"The OxyTOTE Infinity system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla and cannot be used directly in the MRI bore. The device is intended for limited duration use, such as would be necessary during patient transports. "

For Praxair Grab 'n Go Opti:

"The Grab 'n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla and cannot be used directly in the MRI bore. The device is intended for limited duration use, such as would be necessary during patient transports. "

Device Description

The OxyTOTE Infinity and Praxair Grab 'n Go Opti series VIPR (Valve Integrated Pressure Regulator) Systems provide a package for those who need medical oxygen from portable cylinders. The oxygen regulator, analog pressure gauge, cylinder contents indicator and gas supply valve are combined, and permanently attached to the gas cylinder as one system. This design allows medical personnel the ability to provide patient care and treatment without the need to mount a conventional separate regulator.

The regulator reduces cylinder pressure and provides 10 user selectable flow rates (½, 1, 1½, 2, 3, 4, 6, 8, 15, 25 LPM) of USP oxygen that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides flow rates up to 100 LPM oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only.

Key features include; hose barb connection, protective shroud, carrying handle, cylinder content gauge, indexed flow meter, shutoff valve, and AUX (DISS-1240) connection.

AI/ML Overview

The provided document is a 510(k) premarket notification for the OxyTOTE Infinity Series VIPR Systems and Praxair Grab 'n Go Opti Series VIPR systems. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of a study with acceptance criteria and a detailed breakdown of device performance in a clinical or imaging context.

Therefore, many of the requested sections about a study demonstrating the device meets acceptance criteria cannot be extracted from this document, as it describes a medical device for oxygen delivery, not an AI/algorithm-based diagnostic or prognostic device that would typically undergo such studies.

However, I can extract information regarding performance testing against established standards, which serve as acceptance criteria for this type of medical device.

1. A table of acceptance criteria and the reported device performance

For a traditional medical device like an oxygen delivery system, "acceptance criteria" are typically defined by compliance with recognized performance standards. The "device performance" is reported as having "passed" these standards.

Acceptance Criteria (Standards Met)	Reported Device Performance
CGA E-18:2008 (first edition): Medical Gas Valve Integrated Pressure Regulators	Passed
ASTM G175-13: Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications	Passed
ASTM F2052-06 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.	Passed
ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.	Passed

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes engineering and physical performance testing of the device itself (e.g., ignition sensitivity, magnetic displacement force), not a study involving patient data or a "test set" in the context of an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document does not describe a study involving expert-established ground truth for a test set. The testing performed is against engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable, as there is no "test set" requiring adjudication in the context of this device's performance evaluation as described.

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

This is not applicable. The device is an oxygen delivery system, not an AI or algorithm-assisted diagnostic tool.

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

This is not applicable. The device is an oxygen delivery system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance testing described would be the defined parameters and limits set forth in the cited engineering and safety standards (e.g., maximum allowable magnetic displacement, ignition temperature limits). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable as the device is not an AI/algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.

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

April 17, 2015

Western/Scott Fetzer Co. Mr. David C. Simo Director of Quality and Regulatory 875 Bassett Road Westlake, OH 44145-1142

Re: K142149

Trade/Device Name: OxyTote Infinity Series VIPR Systems and Praxair Grab 'n Go Opti Series VIPR systems Regulation Number: Unclassified Regulation Name: Cylinder, Compressed Gas, and Valve Regulatory Class: Unclassified Product Code: ECX Dated: March 17, 2015 Received: March 20, 2015

Dear Mr. Simo:

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 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 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/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 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,

Tina
Kiang -S

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): K142149

Device Name: OxyTOTE Infinity series VIPR systems and Praxair Grab 'n Go Opti series VIPR systems

Indications for Use:

For OxyTOTE Infinity:

For Praxair Grab 'n Go Opti:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the text "OxyTOTE Infinity series and Praxair Grab 'n Go Opti series VIPR Systems". The text appears to be a product name or a description of a product line. The text is written in a clear, sans-serif font and is easy to read.

Image /page/3/Picture/1 description: The image shows the logo for Western, a Scott Fetzer company, above the text "510(k) Premarket Notification". The Western logo is a brown circle with a white design inside. The text "510(k) Premarket Notification" is in a larger font size than the company name.

510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)

1. 510(k) Owner's Name, Address, Telephone Number, Fax Number, Contact Person

Western / Scott Fetzer Co 875 Bassett Rd. Westlake, Ohio 44145 Phone: (440) 871-2160 Fax: (440) 835-8283

Contact Person:

David C. Simo Director of Quality & Regulatory Western / Scott Fetzer Co 875 Bassett Rd. Westlake, Ohio 44145 Phone: (440) 871-2160 Fax: (440) 835-8283 Email: dsimo@westernenterprises.com

2. Date Prepared

April 17, 2015

3. Device Information

Trade/Proprietary Name:	OxyTOTE Infinity series VIPR systems and Praxair Grab 'n Go Optseries VIPR systems
Common Name:	Portable Oxygen Delivery System
Device Classification Name:	Cylinder, Compressed Gas, and Valve
Classification Product Code:	ECX

4. Predicate Device

The predicate device for the OxyTOTE Infinity and Praxair Grab 'n Go Opti series VIPR Systems is the EZ-OX Plus Generation II, which was cleared under 510(k) K131386. Western would like to advise that they were also the manufacturer of this device.

