(14 days)
Not Found
No
The device description details a purely electrochemical process for oxygen sensing, with no mention of AI/ML algorithms or data processing beyond basic signal monitoring.
No
This device is an oxygen sensor that measures oxygen concentration; it does not directly treat or diagnose a medical condition. It is a component of a larger medical device.
No
The device is an oxygen sensor intended to measure oxygen concentration in breathing gas mixtures within other medical devices like anesthesia machines, intensive care units, and incubators. It provides a measurement, but it doesn't diagnose a patient's condition.
No
The device description clearly outlines physical components (plastic body, electrodes, membrane, electrolyte solution) and a chemical/electrical measurement principle, indicating it 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 is to measure oxygen concentration in breathing gas mixtures. This is a measurement of the gas being delivered to the patient, not a test performed on a biological sample from the patient.
- Device Description: The description details an electrochemical sensor that measures oxygen in a gas. It does not involve the analysis of biological specimens like blood, urine, or tissue.
- Lack of Biological Sample Analysis: The core function is to analyze the composition of a gas mixture, not to diagnose or monitor a condition by testing a sample from the human body.
IVD devices are specifically designed to perform tests on biological samples to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device measures the oxygen content of a gas, which is a crucial parameter for patient care, but it doesn't fit the definition of an IVD.
N/A
Intended Use / Indications for Use
Purpose: The purpose of the City Technology Medical Oxygen sensors is to be the oxygen-sensing component to monitor the concentration of oxygen in breathing gas mixtures in finished medical devices at the point of manufacture. The additional purpose of the City Technology Medical Oxygen sensors is to be a replacement for the oxygen-sensing component after the life of the sensor originally supplied in the device is exhausted, to monitor the concentration of oxygen in breathing gas mixtures in medical devices.
Function: The City Technology Medical Oxygen sensors are used in medical device products such as Anaesthesia, Intensive Care and Incubators.
Target Patient Population: The target patient population consists of those patients who require the oxygen concentration in their breathing environment to be monitored.
Environment of Use: The City Technology Medical Oxygen Sensors are used in medical devices (i.e. Anaesthesia, Intensive Care and Incubators) in patient environments whose temperatures range from -20°C to +50°C and from 0 to 99% humidity (non-condensing).
Device Claims: The City Technology Medical Oxygen Sensors consist of oxygen sensing components in medical devices that monitor the oxygen concentration in the patient's breathing environment.
Indications For Use: The City Technology Medical replacement oxygen sensor is intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.
Product codes (comma separated list FDA assigned to the subject device)
CCL
Device Description
These medical Oxygen sensors are based on the amperometric electrochemical measurement principle. The sensors comprise a plastic body in which are two electrodes, a precious metal cathode and a lead anode immersed in a liquid electrolyte solution, as in the schematic below. Oxygen flows into the sensor through a solid membrane, which limits the flow and controls the output signal. Inside the sensor Oxygen reacts on the cathode to form hydroxyl ions as follows: O2 + 2H2O + 4e- ? 4OH- These hydroxyl ions then oxidise the metal anode: 2Pb + 4OH- ? 2PbO + 2H2O + 4e- Overall the effect is the consumption of the lead anode: 2Pb + O2 ? 2PbO The electrons consumed at the cathode are supplied from the anode via the external circuit where a resistor is placed so that the voltage produced may be monitored. This voltage signal then constitutes a measure of the flux of Oxygen into the sensor and hence the partial pressure of Oxygen in front of the membrane. The life of the sensor is governed by the mass of lead and the rate of consumption i.e. by the oxygen partial pressure; hence lifetimes are quoted as % Oxygen hours. Accuracy is governed largely by the variation in diffusion rate of Oxygen through the solid membrane, which is a function of temperature and the presence of interfering gases that may absorb onto the membrane. The MOX-1, 2, 3, 4, 7, 8 and 10 Sensors differ only in body shape and electrical interface type, but are otherwise identical and can be considered equivalent. The MOX-5, 6 and 9 Sensors differ only in body shape and electrical interface type, but are otherwise identical and can be considered equivalent. The MOX-16 sensor is a dual cathode version of the other Medical Oxygen Sensors. It also has a different body shape and electrical interface, but otherwise it is identical and can therefore be considered equivalent.
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
Not Found
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): 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.
Ceramatec CAG-10 Sensor, K972992
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
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).
0
Section 21
'JUL 1 5 2004
510(k) Summary
- Date: 6th April 2004 1.
-
- Submitter/Manufacturer City Technology Limited City Technology Centre Walton Road Portsmouth Hampshire PO6 1SZ Great Britain
-
- Contact Person Debra Wallace Quality/Environmental Systems Scientist
| 4. Contact | |
|---|---|
| Telephone: | +44 23 9232 5511 |
| Fax: | +44 32 9238 6611 |
| E-mail: | debra.wallace@citytech.co.uk |
| Website: | www.citytech.com |
-
- Proprietary Device Name MOX-1 Medical Oxygen Sensor MOX-2 Medical Oxygen Sensor MOX-3 Medical Oxygen Sensor MOX-4 Medical Oxygen Sensor MOX-5 Medical Oxygen Sensor MOX-6 Medical Oxygen Sensor MOX-7 Medical Oxygen Sensor MOX-8 Medical Oxygen Sensor MOX-9 Medical Oxygen Sensor MOX-10 Medical Oxygen Sensor MOX-16 Medical Oxygen Sensor
- ్. Classification Name Oxyqen Gas Analyzer (868.1720)
-
- Common Name Medical Oxygen Sensor
-
- Predicate Devices Ceramatec CAG-10 Sensor
1
- ഗ Indications for Use
Purpose: The purpose of the City Technology Medical Oxygen sensors is to be the oxygen-sensing component to monitor the concentration of oxygen in breathing gas mixtures in finished medical devices at the point of manufacture. The additional purpose of the City Technology Medical Oxygen sensors is to be a replacement for the oxygen-sensing component after the life of the sensor originally supplied in the device is exhausted, to monitor the concentration of oxygen in breathing gas mixtures in medical devices.
