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K Number
K980443
Device Name
PEAK FLOW METER MINIMAX
Manufacturer
THE D&T, INC.
Date Cleared
1998-04-30

(84 days)

Product Code
BZH
Regulation Number
868.1860
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

"MINIMAX" Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR) for the evaluation of lung function of persons with asthma.

Device Description

"MINIMAX" Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR)

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device called "miniMAX" Peak Flow Meter. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given text.

The document primarily focuses on:

  • The FDA's decision of substantial equivalence for the "miniMAX" Peak Flow Meter.
  • The regulatory classification of the device (Class II).
  • General controls and potential additional controls applicable to the device.
  • Contact information for further regulatory inquiries.
  • The intended use of the device: "measurement of peak expiratory flow rate (PEFR) for the evaluation of lung function of persons with asthma."

To answer your questions, I would need a different document, such as the actual 510(k) summary or the premarket notification submission itself, which would detail the performance data and testing conducted for the device.

§ 868.1860 Peak-flow meter for spirometry.

(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).