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510(k) Data Aggregation
(121 days)
The InfaTherm™ Disposable Infant Warming Mattress is an instant warm pack intended to provide warmth during transport of an infant within the hospital or between hospitals. It is recommended for full-term infants. It is a single use, nontoxic, non-sterile, disposable device.
The InfaTherm™ Disposable Infant Warming Mattress is a single use, disposable pouch that is filled with a super saturated solution of food grade sodium acetate and water and a catalyst disk. When the catalyst disk inside the packet is flexed by the user, the catalyst disk reacts with the nontoxic solution and initiates a chemical exothermic crystallization of the sodium acetate, generating heat. When activated at 75°F, the Infant warming mattress will reach between 100-102°F and then gradually decrease in temperature over time. The InfaTherm™ Disposable Infant Warming Mattress is rectangular in shape. Immediately following activation of the mattress, the user places the infant on the mattress.
This document describes the InfaTherm™ Disposable Infant Warming Mattress and its substantial equivalence to a predicate device, as submitted for FDA 510(k) clearance.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or pass/fail threshold manner for performance. Instead, it compares the subject device's characteristics and performance to those of a predicate device to demonstrate substantial equivalence. The implication is that if the subject device's performance is similar to or equivalent to the predicate device, it meets the "acceptance criteria" for safety and effectiveness.
| Criterion (Implicit from Predicate Comparison) | Predicate Device Performance (Rapid Aid Corp - K163295) | Subject Device Performance (InfaTherm™ Disposable Infant Warming Mattress) | Comparison / "Acceptance Met" |
|---|---|---|---|
| Indications for Use | Provides warmth during transport of an infant within the hospital or between hospitals. Recommended for full-term infants. | Provides warmth during transport of an infant within the hospital or between hospitals. Recommended for full-term infants. | Same |
| Environment of Use | Hospitals or between hospitals | Hospitals or between hospitals | Same |
| Prescriptive | Yes | Yes | Same |
| Pouch Material | Polyethylene/60g polyamide (PE/PA) with woven cloth material on bottom outside of bag | Polyethylene LLDPE with white Polyester extrusion (PET) material on bottom of bag | Similar – both utilize polyethylene with cloth material on bottom. Deemed not to introduce new safety/effectiveness issues due to insufficient detail on predicate's cloth material. |
| Solution Material | Sodium acetate and water, thickener, activation disc; supersaturated solution | Sodium acetate (food grade), water, activation disc; supersaturated solution | Similar – subject device omitted thickener as it's redundant and doesn't introduce new safety/effectiveness issues. |
| Activation Method | Activating Disc triggers the exothermic reaction | Activating Disc triggers the exothermic reaction | Same |
| Average Device Maximum Surface Temperature | 101-104°F | 100-102°F | Similar – Subject device has a slightly lower peak temperature, deemed not to introduce new safety/effectiveness issues. |
| Average Skin Surface Temperature | Not Publicly Available | 101°F | Similar – Deemed in line with or slightly lower than predicate (based on device surface temp correlation), not introducing new safety/effectiveness issues. |
| Size of Pouch | 15.7" x 9.6" (151 sq in) | Approximately 10" x 16" (160 sq in) | Similar – Subject device is <0.5" larger, deemed not to introduce new safety/effectiveness issues. |
| Sterility, Number of Uses | Non-sterile, Single Use, Disposable | Non-sterile, Single Use, Disposable | Same |
| Temperature Profile Testing | (Data for predicate device not explicitly detailed for this section, but the subject device was compared to it.) | Testing included activation temperature, surface temperature, temperature duration, and skin temperature. All tests were a pass. | Passed (compared to predicate data) |
| Stability Testing (Shelf Life) | (Not explicitly stated for predicate in summary) | Confirmed 20 months | Passed |
| Seal Strength Testing | (Not explicitly stated for predicate in summary) | 80 psi pressure (pull test) for cross seal, 50 psi pressure for inline seal, subjected to 40 pound for 15 minute burst test. | Safe and Effective (based on internal assessment) |
| Biocompatibility Testing | (Implicitly leveraged from K936084) | Leveraged from K936084 (Omni Therm Inc.- Omni Warm Gel Packs). Considered in accordance with FDA guidance on ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". | In accordance with FDA guidance/standards. |
2. Sample Size for Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical trials or AI model evaluation. The performance evaluation is based on bench testing of the physical device.
- Sample Size: Not explicitly stated for each test (e.g., how many mattresses were tested for temperature profile).
- Data Provenance: Bench testing would be prospective, conducted by the manufacturer, International Biomedical. The country of origin for the testing itself is not specified but is presumably the USA, where the company is located.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The InfaTherm™ device is a physical medical device (warming mattress), not a diagnostic or AI algorithm requiring expert ground truth for its performance evaluation in the context of this 510(k) submission. Its performance criteria are physical properties and safety measures.
4. Adjudication Method
Not applicable for a physical device performance evaluation based on bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is not an AI algorithm or diagnostic tool that would typically undergo an MRMC study comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical warming mattress, not an algorithm.
7. Type of Ground Truth Used
For the physical characteristics and performance (temperature, seal strength, stability), the ground truth is established by:
- Physical Measurements/Instrument Readings: Temperature, pressure, material properties.
- Engineering Standards and Specifications: Adherence to defined parameters for functionality and safety.
- Regulatory Standards: Compliance with FDA guidance and international standards (e.g., ISO-10993 for biocompatibility).
8. Sample Size for Training Set
Not applicable. There is no training set as this is a physical device, not an AI/machine learning model.
9. How Ground Truth for Training Set was Established
Not applicable as there is no training set.
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