostic accuracy or human interpretation.
Here's the breakdown of the information requested, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format that would typically be seen for a diagnostic or AI device. Instead, the acceptance is based on "substantial equivalence" in performance to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Temperature Profile: (i.e., reaches sufficient temperature for intended use, and similar to predicate device) | "The Infant Heel Warmer by Intco was tested against predicate devices for temperature characteristics. They performed very similarly with temperature within the same range, reaching a maximum temperature around 105 F within the first minutes and then steadily decreasing in temperature." |
| Material Safety: (latex-free, non-sensitizing, non-toxic chemical) | "The outer poly/nylon pouch material has been tested following ASTM standard and is latex free and non-sensitizing." |
| "The chemical mixture claims are based on the results of testing the sodium acetate which is a non-toxic, food grade chemical and has been found to be toxicologically acceptable for its intended use." | |
| Pouch Integrity and Durability: (thickness, tensile strength, seal integrity, burst strength) | "The finished packing material is tested for: thickness following ASTM D1203, tensile strength following ASTM D-882 and seal width." |
| "Pouch packing material is subject to incoming inspection for width/length, seal integrity and burst strength." | |
| "Finished product is subject to testing for testing for peak temperature, seal integrity and pressure testing." | |
| Intended Use: (as described for predicate device) | The device's intended use is stated to be "the same to the Rapid Aid Infant Heel Warmer, a legally marketed predicate device." |
Study Proving Device Meets Acceptance Criteria:
The study described is primarily a comparative performance study against a predicate device and various material and product integrity tests.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify a numerical sample size for the "Infant Heel Warmer by Intco" units tested for performance or the predicate devices used for comparison. It refers to "batch production results" for peak temperature, suggesting multiple units from production batches were tested, but no specific number is given.
- Data Provenance: Not explicitly stated. The manufacturer is Shanghai Intco Medical Supply Co., Ltd., suggesting testing likely occurred in China or at an associated facility. The document does not describe the origin of subject data (e.g., patient data) as this is not a diagnostic device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable and not provided in the document. The "ground truth" for this device is based on physical properties and performance (e.g., temperature, material strength) measured by instruments and verified by standard tests, not expert interpretation of medical images or patient data.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth from multiple human expert opinions in diagnostic studies, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and not provided. This is not an AI-powered diagnostic device, and therefore, an MRMC study or assessment of AI assistance for human readers is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. 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 established through:
- Physical measurements and laboratory testing: For temperature characteristics, material properties (e.g., thickness, tensile strength, seal integrity, burst strength), and chemical composition analysis.
- Conformance to standards: ASTM standards (D1203, D-882), ISO 7176, and EN 1021 are mentioned for material and product testing.
- Comparison to a predicate device: The performance (specifically temperature characteristics) was directly compared to the "Rapid Aid Infant Heel Warmer."
8. The Sample Size for the Training Set:
This information is not applicable and not provided. As this is a traditional medical device, there is no "training set" in the context of machine learning or AI. The product validation relies on engineering tests and comparison to a predicate device.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided for the same reasons as #8.
§ 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.