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510(k) Data Aggregation
(113 days)
Flexicare Medical Limited
The ProVu Endotracheal Tube with Video Stylet is intended for intubation procedures. The ProVu Endotracheal Tube with Video Stylet is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.
The ProVu Endotracheal Tube with Video Stylet is indicated for viewing during non-difficult and difficult intubation procedures and for verifying endotracheal tube placement.
The ProVu Video Stylet with Reinforced ET Tube is a sterile, single-use, video-enabled stylet and ETT intubation system with malleable and directional control intended to assist with oral and nasal intubations and designed for use in adults in a hospital environment.
The device comprises of two main components:
- The ProVu Reinforced Endotracheal tube
- The ProVu Video Stylet (with a removable malleable rod)
The provided FDA 510(k) clearance letter and summary for the ProVu Single Use Video Stylet with Reinforced ET Tube does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to its clinical performance or diagnostic accuracy.
The summary focuses on non-clinical data to demonstrate substantial equivalence to a predicate device. This typically means the device has similar technological characteristics and indications for use, and does not raise new questions of safety or effectiveness. The included sections detail biocompatibility, sterilization, electrical safety, bench performance, and usability, but none of these address how well the device performs its intended clinical function (e.g., successful intubation, accurate verification of tube placement) against specific performance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the given text.
Here's an analysis of why each requested point cannot be answered:
- A table of acceptance criteria and the reported device performance: Not provided. The summary lists standards the device complies with (e.g., ISO 5361, IEC 60601-1), which are design and safety standards, not clinical performance acceptance criteria.
- Sample size used for the test set and the data provenance: Not provided. No test set for clinical performance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No ground truth for clinical performance is mentioned.
- Adjudication method for the test set: Not provided. No clinical test set is mentioned.
- 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. This device is not an AI-assisted diagnostic tool for "human readers" in the sense of image interpretation. It's a video stylet for direct visualization during intubation. The concept of "AI assistance" and "effect size of human readers" doesn't apply to the reported information.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device. It's a physical medical device that assists human operators in a procedure.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. No clinical ground truth is mentioned.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
Summary of what was reported in the 510(k) information:
- Non-clinical data provided:
- Biocompatibility testing: Evaluated per ISO 10993-1 and ISO 18562 (Cytotoxicity, Sensitization, Intracutaneous reactivity, Material Mediated Pyrogenicity, Subcutaneous Implantation, Chemical Characterisation, Toxicological Risk Assessment, Gas Pathway Testing).
- Sterilization and shelf-life testing: Validated according to ISO 11135:2014, EO/ECH residual test per ISO 10993-7:2008. Shelf-life of 0.5 year.
- Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1, IEC60601-2-18, and IEC 60601-1-2.
- Bench performance testing: Complies with ISO 5361, ISO 5356-1.
- Usability validation: Conducted according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices".
- Clinical Study: Explicitly stated as "Not applicable."
This is characteristic of a 510(k) submission where substantial equivalence is demonstrated through non-clinical performance and technological comparison, rather than requiring new clinical efficacy or effectiveness data.
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(147 days)
Flexicare Medical Limited
Flexicare Single Use Manometer is attached to the manometer port on Flexicare resuscitation bags to provide visual indication of the patient's airway pressure during ventilation. The device is intended to be used by trained personnel only within a hospital and/or pre-hospital environment.
Flexicare's Single Use Manometer is a single use device that can be attached to the manometer port on resuscitation bags to provide visual indication of the patient's airway pressure during manual ventilation. Flexicare's Single Use Manometer consists of end cap, clear housing with printed pressure scale, concertina seal, slider and stainless steel spring. When pressure rises, the spring is compressed raising the blue concertina seal and showing the pressure via markings on the manometer housing has calibrated marking at 20 cmH2O intervals between 0 through 60 cmH2O. The measured pressures are accurate to ± 1cmH2O. Flexicare's Single Use Manometer is supplied non-sterile and are for use by CPR-trained personnel only within a hospital and/or pre-hospital environments.
