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K Number
K031514
Device Name
MODIFICATION TO TRUPEAK PEAK FLOW METER
Manufacturer
MONAGHAN MEDICAL CORP.
Date Cleared
2003-05-23

(9 days)

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

The TruPeak® Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver. This measurement is useful in detecting changes that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma and emphysema. This device is packaged and labeled so it can be used as a screening device in a hospital or other clinical setting. Labeling is also included for the use of the device if dispensed by a health care provider to a patient for personal use.

Device Description

The TruPeak® Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver.

AI/ML Overview

The provided document is a 510(k) premarket notification letter for the TRUPEAK Peak Flow Meter. It is a regulatory approval document from the FDA and does not contain the detailed study information or acceptance criteria requested in the prompt.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications, general controls, and compliance requirements, but it does not include performance data, study design, or ground truth establishment.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not present.
  2. Sample size used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
  4. Adjudication method for the test set: Not mentioned.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
  6. If a standalone study was done: Not mentioned.
  7. The type of ground truth used: Not mentioned.
  8. The sample size for the training set: Not mentioned (as this is a medical device, not an AI/ML model, training sets are not typically applicable in the same way).
  9. How the ground truth for the training set was established: Not mentioned.

§ 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).