(304 days)
Not Found
No
The description focuses on mechanical components and flow control, with no mention of AI or ML.
Yes
The device is intended to provide supplemental oxygen and is used for oxygen deficiency and resuscitation, which are therapeutic medical applications.
No.
The device is an oxygen delivery system, which treats oxygen deficiency rather than diagnosing a medical condition.
No
The device description explicitly details physical components like an integrated valve-regulator, flow meter, oxygen cylinder, handle, and shroud, indicating it is a hardware device.
Based on the provided text, the EZ-OX Plus Generation II is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "provide supplemental oxygen to patients" for "oxygen deficiency and resuscitation" and "all other medical applications." This involves delivering a substance (oxygen) to the patient's body for therapeutic purposes.
- Device Description: The device is described as a "portable oxygen delivery system" comprised of components like a valve-regulator, flow meter, and oxygen cylinder. These are all components involved in the delivery of a medical gas.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. The EZ-OX Plus Generation II does not perform any such analysis of specimens.
Therefore, the EZ-OX Plus Generation II is a medical device, but it falls under the category of devices used for direct patient treatment and support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The EZ-OX Plus Generation II is an integrated portable oxygen delivery system intended to provide supplemental oxygen to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the EZ-OX Plus Generation II is for emergency use only. For all other medical applications, the device is Rx only.
Product codes (comma separated list FDA assigned to the subject device)
ECX
Device Description
The EZ-OX Plus Generation II portable oxygen system is a solution for supplying Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical D and E-Oxygen aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flowrate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 40 L/min oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the EZ-OX Plus Generation II is for emergency use only. For all other medical applications, the device is Rx only.
Key specifications include hose barb connection, protective shroud, carrying handle, easy to read content gauge, indexed flow meter, integrated valve-regulator and usage chart label with safety instructions. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator.
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
properly trained personnel for oxygen deficiency and resuscitation
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)
The aluminum cylinders conform to the requirements of 49 CFR 178.46, Specification seamless aluminum cylinders.
Safety testing was successfully completed in accordance with the following standards:
- ISO 10524-3 (Pressure regulators for use with medical gases -- Part 3: Pressure regulators integrated with cylinder valves)
- Outlet flow limit §6.3
- Safety valve test §6.3
- Leakage rate §6.4
- Adiabatic compression test §6.6
- EN 15996 (Gas cylinders Residual pressure valves -- General requirements and type testing)
- Characteristics of functional at reception §5.4.1
- Tightness at reception §5.4.2
- RPV performance test §5.4.3
- Tightness after endurance §5.4.2
- Characteristics of functional after endurance §5.4.1
- ASTM G175-03 (Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications)
- Promoted ignition test §8.2.8
The performance bench testing that was performed demonstrated documented evidence that all flow rates and Standard deviations for the proposed EZ-OX Plus Generation II device met acceptance criteria and all obtained results were passing. The acceptance criteria used was per ISO 10524-3:2005 for demonstrating accuracy and a Standard Deviation of ≤2.0, which is supported by the USP and ICH community, for demonstrating precision. The testing was performed across the entire range of user configurable flow control settings. Additionally, the flow data obtained for the proposed device was compared to that of the predicate device across different test pressures. All flow rate testing results indicated that the proposed device was more accurate and had improved precision over the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 868.2700 Pressure regulator.
(a)
Identification. A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
0
IR LIQUIDE
510 (k) Summary EZ-OX Plus Generation II Portable Oxygen System 510(k) Number: __ K131386
Submitted in accordance with the requirements of Safe Medical Device Act (SMDA) 1990 and 21 CFR 807.92
| 1. | APPLICANT'S/SUBMITTER'S INFORMATION |
|---|---|
| Air Liquide Healthcare America Corporation | |
| 12800 West Little York Road | |
| Houston, TX 77041 |
| Direct Phone: | 800-624-8000 |
|---|---|
| Internet: | www.us.airliquide.com |
| Establishment Registration No: | 3003764448 |
| Contact: | Angie Beyer |
| Contact's Phone: | 713-624-8268 |
| Contact's Fax: | 713-803-1246 |
-
- DATE May 31, 2013
3. DEVICE INFORMATION
Trade/Proprietary Name: EZ-OX Plus - Generation 2
| Common Name: | Portable Oxygen Delivery System |
|---|---|
| Device Name: | Cylinder, Compressed Gas, and Integrated Valve- |
| Regulator | |
| Classification Panel: | Cardiovascular and Respiratory Devices |
| Classification Number: | Unclassified |
| Product Nomenclature: | Cylinder, Compressed Gas, and Integrated Valve- |
| Regulator | |
| Product Code(s): | ECX |
| Prior Submission : | No prior submission for the subject device. |
1
Image /page/1/Picture/0 description: The image shows the logo for Air Liquide. The logo consists of a stylized "A" in a black square on the left, followed by the words "AIR LIQUIDE" in bold, black letters. The logo is enclosed in a rectangular box.
