The Grab 'n Go system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is MR Conditional, and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. The device is intended for limited duration use, such as would be necessary during patient transports.

Device Description

The Grab 'n Go Plus / Grab 'n Go Digital (collectively referred to as the Grab 'n Go system) integrated delivery system supplies oxygen using a device comprising an integrated valve-regulator with pressure gauge, flow meter and oxygen gas cylinder with protective shroud all integrated into a single unit. The device is able to provide a range of user selectable flow settings, including low and high flows that may be clinically appropriate for certain classes of patients. An additional DISS connection provides standard 50-PSI oxygen gas delivery. The optional digital pressure gauge (Grab 'n Go Digital) provides both audible and visual low contents alerts and alarms as well as estimated time of use. The system must only be used by trained medical personnel.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the Praxair Grab 'n Go Plus / Grab 'n Go Digital device:

The provided document describes a medical gas delivery system, which is generally a mechanical device, not typically an AI/ML-driven software device. Therefore, many of the typical acceptance criteria and study elements associated with AI/ML devices (like sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, or standalone algorithm performance) are not applicable or not explicitly detailed in this submission.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (LIV Portable Oxygen System) through non-clinical testing against established industry and international standards, and a single "end-user evaluation."

Let's break down what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on compliance with established safety and performance standards for medical gas regulators and MR-conditional devices, rather than specific numerical acceptance criteria with corresponding performance metrics from a dedicated clinical study as would be seen for a diagnostic AI device.

Parameter/Criteria	Acceptance Criteria (Implied by Standards Compliance)	Reported Device Performance
Functional Safety & Performance	Compliance with ISO 13485 (Quality Management), ISO 14971 (Risk Management), IEC 60601-1 (Basic Safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (Alarm Systems), IEC 60529 (IP Code), IEC 60086-4 (Lithium Batteries), CGA E-18 (Med Gas Valve Regulators), ISO 10524-3 (Pressure Regulators), ISO 9170-1 (Terminal Units), ISO 11117 (Valve Protection), ASTM G175 (Oxygen Regulator Ignition Sensitivity).	The Grab 'n Go system "complies with the following industry and international standards" (listed above).
MR-Compatibility	MR-Conditional up to 3.0 Tesla, adhering to ASTM F2052 (Magnetically Induced Displacement), ASTM F2213 (Magnetically Induced Torque), ASTM F2503 (Marking for MR Safety), ASTM F2119 (MR Image Artifacts).	The Grab 'n Go system is "MR-conditional and complies with" the listed ASTM standards, and is "Yes, up to 3.0 T."
End-User Usability/Safety (Usability Study)	End-users able to understand the user manual, properly use the device, and understand alarm functionality. Responses from end-users met established acceptance criteria.	"Data shows that responses from end-users met the established acceptance criteria. End users were able to understand the user manual, properly use the device and understand the alarm functionality. Therefore, the Grab 'n Go system met the validation requirements."

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

Sample Size for Test Set: Not specified. The "end-user evaluation" indicates that "end-users" participated, implying a test set of human users interacting with the device. However, the number of users is not mentioned.
Data Provenance: Not specified. The document does not indicate the country of origin for the end-user evaluation or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a physical device, it's highly likely this was a prospective evaluation conducted by the manufacturer for regulatory purposes.

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

Not Applicable in the traditional sense for this device. The "ground truth" for this device's performance is adherence to engineering standards and a usability assessment. The "end-user evaluation" described seems to validate user interaction and understanding, rather than a diagnostic accuracy based on expert ground truth. Therefore, the document does not mention experts establishing "ground truth" for the test set.

4. Adjudication Method for the Test Set

Not Applicable. Since there's no clinical diagnostic "test set" and no expert ground truth establishment, there is no mention of an adjudication method like 2+1 or 3+1. The end-user evaluation likely involved observing user interaction and collecting feedback, then comparing against predetermined usability criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret cases, and AI assistance might improve their performance. This device is a medical gas delivery system, which does not involve diagnostic interpretation by human readers.

