(14 days)
No
The description mentions a "microprocessor-controlled system" for basic heating and humidification, but there is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies focus on physical characteristics like water turbulence.
Yes
The device is intended for use with positive pressure ventilation systems to provide moisture, which compensates for the drying effect and is a form of treatment for patients using these systems.
No
Explanation: The device is a heated humidifier intended to add moisture and warmth to the air from a positive pressure ventilation device. Its purpose is therapeutic (compensating for drying effects), not diagnostic (identifying or characterizing disease).
No
The device description explicitly details physical components like a thermoplastic enclosure, metal heater plate, control electronics, and a humidification chamber, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the Respironics H2 Heated Humidifier is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide moisture to the patient circuit in positive pressure ventilation systems. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a system for humidifying breathing gases, which is a physical process applied to the air the patient breathes, not a test performed on a biological sample.
- Regulatory Classification: It is classified as a Respiratory Gas Humidifier (heated Passover type) according to 21 CFR 868.5450. This classification falls under the category of medical devices used for respiratory support, not in vitro diagnostics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
Therefore, the Respironics H2 Heated Humidifier is a medical device used for respiratory therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Respironics H2 Heated Humidifier is an accessory for positive pressure ventilation systems to provide moisture to the patient circuit.
It is intended for use with adult patients (> 30 kq), in the home or hospital/institutional environment, who use mask-applied positive pressure ventilation therapy.
Product codes
BTT
Device Description
The H2 Heated Humidifier is a microprocessor-controlled system that has been designed to moisten and warm the air from a positive pressure ventilation device and thus help to compensate for the drying effect. The device is intended for use with the standard patient circuit that is used to connect the device to the patient interface (mask) and to the positive pressure ventilation device.
It is a Respiratory Gas Humidifier (heated Passover type) according to 21 CFR 868.5450. Heat is used to provide an evaporated water content to dry breathing gases.
The H2 Heated Humidifier has a thermoplastic enclosure with dimensions of 5.5 in. high x 6.5 in. wide x 5.25 in. deep and weighs 1.24 lbs. (without the chamber fitted), 1.63 lbs. (with the chamber fitted), and 2.5 lbs. (with the chamber fitted and filled with water). The unit is compromised of a metal heater plate that is controlled from control electronics, contained in a plastic enclosure that is directly supplied with AC power. The heater plate is positioned in the front of the unit. The humidification chamber slides onto the heater plate and is held in place by a rim on the enclosure. The unit controls are located on the top panel.
Accessories for the H2 Heated Humidification chambers, breathing tubing and mounting arrangements.
During the review of the Respironics Heated Humidifier (K012633) submission, a baffle was added to the inlet of the humidifier water chamber in order to minimize the amount of water being blown out of the humidifier at high flow conditions. Without the baffle, a positive pressure ventilation device operating at pressures > 20 cm H2O and flows 30 kg)
Intended User / Care Setting
Not Found
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)
The design of the humidifier was verified through the use of design verification and validation testing. The Hazards Control Measures Traceability Matrix provided in Appendix B of the Risk Analysis assured that all hazards identified by the risk analysis were successfully mitigated.
Verification testing has demonstrated that the addition of the baffle to the water chamber mitigated the water turbulence, which caused the water to spill into the patient circuit, observed at 30 cm H₂O under normal operating conditions and at 40 cm H2O under single fault conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Premarket Notification 510(k) Section 10 - 510(K) Summary
| Official Contact / Address
of Manufacturing facility | Zita A. Yurko
Manager, Regulatory Affairs
Respironics Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | H2 Heated Humidifier |
| Common/Usual Name | Respiratory Gas Humidifier |
| Classification Reference | 21 CFR 868.5450 |
| Classification | Class II |
| Appropriate Classification Panel | Anesthesiology Devices |
| Product Code | BTT - Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Predicate Devices | Respironics Heated Humidifier (K012633) |
| | Fisher & Paykel HC100 Heated Humidifier (K915460) |
| Reason for submission | Additional or expanded indications |
Substantial Equivalence
This premarket notification submission demonstrates that the H2 Heated Humidifier is substantially equivalent to a combination of the Respironics Heated Humidifier (K012633) and the Fisher & Paykel HC100 Heated Humidifier (K915460). The software in the H2 Heated Humidifier is unchanged from the software provided in K012633.
The design of the humidifier was verified through the use of design verification and validation testing. The Hazards Control Measures Traceability Matrix provided in Appendix B of the Risk Analysis assured that all hazards identified by the risk analysis were successfully mitigated.
©2002 Respironics Inc.
1
This submission is seeking to extend the existing claims of the humiditier to include patients using mask applied positive pressure ventilation.
Indications for Use
The Respironics H2 Heated Humidifier is an accessory for positive pressure ventilation systems to provide moisture to the patient circuit.
It is intended for use with adult patients (> 30 kq), in the home or hospital/institutional environment, who use mask-applied positive pressure ventilation therapy.
Device Description
The H2 Heated Humidifier is a microprocessor-controlled system that has been designed to moisten and warm the air from a positive pressure ventilation device and thus help to compensate for the drying effect. The device is intended for use with the standard patient circuit that is used to connect the device to the patient interface (mask) and to the positive pressure ventilation device.
It is a Respiratory Gas Humidifier (heated Passover type) according to 21 CFR 868.5450. Heat is used to provide an evaporated water content to dry breathing gases.
The H2 Heated Humidifier has a thermoplastic enclosure with dimensions of 5.5 in. high x 6.5 in. wide x 5.25 in. deep and weighs 1.24 lbs. (without the chamber fitted), 1.63 lbs. (with the chamber fitted), and 2.5 lbs. (with the chamber fitted and filled with water). The unit is compromised of a metal heater plate that is controlled from control electronics, contained in a plastic enclosure that is directly supplied with AC power. The heater plate is positioned in the front of the unit. The humidification chamber slides onto the heater plate and is held in place by a rim on the enclosure. The unit controls are located on the top panel.
Accessories for the H2 Heated Humidification chambers, breathing tubing and mounting arrangements.
During the review of the Respironics Heated Humidifier (K012633) submission, a baffle was added to the inlet of the humidifier water chamber in order to minimize the amount of water being blown out of the humidifier at high flow conditions. Without the baffle, a positive pressure ventilation device operating at pressures > 20 cm H2O and flows 30 kg), in the home or hospital/institutional environment, who use mask-applied positive pressure ventilation.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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ion Sign-Off)
on Sign-Off)
on of Anesthesiology, General Hospital, Infection Control,
510(k) Number:_