(88 days)
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.
Not Found
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:
- A table of acceptance criteria or reported device performance.
- Sample sizes or data provenance for any test set.
- Information on experts, ground truth establishment, or adjudication methods for a test set.
- Details of any MRMC comparative effectiveness study or standalone algorithm performance.
- Sample sizes or ground truth establishment methods for a training set.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.