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K Number
K981726
Device Name
PERCUSSIVETECH HF, MODEL 2001
Manufacturer
VORTRAN MEDICAL TECHNOLOGY 1, INC.
Date Cleared
1998-09-17

(125 days)

Product Code
NHJ
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use in the removal of mucus from the lungs of patients with retained endobronchial secretions.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the PercussiveTech HFTM device. It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is primarily a regulatory approval notice and does not delve into the technical details of the device's validation studies.

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).