(248 days)
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated breathing circuit is used with Fisher and Paykel MR850 humidifier. The AirLife Infant Heated Wire Circuit is used with pediatic population. specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 vears of age) pediatric subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a doctor's supervision and by skilled clinicians. The AirLife Infant Heated Wire Circuit is used for flow rates greater than 4 LPM.
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. It is provided non sterile for single patient use. The heated breathing circuit is used with Fisher and Paykel heated humidifiers.
This document describes the regulatory submission for the AirLife Infant Heated Wire Circuit, a medical device. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device rather than detailing an AI/ML study. Therefore, some of the requested information regarding AI-specific criteria (like MRMC studies, training set details, expert qualifications for ground truth in AI, etc.) is not applicable to this document.
Here's an analysis based on the provided text:
Device: AirLife Infant Heated Wire Circuit
Intended Use: To deliver and warm breathing gases before they enter the patient's airway, used with a Fisher and Paykel MR850 humidifier for neonatal and infant pediatric populations.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a single table directly comparing acceptance criteria and a single "reported device performance" value for each. Instead, it lists numerous performance tests against established standards. The general acceptance criterion for all these tests is compliance with the specified standard.
Here's a table summarizing the performance characteristics and their corresponding standards, implying that the device met these standards to be considered substantially equivalent. The "Reported Device Performance" column indicates the successful completion of the test in compliance with the standard mentioned.
| Performance Characteristic | Acceptance Criteria (Referenced Standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Implantation, Genotoxicity, Leachables) | ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010, ISO 10993-17:2002, ISO 10993-18:2005 | Compliant with standards |
| Electrical Safety (Patient Leakage Current) | IEC 60601-1:2005, 3rd Edition (AAMI ES60601-1:2005) | Compliant with standard |
| Electrical Safety (Dielectric Strength Means) | IEC 60601-1:2005, 3rd Edition (AAMI ES60601-1:2005) | Compliant with standard |
| Electrical Safety (Insulation) | IEC 60601-1:2005, 3rd Edition (AAMI ES60601-1:2005) | Compliant with standard |
| Length | ISO 5367:2000, 4th Edition (within ±10% of labeled length) | Compliant with standard |
| Resistance to Flow/Rated Flow | ISO 5367:2000, 4th Edition (pressure increase not to exceed 0.2 kPa at rated flow) | Compliant with standard |
| Resistance to Flow @ 2.5 LPM | ISO 5367:2014, 5th Edition (flow resistance not to exceed 0.74 cmH2O/l/min) | Compliant with standard |
| Increase in Flow Resistance w/Bending @ Rated Flow (10 LPM) | ISO 5367:2000, 4th Edition (pressure not to exceed 150% of value with tube straight) | Compliant with standard |
| Increase in Flow Resistance w/Bending @ 2.5 LPM | ISO 5367:2014, 5th Edition (pressure not to exceed 150% of value with tube straight) | Compliant with standard |
| Conical Connectors | ISO 5367:2000, 4th Edition; ISO 5356-1:2004, 3rd Edition; ISO 8185:2008, 3rd Edition (Corrected Version) (correctly sized ports) | Compliant with standards |
| Security of Attachment | ISO 5367:2000, 4th Edition (adaptor not to detach at force > 45N) | Compliant with standard |
| Leakage | ISO 5367:2000, 4th Edition (leakage rate not > 50 ml/min) | Compliant with standard |
| Compliance per Meter | ISO 5367:2000, 4th Edition; ISO 8185:2008, 3rd Edition (Corrected Version) (compliance at 6 kPa not to exceed 10 ml*kPa-1 per meter) | Compliant with standards |
| Humidity Output (Invasive Mode) | ISO 8185:2008, 3rd Edition (Corrected Version) (delivers ≥ 33 mg/L humidity) | Compliant with standard |
| Humidity Output (Non-Invasive Mode) | ISO 8185:2008, 3rd Edition (Corrected Version) (delivers ≥ 10 mg/L humidity) | Compliant with standard |
| Corrugate Melt (100% Duty Cycle, Zero Gas Flow) | ISO 8185:2008, 3rd Edition (Corrected Version) (tubes do not collapse, occlude, or cause safety hazard) | Compliant with standard |
| Security of engagement temperature sensor | ISO 8185:2008, 3rd Edition (Corrected Version) (temperature probes do not disconnect) | Compliant with standard |
| Leakage from sensing port | ISO 8185:2008, 3rd Edition (Corrected Version) (sensing port not to leak > 5 ml/min) | Compliant with standard |
| Specific enthalpy | ISO 8185:2008, 3rd Edition (Corrected Version) (thermal overshoot at patient connection not to exceed energy equivalent to 43°C and 100% RH, averaged over 30s) | Compliant with standard (specific enthalpy not to exceed 194 kJ/kg dry gas) |
| Surface temperature | ISO 8185:2008, 3rd Edition (Corrected Version) (accessible temperature within 25 cm of patient port not to exceed 44°C) | Compliant with standard |
| Steady state noise | ISO 8185:2008, 3rd Edition (Corrected Version) (noise at any point within 1 m of system not to exceed 50 dB) | Compliant with standard |
| Duration of Use (30 days) | N/A (Assessed circuit use over 30 day period) | Assessed, results not explicitly detailed but implied compliant for safety/effectiveness |
| Longitudinal Temperature Profile | N/A (Assessed temperature range of wire once nominal voltage induced) | Assessed, results not explicitly detailed but implied compliant for safety/effectiveness |
| Patient End Temperature Profile | N/A (Assessed temperature of airway gas delivered to patient with humidifier and ventilator) | Assessed, results not explicitly detailed but implied compliant for safety/effectiveness |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes (e.g., number of circuits tested) for each performance test. It only states that "The following tests were performed for the proposed device to support the substantial equivalence decision." The data provenance is internal testing conducted by the manufacturer to demonstrate compliance with international standards. This is prospective testing against product specifications. There is no mention of country of origin for any data or retrospective analysis as would be relevant for an AI/ML study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualification of Those Experts
This information is not applicable. The "ground truth" for this device is established by objective performance criteria defined in international standards (e.g., ISO, IEC). Performance is measured against these engineering and safety specifications, not against expert human interpretations or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., medical imaging reads). For device performance testing against objective standards, the results are typically determined by measurement and adherence to predefined pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic accuracy or clinical utility where human readers are involved, often in the context of AI/ML software. This document describes the safety and performance testing of a physical medical device (heated breathing circuit).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a physical heated breathing circuit and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is objective, measurable criteria and limits set forth in recognized international standards (e.g., ISO 5367, ISO 8185, IEC 60601-1, ISO 10993 series). This is akin to engineering specifications and regulatory standards. It is not based on expert consensus, pathology, or outcomes data in the manner relevant to an AI/ML diagnostic system.
8. The Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" as this is not an AI/ML device. The device likely underwent design verification and validation testing, which is similar in concept to testing for traditional devices.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this is not an AI/ML device and therefore has no "training set" or corresponding ground truth establishment in that context. The "ground truth" for its design and manufacturing is based on established engineering principles, material science, and compliance with the aforementioned international performance and safety standards.
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).