(200 days)
Not Found
No
The document describes a standard oxygen mask with a port for CO2 sampling and does not mention any AI/ML components or functionalities.
No
The device is intended to deliver supplemental oxygen and monitor breathing by sampling carbon dioxide, which are supportive functions, but it does not directly treat a disease or condition. Its primary function is monitoring and oxygen delivery, not therapeutic intervention.
Yes
The device monitors breathing by sampling exhaled carbon dioxide, and the performance studies evaluate its CO2-sampling and waveform performance, which are diagnostic functions.
No
The device description clearly outlines a physical mask with ports, connectors, and air entrainment holes, indicating it is a hardware device.
Based on the provided information, the Capnomask is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "deliver supplemental oxygen to patients and monitor breathing by sampling exhaled carbon dioxide." This describes a device used in vivo (on a living patient) to support respiration and monitor a physiological process (breathing).
- Device Description: The description details a mask worn by the patient, connected to oxygen and a gas sampling line. This is a physical interface with the patient's respiratory system.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) outside the body to diagnose diseases or conditions. The Capnomask does not involve the analysis of such specimens.
The device is a respiratory support and monitoring device used directly on the patient, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Capnomask is intended to deliver supplemental oxygen to patients and monitor breathing by sampling exhaled carbon dioxide.
Environment of use - hospital and sub-acute settings.
Patient population - Non-intubated patients who are breathing spontaneously.
Product codes (comma separated list FDA assigned to the subject device)
CCK
Device Description
The proposed Capnomask design is like a standard oxygen mask with a port for connecting a gas sampling line which is then to be connected to a gas monitor to measure exhaled carbon dioxide.
The mask has a connector which incorporates ports for connecting standard oxygen tubing and a luer fitting to connect a standard gas sampling line.
In addition, it has air entrainment holes to supply room air if needed.
It is available in sizes ranging from large to small, similar to the predicate device.
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 and sub-acute settings.
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)
We have performed a number of performance tests which include:
- Comparative CO-sampling and waveform performance at various breathing rates, tidal volumes and oxygen flow rates. The testing was performed at oxygen flow rates of 1 lpm, 5 lpm, and 10 lpm and CO2% of 1% and 5%.
- Real-time aging was performed and the device evaluated for performance to specifications which included pressure drop and resistance.
- Environmental and mechanical testing
- Total VOC
All testing demonstrated that the proposed device is substantially equivalent to the predicate device. It was noted that with higher oxygen flow rates and breath rates that the measured EtCO2 would be diluted which is as expected. As the proposed devices are a tool to detect the qualitative presence of breathing and delivery supplemental oxygen.
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.
K971229 - Capnoxygen LLC, Capnoxygen mask
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
NOV 2 5 2013
510(k) Summary Page 1 of 4 20-Nov-2013
Date Prepared:
Mediplus Ltd. Unit 7. The Gateway Centre Coronation Road, Cressex Business Park High Wycombe, Bucks, HP12 3SU UK
Tel - +44 (0) 1494 551299 Fax - +44 (0) 1494 536333
| Official Contact: | Tim Ward |
|---|---|
| Operations Manager | |
| Proprietary or Trade Name: | Capnomask |
| Common/Usual Name: | Oxygen mask with gas sampling |
| Classification Name: | analyzer, gas, carbon-dioxide, gaseous phase (accessories) |
| CCK - CFR 868.1400 | |
| Class II | |
| Predicate Devices: | K971229 - Capnoxygen LLC, Capnoxygen mask |
Device Description:
The proposed Capnomask design is like a standard oxygeu mask with a port for connecting a gas sampling line which is then to be comected to a gas monitor to measure exhaled carbon dioxide.
The mask has a connector which incorporates ports for connecting standard oxygen tubing and a luer fitting to counect a standard gas sampling line.
In addition, it has air entrainment holes to supply room air if needed.
It is available in sizes ranging from large to snuall, similar to the predicate device.
Indications for Use:
The Capnomask is intended to deliver supplemental oxygen to patients and monitor breathing by sampling exhaled carbon dioxide.
Environment of use - hospital and sub-acute settings.
Patient population - Non-intubated patients who are breathing spontaneously.
1
510(k) Summary
510(k) Summary
20-Nov-2013
| 20-Nov-2013 | ||
|---|---|---|
| Attribute | Predicate | |
| Capnoxygen LLC | ||
| Capnoxygen Mask K971229 | Proposed | |
| Capnomask | ||
| Indications for Use | The Capnoxygen mask is a medium | |
| concentration single -use mask intended to | ||
| be used for the delivery of supplemental | ||
| oxygen and monitoring breathing by | ||
| sampling exhaled carbon dioxide. Standard | ||
| connectors for the oxygen tubing and a | ||
| standard female luer connector for the gas | ||
| sample line are provided. | The Capnomask is intended to deliver | |
| supplemental oxygen to patients and monitor | ||
| breathing by sampling exhaled carbon | ||
| dioxide. | ||
| Environments of use | Hospitals and sub-acute setting | Hospitals and sub-acute setting |
| Prescriptive | Yes | Yes |
| Patient population | Non-intubated patients who are breathing | |
| spontaneously | Non-intubated patients who are breathing | |
| spontaneously | ||
| Single patient use, | ||
| disposable | Yes | Yes |
| Basic components | Face mask | |
| Elastic head strap | ||
| Connector for oxygen tubing and gas | ||
| sampling line | ||
| Entrainment ports | Face mask | |
| Elastic head strap | ||
| Connector for oxygen tubing and gas | ||
| sampling line | ||
| Entrainment ports | ||
| Sizes | Large and Small | Large and Small |
| Overall dimensions | Large - | |
| Length - 140 mm | ||
| Width - 89 mm (at widest point) | ||
| Height - 67 mm | ||
| Small - | ||
| Length - 95 mm | ||
| Width - 76 mm (at widest point) | ||
| Height - 59 mm | Large - | |
| Length - 121 mm | ||
| Width - 85 mm (at widest point) | ||
| Height - 72 mm | ||
| Small - | ||
| Length - 94 mm | ||
| Width - 74 mm (at widest point) | ||
| Height - 59 mm | ||
| Internal Volume | Large - 155 cc | |
| Small - 65 cc | Large - 160 cc | |
| Small - 72 cc | ||
| Entrainment holes | Yes | Yes |
| Typical Flow Rate | ||
| Range |