(31 days)
The LC Sprint Star is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The LC Sprint Star is intended for pediatric and adult patients consistent with the indications for the aerosol medication.
The LC Sprint Star is a small, single patient use, reusable air-powered nebulizer for the inhalation treatment of aerosolized medications. The device is non-sterile, prescriptionuse only, intended for use in hospital, clinic, or home environments.
LC Sprint Star is a cosmetically and geometrically modified version of the LC Sprint nebulizer currently marketed by PARI. The LC Sprint Star has an inspiratory balve on the top component and an expiratory valve on the mouthpiece, allowing for breathcontrolled aerosol output.
The LC Sprint Star will be available as a stand-alone item or a configuration component containing:
- LC Sprint Star nebulizer (consisting of nebulizer cup, top, and baffle insert) I
- L Mouthpiece
- Oxygen tubing (optional) 트
- 트 Mask (optional)
The provided text describes a 510(k) submission for a nebulizer, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device cannot be extracted from this document, as it does not pertain to such a device.
The document discusses the LC Sprint Star Reusable Nebulizer, comparing it to predicate devices and detailing its indications for use. It's a medical device clearance, not an AI/ML product.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).