The intended use of the OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family is to administer hyperbaric oxygen therapy (HBOT) to treat patients with any of the below listed indications.

The following indications which are listed on the Undersea & Hyperbaric Medical Society (UHMS) web site: www.uhms.org.are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric Oxygen Therapy Committee.

1. Air or Gas Embolism
1. Carbon Monoxide Poisoning
a. Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
1. Clostridial Myositis and Myonecrosis (Gas Gangrene)
1. Crush Injury, Compartment Syndrome and Other Acute Ischemias
1. Decompression Sickness
1. Arterial Insufficiencies
a. Central Retinal Artery Occlusion
b. Enhancement of Healing in Selected Problem Wounds
1. Severe Anemia
1. Intracranial Abscess
1. Necrotizing Soft Tissue Infections
1. Osteomyelitis (Refractory)
1. Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
1. Compromised Grafts and Flaps
1. Acute Thermal Burn Injury

Device Description

The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family is comprised of a multiplace hyperbaric chamber of major subsystems that support the overall system operation, control, and monitoring.

The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber is a pressure vessel for human occupancy (PVHO) that is designed in a horizontally orientated cylindrical geometry. Chamber configurations vary based on the needs of the end user, and may be designed and manufactured in one (1), two (2), or three (3), compartment configurations. Patient capacities may range anywhere from four (4) to twenty-four (24) dependent on chamber size, number of compartments, or the direction provided by the customer to meet their needs. Lastly, maximum operating pressures range from 3ATA (~30psi) to 6ATA (~73.5psi), with each of the compartments designed to operate independently.

The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System design also complies with the hyperbaric facilities requirements specified in the FDA recognized consensus standard NFPA 99 and satisfies the requirements for protection against electrical, explosive, and fire hazards and associated facilities used for medical procedures at gauge pressures within the ranges: 0psi to 100psi.

The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chambers consists of the hyperbaric chamber itself and the major subsystems briefly described below. Each substantially equivalent to that which is contained in the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family predicate device (K152223).

AI/ML Overview

The provided document is a 510(k) premarket notification for a hyperbaric chamber system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that a new, AI-based device meets acceptance criteria.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details for an AI/ML medical device cannot be extracted from this document.

This document describes a change in the shape of a hyperbaric chamber (from rectangular to cylindrical) and demonstrates that it adheres to existing safety and manufacturing standards, mirroring the predicate device. It is a traditional medical device submission, not one pertaining to AI/ML.

No information regarding AI-specific acceptance criteria or a study proving an AI device meets them is present in the provided text.

The document details:

Device: OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family
Predicate Device: OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family (K152223)
Key Modification: Change from rectangular to cylindrical geometry.
Demonstration of Equivalence: Through adherence to recognized industry standards (ASME PVHO-1, NFPA 99, ISO 14971), non-clinical testing (Non-destructive Testing, Hydrostatic Testing, Fire Suppression System Testing, First Operational System Test, Software Validation Testing - note: "software validation" in this context refers to confirming the chamber's control software functions as intended, not AI/ML inference), and factory acceptance testing.

The document explicitly states: "The fundamental technology for this minor modification consists of a change in dimensional specifications; i.e. the predicate device (K152223) is a multiplace hyperbaric chamber with a rectangular geometry. The modified device is a multiplace hyperbaric chamber with a cylindrical geometry. This modification does not change the intended use, indications for use, and product labeling." It also says, "The validation / verification efforts performed for the OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family are identical to those performed for the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family (K152223) predicate device."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

March 22, 2017

OxyHeal Medical Systems, Inc. Edward J. Chomas VP. Regulatory Affairs 3224 Hoover Ave National City, California 91950

Re: K163109

Trade/Device Name: OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family Regulation Number: 21 CFR 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: Class II Product Code: CBF Dated: February 22, 2017 Received: February 23, 2017

Dear Edward Chomas:

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 (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 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,

Image /page/1/Picture/8 description: The image contains a signature and a name. The name is "Tina Kiang-S". The signature is to the left of the name and is illegible.

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)

K163109

Device Name

OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family

Indications for Use (Describe)

The following indications which are listed on the Undersea & Hyperbaric Medical Society (UHMS) web site: www.uhms.org are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric Oxygen Therapy Committee.

1. Air or Gas Embolism
1. Carbon Monoxide Poisoning
a. Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
1. Clostridial Myositis and Myonecrosis (Gas Gangrene)
1. Crush Injury, Compartment Syndrome and Other Acute Ischemias
1. Decompression Sickness
1. Arterial Insufficiencies
a. Central Retinal Artery Occlusion
b. Enhancement of Healing in Selected Problem Wounds
1. Severe Anemia
1. Intracranial Abscess
1. Necrotizing Soft Tissue Infections
1. Osteomyelitis (Refractory)
1. Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
1. Compromised Grafts and Flaps
1. Acute Thermal Burn Injury

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 008- 510(k) Summary for

OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family

Device Name: OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family

1. Submission Sponsor

OxyHeal® Medical Systems, Inc. 3224 Hoover Avenue National City, CA 91950 Phone: 619.336.2022 Fax: 619.336.2017 Contact: W. T. 'Ted' Gurneé, President & CEO

2. Submission Correspondent

OxyHeal® Medical Systems, Inc. 3224 Hoover Avenue National City, CA 91950 Phone: 619.336.2022 Fax: 619.336.2017 Contact: Edward J. Chomas, VP Regulatory Affairs Email: echomas@oxyheal-international.com

3. Date Prepared

28 October 2016

4. Device Name

Trade/Proprietary Name: OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family Common/Usual Name: Multiplace Hyperbaric Chamber Classification Name: Chamber, Hyperbaric Classification Regulation: 21 CBF 868.5470 Classification Panel: Anesthesiology Product Code: CBF Device Class: II

FDA Establishment Registration #: 1000519737

5. Predicate Device

OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family (K15223)

6. Device Description

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The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System is regulated by the same codes and standards as the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System, predicate device K152223.

