Search Results
Found 1 results
510(k) Data Aggregation
(56 days)
The Flexicare FL-9000U Respiratory Humidifier Base is intended to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance via an endotracheal tube or face mask. For use by trained personnel only within a hospital/institutional environment. This device is intended to be used only with the Flexicare Heated Wire Breathing System and Flexicare Autofill Humidification Chamber.
The Flexicare FL-9000U Respiratory Humidifier Base is for use as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated adult patients and those receiving respiratory support, as part of a complete system including a Humidification Chamber and either a heated wire breathing circuit or limb, or a non-heated breathing circuit or limb.
The Flexicare FL-9000U Respiratory Humidifier Base is a non-sterile medical electrical device which when in use forms part of an actively humidified respiratory humidification system. The Flexicare FL-9000U features a heater plate that allows a humidification chamber containing a volume of water to secure in place above it. The Flexicare FL-9000U heats the water within a humidification chamber and provides current to heated wires within Heated Wire Breathing System (if using a heated system) to warm and humidify gases to be administered to the patient. The Flexicare FL-9000U Respiratory Humidifier Base is provided with temperature probe leads that connect to the patient end and humidification chamber end of a breathing system. These probes feedback to the FL-9000U which automatically adjusts heat and current accordingly to maintain the set gas temperature.
When in use the Flexicare FL-9000U Respiratory Humidifier Base has no contact with the patient. The probe tip of the temperature probe lead accessory contacts breathing gases that are to be delivered to the patient and is the only component of the device/its accessories with contact of this nature.
The Flexicare FL-9000U Respiratory Humidifier Base is mains powered (115V), intended for use within a hospital environment and intended for any patient population where active humidification is required.
The Flexicare FL-9000U Respiratory Humidifier Base is a respiratory gas humidifier designed to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance. The device's performance was evaluated against a predicate device, the Fisher & Paykel MR850 Respiratory Humidifier, to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria were primarily established through a "comparison test" against the predicate device, the Fisher & Paykel MR850 Respiratory Humidifier (K073706), and adherence to various recognized standards. The reported device performance is presented as "Substantially equivalent" or "Pass" based on these comparisons and tests.
| Characteristic Compared / Test | Predetermined Acceptance Criteria / Standard | Reported Device Performance |
|---|---|---|
| Device Characteristics (Comparison to Predicate) | ||
| Dimensions & weight | Comparison test (to K073706) | Substantially equivalent |
| Power Supply voltage | Comparison test (to K073706) | Substantially equivalent |
| Power Supply frequency | Comparison test (to K073706) | Substantially equivalent |
| Power Supply current | Comparison test (to K073706) | Substantially equivalent |
| Heater plate capacity | Comparison test (to K073706) | Substantially equivalent |
| Heater Wire Supply Voltage | Comparison test (to K073706) | Substantially equivalent |
| Heater Wire Supply current | Comparison test (to K073706) | Substantially equivalent |
| Heater Wire Supply resistance | Comparison test (to K073706) | Substantially equivalent |
| Heater Wire Supply power | Comparison test (to K073706) | Substantially equivalent |
| Display range | Comparison test (to K073706) | Substantially equivalent |
| Display accuracy | Comparison test (to K073706) | Substantially equivalent |
| High humidity alarm parameters | Comparison test (to K073706) | Substantially equivalent |
| Low humidity alarm parameters | Comparison test (to K073706) | Substantially equivalent |
| Sound pressure level | Comparison test (to K073706) | Substantially equivalent |
| Biocompatibility Testing | ||
| Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Genotoxicity, Implantation & Sub-Acute Toxicity (referring to probe tip) | ISO 10993-10:2010, 10993-5:2009, 10993-3:2014, 10993-6:2009 | Pass |
| Performance Standards | ||
| Requirements for respiratory humidification systems | ISO 8185:2009 | Pass |
| Humidity performance (Invasive) | >33mg/L (Refer to Humidity Test Report NO. HSO-VH-2600A-2015-01,1) | >33mg/L (Substantially equivalent to predicate) |
