(90 days)
Not Found
No
The 510(k) summary describes a pediatric mask for CPAP/bi-level therapy and does not mention any AI or ML components or functionalities.
No
The device is a mask intended to provide an interface for CPAP or bi-level therapy, but it does not directly provide therapy itself. It is an accessory to a therapeutic device.
No
The device is a pediatric mask intended to provide an interface for the application of CPAP or bi-level therapy, not to diagnose a condition.
No
The device description clearly indicates it is a physical mask with vent holes, intended to provide an interface for CPAP or bi-level therapy. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The MiniMe™ Pediatric Mask is an interface for delivering CPAP or bi-level therapy. It is a physical device that connects to a therapy machine and is worn by the patient. It does not perform any tests on bodily samples.
- Intended Use: The intended use is to provide an interface for therapy, not to diagnose or monitor a condition through analysis of bodily samples.
Therefore, the function and intended use of the MiniMe™ Pediatric Mask clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MiniMe™ Pediatric Mask is intended to provide an interface for application of CPAP or bi-level therapy. It is intended for patients > 2 years old and 2 years old and
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
510(k) Summary Page 1 of 2 18-Jun-09
JUL - 1 2009
| SleepNet Corporation | |
|---|---|
| 5 Merrill Industrial Drive | Tel - 603-758-6625 |
| Hampton, NH 03842 | Fax - 603-758-6699 |
| Official Contact: | Jennifer Kennedy - Director of Quality |
| Proprietary or Trade Name: | MiniMe™ Pediatric Mask |
| Common/Usual Name: | Patient interface |
| Classification Code/Name: | BZD - accessory for ventilator, non-continuous (respirator) |
| CFR 868.5905 | |
| Device: | MiniMe™ Pediatric Mask |
| Predicate Devices: | K073600 / K954207 - Respironics ComfortGel |
| K053352 - Respironics ComfortLite2 | |
| K032922 -- Airway Development Clarissa | |
| K060105 - ResMed Kidsta | |
| K013306 - SleepNet MiniMe |
Device Description:
The SleepNet MiniMe™ Pediatric Mask with vent holes for a fixed leak during use and without vent holes when used with a patient circuit that incorporates its own anti-asphyxia valve,
It is single patient, multi-use or multi-patient, reusable.
Indications for Use:
The MiniMe™ Pediatric Mask is intended to provide an interface for application of CPAP or bilevel therapy. It is intended for patients > 2 years old and 2 years and 2 years old and