(118 days)
Flexicare Neonatal Heated Wire Breathing Systems are intented for use to connect a patient's arway 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 Neonatal patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Neonatal (038-33-201U) size. For flow rates >4L/min.
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 Neonatal 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 Neonatal Heated Wire Breathing Systems are supplied with an Auto-fill Humidification chamber. When in use a Humidification 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 Neonatal Heated Wire Breathing Systems are comprised of disposable connectors, tubing and heated wire assemblies. The systems are intended for Neonatal patients.
The provided text describes the Flexicare Neonatal Heated Wire Breathing Systems and Autofill Humidification Chamber seeking clearance via a 510(k) pathway, asserting substantial equivalence to predicate devices (Fisher & Paykel RT235 Heated Breathing Circuit and MR290 Autofill Humidification Chamber).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Key Takeaways:
- Substantial Equivalence Study: The entire document is a 510(k) summary, which is a submission to the FDA to demonstrate that a new medical device is at least as safe and effective as a legally marketed predicate device. The "study" here is thus a comprehensive comparison and verification testing program, often referred to as non-clinical performance testing.
- No AI Component: The devices described (heated wire breathing systems and humidification chambers) are hardware-based medical devices. There is no mention of algorithms, artificial intelligence (AI), machine learning (ML), or software with diagnostic or therapeutic capabilities. Therefore, questions related to expert ground truth, adjudication, MRMC studies, or standalone algorithm performance are not applicable.
- Ground Truth for Testing: The "ground truth" for the non-clinical tests is based on established engineering principles, recognized international standards (ISO, ASTM, IEC, BS EN), and pre-determined acceptance criteria derived from the predicate device's performance or general medical device safety and efficacy requirements.
1. Table of Acceptance Criteria and the Reported Device Performance
The document provides two comparison tables (one for the breathing system and one for the humidification chamber) listing characteristics between the Flexicare device and its predicate. Additionally, a "Summary of performance Testing" table (page 10) outlines specific tests, their standards/acceptance criteria, and the outcome.
Flexicare Neonatal Heated Wire Breathing Systems
| Characteristic Compared | Flexicare Neonatal Heated Wire Breathing Systems | Predicate Device F&P RT235 (K034026) | Acceptance Criteria/Standard | Flexicare Performance (Outcome) |
|---|---|---|---|---|
| Intended Use | Connect patient airway to Ventilator and Humidification Chamber for warmed/humidified inspired gases. Neonatal patients, hospital environment. Compatible with F&P MR850. Flow rates >4L/min. | Conduits of breathing gas for ventilation, maintain temperature of humidified inspired gas. RT235 for flow rates >4L/min, infant patients. | The Flexicare device has the "same intended use as the predicate device" (page 5). | Substantially equivalent |
| Target Population | Neonatal | Neonatal | Matching target population. | Equivalent |
| Volume (ml) | 500 | 375 | No explicit acceptance criterion given for this difference, but overall conclusion states substantial equivalence. Differences in volume, while noted, were deemed not to affect substantial equivalence. | Not directly applicable for pass/fail |
| Wire Resistance (ohms) | Ins – 21.6, Exp - 19.2 | Ins – 21.8, Exp - 22.9 | No explicit acceptance criterion given for this difference, but overall conclusion states substantial equivalence. | Not directly applicable for pass/fail |
| Tube Material/Diameter | Ins - Corrugated 15mm, Exp - Smoothbore 15mm | Ins - Corrugated 15mm, Exp - Corrugated 15mm | No explicit acceptance criterion for the smoothbore vs corrugated expiratory limb difference, but overall deemed to not affect safety/efficacy upon testing (page 11 mentions this difference and concludes it does not affect safety/effectiveness). | Not directly applicable for pass/fail |
| Rated Flow | >4L/min | >4L/min | Matching rated flow. Equivalent | |