1. NFPA 99 (2012 Edition): National Fire Protection Agency Standard for Health Care Facilities Chapter 14 - Hyperbaric Chambers
- FDA recognized consensus standard: (Recognition Number 1-67) .
1. ANSI/ASME PVHO-1 (2012 Edition): American National Standards Institute/American Society of Mechanical Engineers - Safety Standard for Pressure Vessels for Human Occupancy.
- FDA recognized consensus standard: (Recognition Number 1-78) ●
1. ISO 14971 (2012 Edition): International Standard Organization. Medical Devices Application of Risk Management to Medical Devices
- FDA recognized consensus standard: (Recognition Number 5-40) .

OxyHeal® Medical Systems, Inc. complies with the ASME/PVHO-1 the FDA recognized consensus code and standard requirements for materials, design, fabrication, and testing of the OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber. This includes: overall PVHO design, joint design, welding, non-destructive examination (NDE), viewports, penetrations, material reinforcement, pressure relief devices, piping, electrical outfitting, inspections, testing, risk analysis, documentation, and marking (labeling).

OxyHeal® Medical Systems, Inc.'s design control processes for the OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System are the same as those employed for the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System, predicate device K152223. These processes conform to the requirements of 21 CFR 820.30 and comply with the ISO 14971 FDA recognized consensus standard.

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6.1 Compressed Air System.

The compressed air system consists of two (2) rotary screw compressors capable of producing pressurized air that is then stored in an air receiver, which in turn is used to pressurize the hyperbaric chamber. Air is filtered prior to entering the hyperbaric chamber, resulting in a breathable quality. Compressed Gas Association (CGA) Grade "E" air as required by NFPA 99. Details of the parts and components comprising the compressed air system are identified and described in Table 1, Sub-table 1-3, Compressed Air System.

6.2 Fire Suppression System.

The fire suppression system (FSS) consists of both a fire deluge system (primary) and hand line system (secondary). Water (potable) for both systems is stored in pressure vessels manufactured to ASME standards. The fire deluge system is activated in the event of a fire in the hyperbaric chamber, while the hand line system is activated manually. This complies with NFPA 99:2012, Standard for Health Care Facilities Chapter 14 - Hyperbaric Facilities. Details of the parts and components comprising the FSS are identified and described in Table 1, Sub-table 1-4, Fire Suppression System.

6.3 Oxygen Delivery System

An oxygen (O2) delivery system is the primary source for supplying O2 to patients' breathing hoods inside the chamber. OxyHeal® Medical Systems, Inc. (OMS) provides the end user with the requirements needed for an OxyHeal® 4000 hyperbaric chamber system, and it is the end user's responsibility for supplying a system meeting these requirements. Examples of two types of O2 delivery systems and associated piping are identified and described in Table 1-5, Oxygen Delivery Requirements.

6.4 Built-in Breathing System

The built-in breathing system (BIBS) is capable of supplying each individually seated patient with breathing gas via standard oxygen hoods or free-flow masks. Breathing gasses can be O2, medical air, or a gas mixture. Details of the parts and components comprising the BIBS are identified and described in Table 1. Sub-table 1-6. Built-in Breathing System (BIBS).

6.5 Environmental Control System

The environmental control system (ECS) is used to manage the temperature (heating and cooling) and relative humidity (RH) of the hyperbaric chamber. Details of the parts and components comprising the ECS are identified and described in Table 1, Sub-table 1-7, Environmental Control System (ECS).

6.6 Control Console

The control console serves as the central location where a qualified hyperbaric chamber technician (CHT) is capable of controlling and monitoring an OxyHeal® 4000 product family hyperbaric chamber system. The Human-Machine Interface (HMI) touch screen control system installed in the operator control console is the primary location from which a hyperbaric chamber operator is able to initiate and monitor patient hyperbaric oxygen therapy (HBOT) treatments. Manual back-up control systems are built into the system for control of pressurization and depressurization from both inside and outside the hyperbaric chamber in the event that the automatic feature is inoperable for any reason.

From the HMI touchscreen, the operator is also able to control the following:

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Administer BIBS gasses a.
b. Analyze / monitor O2
Analyze/ monitor carbon dioxide (CO2) [option] c.
Analyze / monitor relative humidity inside the hyperbaric chamber d.
Control and monitor the temperature in the hyperbaric environment e.
f. Open and close doors in any hyperbaric chamber compartment
Turn ON/OFF and adjust the intensity of hyperbaric chamber lighting; and g.
h. Perform administrative functions.