Function: The City Technology Medical Oxygen sensors are used in medical device products such as Anaesthesia, Intensive Care and Incubators.
Target Patient Population: The target patient population consists of those patients who require the oxygen concentration in their breathing environment to be monitored.
Environment of Use: The City Technology Medical Oxygen Sensors are used in medical devices (i.e. Anaesthesia, Intensive Care and Incubators) in patient environments whose temperatures range from -20°C to +50°C and from 0 to 99% humidity (non-condensing).
Device Claims: The City Technology Medical Oxygen Sensors consist of oxygen sensing components in medical devices that monitor the oxygen concentration in the patient's breathing environment.
Legally Marketed Predicate Device: The legally marketed predicate device is Ceramatec CAG-10 Oxygen Sensor. The predicate device was assigned 510(k) number K972992 and was declared substantially equivalent by FDA.
Safety and Effectiveness: No differences in intended use or application of the City Technology Medical Oxygen sensors or the predicate device have been identified that could affect safety or effectiveness.
-
- Method of Operation:
These medical Oxygen sensors are based on the amperometric electrochemical measurement principle. The sensors comprise a plastic body in which are two electrodes, a precious metal cathode and a lead anode immersed in a liquid electrolyte solution, as in the schematic below.
- Method of Operation:
2
Image /page/2/Figure/0 description: This image shows a diagram of a solid membrane diffusion barrier. The diagram includes labels for the different components of the barrier, including the solid membrane diffusion barrier, cathode, electrolyte, and anode. The diagram also shows the direction of air supply and the flow of electrons. A load resistor and voltmeter are connected to the cathode and anode.
Oxygen flows into the sensor through a solid membrane, which limits the flow and controls the output signal. Inside the sensor Oxygen reacts on the cathode to form hydroxyl ions as follows:
$$O_2 + 2H_2O + 4e^- \longrightarrow 4OH^-$$
These hydroxyl ions then oxidise the metal anode:
$2Pb + 4OH^- \longrightarrow 2PbO + 2H_2O + 4e^-$
Overall the effect is the consumption of the lead anode:
$$2Pb + O_2 \longrightarrow 2PbO$$
The electrons consumed at the cathode are supplied from the anode via the external circuit where a resistor is placed so that the voltage produced may be monitored. This voltage signal then constitutes a measure of the flux of Oxygen into the sensor and hence the partial pressure of Oxygen in front of the membrane.
The life of the sensor is governed by the mass of lead and the rate of consumption i.e. by the oxygen partial pressure; hence lifetimes are quoted as % Oxygen hours.
Accuracy is governed largely by the variation in diffusion rate of Oxygen through the solid membrane, which is a function of temperature and the presence of interfering gases that may absorb onto the membrane.
-
- Intended Use
These sensors are designed to be used to monitor the partial pressure of oxygen in anaesthesia, critical care, incubators and general oxygen monitors.
- Intended Use
3
Predicate Device Comparison 12.
| | Predicate
Device
CAG-10 | CTL MOX-1,
2, 3, 4, 7, 8
& 10 | CTL MOX-5,
6 and 9 | CTL
MOX-5 | CTL MOX-
16 |
|------------------------------------------------------------|-------------------------------|-------------------------------------|-----------------------|--------------------------|-----------------------|
| Measurement
Range | 0-100% | 0-1500
mBar | 0-1500
mBar | 0-1500
mBar | 0-1500
mBar |
| T90 | 0.9999 | R2>0.9999 | R2>0.9999 | R2>0.9999 |
| Operating Life | >900,000
%O2 Hours | 1,600,000 %
O2 Hours | >900,000
%O2 Hours | >900,000
%O2
Hours | >650,000
%O2 Hours |
The MOX-1, 2, 3, 4, 7, 8 and 10 Sensors differ only in body shape and electrical interface type, but are otherwise identical and can be considered equivalent.
The MOX-5, 6 and 9 Sensors differ only in body shape and electrical interface type, but are otherwise identical and can be considered equivalent.
The MOX-16 sensor is a dual cathode version of the other Medical Oxygen Sensors. It also has a different body shape and electrical interface, but otherwise it is identical and can therefore be considered equivalent.
-
- Conclusion
City Technology's Medical Oxyqen Sensors are substantially equivalent to the predicate devices listed. Medical Oxygen Sensors are safe and effective for their intended use.
- Conclusion
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2004
City Technology Limited C/O Jeff D. Rongero Underwriters Laboratories, Incorporated 12 Laboratory Drive Research Triangle, NC 27709
Re: K041773
Trade/Device Name: Medical Oxygen Sensors, MOX -1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 16 Regulation Number: 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: II Product Code: CCL Dated: June 25, 2004 Received: July 1, 2004
Dear Mr. Rongero:
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.
5
Page 2 - Mr. Rongero
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 (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), please contact the Office of Compliance at (301) 594-4646. 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 yours,
Kein Muluy
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
K041773 510(k) Number (if known):
Device Name:
MOX-1,2,3,4,5,6,7,8,9,10 and 16 Medical Oxygen Sensors
Indications For Use: The City Technology Medical replacement oxygen sensor is intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.
Prescription Use X (Per 21CFR 801.109) OR
Over-The-Counter Use __ www
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quy Syuun
Page I of 1
(Division Sign-Off) (Division Sign-Oil)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices
FD 1030 Issue 1
510(k) Number
(Posted November 13, 2003)