Search Results

Model 2800 is indicated for use with pulmonary function testing equipment, to filter air between the patient's exhaled air and the testing equipment. Single patient use.

The EMS PFT Filter is a compact, electrostatic filter with various end-fitting adaptable to various pulmonary function testing circuits. It has 75 ml deadspace of 0.7 cm H2O at 720 lpm per ATS spirometry guidelines or 0.5 cm H2O @ 60 lpm. There are various connectors to allow connection to various PFT equipment. Single patient use.

Air Safety Model 2800 PFT Filter Acceptance Criteria and Study Findings

This document outlines the acceptance criteria for the Air Safety Model 2800 PFT Filter and the study that demonstrates its conformance.

1. Acceptance Criteria and Reported Device Performance

The Air Safety Model 2800 PFT Filter underwent testing to demonstrate substantial equivalence to the predicate device, the Engineered medical Systems - K013123. The acceptance criteria were based on the performance characteristics of this predicate device.

The study demonstrates that the Air Safety Model 2800 PFT Filter meets all specified acceptance criteria, showing identical performance characteristics to the predicate device for all listed attributes.

2. Sample Size and Data Provenance

• Sample Size for the Test Set: Not explicitly stated for each specific test (BFE, VFE, flow resistance). However, the narrative indicates that "BFE and VFE testing has been performed by Nelson Laboratories to demonstrate substantial equivalence to the predicate device."
• Data Provenance: The data was generated by Nelson Laboratories, a third-party testing facility. The country of origin for the testing is not explicitly stated, but the submission is from Air Safety Ltd. in England. The study appears to be retrospective in the sense that it evaluates the performance of the manufactured device against pre-established criteria based on the predicate.

3. Number of Experts and Qualifications for Ground Truth

This type of device (PFT filter) does not typically involve expert human interpretation or "ground truth" in the diagnostic sense (e.g., image interpretation by radiologists). Instead, its performance is objectively measured against physical and biological metrics. Therefore, the concept of "experts establishing ground truth" as it applies to medical imaging algorithms is not relevant here. The "ground truth" for this device's performance is derived from standardized testing protocols and the established performance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation relies on objective laboratory testing against defined performance metrics, not on human interpretation or adjudication of ambiguous cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not applicable and therefore not performed. This device is a passive filter and does not involve human readers or AI in its operation. Its effectiveness is measured through physical and microbiological performance characteristics.

6. Standalone Performance Study

A standalone performance study was done for the device. The study involved BFE (Bacterial Filtration Efficiency) and VFE (Viral Filtration Efficiency) testing performed by Nelson Laboratories. This testing was conducted on the Air Safety Model 2800 PFT Filter independently of human interaction to objectively measure its filtration capabilities and other physical properties (e.g., dead space, resistance to flow). The results of these standalone tests were then compared directly to the established performance characteristics of the predicate device.

7. Type of Ground Truth Used

The ground truth used for evaluating the Air Safety Model 2800 PFT Filter was objective performance data from standardized laboratory testing. This includes:

• Bacterial and viral filtration efficiency percentages.
• Measured resistance to flow at specified rates (cm H2O).
• Measured dead space (ml).
• Material composition and physical dimensions.

This "ground truth" was established by comparing the results of the Model 2800's tests against the known, documented performance parameters of the legally marketed predicate device (EMS K013123), demonstrating substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical component, not a software algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Ask a specific question about this device

Filtration of exhaled gases in the ventilator circuit.

Model 3000/06 to be placed in the exhalation pathway of the ventilator circuit where filtration of the expired gases is desired. Filter is reusable up to 100 times, extended use as determined by the increase in airflow resistance, which is determined during self testing (SST) mode of the ventilator. For use with the Series 700 and 7200 NPB ventilators.

Cleaning method -- autoclaved -- 30 minutes with 3 minutes at 134°C.

Environment of Use --Hospital, Sub-acute Institutions

The Air Safety Model 3000/06 HEPA filter is a multi-use, reusable ventilator in-line filter which The An Bareey Indust side of the PB 700 series and 7200 ventilators. It can be cleaned by steam ecomeets in the ennation are 1 year service life. It has standard 22 mm tubing connectors and it has a clear housing. It contains the Air Safety standard Multipleat media which has been HEPA tested for enting performance according to BS 3928 Sodium Flame for Air filters and in accordance to DOE 3202-97 and ASTM D2986 - DOP. In addition BFE and VFE testing has been performed by 1902 5202 77 and in the substantial equivalence to the predicate devices.