The FSS is activated from the control console. A communications system is installed at the control console allowing a CHT to communicate to patients and inside attendants within the hyperbaric chamber. The equipment used for the analysis of chamber and BIBS line gasses is mounted at the control console. Chamber lighting is managed at the control console. The control console also contains equipment used to visually monitor patients inside of the hyperbaric chamber from a CCTV, and initiate and adjust patient audio and visual entertainment (radio, CD, DVD, and TV). Details of the parts and components comprising the control console are identified and described in Table 1-8, Control Console.

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Comparison Table 1. OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family Compared to the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family

1-1 Regulatory Info
Manufacturer	OxyHeal® MedicalSystems, Inc.	OxyHeal® MedicalSystems, Inc.	OxyHeal® 4000 FamilySummary Comparison toPredicate (K152223)
Trade Name	OxyHeal® 4000 Family(K163109)	OxyHeal® 5000 Family(K152223)
510(k) Number	K163109	K152223	Unique K numbers for eachproduct family have beenassigned.
Product Code	CBF	CBF	Identical
Regulation Number	21 CFR 868.5470	21 CFR 868.5470	Identical
Regulation Name	Hyperbaric Chamber	Hyperbaric Chamber	Identical
Indications for use:	As defined in theHyperbaric OxygenTherapy Committee Report,dated 2008	As defined in theHyperbaric OxygenTherapy CommitteeReport, dated 2008	Identical

