(76 days)
The Baxter Sodium Acetate Infant Heel Warmer™ is a single-use, non-sterile device. It is a heat therapy pack intended to be used on an infant's heel in order to increase peripheral blood flow and oxygenation prior to blood sampling.
The Baxter Sodium Acetate Infant Heel Warmer™ is comprised of a polyethylene/BON pouch enclosing the phase change chemical and the activator disk-like trigger. Upon pinching and flexing trigger also located within the pouch, aluminum oxide grit is released into the sodium acetate and water mixture thus initiating a chemical exothermic reaction. The hot pack immediately reaches a maximum temperature of 104 °F +/- 2.9 °F and gradually diminishes over time.
Here's an analysis based on the provided text, though it's important to note that the document describes a medical device (infant heel warmer) and not an AI/ML-driven diagnostic tool. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable. I will interpret the acceptance criteria and "device performance" in the context of a physical medical device.
Acceptance Criteria and Study for Baxter Sodium Acetate Infant Heel Warmer™
The provided document, K961154, is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a medical device, not a study evaluating an AI algorithm. Therefore, the questions related to AI/ML performance, ground truth establishment, expert review, training sets, and MRMC studies are not directly relevant to this document. I will focus on the information that is applicable to a physical device's performance and safety assessment.
1. Table of Acceptance Criteria and Reported Device Performance
Device Name: Baxter Sodium Acetate Infant Heel Warmer™
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Temperature | Maximum Temperature | 104 °F +/- 2.9 °F (immediately reaches) |
| Duration of Temperature | Gradually diminishes over time | |
| Material Safety | Skin Sensitization (Outer Pouch Material) | Passed (Guinea pig Maximization) |
| Primary Skin Irritation (Outer Pouch Material) | Passed | |
| Cytotoxicity (Outer Pouch Material) | Passed | |
| Primary Skin Irritation (Active Chemical Mixture) | Passed (non-toxic, food grade, toxicologically acceptable) | |
| Material Composition | USP XXII / Sodium Acetate Solution Evaluation | All materials evaluated through this standard |
| ISO Standard 10993 (Relevant Tests) | All materials evaluated through relevant tests | |
| Physical Integrity | Material Tensile Strength (width/length) | Tested (result not quantified, but implied acceptable) |
| Side and Top Seal Tensile Strength | Tested (result not quantified, but implied acceptable) | |
| Peak Temperature | 104 °F +/- 2.9 °F | |
| Time at Peak Temperature | Tested (result not quantified, but implied acceptable) | |
| Temperature at Five Minutes | Tested (result not quantified, but implied acceptable) | |
| General Compliance | Established Standards | In compliance where applicable, deemed acceptable for intended use |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test. It refers to "All materials used" and "The outer pouch material," and "The active chemical mixture." This implies that the materials constituting the device were sampled and subjected to various tests.
- Sample Size: Not explicitly stated for each test (e.g., number of guinea pigs for sensitization, number of chemical batches tested).
- Data Provenance: The tests are described as being performed internally or by labs adhering to established standards (USP XXII, ISO 10993). The country of origin for the data generation is implied to be within the manufacturer's operational scope (Moberly, Missouri), but no specific external lab locations are given. The studies are by nature retrospective in relation to the submission date, as they were conducted to support the pre-market application.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the document describes a physical medical device, not an AI/ML system requiring expert-established ground truth. The "ground truth" for this device relates to objective physical and biological properties (e.g., actual temperature, material strength, biological response in animal models).
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in expert consensus for diagnostic tasks, not for evaluating the physical and biological properties of a device. The tests performed are objective measurements or standardized animal/in vitro tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This section is not applicable. MRMC studies are designed to compare the diagnostic performance of human readers, often with and without AI assistance. This document describes a physical therapeutic device, not a diagnostic tool where human reader performance would be directly relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This section is not applicable. There is no algorithm described in this document.
7. The Type of Ground Truth Used
For the purpose of this device, the "ground truth" was established by:
- Objective Physical Measurements: Calibrated instruments for temperature, tensile strength, and timing.
- Standardized Biological Assays:
- In vitro cytotoxicity tests.
- In vivo animal models (guinea pig maximization test for skin sensitization, primary skin irritation test).
- Chemical Composition and Purity Standards: USP XXII and ISO 10993 for material evaluation.
8. The Sample Size for the Training Set
This section is not applicable. The concept of a "training set" applies to machine learning algorithms where a model learns from data. This document describes the testing and validation of a physical device.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for a machine learning algorithm.
§ 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.