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510(k) Data Aggregation
(120 days)
ThermoShield HME Filter
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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