(15 days)
The Respironics Heel Snuggler infant heel warmer is intended for use whenever circulation needs to be stimulated in the infant heel in order for blood sampling to occur.
The Heel Snuggler is a butterfly shaped packet that is filled with a non-toxic solution and a catalyst disk. Two straps with adhesive ends are attached to one side of the packet for securing the heel warmer to the infant's foot. Immediately following activation of the user rests the bottom of the infant's foot on the larger portion of the packet and holds the smaller portion of the packet to the ankle. The straps with adhesive tape on the end are then fitted across the infant's foot and ankle and secured to the opposite side of the packet. The adhesive portion of the strap is affixed to the packet only, not the infant's skin. This forms a boot shape around the infant's foot. The heel warmer are perforated, which enables the user to easily tear the straps and remove the heel warmer from the infant's foot after use.
When the catalyst disk inside the packet is flexed by the catalyst reachs with the solution a ri initiates a chemical exothermic reaction, which produces warmth.
The Heel Snuggler Infant Heel Warmer is a Class I device, and the provided documentation is a 510(k) summary for its clearance. Medical devices in Class I, especially those cleared via a 510(k), are generally considered low risk and do not require the rigorous clinical efficacy studies that higher-risk devices or software as a medical device (SaMD) might.
From the provided text, there is no information about an AI/ML powered device, acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML device. The document describes a traditional medical device (an infant heel warmer) and its 510(k) clearance process.
Therefore, I cannot provide the requested table and information about acceptance criteria and studies related to an AI/ML device. The document specifically states:
- "Design verification tests were performed on the Heel Snuggler as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." This indicates that the device underwent engineering and design verification testing to ensure it met pre-defined product requirements and safety standards, which is typical for a non-AI/ML medical device.
- The comparison is made to a predicate device (DeRoyal Industries, Inc. Infant Heel Warmer (K954716)) to establish substantial equivalence, which is the standard pathway for 510(k) clearance for traditional medical devices.
The information you are requesting (AI/ML relevant details) is not present in this document because the device described is not an AI/ML product.
§ 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.