This response describes the acceptance criteria and the study that indicates the device meets the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" sample size in terms of the number of devices or units tested for each performance characteristic. Instead, it refers to the performance of the predicate devices and implies that the Air Safety Model 3000/06 HEPA Filter matches these established performance characteristics.

The provenance of the data is primarily from Nelson Lab for the Bacterial Filtration Efficiency (BFE) and Viral Filtration Efficiency (VFE) testing. The document also refers to testing performed according to BS 3928 Sodium Flame for Air filters and in accordance with DOE 3202-97 and ASTM D2986 - DOP. The context suggests these are retrospective references to established standards and predicate device performance, rather than a prospective, independently designed clinical trial specifically for the 3000/06 model.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

The document does not specify the number or qualifications of experts used to establish a "ground truth" for a specific test set. The data presented is engineering and laboratory performance data (e.g., filtration efficiency, resistance to flow) measured against established industry standards and specifications, rather than clinical outcomes requiring expert consensus on a patient-level "ground truth."

4. Adjudication Method for the Test Set

Not applicable. The evaluation relies on direct measurements against predefined technical specifications and standards, not on subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically used for diagnostic imaging devices where human readers interpret patient cases, and the AI's impact on their performance is evaluated. The Air Safety Model 3000/06 is a physical filter, not a diagnostic tool that involves human interpretation of cases.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. The performance metrics listed (e.g., BFE, VFE, resistance to flow, dead space) are inherent properties of the device itself, measured independently of human interaction in typical clinical use. The "study" here refers to the laboratory testing conducted to ascertain these physical and filtration properties against established standards.

7. Type of Ground Truth Used

The "ground truth" for the performance claims is based on established engineering and laboratory standards and predicate device specifications. For example:

• Bacterial and Viral Filtration Efficiency: Determined by testing performed by Nelson Lab, likely against a standardized challenge (e.g., specific bacterial/viral aerosols) under controlled laboratory conditions.
• Resistance to Flow: Measured using standardized methodologies relevant to ventilator circuits (e.g., flow rates of 60 lpm and 100 lpm).
• HEPA testing: Performance according to BS 3928 Sodium Flame for Air filters and DOE 3202-97 and ASTM D2986 - DOP, which specify testing procedures and filtration efficiency requirements for particulate matter.

8. Sample Size for the Training Set

Not applicable. This device is a physical filter being evaluated against quantifiable performance metrics, not an AI model that requires a "training set" for machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Ask a specific question about this device

Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator. It is a HEPA grade particulate filter for use with the NPB Achieva or LP 10 ventilators. The filter is in the gas flow pathway. As a HEPA particulate filter for the inlet air to be supplied to the patient from the ventilator.

Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator. It is a HEPA grade particulate filter for the NPB Achieva or LP 10 ventilators, which is in the gas flow pathway. Screw-in cartridge to fit the inlet air filter port of the ventilator housing.

The Air Safety HEPA Model 3500 Filter is an inlet filter designed to remove particles of 0.3 micron size or larger from entering ventilators, specifically the NPB Achieva and LP 10 models. It is a HEPA grade particulate filter.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document describes performance testing based on "standard DOP aerosol testing methods" and references specific standards (DOE 3025-99, DOE 3020-97, and ASTM D2986 - DOP). However, it does not specify the sample size for the test set used to generate the reported performance data. The data provenance is implied to be from internal testing conducted by Air Safety Ltd. in England. It's a prospective testing for the device's performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This device is a physical filter, and its performance (filtration efficiency and resistance to flow) is assessed through objective laboratory testing using recognized standards. Therefore, the concept of "experts establishing ground truth" in the way it applies to image analysis or clinical diagnoses is not relevant in this context. The ground truth is the result of the objective measurements obtained through the specified test methods.

4. Adjudication method for the test set:

Not applicable. As described above, the performance is determined by objective, standardized measurements, not through expert judgment or consensus.

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 typically used for diagnostic or imaging devices where human interpretation is involved. This device's performance is quantifiable through laboratory testing.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, the performance testing of the HEPA filter can be considered a standalone assessment. The filtration efficiency and resistance to flow are measured attributes of the device itself, independent of human interaction in its primary function (filtering air).