1-2 Hyperbaric Chamber
Manufacturer	OxyHeal® Medical Systems, Inc.	OxyHeal® Medical Systems, Inc.	OxyHeal® 4000 Family Summary Comparison to Predicate (K152223)
Trade Name	OxyHeal® 4000 Family (K163109)	OxyHeal® 5000 Family (K152223)
Hyperbaric Chamber Code Design	1. ASME: Boiler and Pressure Code2. ASME PVHO-1: Safety Standard for Pressure Vessels for Human Occupancy.FDA consensus standard recognition no. 1-78.	1. ASME: Boiler and Pressure Code2. ASME PVHO-1: Safety Standard for Pressure Vessels for Human Occupancy.FDA consensus standard recognition no. 1-78.	Regardless of PVHO geometry:Rectangular: OxyHeal® 5000 [non-uniform distribution of pressure (worst case)] Cylindrical: OxyHeal® 4000 [uniform distribution of pressure] Codes and standards defining requirements for PVHO materials, design, fabrication, and testing are identical.
Calculations	ASME Section VIII, Div. 1	ASME Section VIII, Div. 1	Identical
1-2 Hyperbaric Chamber
ManufacturerTrade Name	OxyHeal® MedicalSystems, Inc.OxyHeal® 4000 Family(K163109)	OxyHeal® MedicalSystems, Inc.OxyHeal® 5000 Family(K152223)	OxyHeal® 4000 FamilySummary Comparison toPredicate (K152223)
Joint Design-	Design and fabricationshall be in accordancewith specified Divisions ofSection VIII of the ASMECode and the followingrequirements ofASME/PVHO-1, para. 1-7.1 (a) through (c)	Design and fabrication shallbe in accordance withspecified Divisions ofSection VIII of the ASMECode and the followingrequirements ofASME/PVHO-1, para. 1-7.1 (a) through (c)	Identical
ASME PVHO-1-Material	SA 516 Grade 70	SA 516 Grade 70	Identical
Stress Allowance-	Per ASME Section II	Per ASME Section II	Identical
Non-Destructive-Examinations(NDE)	NDE shall be performed inaccordance withASME/PVHO-1, para. 1-7.3	NDE shall be performed inaccordance withASME/PVHO-1, para. 1-7.3	Identical
Hydrostatic Test-	Hydrostatic testing to beperformed in accordancewith ASME Boiler andPressure Vessel Code,Section UG-99 @ 1.3times max. allowableworking pressure.	Hydrostatic testing to beperformed in accordancewith ASME Boiler andPressure Vessel Code,Section UG-99 @ 1.3 timesmax. allowable workingpressure.	Identical
HyperbaricChamber SystemFire Safety Design	NFPA 99, Chapter 14 -Hyperbaric Facilities.FDA consensus standardrecognition no. 1-76.	NFPA 99, Chapter 14 -Hyperbaric Facilities. FDAconsensus standardrecognition no. 1-76.	Regardless of PVHOgeometry:• Rectangular: OxyHeal®5000• Cylindrical: OxyHeal®4000This standard definingrequirements for protectionagainst electrical, explosive,and fire hazards inhyperbaric facilities isidentical
Operating Pressure	3.0ATA – 6.0ATA	3.0ATA – 6.0ATA	Identical
OperatingTemperature	50°F – 125°F	50°F – 125°F	Identical
Design Temperature	50°F – 125°F	50°F – 125°F	Identical
1-2 Hyperbaric Chamber
Manufacturer	OxyHeal® Medical Systems, Inc.	OxyHeal® Medical Systems, Inc.OxyHeal® 4000 Family Summary Comparison to Predicate (K152223)
Trade Name	OxyHeal® 4000 Family (K163109)	OxyHeal® 5000 Family (K152223)
Design Pressure	30psig – 75psig	30psig – 75psig
Design Life	90,000 cycles or 60 years, which ever happens first	90,000 cycles or 60 years, which ever happens first	Identical
Hydrostatic Pressure	39psi - 97.5psi	39psi - 97.5psi	Identical
Inspection Authority	Independent 3rd Party ASME Authorized Inspector (AI).Affix ASME Stamp on chamber data plate	Independent 3rd Party ASME Authorized Inspector (AI).Affix ASME Stamp on chamber data plate	IdenticalReference FDA recognized consensus standard: ASME PVHO-1 (Recognition Number 1-78)
Weight (lbs.)	12,600lbs to 100,000lbs	15,000lbs to 120,000lbs	Substantially equivalent
Dimensions	For all compartments, the following min/max apply	For all compartments, the following min/max apply	Substantially equivalent
Main Compartment (Lock) (ML)	Min: 60" Diameter x 10'LMax: 120" Diameter x 20'L	Min: 8' W x 7' H x 10'LMax: 11'W x 8'H x 20'L
Transfer Compartment (Lock) (EL)		Flat Heads, Rectangular Shell, and Rectangular Door Frames.
Inner Compartment (Lock) (IL)	Semi-elliptical or flat heads, cylindrical or semi-cylindrical shell, and circular or rectangular door frames
Total Volume	From 567 ft3 to 2434 ft3	600 ft3 to 2,600 ft3	Substantially equivalent
Medical Lock	CylindricalMin: 10 inch diameterMax: 16 inch diameter	CylindricalMin: 10 inch diameterMax: 16 inch diameter	Identical
Main Doorway Size	Rectangular DoorMin: 39.5" W x 65" HMax: 47.75" W x 75.5" H	Rectangular DoorMin: 44" W x 80" HMax: 52" W x 80" H	Substantially equivalent
1-2 Hyperbaric Chamber
Manufacturer	OxyHeal® MedicalSystems, Inc.	OxyHeal® 4000 FamilySummary Comparison toPredicate (K152223)
	OxyHeal® MedicalSystems, Inc.
Trade Name	OxyHeal® 4000 Family(K163109)
	OxyHeal® 5000 Family(K152223)
	Min: 33.5" DMax: 90" D
Penetrators	Maximum of 30Penetrations of 2" x 12"blocks.	Identical
Viewports(PVHO-1)	Minimum: One (1) perhyperbaric chamber.Maximum: Six (6) percompartment.Minimum: 8" Diameter,Maximum: 30" Diameter.	Identical
Compartment Relief	One (1) ASME certifiedpressure relief valve percompartment.30 psig to 75 psig	Identical
Compartment Drain	Minimum One (1) manualdrain in each compartment	Identical
Finish - Chamber	Sandblasted and finishedwith 2-part high qualityepoxy paint with glossyfinish.	Identical
Capacity MainCompartment	4 Patients Up to 24Patients	Identical
Hyperbaric Chamber Interior
Lighting Subsystem	LED lightsMin: 4Max: 15Chamber illuminationcomplies with paragraph14.2.3 of NFPA 99 (FDAconsensus std. recognitionno. 1-67).	Identical
BIBS withOverboard Dump	Four (4) to Twenty-Four(24), on demand gasdelivery.	Identical
Hoods withOverboard Dump	Four (4) to Twenty-Four(24), 1-100LPM delivery	Identical
	1-2 Hyperbaric Chamber
Manufacturer	OxyHeal® Medical Systems, Inc.	OxyHeal® Medical Systems, Inc.	OxyHeal® 4000 Family Summary Comparison to Predicate (K152223)
Trade Name	OxyHeal® 4000 Family (K163109)flow for hoods: 40-lpm.	OxyHeal® 5000 Family (K152223)flow for hoods: 40-lpm.
Depth Measurement	Digital with analog backup	Digital with analog backup	Identical
Pressure Transmitter	Ranges:Minimum = 0 psigMaximum = 75 psig	Ranges:Minimum = 0 psigMaximum = 75 psig	Identical
Temperature Sensor	75°F ± 5°F	75°F ± 5°F	Identical
Relative Humidity Sensor	0% - 100%	0% - 100%	Identical
Television (TV) System	24VDC LED TV Monitors. Customer specified. Two (2) or four (4) per treatment compartment	24VDC LED TV Monitors. Customer specified. Two (2) or four (4) per treatment compartment	Identical

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1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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flow meters. Minimum

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nsmitter	Minimum = 0 psigMaximum = 75 psig	Minimum = 0 psigMaximum = 75 psig
perature Sensor	75°F ± 5°F	75°F ± 5°F	Identical
ative Humiditysor	0% - 100%	0% - 100%	Identical
vision (TV)em	24VDC LED TVMonitors. Customerspecified.Two (2) or four (4) pertreatment compartment	24VDC LED TV Monitors.Customer specified.Two (2) or four (4) pertreatment compartment	Identical

