(174 days)
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.
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.
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.
§ 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).