(189 days)
The DMOS is intended to convert liquid oxygen to gaseous oxygen for delivery to a patient and/or for delivery to rescue personnel to supplement environmental oxygen at high altitudes while being carried by a rescue personnel at one-half (0.5) to fifteen (15) liters per minute (LPM) and fifty (50) pounds per square inch gauge (psig).
The DMOS, when filled with liquid oxygen, will be used to provide medical oxygen treatment to injured personnel or provide supplemental oxygen to operator during dismounted operations above 10,000 feet MSL. The DMOS provides for storing of 1.4 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. The DMOS is capable of being filled with liquid oxygen from the Oxygen Generator System (OGS) and with current liquid oxygen storage/ filling stations. The DMOS contains a thermally insulated container of liquid oxygen (LOX) that is intended to supplement gases to be inhaled by a patient. The DMOS supports medical devices provided by the user including masks, cannulas, and Bag Valve Mask (BVM) being attached to the flow control patient outlets. The DMOS is portable and can be carried onboard, tied down, transported and operationally perform on various aircraft and ground vehicles. The DMOS 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.
The furnished information describes the Dismounted Medical & Supplemental Oxygen System (DMOS), a portable liquid oxygen unit. It is being compared to a predicate device, the Backpack Medical Oxygen System (BMOS) (K071581).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate set of pass/fail metrics. Instead, it provides a comprehensive list of "Physical and performance characteristics" that the DMOS is designed to meet, and implicitly, these act as the acceptance criteria for the device's functionality and safety. The reported device performance is indicated by the fact that the device was deemed "substantially equivalent" to its predicate after "extensive DMOS capability, performance, and environmental testing." The table below merges the stated requirements with the implied "met" status based on the submission's conclusion.
| Performance Characteristic (Acceptance Criteria) | Reported Device Performance (Implied) |
|---|---|
| Supply 93% oxygen concentration when filled from OGS | Met |
| Capable of delivering gaseous oxygen to one patient at a maximum flow rate of 15 ambient LPM | Met |
| Capable of connecting to medical mask or cannula to supply oxygen during operations above 10,000 feet MSL | Met |
| Capable of delivering oxygen to one patient at a flow rate of 5 LPM for a minimum duration of 4 hours | Met |
| Operating pressure shall be 50 ± 5 psig | Met (explicitly 50 PSIG outlet pressure) |
| LOX capacity shall be 1.4 liters | Met |
| Operate up to 35,000 feet MSL | Met |
| Overall weight, including LOX, less than 16 lbs | Met (15.3 lbs when filled with LOX) |
| Oxygen delivery pressure monitored and displayed | Met |
| Liquid oxygen quantity monitored and displayed | Met |
| Any power required by the DMOS self-contained | Met (Battery operated) |
| Capability to be filled with LOX by standard DoD and NATO servicing connectors | Met (Standard Military CRU-50/A connection) |
| Refilled in 10 minutes or less from the OGS | Met |
| Delivery Rate (outlet flow) 15 LPM @ 50 PSIG | Met |
| Delivery Temperature within +10/-20 °F of low ambient (-40 °F) and within +10/-65 °F of high ambient (130 °F) at outlet ports | Met |
| No Delivery Temperature Alarm | Met |
| 1-Person-unit has one handle | Met |
| LOX Quantity Indicator: Battery powered | Met (One 9V battery) |
| No Low Quantity Alarm | Met |
| 50 PSIG outlet pressure | Met |
| No Outlet Pressure Alarm | Met |
| Outlet Ports: 2 (DISS 1240 & Female Dixon Quick-Disconnect) | Met |
| Flow Control Valve (0.5-15 LPM, with 12 settings) | Met |
| Single-person carry | Met |
| Standards Met: DOT-4L (Production Units) | Met |
| Sterility / Shelf Life: N/A | Met |
| Electrical Safety: Tested IAW MIL-STD-810G | Met |
| Medical Devices Compatibility: Commercial Mask, Commercial Cannula, Flow Control Valve | Met |
| Fill Connection: Standard Military CRU-50/A connection | Met |
| Operating Temperature: -40°F to 130°F | Met |
| Storage Temperature: -40°F to 130°F | Met |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in terms of a number of devices tested in a statistically powered study, nor does it refer to a "test set" in the context of a dataset for algorithm validation. Instead, it states that "Essex Industries, Inc. Engineering personnel completed extensive DMOS capability, performance, and environmental testing." This implies testing of physical device prototypes.