1-3 Compressed Air System
Manufacturer	OxyHeal® MedicalSystems, Inc.	OxyHeal® MedicalSystems, Inc.	OxyHeal® 4000 FamilySummary Comparison toPredicate (K152223)
Trade Name	OxyHeal® 4000 Family(K163109)	OxyHeal® 5000 Family(K152223)
Air Compressors	Qty. two (2) rotary screwOperating range:Rated Power:208V ±10%, 3-ph, 60Hz -460V ±10%, 3-ph, 60HzMax Working Pressure:125psig - 217psigAir Delivery155 CFM - 288 CFM	Qty. two (2) rotary screwOperating range:Rated Power:208V ±10%, 3-ph, 60Hz -460V ±10%, 3-ph, 60HzMax Working Pressure:125psig - 217psigAir Delivery155 CFM - 288 CFM	Identical
Air Receiver	Ranges: Qty. 1 – Qty.5depending on space andlocation within clientfacility.	Ranges: Qty. 1 – Qty.5depending on space andlocation within clientfacility.	Substantially equivalent
- Design Code	ASME Boiler and PressureCode	ASME Boiler and PressureCode	Identical
- Calculations	ASME Section VIII, Div. 1	ASME Section VIII, Div. 1	Identical
- Joint Design	Joint design and fabricationshall be performed in	Joint design and fabricationshall be performed in	Identical
1-3 Compressed Air System
Manufacturer	OxyHeal® MedicalSystems, Inc.OxyHeal® 4000 Family(K163109)	OxyHeal® MedicalSystems, Inc.OxyHeal® 5000 Family(K152223)	OxyHeal® 4000 FamilySummary Comparison toPredicate (K152223)
Trade Name	accordance with UW-12and Table UW-12 ofASME Boiler and PressureVessel Code, Division, I,Section VIII	accordance with UW-12and Table UW-12 ofASME Boiler and PressureVessel Code, Division, I,Section VIII	Identical
Non--DestructiveExaminations(NDE)	Radiographic examinationand ultrasonic examinationshall be performed inaccordance with UW-51 ofASME Boiler and PressureVessel Code, Division, I,Section VIII	Radiographic examinationand ultrasonic examinationshall be performed inaccordance with UW-51 ofASME Boiler and PressureVessel Code, Division, I,Section VIII	Identical
	Ultrasonic examinationshall be performed inaccordance with UW-53and Appendix 12 of ASMEBoiler and Pressure VesselCode, Division, I, SectionVIII	Ultrasonic examinationshall be performed inaccordance with UW-53and Appendix 12 of ASMEBoiler and Pressure VesselCode, Division, I, SectionVIII	Identical
Hydrostatic-Test	Hydrostatic testing to beperformed in accordancewith ASME Boiler andPressure Vessel Code,Section UG-99 @ 1.3 timesmaximum allowableworking pressure.	Hydrostatic testing to beperformed in accordancewith ASME Boiler andPressure Vessel Code,Section UG-99 @ 1.3 timesmaximum allowableworking pressure.	Identical
Pressure VesselRelief	One (1) pressure reliefsatisfying the requirementsof ASME Boiler andPressure Vessel Code,Section UG-125.Rated at 200 psig	One (1) pressure reliefsatisfying the requirementsof ASME Boiler andPressure Vessel Code,Section UG-125.Rated at 200 psig	Identical
Filters			Identical
Liquid Separator-	Removes moisture from airusing centrifugal force	Removes moisture from airusing centrifugal force	Identical
Prefilter Filter-	5 micron element	5 micron element	Identical
Coalescing Filter-	1 micron element	1 micron element	Identical
Active Carbon-Filter	Charcoal element	Charcoal element	Identical
1-3 Compressed Air System
Manufacturer	OxyHeal® MedicalSystems, Inc.	OxyHeal® MedicalSystems, Inc.	OxyHeal® 4000 FamilySummary Comparison to
Trade Name	OxyHeal® 4000 Family(K163109)	OxyHeal® 5000 Family(K152223)	Predicate (K152223)
Particulate Filter	3 micron element	3 micron element	Identical
High EfficiencyFilter	.01 micron element	.01 micron element	Identical
Piping	ASTM B88	ASTM B88	Identical
Testing	OMS Factory AcceptanceTest (FAT)	OMS Factory AcceptanceTest (FAT)	Substantially Equivalent

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-て . (

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1-5 Oxygen Delivery Requirements
Manufacturer	OxyHeal® MedicalSystems, Inc.	OxyHeal® MedicalSystems, Inc.	OxyHeal® 4000 FamilySummary Comparison toPredicate (K152223)
Trade Name	OxyHeal® 4000 Family(K163109)	OxyHeal® 5000 Family(K152223)
Facility SuppliedGround Storage andBulk Liquid O2	(Customer Provided)Ranges:Gallons: 500-13,000SCF: 50K - 1.3M100psi - 150PSIPermitted by AuthorityHaving Jurisdiction (AHJ)	(Customer Provided)Ranges:Gallons: 500-13,000SCF: 50K - 1.3M100psi - 150PSIPermitted by AuthorityHaving Jurisdiction (AHJ)	Identical
or
Microbulk	(Customer Provided)Ranges:Gallons: 230-715SCF: 5,658 - 66,592100psi - 150PSIPermitted by AuthorityHaving Jurisdiction (AHJ)	(Customer Provided)Ranges:Gallons: 230-715SCF: 5,658 - 66,592100psi - 150PSIPermitted by AuthorityHaving Jurisdiction (AHJ)	Identical
Piping	ASTM B819	ASTM 819	Identical

