(42 days)
Hot disposable pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces. Also used as a heat therapy pack with an absorbent perineal pad; for use post delivery to absorb lochea while relieving edema and inflammation associated with an an episiotomy.
The Allegiance Kwik Heat™ Perineal Warm Pack is comprised of an outer pouch which is secured to a perineal pad and then wrapped in a polyester material. The heat source pouch consists of a supercooled solution of sodium thiosulfate, dextrose and water. The sodium thiosulfate, dextrose and water "bubble" is housed in a separate plastic pouch inside the outer pouch. The perineal pad is made of a non-woven wrapped cellulose wood pulp fiber. Activation of the heat source occurs by folding the unit to open the inner bubble which releases the liquid, and kneading the unit, thus creating a physical exothermic reaction.
The document describes the Allegiance Kwik Heat™ Perineal Warm Pack, a hot therapy pack intended for medical purposes, including post-delivery use to absorb lochia and provide therapeutic heat to relieve pain associated with an episiotomy incision.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Skin sensitization | "materials were subjected to skin sensitization...testing." |
| Intracutaneous reactivity | "materials were subjected to...intracutaneous reactivity...testing." | |
| Cytotoxicity | "materials were subjected to...cytotoxicity testing." | |
| Primary Skin Irritation | "The active chemical mixture was subjected to primary skin irritation testing." | |
| Material Safety | Toxicological Acceptability | "This mixture was found to be toxicologically acceptable for its intended usage." |
| Food Grade Requirements | "Sodium Thiosulfate meets all food grade requirements." (Referencing Food Chemicals Codex, 3rd Ed. (1981), p. 304, incorporated by reference in 21 CFR 184.1807) | |
| Physical Performance | Temperature Performance | "Physical tests completed include: temperature performance testing." |
| General Standards Compliance | Established Standards | "This product is in compliance with established standards, where applicable, and was deemed acceptable for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for the test sets related to the biological and physical testing. It only states that "All materials used in the composition of this hot pack were identified, evaluated and tested."
The data provenance is also not specified. Given the context of a 510(k) submission in 1997, it's highly likely that testing was done by or for the manufacturer (Allegiance Healthcare Corporation) and would be considered prospective data for the purpose of demonstrating device safety and effectiveness. There is no information about country of origin of the data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for the test data. The types of tests (biocompatibility, chemical composition, temperature performance) would typically rely on standardized laboratory protocols and measurements rather than expert consensus on a 'ground truth' in the way it's understood for diagnostic AI.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method. This is not relevant for the type of safety and performance testing described (e.g., cytotoxicity, temperature measurement) which relies on objective laboratory results rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, often aided by AI. The Allegiance Kwik Heat™ Perineal Warm Pack is a physical medical device (a hot pack), not a diagnostic tool, and therefore, an MRMC study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
No, a standalone study (in the context of an algorithm) was not done. The device itself is a physical product and does not involve any algorithms or artificial intelligence. Therefore, this question is not applicable.
7. The Type of Ground Truth Used:
The "ground truth" for the device's safety and performance was established through a combination of:
- Standardized laboratory testing results: For biocompatibility (skin sensitization, intracutaneous reactivity, cytotoxicity, primary skin irritation) and physical temperature performance.
- Compliance with established specifications and standards: For the chemical composition (e.g., Food Chemicals Codex for Sodium Thiosulfate) and general safety standards (ISO Standard 10993 Part 1).
- Toxicological assessment: Determining that the chemical mixture was "toxicologically acceptable."
8. The Sample Size for the Training Set:
The concept of a "training set" is applicable to machine learning and AI algorithms. Since this device is a physical product and does not involve AI, there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for an AI algorithm, this question is 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.