(8 days)
The NightForm product is indicated for healthy infants 0-9 months to aid in the prevention of skull deformities that can rise from consistent back-sleeping postures, known as Deformational (or positional) plagiocephaly.
NightForm is a fabric-covered polyurethane foam mattress with two accompanying fabric-covered polyurethane wedges that affix to the mattress by hook/loop fasteners in various positions that permit parents to modify nightly the supine sleeping position of their sleeping infants and thereby prevent a condition known as deformational plagiocephaly.
The provided text describes a 510(k) premarket notification for the "NightForm Infant Sleep Positioner." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria and results.
Therefore, there is no information available in the provided text to fulfill the request for acceptance criteria and the study that proves the device meets those criteria. The document explicitly states: "Performance Summary: FDA has not established special controls or performance standards for this device."
The text contains the following details that are relevant to the device's regulatory submission but do not address performance criteria:
- Device Name: NightForm™ Infant Sleep Positioner
- Intended Use: To be used preventatively during sleep for infants 0-9 months of age to prevent a condition known as deformational plagiocephaly.
- Predicate Device: Pedicraft Infant Reflux Wedge (K905629)
- Predicate Comparison Table: Compares the new device to the predicate device on application, target population, purpose, and materials. This is for demonstrating substantial equivalence, not for presenting performance study results against specific criteria.
- Regulatory Classification: Class I, Product Code FRP, Regulation Number 880.5680 (Pediatric Position Holder).
- FDA Communication: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed. This is a regulatory approval based on equivalence, not a performance study outcome.
§ 880.5680 Pediatric position holder.
(a)
Identification. A pediatric position holder is a device used to hold an infant or a child in a desired position for therapeutic or diagnostic purposes, e.g., in a crib under a radiant warmer, or to restrain a child while an intravascular injection is administered.(b)
Classification. Class I (general controls). Except when the device is an infant positioner for prescription use in highly monitored settings or an infant sleep position holder, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. The device is exempt from the good manufacturing practice regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.