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K Number
K083056
Device Name
NEO-STAT CO2 <KG
Manufacturer
MERCURY MEDICAL
Date Cleared
2009-02-23

(132 days)

Product Code
CCK
Regulation Number
868.1400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neo-StatCO2 <Kg is indicated to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. Intended for use with neonate and infant patients from 250g to 6 kg.
Device Description
Mercury Medical, Inc. Neo-StatCO2 <Kg is a colorimetric breath indicator for visualization of exhaled CO2. It is designed to connect between an endotracheal tube and a breathing device to help verify proper intubation. Exhaled gas passes through the indicator to detect approximate ranges of end-tidal CO2 by color comparison. Color change is rapid and the detector has the ability to show color changes with 1 ml tidal volume and up to a respiratory rate of 100 breaths per minute. The detector may be used during patient transport or in locations when intubations are performed. While the indicator functions at relative humidity (RH) of up to 100%, it is not recommended for use below 10% RH. It may be used for up to 24 hours.
More Information

K031411, K944400, K024300

K031411,K944400,K024300

No
The device description and performance studies indicate a simple colorimetric indicator based on chemical reaction, with no mention of computational analysis, algorithms, or learning processes.

No
The device is a colorimetric breath indicator that visualizes CO2 to help verify proper intubation; it is an adjunct in patient assessment and does not directly treat a condition.

Yes

Explanation: The device provides "semi-quantitative visualization of the CO2 in the patient airway" and "detect[s] approximate ranges of end-tidal CO2 by color comparison" to "verify proper intubation," which are diagnostic functions.

No

The device description clearly states it is a "colorimetric breath indicator" and describes a physical component that connects between an endotracheal tube and a breathing device, indicating it is a hardware device with a color-changing element.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
  • Device Function: The Neo-StatCO2

N/A

Intended Use / Indications for Use

The Neo-StatCO2

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).

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L083056
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510(k) Summary Page 1 of 3 11-Feb-09

FEB 2 3 2009

| 11300 - 49th St. North
Clearwater, FL 33762-4800 | Tel - (727) 573-0088
Fax - (727) 571-3922 |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Official Contact: | Jeff Ratner - VP Engineering and Quality Assurance |
| Proprietary or Trade Name: | Neo-StatCO2 |
| Common/Usual Name: | CO₂ detector |
| Classification Name/Code: | CCK - carbon dioxide gas analyzer |
| Device: | Neo-StatCO2 |
| Predicate Devices: | Mercury Medical - Mini-StatCO₂ - K031411
Nellcor - Pedi-CAP™ - K944400
Oridion - MicroCan - K024300 |

Device Description:

Mercury Medical, Inc.

Neo-StatCO2 Trade/Device Name: Neo-StatCO2