(63 days)
Not Found
No
The description focuses on colorimetric detection and pressure measurement, with no mention of AI/ML terms or functionalities.
No
The device is described as an "adjunct in patient assessment" used for visualization and measurement of CO2 and pressure, not for treating a condition.
Yes
The device provides "semi-quantitative visualization of the CO2 in the patient airway" and measures "Airway and PEEP pressure," which are used "in patient assessment" to "determine clinical signs and symptoms." This indicates its use in aiding the identification or monitoring of a medical condition.
No
The device description clearly indicates it is a physical device that connects between an endotracheal tube and a breathing device, and it uses a colorimetric breath indicator and measures pressure. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as providing a "semi-quantitative visualization of the CO2 in the patient airway" and measuring "Airway and PEEP pressure." This is a direct measurement of a physiological parameter (CO2 in exhaled breath) and physical parameters (pressure) within the patient's body.
- Device Description: The description reinforces this by stating it's a "colorimetric breath indicator for visualization of exhaled CO2" and "measures Airway and PEEP pressure." It connects between an endotracheal tube and a breathing device, directly interacting with the patient's respiratory system.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not analyze samples taken from the body; it analyzes gas exhaled by the body in real-time within the airway.
Therefore, the Mercury Medical StatCO2meter™ End Tidal CO2 Detector with Integrated Airway Pressure Manometer is a medical device used for monitoring physiological and physical parameters within the patient's airway, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mercury Medical StatCO2meter™ 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.
Product codes (comma separated list FDA assigned to the subject device)
CCK, CAP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment of Use: 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)
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,
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AUG 1 4 2003
ENCLOSURE L
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:
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.
1
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring a caduceus-like design with three horizontal bars above a wavy line, representing health and well-being.
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.
3
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
4
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)
or
Over-the-counter use