The document provided is a 510(k) Premarket Notification for the Flexicare Single Use Manometer. It describes the device, its intended use, and compares it to a legally marketed predicate device (Ambu Disposable Pressure Manometer, K040991) to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria / Standard | Reported Device Performance |
|---|---|---|
| Accuracy | ± 1 cm H₂O at 20, 40, 60 cm H₂O | Pass |
| Repeatability | Within accuracy tolerance (Graduation print and manometer slider overlap at each marked pressure graduation) | Pass |
| Leak Testing | No standard criteria available; Test for comparative use only ( |
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(250 days)
Flexicare Medical Limited
Flexicare's HepaShield Bacterial Viral Breathing System Filters are intended to reduce the transmission of bacteria and viruses to/from a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are single patient for use on a single patient for up to 24hrs and are available in Adult size. FlepaShield Bacterial Viral Breathing System Filters are designed to be used in hospital environments by trained personnel.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are designed to reduce the transmission of bacteria and viruses to and from a patient who requires aesthesia, artificial respiration or other types of assisted respiration
Flexicare's HepaShield Bacterial Viral Breathing System Filters consist of a top/bottom housing, pleated paper filter pack and a luer port cap. The Female luer-lock port allows connection of a luer-terminating monitoring line for monitoring of patient exhaled CO2 & is supplied with a tethered cap to seal port when not in use.
The patient side of the Flexicare's HepaShield Bacterial Viral Breathing System Filters feature a 22mm Male and a 15mm Female conical. The machine side features a 22mm Female and a 15mm Male conical.
All conical connectors comply with dimensions stated within BS EN ISO 5356-1 standard.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in Adult sizes.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in a both Sterile and non-sterile state, packaged in individually sealed polybags, or blister trays (if sterile).
The provided text describes the acceptance criteria and study results for the Flexicare HepaShield Bacterial Viral Breathing System Filter, which is a medical device.
1. Table of acceptance criteria and the reported device performance:
| Test | Standard / Pre-Determined Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Visual Inspection | Product packaging must remain sealed & undamaged. All components of devices must be free of flash, cracking, warping, discoloration or contamination. | Pass |
| Compliance testing (Internal Volume/dead space) | BS EN ISO 9360: 2009 (Methodology only, no pass criteria) | Methodology only, no pass criteria - Comparable performance outcome between Flexicare's new devices and the predicate devices (47ml vs 35ml for predicate) |
| Pressure drop | BS EN ISO 23328-2 (Refers to: BS EN ISO 9360: 2009) - Methodology only, no pass criteria | Methodology only, no pass criteria - Comparable performance outcome between Flexicare's new devices and the predicate devices (1.70 cmH2O @ 30LPM; 3.92 cmH2O @ 60LPM; 6.56 cmH2O @ 90LPM) |
| Gas Leakage (for comparison only, HME aspects not applicable) | Pre-determined Acceptance Criteria* (implies visual inspection criteria for gas leakage if unspecified) | methodology only, no pass criteria |
| Conical Connector compliance | BS EN ISO 5356-1 2004 | Pass |
| Leak testing | Not explicitly stated (likely internal specification) | Pass |
| Drop testing | Not explicitly stated (likely internal specification) | Pass |
| Cytotoxicity, Irritation, Sensitization, Systemic toxicity, Material Mediated | BS EN ISO 10993-10:2010, BS EN ISO 10993-5:2009 | Pass |
| Pyrogenicity | BS EN ISO 10993-11:2009 | Pass |
| Bacterial Endotoxin | (USP) guidelines and , ANSI/AAMI ST72:2011 | Pass |
| Particulate emissions (gas pathway) | EN ISO 18562-2:12017 | Pass |
| VOC emissions (gas pathway) | EN ISO 18562-3:2017 | Pass |
| Gauging tests on luer | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Liquid leakage from luer | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Air leakage from luer | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Luer separation force | BS EN ISO 80369-7:2016 | Pass |
| Luer unscrewing torque | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Luer ease of assembly | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Luer resistance to overriding | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Luer testing for stress cracking | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Shelf life testing | Standards included within this table (implying all relevant performance criteria are met over shelf life) | Pass |
| Filter integrity | Based on ASTM F2101 (Nelson Labs Protocol), BS EN ISO 23328-1 (2008) (Methodology only, no pass criteria within standard) | Methodology only, no pass criteria within standard (Reported BFE - 99.99999%, VFE - 99.9999%, Salt Method filtration efficiency - 99.89%) |
| Pressure Drop (as part of Filter integrity or separate measurement) | BS EN ISO 23328-2 (2009) (Methodology only, no pass criteria within standard) | Methodology only, no pass criteria within standard |
| Housing Leakage | BS EN ISO 23328-2(2009) (Methodology only, no pass criteria within standard) | Methodology only, no pass criteria within standard (Reported |
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(175 days)
Flexicare Medical Limited
Flexicare's Adult Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.
