Who is the manufacturer of M1 CAPNOGRAPHY MASK?

Monitor Mask, Inc. filed the 510(k) submission for M1 CAPNOGRAPHY MASK (K133806).

What is the FDA product code for M1 CAPNOGRAPHY MASK?

CCK. It is classified under 21 CFR 868.1400 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for M1 CAPNOGRAPHY MASK?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like M1 CAPNOGRAPHY MASK?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

M1 CAPNOGRAPHY MASK

K133806 · Monitor Mask, Inc. · CCK · Dec 31, 2013 · Anesthesiology

Device Facts

Record ID	K133806
Device Name	M1 CAPNOGRAPHY MASK
Applicant	Monitor Mask, Inc.
Product Code	CCK · Anesthesiology
Decision Date	Dec 31, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1400
Device Class	Class 2
Attributes	3rd-Party Reviewed

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.

Device Story

M1 Capnography Mask is a single-use, patient-worn interface for oxygen delivery and CO2 monitoring; connects to external gas source via flexible tubing and to capnograph monitor via integrated female Luer ports. Device features include PVC mask, elastic strap, and metal nose clip. Used in clinical settings for non-intubated, spontaneously breathing patients. Healthcare providers attach capnograph sample lines to Luer ports to monitor exhaled CO2 levels. Output provides real-time respiratory gas data to the capnograph, enabling clinicians to assess patient ventilation status and adjust oxygen therapy or clinical interventions accordingly. Benefits include simultaneous oxygenation and continuous respiratory monitoring.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility per ISO 10993-1, functional performance per ISO 594-2, mechanical strength testing of bonded Luers, and side-by-side bench testing against the predicate device for CO2 detection performance.

Technological Characteristics

Materials: Polyvinylchloride (mask, tubing, connector), Acrylic (Luers), adhesive, elastic strap, metal nose clip. Connectivity: Standard female Luer ports for capnograph sample line. Form factor: Adult large mask. Non-sterile, single-use. Standards: ISO 10993-1 (biocompatibility), ISO 594-2 (Luer performance), ASTM F 1980-07 (shelf life), ASTM D 4169-09 (packaging).

Indications for Use

Indicated for non-intubated, spontaneously breathing patients requiring supplemental oxygen and exhaled carbon dioxide monitoring.

Regulatory Classification

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.

Predicate Devices

Capnoxygen® Mask (K971229)

Submission Summary (Full Text)

{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 < 24 hours duration: 1. Surface contacting device (direct skin; indirect mucosal membrane). | Yes, limited exposure < 24 hours duration: 1. Surface contacting device (direct skin; indirect mucosal membrane). | Same: Both the subject and predicate device are intended to be used for less than 24 hour of duration. | | Materials | Mask (Polyvinylchloride) Oxygen line connector (Polyvinylchloride) Oxygen tubing (Polyvinylchloride) Elastic strap | Mask (Polyvinylchloride) Oxygen line connector (Polyvinylchloride) Oxygen tubing (Polyvinylchloride) Luers (Acrylic - Acrylite®) Adhesive Elastic strap Metal nose clip | Similar. Both the subject and predicate device are made from the same materials, with the exception of the Luers and adhesive used to bond them on the subject device. | | Sterile | No | No | Same. Both the subject and predicate device are supplied non-sterile. | | Single Use | Yes | Yes | Same. Both the subject and predicate device are for single use. | | O₂ Delivery | Yes | Yes | Same. Both the subject and predicate device are used to deliver O₂ to the patient. | Table 5-A Comparison of Characteristics {2}------------------------------------------------ . . {3}------------------------------------------------ : . {4}------------------------------------------------ | ETCO₂ Sampling | 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 attachment Luer | 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 | ., . {5}------------------------------------------------ | | | | not known if the predicate device was subjected to such testing. | |-----------------------------------|-----|-----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CO2 measurement performance | Yes | Yes | The M1 Capnography mask and the predicate were subjected to side- by-side bench testing and found to be functionally equivalent in 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. {6}------------------------------------------------ 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. {7}------------------------------------------------ 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. {8}------------------------------------------------ "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 {9}------------------------------------------------ ## 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

M1 CAPNOGRAPHY MASK

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

M1 CAPNOGRAPHY MASK

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps