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For aspiration during flexible endoscopy and general or surgical suction within a health care establishment. It is not intended for thoracic, domiciliary, field or transport use.

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I am sorry, but the provided text does not contain 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 the Olympus Suction Pump Model KV-5, confirming its substantial equivalence to a legally marketed predicate device.

It details:

• The device name and model.
• The regulation number and regulatory class.
• The date of the letter and previous correspondence dates.
• The contact information for the recipient.
• General information about FDA regulations and responsibilities.
• The intended use of the device: "For aspiration during flexible endoscopy and general or surgical suction within a health care establishment. It is not not intended for thoracic, domiciliary, field or transport use."

It does not provide:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes or data provenance for any test set.
3. Information on experts, ground truth establishment, or adjudication methods for a test set.
4. Details of any MRMC comparative effectiveness study or standalone algorithm performance.
5. Sample sizes or ground truth establishment methods for a training set.

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