Flexicare's Pediatric Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of infants and children with a body weight of 22lbs to 66lbs (10-30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.
Flexicare's Infant Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight of up to 22lbs (10kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.
Flexicare's Single Use Resuscitator Bags are Single Use devices For manual ventilation of a patient by trained operators in emergency/critical situations where short term ventilation is demanded by the patient's medical condition (e.g. inadequate or no breathing). Manual squeezing of the resuscitator bag forces air or air /O2 mixture into the patient's lungs via a face mask or pre-positioned airway tube with a 15mm male connection. A reservoir bag is present at the distal end of the device which fills with supplementary O2 (if using). This can be squeezed into the resuscitator for administration if required.
Flexicare's Single Use Resuscitator Bags feature a one-way duck bill valve at the patient end to deliver fresh gas to the patient whilst preventing ingress of exhaled air and potential rebreathing. A one-way valve is also present at the distal end of the device, ensuring that upon squeezing the Resuscitator bag air only travels toward the patient, and upon release of a squeezed bag fresh ambient air with/without supplementary O2 is drawn in. Flexicare's Single Use Resuscitator Bags incorporate a pressure relief valve. This valve limits the pressure within the resuscitator and patient lungs to 60cmHzO (Adult) or 40cmHzO (Adult, Pediatric, Infant). One variant of Flexicare's Adult Single Use Resuscitator Bags does not feature a pressure relief valve.
Flexicare's Single Use Resuscitator Bags are comprised of disposable components including a compression bag, valves, tubing and connectors. The Single Use Resuscitator Bags are intended for Adult. Pediatric and Infant patients, are supplied non sterile and are for use by CPR-trained personnel only within a hospital and/ pre-hospital environments.
The provided text describes the acceptance criteria and a study demonstrating the Flexicare Single Use Resuscitator Bags meet these criteria by showing substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting recognized standards and performance characteristics comparable to the predicate devices. The "Outcome" column in the table below indicates that the Flexicare device "Passed" each test, implying that it met the respective criteria.
| Test / Characteristic compared | Acceptance Criteria (or Standard Met) | Reported Device Performance (Outcome) |
|---|---|---|
| Visual inspection | Comparison test | Substantially equivalent |
| Valve Function after contamination with vomitus | BS EN ISO 10651-4:2009 | Pass |
| Mechanical shock - Drop testing | - (Implied to meet performance of predicate / safety standards) | Pass |
| Immersion in Water | - (Implied to meet performance of predicate / safety standards) | Pass |
| Supplementary Oxygen & Delivered Oxygen Concentration | - (Implied to meet performance of predicate / safety standards) | Pass |
| Expiratory Resistance | - (Implied to meet performance of predicate / safety standards. Specific values provided in comparison tables indicate a required resistance range) | Pass |
| Inspiratory Resistance | - (Implied to meet performance of predicate / safety standards. Specific values provided in comparison tables indicate a required resistance range) | Pass |
| Patient Valve Malfunction | - (Implied to meet performance of predicate / safety standards) | Pass |
| Tidal Volume - Minimum Delivered Volume | - (Implied to meet performance of predicate / safety standards. Specific values provided in comparison tables indicate a required volume range) | Pass |
| Pressure Limitation - Pressure Relief Blow off | - (Implied to meet performance of predicate / safety standards. Specific values provided in comparison tables indicate a required pressure) | Pass |
| Conical Connector compliance | ISO 5356-1:2004 | Pass |
| Leak testing | - (Implied to meet performance of predicate / safety standards) | Pass |
| Drop testing | - (Implied to meet performance of predicate / safety standards) | Pass |
| Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Extractables & Leachables | ISO 10993-10:2010, ISO 10993-5:2009, ISO 10993-11:2009, ISO 10993-17:2009 | Pass |
| Tubing resistance to gas flow | BS EN 13544-2:2002+A1:2009 | Pass |
| Tensile strength – connector to tubing | - (Implied to meet performance of predicate / safety standards) | Pass |
| Tensile strength – connector to O2 spout | - (Implied to meet performance of predicate / safety standards) | Pass |
| Resistance to kinking | - (Implied to meet performance of predicate / safety standards) | Pass |
| Accelerated Ageing | ASTM F1980 | Pass |
| Particulate Emissions | BS ISO 18562-2 2017 | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of devices) used for each specific test in the "test set". However, it mentions "Verification tests were performed to establish the safety and efficacy of Flexicare's Adult Single Use Resuscitator Bag." and similarly for Pediatric and Infant versions. The tests would likely involve a statistically relevant number of devices to ensure reliability.
