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Filter CareStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in pediatric (with a tidal volume between 100 and adult patients, depending on the respective device. Filter SafeStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult patients. Filter/HME TwinStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and for respiratory use, as well as heat and moisture exchanger for humidifying respired gases for the patient. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult, pediatric and neonatal patients, depending on the respective device.

The devices are breathing circuit filters used to filter the inhaled and/or the exhaled air of the patient against microbiological and particulate matter from the gases in the breathing circuit. They enclose a filter material in a housing that fits to standard breathing system connectors. Additionally, there are breathing system filters combined with a foam to function as HME (Heat and Moisture Exchangers) for passively humidifying the inspired air. The portfolio contains the following types of breathing circuit filters: - Filter CareStar Plus are electrostatic filters for use against contamination with microorganisms - . Filter SafeStar Plus are mechanical filters for use against contamination with microorganisms - Filter/HME TwinStar Plus are filters for use against contamination with microorganisms and for passive humidification of breathing gases

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided document describes three devices: Filter CareStar Plus, Filter SafeStar Plus, and Filter/HME TwinStar Plus. The table below compiles the acceptance criteria and reported performance for these devices based on the "Summary of non-clinical testing" section (pages 18-19).

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

The document does not explicitly state the sample sizes used for each non-clinical test. It mentions that "The devices... have undergone extensive testing" but does not detail the number of units tested for each criterion. The data provenance is also not specified; however, given that the submitter is "Drägerwerk AG & Co. KGaA" based in "Lübeck, Germany" and they tested against international standards (ISO, ASTM, IEC), it is likely that the testing was conducted in a controlled laboratory environment, potentially in Germany or by a certified testing facility adhering to these standards. The testing appears to be prospective, specifically designed to verify the devices' adherence to the mentioned standards.

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

The document does not mention the use of experts to establish ground truth for the non-clinical test set. The validation relies on adherence to established international and national standards (e.g., ISO, ASTM, IEC) rather than expert consensus on a test set. This implies that the "ground truth" is defined by the objective metrics and methodologies outlined in these standards.

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

There is no mention of an adjudication method in the text for the non-clinical test set. Given the nature of the tests (physical and performance characteristics against standards), it's a pass/fail determination based on quantitative measurements against predefined criteria, not a subjective assessment requiring adjudication.

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

The document explicitly states "Summary of Clinical Testing N/A" (page 20). This indicates that no clinical studies, including MRMC comparative effectiveness studies involving human readers or AI assistance, were performed or submitted. The entire submission focuses on non-clinical performance and substantial equivalence based on technical characteristics and adherence to standards.

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

Since the devices are breathing circuit filters and not software or AI-powered devices, the concept of a "standalone (algorithm only)" performance study is not applicable. The device's performance is intrinsically mechanical and material-based, not algorithmic.

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

The ground truth for this submission is based on established international and national consensus standards (e.g., ISO 9360-1, ISO 5356-1, ISO 80369-7, IEC 60601-1, ISTA 3A, ISO 23328-1, ASTM F2101, ISO 10993, ISO 18562-1). The device's performance is measured against the quantitative requirements and methodologies specified within these standards.

8. The sample size for the training set

This question is not applicable. The document describes physical medical devices (filters), not machine learning or AI models that require a "training set."

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

This question is not applicable, as there is no training set for these devices.

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For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to add, maintain, retain moisture for the exhaled breathe of the patient. Use up to 24 hours.

The Models of the filters are A501-1, A501-2, A501-3, and A501-4. The filters are intended for patient population that weighs greater than 10Kgs.

Breathing circuit bacterial/viral filter has into two models: - 1) Bacterial/ viral filters; 2) Bacterial/viral filters HME. Breathing circuit bacterial/viral filters are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15/22 mm connectors with a gas sampling luer port. The depth filter use electrostatic media for filtration and a foam media for the HME media.

The provided document is a 510(k) premarket notification for a medical device: a Breathing Circuit Bacterial/Viral Filter manufactured by Zhejiang Haisheng Medical Device Co., Ltd. The document asserts that the device is substantially equivalent to a legally marketed predicate device (EMS Electra Filter and Filter/HME, K013122).

Based on the provided text, here's information regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is compared directly to the predicate device, implying that the predicate's performance metrics serve as the acceptance criteria for achieving substantial equivalence.

Additionally, other characteristics are compared for substantial equivalence:

• Indications For Use: Same
• Product Structure: Same (top cover, filter media, lower cover, sampling port)
• Materials (Top Cover, Filter Media, Lower Cover, Gas Sampling Port, Package): Same (polystyrene, electrostatic polypropylene, PE, dialyzing paper and PE film)
• Color Additive: None (Same)
• Sterilization: EO (Same)

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

The document mentions that "Test data and reports were provided as part of the 510(k) submission," but does not specify the sample sizes of devices tested for each performance metric (e.g., how many filters were tested for bacterial filtration efficiency).

The data provenance is not explicitly stated in terms of country of origin for the testing, nor is it classified as retrospective or prospective. It is implied that the testing was conducted specifically for this 510(k) submission, suggesting it was prospective testing on the Zhejiang Haisheng device. The document states that some tests were performed by "Nelson Lab," which is a known independent laboratory (likely Nelson Laboratories, LLC in the USA), but this is not explicitly stated as the sole source of all test data.

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

This type of information (number and qualifications of experts) is not applicable to this device and submission. The device is a physical breathing circuit filter, and its performance (e.g., filtration efficiency, resistance) is measured objectively through standardized laboratory tests, not through expert interpretation or clinical judgment that would require establishing a "ground truth" by experts.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the performance is determined by objective laboratory measurements and does not involve human interpretation or adjudication in the context of, for example, image analysis or diagnostic tasks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

This is not applicable as the device is a physical medical device (a filter) and not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and effects of AI assistance are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the device is a physical filter, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for verifying the device's performance is established through objective laboratory testing against recognized international standards and specific performance thresholds. For example:

• Bacterial/Viral Filtration: Determined by laboratory tests (e.g., Nelson Lab) measuring the percentage removal of specific microorganisms.
• Resistance to Flow: Measured using flow meters and pressure transducers.
• Humidification Output: Measured in a laboratory setting under controlled conditions (e.g., per ISO 9360).
• Material Compatibility/Biocompatibility: Determined by standardized material testing.
• Sterilization: Verified by ethylene oxide residual testing.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not a machine learning model, so there is no "training set" in the context of artificial intelligence or algorithm development. Production samples are tested for performance.

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

This is not applicable for the same reasons as #8.

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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.

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