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Intended use for all models is the same. Different products are offered for variations in size. Specifically, MS-101 is for use in pediatric cases; MS-111 and VIS-121 are for use in cases where a larger dead space is not a concern for the physician.

Indications For Use:

1. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.
2. A Heat and Moisture Exchanger (HME) is a device intended to be positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by a patient during anesthesia and ventilator care.

Device name: Bacterial/Viral filter and HME combination device.
Product numbers: MS-101, MS-111, MS-121

This document is an FDA 510(k) clearance letter for a medical device and does not contain the acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to a predicate device, not on new clinical trials or detailed performance studies with acceptance criteria as one would find in a clinical trial report. The FDA is acknowledging that the device is similar enough to existing, legally marketed devices that it can be marketed without requiring new, extensive proof of safety and efficacy.

Therefore, I cannot extract the requested information from the provided text as it is not present.

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A bacterial filter is indicated for use when the care provider desires to protect the patient, care provider, equipment, or all three from the transference of bacteria or virus through the breathing circuit. This filter is provided only in combination with a King Systems Universal F2™ breathing circuit. Within this combination the overall intended use is to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.

Breathing Circuit Bacterial Filter

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a "Breathing Circuit Bacterial Filter" and discusses regulatory aspects, not performance studies or acceptance criteria for a device.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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