The data provenance is from Flexicare Medical Limited, United Kingdom. The study is retrospective in the sense that it compares the newly developed Flexicare device against existing, legally marketed predicate devices (Ambu SPUR II Adult, Pediatric, and Infant Single Patient Use Resuscitators) that have already been cleared by the FDA. The performance testing itself would be prospective for the Flexicare device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the performance testing. Instead, the ground truth is established by objective measurements against recognized international standards and direct comparison of performance characteristics with legally marketed predicate devices.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method involving human reviewers for the test set. The validation relies on objective laboratory testing against predefined criteria and standards, and direct comparison of measured characteristics with those of predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with AI/CAD systems for image interpretation, which is not applicable to a manual resuscitator bag. The study is a non-clinical performance and biocompatibility evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone (algorithm-only) study was not done. This device is a manual medical device and does not involve any algorithms or AI for its operation.
7. The Type of Ground Truth Used
The ground truth used for this device's validation is based on:
- Recognized International Standards: Compliance with standards such as BS EN ISO 10651-4:2009, ISO 10993 series, ISO 5356-1:2004, BS EN 13544-2:2002+A1:2009, BS ISO 18562-2 2017, and ASTM F1980.
- Performance Specifications of Legally Marketed Predicate Devices: The performance characteristics (e.g., volume, resistance, force, dead space, stroke volume, pressure relief) of the Flexicare devices are compared directly to those of the Ambu SPUR II predicate devices. The goal is to demonstrate "substantial equivalence," meaning the new device performs as safely and effectively as the predicate.
- Objective Laboratory Measurements: The "Non-clinical Test Results" section explicitly states that "Verification tests were performed to establish the safety and efficacy" including visual inspection, dimensional inspection, internal volume, valve function, drop testing, immersion in water, oxygen concentration, resistances, valve malfunction, tidal volume calculation, O2 tube testing, conical connector compliance, biocompatibility, and particulate emission testing.
8. The Sample Size for the Training Set
There is no training set as this is a physical medical device, not an AI or machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
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(120 days)
Flexicare Medical Limited
Flexicare's ThermoShield HME (Heat and Moisture Exchange) Filters are intended to reduce the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation.
An HMEF is normally positioned at the patient end of the breathing system between the circuit Y-piece and the catheter mount or patient airway device.
Flexicare's ThermoShield HME Filters are single use on a single patient for up to 24hrs and are available in Adult and Mini (pediatric) sizes.
Flexicare's ThermoShield HME Filters are designed to be used in pre-hospital and homecare environments by trained personnel.
Expert clinical judgment must be used in assessing patient humidification requirements.
Flexicare's ThermoShield HME Filters are designed to prevent the transmission of bacteria and viruses to and from a patient who requires aesthesia, artificial respiration or other types of assisted respiration
Flexicare's ThermoShield HME Filters include a HME (Heat and Moisture Exchanger) Media in addition to a filter. The Inclusion of HME media is intended to help prevent complications due to drying of the respiratory mucosa, such as mucus plugging and endotracheal tube (ETT) occlusion. This is achieved by the HME media preventing a large amount of the water vapor from passing through the device.
Flexicare's ThermoShield HME Filters consist of a top/bottom housing, filter pad, HME media and a luer port cap. The Female luer-lock port allows monitoring of patient exhaled CO2 & is supplied with a tethered cap to seal port when not in use.
The patient side of the Flexicare's ThermoShield HME Filters feature a 22mm Male and a 15mm Female conical connector. The machine side features a 22mm Female and a 15mm Male conical connector.
All conical connectors comply with dimensions stated within BS EN ISO 5356-1: 2004
Flexicare's ThermoShield HME Fitters have rounded housing with no sharp edges. This reduces the risk of pressure marks on the patient.
Flexicare's ThermoShield HME Fitters are available in Adult and Mini (Pediatric) sizes.
Flexicare's ThermoShield HME Filters are supplied non sterile in individually sealed polybags.
