(620 days)
Intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.
The Hanger Cranial Band 3D is a cranial remolding orthosis comprised of an additivemanufactured outer shell with a polyethylene foam inner lining.
The device is custom fabricated for individual patients by obtaining measurements via a handheld 3D laser scanner. Clinical measurements of the infant's cranium are taken from the digital file. The scan is then modified utilizing a CAD/CAM technology package—to add or remove material, increase or decrease the circumference of model to aid in fit and functionality of the cranial orthosis. The 3D image is used to produce a positive mold using a routing machine, to which the foam liner is pulled onto. The 3D file is also used manufacture the outer shell, which is then attached to the foam-lined positive model.
The completed device applies gentle pressure to the elevated areas of the skull while leaving space for cranial growth in the depressed regions. It is open at one side and closed with a fastener to provide the selected fit and proper stability.
The provided document describes a 510(k) submission for the Hanger Cranial Band 3D, a cranial orthosis, and does not contain information about acceptance criteria and a study proving a device meets them. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information about acceptance criteria and a study for this specific document.
Here's why and what information is available:
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No Acceptance Criteria or Study for Performance: The document explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The predicate device has been on the market for years with a proven safety and efficacy for the use of the device." This indicates that a study proving the device meets specific performance acceptance criteria was not conducted or presented in this submission because the device's performance is assumed to be substantially equivalent to the predicate.
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Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is often achieved by showing similar intended use, technological characteristics, and principles of operation, rather than rigorous new performance testing against specific acceptance criteria.
What information is present in the document that somewhat relates to testing, even if not a formal performance study:
- Non-Clinical Performance Data (Section VII):
- Biocompatibility: Both the outer shell and inner foam lining were tested and found to be biocompatible (reference Section 15, which is not provided).
- Tensile Stress Testing: Conducted on the outer shell material of the subject device, showing average tensile strength was higher than the predicate device's outer shell material (copoly plastic). This is a comparative test, not a performance test against acceptance criteria.
- Drop and Chemical Tests: Performed on the outer shell and "had passed the attribute acceptance criteria." However, what those acceptance criteria were (e.g., specific thresholds for impact or chemical resistance) is not detailed.
- Validation of Manufacturing: "Validation activities were performed and demonstrated that the device can be reliably manufactured with the intended geometry and dimensional tolerances based upon patient-specific scan information." No specific metrics or acceptance criteria for these tolerances are provided.
In summary, based on the provided document, I cannot fill out the requested table and answer the study-related questions because a formal study proving the device meets specific performance acceptance criteria was explicitly not required or conducted for this 510(k) submission. The submission relies on establishing substantial equivalence to a predicate device that is already deemed safe and effective.
§ 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)).