DEVICE CLASSIFICATION 4.
Empty Compressed gas cylinders and compressed gas cylinder with valve assemblies are unclassified devices under product code ECX and reviewed by the Anesthesiology and Respiratory Devices Branch, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices.
Individually, gas cylinder pressure regulators and gas pressure gauges are Class 1 devices and exempted from pre-market notification, but are part of the above mentioned assembly.
PREDICATE DEVICE(s) న.
The predicate device for the EZ-OX Plus Generation II is the EZ-OX Plus, which was approved under 510(k) K053117.
DEVICE DESCRIPTION રે.
The EZ-OX Plus Generation II portable oxygen system is a solution for supplying Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical D and E-Oxygen aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flowrate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 40 L/min oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the EZ-OX Plus Generation II is for emergency use only. For all other medical applications, the device is Rx only.
Key specifications include hose barb connection, protective shroud, carrying handle, easy to read content gauge, indexed flow meter, integrated valve-regulator and usage chart label with safety instructions. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator.
2
AIR LIQUIDE
Very similar to the original EZ-OX Plus, the newly designed EZ-OX Plus Generation II has a few modifications to increase the safety and performance of the device. These changes include:
- The first level of filtration (out of three levels) was replaced with an excess . flow device.
Image /page/2/Figure/3 description: The image shows a technical diagram of a device, with a cross-sectional view on the left and a schematic diagram on the right. The cross-sectional view shows the internal components of the device, with various parts labeled with numbers such as 41 and 87. The schematic diagram illustrates the flow of fluids or gases through the device, including components such as filters, valves, and a pressure regulator. The diagram also includes text labels such as 'SAFETY RELIEF VALVE' and 'PRESSURE REGULATOR'.
Figure 1: EZ-OX Plus with no Flow Limiter showing the inlet filter that was removed and replaced with the excess flow device.
Figure 2: Flow Limiter Subassembly
3
Image /page/3/Figure/0 description: This image is a technical drawing of a valve. The drawing includes labels with numbers such as 33, 28, 17, 30, 29, 16, and 22. The drawing shows the internal components of the valve and how they fit together.
Figure 2: EZ-OX Plus Generation II with Flow Limiter
By adding the excess flow device, this will assure the body does not become a projectile if the valve is sheered. Air Liquide has not received any complaints of this nature, but the firm feels this proactive design will increase the safety of the device.
4
Image /page/4/Picture/0 description: The image shows the logo for Air Liquide. The logo consists of the company's name, "AIR LIQUIDE," in a bold, sans-serif font. To the left of the name is a stylized symbol, possibly representing the company's focus on gases or industrial processes. The logo is presented in a simple, clean design.
- The multiple piece nickel orifice plate was replaced with a one piece brass @ orifice plate.
Image /page/4/Figure/2 description: This image shows a technical drawing of a mechanical part with various dimensions and annotations. The drawing includes dimensions such as 0.925, 0.915, 0.470, 0.496, 0.066, 0.060, 0.822, 0.816, 0.239, 0.233, 0.302, and 0.295. It also specifies a minimum finish length of 150 and an angle of 27 to 31 degrees. The drawing includes tolerance specifications such as a diameter of 0.241 to 0.239 with a tolerance of 0.002 relative to datum B.
Figure 3: EZOX Plus Generation II Orifice Plate drawing
Image /page/4/Picture/4 description: The image shows two different views of a mechanical part. The top view shows a solid disk attached to a cylindrical shaft with a keyway cut into it. The bottom view shows a similar disk, but with a series of holes drilled around its circumference, also attached to a cylindrical shaft.
Figure 4: EZOX Plus Generation II Orifice Plate model
Concerning the design change to the orifice plate, the new design allows for an increase in performance which translates into a more effective device. Utilizing a one piece design reduces the opportunity for failure at a connection point of a multiple piece assembly. By utilizing this one piece orifice plate design, the firm was also able to eliminate the nickel plate and incorporate it in to the existing brass plate. This change eliminated any potential risk of the nickel slipping out of alignment.
5
Image /page/5/Picture/0 description: The image shows the logo for Air Liquide. The logo consists of the company's name, "AIR LIQUIDE", in bold, sans-serif font. To the left of the name is the company's symbol, which appears to be an abstract representation of a gas cylinder or a stylized "A". The logo is enclosed in a rectangular border.
- Two vent holes were added to the low pressure safety (piston guide) to � relieve pressure in the o-ring cavity.
Image /page/5/Picture/2 description: This image shows a cross-sectional view of a mechanical assembly, possibly a valve or pump mechanism. The components are rendered in grayscale, highlighting the internal structure and interaction of parts. The text "Shear Force" is visible, indicating a critical area where shear stress is a factor in the design or operation of the mechanism.
Figure 5: EZOX Plus Low Pressure safety
Image /page/5/Picture/4 description: This image shows a diagram of a piston guide with vent holes. The piston is in the center of the image and is surrounded by the guide. The vent holes are located on the side of the piston guide. The text in the image labels the vent holes as "Piston Guide Vent Holes."
Figure 6: EZOX Plus Generation II Low Pressure safety
To increase the safety and effectiveness of the device, two vent holes were added to the low pressure safety (piston guide) to relieve pressure in the o-ring cavity. This relief in pressure will stop the piston guide from sufficiently moving upwards, therefore, preventing the o-ring from extruding and preventing an oxygen leak greater then what a cylinder would otherwise leak.
6
Image /page/6/Picture/0 description: The image shows the logo for Air Liquide. The logo consists of a stylized letter "A" in a square to the left of the words "AIR LIQUIDE" in a sans-serif font. The logo is simple and modern, and the colors are muted.
- Changed from a shuttling residual pressure valve design to a non-shuttling residual pressure valve to eliminate audible vibration and noise.
Image /page/6/Picture/2 description: This image shows a diagram of a non-shuttling RPV poppet in the open position. The diagram shows the internal components of the poppet, including a spring and a cylinder. The text in the image indicates that the cylinder gas pressure holds the RPV poppet open, and that the RPV poppet is in the open position.
Figure 7: EZOX Plus Generation II RPV
The original design included a shuttling residual pressure valve (PRV). With a shuttling RPV design, the flow of gas from the cylinder through the RPV to the regulator drives intermittent opening and closing of the RPV poppet assembly as the pressure differential across the poppet fluctuates. With this original design, it was observed that an audible vibration or humming was occurring in the EZ-OX Plus units during flowing conditions when it was installed on cylinders. In order to eliminate the humming, the shuttling RPV was replaced with a non-shuttling RPV. In the non-shuttling RPV design, the RPV poppet spring overcomes the force on the poppet due to cylinder gas pressure when the cylinder pressure is depleted below approximately 2.5 bar and forces the RPV poppet to close. After shutting, the RPV poppet interrupts gas flow from the cylinder to the regulator, thereby preventing further cylinder depletion.
7. INDICATIONS FOR USE
The EZ-OX Plus is an integrated portable oxygen delivery system intended to provide supplemental oxygen to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the EZ-OX Plus is for emergency use only. For all other medical applications, the device is Rx only.
7
AIR LIQUIDE
DEVICE FUNCTION 8
The EZ-OX Plus Generation II is a compressed gas cylinder with an adjustable valve to control the flow of Oxygen, USP to the patient.
9. TECHNOLOGICAL CHARACTORISTICS
A summary comparison of technological characteristics, including design and materials is provided in the table below:
| Parameter | EZ-OX Plus | EZ-OX Plus Gen II |
|---|---|---|
| Valve/Regulator | ||
| Low Flow Settings | Yes (≥ .5L) | Yes (≥ .5L) |
| Flow Between Settings | No | No |
| Cylinder on/off | No | No |
| Filling Port | Active | Active |
| Contents Gauge | Active | Active |
| Filters | 3 | 2 |
| Pressure Design | 3,000 psi (max) | 3,000 psi |
| Single stage piston style | Yes. | Yes |
| Guard | ||
| Hand Grip | 1 grip | 1 grip |
| Access Ports | Yes | Yes |
| Flow selector/ hose barb/ | Yes | Yes |
| gauge aligned | ||
| Color | Green | Green |
| Height (guard and | ||
| integrated valve-regulator) | 7" | 7" |
| Cylinder | ||
| Cylinder Sizes | D, E | D, E |
| Weight (E) (product) | 950 gr | 950gr |
| Materials/construction | Aluminum | Aluminum |
The manufacturer believes that the technological characteristics of the EZ-OX Plus Generation II portable oxygen system are substantially similar to those of the predicate device. The predicate device have been granted marketing clearance by FDA following the submission of a 510(k) (510(k) number for EZ-OX Plus is K053117). The modified device has the same intended use and indications for use as the predicate device.
10. PERFORMANCE DATA
The aluminum cylinders conform to the requirements of 49 CFR 178.46, Specification seamless aluminum cylinders.
11. SAFETY TESTING
Safety testing was successfully completed in accordance with the following standards (see Attachment A):
- . ISO 10524-3 (Pressure regulators for use with medical gases -- Part 3: Pressure regulators integrated with cylinder valves)
8
Image /page/8/Picture/0 description: The image shows the logo for Air Liquide. The logo consists of the company's initials, "AL", in a stylized, blocky font on the left side of the image. To the right of the initials is the company's name, "AIR LIQUIDE", in a bold, sans-serif font.
- Outlet flow limit $6.3 o
- Safety valve test §6.3 o
- Leakage rate §6.4 o
- O Adiabatic compression test $6.6
- EN 15996 (Gas cylinders Residual pressure valves -- General requirements and type testing)
- Characteristics of functional at reception $5.4.1 O
- Tightness at reception $5.4.2 o
- RPV performance test §5.4.3 o
- Tightness after endurance $5.4.2 O
- Characteristics of functional after endurance §5.4.1 o
- . ASTM G175-03 (Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications)
- o Promoted ignition test $8.2.8
12. DESCRIPTION OF GAS OUTPUT PERFORMANCE BENCH TESTING
The performance bench testing that was performed demonstrated documented evidence that all flow rates and Standard deviations for the proposed EZ-OX Plus Generation II device met acceptance criteria and all obtained results were passing. The acceptance criteria used was per ISO 10524-3:2005 for demonstrating accuracy and a Standard Deviation of ≤2.0, which is supported by the USP and ICH community, for demonstrating precision. The testing was performed across the entire range of user configurable flow control settings. Additionally, the flow data obtained for the proposed device was compared to that of the predicate device across different test pressures. All flow rate testing results indicated that the proposed device was more accurate and had improved precision over the predicate device.
13. STATEMENT OF SUBSTANTIAL EQUIVALENCE
Based upon the safety and performance testing and compliance with voluntary standards, the manufacturer believes that the EZ-OX Plus Generation II portable oxygen delivery system is substantially equivalent to the predicate device, and does not raise any new questions of safety or effectiveness.
9
Image /page/9/Picture/0 description: The image shows the logo for Air Liquide. The logo consists of the company's name, "AIR LIQUIDE", in a bold, sans-serif font. To the left of the name is a stylized symbol, possibly representing the letter "A" or a graphic element associated with the company's brand. The logo is simple and clean, with a focus on readability and brand recognition.
14. EZ-OX PLUS GENERATION II PHOTOGRAPH
The photo below is the assembled device with the regulator head and aluminum cylinder.
Image /page/9/Picture/3 description: In the image, there is a close-up of a glass bottle. The bottle is dark in color and has a rounded shape. The bottle appears to be hanging from something, possibly a tree branch. The bottle is partially obscured by the background.
The illustration below shows the details of the regulator head of the assembly.
Image /page/9/Figure/5 description: The image shows a medical device with various labeled parts. On the left side, the labels point to the flow selector knob, flow setting (LPM), delivery/use port, auxiliary port, cylinder contents gauge, and cylinder connection. On the right side, the labels indicate the product identification label, shut-off valve, CGA 540 fill port, and high-pressure safety feature.
10
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2014
Air Liquide Healthcare America Corporation Ms. Angie Beyer Compliance Specialist 2700 Post Oak Boulevard, Suite 325 Houston, TX 77056
Re: K131386
Trade/Device Name: EZ-OX Plus - Generation II Regulation Number: Unclassified Regulation Name: Cylinder, Compressed Gas, And Valve Regulatory Class: Unclassified Product Code: ECX Dated: February 20, 2014 Received: February 24, 2014
Dear Ms. Beyer:
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.
11
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/ResourcesforYou/Industry/default.htm.
https://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Teiashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID' FEDA, I
Sincerely yours,
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
FOR
Enclosure
12
Indications for Use
510(k) Number (if known):
Device Name: EZ-OX Plus Generation II Portable Oxygen Delivery System
Indications For Use:
The EZ-OX Plus Generation II is an integrated portable oxygen delivery system intended to provide supplemental oxygen to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the EZ-OX Plus Generation II is for emergency use only. For all other medical applications, the device is Rx only.
AND/OR Over-The-Counter Use Prescription 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 CDRH, Office of Device Evaluation (ODE)
Image /page/12/Picture/8 description: The image shows two lines of text. The first line says "Anya C." and the second line says "Harry -S". The text is written in a simple, sans-serif font and is black against a white background. The text is slightly blurry.
Digitally signed by Anya C. Harry -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Anya C. Harry -S. cheAnya C. Hany -5,
0.9.2342.19200300.100.1.1=0011315 Page 1 of _f
500 590 Date: 2014.03.14 04:36:11 -04/00'