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K Number
K991212
Device Name
MODIFICATION TO TRUZONE PEAK FLOW METER
Manufacturer
MONAGHAN MEDICAL CORP.
Date Cleared
1999-07-01

(83 days)

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

Portable monitoring device which measures the peak expiratory flow (PEF) generated by the patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma or emphysema.

Device Description

TruZone™ Peak Flow Meter

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the TruZone™ Peak Flow Meter. It describes the device and its indications for use, but it does not contain a detailed study report or acceptance criteria for the device's performance. The letter itself states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than a presentation of new performance data against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided document. I can, however, extract the device name and indications for use.

Device Name: TruZone™ Peak Flow Meter

Indications for Use: Portable monitoring device which measures the peak expiratory flow (PEF) generated by the patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma or emphysema.

Missing Information (Not available in the provided text):

  1. A table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter. Such data would typically be found in a separate study report or a detailed section of the 510(k) submission itself.
  2. Sample size used for the test set and the data provenance: Not provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
  4. Adjudication method for the test set: Not provided.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as this is a peak flow meter, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical measurement device, not an algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
  8. The sample size for the training set: Not applicable, as this is a physical measurement device, not a machine learning model.
  9. How the ground truth for the training set was established: Not applicable.

§ 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).