(89 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on standard CPAP functionality.
Yes.
The device provides CPAP (Continuous Positive Airway Pressure) to treat newborns and infants with Respiratory Distress Syndrome (RDS), which is a direct therapeutic intervention.
No
Explanation: The device is described as a non-invasive respiratory support device providing CPAP, which is a treatment modality, not a diagnostic one. Its intended use is for treating infants with RDS or recovering from it, not for diagnosing the condition.
No
The device description explicitly states it is a "system" and a "non-invasive respiratory support device," implying hardware components are involved in delivering CPAP. The mention of humidification capabilities further supports this.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide CPAP (Continuous Positive Airway Pressure) for respiratory support. This is a therapeutic intervention, not a diagnostic test performed on in vitro samples (like blood, urine, or tissue).
- Device Description: The description clearly states it's a "non-invasive respiratory support device." This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Guardian Neonate CPAP / Humidification system falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended to provide CPAP for use in hospitals to treat newborns and infants less than 5kg body weight with RDS or which are recovering from RDS (Respiratory Distress Syndrome). May or may not include humidification capabilities.
Product codes
CBK
Device Description
The Guardian Neonate CPAP / Humidification systems is non-invasive respiratory support device for neonatal patients
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
newborns and infants less than 5kg body weight
Intended User / Care Setting
hospitals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EME - Infant Flow systems - K011516, Vapotherm - 2000I - K000401
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Summary of Safety and Effectiveness
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 29 June 2004
| Official Contact: | John O'Dea, Ph.D. - General Manager | |
|---|---|---|
| Proprietary or Trade Name: | Guardian Neonatal CPAP / Humidification System | |
| Common/Usual Name: | CPAP system | |
| Classification Name: | Ventilator, non-continuous (Respirator) | |
| Predicate Devices: | EME - Infant Flow systems - K011516 | |
| Vapotherm - 2000I - K000401 |
Device Description
The Guardian Neonate CPAP / Humidification systems is non-invasive respiratory support device for neonatal patients
| Intended Use and Environments | |
|---|---|
| Intended Use -- | Intended to provide CPAP for use in hospitals to |
| treat newborns and infants less than 5kg body weight with | |
| RDS or which are recovering from RDS (Respiratory | |
| Distress Syndrome). May or may not include humidification | |
| capabilities. | |
| Environment of Use -- | Hospital |
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 29-Jun-04
General Technical Characteristics
| Attribute | Guardian CPAP System |
|---|---|
| Intended to provide CPAP for neonates and infants |