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Image /page/4/Picture/0 description: The image contains the logo for Western, a Scott Fetzer company. The logo features a circular emblem on the left, with a brown background and a white interwoven design in the center. To the right of the emblem, the word "WESTERN" is written in bold, black letters, and below it, the phrase "a Scott Fetzer company" is written in a smaller font, enclosed in a curved banner.

OxyTOTE Infinity series and Praxair Grab 'n Go Opti series VIPR Systems

5. Device Description

Key features include; hose barb connection, protective shroud, carrying handle, cylinder content gauge, indexed flow meter, shutoff valve, and AUX (DISS-1240) connection.

6. Device Function

The device is an integrated portable oxygen delivery system intended to provide supplemental oxygen to patients. This is a multiple use product that is used in healthcare applications (hospitals, clinics and ambulance use), where medical grade oxygen gas is required at prescribed flow rates or as determined by the emergency medical provider. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only.

In comparison to the predicate device, the OxyTOTE Infinity and Praxair Grab 'n Go Opti series VIPR systems incorporate the following additional features:

The fill valve includes a reverse flow check valve to prevent gas from exiting the fill port. The 1 predicate device has a manual shutoff valve that requires a proprietary tool to actuate.
The fill valve is biased in an open position during cylinder evacuation process, and closes 2. automatically when the device is disconnected from the fill rack. The valve on the predicate device must be manually opened during the evacuation process and manually closed before disconnecting from the fill rack.
The cylinder Pressure Relief Device (PRD) operates when a specific pressure has been reached. The 3. predicate device PRD only operates when specific temperature and pressure requirements are met, meaning the PRD will not open if the cylinder is overfilled until exposed to an external heat source.
1. A Cylinder Contents Indicator (CCI) provides an indication of the cylinder contents in addition to the pressure gauge providing an assessment of cylinder content levels.
1. A high pressure shutoff valve which prevents gas from flowing into the pressure regulator. The predicate device is less redundant since it does not have a high pressure shutoff function resulting in more potential leak paths to be pressurized during transport and storage.

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Image /page/5/Picture/0 description: The image contains the logo for Western, a Scott Fetzer company. The logo features a circular emblem on the left, with a brown border and a woven design inside. To the right of the emblem, the word "WESTERN" is written in bold, black letters. Below "WESTERN" is the phrase "a Scott Fetzer company" in a smaller font, enclosed in a curved box.

OxyTOTE Infinity series and Praxair Grab 'n Go Opti series VIPR Systems

7. Design Description

The cylinder (Figure 1, item 13) is filled with Oxygen gas through the gas specific fill port (1) connection. The gas entering the fill port pushes open the check valve (2) allowing gas to flow through the valve body and into the cylinder (13). Once the cylinder is filled, the connection is detached from the fill port (1), and the fill port check valve (2) will automatically close to retain the device. The gas pressure in the cylinder is indicated on the pressure gauge (12).

To deliver calibrated flow the practitioner opens the shutoff valve (3) by rotating the flow control knob (4) clockwise to the desired flow setting. Gas is then permitted to flow into the regulator (5) portion of the device where cylinder pressure (up to 3000 psig) is reduced to around 50 psig. This regulated gas goes downstream to feed the flow control (6) portion of the device where thee gas flows through an orifice (8) to provide a calibrated flow out the outlet barb (9). The gas flows through a nasal cannula or mask (not shown and not provided with the device) to the patient.

The flow control knob (7) can also be rotated to the AUX position, which opens the shutoff valve (3) and allows the gas to flow into the pressure regulator (5) portion of the device. This permits gas to be supplied through the AUX port connection (10) while preventing simultaneous flow from the outlet barb (9). The AUX port will provide flow up to 100 LPM when the demand valve is actuated by connecting fitting to the AUX outlet connection.

Image /page/5/Figure/7 description: The image shows three cross-sectional diagrams of a device, labeled as Cross Section 1, Cross Section 2, and Cross Section 3. Each diagram highlights different internal components with labels and arrows pointing to them. Some of the labeled components include a fill port, check valve, shutoff valve, regulator, demand valve, and cylinder pressure relief device.

Figure 1 - OxyTOTE Infinity and Praxair Grab 'n Go Opti series VIPR Systems

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Image /page/6/Picture/0 description: The image contains the logo for Western, a Scott Fetzer company. The logo consists of a circular emblem on the left and the word "WESTERN" in bold, black letters on the right. Below "WESTERN" is the phrase "a Scott Fetzer company" in a smaller font, enclosed in a decorative border. The emblem features a brown circular design with a woven pattern inside.

