OxyHeal 4000 Multiplace Hyperbaric Chamber Family

K163109 · Oxyheal Medical Systems, Inc. · CBF · Mar 22, 2017 · Anesthesiology

Device Facts

• Record ID: K163109
• Device Name: OxyHeal 4000 Multiplace Hyperbaric Chamber Family
• Applicant: Oxyheal Medical Systems, Inc.
• Product Code: CBF · Anesthesiology
• Decision Date: Mar 22, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 2. Carbon Monoxide Poisoning a. Carbon Monoxide Poisoning Complicated by Cyanide Poisoning 3. Clostridial Myositis and Myonecrosis (Gas Gangrene) 4. Crush Injury, Compartment Syndrome and Other Acute Ischemias 5. Decompression Sickness 6. Arterial Insufficiencies a. Central Retinal Artery Occlusion b. Enhancement of Healing in Selected Problem Wounds 7. Severe Anemia 8. Intracranial Abscess 9. Necrotizing Soft Tissue Infections 10. Osteomyelitis (Refractory) 11. Delayed Radiation Injury (Soft Tissue and Bony Necrosis) 12. Compromised Grafts and Flaps 13. Acute Thermal Burn Injury

Device Story

Multiplace hyperbaric chamber system for administering hyperbaric oxygen therapy (HBOT). System comprises a cylindrical pressure vessel for human occupancy (PVHO) with 1-3 compartments; capacity 4-24 patients. Operates at 3-6 ATA. Inputs include compressed air (rotary screw compressors) and breathing gases (O2, medical air, mixtures) via built-in breathing system (BIBS). Controlled by a central console with HMI touchscreen; operator (qualified hyperbaric chamber technician) monitors chamber pressure, O2/CO2 levels, temperature, and humidity. Includes fire suppression (deluge/hand line), environmental control, and patient entertainment systems. Output is a pressurized, controlled environment for clinical treatment. Affects clinical decision-making by providing controlled hyperbaric environment for indicated conditions; benefits patients through therapeutic oxygen delivery.

Clinical Evidence

Bench testing only. Verification included non-destructive testing (penetrant, ultrasonic, radiographic, magnetic particle), hydrostatic testing at 1.3x MAWP, fire suppression system testing, and first operational system testing (FOST) to verify pressurization/depressurization/ventilation rates and gas delivery accuracy. Software validation confirmed control functions met design specifications.

Technological Characteristics

Cylindrical pressure vessel (PVHO) constructed of SA 516 Grade 70 steel. Complies with ASME PVHO-1, NFPA 99, and ISO 14971. Operating pressure 3-6 ATA. Features rotary screw air compressors, fire deluge/hand line suppression, BIBS, and environmental control (temp/humidity). Control console uses HMI touchscreen and PLC. Connectivity includes CCTV and entertainment systems. Sterilization/cleaning per facility protocols for hyperbaric environments.

Indications for Use

Indicated for patients requiring hyperbaric oxygen therapy for conditions including air/gas embolism, carbon monoxide poisoning (with/without cyanide), gas gangrene, crush injury/compartment syndrome, decompression sickness, arterial insufficiencies (central retinal artery occlusion, problem wounds), severe anemia, intracranial abscess, necrotizing soft tissue infections, refractory osteomyelitis, delayed radiation injury, compromised grafts/flaps, and acute thermal burns.

Regulatory Classification

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).

Predicate Devices

• OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family (K152223)

Submission Summary (Full Text)

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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 [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,

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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
- 2. Carbon Monoxide Poisoning
- a. Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
- 3. Clostridial Myositis and Myonecrosis (Gas Gangrene)
- 4. Crush Injury, Compartment Syndrome and Other Acute Ischemias
- 5. Decompression Sickness
- 6. Arterial Insufficiencies
- a. Central Retinal Artery Occlusion
- b. Enhancement of Healing in Selected Problem Wounds
- 7. Severe Anemia
- 8. Intracranial Abscess
- 9. Necrotizing Soft Tissue Infections
- 10. Osteomyelitis (Refractory)
- 11. Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
- 12. Compromised Grafts and Flaps
- 13. Acute Thermal Burn Injury

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|--|
| <div style="display:flex; align-items:center;"><span style="margin-right:5px;"> </span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | |
| <div style="display:flex; align-items:center;"><span style="margin-right:5px;"> </span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | |

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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: [phone] Fax: [phone] Contact: W. T. 'Ted' Gurneé, President & CEO

## 2. Submission Correspondent

OxyHeal® Medical Systems, Inc. 3224 Hoover Avenue National City, CA 91950 Phone: [phone] Fax: [phone] Contact: Edward J. Chomas, VP Regulatory Affairs Email: [e-mail]

## 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

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.

