The Walk-O2-Bout® is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults in hospital, sub-acute care, and pre-hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM F2052-15), and intended for use during MR imaging for static magnetic fields of 3.0 T or less. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.

Device Description

The Walk-O2-Bout® regulator is designed to be installed on a medical grade aluminum cylinder having 0.750-16 UNF-2B threads; regulate high pressure oxygen from 300-2000 psig nominal; deliver a prescribed amount of oxygen; and be ignition fault resistant. The device consists of: A threaded fill fitting per CGA 540. It shall allow the regulator installed on a cylinder to be refilled to its service pressure. It also allows for the pulling of a vacuum on the system. A pressure regulator section to reduce the pressure from 300-2000 psig to 50 psig nominal. Options of flow selector valves to control the flow between 0 and 25 L/min, at the regulated pressure. A vinyl dipped handle for ease of carrying. A DISS 1240 check valve to deliver 50 psig of oxygen high flow rates of oxygen to ventilators. There are several models offered. In all cases the basic pressure regulator is identical for all models. The models are offered with the following options: Flow rate range of 0 4 L/min (Pediatric), 0 15 L/min and 0 25 L/min (adult) Check Valve Swivel or Fixed Barb Fitting Handle style MR Conditional.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Walk-O2-Bout®, a portable oxygen delivery system. However, it does not contain the detailed acceptance criteria and study results in the format requested. The document focuses on demonstrating substantial equivalence to a predicate device (K101792 – Linde – LIV Portable Oxygen System) rather than providing specifics of direct performance against pre-defined acceptance criteria with empirical data.

The "Acceptance Test Procedure" mentioned under "Non-clinical Testing Summary" suggests that such tests were performed, but the results and specific criteria are not detailed. Similarly, while "Flow accuracy: +/- 10%" is listed as a specification, the study proving the device meets this accuracy is not described.

Therefore, I cannot fulfill all parts of your request with the provided input. However, I can extract the available information as much as possible.

Here's a breakdown of what can be extracted and what information is missing from the provided document:

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

Based on the document, the acceptance criteria are generally implied by the specifications and compliance with standards. The specific reported device performance values against these criteria are not explicitly provided in a quantitative table within this document.

Acceptance Criteria (from "Specifications" and standards)	Reported Device Performance
Flow accuracy	±10% (Stated as specification, not a measured performance)
Maximum inlet pressure	2000 psig (Stated as specification)
Outlet pressure range	48-65 psi (Stated as specification)
Operating Pressure range	300-2000 psig (Stated as specification)
Operating Temperature Range	-20°F to 130°F (Stated as specification)
Oxygen cylinder size	E (Stated as specification)
MR Conditional (per ASTM F2052-15)	3.0 Tesla or less (Stated as specification, tested per ASTM F2052-06 which is acknowledged to be different than -15 but testing was done for -06, not -15
CGA E-7 Guidelines	Testing performed per CGA E-7 (not specific results)
ASTM G175-03 (Ignition)	Materials evaluated per ASTM G175-03
Biocompatibility	Materials evaluated for biocompatibility via VOC and PM2, "demonstrated that the materials were safe for their intended use."
Specific Non-clinical Tests (e.g., Gas tightness, Endurance Inlet, Drop, Burst pressure, etc.)	Tests were performed, but specific acceptance criteria and results are not detailed.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "a number of tests appropriate for the proposed device" were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The testing appears to be primarily engineering and bench testing, not involving expert interpretation or "ground truth" in the clinical sense.

4. Adjudication method for the test set

This information is not applicable and not provided. The testing appears to be primarily engineering and bench testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical gas pressure regulator, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used

The concept of "ground truth" as it applies to clinical diagnoses (e.g., pathology, outcomes data) is not relevant here. The ground truth for this device's performance would be established by physical measurement against engineering standards and specifications.

8. The sample size for the training set

This is not applicable as the device is a physical product and not an AI/machine learning algorithm that requires a training set.

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

This is not applicable.

Summary of Study (Based on Provided Text):

The "study" described in this document is a series of non-clinical, bench-testing evaluations to demonstrate the physical and functional performance of the Walk-O2-Bout® device. The primary goal was to show substantial equivalence to a legally marketed predicate device (Linde – LIV Portable Oxygen System, K101792) and compliance with relevant industry standards (ISO, ASTM, CGA).

Type of Study: Non-clinical bench testing.
Purpose: To demonstrate the device's physical performance, safety (ignition, MR compatibility), and biocompatibility, and to support a claim of substantial equivalence to a predicate device.
Key Tests Mentioned: Acceptance Test Procedure, Low/High temperature, Gas tightness, Flow regulation (Flow capacity), Outlet Flow vs. inlet pressure, Pressure regulation, Static increment, Pressure relief, Mechanical resistance, Endurance Inlet, Fill fitting endurance, Safety, Drop, Vibration and Shock, Proof pressure, Burst pressure, Ignition (ASTM G175), MR Conditional Testing (ASTM F2052-15, tested per ASTM F2052-06), Biocompatibility.
Clinical Testing: "There was no clinical testing."

In conclusion, while the document confirms that various tests were performed to assess the device's performance against established standards and specifications, it does not provide the quantitative results or detailed acceptance criteria for each test in a manner that would fully answer your request. It mainly serves as a summary for a 510(k) submission, confirming adherence to regulatory requirements and substantial equivalence.

Summary

{0}------------------------------------------------

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 image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

November 18, 2016

Essex Industries, Inc. c/o Paul Dryden Consultant 7700 Gravois St. Louis, Missouri 63123

Re: K161472

Trade/Device Name: Walk-O2-Bout® Regulation Number: 21 CFR 868.2700 Regulation Name: Pressure Regulator Regulatory Class: Class I Product Code: ECX Dated: October 20, 2016 Received: October 21, 2016

Dear Paul Dryden:

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.

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 and Part 809); 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

{1}------------------------------------------------

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 and Part 809), 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K161472

Device Name

Walk-O2-Bout®

Indications for Use (Describe)

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

|XX Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE

ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (8/14)

Page 1 of 1

{3}------------------------------------------------

510(k) Summary Page 1 of 5 11/14/2016

Essex Industries, Inc. 7700 Gravois St. Louis, MO 63123

Official Contact:	Russ Jacobsmeyer - Vice President of EngineeringTel – 314.338.8723
Proprietary or Trade Name:	Walk-O2-Bout®
Common/Usual Name:	Cylinder, Compressed Gas, and Valve
Classification Name/Code:	ECX - Cylinder, Compressed Gas, and Valve21 CFR 868.2700, Class I
Predicate Device:	K101792 – Linde – LIV Portable Oxygen System

Device Description:

The device consists of:

· A threaded fill fitting per CGA 540. It shall allow the regulator installed on a cylinder to be refilled to its service pressure. It also allows for the pulling of a vacuum on the system.
· A pressure regulator section to reduce the pressure from 300-2000 psig to 50 psig nominal.
· Options of flow selector valves to control the flow between 0 and 25 L/min, at the regulated pressure.
· A vinyl dipped handle for ease of carrying.
A DISS 1240 check valve to deliver 50 psig of oxygen high flow rates of oxygen to ventilators. .

There are several models offered. In all cases the basic pressure regulator is identical for all models. The models are offered with the following options:

Flow rate range of 0 4 L/min (Pediatric), 0 15 L/min and 0 25 L/min (adult) ●
Check Valve
Swivel or Fixed Barb Fitting .
Handle style
MR Conditional .

Indications for Use:

The Walk-O2-Bout® is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults in hospital, sub-acute care, and pre-hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM standard F2052-15), and intended for use during MR imaging for static magnetic fields of 3.0 T or less. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.

Patient Population: Patients requiring supplement oxygen, Pediatrics and adults

Environments of Use: Hospital, sub-acute care, and pre-hospital / ground transport settings

{4}------------------------------------------------

510(k) Summary Page 2 of 5 11/14/2016

Contraindications: None.

Summary of substantial equivalence

The proposed Walk-O2-Bout® has been compared to the predicate K101792 – Linde – LIV Portable Oxygen System, see Table 1.

Device Comparison

Description	Predicate DeviceK101792	Subject DeviceWOBWALK-O2-BOUT®
Device Name	LIV
Device Classification& Product code	Class I / ECX868.2700	Class I / ECX868.2700
Prescription Device:	Yes	Yes
Indications for Use	The LIV is an integrated portableoxygen delivery system intended toprovide supplemental oxygen topediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05*), and intended for use during MRimaging for MRI systems up to 3.0T. Rxonly.	The Walk-O2-Bout® is an integratedportable oxygen delivery systemintended to provide supplementaloxygen to pediatrics and adults inhospital, sub-acute care, and pre-hospital/ ground transport settings. It is offeredin models that are MR-conditional (perASTM F2052-15), and intended for useduring MR imaging for static magneticfields of 3.0 T or less.
	Environments ofUse	Compressed gas cylinders in service orin storage shall be stabilized orotherwise secured to prevent falling androlling.	Compressed gas cylinders in service orin storage shall be stabilized orotherwise secured to prevent falling androlling.
		Hospital, sub-acute care, and pre-hospital / ground transport settings	Hospital, sub-acute care, and pre-hospital / ground transport settings
		Imaging suites	Imaging suites
		Patient requiring supplemental oxygen	Patient requiring supplemental oxygen
	Patient population	Models offered at different flow rates foruse with patient populations asdetermined by the clinician	Models offered at different flow rates foruse with patient populations asdetermined by the clinician
		Flow selector andFlow Outlet control	Yes
Nominal pressureoutlet		50 psig	50 psig
Cylinder On/Off	Yes	Yes
Filling Port	Yes	Yes
Contents Gauge	Yes / active	Yes / active
Excess Flow	No	Yes
Burst Disk	Yes	Yes
Single stage pistontype	Yes	Yes
Hand grip	Yes	Yes
Oxygen cylinder size	E	E
Description	Predicate DeviceK101792	Subject DeviceWOB
Access ports	Yes	Yes
MR Conditional	3.0 Tesla or less	3.0 Tesla or less
MaximumPressure Inlet	2000 - 3000 psig	2000 psig
DISS 1240 fittings	Yes	Yes
Flow rates	0-25 L/min	0-4 lpm
	Offered with difference flow rates	0-15 lpm
		0-25 L/min
Flow accuracy	±10%	±10%
Operating Pressurerange	Up to 3000 psig	300-2000 psig
Outlet pressurerange	48-65 psi	48-65 psi
OperatingTemperature Range		-20°F to 130°F
Standards	ISO 10524-3	ISO 10524-3
	ASTM G173-03	ASTM G175-03
	CGA E-7	CGA E-7
	CGA 540	CGA G4.1
	ASTM F2503-05*	ASTM F2052-15*
Materials ofConstruction	Basic materials include non-magneticmaterials to meet the ASTM F2052requirements for MR conditional use.	Basic materials include non-magneticmaterials to meet the ASTM F2052requirements for MR conditional use.

	Components are comprised on brass,aluminum, silicone, stainless steel	Components are comprised on brass,aluminum, silicone, stainless steel

Biocompatibility	Externally communicating, Tissue,Permanent Duration	Externally communicating, Tissue,Permanent Duration
		VOC
		PM

{5}------------------------------------------------

510(k) Summary Page 3 of 5 11/14/2016

*Note ASTM F2503-05 is a device marking and labeling standard whereas ASTM F2052-15 is the Testing and Performance standard.

The proposed Walk-O2-Bout® is viewed as substantially equivalent to the predicate device. In the table above, we have outlined the similarities and differences, if any, between the subject device and the predicate.

Indications -

The Walk-O2-Bout® is an integrated oxygen pressure regulator intended to provide . supplemental oxygen to patients. It is available in non-MR and MR conditional styles depending upon their respective environment of use.
. Discussion - This is similar to the predicate - K101792 - Linde - LIV (Linde Integrated Valve), there are no differences except clarification of the environments of use. This difference does not raise different questions of safety and effectiveness.

Patient Population -

It is intended for patient requiring supplemental oxygen, pediatric to adults. .

{6}------------------------------------------------

510(k) Summary Page 4 of 5 11/14/2016

. Discussion - The patient population is similar to the predicate - K101792 - Linde - LIV (Linde Integrated Valve).

Environment of Use -

For use in professional healthcare settings - hospitals, ambulatory, imaging centers, prehospital.
Discussion The environments of use are similar to the predicate K101792 Linde LIV . (Linde Integrated Valve).

Technology -

The principle of pressure regulating is based upon a single stage piston style with adjustable ● flow rates, flow gauge, burst disk, handle. The models and styles may vary with different flow rates, handles, oxygen fittings but in all cases the technology is similar.
. Discussion - This technology is similar to the predicate - K101792 - Linde - LIV (Linde Integrated Valve). There are no differences in technology, design, and model styles offered do not raise different questions of safety and effectiveness.

Specifications -

The performance specifications were evaluated and compared:

Maximum inlet pressure ●
Outlet pressure
Flow rate ranges 0-25 lpm available with different ranges for user preference ●
Flow rate and Pressure accuracy
Testing per ASTM F2052 for MR Conditional use .
. Meeting applicable CGA standards
Discussion The subject device is similar to the predicate in all faucets of performance and ● specifications and any differences do not raise different questions of safety and effectiveness.

Differences

As discussed in the above none of the differences raise different questions of safety and ● effectiveness.

Non-clinical Testing Summary -

We have performed a number of tests appropriate for the proposed device. These tests are listed in CGA E-7 as guidelines in design and manufacturing of high pressure valves. These tests include:

Acceptance Test Procedure
Low temperature ●
High temperature ●
Gas tightness (creep and leakage) ●
Flow regulation (Flow capacity)
Outlet Flow vs. inlet pressure
. Pressure regulation
. Static increment
. Pressure relief
Mechanical resistance ●
Endurance Inlet ●
Fill fitting endurance ●

{7}------------------------------------------------

510(k) Summary Page 5 of 5 11/14/2016

Safety ●
Drop ●
. Vibration and Shock
Proof pressure
Burst pressure
Ignition (ASTM G175)
MR Conditional Testing per ASTM F2052-15 (Note testing was done according to ASTM ● F2052-06).
. Biocompatibility

Bench Testing -

The performance testing is based upon standards for material, construction, ignition, MRI compatibility, and accuracy. Direct comparative testing is not required as the specifications as well understood.
Discussion - Based upon the testing and comparison to the standards and the available information on the predicate, we can find the subject device and the predicate substantially equivalent.

Biocompatibility of Materials -

The materials were evaluated per ASTM G175-03 for ignition and for biocompatibility via ● VOC and PM2 <. The testing demonstrated that the materials were safe for their intended use.
Discussion The materials were found to be compatible for their intended use and similar to ● the predicate.

Clinical Testing Summary -

There was no clinical testing.

Substantial Equivalence Conclusion: The sponsor has demonstrated through performance testing and non-clinical testing that the proposed device is substantially equivalent to the predicate.

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.