6. Standalone (Algorithm Only) Performance Study

No. This device is a hardware system; there is no standalone algorithm to evaluate. Its "performance" is assessed through engineering tests (compliance with standards) and a usability evaluation of the integrated system.

7. Type of Ground Truth Used

For engineering performance: The "ground truth" is defined by the objective pass/fail criteria of the referenced industry and international standards (e.g., pressure output accuracy, leak rates, material compatibility, MR safety thresholds, alarm specifications).
For end-user evaluation: The "ground truth" relates to predefined usability criteria, such as successfully operating the device, correctly interpreting alarms, and understanding the user manual. This is typically established by device design and human factors engineering principles.

8. Sample Size for the Training Set

Not Applicable. This is a hardware device; there is no "training set" in the context of machine learning. The design and manufacturing processes are informed by engineering principles, predicate device evaluation, and standards, not data training.

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

Not Applicable. As there is no training set, there is no ground truth established for it.

Summary

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K132778 510(k) Summary

for the Praxair Grab 'n Go Plus / Grab 'n Go Digital

(per 21CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm)

1. SUBMITTER/510(K) HOLDER

Praxair Healthcare Services 175 East Park Drive Tonawanda, NY 14150 800-772-9247 Phone: Internet: www.praxair.com

Establishment Registration No: 1000448358

Contact: Mike Skrjanc, Director FDA Compliance and Project Safety Contact's Phone: +1 (330) 949-3324 Contact's Fax: +1 (203) 837-2503 Contact's Email: Mike Skrjanc@praxair.com Date Prepared: September 3, 2013

2. DEVICE NAME

Trade Name:

Common Name:

Grab 'n Go Plus - Portable Medical Gas Delivery System (D, E cylinders)
Grab 'n Go Digital - Portable Medical Gas Delivery System (D, E cylinders)

Medical Gas Delivery System

Device Name: Integrated Valve-Regulator and Compressed Gas Cylinder Classification Panel: Anesthesiology Classification Number: Unclassified

Product Code: ECX

3. PREDICATE DEVICES

The following device is a legally marketed device to which equivalence is being claimed:

· LIV (Linde Integrated Valve) Portable Oxygen System (Linde North America, Inc.), K101792

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4. DEVICE DESCRIPTION

The optional digital pressure gauge (Grab 'n Go Digital) provides both audible and visual low contents alerts and alarms as well as estimated time of use.

The system must only be used by trained medical personnel.

5. INDICATION FOR USE/INTENDED USE

The Grab 'n Go system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics and adults. The device is MR-Conditional, and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. The device is intended for limited duration use, such as would be necessary during patient transports.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE 6. DEVICE

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

Parameter	Grab 'n Go Plus / Grab 'n Go Digital(Praxair Healthcare Services)	LIV (Linde Integrated Valve)(Linde North America, Inc.)
Regulatory Status	Proposed device	K101792
Indications for Use	The Grab 'n Go system is an integrated deliverysystem intended to provide supplementaloxygen, by Rx only, to neonates, pediatrics andadults. The device is MR-Conditional, andsuitable for use during MR imaging for MRIsystems up to 3.0 Tesla. The device is intendedfor limited duration use, such as would benecessary during patient transports.	The LIV is an integrated portable oxygendelivery system intended to providesupplemental oxygen to pediatric and adults.The device is MR-conditional (per ASTMstandard 2503-05), and intended for use duringMR imaging for MRI systems up to 3.0T. Rxonly. Compressed gas cylinders in service or instorage shall be stabilized or otherwise securedto prevent falling and rolling.
Low Flow Setting	Yes	Yes
Flow Between Settings	No	No
One or Two Knob Operation	One	Two

Praxair Healthcare Services, Traditional 510(k) September 3, 2013 Grab 'n Go Plus / Grab 'n Go Digital

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Parameter	Grab 'n Go Plus / Grab 'n Go Digital(Praxair Healthcare Services)	LIV (Linde Integrated Valve)(Linde North America, Inc.)
DISS Connection	Yes	Yes
Filling Port	Yes	Yes
Contents Gauge	Active	Active
Contents Gauge Type	Bourdon-tube or Transducer, Digital	Bourdon-tube
Filters	4	3
Service Pressure Maximum	3335 PSI (max)	3000 PSI (max)
Regulator Style	Single stage piston	Single stage piston
MR Compatibility	Yes, up to 3.0 T.	Yes, up to 3.0 T
Hand Grip	1 grip	2 grips
Access Ports	Yes	Yes
Flow Selector	Yes	Yes
Color	Green	Green
Height(valve-regulator and shroud)	7.5"	6.5"
Width	4.25"	4.75"
Cylinder Sizes	D, E	D, E
Medical Gases	Oxygen	Oxygen
Cylinder Material	Aluminum	Aluminum

The manufacturer believes that the technological characteristics of the Grab 'n Go system is substantially equivalent to those of the predicate device. Both the proposed and predicate devices are oxygen gas delivery systems comprised of an integrated valveregulator with pressure gauge, flow meter and oxygen gas cylinder with protective shroud all integrated into a single unit. Differences of the Grab 'n Go system include the design and dimensions of the shroud, single knob operation, optional digital gauge and number of internal filters.

7. SUMMARY OF NON-CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

The Grab 'n Go system complies with the following industry and international standards that are applicable to medical gas regulators:

· ISO 13485:2003, "Medical devices -- Quality management systems -- Requirements for regulatory purposes"
· ISO 14971: 2007, "Medical devices -- Application of risk management to medical devices"
· IEC 60601-1:2012, "Medical electrical equipment Part 1: General requirements 'for basic safety and essential performance"
· IEC 60601-1-2:2007, "Medical electrical equipment Part. 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests"

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· IEC 60601-1-8:2006, "Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems"
· IEC 60529:2001, "Degrees of protection provided by enclosures (IP Code)"
· IEC 60086-4:2007, "Primary batteries Part 4: Safety of lithium batteries"
· CGA E-18:2008, "Medical Gas Valve Integrated Pressure Regulators"
· ISO 10524-3:2005/Amd 1:2013, "Pressure regulators for use with medical gases --Part 3: Pressure regulators integrated with cylinder valves"
· ISO 9170-1:2008, "Terminal units for medical gases pipeline systems Part 1: terminal units for use with compressed medical gases and vacuum"
· ISO 11117:2008 / Corr:2009, "Gas cylinders -- Valve protection caps and valve guards -- Design, construction and tests"
· ASTM G175 03(2011), "Standard Test methods for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications"

The Grab 'n Go system is MR-conditional and complies with:

. ASTM F2052 - 06e1, "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment"
ASTM F2213 06(2011), "Standard Test Method for Measurement of . Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment"
ASTM F2503 13, "Standard Practice for Marking Medical Devices and Other . Items for Safety in the Magnetic Resonance Environment"
. ASTM F2119-01, "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants"

SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE 8.

An end-user evaluation of the Grab 'n Go system was performed to validate the intended use of the device in the intended environment. Data shows that responses from endusers met the established acceptance criteria. End users were able to understand the user manual, properly use the device and understand the alarm functionality. Therefore, the Grab 'n Go system met the validation requirements.

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9. STATEMENT OF SUBSTANTIAL EQUIVALENCE

The indications for use and overall design of the Grab 'n Go systems are identical to the predicate device. The proposed Grab 'n Go'system complies with internationally recognized standards and meets all established safety and performance criteria. Therefore, the manufacturer believes that the Grab 'n Go system is substantially equivalent to the predicate device and the differences between the two products are minor, and raise no new issues of safety and effectiveness.

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

July 7, 2014

Praxair Healthcare Services c/o Tina Wu, Ph.D., RAC AptivSolutions 62 Forest Street, Suite 300 Marlborough, MA 01752

Re: K132778

Trade/Device Name: Grab 'n Go Plus I Grab 'n Go Digital Regulation Number: Unclassified Regulation Name: Medical Gas Delivery System Regulatory Class: Unclassified Product Code: ECX Dated: June 2, 2014 Received: June 3, 2014

Dear Dr. Tina Wu:

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 - Dr. Wu

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 (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

MaryFBAner-S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132778

Device Name

Grab 'n Go Plus / Grab 'n Go Digital

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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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.