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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 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) .
- 2. 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) ●
- 3. 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).

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.

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.

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).

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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® Medical<br>Systems, Inc. | OxyHeal® Medical<br>Systems, Inc. | OxyHeal® 4000 Family<br>Summary Comparison to<br>Predicate (K152223) |
| Trade Name | OxyHeal® 4000 Family<br>(K163109) | OxyHeal® 5000 Family<br>(K152223) | |
| 510(k) Number | K163109 | K152223 | Unique K numbers for each<br>product family have been<br>assigned. |
| 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 the<br>Hyperbaric Oxygen<br>Therapy Committee Report,<br>dated 2008 | As defined in the<br>Hyperbaric Oxygen<br>Therapy Committee<br>Report, 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 Code<br>2. ASME PVHO-1: Safety Standard for Pressure Vessels for Human Occupancy.<br>FDA consensus standard recognition no. 1-78. | 1. ASME: Boiler and Pressure Code<br>2. ASME PVHO-1: Safety Standard for Pressure Vessels for Human Occupancy.<br>FDA consensus standard recognition no. 1-78. | Regardless of PVHO geometry:<br>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 | | | |
| Manufacturer<br>Trade Name | OxyHeal® Medical<br>Systems, Inc.<br>OxyHeal® 4000 Family<br>(K163109) | OxyHeal® Medical<br>Systems, Inc.<br>OxyHeal® 5000 Family<br>(K152223) | OxyHeal® 4000 Family<br>Summary Comparison to<br>Predicate (K152223) |
| Joint Design<br>- | Design and fabrication<br>shall be in accordance<br>with specified Divisions of<br>Section VIII of the ASME<br>Code and the following<br>requirements of<br>ASME/PVHO-1, para. 1-<br>7.1 (a) through (c) | Design and fabrication shall<br>be in accordance with<br>specified Divisions of<br>Section VIII of the ASME<br>Code and the following<br>requirements of<br>ASME/PVHO-1, para. 1-<br>7.1 (a) through (c) | Identical |
| ASME PVHO-1<br>-<br>Material | SA 516 Grade 70 | SA 516 Grade 70 | Identical |
| Stress Allowance<br>- | Per ASME Section II | Per ASME Section II | Identical |
| Non-Destructive<br>-<br>Examinations<br>(NDE) | NDE shall be performed in<br>accordance with<br>ASME/PVHO-1, para. 1-<br>7.3 | NDE shall be performed in<br>accordance with<br>ASME/PVHO-1, para. 1-<br>7.3 | Identical |
| Hydrostatic Test<br>- | Hydrostatic testing to be<br>performed in accordance<br>with ASME Boiler and<br>Pressure Vessel Code,<br>Section UG-99 @ 1.3<br>times max. allowable<br>working pressure. | Hydrostatic testing to be<br>performed in accordance<br>with ASME Boiler and<br>Pressure Vessel Code,<br>Section UG-99 @ 1.3 times<br>max. allowable working<br>pressure. | Identical |
| Hyperbaric<br>Chamber System<br>Fire Safety Design | NFPA 99, Chapter 14 -<br>Hyperbaric Facilities.<br>FDA consensus standard<br>recognition no. 1-76. | NFPA 99, Chapter 14 -<br>Hyperbaric Facilities. FDA<br>consensus standard<br>recognition no. 1-76. | Regardless of PVHO<br>geometry:<br>• Rectangular: OxyHeal®<br>5000<br>• Cylindrical: OxyHeal®<br>4000<br>This standard defining<br>requirements for protection<br>against electrical, explosive,<br>and fire hazards in<br>hyperbaric facilities is<br>identical |
