(191 days)
Not Found
No
The description focuses on the mechanical process of converting liquid oxygen to gas and its physical characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as providing "medical treatment to injured isolated personnel" and includes a predicate device that is a "Portable Therapeutic Liquid Oxygen System."
No
The device description states that the MMOS is used to convert liquid oxygen to gaseous oxygen for delivery to a patient to supplement environmental oxygen. There is no mention of the device being used to diagnose conditions or process diagnostic information.
No
The device description clearly outlines a physical device that converts liquid oxygen to gaseous oxygen, including a thermally insulated container, heat exchanger, and outlet ports. It is a hardware device with a physical function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to convert liquid oxygen to gaseous oxygen for delivery to a patient and rescue personnel for inhalation. This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The description focuses on the mechanical process of converting liquid oxygen to gas and its use in providing oxygen for breathing. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for providing oxygen for respiration, which falls under the category of medical devices used for treatment and life support.
N/A
Intended Use / Indications for Use
The MMOS is intended to convert liquid oxygen to gaseous oxygen for delivery to a patient and for delivery to rescue personnel to supplement environmental oxygen at high altitudes while mounted in rescue vehicles, e.g. HH-60 and HC-130 Guardian Angel (GA) rescue vehicles, at one-half (0.5) to fifteen (15) liters per minute (LPM) and fifty (50) pounds per square inch gauge (psig).
Product codes
BYJ
Device Description
The MMOS, when filled with liquid oxygen, is used to provide medical treatment to injured isolated personnel and to supplement environmental oxygen during high altitude and parachuting operations. The MMOS is primarily employed on board the HH-60, HC-130, and Guardian Angel (GA) rescue Vehicle to treat 1-2 patients for durations of 4-8 hours.
The MMOS supplies 93% oxygen concentration when filled from an Oxygen Generator System (OGS).
The MMOS is capable of delivering gaseous oxygen to two patients at a combined maximum system flow rate of 22 Liters-Per-Minute (LPM) ambient.
The MMOS is capable of delivering oxygen at flow rate of 7 LPM for a minimum duration of 8 hours at one outlet.
The MMOS operating pressure is 50± 5 pounds per square inch gauge (psig).
The liquid oxygen (LOX) capacity is 4 liters.
The MMOS has two secondary accessory ports in addition to both patient ports.
The MMOS operates up to 14,000 Ft. MSL.
The oxygen delivery pressure is monitored and displayed.
The liquid oxygen quantity is monitored and displayed.
The MMOS has a visual low quantity alarm that triggers when the liquid capacity is at or below 10%.
Power required by the MMOS is a self-contained 9-volt lithium battery.
The MMOS has the capability to be filled with LOX by standard Department of Defense (DoD) and North Atlantic Treaty Organization (NATO) servicing connectors.
The overall system weight (when filled with 4.0 liters of liquid oxygen) is 35 lbs. Empty weight is 25 lbs.
The MMOS is 10.63 inches wide x 17.00 inches long x 8.75 inches wide within a tolerance of .06 inches in all directions.
The MMOS provides for storing of 4 liters of liquid oxygen and converting this liquid into its gaseous state. The gaseous oxygen is capable of being delivered in controlled amounts to provide medical treatment to injured patients and uncontrolled amounts to drive respiratory medical devices or supplemental oxygen in high altitude and parachuting operations. The MMOS is capable of being filled with liquid oxygen from parachages Generator System (OGS) and with current liquid oxygen storage/ filling stations.
MMOS contains liquid oxygen (LOX). The MMOS contains a thermally insulated container of liquid oxygen (LOX) that is intended to supplement gases to be inhaled by a patient. The MMOS supports medical devices provided by the user including masks, cannulas, and Bag Valve Mask (BVM) being attached to the flow control patient outlets. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.
The MMOS is portable. The handle on top of the housing, as well as the handles on the left and right side of the front-angled user interface, make the MMOS portable. The MMOS can be carried onboard, tied down, transported and operationally perform on various aircraft and ground vehicles.
The MMOS converts liquid oxygen from its insulated container through its heat exchanger into gaseous oxygen and finally the gaseous oxygen is available for distribution from an outlet port on the user interface. After connecting a tube assembly connector of a mask, cannula, and Bag Valve Mask (BVM) to an outlet port, masks, cannulas, and BVMs or other similar medical device (none of these devices is included in the MMOS) the patient can inhale the gaseous oxygen.
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
rescue personnel, HH-60 and HC-130 Guardian Angel (GA) rescue vehicles
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)
Essex Cryogenics of Missouri, Inc. Engineering personnel completed extensive MMOS capability, performance, and environmental testing with no issues arising regarding its safety and efficiency. The combined testing and analysis of results provides assurance that the device meets it specifications and is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 868.5655 Portable liquid oxygen unit.