The provenance of this testing data is prospective, as it refers to testing performed on the DMOS device itself. There is no explicit mention of the country of origin of the data, but given the company's address in St. Louis, Missouri, USA, and the reference to DoD and NATO standards, it is highly likely that testing was conducted in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a physical medical device (portable liquid oxygen unit), not an algorithm that requires expert annotation for ground truth. The "ground truth" for this device's performance is established through physical and environmental benchmark testing against defined engineering specifications and regulatory standards.
4. Adjudication Method for the Test Set
This is not applicable for the same reason as point 3. Testing involves objective measurements against engineering specifications rather than interpretative decisions requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. The device is a physical medical device, not an AI algorithm intended for diagnostic or assistive interpretation by human readers. Therefore, an MRMC study to measure improvement with AI assistance is irrelevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable. The device is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth used for evaluating the DMOS is based on engineering specifications, direct physical measurements, and compliance with military standards (e.g., MIL-STD-810G, DOT-4L). For example:
- Oxygen concentration: Measured directly.
- Flow rates and pressures: Measured directly.
- Duration: Measured directly.
- Weight and capacity: Measured directly.
- Environmental tolerances (temperature, altitude, vibration, shock): Demonstrated through specific tests described in MIL-STD-810G.
8. Sample Size for the Training Set
This is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo for Essex Industries. The logo is in black and white and features a stylized font. The word "ESSEX" is in large letters, and the word "INDUSTRIES" is in smaller letters below.
JUL 1 9 2013
510(k) Summary
- Owner Information
| Owner's Name: | Essex Industries, Inc. d/b/a Essex Cryogenics of Missouri |
|---|---|
| Address: | 8007 Chivvis Drive |
| St. Louis, Missouri 63123-2395 | |
| Phone Number: | 314-338-8533 |
| Fax Number: | 314-832-8208 |
| Contact Person: | Kenneth L. Seise |
| Date: | January 5, 2013 (Revised July 19, 2013) |
- Medical Device Information
Dismounted Medical & Supplemental Oxygen System (DMOS) Trade Name: Common Name: Portable Liquid Oxygen System Classification Name: Portable Liquid-Oxygen Unit Classification Code: II Product Code: BYJ CFR Section: 21CFR 868.5655
510(k): K130068
- Substantial Equivalence to Predicate Medical Device
The DMOS is substantially equivalent to the Backpack Medical Oxygen System (BMOS) (K071581).
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4. Medical Device Description
Physical and performance characteristics
The DMOS, when filled with liquid oxygen, will be used to provide medical oxygen treatment to injured personnel or provide supplemental oxygen to operator during dismounted operations above 10,000 feet MSL. The following general requirements apply.
- The DMOS shall supply 93% oxygen concentration when filled from Oxygen a) Generator System (OGS).
- The DMOS shall be capable of delivering gaseous oxygen to one patient at a b) maximum flow rate of 15 ambient Liters Per Minute (LPM).
- The DMOS shall be capable of connecting to medical mask or cannula to supply c) oxygen during operations above 10,000 feet MSL.
- d) The DMOS shall be capable of delivering oxygen to one patient at a flow rate of 5 LPM for a minimum duration of 4 hours.
- The DMOS operating pressure shall be 50 ± 5 pounds per square inch gauge e) (psig).
- f) The liquid oxygen (LOX) capacity shall be 1.4 liters.
- The DMOS shall operate up to 35,000 feet MSL. g)
- The overall weight of the DMOS, including LOX, shall be less than 16 lbs. h)
- The oxygen delivery pressure shall be monitored and displayed. i)
- The liquid oxygen quantity shall be monitored and displayed. j)
- Any power required by the DMOS shall be self-contained. k)
-
- The DMOS shall have the capability to be filled with LOX by standard Department of Defense (DoD) and North Atlantic Treaty Organization (NATO) servicing connectors.
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- The DMOS shall be refilled in 10 minutes or less from the Oxygen Generator m) System (OGS).
How the device functions
The DMOS provides for storing of 1.4 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. The DMOS is capable of being filled with liquid oxygen from the Oxygen Generator System (OGS) and with current liquid oxygen storage/ filling stations.
DMOS contains liquid oxygen (LOX). The DMOS contains a thermally insulated container of liquid oxygen (LOX) that is intended to supplement gases to be inhaled by a patient. The DMOS 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 DMOS is portable. The handle on the front control make the DMOS portable. The DMOS can be carried onboard, tied down, transported and operationally perform on various aircraft and ground vehicles.
The DMOS 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 DMOS) the patient can inhale the gaseous oxygen.
