(199 days)
The Respironics Heated Humidifier is an accessory for CPAP and Bi-level systems to provide moisture to the patient circuit. It is intended for use with adult patients, in the home or hospital/institutional environment, who use maskapplied CPAP or Bi-level therapy for the treatment of Obstructive Sleep Apnea.
The Respironics Heated Humidifier 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 Respironics 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.
This document describes a 510(k) submission for the Respironics Heated Humidifier, a respiratory gas humidifier.
Here's an analysis of the provided text with respect to acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a structured table or numerical targets for device performance. Instead, it relies on demonstrating equivalence to a predicate device and compliance with general safety and performance standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Safety (as per IEC 60601-1 and UL 2601-1) | The Respironics Heated Humidifier meets the requirements of the IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for safety and the relevant USA deviations in UL 2601-1. |
| Electrical Safety (as per IEC 60601-1 and UL 2601-1) | The Respironics Heated Humidifier meets the requirements of the IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for safety and the relevant USA deviations in UL 2601-1. |
| Thermal Safety (as per IEC 60601-1 and UL 2601-1) | The Respironics Heated Humidifier meets the requirements of the IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for safety and the relevant USA deviations in UL 2601-1. |
| Environmental Conditions (Relevant Standards) | Non-clinical testing for environmental conditions was carried out. The device meets relevant international and USA medical electrical equipment standards for safety. |
| Electromagnetic Compatibility (Relevant Standards) | Non-clinical testing for electromagnetic compatibility was carried out. The device meets relevant international and USA medical electrical equipment standards for safety. |
| Functional Verification | Non-clinical testing for functional verification was carried out. The device meets design and performance functional requirements. |
| Software Verification | Non-clinical testing for software verification was carried out. The device meets design and performance functional requirements. |
| System Validation | Non-clinical testing for system validation was carried out. The device meets design and performance functional requirements. |
| Performance (Humidification capability, temperature range) | Functionally equivalent to the predicate (Fisher & Paykel HC100 Respiratory Humidifier), with differences noted in weight, size, energy type, user controls (5 settings vs. 9 settings), and temperature range (off to 65°C) and delivered humidity. Non-clinical testing indicates it meets performance functional requirements and key performance from particular standards for humidification systems. The device is intended to warm and add moisture to breathing gases. |
| Equivalence to Predicate (Safety, Effectiveness, Performance) | The Respironics Heated Humidifier is equivalent to the predicate device (Fisher & Paykel HC100 Respiratory Humidifier) in terms of safety, effectiveness, and performance. ("The technological characteristics of the Respironics Heated Humidifier are equivalent to the Fisher & Paykel HC100 humidifier predicate device listed above.") Equivalence is stated for type (heated Passover), configuration (chamber, tubing, physical design, user controls, energy delivered, humidifier design concept, inlet/outlet sizing). Differences in weight, size, energy type, user controls, temperature range (off to 65°C), and delivered humidity exist but are implied not to impede equivalence. |
| Compliance with 21 CFR 868.5450 (Respiratory Gas Humidifier) | The device is classified as a Respiratory Gas Humidifier (heated Passover type) according to 21 CFR 868.5450. |
| Intended Use/Indications for Use (as stated by sponsor) | Intended use is to warm and add moisture to breathing gases for CPAP/Bi-level users with Obstructive Sleep Apnea, to relieve drying and irritating effects. The device is for adult patients in home or hospital/institutional environments. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: Not applicable. This submission is for a medical device (humidifier), not an AI algorithm evaluated on a 'test set' of data in the typical sense. Performance was assessed through non-clinical laboratory testing of the device itself and comparison to a predicate.
- Data Provenance: Not applicable in the context of clinical trial data. The data refers to the results of engineering and functional tests conducted on the physical device. The country of origin for these tests is implied to be within the company's (Respironics, Inc. in Murrysville, PA) testing facilities, or by certified third-party testing labs for standards compliance. The data is prospective for this specific device, meaning the tests were performed on the newly designed humidifier.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. "Ground truth" in the context of expert consensus on diagnostic images or patient outcomes is not relevant for this type of device submission. Ground truth for device performance would be established by validated measurement equipment and adherence to defined engineering and medical device standards.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. No adjudication method involving multiple experts for a test set is mentioned or relevant for this type of device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance?
No. This is a submission for a physical medical device (respiratory gas humidifier), not an AI-powered diagnostic or assistive technology where MRMC studies would be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by:
- Compliance with recognized international and national safety standards (IEC 60601-1, UL 2601-1).
- Functional verification against design specifications.
- Comparison of technological characteristics and performance to the legally marketed predicate device (Fisher & Paykel HC100 Respiratory Humidifier), demonstrating substantial equivalence.
- The intended function of warming and adding moisture to breathing gases is physically measurable.
8. The Sample Size for the Training Set
Not applicable. There is no AI algorithm being trained. Performance is based on physical device testing and comparison to a predicate.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI algorithm being trained, and therefore no training set or ground truth for it.
§ 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).