(293 days)
The Curasa AUTO CPAP (Continuous Positive Airway Pressure) with heated humidifier system is intended for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is for use in the home or hospital /institutional environment.
The Curasa AUTO CPAP System with heated humidifier is used on adult patients for treatment of obstructive sleep apnea (OSA). The Auto CPAP system provides a stable continuous positive airway pressure (CPAP). The Auto mode detects breathing phenomena (e.g. snore, hypopnea) and automatically adjusts the delivered pressure. The humidifier provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. The Curasa AUTO CPAP system includes the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier. All of the accessories provided with the Curasa AUTO CPAP are identical to those provided with the predicate Curasa CPAP SD (K123897).
The Auto CPAP system has been modified based Curasa CPAP SD (K123897) hardware and software. The design of the humidifier and humidifier interface is identical to the referenced predicate device (Curasa CPAP SD, K123897). The basic function and performance characteristics of Curasa AUTO CPAP are similar to the referenced predicate device (Curasa CPAP SD K123897). The Auto mode of operation is similar to the referenced predicate, Respironics Remstar Auto CPAP (K012554).
The Curasa AUTO CPAP with Heated Humidifier System is intended for the treatment of Obstructive Sleep Apnea (OSA). The studies performed for this device included compliance with a number of electrical safety, biocompatibility, and performance standards, as well as a clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General Safety | IEC 60601-1-1: Medical Electrical equipment Part 1: General requirement for Safety | Pass |
| EMC | IEC 60601-1-2: Medical Electrical equipment Part 1-2: General requirement for Safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests | Pass (ESD / EMC / EMI Testing) |
| Respiratory Humidifier | EN ISO 8185: Respiratory Tract humidifiers for medical use Particular requirements for respiratory humidifier systems | Pass (Humidity ISO 8185 Test - leveraged from predicate) |
| Sleep Apnoea Therapy Equipment | EN ISO 17510: Sleep Apnoea Breathing therapy Part 1: Sleep apnoea breathing therapy equipment specifically related to: |
- Pressure Range: 4-20 cm H2O
- Pressure Stability: 4-20 cm H2O, +/- 2.0 cm H20
- Maximum Flow: 35 LPM | Pass (ISO 17510 compliant:
- Pressure Range: 4-20 cm H2O
- Pressure Stability: 4-20 cm H20 +/- 2.0 cm H20
- Maximum Flow: 35 LPM) |
| Biocompatibility | ISO 10993-3: Genotoxicity, Carcinogenicity and Reproductive Toxicity
ISO 10993-5: Tests for in vitro cytotoxicity
ISO 10993-6: Test for local effect after implantation
ISO 10993-10: Tests for irritation and skin sensitization
ISO 10993-12: Sample Preparation and reference materials | Pass (Biocompatibility Tests - leveraged from predicate) |
| Software | IEC 62304: Medical Device Software Software Life Cycle Process | Pass (Software Verification Testing) |
| Environmental | IEC 60068-2-6: Environmental Testing -- Test FC: Vibration (sinusoidal)
IEC 60068-2-34: Environmental Testing Test FC: Vibration (Random)
IEC 60068-2-27: Basic Environmental Testing Procedure: Test Ea and guidance: Shock | Pass (Shock and Vibration Testing) |
| Sound | Not explicitly defined, but generally related to acceptable noise levels for medical devices. | Pass (Sound Testing) |
| Air Quality | Not explicitly defined, but related to user safety regarding airborne particles and volatile organic compounds. | Pass (VOC and PM2.5 Testing) |
| Predicate Comparison (Functional Equivalence) | No statistical difference in AHI and SpO2 compared to predicate Respironics Auto CPAP. | Results showed that the Curasa AUTO CPAP is effective and that there is no statistical difference between the Curasa AUTO CPAP and the predicate Respironics Auto CPAP device based on AHI (Apnea/Hypopnea Index), minimum SpO2, and average SpO2. |
| System and User Interface | Not explicitly defined, but generally refers to the device's operational functionality and ease of use. | Pass (System and User Interface Testing) |
| IFU Validation | Not explicitly defined, but generally refers to ensuring the Instructions for Use are clear, complete, and accurate. | Pass (IFU Validation Testing) |
| Safety (IPX1 / ESD) | IPX1 (Drip Proof Equipment) and Class II Electrical shock protection. | Pass (IPX1 / ESD) |
| Reliability | Not explicitly defined, but generally refers to the consistent performance over time. | Pass (Reliability Test - leveraged from predicate) |
| Packaging | Not explicitly defined, but generally refers to the ability of the packaging to protect the device during transport and storage. | Pass (Packaging Test - leveraged from predicate) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: 60 adult patients diagnosed with Obstructive Sleep Apnea (OSA).
- Data Provenance: Clinical study conducted at two (2) hospitals in China.
- Retrospective or Prospective: Prospective, as patients were enrolled and underwent a 3-night study protocol specifically for this evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the "ground truth" for the test set in the clinical study. However, the study involved Polysomnography (PSG) for diagnosing OSA and recording AHI and SpO2, which implies interpretation by trained sleep specialists or technicians.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set. It mentions that AHI, minimum SpO2, and average SpO2 were recorded by PSG, and p-values were calculated for before and after treatment groups, and for trial and control groups. This implies direct measurement and statistical comparison rather than a human reader adjudication process for the primary endpoints.
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
A MRMC comparative effectiveness study involving human readers and AI assistance was not performed. The clinical study compared the Curasa AUTO CPAP system's performance to a predicate device (Respironics Auto CPAP) in treating OSA patients, not the performance of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is an automated CPAP system, implying it operates "standalone" in its function of automatically adjusting pressure based on detected breathing phenomena. The clinical study evaluated the effectiveness of this automated function. However, the term "standalone performance" often refers to an algorithm's performance against a ground truth in an AI/imaging context, which is not directly applicable here. The clinical study assessed the overall device (hardware + embedded algorithms) performance in vivo.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established using objective physiological measurements from Polysomnography (PSG). Specifically, AHI (Apnea/Hypopnea Index), minimum SpO2 (Pulse Oximeter Oxygen Saturation), and average SpO2 were recorded by PSG. These are standard, objective metrics for assessing the severity and treatment effectiveness of Obstructive Sleep Apnea.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" sample size. The clinical study enrolled 60 patients to evaluate the device's performance, implying this dataset was for verification/validation rather than training a machine learning model from scratch. Given the device's "Auto mode" functionality is described as "similar to the referenced predicate, Respironics Remstar Auto CPAP (K012554)," it's likely the auto-adjusting algorithm was developed and refined using prior knowledge and potentially internal datasets, but this information is not provided for the Curasa device.
9. How the Ground Truth for the Training Set Was Established
As no "training set" is explicitly mentioned for the Curasa AUTO CPAP's auto-adjustment algorithm within this document, the method for establishing its ground truth for training is not provided. If the auto-mode algorithm was adapted from the predicate, then its initial ground truth would have been established during the predicate's development.
§ 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).