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.

AI/ML Overview

This document describes the Neo-StatCO2 device, a colorimetric breath indicator for CO2 that helps verify proper intubation. The submission aims to demonstrate substantial equivalence to predicate devices, particularly the Mercury Medical Mini-StatCO2 (K031411).

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria by comparing the new device (Neo-StatCO2) to predicate devices in terms of its physical, performance, and operating characteristics. The primary new "performance" aspect is the expanded patient population, which required specific testing.

Feature / Criteria (Derived from Predicate Comparison)	Acceptance Criteria (Predicate)	Reported Device Performance (Neo-StatCO2)
Indications for Use	"semi-quantitative visualization of the CO2 in the patient airway. Adjunct in patient assessment... in conjunction with other methods... by or on the order of a physician."	Identical to predicate (Mercury Mini-StatCO2 K031411)
Environment of Use	Hospital, sub-acute, pre-hospital & transport	Identical to predicate (Mercury Mini-StatCO2 K031411)
Patient Population	Neonate and Pediatric (Mini-StatCO2), Adult, Pediatric, Infant/Neonatal (Oridion MicroCap)	Neonate and infant (250g to 6 kg) Expanded from predicate, similar to Oridion MicroCap.
Weight	5 g	3 g
Internal Volume	3 cc	1 cc
Resistance to Flow	1.23 cm H2O @ 10 Lpm; 8.8 cm H2O @ 30 Lpm	1.86 cm H2O @ 10 Lpm; 15.6 cm H2O @ 30 Lpm
Duration of CO2 Detection	Up to 24 hours	Up to 24 hours
Operating Conditions	-10°C to +50°C	-10°C to +50°C
Storage Conditions	Color change function after storage at 0°C and 60°C	Color change function after storage at 0°C and 60°C
Contraindications & Warnings	Do not use for detection of hypercapnia, main-stem bronchial intubation, mouth-to-tube ventilation, oropharyngeal tube placement. Standard clinical assessment must be used.	Same as predicate
Effectiveness of color change for intended population	Demonstrated ability of color change for predicate's population.	Performance testing to demonstrate ability of indicator to change color for the intended body weight, tidal volume and breath rate under conditions of use. (This is the specific study mentioned).

Study Proving Device Meets Acceptance Criteria:

The document explicitly states: "The only difference between the Mercury Mini-Stat CO2 is the expansion of the patient population to include patients with a body weight of 250 g to 6 Kg which we have demonstrated as being effective via comparative bench testing."

This implies that the "comparative bench testing" was the study conducted to ensure the device's effectiveness for the expanded patient population (neonate and infant - 250g to 6 kg) under the specified tidal volumes and breath rates.

Additional Information (Based on the Provided Text):

2. Sample size used for the test set and the data provenance:

Sample size: Not specified. The document mentions "comparative bench testing" but does not give specific numbers for the test set used in this bench testing.
Data provenance: The testing was described as "bench testing," suggesting a laboratory environment. There is no information about the country of origin or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as the testing was "bench testing." Ground truth would likely be established by objective measurements of CO2, tidal volume, and breath rate, rather than expert interpretation of the device's color change.

4. Adjudication method for the test set:

Not applicable for bench testing. The evaluation would be based on direct measurement outcomes rather than human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This device is a colorimetric indicator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, implicitly. The "comparative bench testing" would be a standalone performance evaluation of the device's ability to change color under specific simulated conditions, independent of human interpretation for the physical manifestation of the color change itself. The human-in-the-loop aspect refers to a clinician interpreting the color output. The bench testing would confirm the device produces the correct color change.

7. The type of ground truth used:

For the "comparative bench testing," the ground truth would be precise, known values of CO2 concentration, tidal volume, and respiratory rate, simulated in a controlled environment. The device's color change would then be observed and compared against these known conditions to verify its accuracy.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/machine learning algorithm that requires a training set in the conventional sense.

9. How the ground truth for the training set was established:

Not applicable as there is no training set for this type of device.