8. Intended Use

For OxyTOTE Infinity:

For Praxair Grab 'n Go Opti:

9. Summary of Technological Characteristics

	A summary comparison of technological characteristics, including design and materials is provided in the
table below:

Feature	OxyTOTE Infinity and PraxairGrab 'n Go VIPR Systems	EZ-OX Plus Generation II(Predicate)	Explanation of Differences
510(k) Number	K142149	K131386	NA
Clearance Date	TBD	March 14, 2014	NA
Indications for Use	The (OxyTOTE Infinity /Praxair Grab 'n Go Opti)system is an integrateddelivery system intended toprovide supplemental oxygen,by Rx only, to patients. Whenadministered by properlytrained personnel for oxygendeficiency and resuscitation,the device is for emergencyuse only. For all other medicalapplications, the device is Rxonly. The device is MRConditional and suitable foruse during MR imaging forMRI systems up to 3.0 Teslaand cannot be used directly inthe MRI bore. The device isintended for limited durationuse, such as would benecessary during patienttransports.	The device is an integratedportable oxygen deliverysystem intended to providesupplemental oxygen topatients. When administeredby properly trained personnelfor oxygen deficiency andresuscitation, the device is foremergency use only. For allother medical applications, thedevice is Rx only.	The OxyTOTE Infinity / PraxairGrab 'n Go Opti statementarticulates the MR Conditionality ofthe device, and states that thedevice is only intended for limitedduration use. The predicate'sstatement contained neither.
Valve/Regulator
Low Flow Settings	Yes (≥ 0.5L), 10 specificcalibrated flow rates.(0.5, 1, 1.5, 2, 3, 4, 6, 8, 15, 25SLPM Oxygen)	Yes (≥ 0.5L), 11 specificcalibrated flow rates.(0.5, 1, 1.5, 2, 3, 4, 6, 8, 10,15, 25 SLPM Oxygen)	The lack of a 10 LPM position isnot a significant difference inperformance.
Cylinder On/off	No	No	NA

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Image /page/7/Picture/0 description: The image shows the logo for Western, a Scott Fetzer company. The logo consists of a brown circular emblem on the left, featuring a complex interwoven design. To the right of the emblem, the word "WESTERN" is written in bold, black capital letters, with the words "a Scott Fetzer company" written in a smaller font size underneath the word "WESTERN".

OxyTOTE Infinity series and Praxair Grab 'n Go Opti series VIPR Systems

Feature	OxyTOTE Infinity and PraxairGrab 'n Go VIPR Systems	EZ-OX Plus Generation II(Predicate)	Explanation of Differences
Filling Port Connection	CGA 540	CGA 540	NA
Auxiliary Port Connection	DISS 1240100 LPM at > 600 PSIG	DISS 124040 LPM at > 290 PSIG	100 LPM targeted for Oxy-TOTEand Opti, 40 LPM targeted forpredicate
Contents Gauge	Active	Active	NA
Cylinder Contents Indicator(CCI)	Yes	No	Red/Green visual indication ofremaining gas pressure providesan assessment of cylinder contentlevel.
Pressure Design	3,000 psi	3,000 psi	NA
Fill Valve	Automatic	Manual	A manual shutoff valve must beopened to evacuate the cylinder.
Residual Pressure Valve(RPV)	No	Yes	The RPV requires an additionalstep to be performed at the fillplant to vent the cylinders prior tofilling.
Guard / Shroud
Hand Grip	Yes	Yes	NA
Color	Green	Green	NA
Height (quard & integratedvalve regulator)	5.88"	7"	NA
Cylinder
Sizes	D and E	D and E	NA
Materials	Aluminum	Aluminum	NA
MRI Conditionality	Claimed: suitable foruse during MR imaging forMRI systems up to 3.0 Teslaand cannot be used directly inthe MRI bore.	Claimed: suitable foruse during MR imaging forMRI systems up to 3.0 Teslaand cannot be used directly inthe MRI bore.	NA

10. Performance Data (Non-clinical Testing)

Performance testing was completed and the device passed in accordance with the following standards:

. CGA E-18:2008 (first edition) : Medical Gas Valve Integrated Pressure Regulators
ASTM G175-13: Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
ASTM F2052-06 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
. ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.

Test results confirm that the OxyTOTE Infinity and Praxair Grab 'n Go Opti series VIPR systems meet its performance requirements.

11. Substantial Equivalence

Based upon the performance testing and subsequent passing results, the manufacturer believes that the OxyTOTE Infinity and Grab 'n Go Opti portable oxygen delivery systems are substantially equivalent to the predicate device, and do not raise any new questions of safety or effectiveness.

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.