(15 days)
No
The summary describes a physical medical device (a mask) for delivering oxygen and monitoring CO2. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies focus on physical and functional characteristics of the mask itself.
Yes
The device is described as "delivering supplemental oxygen," which is a therapeutic intervention.
No
The device is a mask for delivering oxygen and enabling the monitoring of exhaled carbon dioxide by connecting to a capnograph, which is the diagnostic device. The mask itself is not performing a diagnostic function; it is an accessory for diagnostic monitoring.
No
The device description clearly indicates it is a physical mask with tubing and luer ports, and the performance studies focus on physical and functional testing of the hardware components.
Based on the provided information, the M1 Capnography Mask is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "delivering supplemental oxygen and monitoring exhaled carbon dioxide in non-intubated spontaneously breathing patients." This involves direct interaction with the patient's respiratory system and the collection of a gas sample (exhaled CO2) from the patient's breath.
- Device Description: The device is a mask that connects to a gas source and a capnograph. It facilitates the delivery of oxygen and the collection of a gas sample from the patient's breath.
- Lack of In Vitro Testing: The description of performance studies focuses on biocompatibility, functional performance, simulated use, and mechanical strength. There is no mention of testing involving biological samples or reagents outside of the body, which is characteristic of IVD devices.
- Nature of the Measurement: The device is used to monitor exhaled carbon dioxide, which is a physiological parameter measured directly from the patient's breath. IVD devices typically analyze samples like blood, urine, or tissue to diagnose or monitor conditions.
In summary, the M1 Capnography Mask is a medical device used for patient monitoring and oxygen delivery, not for performing tests on biological samples in vitro.
N/A
Intended Use / Indications for Use
The M1 Capnography Mask is a single-use device intended for delivering supplemental oxygen and monitoring exhaled carbon dioxide in non-intubated spontaneously breathing patients. Standard oxygen tubing and two female Luer ports for gas sample line attachment are included.
Product codes
CCK, BYG
Device Description
The M1 Capnography Mask is connected to a gas source for delivering low flow oxygen through flexible tubing to the patient, and at the same time provides a means to attach a capnograph for monitoring exhaled carbon dioxide during nose and mouth breathing. The capnograph gas sample tube attaches to a standard female Luer connector on either the left or right side of the M1 Capnography Mask. The M1 Capnography Mask will initially be made available in only one size, adult large (Model #001).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose, mouth
Indicated Patient Age Range
Adult
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)
Non-Clinical Performance Data:
The M1 Capnography Mask was subjected to a wide range of testing applicable to oxygen/Capnography masks. Testing included: Device Shelf Life per ASTM F 1980-07, Device Packaging and Distribution per ASTM D 4169-09, Device Functional Performance per ISO 594-2, Device Biocompatibility per ISO 10993-1, Simulated Use Testing per Monitor Mask Internal Company Protocol, and Mechanical Strength Testing of Bonded Luer to Device. The M1 Capnography Mask meets all the requirements for biocompatibility, functional performance, and simulated use, with testing results confirming that the design outputs meet the design inputs and user specification requirements.
Clinical Performance Data:
No clinical testing was required to support the M1 Capnography Mask as its indications for use are equivalent to the predicate device. These types of devices have been on the market for many years with a proven safety and efficacy record. Non-clinical testing detailed in the submission supports the substantial equivalence of the M1 Capnography Mask, and its safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Capnoxygen® Mask (K971229)
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
K133806
DEC 3 1 2013
510(K) Summary for M1 Capnography Mask
1. Submission Sponsor
Monitor Mask, Inc. 5515 43'd Avenue NE Seattle WA, 98105 USA Phone: 877.226.1776 Contact: JW Beard MD, MBA, Founder and CEO
2. Submission Correspondent
Emergo Group, Inc. 816 Congress Avenue, Suite 1400 Austin, TX 78701 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Stuart R Goldman, Senior Consultant, RA/QA Email: project.management@emergogroup.com
3. Date Prepared
September 20, 2013
4. Device Identification
| Trade/Proprietary Name: | M1 Capnography Mask |
|---|---|
| Common/Usual Name: | oxygen/capnography mask |
| Classification Name: | analyzer, gas, carbon-dioxide, gaseous-phase |
| Classification Regulation: | §868.1400 |
| Product Code: | CCK (primary); BYG (secondary) |
| Device Class: | Class II |
| Classification Panel: | Anesthesiology |
5. Legally Marketed Predicate Device
Capnoxygen® Mask (K971229) manufactured by Medsys (Southmedic)
6. Device Description
The M1 Capnography Mask is connected to a gas source for delivering low flow oxygen through flexible tubing to the patient, and at the same time provides a means to attach a capnograph for monitoring exhaled carbon dioxide during nose and mouth breathing. The capnograph gas sample tube attaches to a standard female Luer connector on either the left or right side of the M1 Capnography Mask. The M1 Capnography Mask will initially be made available in only one size, adult large (Model #001).