| Humidity performance (Non-invasive) | >10mg/L (Refer to Humidity Test Report NO. HSO-VH-2600A-2015-01,1) | >10mg/L (Substantially equivalent to predicate) |
| Warm-up time | Less than 30 minutes (Substantially equivalent to predicate) | Less than 30 minutes (Substantially equivalent to predicate) |
| Recommended ambient Temperature range | 18 - 26°C (Substantially equivalent to predicate) | 18 - 26°C (Substantially equivalent to predicate) |
| Recommended Flow range (Invasive) | Up to 60 L/min (Substantially equivalent to predicate) | Up to 60 L/min (Substantially equivalent to predicate) |
| Recommended Flow range (Non-invasive) | Up to 120 L/min (Substantially equivalent to predicate) | Up to 120 L/min (Substantially equivalent to predicate) |
| Heater plate over temperature cutout | 115 ± 3°C (Flexicare) vs 118 ± 6°C (Predicate) - considered substantially equivalent | 115 ± 3°C (Reported for Flexicare) |
| Safety cutoff software | 110°C (Substantially equivalent to predicate) | 110°C (Substantially equivalent to predicate) |
| Safety and Electrical Standards | ||
| 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 | Pass |
| Enclosure testing - IP rating (IPX1) | IEC 60529 Edition 2.2: 2013 | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a dataset for AI/ML performance evaluation. Instead, performance was evaluated through non-clinical testing on the physical device and its accessories. This involved:
- Comparison testing: Directly comparing the Flexicare FL-9000U with the predicate device (Fisher & Paykel MR850).
- Adherence to recognized standards: Testing the device against specific criteria outlined in various international standards (e.g., ISO, IEC, EN).
The provenance of this testing data would be from Flexicare's own testing facilities or accredited third-party laboratories performing these tests on the physical device. The information does not state the country of origin of the data explicitly, but Flexicare Medical Limited is based in the United Kingdom.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this 510(k) summary. The device is a physical medical device, not an AI/ML diagnostic tool that requires expert-established ground truth from images or clinical data for performance evaluation in the same way. The "ground truth" for this device's performance is derived from physical measurements, electrical tests, and compliance with established engineering and medical device standards, as well as direct comparison to a predicate device.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. The evaluation of this physical medical device does not involve human readers or a consensus-based adjudication method for a test set of data.
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 relevant for diagnostic devices (especially those using AI) where human reader performance is being evaluated, often with and without AI assistance. This device is a respiratory humidifier, a therapeutic device, and its performance evaluation does not involve such studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone (algorithm only) performance evaluation was not done. This concept is specific to AI/ML software devices. The Flexicare FL-9000U is a hardware device with embedded software, and its evaluation focuses on its physical and electrical performance in delivering warmed and humidified gases, not standalone algorithm performance.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the Flexicare FL-9000U Respiratory Humidifier Base is primarily established through:
- Engineering specifications and measurements: Direct measurement of physical characteristics (dimensions, weight), electrical parameters (voltage, current, power), temperature control, and sound levels.
- Compliance with international standards: Verification that the device meets the requirements outlined in standards like ISO 8185 for respiratory humidifiers, ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety and EMC, and IEC 60529 for IP rating.
- Comparative performance to a legally marketed predicate device: Demonstrating that its performance in function is substantially equivalent to the Fisher & Paykel MR850 Respiratory Humidifier, which has an established safety and effectiveness profile. For humidity performance, a specific "Humidity Test Report (NO. HSO-VH-2600A-2015-01,1)" is referenced, implying data derived from specific testing protocols.
There is no "expert consensus," "pathology," or "outcomes data" ground truth in the sense typically used for diagnostic or predictive AI/ML devices.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device and is not an AI/ML algorithm that requires a "training set" for model development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
Ask a specific question about this device
Page 1 of 1