-
- Indications for Use of Medical Device
The DMOS is intended to convert liquid oxygen to gaseous oxygen for delivery to a patient and/or for delivery to rescue personnel to supplement environmental oxygen at high altitudes while being carried by a rescue personnel at one-half (0.5) to fifteen (15) liters per minute (LPM) and fifty (50) pounds per square inch gauge (psig).
- Indications for Use of Medical Device
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6. Comparison to Predicate Medical Device
The BMOS (K071581) is the predicate medical device to which DMOS (K130068) is compared. Indications for Use for BMOS is that the BMOS is intended to be used by emergency response personnel in military and commercial fields to provide an emergency source of supplemental oxygen for a patient while being transported from a crisis situation to a health care facility. The BMOS is not intended to be a life sustaining or life-supporting device.
- Both the submission device and predicate device convert liquid oxygen to gaseous . oxygen
- Both devices can be used in military and commercial applications .
- Both devices supply supplemental oxygen to a patient .
- Both flow at one-half (0.5) to fifteen (15) liters per minute (LPM) and fifty (50) . pounds per square inch gauge (psig)
- The only difference between the two devices is that DMOS is capable of . supplying oxygen to rescue personnel in situations where they themselves need additional oxygen when they are in high altitude, mountainous region
BMOS & DMOS are both portable. Personnel can move a BMOS device by picking up the unit by the handle on the front face and walking with it while personnel can move a DMOS device by in the same manner. Both the BMOS and DMOS 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 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 BMOS and DMOS are in the container size and LOX capacity. The BMOS container is a cylinder that is approximately 13.1 inches long and 5.0 inches in diameter with a LOX capacity of 2 liters while the DMOS container is a cylinder that is approximately 12.3 inches long and 4.4 inches in diameter with a LOX capacity of 1.4 liters.
The DMOS has an additional parachute port, which the BMOS does not have, that allows the military rescue personnel to plug in his/her parachutist mask for additional oxygen when they are in high altitude, mountainous region.
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DMOS is a slightly smaller version of the BMOS, where both systems function exactly the same, with the exception that DMOS has the capability to provide oxygen at high altitude for rescue personnel.
| Performance | DMOS (K130068) | BMOS (K071581) |
|---|---|---|
| Characteristics | (PREDICATE DEVICE) | |
| Indications for Use | The DMOS is intended to convert liquid | The BMOS is intended to be used by |
| oxygen to gaseous oxygen for delivery to a | emergency response personnel in military | |
| patient and/or for delivery to rescue personnel | and commercial fields to provide an | |
| to supplement environmental | emergency source of supplemental oxygen | |
| oxygen at high altitudes while being carried | for a patient while being transported from a | |
| by a rescue personnel at one-half (0.5) to | crisis situation to a health care facility. The | |
| fifteen (15) liters per minute (LPM) and fifty | BMOS is intended to be a life sustaining or | |
| (50) pounds per square inch gauge | life-supporting device. | |
| (psig). | ||
| Target Population | Adult | Adult |
| Where Used | Military & commercial emergency response | Military & commercial emergency response |
| /rescue | /rescue | |
| Dimensional Envelope | Height = 5.5" | Height = 6.5" |
| Width = 7.25" | Width = 7.5" | |
| Depth = 17.0" | Depth = 17.5" | |
| System Weight | 15.3 lbs when filled with LOX | 18.5 lbs max when filled with LOX |
| Delivery Rate (outlet | 15 LPM @ 50 PSIG | 15 LPM @ 50 PSIG |
| flow) | ||
| Delivery Temperature | Within +10/-20 °F of low ambient (-40 °F) | Within +10/-20 °F of ambient at outlet ports. |
| and within +10/-65 °F of high ambient (130 | ||
| °F) at the outlet ports. | ||
| Delivery Temperature | No alarm | No alarm |
| Alarm | ||
| # Person Carry | 1-Person-unit has one handle. | 1-Person-unit has one handle. |
| Energy Used | Battery operated | Battery operated |
| LOX Quantity Indicator | Battery powered indicator (One 9V) | Battery powered indicator (Six AA) |
| Low Quantity Alarm | No alarm | No alarm |
| Outlet Pressure | 50 PSIG outlet pressure | 50 PSIG outlet pressure |
| Outlet Pressure Alarm | No alarm | No alarm |
| Outlet Ports | 2 Outlet Ports (DISS 1240 & Female Dixon | 1 Outlet Port (DISS 1240) |
| Quick-Disconnect) | ||
| Flow Control Outlet | 1 Flow Control Valve (0.5-15 LPM, with 12 | 1 Flow Control Valve (0.5-15 LPM, with 12 |
