(174 days)
No
The device description and performance studies indicate a chemical indicator technology, not AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is used for "semi-quantitative visualization of the CO2 in the patient airway" and "assists in verification of tube placement," serving as an adjunct in patient assessment rather than directly treating a condition.
Yes
The device provides "semi-quantitative visualization of the CO2 in the patient airway" and "assists in verification of tube placement" and "detect approximate ranges of end-tidal CO2," which are all diagnostic functions.
No
The device description explicitly states it consists of a housing unit, filter media, and an indicator mounted to the housing, indicating it is a physical hardware device.
Based on the provided information, the Mercury Medical STATCO2TM End Tidal CO2 Detector is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide a semi-quantitative visualization of CO2 in the patient airway. This is a measurement taken directly from the patient's respiratory system, not from a sample of bodily fluid or tissue that is analyzed in vitro (outside the body).
- Device Description: The device connects to the patient's airway and uses a chemical indicator to visualize CO2 levels. This is a direct measurement of a physiological parameter in the airway.
- Lack of IVD Characteristics: IVD devices typically involve the analysis of samples like blood, urine, tissue, etc., to diagnose, monitor, or screen for diseases or conditions. This device does not perform such analysis on a sample.
Therefore, the Mercury Medical STATCO2TM End Tidal CO2 Detector is a medical device used for monitoring a physiological parameter in the patient's airway, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
CCK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician; Hospital/Transport
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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:
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.
1
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.
2
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.
3
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
4
ENCLOSURE B
Indications for Use
510(k) Number:
Device Name:
Intended Use:
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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per CFR 801.109)
or
Over-the-counter use _________________________________________________________________________________________________________________________________________________________
follwhas
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
(021576 510(k) Number .
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