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510(k) Data Aggregation
(135 days)
The Transcend Heated Humidifier is indicated for the humidification of the air delivered from a compatible Transcend positive airway pressure therapy device. The Humidifier is intended for single patient re-use in the home environment and in a hospital/institutional environment. The Humidifier is for use only as recommended by a physician.
The Transcend Heated Humidifier is a humidifier that is designed to humidify the air delivered to the airway during positive airway pressure (PAP) therapy with a compatible Transcend PAP device.
The provided document describes the acceptance criteria and supporting studies for the Transcend Heated Humidifier, a medical device for humidifying air during positive airway pressure (PAP) therapy.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Transcend Heated Humidifier are primarily based on compliance with recognized consensus standards and direct comparison to a predicate device (ResMed HumidAire 2i™). The document presents a comparison of various characteristics, some of which serve as performance criteria.
| Acceptance Criterion | Specifics/Standard | Reported Device Performance (Transcend Heated Humidifier) | Comparison to Predicate / Compliance |
|---|---|---|---|
| Standards Compliance | |||
| Electrical Safety | IEC 60601-1 | Compliant | Compliant |
| Electromagnetic Compatibility | IEC 60601-1-2 | Compliant with IEC 60601-1-2 | Identical (Predicate also compliant) |
| Usability | IEC 60601-1-6 | Not explicitly stated, but implied compliance through substantial equivalence | Implied compliance |
| Home Health Care Environment | IEC 60601-1-11 | Not explicitly stated, but implied compliance through substantial equivalence | Implied compliance |
| Respiratory Humidifiers | ISO 8185:2007 | Compliant (Stated for multiple parameters) | Confirmed compliance, predicate's compliance unknown |
| Biological Evaluation | ISO 10993-1 | Biocompatible: Yes | Identical |
| Risk Management | ISO 14971 | Implied compliance through risk assessments | Implied compliance |
| Performance Characteristics (compared to predicate or ISO 8185) | |||
| Indications for Use | Humidification of air for compatible Transcend PAP device, single patient re-use in home/hospital | The Transcend Heated Humidifier is indicated for the humidification of the air delivered from a compatible Transcend positive airway pressure therapy device. The Humidifier is intended for single patient re-use in the home environment and in a hospital/institutional environment. | Similar (Transcend is single-patient vs. predicate's multi-patient option). |
| Intended Population of Use | Adult | Adult | Identical |
| Compatible Devices | Transcend PAP device and associated accessories | Transcend PAP device and associated accessories | Similar (both are manufacturer-specific) |
| Disinfection | None (single patient re-use only) | Differs from predicate (which should be disinfected between patients) | |
| Cleaning | Distilled water using a mild detergent | Distilled water using a mild detergent | Identical |
| Sterilization | Not sterilized | Not sterilized | Identical |
| Pressure Regulation | Determined by compatible PAP device | Determined by compatible PAP device | Identical |
| Working Pressure Range | 4-20 cm H₂O | 4-20 cm H₂O | Identical |
| Humidifier Settings | 1-5 | Similar (Predicate has 1-6 settings) | |
| Inspiratory / Expiratory Pressure Drop | Meets ISO 8185 requirements | 0.375 cmH₂O at 50 L/min | Meets ISO 8185 |
| Gas Leak at Max Operating Pressure | Meets ISO 8185 requirements | 4.85 L/min | Meets ISO 8185 |
| Sound Power Level at 10 cm H₂O static pressure | Meets ISO 8185 requirements | 37 dB | Meets ISO 8185 |
| Maximum Heater Plate Temperature | Meets ISO 8185 requirements | 131 °F | Meets ISO 8185 (Predicate: 167°F) |
| Maximum Output Humidity | >95% | >95% | Similar (Predicate: 95%) |
| Maximum Gas Temperature | Meets ISO 8185 requirements | 77 °F | Meets ISO 8185 |
| Water Capacity | Enough water to last a minimum of 8 hours | 325 ml | Similar (Predicate: 400ml; both intended for 8+ hours) |
| Operating Temperature | Based on compatible PAP device | +41°F to +95°F | Similar (Predicate: +41°F to +104°F) |
| Operating Humidity | Based on compatible PAP device | 10 - 80% relative humidity, non-condensing | Similar (Predicate: 10-95% RH) |
| Shipping/Storage Temperature | -4° F to +140° F | Identical | |
| Gas Inlet Temperature Range | Based on compatible PAP device | +41°F to +95°F | Similar (Predicate: +41°F to +104°F) |
| Shipping/Storage Humidity | 10 - 90% relative humidity, non-condensing | Similar (Predicate: 15-95% RH) | |
| Power Supply | 100-240 VAC, 50/60 Hz | 100-240 VAC, 50/60 Hz | Identical |
| IEC 60601-1 Classification | Type BF or CF (ISO 8185 section 6.8.2-14) | Type BF | Subject device is compliant |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for particular performance tests. The studies conducted are described as "Device design was qualified through the following tests and assessments" which implies these were bench and lab-based tests, not human studies. Therefore, typical "sample sizes" (as in patient data) and "data provenance" (e.g., country of origin, retrospective/prospective) are not applicable in the context of this device's premarket submission, which focuses on engineering, safety, and performance characteristics rather than clinical diagnostic accuracy. The studies performed are:
- Electrical Safety
- Electromagnetic Compatibility
- Biocompatibility Assessment
- Cleaning Validation
- Software Validation
- Packaging and Shipping
- Performance: physical (cycling), resistance to flow, spillage, flow sensing, sound power level, humidification output, out of water shutdown, temperature, runtime, warm-up duration, and reservoir gas leak
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. The device relies on physical and electrical performance data, and compliance with engineering standards (e.g., ISO 8185, IEC 60601-1). Ground truth is established by the specifications defined in these standards and by direct laboratory measurements, not by expert interpretation of patient data.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple experts evaluate ambiguous cases to reach a consensus for ground truth. This submission focuses on engineering and performance testing, where outcomes are determined by objective measurements against predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and their performance with and without AI assistance is compared. The Transcend Heated Humidifier is a therapeutic accessory, not a diagnostic device involving human interpretation of complex data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable in the typical sense of AI algorithms. The "device" itself operates "standalone" in its function as a humidifier, based on its internal programming and hardware. However, it's not an AI algorithm in the context of data analysis or diagnostic support where a "human-in-the-loop" would be relevant. The software validation mentioned ensures the device's internal algorithms and controls function correctly, which is a standalone performance test.
7. The Type of Ground Truth Used
The ground truth for the device's performance is based on:
- Engineering Standards and Specifications: Metrics defined by standards such as ISO 8185 (e.g., maximum output humidity, pressure drop, gas leak, sound power level, temperatures).
- Predicate Device Characteristics: Direct comparison of physical, functional, and safety attributes against a legally marketed predicate device.
- Laboratory Measurements: Objective measurements of the device's performance against the specified criteria (e.g., humidification output, temperature, water capacity).
8. The Sample Size for the Training Set
This section is not applicable. This device is not an AI/machine learning model where a "training set" of data would be used to develop an algorithm. Its design and validation are based on traditional engineering principles and testing.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no "training set" in the context of this device.
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