| Compliance (ml/Kpa) | 5.18 ml/kPa | 3.64 ml/kPa | No explicit acceptance criterion for this difference, but overall conclusion states substantial equivalence. | Not directly applicable for pass/fail |
| Resistance to Flow @ 30 Lpm | 2.7 mb | 2.1 mb | No explicit acceptance criterion for this difference, but overall conclusion states substantial equivalence. | Not directly applicable for pass/fail |
| Compatibility | Flexicare Autofill Humidification Chamber, F&P MR850 Resp Gas Humidifier | F&P MR290 Humidification Chamber, F&P MR850 Resp Gas Humidifier | The Flexicare device is compatible with the required humidifier predicate (F&P MR850). | Compatible |
| Sterility | Sterile - Ethylene Oxide Gas | Non-Sterile | Standards for sterility were met (BS EN 556 listed). This difference is noted but not deemed to preclude substantial equivalence. | Passed sterility standard |
| Standards Met | ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993, BS EN 556 | ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993 | Compliance with relevant recognized international standards is a core acceptance criterion. | All standards passed |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant | ISO 10993 compliance. | Compliant |
| Electrical Safety | IEC 60601-1 compliant, IEC 60601-1-2 compliant | IEC 60601-1 compliant, IEC 60601-1-2 compliant | IEC 60601-1 and 60601-1-2 compliance. | Compliant |
Flexicare Autofill Humidification Chamber
| Characteristic Compared | Flexicare Autofill Humidification Chamber | Predicate Device F&P MR290 (K934140) | Acceptance Criteria/Standard | Flexicare Performance (Outcome) |
|---|---|---|---|---|
| Intended Use | Hold water to humidify air delivered to patients. Any patient, hospital environment. | Hold water to humidify air delivered to patients. | The Flexicare device has the "same intended use as the predicate device" (page 9). | Substantially equivalent |
| Fill Volume (ml) | Full = 292, Max = 114.9 | Full = 340, Max = 83.9 | No explicit acceptance criterion for this difference, but overall conclusion states substantial equivalence. | Not directly applicable for pass/fail |
| Weight (g) | 124 | 109.5 | No explicit acceptance criterion for this difference, but overall conclusion states substantial equivalence. | Not directly applicable for pass/fail |
| Leakage (ml/min) | No leakage | No leakage | No leakage. | Passed |
| Compliance at empty (ml/Kpa) | 5.5 | 5.5 | Matching compliance. | Equivalent |
| Resistance to Flow @ 60 lpm (mb) | 0.1 | 0.3 | Lower resistance to flow than predicate, which is a positive performance characteristic. | Passed |
| Moisture Output (mg/l) at 10 lpm | 46.6 | 53.9 | The moisture output is slightly lower than the predicate (46.6 vs 53.9). However, no specific acceptance criterion is stated for this. The overall conclusion still asserts substantial equivalence, implying this difference was acceptable within the context of the device's intended use and overall performance profile. | Not directly applicable for pass/fail |
| Compatibility | Flexicare's Heated Wire Breathing Systems, F&P MR850 Respiratory Gas Humidifier | F&P Heated Wire Breathing Systems, F&P MR850 Respiratory Gas Humidifier | The Flexicare device is compatible with the required humidifier predicate (F&P MR850). | Compatible |
| Sterility | Sterile - Ethylene Oxide Gas | Non-Sterile | Standards for sterility were met (BS EN 556 listed). This difference is noted but not deemed to preclude substantial equivalence. | Passed sterility standard |
| Standards Met | ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993, BS EN 556 | ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993 | Compliance with relevant recognized international standards is a core acceptance criterion. | All standards passed |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant | ISO 10993 compliance. | Compliant |
| Electrical Safety | IEC 60601-1 compliant, IEC 60601-1-2 compliant | IEC 60601-1 compliant, IEC 60601-1-2 compliant | IEC 60601-1 and 60601-1-2 compliance. | Compliant |
Performance Testing Summary (Page 10)
| Test | Standard / Pre-Determined Acceptance Criteria | Outcome |
|---|---|---|
| Visual inspection | Pre-Determined Acceptance Criteria | Pass |
| Dimensional inspection | Pre-Determined Acceptance Criteria | Pass |
| System internal volume | Pre-Determined Acceptance Criteria | Pass |
