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VentStar Dual Heated / VentStar Heated: Disposable inspiratory heated breathing circuit with humidifier chamber for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidifier and adult patients with a body weight of at least 40 kg (88 lbs).

VentStar Heated (N) / VentStar Heated (N) basic: Disposable inspiratory heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidifier and neonatal patients with a body weight of up to 5 kg (11 lbs).

Infinity ID Breathing Circuit Heated (N): Inspiratory heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for moping moistened breathing gas between the humidifier and neonates with a body weight of up lo 5 kg (11 Ibs) Intended for single-use only. Breathing circuit with integrated transponder. The transponder serves as a carrier of product-specific data for processing by Dräger Infinity ID equipment.

Infinity ID Breathing Circuit Dual Heated / Infinity ID Breathing Circuit Heated: Heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidfier and adults with a body welght of at least 40 kg (88 moration broaining goo Doching circuit with integrated transponder. The transponder. The transponder serves as a carrier of product-specific data for processing by Dräger Infinity ID equipment.

The 510(k) comprises heated breathing gas hose systems including a humidifier chamber for the ventilation of neonatal or adult patients in Intensive Care Units. The hose systems consist of two breathing hoses (inspiratory and expiratory limb) with an additional y- piece.

Inside the inspiratory and in case of the dual heated systems also in the expiratory limb of the hose system there is a heating wire which can be connected to a Fisher & Paykel humidifier MR850 to heat up the breathing gas to minimise condensation. An expiratory limb without heating wire includes a water trap. There are additional sensor ports where the temperature sensors of the Fisher & Paykel humidifier MR850 (e.g. Fisher & Paykel 900MR868) can be placed in.

In case of the neonatal system, the hose is equipped with an incubator extension for use inside an incubator.

The Infinity ID heated breathing circuits are based on the heated breathing circuits additionally equipped with an RFID identification tag. The tag stores characteristics of the breathing hose (e.g. patient type, hose diameter, resistance and compliance values, manufacturing date and shelf life) and is automatically be readout when connected to the outlets of a ventilator device which supports this function.

The provided document (K102618) describes heated breathing circuits manufactured by Dräger Medical AG & Co. KG. The summary of testing indicates that the device has undergone performance evaluations; however, it does not provide specific quantitative acceptance criteria or detailed study results that would allow for a precise filling of the table requested.

Therefore, many sections of your request cannot be fully answered with the information given. I will extract what is available and indicate where information is missing.

Acceptance Criteria and Device Performance Study for Dräger Heated Breathing Circuits (K102618)

The provided document describes the safety and performance testing for Dräger's VentStar Heated and Infinity ID Breathing Circuit Heated devices. However, explicit quantitative acceptance criteria and detailed quantitative performance results are not presented in a traditional "acceptance criteria vs. reported performance" format. The document generally states that "product performance is given within the range the device can be used by clinicians" and that "the technological characteristics and the results of the performance data demonstrated that the heated breathing hoses issued no new risks." This suggests a qualitative assessment of performance against design specifications or clinical utility rather than specific numerical thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Detailed quantitative acceptance criteria (e.g., temperature ranges, flow rates, humidity levels, specific electrical thresholds) and corresponding numerical performance data are not available in this document.

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

• Test Set Sample Size: Not specified. The document mentions "the following testing has been performed on the breathing systems," but does not list the number of units tested for each type of assessment.
• Data Provenance: The manufacturer is Dräger Medical AG & Co. KG, based in Lübeck, Germany. The data would therefore be prospective product development and validation testing conducted by the manufacturer, likely in Germany.

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

This section is not applicable or not provided in the document. The testing described appears to be engineering and biocompatibility validation, not clinical studies requiring a ground truth established by medical experts in the traditional sense of diagnostic accuracy algorithms. Performance is likely measured against engineering specifications and relevant international standards.

4. Adjudication Method for the Test Set

This is not applicable as the tests performed are primarily engineering and compliance checks, not diagnostic interpretations requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or at least not described in this document. This typically applies to AI systems assisting human readers in diagnostic tasks, which is not the nature of this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable in the context of this device. The heated breathing circuits are passive disposables designed to work in conjunction with other medical equipment (humidifiers, ventilators) and human clinicians. They do not involve an AI algorithm operating independently.

7. Type of Ground Truth Used

The "ground truth" for this device's performance would be defined by:

• Engineering Specifications: Design tolerances and intended operational parameters for temperature, flow, humidity, and material integrity.
• International Standards: Compliance with ISO standards (e.g., ISO 10993-1 for biocompatibility) and other relevant safety and performance mandates for medical devices (e.g., electrical safety standards).
• Clinical Requirements: The ability to effectively humidify and convey breathing gas to patients within clinically acceptable and safe ranges, as determined by medical device regulations and established clinical practice.

8. Sample Size for the Training Set

This is not applicable. This device is not an AI algorithm trained on data; it is a physical medical device (breathing circuit).

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

This is not applicable for the same reason as point 8.

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