| Operating Pressure | 3.0ATA – 6.0ATA | 3.0ATA – 6.0ATA | Identical |
| Operating<br>Temperature | 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.<br>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).<br>Affix ASME Stamp on chamber data plate | Independent 3rd Party ASME Authorized Inspector (AI).<br>Affix ASME Stamp on chamber data plate | Identical<br>Reference 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'L<br>Max: 120" Diameter x 20'L | Min: 8' W x 7' H x 10'L<br>Max: 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 | Cylindrical<br>Min: 10 inch diameter<br>Max: 16 inch diameter | Cylindrical<br>Min: 10 inch diameter<br>Max: 16 inch diameter | Identical |
| Main Doorway Size | Rectangular Door<br>Min: 39.5" W x 65" H<br>Max: 47.75" W x 75.5" H | Rectangular Door<br>Min: 44" W x 80" H<br>Max: 52" W x 80" H | Substantially equivalent |
| 1-2 Hyperbaric Chamber | | | |
| Manufacturer | OxyHeal® Medical<br>Systems, Inc. | OxyHeal® 4000 Family<br>Summary Comparison to<br>Predicate (K152223) | |
| | OxyHeal® Medical<br>Systems, Inc. | | |
| Trade Name | OxyHeal® 4000 Family<br>(K163109) | | |
| | OxyHeal® 5000 Family<br>(K152223) | | |
| | Min: 33.5" D<br>Max: 90" D | | |
| Penetrators | Maximum of 30<br>Penetrations of 2" x 12"<br>blocks. | Identical | |
| Viewports<br>(PVHO-1) | Minimum: One (1) per<br>hyperbaric chamber.<br>Maximum: Six (6) per<br>compartment.<br>Minimum: 8" Diameter,<br>Maximum: 30" Diameter. | Identical | |
| Compartment Relief | One (1) ASME certified<br>pressure relief valve per<br>compartment.<br>30 psig to 75 psig | Identical | |
| Compartment Drain | Minimum One (1) manual<br>drain in each compartment | Identical | |
| Finish - Chamber | Sandblasted and finished<br>with 2-part high quality<br>epoxy paint with glossy<br>finish. | Identical | |
| Capacity Main<br>Compartment | 4 Patients Up to 24<br>Patients | Identical | |
| Hyperbaric Chamber Interior | | | |
| Lighting Subsystem | LED lights<br>Min: 4<br>Max: 15<br>Chamber illumination<br>complies with paragraph<br>14.2.3 of NFPA 99 (FDA<br>consensus std. recognition<br>no. 1-67). | Identical | |
| BIBS with<br>Overboard Dump | Four (4) to Twenty-Four<br>(24), on demand gas<br>delivery. | Identical | |
| Hoods with<br>Overboard Dump | Four (4) to Twenty-Four<br>(24), 1-100LPM delivery | Identical | |
| | <b>1-2 Hyperbaric Chamber</b> | | |
| Manufacturer | OxyHeal® Medical Systems, Inc. | OxyHeal® Medical Systems, Inc. | OxyHeal® 4000 Family Summary Comparison to Predicate (K152223) |
| Trade Name | OxyHeal® 4000 Family (K163109)<br>flow for hoods: 40-lpm. | OxyHeal® 5000 Family (K152223)<br>flow for hoods: 40-lpm. | |
| Depth Measurement | Digital with analog backup | Digital with analog backup | Identical |
| Pressure Transmitter | Ranges:<br>Minimum = 0 psig<br>Maximum = 75 psig | Ranges:<br>Minimum = 0 psig<br>Maximum = 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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flow meters. Minimum