1-6 Built In Breathing System (BIBS)
Manufacturer	OxyHeal® MedicalSystems, Inc.	OxyHeal® MedicalSystems, Inc.	OxyHeal® 4000 FamilySummary Comparison to
Trade Name	OxyHeal® 4000 Family(K163109)	OxyHeal® 5000 Family(K152223)	Predicate (K152223)
HP Oxygen	Cylinder Size: KPressure: 3000 psigCGA 346	Cylinder Size: KPressure: 3000 psigCGA 346	Identical
HP Medical Air	Cylinder Size: KPressure: 3000 psigCGA 346	Cylinder Size: KPressure: 3000 psigCGA 346	Identical
HP Mixed Gas (e.g.)- Nitrogen- Nitrox- Helium	Cylinder Size: KPressure: 3000 psig- CGA 580- CGA 326- CGA 580	Cylinder Size: KPressure: 3000 psig- CGA 580- CGA 326- CGA 580	Identical
Piping	ASTM B819	ASTM B819	Identical
Testing	OMS Factory AcceptanceTest (FAT)	OMS Factory AcceptanceTest (FAT)	Substantially Equivalent

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7. Intended Use and indications for Use

1. Air or Gas Embolism
1. Carbon Monoxide Poisoning
- a. Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
1. Clostridial Myositis and Myonecrosis (Gas Gangrene)

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1. Crush Injury, Compartment Syndrome and Other Acute Ischemias
1. Decompression Sickness
1. Arterial Insufficiencies
- a. Central Retinal Artery Occlusion
- b. Enhancement of Healing in Selected Problem Wounds
1. Severe Anemia
1. Intracranial Abscess
1. Necrotizing Soft Tissue Infections
1. Osteomyelitis (Refractory)
1. Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
1. Compromised Grafts and Flaps
1. Acute Thermal Burn Injury

There is no difference between the OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family and the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family in regards to intended use or these indications for use.

8. Technological Characteristics and Substantial Equivalence

The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family in this Special 510(k) submittal consists of a minor modification of the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family predicate device (K152223).

The fundamental technology for this minor modification consists of a change in dimensional specifications; i.e. the predicate device (K152223) is a multiplace hyperbaric chamber with a rectangular geometry. The modified device is a multiplace hyperbaric chamber with a cylindrical geometry. This modification does not change the intended use, indications for use, and product labeling. The design of the modified device conforms to the same three FDA recognized standards as the predicate device; two (2) of which are the design and manufacturing standards / codes. The company's design control procedures are the same for the predicate and modified device and conform to the requirements as specified in 21 CFR 820.30.

Table 1 provides a substantially equivalent comparison between the OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family and the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family; thereby providing more detailed information regarding the basis for the determination of substantial equivalence.

9. Non-Clinical Testing

In accordance with the requirements of the ASME PVHO-1 standard (the FDA consensus standard recognition number 1-78), the only test methods and /or examinations required for verifying the modification of the pressure vessel for human occupancy [(PVHO) or hyperbaric chamber] from a rectangular to a cylindrical geometry consists of certifying the weld integrity of the joint design and the integrity of the entire PVHO consist of non-destructive testing and hydrostatic testing. These are the identical tests required by the aforementioned standard and also performed on the OxyHeal® 5000 hyperbaric chambers (predicate device K152223). A description of the non-destructive tests and the hydrostatic test conducted for all OxyHeal® 4000 hyperbaric chambers is described below.

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9.1 Non-destructive Testing

There are four different types of non-destructive examinations (NDEs) which are used to verify the integrity of the structural welds comprising the OxyHeal® 4000 hyperbaric chamber structure.

Penetrant Examination (PE) is a color contrast procedure used to identify surface weld defects. a. OMS welders apply this liquid penetrant by spraying onto the surface of a root pass (1" pass) weld to ensure that the very base of the weld is without imperfections.
b. Ultrasonic Testing (UT) is a technique used to test the integrity of a weld using the propagation of ultrasonic sound waves into the steel material to detect internal flaws. This testing is contracted to an ASME qualified independent 3th party testing organization who provides a written copy of the results of this testing.
Radiographic Examinations (RT) is a method employed for weld testing which makes use of C. X-rays to verify the internal structure and integrity of the welded steel material. This testing is contracted to an ASME qualified independent 3th party testing organization who provides a written copy of the results of this testing.
d. Magnetic Particle Examination (MT) is process which propagates a magnetic field into the welded steel and is used for detecting surface and slightly subsurface discontinuities. This testing is contracted to an ASME qualified independent 3d party testing organization who provides a written copy of the results of this testing.

Hydrostatic Testing 9.2

A Standard Hydrostatic Test is conducted in accordance with the ASME Section VIII, Division 1 Code paragraph UG-99. This test consists of completely filling the OxyHeal 4000 hyperbaric chamber with water and pressure testing at 1.3 times the maximum allowable working pressure (MAWP) of the PVHO. Each viewport is installed in its location and hydrostatically tested as part of the overall structural test. This test is witnessed by an ASME qualified independent 3d party authorized inspector (AI). The AI will also review/ approve the nameplate to be affixed on the PVHO to ensure all applicable data, the certification mark, and designator are stamped into the nameplate. Upon successful completion of this testing and review of the nameplate data, the manufacturer (OxyHeal® Medical Systems, Inc.) and the AI will sign the Form U-1 Manufacturer's Data Report for Pressure Vessels as required by the provisions of the ASME Boiler and Pressure Vessel Code Rules, Section VIII, Division 1. Once the Form U-i1 has been signed, OMS is authorized to affix the nameplates to the PVHO.

