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CareStar 30 and SafeStar 55 are Breathing System Filters which are designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems.

The products may either be used on the patient side or on the device side of the ventilator/ anaesthetic device and are used as a hygienic measure alternatively to decontamination of breathing system and/or breathing gas conveying parts of the ventilator.

TwinStar 55 is a Breathing System Filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture Exchanger offer the benefit of both product features. Heat and Moisture Exchanger are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The products are the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since Heated Humidifiers are almost impossible to use.

The products mentioned above are designed for disposable use and should be changed at least every 24 hours.

The filters CareStar 30 and SafeStar 55 are designed to reduce possible air or liquid borne cross contamination with microorganisms via anesthetic or ventilator breathing systems. The strategic use of an effective breathing filter protects, bi-directionally, both the patient and equipment.

The filter CareStar 30 contains an electrostatic filter pad while the filter SafeStar 55 incorporates a mechanical pleated filter pad. Both filters consist of a plastic body which incorporates 22 female / 15 male connectors in accordance with EN ISO 5326 and a luer lock connector which may only be used for gas monitoring.

The Filter/HME TwinStar 55 is designed to combine the feature of reducing possible cross contamination with micro-organisms and an ideal heat and moisture return.

The Filter/HME TwinStar 55 consist of a plastic body which incorporates an electrostatic filter pad, 22 female / 15 male connectors in accordance with EN ISO 5326 and a gas luer lock connector which may only be used for gas monitoring.

Here's an analysis of the provided text regarding the Dräger Medical breathing system filters, focusing on the acceptance criteria and the study proving compliance.

It's important to note that this document is a 510(k) Summary, which typically provides a high-level overview of the device and its substantial equivalence to predicate devices, rather than a detailed study report. Therefore, specific details about study design, raw data, or comprehensive statistical analyses are often summarized or omitted.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance specifications for the devices, comparing them to generally accepted standards for breathing system filters. The "acceptance criteria" are implied by the listed performance values and the claim of substantial equivalence to predicate devices.

*BFE: Bacterial filtration efficiency; VFE: Virus filtration efficiency

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

The document states filtration efficiency tests were done "by Nelson Lab." Nelson Laboratories is a well-known contract research organization specializing in microbiology and material testing for medical devices.

• Sample Size for Test Set: Not explicitly stated in the provided document. Standard laboratory testing, especially for filtration efficiency, would involve a statistically significant number of samples, but the exact count is not given here.
• Data Provenance: The document implies the data comes from laboratory testing (Nelson Labs). This is not patient-specific clinical data. It is a prospective test of the physical properties and performance of the manufactured devices. The country of origin for Nelson Labs is the United States.

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

• This type of device (breathing system filter) does not typically involve human expert adjudication for its primary performance metrics like filtration efficiency or resistance to flow. These are objective, quantifiable physical properties measured by laboratory equipment.
• Therefore, the concept of "ground truth established by experts" in the way it applies to image-based diagnostics is not relevant here. The "ground truth" for the test results is established by the methods and standards used by Nelson Laboratories, which are highly specialized technicians and scientists in their field.

4. Adjudication Method for the Test Set

• Not applicable (see point 3). Performance metrics are determined by laboratory measurements according to established test standards (e.g., for BFE/VFE, resistance to flow, moisture loss).

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

• No. This is a hardware medical device (breathing system filter), not an AI-powered diagnostic or therapeutic tool. Therefore, MRMC studies and AI assistance are not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• No. This is not an algorithm or AI device. The performance data presented is the "standalone" performance of the physical device itself in a laboratory setting.

7. The Type of Ground Truth Used

• For physical performance metrics (filtration efficiency, resistance to flow, internal volume, moisture loss), the ground truth is derived from standardized laboratory testing methods and measurements. These methods are designed to objectively quantify the device's physical properties under controlled conditions. This is not pathology, expert consensus (in the clinical sense), or outcomes data.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The device's design and manufacturing processes are refined based on engineering principles and material science, not data training.

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

• Not Applicable. (See point 8).

Summary of the Study Proving Device Meets Acceptance Criteria:

The document states that the performance data for filtration efficiency was "[measured] by Nelson Lab." It also lists other performance characteristics such as resistance to flow, internal volume, and moisture loss. The study demonstrating that the device meets criteria is implicitly the laboratory testing conducted by Nelson Laboratories and Dräger Medical's internal R&D, which measured these specific physical and biological filtration properties of the filters.

The overall claim of the 510(k) submission is Substantial Equivalence. This means the applicant argues that the proposed devices (Filter CareStar 30, Filter SafeStar 55, Filter/HME TwinStar 55) are as safe and effective as existing, legally marketed predicate devices (listed in the document). The "study" isn't a comprehensive clinical trial but rather a comparison of key performance data to established values of predicate devices and relevant ISO/EN standards. The document states:

"The comparison of the data shows similar values for the key performance data. Proposed devices show similar values in filtration efficiency, dead space, resistance to flow and recommended tidal volumes when compared to the legally marketed devices."

The acceptance criteria are therefore implicitly defined by the performance benchmarks set by these predicate devices and relevant industry standards (like EN ISO 5326 and ISO 9360), which the new devices' laboratory test results must meet or demonstrate equivalence to. The FDA's clearance (K072002) signifies their agreement that this substantial equivalence has been demonstrated.

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