Summary

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L083056
P. 1 of 3

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

FEB 2 3 2009

11300 - 49th St. NorthClearwater, FL 33762-4800	Tel - (727) 573-0088Fax - (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 - K031411Nellcor - Pedi-CAP™ - K944400Oridion - MicroCan - K024300

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.

Use only ET tubes and connectors and gas source devices, i.e. manual resuscitators and ventilators, which are intended for use with neonates and infants.

Indications for Use:

Patient Population:	Neonate and infant - 250 g to 6 Kg
Environment of Use:	Hospital, sub-acute facilities, pre-hospital and transport

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! 510(k) Summary Page 2 of 3 11-Feb-09

Summary of substantial equivalence

	PredicateMini-StatCO2TMK031411Or other predicates as indicated	New ModelNeo-StatCO2<KgTM
Indications for Use	The Mini-StaCO2 is indicated toprovide a semi-quantitativevisualization of the CO2 in the patientairway. It is an adjunct in patientassessment to be used in conjunctionwith other methods to determine clinicalsigns and symptoms by or on the orderof a physician.	Same as predicate device
Environment of use	Hospital, sub-acute facilities, pre-hospital and transport	Same as predicate
Patient Population	Neonate and pediatricOridion MicroCap - K024300	Neonate and infant (250g to 6 kg)
	Indications as listed in 510(k) Summaryand Instructions for Use:
	Include “The monitor is intended for useon adult, pediatric, and infant/neonatalpatients.”
Physical and Performance Characteristics
Weight	5 g	3 g
Internal volume	3 cc	1 cc
Resistance to flow	1.23 cm H2O @ 10 Lpm8.8 cm H2O @ 30 Lpm	1.86 cm H2O @ 10 Lpm15.6 cm H2O @ 30 Lpm
Duration of CO2 detection	Up to 24 hours	Up to 24 hours

Effectiveness of color change for the intended population

Performance testing to demonstrate ability of indicator to change color for the intended body weight, tidal volume and breath rate under conditions of use

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510(k) Summary Page 3 of 3

	11-Feb-09
	PredicateMini-StatCO₂ TMK031411Or other predicates as indicated	New ModelNeo-StatCO₂ <KgTM
Operating Conditions	Operating range --10°C to +50°C	Operating range --10°C to +50°C
Storage Conditions	Color change function after storage at0°C and 60°C	Color change function after storage at0°C and 60°C
Contraindications and Warnings
Contraindications andWarnings	Do not use for detection of hypercapniaDo not use for the detection of main-stem bronchial intubationDo not use during mouth to tubeventilationDo not use the CO₂ detector to detectoropharyngeal tube placementStandard clinical assessment must beused	Same

The Neo-StatCO2 <Kg™ is viewed as substantially equivalent to the predicate device because:

Indications -

Identical to predicate Mercury Mini-StatCO2™ K031411 .

Patient Population -

Expanded from predicate Mercury Mini-StatCO2TM K031411 .
. Similar to - Oridion MicroCap - K024300

Technology -

Chemical indicator technology for detection of the presence of CO2 Mercury Mini-StatCO2™ -. K031411

Materials -

The materials in patient contact are identical to predicate devices ●

Environment of Use -

Identical to predicate Mercury Mini-StatCO2IM K031411 .

Differences -

The only difference between the Mercury Mini-Stat CO2 is the expansion of the patient population to include patients with a body weight of 250 g to 6 Kg which we have demonstrated as being effective via comparative bench testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mercury Medical C/o Mr. Paul Dryden Promedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

FEB 2 3 2009

K083056 Re:

Trade/Device Name: Neo-StatCO2<Kg Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: February 11, 2009 Received: February 12, 2009

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Dryden

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Snette y. Michie Dmd.

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number: K083056

Device Name: Neo-StatCO2 <Kg

Indications for Use:

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Zuz M. Z.

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083056

Page S1.7

Regulation Number and Section

§ 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).