This document describes the acceptance criteria and the studies performed to demonstrate substantial equivalence for the Flexicare ThermoShield HME Filter (Adult and Mini/Pediatric sizes) to their respective predicate devices.
1. Table of Acceptance Criteria and the Reported Device Performance:
The document presents separate comparison tables for the Adult and Mini (Pediatric) filters against their respective predicate devices. The "Non-clinical Test Results" section summarizes the primary studies conducted to meet acceptance criteria.
Adult Filters:
| Acceptance Criteria / Test | Standard / Pre-determined Acceptance Criteria | Reported Device Performance (Flexicare ThermoShield HME Filters - Adult) | Predicate Device Performance (Gibeck Humid-vent Filter Compact) |
|---|---|---|---|
| Components | Same components | Filter housing top, Filter housing bottom, Filter pad, HME paper, Tethered luer port cap, Outer shrink sleeve | Filter housing top, Filter housing bottom, Filter pad, HME paper, Luer port cap, Outer sticker |
| Materials | Comparable materials | Polypropylene (housing, filter pad), Paper (HME paper), PVC (luer cap), LDPE (shrink sleeve) | ABS (housing top, luer cap), Polypropylene (housing bottom, filter pad), Paper (HME paper, sticker) |
| Assembly Method | Same method | Snap Fit casing | Snap Fit casing |
| Patient population | Same population | Adult | Adult |
| Emergency use | Same use | Yes | Yes |
| Environment of use | Same environments | Pre-hospital, Hospital & Homecare | Pre-hospital, Hospital & Homecare |
| Patient use/Duration of use | Same use context | Single use, disposable, 101kPa | >101kPa |
| Leakage per ISO 9360-1 6.4 | No leak at 101kPa | No leak at 101kPa | No leak at 101kPa |
| Compliance per ISO 9360-1 6.5 | Comparable | Straight: 14ml/kPa | Straight: 13ml/kPa |
| Reuse, Cleaning & Disinfection | Same usage | N/A – Single use | N/A – Single use |
| Shelf Life | Comparable | 4 years | 5 years |
| Packaging | Same packaging type | Non-sterile Polybag | Non-sterile Polybag |
| Temp/humidity req's | Same | None stated | None stated |
| Visual Inspection | Pre-determined Acceptance Criteria* | Pass | N/A (Internal test for Flexicare device) |
| CO2 monitoring function test | Pre-determined Acceptance Criteria ** | Pass | N/A (Internal test for Flexicare device) |
| Conical Connector compliance | BS EN ISO 5356-1 2004 | Pass | N/A (Internal test for Flexicare device) |
| Luer lock compliance (Dimensional, Gauging, Liquid leakage, Air leakage, Separation force, Unscrewing torque, Ease of assembly, Resistance to overriding, Stress cracking) | ISO 594-1, ISO 594-2 (BS EN 1707:1997) | Pass | N/A (Internal test for Flexicare device) |
| Shelf life testing | All standards included in table | Pass | N/A (Internal test for Flexicare device) |
| Filter integrity | BS EN ISO 23328-1 (2008) | Methodology only, no pass criteria within standard. | N/A (Internal test for Flexicare device) |
| Biocompatibility (Cytotoxicity, Implant, Sensitization, Genotoxicity) | BS EN ISO 10993-10:2010, -5:2009, -3:2014, -6:2009 | Pass | N/A (Internal test for Flexicare device) |
Mini (Pediatric) Filters:
| Acceptance Criteria / Test | Standard / Pre-determined Acceptance Criteria | Reported Device Performance (Flexicare ThermoShield HME Filters - Mini) | Predicate Device Performance (Gibeck Humid-vent Filter Pedi) |
|---|---|---|---|
| Components | Same components | Filter housing top, Filter housing bottom, Filter pad, HME paper, Tethered luer port cap, Outer shrink sleeve | Filter housing top, Filter housing bottom, Filter pad, HME paper, Luer port cap, Outer sticker |
| Materials | Comparable materials | Polypropylene (housing, filter pad), Paper (HME paper), PVC (luer cap), LDPE (shrink sleeve) | ABS (housing top/bottom, luer cap), Polypropylene (filter pad), Paper (HME paper, sticker) |
| Assembly Method | Same method | Snap Fit casing | Snap Fit casing |
| Patient population | Same population | Pedi | Pedi |
| Emergency use | Same use | Yes | Yes |
| Environment of use | Same environments | Pre-hospital, Hospital & Homecare | Pre-hospital, Hospital & Homecare |
| Patient use/Duration of use | Same use context | Single use, disposable, 101kPa | >101kPa |
| Leakage per ISO 9360-1 6.4 | No leak at 101kPa | No leak at 101kPa | No leak at 101kPa |
| Compliance per ISO 9360-1 6.5 | Comparable | Straight: 10ml/kPa | Straight: 10ml/kPa |
| Reuse, Cleaning & Disinfection | Same usage | N/A – Single use | N/A – Single use |
| Shelf Life | Comparable | 4 years | 5 years |