In parallel, OxyHeal® Medical Systems, Inc. is responsible for signing the FORM PVHO-1 Manufacturer's Data Report for Pressure Vessels for Human Occupancy as required by the provisions of ASME PVHO-1 certifying the design and certification of compliance of the PVHO.

9.3 Other V&V Testing

The validation / verification efforts performed for the OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family are identical to those performed for the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family (K152223) predicate device.

The following V&V activities listed in this Special 510(k) provide an overview of the V&V activities performed for the predicate device (K152223) and apply to the OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family.

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9.3.1 Fire Suppression System Testing

A Fire Suppression System (FSS) test was conducted at the completion of the hydrostatic test to ensure that the fire deluge system water spray system and the hand line met the requirements of the FDA recognized consensus standard NFPA 99 (Recognition Number 1-67).

First Operational System Test 9.3.2

A first operational system test (FOST) was performed to verify that the system design met each of the specification requirements. This testing includes the following items specified in the OxyHeal® 4000 hyperbaric chamber system product family as defined in the User Design Specification satisfies the requirements of the FDA recognized consensus standard: ASME PVHO-1 (Recognition Number 1-78).

a. Testing of the minimum and maximum pressurization rates
Testing of the minimum and maximum depressurization rates b.
Testing of the minimum and maximum ventilation rates C.
Testing of the conditions under which these rates are to be maintained d.
Testing of the patient gas delivery systems and flow meter range e.
f. Testing of the chamber pressurization and ventilation gas for meeting requirements for CGA Grade E

9.3.3 Software Validation Testing.

A software validation test was conducted to validate that observed output of designated hyperbaric chamber control functions met the output that they were designed to perform. This testing includes the following items specified in the OxyHeal® 4000 hyperbaric chamber system product family as defined in the User Design Specification.

Testing of the minimum and maximum pressurization rates a.
Testing of the minimum and maximum depressurization rates b.
Testing of the minimum and maximum ventilation rates C.
d. Testing of the conditions under which these rates are to be maintained
e. Testing of the patient gas delivery systems and flow meter range

9.3.4 Factory Acceptance Test

A Factory Acceptance Test (FAT) was performed to verify that the system is able to perform all required operational functions. The FAT is witnessed by and signed off by an independent 3rd party Authorized Inspector (AI). This testing satisfies the requirements of the FDA recognized consensus standards: ASME PVHO-1 (Recognition Number 1-78).and NFPA 99 (Recognition Number 1-67).

10 Conclusion

It has been shown in this Special 510(k) submission that the OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family as designed, manufactured, and tested does not raise any different questions regarding its safety and effectiveness, there is no difference in the indications and intended use, is designed to the same FDA recognized consensus standards, and is determined to be substantially equivalent to the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family predicate device (K152223).

Regulation Number and Section

§ 868.5470 Hyperbaric chamber.

(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).