7. The type of ground truth used:

The ground truth used for this device's performance assessment is based on objective measurements obtained through standardized laboratory protocols. Specifically, it involves:

• DOP aerosol testing for particulate filtration efficiency (retention).
• Measurement of resistance to flow at specified flow rates.

These are established engineering and scientific methods to quantify the physical properties of filters.

8. The sample size for the training set:

Not applicable. This device is a physical product, not an algorithmic model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

Anesthesia / Respiratory Filters
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired.
Model – HEPA filter 3000/04 – Single patient use for exhalation limb of circuit on NPB 700 series ventilators
Models – HEPA filters - 6500/01, 6888/01, 8222/01, 8444/01 Model – Non-HEPA filters - 4000/01 Single patient use up to 24 hours. Patient tidal volumes > 150 ml, when applicable.

The Air Safety HEPA and Non-HEPA filters are available in multiple sizes and shapes, and incorporate standard 15 / 22 mm connectors with or without a gas sampling luer port. Some models adapt to fit ventilator exhalation limb only. The depth (HEPA filtration) filter uses a pleated paper fiber for filtration. Filters are tested for rating performance according to EN 13328 Salt for Breathing System filtration performance. The "HEPA" performance was also tested in accordance to DOE-3025-99, DOE-3020-97 and ASTM D2986 - DOP. The electrostatic (non-HEPA filtration) filters are tested by Nelson Laboratories for BFE and VFE.

This document describes the safety and effectiveness of Air Safety HEPA and Non-HEPA Filters. However, it does not fit the typical format of a study designed to prove a device meets acceptance criteria, especially in the context of an AI/ML powered device. This is a 510(k) premarket notification for traditional medical devices (filters), and therefore, many of the requested categories are not applicable.

Here's an attempt to answer the questions based on the provided text, with clear indications where the information is not available or not relevant to this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a pass/fail format with direct device performance comparison in a single table, as might be found in a study for an AI/ML device. Instead, it lists technical characteristics and performance standards that the device meets.

However, based on the General Technical Characteristics table, we can infer performance criteria and compare them to the device's reported performance:

Summary of "Study" to Prove Device Meets Criteria:

The document details the device characteristics and states that the devices were tested to specific performance standards. This is not a "study" in the clinical trial sense but rather a series of engineering and laboratory performance tests.

• Testing Methodologies:
  • Filtration Performance: Tested according to EN 13328 Salt for Breathing System filtration performance.
  • HEPA Performance (Specific models): Tested in accordance with DOE-3025-99, DOE-3020-97, and ASTM D2986 - DOP.
  • Electrostatic (non-HEPA) Filtration (BFE and VFE): Tested by Nelson Laboratories.
• Conclusion: The submission concludes that "The data within the submission demonstrates that the proposed devices when compared to the legally marketed predicate devices are safe and effective and substantially equivalent." This implies that the performance characteristics met or exceeded those of the predicate devices and applicable standards.

Information Not Applicable / Not Provided for this Device Type:

The following requested information is primarily relevant for AI/ML-powered diagnostic or predictive devices, or those requiring clinical studies with human assessors. The provided document concerns a physical filter, for which these criteria are generally not applicable or not detailed in this type of 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable / Not provided in this context. For physical filters, testing typically involves laboratory samples of the filters themselves, not patient data in the sense of AI/ML. The number of filter units tested for each specific performance claim (e.g., BFE, VFE, resistance) is not specified. Data provenance like "country of origin" for test data is not a typical requirement for device performance testing in this manner.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. "Ground truth" established by experts (like radiologists for an image analysis AI) is not relevant for a breathing circuit filter. Performance is measured objectively through standardized laboratory tests (e.g., particle counts, pressure measurements).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. Adjudication methods are used to resolve discrepancies in expert opinions, typically for establishing ground truth in clinical datasets. This is not relevant for the objective performance testing of a physical filter.

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 is a physical filter, not an AI/ML-powered diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical filter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable. The "ground truth" for a filter's performance is derived from standardized physical and biological challenge tests (e.g., aerosolized particles, bacterial/viral suspensions) and measurements, not clinical expert consensus or pathology.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Ask a specific question about this device