(a)
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows a circular shape with a 'C' shape cut out from the center. The 'C' shape is not fully closed, leaving a small gap on the right side. The area between the outer circle and the 'C' shape is filled with a gray pattern, creating a visual contrast.
8007 Chivvis Drive · St. Louis. MO 63123-2395 tel: 314.832.8077 • fax: 314.832.8208 www.essexind.com • www.medlox.com
JUN 2 9 2012
K-113767 510(k) Summary
- Owner Information
| Owner's Name: | Essex Cryogenics of Missouri, Inc. |
|---|---|
| Address: | 8007 Chivvis Drive |
| St. Louis, Missouri 63123-2395 | |
| Phone Number: | 314-832-8077 |
| Fax Number: | 314-832-8208 |
| Contact Person: | Kenneth L. Seise |
| Date: | December 16, 2011 |
- Medical Device Information
| Trade Name: | Mounted Medical Oxygen System (MMOS) |
|---|---|
| Common Name: | Portable Liquid Oxygen System |
| Classification Name: | Portable Liquid-Oxygen Unit |
-
- Substantial Equivalence to Predicate Medical Device
The MMOS is substantially equivalent to the Portable Therapeutic Liquid Oxygen System (NPTLOX) (K033000).
- Substantial Equivalence to Predicate Medical Device
-
- Medical Device Description
Physical and performance characteristics
The MMOS, when filled with liquid oxygen, is used to provide medical treatment to injured isolated personnel and to supplement environmental oxygen during high altitude and parachuting operations. The MMOS is primarily employed on board the HH-60, HC-130, and Guardian Angel (GA) rescue Vehicle to treat 1-2 patients for durations of 4-8 hours. The following general requirements apply.
- The MMOS supplies 93% oxygen concentration when filled from an Oxygen a) Generator System (OGS).
- The MMOS is capable of delivering gaseous oxygen to two patients at a b) combined maximum system flow rate of 22 Liters-Per-Minute (LPM) ambient.
1
Image /page/1/Picture/0 description: The image shows a logo that resembles the letter 'C' inside of a circle. The 'C' is not fully closed, and it has a small extension on the right side. The logo is composed of two concentric circles, with the 'C' shape formed by the inner circle and the extension. The lower right portion of the logo is shaded, creating a visual contrast.
8007 Chivvis Drive · St. Louis. MO 63123-2395 tel: 314.832.8077 • fax: 314.832.8208 www.essexind.com · www.medlox.com
- The MMOS is capable of delivering oxygen at flow rate of 7 LPM for a minimum c) duration of 8 hours at one outlet.
- d) The MMOS operating pressure is 50± 5 pounds per square inch gauge (psig).
- The liquid oxygen (LOX) capacity is 4 liters. e)
- The MMOS has two secondary accessory ports in addition to both patient ports. f)
- The MMOS operates up to 14,000 Ft. MSL. g)
- The oxygen delivery pressure is monitored and displayed. h)
- The liquid oxygen quantity is monitored and displayed. i)
- The MMOS has a visual low quantity alarm that triggers when the liquid capacity j) is at or below 10%.
- Power required by the MMOS is a self-contained 9-volt lithium battery. k)
- The MMOS has the capability to be filled with LOX by standard Department of 1) Defense (DoD) and North Atlantic Treaty Organization (NATO) servicing connectors.
- The overall system weight (when filled with 4.0 liters of liquid oxygen) is 35 lbs. m) Empty weight is 25 lbs.
- The MMOS is 10.63 inches wide x 17.00 inches long x 8.75 inches wide within a n) tolerance of .06 inches in all directions.
How the device functions
The MMOS provides for storing of 4 liters of liquid oxygen and converting this liquid into its gaseous state. The gaseous oxygen is capable of being delivered in controlled amounts to provide medical treatment to injured patients and uncontrolled amounts to drive respiratory medical devices or supplemental oxygen in high altitude and parachuting operations. The MMOS is capable of being filled with liquid oxygen from parachages Generator System (OGS) and with current liquid oxygen storage/ filling stations.
2
Image /page/2/Picture/0 description: The image shows a circular shape with a gap in the lower right quadrant. Inside the larger circle is a smaller, incomplete circle that is connected to a smaller, filled circle on the left side. The overall design resembles a stylized letter 'C' within a circle, with the gap in the outer circle mirroring the opening of the 'C'.
1
8007 Chivvis Drive · St. Louis. MO 63123-2395 tel: 314.832.8077 • fax: 314.832.8208 www.essexind.com • www.medlox.com
MMOS contains liquid oxygen (LOX). The MMOS contains a thermally insulated container of liquid oxygen (LOX) that is intended to supplement gases to be inhaled by a patient. The MMOS supports medical devices provided by the user including masks, cannulas, and Bag Valve Mask (BVM) being attached to the flow control patient outlets. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.
