(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 |
§ 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.