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K Number
K983631
Device Name
AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P
Manufacturer
INSTRUMENTATION INDUSTRIES, INC.
Date Cleared
1999-07-01

(259 days)

Product Code
CBP
Regulation Number
868.5870
Type
Traditional
Panel
Anesthesiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The disposable KC 9-P one-way valve with removable cap allows a single breath measurement of auto-PEEP when used with certain ventilator circuits.

Device Description

KC 9-P Auto-PEEP Measurement Device

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the Instrumentation Industries, Inc. Auto-PEEP Measurement Device (K983631). It confirms substantial equivalence to a predicate device and outlines regulatory information. However, this document does not contain the detailed information necessary to describe the acceptance criteria, reported device performance, or the study that proves the device meets the acceptance criteria as requested in the prompt.

The letter explicitly 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 marketed in interstate commerce prior to May 28, 1976...". This means the device was cleared based on its substantial equivalence to an older, already-marketed device, rather than requiring a detailed comparative clinical study against specific acceptance criteria for a novel device.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter. The letter focuses on regulatory substantial equivalence, not performance metrics.
  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 the qualifications of those experts: 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 the effect size: Not mentioned, and highly unlikely for a device cleared through substantial equivalence without a new claim of improved diagnostic or therapeutic performance.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This device appears to be a physical measurement device (one-way valve) rather than an AI/algorithm-driven one.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
  8. The sample size for the training set: Not applicable, as this is not an AI/algorithm-driven device requiring a training set.
  9. How the ground truth for the training set was established: Not applicable.

§ 868.5870 Nonrebreathing valve.

(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).