Walk-O2-Bout

K161472 · Essex Industries, Inc. · ECX · Nov 18, 2016 · Anesthesiology

Device Facts

• Record ID: K161472
• Device Name: Walk-O2-Bout
• Applicant: Essex Industries, Inc.
• Product Code: ECX · Anesthesiology
• Decision Date: Nov 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2700
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended 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 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 Story

Walk-O2-Bout® is an integrated portable oxygen delivery system; consists of a pressure regulator designed for installation on medical-grade aluminum cylinders (0.750-16 UNF-2B threads). Device reduces high-pressure oxygen (300-2000 psig) to a nominal 50 psig for delivery. Features include flow selector valves (0-25 L/min), threaded fill fitting (CGA 540), DISS 1240 check valve for ventilator supply, and vinyl-dipped carrying handle. Operated by clinicians in hospitals, sub-acute care, and transport settings. Provides supplemental oxygen to patients; output flow is controlled by the clinician based on patient needs. MR-conditional models allow use in imaging suites. Benefits include portable, regulated oxygen delivery with ignition fault resistance.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including performance testing for gas tightness, flow regulation, pressure relief, mechanical resistance, endurance, ignition (ASTM G175), and MR-conditional testing (ASTM F2052-15).

Technological Characteristics

Materials: brass, aluminum, silicone, stainless steel. Principle: single-stage piston pressure regulator. Energy: pneumatic (compressed oxygen). Form factor: cylinder-mounted regulator. Connectivity: none. Sterilization: not specified. Standards: ISO 10524-3, CGA E-7, CGA G4.1, ASTM G175-03, ASTM F2052-15.

Indications for Use

Indicated for pediatric and adult patients requiring supplemental oxygen in hospital, sub-acute care, and pre-hospital/ground transport settings. Includes MR-conditional models for use in static magnetic fields up to 3.0 T.

Regulatory Classification

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.

Predicate Devices

• Linde – LIV Portable Oxygen System (K101792)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known)

#### K161472

Device Name

#### Walk-O2-Bout®

Indications for Use (Describe)

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.

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

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#### 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 Engineering<br>Tel – 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 Valve<br>21 CFR 868.2700, Class I |
| Predicate Device: | K101792 – Linde – LIV Portable Oxygen System |

#### 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 .

#### 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

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#### 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 Device<br>K101792 | Subject Device<br>WOB<br>WALK-O2-BOUT® | |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | LIV | | |
| Device Classification<br>& Product code | Class I / ECX<br>868.2700 | Class I / ECX<br>868.2700 | |
| Prescription Device: | Yes | Yes | |
| Indications for Use | The LIV is an integrated portable<br>oxygen delivery system intended to<br>provide supplemental oxygen to<br>pediatrics and adults. The device is MR-<br>conditional (per ASTM standard 2503-<br>05*), and intended for use during MR<br>imaging for MRI systems up to 3.0T. Rx<br>only. | The Walk-O2-Bout® is an integrated<br>portable oxygen delivery system<br>intended to provide supplemental<br>oxygen to pediatrics and adults in<br>hospital, sub-acute care, and pre-hospital<br>/ ground transport settings. It is offered<br>in models that are MR-conditional (per<br>ASTM F2052-15), and intended for use<br>during MR imaging for static magnetic<br>fields of 3.0 T or less. | |
| | Environments of<br>Use | Compressed gas cylinders in service or<br>in storage shall be stabilized or<br>otherwise secured to prevent falling and<br>rolling. | Compressed gas cylinders in service or<br>in storage shall be stabilized or<br>otherwise secured to prevent falling and<br>rolling. |
| | | Hospital, sub-acute care, and pre-<br>hospital / ground transport settings | Hospital, sub-acute care, and pre-<br>hospital / ground transport settings |
| | | Imaging suites | Imaging suites |
| | | Patient requiring supplemental oxygen | Patient requiring supplemental oxygen |
| | Patient population | Models offered at different flow rates for<br>use with patient populations as<br>determined by the clinician | Models offered at different flow rates for<br>use with patient populations as<br>determined by the clinician |
| | | Flow selector and<br>Flow Outlet control | Yes |
| Nominal pressure<br>outlet | | 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 piston<br>type | Yes | Yes | |
| Hand grip | Yes | Yes | |
| Oxygen cylinder size | E | E | |
| Description | Predicate Device<br>K101792 | Subject Device<br>WOB | |
| Access ports | Yes | Yes | |
| MR Conditional | 3.0 Tesla or less | 3.0 Tesla or less | |
| Maximum<br>Pressure 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 Pressure<br>range | Up to 3000 psig | 300-2000 psig | |
| Outlet pressure<br>range | 48-65 psi | 48-65 psi | |
| Operating<br>Temperature 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 of<br>Construction | Basic materials include non-magnetic<br>materials to meet the ASTM F2052<br>requirements for MR conditional use. | Basic materials include non-magnetic<br>materials to meet the ASTM F2052<br>requirements for MR conditional use. | |
| | | | |
| | Components are comprised on brass,<br>aluminum, silicone, stainless steel | Components are comprised on brass,<br>aluminum, silicone, stainless steel | |
| | | | |
| Biocompatibility | Externally communicating, Tissue,<br>Permanent Duration | Externally communicating, Tissue,<br>Permanent Duration | |
| | | VOC | |
| | | PM | |

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#### 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. .

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#### 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 ●

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#### 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.