| Packaging | Same packaging type | Non-sterile Polybag | Non-sterile Polybag |
| Temp/humidity req's | Same | None stated | None stated |
| Visual Inspection | Pre-determined Acceptance Criteria* | Pass | N/A (Internal test for Flexicare device) |
| CO2 monitoring function test | Pre-determined Acceptance Criteria ** | Pass | N/A (Internal test for Flexicare device) |
| Conical Connector compliance | BS EN ISO 5356-1 2004 | Pass | N/A (Internal test for Flexicare device) |
| Luer lock compliance (Dimensional, Gauging, Liquid leakage, Air leakage, Separation force, Unscrewing torque, Ease of assembly, Resistance to overriding, Stress cracking) | ISO 594-1, ISO 594-2 (BS EN 1707:1997) | Pass | N/A (Internal test for Flexicare device) |
| Shelf life testing | All standards included in table | Pass | N/A (Internal test for Flexicare device) |
| Filter integrity | BS EN ISO 23328-1 (2008) | Methodology only, no pass criteria within standard. | N/A (Internal test for Flexicare device) |
| Biocompatibility (Cytotoxicity, Implant, Sensitization, Genotoxicity) | BS EN ISO 10993-10:2010, -5:2009, -3:2014, -6:2009 | Pass | N/A (Internal test for Flexicare device) |
2. Sample sizes used for the test set and the data provenance:
The document summarizes "non-clinical tests" performed on the Flexicare ThermoShield HME Filter (Adult and Mini sizes). The specific sample sizes for each test are not explicitly stated within the provided text. However, the tests are identified as "Verification tests were performed on Flexicare's Adult/Mini ThermoShield HME Filter." and the results are presented as "All Samples passed the performance testing." This implies that a sufficient number of devices were tested to draw the stated conclusions.
The data provenance is internal to Flexicare Medical Limited, as the studies are described as "Flexicare's ThermoShield HME Filters have been evaluated..." and conducted "against methods and criteria from predetermined acceptance criteria in-house test methods and relevant BS EN & ISO FDA recognized standards." This indicates the data is retrospective internal testing to demonstrate substantial equivalence to previously marketed predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a technical device (breathing circuit filter); therefore, the concept of "ground truth established by experts" in the context of interpretation (e.g., radiological images) is not directly applicable. The "ground truth" for the performance characteristics of the device (such as filtration efficiency, moisture output, pressure drop) is established through standardized laboratory testing protocols (e.g., ISO, ASTM standards) and predefined engineering specifications. The implication is that the tests were conducted by qualified personnel in a laboratory setting, not by "experts" rendering opinions on cases.
4. Adjudication method for the test set:
Not applicable. As described above, this is a technical device evaluated against objective performance criteria and standards, not a diagnostic device requiring expert adjudication of results.
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. This device is a mechanical filter (breathing circuit bacterial filter) and does not involve AI or human readers for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical filter and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established via objective, quantitative measurements against recognized international standards (e.g., ISO, BS EN, ASTM) and predefined internal acceptance criteria. For example:
- Filtration efficiency: Measured experimentally using a challenge organism/material.
- Moisture output/loss: Measured experimentally under controlled conditions.
- Pressure drop: Measured experimentally at various flow rates.
- Biocompatibility: Evaluated through standard in-vitro and in-vivo tests.
- Dimensional compliance: Measured against ISO standard specifications.
These are empirical measurements, not expert consensus or pathological findings.
8. The sample size for the training set:
Not applicable. This device is a mechanical product and does not involve a training set for an algorithm.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, there is no ground truth established for one.
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(56 days)
FLEXICARE MEDICAL LIMITED
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.
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(118 days)
FLEXICARE MEDICAL LIMITED
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.
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