(262 days)
The Intelliflo Spacer is intended to be used in combination with Metered Dose Inhaler's (MDI) to assist in respiratory steroid drug delivery. The target population includes all patients using MDI's i.e., children, elderly, and adults.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Intelliflo Spacer." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about a standalone algorithm study or an MRMC comparative effectiveness study.
The letter only provides:
- Device Name: Intelliflo Spacer
- Regulatory Class: II
- Product Code: CAF
- Indications for Use: "The Intelliflo Spacer is intended to be used in combination with Metered Dose Inhaler's (MDI) to assist in respiratory steroid drug delivery. The target population includes all patients using MDI's i.e., children, elderly, and adults."
Therefore, I cannot provide the requested table and study details based solely on the input provided. The document is a clearance letter, not a study report or a summary of performance data.
§ 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).