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The 840 Ventilator with Respiratory Mechanics Option is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients with an Ideal Body Weight (IBW) as low as 0.5 kg (with NeoMode option) to adult, and for use in a wide variety of clinical conditions.

The 840 Ventilator with Respiratory Mechanics Options is intended for a wide range of patients ranging from neonate to adult (Vr 5-2500 mL with NeoMode) or from infant to adult (VJ-25-2500 mL).

The 840 Ventilator with Respiratory Mechanics is intended for use in hospital and hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.

The Respiratory Mechanics Option enables the 840 Ventilator System to implement three new respiratory maneuvers, and permits the device to calculate and display ten additional measurements for use in the assessment of mechanical pulmonary functions of the patient's airways. The Respiratory Mechanics feature is implemented on the 840 Ventilator through additional functionality in software and by use of the existing User Interface panel. No hardware or firmware changes or additions were required. The 840 Ventilator is a dual-microprocessor controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult (with NeoMode Option) or infant to adult (without NeoMode Option) patients who require either invasive ventilation or non-invasive ventilation (via face mask).

This 510(k) summary (K063650) describes the 840 Ventilator System with Respiratory Mechanics, but it does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or clinical performance data.

The document primarily focuses on:

• Device Description: What the device is and what new features the "Respiratory Mechanics Option" adds (three new maneuvers, ten additional measurements).
• Intended Use: The patient population, use environment, and purpose of the device.
• Determination of Substantial Equivalence: It asserts that the device is substantially equivalent to predicate devices based on intended use, materials, design, and technical characteristics, and that it "does not introduce new questions regarding safety or effectiveness."
• Regulatory Compliance: It mentions that software design and development followed FDA guidance (May 29, 1998) and internal company requirements.

Therefore, I cannot provide the requested information from the provided text. The document states that "information provided in this Special 510(k) submission provides comparative, predicate device information and describes development procedures that support the determination of substantial equivalence and assertion that the modified device is safe and effective for its intended use." However, these supporting details, including any performance studies or acceptance criteria, are not included in this summary.

In summary, none of the requested points (1-9) can be answered from the provided text.

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Humidifiers are defined as a device that is intended to add moisture to the breathing gases for administration to a patient. The HUMIDIFLOW™ is intended to be installed on oxygen concentrators to add moisture to the breathing gases for administration to a patient.

The HUMIDIFLOW™ is a new device that humidifies oxygen. The device attaches to the inlet side of the air compressor and to the outlet oxygen used in oxygen concentrators and operates as a mass exchanger to transfer the room air humidity to the patient gas.

While the provided text describes the HUMIDIFLOW™ Humidifier and its substantial equivalence to predicate devices, it does not contain the detailed information required to fill out all the acceptance criteria and study details as requested. The summary focuses on technological characteristics and biocompatibility, not performance metrics directly tied to numerical acceptance criteria.

However, I can extract the available information and indicate where details are missing based on the prompt's requirements.

Here's a breakdown of what can be inferred and what is explicitly not available in the provided text:

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

The document states: "Performance characteristics that could be affected by the installation of the HUMIDIFLOW™ were identified for the various oxygen concentrators for which HUMIDIFLOW™ would be installed. The device was also measured for humidity output. All testing indicates that the device is substantially equivalent to the predicate device."

This statement implies that some performance metrics related to "humidity output" were measured and compared. However, it does not provide specific numerical acceptance criteria (e.g., minimum humidity level, maximum humidity variability) or the reported device performance against those criteria. It only states that the device was found to be "substantially equivalent" to the predicate.

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

• Sample size for the test set: Not specified.
• Data provenance: Not specified. (The testing was likely internal to Porous Media Corporation, but no details are given.)

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)

This type of information is generally relevant for studies involving subjective interpretation (e.g., medical imaging). For a device like a humidifier, "ground truth" would typically refer to objective measurements using calibrated equipment (e.g., hygrometers). The document does not describe the use of human experts to establish ground truth for performance.

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

Not applicable as there's no indication of human expert interpretation or a need for adjudication in the context of humidifier performance testing presented.

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

• MRMC study: Not done. This type of study is relevant for AI-assisted image interpretation or diagnostic tools, which the HUMIDIFLOW™ is not.
• Effect size of human readers: Not applicable.

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

The HUMIDIFLOW™ is a physical device, not an algorithm. Therefore, "standalone" performance testing would refer to the device's intrinsic mechanical and humidification performance. The document states that "The device was also measured for humidity output," indicating standalone testing, but no specific results are provided beyond the general claim of substantial equivalence.

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

For a humidifier, ground truth would be established through objective physical measurements of humidity, temperature, and potentially airflow using calibrated sensors and instrumentation. The document implies this type of measurement was done ("measured for humidity output") but doesn't detail the specific methods or equipment used to establish this "ground truth."

8. The sample size for the training set

This is not applicable as the HUMIDIFLOW™ 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 a physical device.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence primarily through technological characteristics and biocompatibility, rather than detailed quantitative performance studies with specific acceptance criteria and outcome measurements typical for AI/ML devices or complex diagnostic tools.

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