| Wire resistance | Pre-Determined Acceptance Criteria | Pass |
| Tubing resistance to flow | Pre-Determined Acceptance Criteria | Pass |
| MR850 start-up test/ system compatibility check | Pre-Determined Acceptance Criteria | Pass |
| Means of connection | ISO 5367:2000 | Pass |
| Tubing resistance to flow, Increase in flow with bending, Leakage, Compliance | (These are listed separately without explicit standards, assumed under Pre-Determined Acceptance Criteria or relevant ISO standards) | Pass |
| Packaging Pouch Integrity | ASTM F1886-09, ASTM F88-09, ASTM F1929-12 | Pass |
| Conical Connector compliance | ISO 5356-1:2004 | Pass |
| Leak testing | (Assumed under Pre-Determined Acceptance Criteria) | Pass |
| Drop testing | (Assumed under Pre-Determined Acceptance Criteria) | Pass |
| Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Genotoxicity, Implantation, Sub-Acute Toxicity, Extractables & Leachables testing. | 10993-10:2010, 10993-5:2009, 10993-3:2014, 10993-6:2009, 10993-17:2009 | Pass |
| Testing to ISO 5367, temp probe tensile testing, temp port leaking | ISO 8185:2007 | Pass |
| 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 |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of units/samples used for each non-clinical test (e.g., how many systems were visually inspected, or how many were subjected to drop testing). It generally states "Verification tests were performed" or "Testing demonstrated."
- Data Provenance: The tests are explicitly referred to as "Non-clinical Test Results" and "Verification tests." These are laboratory-based engineering and performance tests conducted on the physical devices. The country of origin for the data is implicitly the UK, where Flexicare Medical Limited is located. The nature of testing is prospective in the sense that the new Flexicare devices were manufactured and then specifically tested against established standards and in comparison to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a non-clinical device clearance, not an AI/clinical diagnostic study. The "ground truth" for the test set is determined by the specifications in recognized international standards (ISO, ASTM, IEC, BS EN) and the pre-determined acceptance criteria established by the manufacturer, which are based on engineering requirements and predicate device performance. There are no "experts" establishing a clinical "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
- Not Applicable. As this is non-clinical device testing, there is no need for adjudication as typically understood in clinical or AI performance studies involving human readers. Test results are objectively measured against predefined criteria.
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
- Not Applicable. The device is not an AI-powered diagnostic tool, and no human-reader study was conducted or is relevant for this type of device clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The device is a physical medical device (breathing systems and humidification chambers), not an algorithm or software. No standalone algorithm performance was evaluated.
7. The Type of Ground Truth Used
- The "ground truth" for these tests is based on:
- Recognized International Standards: Such as ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993, BS EN 556, ASTM F1886-09, ASTM F88-09, ASTM F1929-12. These standards define the expected performance metrics, safety requirements, and test methodologies for medical devices of this type.
- Predicate Device Performance: Direct comparison to the Fisher & Paykel RT235 and MR290 devices forms a key basis for establishing substantial equivalence.
- Pre-Determined Acceptance Criteria: For tests not covered by specific standards, Flexicare established internal "Pre-Determined Acceptance Criteria" based on engineering specifications and ensuring safety and effectiveness comparable to the predicate.
8. The Sample Size for the Training Set
- Not Applicable. This refers to machine learning models, which are not part of this submission. There is no "training set" in the context of this traditional medical device clearance. The development of the device itself would involve engineering design and iterative prototyping, but not a dataset for training an algorithm.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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).