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K Number
K970507
Device Name
PEAK FLOW METER
Manufacturer
INTL. MEDICAL, INC.
Date Cleared
1997-06-13

(123 days)

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

The intended use of IMI Peak Flow Meter is for Hospital Respiratory Therapy Departments, and home monitoring used by the Asthma patient as prescribed by the physician. The device is for single patient use. However, the home patient can reuse the instrument himself after cleaning. The device is non-sterile. The device is for prescription use.

Device Description

IMI Peak Flow Meter

AI/ML Overview

I am sorry, but the provided text from the FDA document does not contain the detailed information necessary to answer your request regarding the acceptance criteria and the study that proves the device meets those criteria for the IMI Peak Flow Meter (K970507).

The document is an FDA 510(k) clearance letter, which states that the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory classifications, general controls, and points regarding marketing and labeling. It also includes an "Intended Use" statement. However, it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details about a specific study proving device performance against acceptance criteria. This would typically involve specific metrics like accuracy, precision, sensitivity, specificity, etc., and the results obtained.
  3. Sample size used for the test set or its data provenance.
  4. Number or qualifications of experts used for ground truth.
  5. Adjudication method.
  6. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
  7. Information about a standalone (algorithm only) performance study.
  8. Type of ground truth used (e.g., pathology, outcomes data).
  9. Sample size for the training set or how its ground truth was established.

To obtain this information, you would typically need to consult the 510(k) summary or the full 510(k) submission for K970507, which might contain the scientific and clinical data supporting the substantial equivalence determination, including performance testing results. The provided document is only the clearance letter itself.

§ 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).