(33 days)
The Ballert Cranial Molding Helmet is intended for use by or under the direction of a physician for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-and brachycephalic-shaped heads.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "Ballert Cranial Molding Helmet." This type of document does not contain the information requested regarding acceptance criteria, study details, and performance metrics because it is a clearance letter, not a study report or a technical datasheet.
A 510(k) clearance letter indicates that the FDA has determined a new device is "substantially equivalent" to a legally marketed predicate device. This determination is based on the manufacturer's submission which includes information like intended use, technological characteristics, and safety and effectiveness data, but the letter itself does not detail the specific performance study results.
Therefore, I cannot provide the requested information based on the provided text.
§ 882.5970 Cranial orthosis.
(a)
Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.(b)
Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).