(15 days)
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.
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).
Here's a summary of the acceptance criteria and study information for the M1 Capnography Mask, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1) | Passed |
| Functional Performance (ISO 594-2) | Passed |
| Simulated Use Testing (Monitor Mask Internal Company Protocol) | Passed |
| Mechanical Strength Testing of Bonded Luer to Device | Passed |
| ETCO₂ Sampling | Functionally equivalent to predicate device |
| Device Shelf Life (ASTM F 1980-07) | Meets all requirements |
| Device Packaging and Distribution (ASTM D 4169-09) | Meets all requirements |
Study Information
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Sample size used for the test set and the data provenance: Not specified for individual tests. The text indicates "a wide range of testing."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies described are non-clinical (bench testing, simulated use, biocompatibility).
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Adjudication method for the test set: Not applicable. The studies described are non-clinical.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (capnography mask), not an AI-powered diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
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The type of ground truth used:
- Biocompatibility: Established by testing against ISO 10993-1 standards.
- Functional Performance: Established by testing against ISO 594-2 standards.
- ETCO₂ Sampling performance: Established by side-by-side bench testing with a legally marketed predicate device (Capnoxygen® Mask K971229) to demonstrate functional equivalence.
- Device Shelf Life and Packaging: Established by testing against ASTM F 1980-07 and ASTM D 4169-09 standards, respectively.
- Simulated Use and Mechanical Strength: Established by internal company protocols.
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The sample size for the training set: Not applicable. This is a medical device, not an AI model requiring a training set.
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How the ground truth for the training set was established: Not applicable. This is a medical device, not an AI model.
Summary of the "Study" (Non-Clinical Performance Data):
The M1 Capnography Mask did not require clinical testing because its indications for use were deemed equivalent to the predicate device, which has a proven safety and efficacy record. The demonstration of safety and effectiveness relied entirely on non-clinical performance data, primarily bench testing and simulated use testing.
The key study for comparison was a side-by-side bench test comparing the M1 Capnography Mask with the predicate Capnoxygen® Mask for CO₂ measurement performance. This testing found the two devices to be functionally equivalent in the detection of CO₂.
Other non-clinical tests included:
- Biocompatibility testing per ISO 10993-1.
- Functional performance testing per ISO 594-2.
- Simulated Use Testing per Monitor Mask Internal Company Protocol.
- Mechanical Strength Testing of Bonded Luer to Device.
- Device Shelf Life per ASTM F 1980-07.
- Device Packaging and Distribution per ASTM D 4169-09.
All these tests were successfully passed, indicating that the device design outputs meet the design inputs and user specification requirements for the M1 Capnography Mask.
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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).
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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 EquivalenceComparison | |
|---|---|---|---|
| Trade Name | Capnoxygen® Mask | M1 CapnographyMask | - |
| 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 |
| RegulationNumber | §868.1400 | §868.1400 | Same |
| Device Class | II | II | Same |
| Device Description | |||
| Device Image | Image: Capnoxygen Mask | Image: M1 Capnography Mask | - |
| DeviceDescription | The Capnoxygen®Mask provides ameans to sampleexhaled carbondioxide via asample tube insidethe oxygen mask,during mouthand/or nosebreathing. The gas | The M1Capnography Maskis connected to agas source fordelivering low flowoxygen throughflexible tubing tothe patient, and atthe same timeprovides a means | The primary differencein design between thesubject and predicatedevice is that the M1Capnography Mask isdesigned to attach moreeasily to a capnographsample line thusfacilitating the use ofCO2 monitoring. The |
| connected to theCapnographymonitor by astandard femaleLuer connector. | capnograph formonitoring exhaledcarbon dioxideduring nose andmouth breathing.The capnographgas sample tubeattaches to astandard femaleluer connector oneither the left orright side of the M1Capnography Mask. | device are essentiallythe same with respectto all other functionalfeatures. | |