The MMOS is portable. The handle on top of the housing, as well as the handles on the left and right side of the front-angled user interface, make the MMOS portable. The MMOS can be carried onboard, tied down, transported and operationally perform on various aircraft and ground vehicles.
The MMOS converts liquid oxygen from its insulated container through its heat exchanger into gaseous oxygen and finally the gaseous oxygen is available for distribution from an outlet port on the user interface. After connecting a tube assembly connector of a mask, cannula, and Bag Valve Mask (BVM) to an outlet port, masks, cannulas, and BVMs or other similar medical device (none of these devices is included in the MMOS) the patient can inhale the gaseous oxygen.
5. Intended Use of Medical Device
The MMOS is intended to convert liquid oxygen to gaseous oxygen for delivery to a patient and for delivery to rescue personnel to supplement environmental oxygen at high altitudes while mounted in rescue vehicles, e.g. HH-60 and HC-130 Guardian Angel (GA) rescue vehicles, at one-half (0.5) to fifteen (15) liters per minute (LPM) and fifty (50) pounds per square inch gauge (psig).
- Comparison to Predicate Medical Device
The NPTLOX is the predicate medical device to which MMOS is compared. Both are portable. Personnel can move an NPTLOX device by picking up the unit by its two side handles and walking with it while personnel can move an MMOS device by picking up the unit by its two handles on the front-angled user interface or single top handle. Both the NPTLOX and MMOS devices are similar in that they include a thermally insulated container. Both containers are designed built, and tested per 49 CFR §178.57, Specification 4L welded insulated cylinders, and are housed in aluminum sheet metal enclosures that contain heat exchangers that convert the liquid oxygen to gaseous oxygen. Both devices have ports that can be connected to tubing intended for connection to an
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Image /page/3/Picture/0 description: The image shows a white circle with a shape inside that resembles the letter 'C'. The 'C' shape is also white and is surrounded by a thicker, gray ring. The 'C' shape has a small, rounded extension on its top end, and the bottom end is open, creating a gap in the circle.
8007 Chiwis Drive · St. Louis. MO 63123-2395 tel: 314.832.8077 · fax: 314.832.8208 www.essexind.com · www.medlox.com
oxygen mask or other similar medical device to ultimately supplement gases to be inhaled by a patient.
Both devices can be monitored for pressure and liquid oxygen quantity.
The differences in the NPTLOX and MMOS are in the container size and LOX capacity. The NPTLOX container is a sphere that is approximately 13.5 inches in diameter with a LOX capacity of 25 liters while the MMOS container is a cylinder that is approximately 11.3 inches long and 6.1 inches in diameter with a LOX capacity of 4 liters. Thus both the NPTLOX and MODS are portable liquid-oxygen units that function the same but are simply different sizes.
- Medical Device Tests
Essex Cryogenics of Missouri, Inc. Engineering personnel completed extensive MMOS capability, performance, and environmental testing with no issues arising regarding its safety and efficiency. The combined testing and analysis of results provides assurance that the device meets it specifications and is safe and effective for its intended use.
- Conclusions
Based on review of the design and test results, Essex Cryogenics of Missouri, Inc. believes that no significant differences exist between this medical device, MMOS, and the predicate medical device, NPTLOX, and therefore the MMOS as safe, as effective and performs as well as or better than the NPTLOX.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the staff and two snakes intertwined around it. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Essex Industries, Incorporated Mr. Ken Seise Quality Assurance Manager Essex Cryogenics of Missouri, Incorporated 8007 Chivvis Drive Saint Louis, Missouri 63123
Re: K113767
Trade/Device Name: Mounted Medical Oxygen System Regulation Number: 21 CFR 686.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: June 14, 2012 Received: June 18, 2012
Dear Mr. Seise:
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.
JUN 2 9 2012
5
Page 2- Mr. Seise
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
th for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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8007 Chiwis Drive · St. Louis. MO 63123-2395 tel: 314.832.8077 • fax: 314.832.8208 www.essexind.com • www.medlox.com
Indications for Use Statement
510(k) Number (if known):
Device Name: Mounted Medical Oxygen System
Indications for Use: The MMOS is intended to convert liquid oxygen to gaseous oxygen for delivery to a patient and for delivery to rescue personnel to supplement environmental oxygen at high altitudes while mounted in rescue vehicles, e.g. HH-60 and HC-130 Guardian Angel (GA) rescue vehicles, at one-half (0.5) to fifteen (15) liters per minute (LPM) and fifty (50) pounds per square inch gauge (psig).
Prescription Use (CFR Title 21, Part 801, Subpart D) AND/OR
Over-The-Counter Use (CFR Title 21, Part 801, Subpart C)
(PLEASE DON NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schullhm
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
4-1
510/k) Number: