The Medipure Oxygen-LC System is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is intended for limited duration use, such as would be necessary during patient transport.

Device Description

The Medipure Oxygen-LC System is an integrated medical gas delivery system. The Medipure Oxygen-LC System is comprised of the Cavagna MVA2 series oxygen Valve Integrated Pressure Regulator (VIPR) permanently mounted to a large steel cylinder, either K or T size, and protected by a plastic guard. The Medipure Oxygen-LC System is a result of a design modification to the previously cleared Praxair Grab 'n Go Plus System (K132778).

AI/ML Overview

This document describes the Medipure Oxygen-LC System, an integrated medical gas delivery system, and its substantial equivalence to a predicate device (Grab 'n Go Plus System, K132778). The modification involves using a high-strength Cr Mo steel cylinder (K or T size) instead of an aluminum one, and a new plastic shroud.

The information provided focuses on demonstrating substantial equivalence rather than a detailed clinical effectiveness study with acceptance criteria and performance statistics of a novel medical device. The data presented is primarily non-clinical performance data to verify that the design changes do not negatively impact safety and effectiveness compared to the predicate.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with specific numerical targets and matching device performance statistics in the way a clinical study evaluating a novel diagnostic or therapeutic device would. Instead, it refers to compliance with established standards and specifications for medical gas delivery systems.

Test Category	Acceptance Criteria (Implicit from standards)	Reported Device Performance
Mechanical/Physical	- ISO 11117:2008: "Gas cylinders Valve protection caps and valve guards-Design, construction and tests" (Ensuring valve protection and structural integrity of the plastic guard).- 49 CFR §173.301(h)(3) DOT: "Cylinder valve protection" (Ensuring compliance with Department of Transportation regulations for cylinder valve protection).	The device "passed all testing" and is compliant with ISO 11117-2008 and DOT Title 49 CFR Part 173.301(h)(3).
Functional/Gas Delivery	- ISO 10524-3: "Pressure regulators for use with medical gases -- Part 3: Pressure regulators integrated with cylinder valves" (Ensuring proper function, pressure regulation, and safety of the integrated valve pressure regulator).- Product specifications of the Medipure Oxygen-LC System (equivalent to the predicate device).	The device "passed all testing". Internal verification and validation testing confirms that product specifications are met and are equivalent to the predicate device.
Purity/Safety	- Total Suspended Particulate, Odor and Oxygen Analysis: (Ensuring the delivered oxygen is free from contaminants and meets purity standards).	The device "passed all testing".

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the number of units or cylinders tested. It refers to "verification testing of the Medipure Oxygen-LC System," implying a device-level testing approach rather than a population-based study.
Data Provenance: The testing was "Internal verification and validation testing," which indicates it was conducted by the manufacturer (Praxair Distribution, Incorporated).
Retrospective or Prospective: The testing described is prospective as it was conducted on the newly designed Medipure Oxygen-LC System.
Country of Origin of the Data: Not explicitly stated, but given the manufacturer's location (Tonawanda, New York, U.S.A.) and the US regulatory context (FDA submission), it's highly likely the testing was conducted in the US or by facilities compliant with US standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of information is not applicable to the non-clinical performance and engineering validation tests described. Ground truth for these tests is established by objective measurements against engineering specifications and regulatory standards, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This is not applicable for the engineering and functional tests performed. Adjudication methods are typically used in clinical trials or studies where there are subjective interpretations of data (e.g., medical image reading).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. The device is a medical gas delivery system, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. The device is a physical integrated delivery system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests was:

Compliance with International Standards: ISO 11117:2008, ISO 10524-3.
Compliance with Federal Regulations: 49 CFR §173.301(h)(3) DOT.
Internal Product Specifications: The device's design specifications, which are stated to be equivalent to the previously cleared predicate device.
Objective Measurements: Such as pressure regulation, particulate analysis, odor analysis, and oxygen analysis.

8. The Sample Size for the Training Set

Not Applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As above, no training set was used.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 3, 2016

Praxair Distribution, Incorporated % Ms. Audrey Swearingen Director, Regulatory Affairs Emergo Global Consulting, LLC 816 Congress Avenue Suite 1400 Austin, TX 78701

Re: K153518

Trade/Device Name: Medipure Oxygen-LC System Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: ECX Dated: May 5, 2016 Received: May 5, 2016

Dear Ms. Swearingen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Sincerely yours,

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for Erin I. Keith, M.S. 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

510(k) Number (if known) K153518

Device Name Medipure Oxygen-LC System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5 – 510(k) Summary (Special 510(k))

Medipure Oxygen-LC System

1. Submission Sponsor

Praxair Distribution, Incorporated 175 East Park Drive Tonawanda, New York 14150 U.S.A. Phone number: (330) 949-3324 Contact: Mr. Mike Skrjanc Title: Director FDA Compliance and Project Safety

2. Submission Correspondent

Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (512) 818.3811 Office Phone: (512) 327.9997 Contact: Audrey Swearingen, Director Regulatory Affairs Email: project.management@emergogroup.com

3. Date Prepared

May 5, 2016

4. Device Identification

Trade/Proprietary Name:	Medipure Oxygen-LC System
Common/Usual Name:	Medical Gas Delivery System
Classification Name:	N/A - Unclassified
Regulation Number:	N/A - Unclassified
Product Code:	ECX - Cylinder, compressed gas, and valve
Device Class:	Unclassified (pre-amendment)
Classification Panel:	Anesthesiology

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5. Legally Marketed Predicate Device

K132778, Grab 'n Go Plus, Praxair Healthcare Services.

6. Device Description

The Cavagna MVA2 series VIPR is currently used on the Grab 'n Go Plus predicate device. It is compliant with CGA E-18. The plastic shroud is a new design and is compliant with ISO 11117-2008 and DOT Title 49 CFR Part 173.301(h)(3).

The modified design of the Medipure Oxygen-LC System is intended to satisfy customers with high oxygen demands who may not have access to a medical pipeline. The all-in-one concept of the VIPR (used in both the modified and unmodified predicate devices) provides ease of use and convenience over the traditional setup of separate regulator and flow meter.

7. Indications for Use Statement

8. Substantial Equivalence Discussion

The following table compares the Medipure Oxygen-LC System to the unmodified predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence, and supports that the subject device, as modified, does not raise any new issues of safety or effectiveness than the predicate device.

Manufacturer	Praxair Distribution, Inc.(previously PraxairHealthcare Services)	Praxair HealthcareServices	Significant Differences
Trade Name	Medipure Oxygen-LCSystem	Grab 'n Go Plus System
510(k) Number	-	K132778	N/A
Product Code	ECX	ECX	Same
Regulation Number	unclassified	unclassified	Same
Intended Use	Medical gas providingsupplemental oxygen, byRx only, to neonates,	Medical gas providingsupplemental oxygen,by Rx only, to neonates,	Same
	pediatrics, and adults.	pediatrics, and adults.
Indications for Use	The Medipure Oxygen-LCSystem is an integrateddelivery system intended toprovide supplementaloxygen, by Rx only, toneonates, pediatrics, andadults. The device isintended for limitedduration use, such as wouldbe necessary during patienttransport.	The Grab 'n Go PlusSystem is an integrateddelivery system intendedto provide supplementaloxygen, by Rx only, toneonates, pediatrics, andadults. The device is MRConditional, and suitablefor use during MRimaging for MRI systemsup to 3.0 Tesla.The device is intended forlimited duration use, suchas would be necessaryduring patient transport.	Similar. The unsuitabilityof the Medipure Oxygen-LC steel cylinder for usein an MRI environment isa restriction of the useenvironment, but doesnot change the intendeduse of the device toprovide supplementaloxygen, by Rx only, toneonates, pediatrics, andadults.
Medical Gas	Oxygen	Oxygen	Same
Low Flow Setting	Yes	Yes	Same
Contents Gauge Type	Bourdon Tube	Bourdon Tube	Same
Filters	4	4	Same
Service Pressure Max.	3335 psi	3335 psi	Same
Regulator Style	Single Stage Piston	Single Stage Piston	Same
Cylinder Material	High strength Steel	Aluminum	The larger capacityMedipure Oxygen-LCcylinders utilize highstrength Cr Mo steel toaccommodate the higherstresses. The steelcylinders are industrystandard and commonlyused for medical gases,thereby raising no newquestions of safety andeffectiveness.
Cylinder Sizes	K, T	D, E	Medipure Oxygen-LC haslarger cylinders toprovide a larger oxygencapacity during use.Verification testing showsthe larger volume raisesno new questions ofsafety and effectiveness.
Access Ports	Yes	Yes	Same
Flow Selector	Yes	Yes	Same

Table 5A – Comparison of Characteristics

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9. Non-Clinical Performance Data

Internal verification and validation testing confirms that product specifications of the Medipure Oxygen-LC System are met. These are equivalent to those of the predicate device. The testing results support that the device's design changes do not affect the safe and effective use of the device as compared to the unmodified predicate device. Verification testing of the Medipure Oxygen-LC System, in accordance

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with design controls, demonstrated the device meets the specifications for its intended use. Verification testing was performed as follows:

ISO 11117:2008 Gas cylinders Valve protection caps and valve guards-Design, construction and tests
ISO 10524-3, Pressure regulators for use with medical gases -- Part 3: Pressure regulators integrated with cylinder valves
· 49 CFR §173.301(h)(3) DOT Cylinder valve protection
Total Suspended Particulate, Odor and Oxygen Analysis

The device passed all testing and is determined to be substantially equivalent to the unmodified Grab 'n Go Plus device.

10. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the same intended use and the same technological characteristics as the previously cleared predicate device; or the device has the same intended use and different technological characteristics, but can be demonstrated to be substantially equivalent to the predicate device, and does not raise additional questions regarding its safety and effectiveness.

As such, the Medipure Oxygen-LC System, as modified, is determined to be substantially equivalent to the Grab 'n Go Plus predicate device.

Regulation Number and Section

§ 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.