flow meters. Minimum

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| nsmitter | Minimum = 0 psig<br>Maximum = 75 psig | Minimum = 0 psig<br>Maximum = 75 psig | |
|-----------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------|
| perature Sensor | 75°F ± 5°F | 75°F ± 5°F | Identical |
| ative Humidity<br>sor | 0% - 100% | 0% - 100% | Identical |
| vision (TV)<br>em | 24VDC LED TV<br>Monitors. Customer<br>specified.<br>Two (2) or four (4) per<br>treatment compartment | 24VDC LED TV Monitors.<br>Customer specified.<br>Two (2) or four (4) per<br>treatment compartment | Identical |

| 1-3 Compressed Air System | | | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Manufacturer | OxyHeal® Medical<br>Systems, Inc. | OxyHeal® Medical<br>Systems, Inc. | OxyHeal® 4000 Family<br>Summary Comparison to<br>Predicate (K152223) |
| Trade Name | OxyHeal® 4000 Family<br>(K163109) | OxyHeal® 5000 Family<br>(K152223) | |
| Air Compressors | Qty. two (2) rotary screw<br>Operating range:<br>Rated Power:<br>208V ±10%, 3-ph, 60Hz -<br>460V ±10%, 3-ph, 60Hz<br>Max Working Pressure:<br>125psig - 217psig<br>Air Delivery<br>155 CFM - 288 CFM | Qty. two (2) rotary screw<br>Operating range:<br>Rated Power:<br>208V ±10%, 3-ph, 60Hz -<br>460V ±10%, 3-ph, 60Hz<br>Max Working Pressure:<br>125psig - 217psig<br>Air Delivery<br>155 CFM - 288 CFM | Identical |
| Air Receiver | Ranges: Qty. 1 – Qty.5<br>depending on space and<br>location within client<br>facility. | Ranges: Qty. 1 – Qty.5<br>depending on space and<br>location within client<br>facility. | Substantially equivalent |
| - Design Code | ASME Boiler and Pressure<br>Code | ASME Boiler and Pressure<br>Code | Identical |
| - Calculations | ASME Section VIII, Div. 1 | ASME Section VIII, Div. 1 | Identical |
| - Joint Design | Joint design and fabrication<br>shall be performed in | Joint design and fabrication<br>shall be performed in | Identical |
| 1-3 Compressed Air System | | | |
| Manufacturer | OxyHeal® Medical<br>Systems, Inc.<br>OxyHeal® 4000 Family<br>(K163109) | OxyHeal® Medical<br>Systems, Inc.<br>OxyHeal® 5000 Family<br>(K152223) | OxyHeal® 4000 Family<br>Summary Comparison to<br>Predicate (K152223) |
| Trade Name | accordance with UW-12<br>and Table UW-12 of<br>ASME Boiler and Pressure<br>Vessel Code, Division, I,<br>Section VIII | accordance with UW-12<br>and Table UW-12 of<br>ASME Boiler and Pressure<br>Vessel Code, Division, I,<br>Section VIII | Identical |
| Non-<br>-<br>Destructive<br>Examinations<br>(NDE) | Radiographic examination<br>and ultrasonic examination<br>shall be performed in<br>accordance with UW-51 of<br>ASME Boiler and Pressure<br>Vessel Code, Division, I,<br>Section VIII | Radiographic examination<br>and ultrasonic examination<br>shall be performed in<br>accordance with UW-51 of<br>ASME Boiler and Pressure<br>Vessel Code, Division, I,<br>Section VIII | Identical |
| | Ultrasonic examination<br>shall be performed in<br>accordance with UW-53<br>and Appendix 12 of ASME<br>Boiler and Pressure Vessel<br>Code, Division, I, Section<br>VIII | Ultrasonic examination<br>shall be performed in<br>accordance with UW-53<br>and Appendix 12 of ASME<br>Boiler and Pressure Vessel<br>Code, Division, I, Section<br>VIII | Identical |
| Hydrostatic<br>-<br>Test | Hydrostatic testing to be<br>performed in accordance<br>with ASME Boiler and<br>Pressure Vessel Code,<br>Section UG-99 @ 1.3 times<br>maximum allowable<br>working pressure. | Hydrostatic testing to be<br>performed in accordance<br>with ASME Boiler and<br>Pressure Vessel Code,<br>Section UG-99 @ 1.3 times<br>maximum allowable<br>working pressure. | Identical |
| Pressure Vessel<br>Relief | One (1) pressure relief<br>satisfying the requirements<br>of ASME Boiler and<br>Pressure Vessel Code,<br>Section UG-125.<br>Rated at 200 psig | One (1) pressure relief<br>satisfying the requirements<br>of ASME Boiler and<br>Pressure Vessel Code,<br>Section UG-125.<br>Rated at 200 psig | Identical |
| Filters | | | Identical |
| Liquid Separator<br>- | Removes moisture from air<br>using centrifugal force | Removes moisture from air<br>using centrifugal force | Identical |
| Prefilter Filter<br>- | 5 micron element | 5 micron element | Identical |
| Coalescing Filter<br>- | 1 micron element | 1 micron element | Identical |
| Active Carbon<br>-<br>Filter | Charcoal element | Charcoal element | Identical |
| 1-3 Compressed Air System | | | |
| Manufacturer | OxyHeal® Medical<br>Systems, Inc. | OxyHeal® Medical<br>Systems, Inc. | OxyHeal® 4000 Family<br>Summary Comparison to |
| Trade Name | OxyHeal® 4000 Family<br>(K163109) | OxyHeal® 5000 Family<br>(K152223) | Predicate (K152223) |
| Particulate Filter | 3 micron element | 3 micron element | Identical |
| High Efficiency<br>Filter | .01 micron element | .01 micron element | Identical |
| Piping | ASTM B88 | ASTM B88 | Identical |
| Testing | OMS Factory Acceptance<br>Test (FAT) | OMS Factory Acceptance<br>Test (FAT) | Substantially Equivalent |

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| 1-4 Fire Suppression System | | | | |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------|
| Manufacturer | OxyHeal® Medical<br>Systems, Inc. | OxyHeal® Medical<br>Systems, Inc.…