The Mercury Medical StatCO2meter™ End Tidal CO2 Detector with Integrated Airway Pressure Manometer is intended to provide a semi-quantitative visualization of the CO2 in the patient airway while measuring Airway and PEEP pressure. 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.

Device Description

The Mercury Medical StatCO2meter™ is a fast, durable colorimetric breath indicator for visualization of exhaled CO2 and also measures Airway and PEEP pressure. The StatCO2meter™ 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. The detector may be used during patient transport or in locations where intubations are performed.

AI/ML Overview

Here's an analysis of the provided text regarding the Mercury Medical StatCO2meter™:

Important Note: The provided text is a summary of safety and effectiveness for a 510(k) premarket notification and the FDA's clearance letter. It focuses on demonstrating substantial equivalence to predicate devices rather than a detailed clinical study demonstrating new performance criteria against defined metrics. As such, information typically found in detailed study reports (like precise sample sizes for test sets, expert qualifications for ground truth, specific statistical methods, standalone performance studies, training set details for AI, etc.) is largely not present in this type of document. The device is a physical, colorimetric and manometer device, not an AI/algorithm-driven device, so many of the requested AI-specific points are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the way an AI algorithm might define sensitivity, specificity, etc. Instead, it refers to consistency with established standards for physical devices and substantial equivalence to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
CO2 Detection: Semi-quantitative visualization of CO2 in patient airway.	The device is a fast, durable colorimetric breath indicator for visualization of exhaled CO2, detecting approximate ranges of end-tidal CO2 by color comparison.
Airway and PEEP Pressure Measurement: Ability to measure Airway and PEEP pressure.	The device measures Airway and PEEP pressure.
Connectors: Conforms to ISO 5356-1:1987 for conical connectors.	Performance and specifications are consistent with ISO 5356-1:1987.
Fittings: Conforms to ASTM F1054 for conical fittings (15mm and 22mm).	Performance and specifications are consistent with ASTM F1054.
Safety and Effectiveness: Demonstrated to be safe and effective.	Conclusion reached based on comparison to predicate devices.
Substantial Equivalence: Equivalent to predicate devices (StatCO2™ and Airway Pressure Manometer).	Comparison to predicate devices demonstrates substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. This document relies on the technical characteristics and consistency with standards for its validation, not a patient-based test set with a specific sample size.
Data Provenance: Not applicable in the context of a "test set" for this type of device. The evaluation is against engineering standards and comparison to existing, cleared devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. The "ground truth" for this device's performance is adherence to industry standards (ISO, ASTM) for its physical design and functional principles, and a comparison of its technical specifications to those of its predicate devices. It's not an AI system requiring expert-labeled data.
Qualifications of Experts: Not applicable for establishing ground truth in this context. Regulatory bodies (like the FDA) and standards organizations set the requirements.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This device is a physical medical instrument, not a diagnostic AI algorithm that requires adjudicating expert disagreements on ground truth labels. Its performance is evaluated through engineering testing and comparison of technical specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done, and it's not applicable for this type of device. This isn't an AI-assisted diagnostic tool for human readers; it's a direct-reading physical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Not applicable. This device does not contain an AI algorithm. It's a physical detector and manometer. Its "standalone" performance would be its ability to display color changes and pressure readings consistently, which is covered by adherence to the cited ISO and ASTM standards.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" implicitly used for this device is compliance with established engineering and performance standards (ISO 5356-1:1987, ASTM F1054) and the established safety and effectiveness of its predicate devices. For a physical device, this typically involves manufacturing specifications, design verification, and bench testing against known reference values, not expert consensus on clinical cases or pathology.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not utilize an AI algorithm, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm.

Summary

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AUG 1 4 2003

ENCLOSURE L

K031814

Premarket Notification (510(k) - Mercury Medical StatCO2meter™ End Tidal CO2 Detector with Integrated Airway Pressure Manometer.

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 June 10, 2003

Mercury Enterprises, Inc./Mercury Medical 11300 49th St. N. Clearwater, FL 33762 Tel: (800) 237-6418 Fax: (727) 572-4501

Official Contact: Wayne Glover QA/RA Engineer

Proprietary or Trade Name: StatCO2meter™

Common/Usual Name: End Tidal CO2 detector with Integrated Airway Pressure Manometer

Classification: Class II, CCK, 21 CFR 868.1400

Classification Name: Analyzer, Gas, Carbon Dioxide, Gaseous Phase

Device: StatCO2meter™

Predicate Devices: StatCO2™ (K021576) and Airway Pressure Manometer (K954486)

Device Description:

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Premarket Notification (510(k) - Mercury Medical StatCO2meter™ End Tidal CO2 Detector with Integrated Airway Pressure Manometer.

Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2 June 10, 2003

Intended Use:

Indicated Use: The Mercury Medical StatCO2™ End Tidal CO2 Detector with Integrated Airway Pressure Manometer provides a semi-quantitative visualization of the CO2 in the patient airway while measuring Airway and PEEP pressure. 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.

Technical Characteristics: The device has the same technical characteristics as the combination of the following Mercury Medical predicate devices:

StatCO2™ End Tidal CO2 Detector Airway Pressure Manometer

Non-Clinical Data: Performance and specifications of the device are consistent with all requirements for this device type specified by ISO 5356-1: 1987 - Anesthetic and Respiratory Equipment-Conical connectors-Part 1: Cones and Sockets. ASTM F1054 - Standard Specification for Conical Fittings of 15mm and 22mm sizes,

Environment of Use: Hospital/Transport

Conclusions: The comparison to the predicate devices demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2003

Mr. Wayne Glover QA/RA Engineer Mercury Medical 11300-49th Street North Clearwater, Florida 33762-4800

Re: K031814

Trade/Device Name: StatCO2meterTM Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK, CAP Dated: June 10, 2003 Received: June 12, 2003

Dear Mr. Glover:

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 brior 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. Glover

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 (OS) 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 Office of Compliance at (301) 594-46. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Suelunse

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. Infector Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ENCLOSURE B

Indications for Use

Page lof l

KO31814 510(k) Number: (To be assigned) StatCO2meter™ Device Name: The Mercury Medical StatCO2meter™ End Tidal CO2 Detector Intended Use: with Integrated Airway Pressure Manometer is intended to provide a semi-quantitative visualization of the CO2 in the patient airway while measuring Airway and PEEP pressure. 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

SAWich

510(k) Number

Prescription Use X (Per CFR 801.109)

Over-the-counter use

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).