| Indications forUse | The Capnoxygen®Mask is a mediumconcentrationsingle-use maskintended to beused for thedelivery ofsupplementaloxygen andmonitoringbreathing bysampling exhaledcarbon dioxide.Standardconnectors for theoxygen tubing anda standard femaleLuer connector forthe gas sample lineare provided. Themask is intended tobe used formonitoring non-intubated patientswho are breathingspontaneously. | The M1Capnography Maskis a single-usedevice intended fordeliveringsupplementaloxygen andmonitoring exhaledcarbon dioxide innon-intubatedspontaneouslybreathing patients.Standard oxygentubing and twofemale Luer portsfor gas sample lineattachment areincluded. | Similar. Both the subjectand predicate device areintended to supply O₂while at the same timemonitoring exhaled CO₂in non-intubatedspontaneouslybreathing patients. Themain difference beingthe location of the CO₂monitor attachmentpoint. |
| Intended Use | The Capnoxygen®Mask is a single-use deviceintended fordeliveringsupplementaloxygen andmonitoring exhaledcarbon dioxide innon intubated | The M1Capnography Maskis a single-usedevice intended fordeliveringsupplementaloxygen andmonitoring exhaledcarbon dioxide innon-intubated | Similar. Both the subjectand predicate device areintended to supply O2while at the same timemonitoring exhaled CO2in non-intubatedspontaneouslybreathing patients. Themain difference beingthe location of the CO |
| spontaneouslybreathing patients.Standard oxygentubing areincluded. | spontaneouslybreathing patients.Standard oxygentubing and twofemale Luer portsfor gas sample lineattachment areincluded. | monitor attachmentpoint. | |
| Mode ofOperation | O₂ delivery to apatient through astandard O₂ supplyline andsimultaneous CO₂monitoringthrough a gassample lineconnecting themask to acapnograph; or O₂only delivery. | O₂ delivery to apatient through astandard O₂ supplyline andsimultaneous CO₂monitoring througha gas sample lineconnecting themask to acapnograph; or O₂only delivery. | Similar. Both the subjectand predicate device areintended to supply O₂while at the same timemonitoring exhaled CO₂in non-intubatedspontaneouslybreathing patients. Themain difference beingthe location of the CO₂monitor attachmentpoint. |
| Body Contact | Yes, limitedexposure < 24hours duration: 1.Surface contactingdevice (direct skin;indirect mucosalmembrane). | Yes, limitedexposure < 24hours duration: 1.Surface contactingdevice (direct skin;indirect mucosalmembrane). | Same: Both the subjectand predicate device areintended to be used forless than 24 hour ofduration. |
| Materials | Mask(Polyvinylchloride)Oxygen lineconnector(Polyvinylchloride)Oxygen tubing(Polyvinylchloride)Elastic strap | Mask(Polyvinylchloride)Oxygen lineconnector(Polyvinylchloride)Oxygen tubing(Polyvinylchloride)Luers (Acrylic -Acrylite®)AdhesiveElastic strapMetal nose clip | Similar. Both the subjectand predicate device aremade from the samematerials, with theexception of the Luersand adhesive used tobond them on thesubject device. |
| Sterile | No | No | Same. Both the subjectand predicate device aresupplied non-sterile. |
| Single Use | Yes | Yes | Same. Both the subjectand predicate device arefor single use. |
| O₂ Delivery | Yes | Yes | Same. Both the subjectand predicate device areused to deliver O₂ tothe patient. |
Table 5-A Comparison of Characteristics
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| ETCO₂Sampling | Yes | Yes | Similar. The primary difference in design between the subject and predicate device is the location of the CO₂ monitor attachment points. |
|---|---|---|---|
| Female sample line attachmentLuer | Yes | Yes | The M1 Capnography Mask uses custom molded female Luers centered in both exhalation vents that serve as capnograph sample line connection points. The predicate uses a single female Luer molded into the oxygen supply line connector for sample line attachment. |
| Profile | Over nose/mouth | Over nose/mouth | Same. Both the subject and predicate device are designed to fit over the nose/mouth of the patient. |
| Face Strap | Yes | Yes | Same. Both the subject and predicate device utilize an elastic strap to secure the face mask to the patient. |
| Sizes | Adult - Infant | Adult Large(Model #001) | The subject device is offered in one size (adult large) while the predicate device is offered in sizes from adult - pediatric. |
| Biocompatibility Testing | |||
| ISO 10993-1 | Yes | Yes | The M1 Capnography Mask was subjected to biocompatibility testing in accordance with the applicable parts of ISO 10993-1. |
| Performance Testing | |||
| ISO 594-2 | Not known | Yes | The M1 Capnography Mask was subjected to performance testing in accordance with ISO 594-2 and passed it is |
., .
