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K Number
K980960
Device Name
IN-CHECK INSPIRATORY FLOWMETER
Manufacturer
CLEMENT CLARKE INTL., LTD.
Date Cleared
1998-06-10

(86 days)

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

The IN-CHECK is one of a family of simple devices used for monitoring respiratory conditions, and is suitable for use by the Health Care Professional or for home monitoring of nasal or oral inspiratory flow by the patient.

Some uses for the device are :-

  1. Diagnosis of Nasal Obstruction
  2. Assessment of Response to Nasal Provocation
  3. Home Monitoring of PNIF
  4. Oral Inspiratory Flow Measurement
Device Description

The IN-CHECK is one of a family of simple devices used for monitoring respiratory conditions.

AI/ML Overview

The provided document focuses on the FDA 510(k) submission for the "IN-CHECK Inspiratory Flowmeter". It primarily addresses the regulatory approval process and indications for use. The document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in the detail required to populate the requested table and answer the specific study questions.

The document states:

  • Safety Problems: "No safety problems should be experienced during use of the device for its intended purpose, and none have been reported for either the IN-CHECK OR YOULTON INSPIRATORY MINI." This indicates a lack of reported issues rather than a rigorous study proving safety against specific criteria.
  • Effectiveness: The FDA determined the device to be "substantially equivalent" to predicate devices. This regulatory pathway does not typically require new clinical studies to prove effectiveness against specific quantitative acceptance criteria, but rather demonstrates that the new device is as safe and effective as a legally marketed device.

Therefore, since the document does not provide the requested details, I cannot complete the table or answer the specific study questions.

Information NOT available in the provided text:

  • A table of acceptance criteria and reported device performance (e.g., accuracy, precision).
  • Sample sizes for test sets, training sets, or data provenance.
  • Number of experts, their qualifications, or adjudication methods for ground truth.
  • Details of any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.
  • Specific ground truth types (beyond general safety and equivalence to predicate devices).

To answer your questions, additional documentation regarding the performance testing of the IN-CHECK Inspiratory Flowmeter would be required.

§ 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).