(42 days)
Flexicare Heated Wire Breathing Systems are intended for use to connect a patient's airway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Adult patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Adult (038-31-748U) size.
Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.
Flexicare Heated Wire Breathing Systems are sterile single patient use devices which form part of a respiratory humidification system. In this system the inspiratory limb delivers heated humidified gas to the patient and expiratory limb carries the expired gas away from the patient.
Flexicare Heated Wire Breathing Systems are supplied with an Auto-fill Humidification chamber. When in use a Humidfication Chamber holds a volume of water and is placed onto a heater unit and fills automatically from a suspended water source.
The air from the ventilator is passed through the Humidification Chamber, gaining heat and humidity. This air is then channeled through the Heated Wire Breathing System to the patient.
The inclusion of a heated wire within the lumen of both the System tubes the amount that the humidified air cools when travelling to/from the patient. This in turn reduces the amount of condensation and water build-up within the System.
Flexicare's Heated Wire Breathing Systems are comprised of disposable connectors, tubing and heated wire assemblies. The systems are intended for Adult patients.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for Flexicare Heated Wire Breathing Systems and Autofill Humidification Chambers.
It's important to note that this document is a 510(k) summary for a medical device cleared in 2015. It focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a de novo application with extensive clinical trials. Therefore, the information provided is geared towards proving equivalence through performance testing against established standards and predicate device characteristics, rather than detailing a study that "proves the device meets the acceptance criteria" in the sense of a clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
Device 1: Flexicare Heated Wire Breathing Systems
| Characteristic compared (Acceptance Criteria) | Flexicare Adult Heated Wire Breathing Systems (Reported Performance) |
|---|---|
| Intended use | Flexicare Heated Wire Breathing Systems are intended for use to connect a patient's airway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Adult patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Adult (038-31-748U) size. (Matches Predicate Device's intended use) |
| Target population | Adult (Matches Predicate Device) |
| Environment used | Hospital (Matches Predicate Device) |
| Volume (ml) | 926 (Predicate: 1090) - Difference acknowledged, but deemed substantially equivalent |
| Tube length (m) | Ins - 1.6m; Exp - 1.6m (Matches Predicate Device) |
| Wire resistance (ohms) | Ins - 18.55; Exp - 25.9 (Predicate: Ins - 17.5, Exp - 22.6) - Differences acknowledged, but outcomes of heat dispersal and temperature not exceeding 37ºC maintained |
| Tube material and designated diameter | Ins - Corrugated 22MM; Exp - Smoothbore 22MM (Predicate: Ins - Corrugated 22MM, Exp - Smoothbore 22MM) - The summary later clarifies a difference: Flexicare has corrugated inspiratory and smoothbore expiratory, while F&P has corrugated for both. This difference is discussed as not impacting substantial equivalence. |
| Rated Flow | 40L.min (Matches Predicate Device) |
| Compliance (ml/Kpa) | 7.68ML/kPa (Predicate: 8.93ML/kPa) - Difference acknowledged, but deemed substantially equivalent |
| Resistance to flow @ 30 lpm (mb) | 0.3 (Predicate: 0.2) - Difference acknowledged, but deemed substantially equivalent |
| Compatibility with environment and other devices | To be used with Flexicare Autofill Humidification Chamber. Compatible with F & P MR850 Respiratory Gas Humidifier. (Matches Predicate Device's compatibility with F&P MR290 and MR850) |
| Active controller | No - Humidifier controlled (Matches Predicate Device) |
| Energy used and/or delivered | Due to the wire resistance, heat is dispersed into the breathing tube lumen. As a result, the air passing through the tubing is warmed whilst travelling to patient, reducing the water condensation in the breathing System. The raising of the gas temperature does not exceed 37ºC. (Matches Predicate Device) |
| Sterility Standards Met | Sterile – Ethylene Oxide Gas (Predicate: Non-Sterile) - Difference in sterility presented, but likely mitigated by device classification and subsequent testing |
| ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993, BS EN 556 (Predicate met similar standards, but not BS EN 556) | |
| Biocompatibility | ISO 10993 compliant (Matches Predicate Device) |
| Electrical Safety | IEC 60601-1 compliant, IEC 60601-1-2 compliant (Matches Predicate Device) |
| Non-clinical Test Results (various performance tests) | All tests listed below are reported as "Pass" against "Pre-Determined Acceptance Criteria" or relevant ISO/ASTM/IEC standards: |
| Visual inspection, Dimensional inspection, System internal volume, Wire resistance, Tubing resistance to flow, MR850 start-up test/system compatibility check, Means of connection (ISO 5367:2000), Tubing resistance to flow, Increase in flow with bending, Leakage, Compliance, Packaging Pouch Integrity (ASTM F1886-09, ASTM F88-09, ASTM F1929-12), Conical Connector compliance (ISO 5356-1:2004), Leak testing, Drop testing, Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Genotoxicity, Implantation, Sub-Acute Toxicity (ISO 10993-10:2010, 10993-5:2009, 10993-3:2014, 10993-6:2009), Testing to ISO 5367, temp probe tensile testing, temp port leaking (ISO 8185:2007), Electromagnetic capability & Electrical safety testing (BS EN 60601-1:2006, BS EN 60601-1-2:2007, IEC 60601-1:2005 +CORR.1:2006 CORR. 2:2007). |