1
7. Indication for Use Statement
The M1 Capnography Mask is a single-use device intended for delivering supplemental oxygen and monitoring exhaled carbon dioxide in non-intubated spontaneously breathing patients. Standard oxygen tubing and two female Luer ports for gas sample line attachment are included.
8. Substantial Equivalence Discussion
The following table compares the M1 Capnography Mask to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| | Medsys
(Southmedic) | Monitor Mask | Substantial Equivalence
Comparison |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Capnoxygen® Mask | M1 Capnography
Mask | - |
| 510(k) | K971229 | Pending | - |
| | Regulatory Classification | | |
| Product Code | CCK | CCK | Same |
| Device Name | analyzer, gas,
carbon-dioxide,
gaseous-phase | analyzer, gas,
carbon-dioxide,
gaseous-phase | Same |
| Regulation
Number | §868.1400 | §868.1400 | Same |
| Device Class | II | II | Same |
| | Device Description | | |
| Device Image | Image: Capnoxygen Mask | Image: M1 Capnography Mask | - |
| Device
Description | The Capnoxygen®
Mask provides a
means to sample
exhaled carbon
dioxide via a
sample tube inside
the oxygen mask,
during mouth
and/or nose
breathing. The gas | The M1
Capnography Mask
is connected to a
gas source for
delivering low flow
oxygen through
flexible tubing to
the patient, and at
the same time
provides a means | The primary difference
in design between the
subject and predicate
device is that the M1
Capnography Mask is
designed to attach more
easily to a capnograph
sample line thus
facilitating the use of
CO2 monitoring. The |
| | | | |
| | connected to the
Capnography
monitor by a
standard female
Luer connector. | capnograph for
monitoring exhaled
carbon dioxide
during nose and
mouth breathing.
The capnograph
gas sample tube
attaches to a
standard female
luer connector on
either the left or
right side of the M1
Capnography Mask. | device are essentially
the same with respect
to all other functional
features. |
| 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
mask is intended to
be used for
monitoring non-
intubated patients
who are breathing
spontaneously. | The M1
Capnography Mask
is a single-use
device intended for
delivering
supplemental
oxygen and
monitoring exhaled
carbon dioxide in
non-intubated
spontaneously
breathing patients.
Standard oxygen
tubing and two
female Luer ports
for gas sample line
attachment are
included. | Similar. Both the subject
and predicate device are
intended to supply O₂
while at the same time
monitoring exhaled CO₂
in non-intubated
spontaneously
breathing patients. The
main difference being
the location of the CO₂
monitor attachment
point. |
| Intended Use | The Capnoxygen®
Mask is a single-
use device
intended for
delivering
supplemental
oxygen and
monitoring exhaled
carbon dioxide in
non intubated | The M1
Capnography Mask
is a single-use
device intended for
delivering
supplemental
oxygen and
monitoring exhaled
carbon dioxide in
non-intubated | Similar. Both the subject
and predicate device are
intended to supply O2
while at the same time
monitoring exhaled CO2
in non-intubated
spontaneously
breathing patients. The
main difference being
the location of the CO |
| | | | |
| | spontaneously
breathing patients.
Standard oxygen
tubing are
included. | spontaneously
breathing patients.
Standard oxygen
tubing and two
female Luer ports
for gas sample line
attachment are
included. | monitor attachment
point. |
| Mode of
Operation | O₂ delivery to a
patient through a
standard O₂ supply
line and
simultaneous CO₂
monitoring
through a gas
sample line
connecting the
mask to a
capnograph; or O₂
only delivery. | O₂ delivery to a
patient through a
standard O₂ supply
line and
simultaneous CO₂
monitoring through
a gas sample line
connecting the
mask to a
capnograph; or O₂
only delivery. | Similar. Both the subject
and predicate device are
intended to supply O₂
while at the same time
monitoring exhaled CO₂
in non-intubated
spontaneously
breathing patients. The
main difference being
the location of the CO₂
monitor attachment
point. |
| Body Contact | Yes, limited
exposure