| Ports | settings) | settings) |
| Human Factors | Single-person carry | Single-person carry |
| Standards Met | DOT-4L (Production Units) | DOT-4L |
| Sterility / Shelf Life | N/A | N/A |
| Electrical Safety | Tested IAW MIL-STD-810G | Tested IAW MIL-STD-810F |
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| Performance/Characteristics | DMOS (K130068) | BMOS (K071581)(PREDICATE DEVICE) |
|---|---|---|
| Medical DevicesCompatibility | Commercial MaskCommercial CannulaFlow Control Valve (0.5-15 LPM, with 12 settings) | Commercial MaskCommercial CannulaFlow Control Valve (0.5-15 LPM, with 12 settings) |
| Fill Connection | Standard Military CRU-50/A connectionwhich connects with the military standardCRU-59/E connector on all the LOX fillingequipment | Standard Military CRU-50/A connectionwhich connects with the military standardCRU-59/E connector on all the LOX fillingequipment |
| Storage Capacity | 1.4 Liters of LOX | 2 Liters of LOX |
| Operating Temperature | -40°F to 130°F | 32°F to 120°F |
| Storage Temperature | -40°F to 130°F | -40°F to 160°F |
7. Medical Device Tests
Essex Industries, Inc. Engineering personnel completed extensive DMOS capability, performance, and environmental testing with similar acceptable results as that of BMOS and so have determined that DMOS is substantially equivalent to BMOS. The combined testing and analysis of results provides assurance that the device meets it specifications and meets its intended use. See the following table for bench tests and standards.
| Bench Test | Test or Analysis | Test Standard |
|---|---|---|
| Insulation Resistance | Test | |
| Visual & DimensionalExamination | Test | |
| Leakage | Test | |
| Quantity Indicator Performance | Test | |
| Weight & Capacity | Test | |
| Fill Time | Test | |
| Buildup Time | Test | |
| Parachutist Mask Delivery Rate | Test | |
| Patient Delivery Rate | Test | |
| Patient Delivery Temperature | Test | |
| Delivery Duration | Test | |
| Normal Evaporative Rate | Test | |
| High Temperature Operation | l est | MIL STD 810 Rev. G |
| Low Temperature Operation | Test | MIL STD 810 Rev. G |
| Altitude | Test | MIL STD 810 Rev. G |
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| Bench Test | Test or Analysis | Test Standard |
|---|---|---|
| Helicopter Vibration | Test | MIL STD 810 Rev. G |
| Aircraft Vibration | Test | MIL STD 810 Rev. G |
| Ground Vehicle Vibration | Test | MIL STD 810 Rev. G |
| Functional Shock | Test | MIL STD 810 Rev. G |
| Crash Hazard Shock | Test | MIL STD 810 Rev. G |
| Safety Drop | Test | MIL STD 810 Rev. G |
| Ballistic Test | Analysis | |
| Salt Fog | Analysis | |
| Humidity | Analysis | |
| Rain | Analysis | |
| Freezing Rain | Analysis | |
| Blowing Snow | Analysis |
8. Conclusions
Based on review of the design and test results, Essex Industries, Inc. believes that no significant differences exist between this medical device, DMOS, and the predicate medical device, BMOS, and therefore DMOS is substantially equivalent to BMOS.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2013
Essex Industries, Inc. d/b/a Essex Cryogenics of Missouri C/O Mr. Kenneth Seise Quality Assurance/Regulatory Compliance Manager 8007 Chivvis Drive St. Louis, MO 63123-2395
Re: K130068
Trade/Device Name: Dismounted Medical & Supplemental Oxygen System Regulation Number: 21 CFR 868.5655 Regulation Name: Portable Liquid-Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: June 17, 2013 Received: June 19, 2013
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.
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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 devicerelated 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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
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Kwame Ulmer, M.S. Acting Division 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):
Device Name: Dismounted Medical & Supplemental Oxygen System
Indications for Use: The DMOS is intended to convert liquid oxygen to gaseous oxygen for delivery to a patient and/or for delivery to rescue personnel to supplement environmental oxygen at high altitudes while being carried by a rescue personnel at one-half (0.5) to fifteen (15) liters per minute (LPM) and fifty (50) pounds per square inch gauge (psig).
Anya C. Harry Digitally signed by Anya C. Harry
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Anya C. Harry,
0.9.2342.19200300.100.1.1=0011315590
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K130068
Prescription Use. X (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)
4-1
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assexindustries.com
Even Industries, Inc. | 9007 Chivats Drive | St. Lovic, MC143123 | 314.832.8077 | 314.832.8208 Fax
§ 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).