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K Number
K991412
Device Name
VITALOGRAPH MICRO
Manufacturer
VITALOGRAPH, INC.
Date Cleared
2000-02-04

(287 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

The Vitalograph Micro Spirometer is intended to measure, FVC, FEVI, PEF and FEV1% in patients with respiratory conditions such as Asthma, COPD, etc.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) clearance letter for the Vitalograph Micro Spirometer does not contain sufficient information to answer your request.

The document is a clearance letter, which confirms that the device is substantially equivalent to a predicate device based on its intended use and performance. However, it does not include the detailed study report, acceptance criteria, or performance data that would allow me to fill out all the requested sections.

Specifically, the letter states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that performance data was submitted, but the data itself and the specific acceptance criteria met are not present in the provided text.

Therefore, I cannot provide:

  1. A table of acceptance criteria and the reported device performance: This information is not in the clearance letter.
  2. Sample size used for the test set and the data provenance: Not detailed in the letter.
  3. Number of experts used to establish the ground truth for the test set and their qualifications: Not detailed.
  4. Adjudication method for the test set: Not detailed.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not detailed.
  6. If a standalone performance study was done: While implied by substantial equivalence, the specific study details are not provided.
  7. The type of ground truth used: Not detailed.
  8. The sample size for the training set: Not applicable for this type of device and submission (no AI/ML training set is mentioned or implied).
  9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on the regulatory clearance based on substantial equivalence to a predicate device, and the intended use of the Vitalograph Micro Spirometer for measuring FVC, FEV1, PEF, and FEV1% in patients with respiratory conditions.

§ 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).