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| not known if thepredicate device wassubjected to suchtesting. | |||
|---|---|---|---|
| CO2measurementperformance | Yes | Yes | The M1 Capnographymask and the predicatewere subjected to side-by-side bench testingand found to befunctionally equivalentin the detection of CO2. |
9. Non-Clinical Performance Data
As part of demonstrating the safety and effectiveness of its M1 Capnography Mask and in showing substantial equivalence to the predicate device that is the subject to this 510(k) submission, Monitor Mask, Inc. subjected its device to a wide range of testing that are applicable to oxygen/Capnography masks. In some instances testing was performed independent of the predicate device, while in other cases testing was performed in a side-byside manner against the predicate device.
The M1 Capnography Mask meets all the requirements for biocompatibility, functional performance and simulated use and these testing results confirm that the design outputs meet the design inputs and user specification requirements for the M1 Capnography Mask successfully passed all testing stated below by the acceptable results obtained.
- 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
- � Mechanical Strength Testing of Bonded Luer to Device
10. Clinical Performance Data
There was no clinical testing required to support the M1 Capnography Mask as the indications for use is equivalent to the predicate device. These types of devices, including the predicate device, have been on the market for many years with a proven safety and efficacy record for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the M1 Capnography Mask, and its safety and effectiveness.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared device, or has the same intended use and different technological characteristics, but it can be demonstrated that the new device is substantially equivalent to the predicate device, and that the new device does not raise any questions regarding its safety and effectiveness when compared to the predicate device.
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The M1 Capnography Mask has the same intended use, technological characteristics, and is made from the same materials as the Capnoxygen® Mask predicate device. The subject device also shares similar indications for use; device operall technical features and functional capabilities with the predicate device.
The M1 Capnography Mask, as designed, manufactured and tested in a non-clinical setting by Monitor Mask and when compared to the predicate device manufactured by Medsys (Southmedic) previously cleared under K971229, demonstrates that the subject device is as safe, as effective, and performs at least as safely and effectively as the predicate device that is the subject of this 510(k) submission, and therefore is determined to be substantially equivalent to it.
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Image /page/7/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 31, 2013
Monitor Mask, Incorporated C/O Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313
Re: K133806
Trade/Device Name: M1 Capnography Mask Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK, BYG Dated: December 12, 2013 Received: December 16, 2013
Dear Mr. Job:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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"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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/8/Picture/8 description: The image shows a logo with the text "Tejashri Purohit-Sheth, M.D." and "Clinical Deputy Director" above the acronym "DAGRID". The logo is in black and white and appears to be a stamp or seal. The word "FOR" is visible in the bottom right corner of the image.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
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Indications for Use Statement
510(k) Number (if known): Not Assigned
Device Name: M1 Capnography Mask
Indications for Use: The M1 Capnography Mask is a single-use device intended for delivering supplemental oxygen and monitoring exhaled carbon dioxide in nonintubated spontaneously breathing patients. Standard oxygen tubing and two female luer ports for gas sample line attachment are included.
Prescription Use ×
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
K133806 Nayan J. 2013.12.5
§ 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).