1-7 Environmental Control System (ECS)
Manufacturer	OxyHeal® MedicalSystems, Inc.	OxyHeal® MedicalSystems, Inc.	OxyHeal® 4000 FamilySummary Comparison toPredicate (K152223)
Trade Name	OxyHeal® 4000 Family(K163109)	OxyHeal® 5000 Family(K152223)
EnvironmentalControl System	Chamber temperature andhumidity control complieswith paragraph 14.2.4.3 ofNFPA 99 (FDA consensusstd. recognition no. 1-67).	Chamber temperature andhumidity control complieswith paragraph 14.2.4.3 ofNFPA 99 (FDA consensusstd. recognition no. 1-67).	Identical
EnvironmentalControl Unit (ECU)	Quantity ranges based onnumber of chambercompartments:1 Compartment: Qty. 12 Compartment: Qty. 23 Compartment: Qty. 3	Quantity ranges based onnumber of chambercompartments:1 Compartment: Qty. 12 Compartment: Qty. 23 Compartment: Qty. 3	Identical
ECU PhysicalDimensions	24"L X 24"W X 36"H	24"L X 24"W X 36"H	Identical
ECU Heat Load(Heat Mode)	~ 12000 BTU/HR	~ 12000 BTU/HR	Identical
ECU Heat Load(Heat Mode)	~ 16000 BTU/HR	~ 16000 BTU/HR	Identical
ECU Coolant PumpMotor	2.2 AMPS	2.2 AMPS	Identical
ECU Coolant PumpFlow Rate	4.2 GPM @ 24 FT HEAD	4.2 GPM @ 24 FT HEAD	Identical
Testing	OMS Factory AcceptanceTest (FAT)	OMS Factory AcceptanceTest (FAT)	Substantially Equivalent
1-8 Control Console
Manufacturer	OxyHeal® MedicalSystems, Inc.	OxyHeal® MedicalSystems, Inc.	OxyHeal® 4000 FamilySummary Comparisonto Predicate (K152223)
Trade Name	OxyHeal® 4000 Family(K163109)	OxyHeal® 5000 Family(K152223)
HMI TouchscreenMonitor	Quantity ranges based onnumber of chambercompartments (Comp):1 Comp: Qty. 12 Comp: Qty. 1-23 Comp: Qty. 2-3	Quantity ranges based onnumber of chambercompartments (Comp):1 Comp: Qty. 12 Comp: Qty. 1-23 Comp: Qty. 2-3	Identical
	Primary method ofcontrolling chamber Primary means formonitoring chambersystem status	Primary method ofcontrolling chamber Primary means formonitoring chambersystem status
Life SupportControls	Automatic pressurization &depressurization withmanual back-up from bothinside and outside eachchamber compartment.	Automatic pressurization &depressurization withmanual back-up from bothinside and outside eachchamber compartment.	Identical
EmergencyDepressurization	Chamber depressurizationcomplies with paragraph14.2.4.5 of NFPA 99 (FDAconsensus std. recognitionno. 1-67).	Chamber depressurizationcomplies with paragraph14.2.4.5 of NFPA 99 (FDAconsensus std. recognitionno. 1-67).	Identical
Ventilation	Automatic chamberventilation with manualback-up. Ranges are asfollows:- Min = 6 cfm/min- Max = 48 cfm/min ± 1FSW stabilityChamber ventilationcomplies with paragraph14.2.4.1 of NFPA 99 (FDAconsensus std. recognitionno. 1-67).	Automatic chamberventilation with manualback-up. Ranges are asfollows:- Min = 6 cfm/min- Max = 48 cfm/min ± 1FSW stabilityChamber ventilationcomplies with paragraph14.2.4.1 of NFPA 99 (FDAconsensus std. recognitionno. 1-67).	Identical
ProgrammableLogic Controller(PLC)	Controls the operatorinitiated actions at the HMItouch screen bycommunicating with various	Controls the operatorinitiated actions at the HΜΙtouch screen bycommunicating with various	Identical
1-8 Control Console
Manufacturer	OxyHeal® MedicalSystems, Inc.	OxyHeal® MedicalSystems, Inc.	OxyHeal® 4000 FamilySummary Comparisonto Predicate (K152223)
Trade Name	OxyHeal® 4000 Family(K163109)	OxyHeal® 5000 Family(K152223)
	devices managing theperformance of chambersubsystems	devices managing theperformance of chambersubsystems
Keyboard andMouse #1 and #2	Alternate method forproviding input to controlhyperbaric chamber	Alternate method forproviding input to controlhyperbaric chamber	Identical
	Quantity ranges based onnumber of chambercompartments (Comp):1 Comp: Qty. 12 Comp: Qty. 1-23 Comp: Qty. 2-3	Quantity ranges based onnumber of chambercompartments (Comp):1 Comp: Qty. 12 Comp: Qty. 1-23 Comp: Qty. 2-3
Patient Monitor,Quad Screen	Visual method formonitoring patientsundergoing HBOT	Visual method formonitoring patientsundergoing HBOT	Identical
	Quantity ranges based onnumber of chambercompartments (Comp):1 Comp: Qty. 12 Comp: Qty. 1-23 Comp: Qty. 2-3	Quantity ranges based onnumber of chambercompartments (Comp):1 Comp: Qty. 12 Comp: Qty. 1-23 Comp: Qty. 2-3
Fire SuppressionSystem (FSS)ActivationPushbutton	When depressed, activatesFSS and illuminates green	When depressed, activatesFSS and illuminates green	Identical
	Quantity ranges based onnumber of chambercompartments (Comp):1 Comp: Qty. 12 Comp: Qty. 23 Comp: Qty. 3	Quantity ranges based onnumber of chambercompartments (Comp):1 Comp: Qty. 12 Comp: Qty. 23 Comp: Qty. 3
CommunicationsSystem	Primary: Wireless telephoneSecondary: IntercomTertiary: (OPTION) Soundpowered backup	Primary: Wireless telephoneSecondary: IntercomTertiary: (OPTION) Soundpowered backup	Identical
Gas Analysis System	Determines the O2 and CO2from within a treatmentcompartment or from theBIBS gases.	Determines the O2 and CO2from within a treatmentcompartment or from theBIBS gases.	Identical
1-8 Control Console
Manufacturer	OxyHeal® Medical Systems, Inc.OxyHeal® 4000 Family (K163109)	OxyHeal® Medical Systems, Inc.OxyHeal® 5000 Family (K152223)	OxyHeal® 4000 Family Summary Comparisonto Predicate (K152223)
Trade Name
	Monitor w/SDA Carbon DioxideMonitor (OPTION add on)	Monitor w/SDA Carbon DioxideMonitor (OPTION add on)
	O₂ @ 0% - 100% ± 1%CO₂ @ 0 – 5250NOTE parts per million(ppm) ± 25ppm.	O₂ @ 0% - 100% ± 1%CO₂ @ 0 – 5250NOTE parts per million(ppm) ± 25ppm.
	Oxygen monitoringcomplies with paragraph14.2.8.4 of NFPA 99 (FDAconsensus std. recognitionno. 1-67).	Oxygen monitoringcomplies with paragraph14.2.8.4 of NFPA 99 (FDAconsensus std. recognitionno. 1-67).
Flowmeters	Controls the flow of gas tothe gas analyzer so as not todamage the analyzersinternal parts.	Controls the flow of gas tothe gas analyzer so as not todamage the analyzersinternal parts.	Identical
Selector Switch	Two (2) per compartmentUser adjustable and used forselecting between zero gas,calibration gas or gas flowfrom the chambercompartment.	Two (2) per compartmentUser adjustable and used forselecting between zero gas,calibration gas or gas flowfrom the chambercompartment.	Identical
	One (1) per compartment	One (1) per compartment