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K Number
K081778
Device Name
NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
Manufacturer
INSTRUMENTATION INDUSTRIES, INC.
Date Cleared
2008-09-12

(81 days)

Product Code
CAP
Regulation Number
868.2600
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Instrumentation Industries, Inc. NS Series Airway Pressure Monitors are devices used to monitor patient airway pressure during ventilation within a breathing circuit. The pressure gauge is placed in the patient circuit at a point that provides optimal airway pressure readings. These devices are intended to be used by or on the order of a physician.

During ventilation, the NS Series Cuff Pressure Monitors are devices used to periodically monitor endotracheal or tracheostomy tube balloon pressure to assure an adequate seal between the tube and the tracheal wall. These devices are intended to be used by or on the order of a physician.

Device Description

The NS Airway Pressure Gauges are intended to measure airway pressures of up to 30, 60 or 120 cm. H20, dependent upon the specific model used.

AI/ML Overview

The provided text is a 510(k) summary for the NS Series Airway Pressure Monitors, which are physical devices. This document does NOT contain information about an AI/ML powered medical device, therefore, the requested information in the prompt is not applicable.

Here's why and what information is available:

  • Device Type: The document describes "NS Series Airway Pressure Monitors" and "NS Series Cuff Pressure Monitors," which are explicitly stated to be "analog-faced manometers used to measure low pressures within a patient breathing circuit." This indicates a mechanical or electronic pressure gauge, not an AI/ML software device.
  • No AI/ML Specifics: The text does not mention any algorithms, software, training data, test sets, ground truth, expert adjudication, or any other element typically associated with AI/ML device studies.
  • Focus of the Document: The document focuses on demonstrating substantial equivalence to predicate devices (BE 148 and Anesthesia Associates, Inc. Model # 00-199) based on similarities in function, performance, and intended use, as well as differences in capacity/pressure ranges. This is a standard 510(k) pathway for traditional medical devices.

Therefore, I cannot provide the requested information, as it pertains to AI/ML device studies that are not described in this document.

The document does provide:

  • Device Description: The NS Airway Pressure Gauges are intended to measure airway pressures of up to 30, 60 or 120 cm H2O.
  • Intended Use: To monitor patient airway pressure during ventilation within a breathing circuit, or to periodically monitor endotracheal or tracheostomy tube balloon pressure.
  • Predicate Devices: Instrumentation Industries, Inc. - BE 148 - Preamendment device; Anesthesia Associates, Inc. Model # 00-199 - Preamendment device; and Smith Portex Cuff Pressure Indicator (for the cuff pressure monitors).
  • Technological Characteristics: Similarities and differences in function, performance, usage, and pressure range compared to predicate devices.

§ 868.2600 Airway pressure monitor.

(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).