Device 2: Flexicare Autofill Humidification Chamber
| Characteristic compared (Acceptance Criteria) | Flexicare Autofill Humidification Chamber (Reported Performance) |
|---|---|
| Intended use | Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment. (Slightly broader than predicate, but still within scope of humidification) |
| Target population | Any patient using a heated humidifier (Matches Predicate Device) |
| Environment used | Hospital (Matches Predicate Device) |
| Fill Volume (ml) | Full = 292; Max = 114.9 (Predicate: Full = 340; Max = 83.9) - Differences acknowledged, but deemed substantially equivalent |
| Weight (g) | 124 (Predicate: 109.5) - Difference acknowledged, but deemed substantially equivalent |
| Leakage (ml/min) | No leakage (Matches Predicate Device) |
| Compliance at empty (ml/Kpa) | 5.5 (Matches Predicate Device) |
| Resistance to flow @ 60 lpm (mb) | 0.1 (Predicate: 0.3) - Difference acknowledged, indicating potentially better performance, but deemed substantially equivalent |
| Moisture output (mg/l) at 10lpm | 46.6 (Predicate: 53.9) - Difference acknowledged, but deemed substantially equivalent. This is a performance parameter and the difference may be material depending on exact requirements, but the submission claims substantial equivalence. |
| Compatibility with environment and other devices | To be used with Flexicare's Heated Wire Breathing Systems and F & P MR850 Respiratory Gas Humidifier. (Matches Predicate Device's compatibility with F&P Heated Wire Breathing Systems and MR850) |
| Energy used and/or delivered | Electrical energy within heater unit is used to raise the temperature and humidity of the gas delivered to the patient. (Matches Predicate Device) |
| Sterility Standards Met | Sterile - Ethylene Oxide Gas (Predicate: Non-Sterile) - Difference in sterility presented, but likely mitigated by device classification and subsequent testing |
| ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993, BS EN 556 (Predicate met similar standards, but not BS EN 556) | |
| Biocompatibility | ISO 10993 compliant (Matches Predicate Device) |
| Electrical Safety | IEC 60601-1 compliant, IEC 60601-1-2 compliant (Matches Predicate Device) |
| Non-clinical Test Results (various performance tests) | All tests listed below are reported as "Pass" against "Pre-Determined Acceptance Criteria" or relevant ISO/ASTM/IEC standards: |
| Visual inspection/comparison, Dimensional inspection, Internal Volume, resistance to flow, conical connector compliance, connector strength, leaking, tensile strength, compliance, humidification output, shelf life verification, Electromagnetic Capability, Electrical Safety and Biocompatibility. |
Study Information (Based on provided 510(k) Summary)
The document describes non-clinical performance testing rather than a clinical study as would be typical for proving effectiveness for new technology. The primary study presented is a substantial equivalence comparison with predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a numerical count of individual units for each test, but it refers to "All Samples" passing performance testing. The provenance is internal company testing (Flexicare Medical Limited, UK). The tests are retrospective in the sense that they are conducted on manufactured devices to demonstrate compliance.
- Data Provenance: The testing was conducted by Flexicare Medical Limited, located in the United Kingdom.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This is not applicable as the "ground truth" for these tests are objective, measurable physical properties and compliance with engineering standards (e.g., resistance values, leakage rates, dimensional properties). These are not subjective interpretations requiring human experts for ground truth establishment.
4. Adjudication Method for the Test Set
- Not applicable. The tests involve objective measurements and comparisons against pre-defined acceptance criteria or industry standards. There is no subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is a technical device and not an AI or diagnostic imaging device that would typically involve human readers for interpretation. Therefore, a MRMC study is not relevant here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, in a sense. The performance tests ("Non-clinical Test Results") are standalone evaluations of the device's physical and functional properties against predefined criteria and standards. There is no "human-in-the-loop" component in evaluating the device's technical specifications. The devices themselves do not incorporate AI or complex algorithms requiring such evaluation.
7. Type of Ground Truth Used
- The "ground truth" for these tests is based on:
- Objective physical measurements: (e.g., volume, length, resistance, weight, flow rates).
- Compliance with international standards: (e.g., ISO 5367, ISO 5356-1, ISO 8185, IEC 60601-1, ISO 10993, ASTM F1886, ASTM F88, ASTM F1929, BS EN 556).
- Comparison to a legally marketed predicate device: The characteristics and performance of the predicate device (Fisher & Paykel RT380 and MR290) serve as a benchmark for demonstrating substantial equivalence.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As this device does not involve AI/ML, there is no training set or associated ground truth for it.
§ 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).