The Mercury Medical STATCO2TM End Tidal CO2 Detector is 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.

Device Description

The Mercury Medical STATCO2™ uses the same technology as the Nellcor Easy Cap II, (K894053, FENEM submitter). The STATCO2™ End Tidal CO2 Detector is a "Single Patient Use" only device. The device assists in verification of tube placement during endotracheal or nasotracheal intubation. It may be used on intubated patients to detect approximate ranges of end tidal CO2 when clinically significant. The device consists of a housing unit made with material of polycarbonate, filter media consisting of 3M Filtrete GSB30 and Bregas C-it Indicator, 510(k) K000520 mounted to the housing.

AI/ML Overview

The Mercury Medical STATCO2™ End Tidal CO2 Detector is a device designed to assist in verifying tube placement during endotracheal or nasotracheal intubation and to detect approximate ranges of end-tidal CO2. The device's acceptance criteria and the study proving its performance are primarily based on demonstrating substantial equivalence to a predicate device and adherence to relevant technical standards, rather than a traditional clinical study with detailed performance metrics and expert-established ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Equivalence to Predicate Device: The device should have the same technology and technical characteristics as the cleared predicate device.	The Mercury Medical STATCO2™ uses the "same technology as the Nellcor Easy Cap II, (K894053, FENEM submitter)." It "has the same technical characteristics as the predicate device marketed by Nellcor, Easy Cap II." The conclusion states it "is substantially equivalent to the predicate devices."
Compliance with ISO 5356-1: 1987 - Anesthetic and Respiratory Equipment - Conical connectors - Part 1: Cones and Sockets. This standard relates to the physical connectors of the device.	"Performance and specifications of the modified device are consistent with all requirements for this device type specified by ISO 5356-1: 1987."
Compliance with ASTM F1054 - Standard Specification for Conical Fittings of 15mm and 22mm sizes. This standard also relates to the physical fittings.	"Performance and specifications of the modified device are consistent with all requirements for this device type specified by... ASTM F1054 - Standard Specification for Conical Fittings of 15mm and 22mm sizes."
Safety and Effectiveness: The device must be demonstrated to be safe and effective for its intended use.	The comparison to predicate devices, along with compliance to standards, led to the conclusion that the device "is safe and effective."
Semi-quantitative visualization of CO2 in patient airway: The device should provide this functionality.	The "Indicated Use" states the device "is to provide a semi-quantitative visualization of the CO2 in the patient airway." As it's substantially equivalent to the predicate, it is implied to meet this.
Adjunct in patient assessment: The device should function as an aid, to be used with other methods.	The "Indicated Use" states it "is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms." This is part of the intended use, and its equivalence to the predicate implies it fulfills this role.

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

The provided documentation does not detail a specific "test set" in the context of a clinical performance study with a defined sample size. The device's performance is established through a demonstration of substantial equivalence to an existing predicate device (Nellcor Easy Cap II, K894053) and adherence to international and industry standards (ISO 5356-1:1987 and ASTM F1054). This approach is typical for 510(k) submissions where a new device is shown to be as safe and effective as a legally marketed predicate device.

Therefore, there is no explicit sample size reported for a clinical test set to assess device performance in this submission. The data provenance is based on the technical specifications and performance of the predicate device and the adherence of the new device to established engineering standards. The submission itself is a premarket notification (510(k)) from the United States.

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

No explicit "ground truth" establishment by experts for a specific test set is described in the provided documents. The basis for safety and effectiveness relies on:

The established performance and safety record of the predicate device.
Compliance with technical standards.
The regulatory body (FDA)'s review of the submission, where their experts (e.g., in the Division of Anesthesiology, General Hospital, Infection Control and Dental Devices) assessed the data provided by the manufacturer.

4. Adjudication Method for the Test Set

Not applicable. There was no specific clinical "test set" requiring an adjudication method by external experts in the context of this 510(k) summary. The FDA's review process serves as the primary "adjudication" of the submitted information.

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

No. The provided documentation does not mention an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a semi-quantitative detector, not an AI-powered diagnostic tool.

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

Not applicable. This device is a physical, semi-quantitative CO2 detector, not an algorithm, and its use inherently involves a human (physician or medical professional) interpreting its visual output.

7. Type of Ground Truth Used

The "ground truth" in this submission is implicitly established by:

The performance of the predicate device, which was previously cleared by the FDA and serves as the benchmark for substantial equivalence.
The requirements set forth by international and industry standards (ISO 5356-1:1987 and ASTM F1054) for physical and functional characteristics.

There is no mention of "expert consensus, pathology, or outcomes data" being specifically used to establish ground truth for this device's performance in a de novo study.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device's design and manufacturing are based on established engineering principles and the specifications of the predicate device.

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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4 2002

NOV

Premarket Notification (510(k) - Mercury Medical STATCO2™ End Tidal CO2 Detector

Summary of Safety and Effectiveness

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 May 10, 2002

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

Official Contact: Ron Rupenski Director, QA/RA

Proprietary or Trade Name: Mercury Medical STATCO2 114 End Tidal CO2 Detector

Common/Usual Name: Mercury Medical CO2 Detector

Classification: Class II, 73CCK, 21 CFR 868.1400

Classification Name: ET Tube Placement Detector

Device: STATCO2™ End Tidal CO2 Detector

Predicate Devices: Nellcor, Easy Cap II, K894053 (FENEM submitter)

Device Description:

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Premarket Notification (510(k) - Mercury Medical STATCO2™ End Tidal CO2 Detector

Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2 May 10, 2002

The device consists of a housing unit made with material of polycarbonate, filter media consisting of 3M Filtrete GSB30 and Bregas C-it Indicator, 510(k) K000520 mounted to the housing.

Intended Use:

Indicated Use: The Mercury Medical STATCO2™ End Tidal CO2 Detector is 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.

Technical Characteristics: The device has the same technical characteristics as the predicate device marketed by Nellcor, Easy Cap II.

Non-Clinical Data: Performance and specifications of the modified 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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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three human profiles facing right, arranged in a stacked formation. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the central design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV . 4 2002

Mr. Ron Rupenski Director, QA/RA Mercury Medical 11300 49th Street North Clearwater, Florida 33762-4800

Re: K021576

Trade/Device Name: Mercury Medical STATCO,TM End Tidal CO2 Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: September 3, 2002 Received: September 5, 2002

Dear Mr. Rupenski:

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.

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.

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Page 2 - Mr. Rupenski

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours

Tim Ulatowski

Timothy A. Ulatowski 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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ENCLOSURE B

Indications for Use

510(k) Number:

K021576

Device Name:

Intended Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per CFR 801.109)

Over-the-counter use _________________________________________________________________________________________________________________________________________________________

follwhas

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

(021576 510(k) Number .

Page 2-1

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).