Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System

K152223 · Oxyheal Medical Systems, Inc. · CBF · Apr 29, 2016 · Anesthesiology

Device Facts

• Record ID: K152223
• Device Name: Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
• Applicant: Oxyheal Medical Systems, Inc.
• Product Code: CBF · Anesthesiology
• Decision Date: Apr 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The following indications which are listed on the Undersea and Hyperbaric Medical Society (UHMS) website: 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 clinical hyperbaric oxygen therapy (HBOT); rectangular pressure vessel design; accommodates 6-24+ patients. System inputs: compressed air (rotary screw compressors), medical gases (O2, air, helium/nitrogen mixes). Operation: HMI touchscreen console controls pressurization/depressurization, BIBS gas delivery, environmental control (temp/humidity), and lighting. Features fire suppression (deluge/hand line), CCTV patient monitoring, and entertainment systems. Manual back-up controls provided for safety. Used in clinical settings by trained operators to deliver pressurized oxygen; facilitates wound healing and treatment of ischemic/toxic conditions. Benefits patients via controlled hyperbaric environment.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including structural integrity (penetrant, ultrasonic, radiographic, magnetic particle, hydrostatic testing), fire suppression system testing, and operational system validation.

Technological Characteristics

Rectangular pressure vessel; ASME/PVHO-1 and NFPA 99 compliant. Materials: steel construction with epoxy finish. Operating pressure: 3-6 ATA. Environmental control: heating/cooling. Gas delivery: BIBS with overboard dump. Connectivity: HMI touchscreen control console. Lighting: LED. Sterilization: N/A (facility-based).

Indications for Use

Indicated for patients requiring hyperbaric oxygen therapy for conditions including air/gas embolism, carbon monoxide poisoning, gas gangrene, crush injury, decompression sickness, arterial insufficiencies, 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

• Fink Engineering PTY LTD SL8, DL8, and TL20 Hyperbaric Oxygen Facility (K031649)
• OxyHeal Health Group®, Inc. OxyHeal® 2000 Hyperbaric Chamber Series (K011866)

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

April 29, 2016

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

Re: K152223

Trade/Device Name: OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family Regulation Number: 21 CFR 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: Class II Product Code: CBF Dated: March 18, 2016 Received: March 21, 2016

Dear Mr. 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.

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

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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 yours,

*Tejashri Purohit-Sheth, M.D.*

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

Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known) K152223

#### Device Name

OxyHeal 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family

Indications for Use (Describe)

The following indications which are listed on the Undersea and Hyperbaric Medical Society (UHMS) website: 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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### Section 6 = 510(k) Summary for OxyHeal® 5000 Rectangular 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

26 April 2016

### 4. Device Name

| Trade/Proprietary Name: | OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System |
|----------------------------|----------------------------------------------------------------|
| | Product Family |
| Common/Usual Name: | Rectangular 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 Devices

Fink Engineering PTY LTD SL8, DL8, and TL20 Hyperbaric Oxygen Facility (K031649) OxyHeal Health Group®, Inc. OxyHeal® 2000 Hyperbaric Chamber Series (K011866)

### 6. Device Description

The OxyHeal® 5000, Rectangular Multiplace Hyperbaric Chamber System is comprised of a multiplace hyperbaric chamber and a number of major subsystems that support the overall system operation, control, and monitoring.

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An OxyHeal® 5000 multiplace hyperbaric chamber is a pressure vessel for human occupancy that is designed in a rectangular geometry. Configurations vary based on the needs of the end user and may consist of two (2), three (3), or more compartments. Capacities may range anywhere from six (6) to twenty-four (24) patients or more, dependent on chamber of compartments, or the direction of 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.

Each OxyHeal® 5000 multiplace hyperbaric chamber is designed, inspected, tested, marked and stamped to meet the standards defined in the American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1). These chambers comply with the National Fire Protection Agency (NFPA) 99, Health Care Facilities.

The OxyHeal 5000, Rectangular Multiplace Hyperbaric Chamber System consists of the hyperbaric chamber itself and the major subsystems briefly described below:

# 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. Grade "E" air as required by NFPA 99.

# 6.2 Fire Suppression System.

The fire suppression system 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.

# 6.3 Bulk Oxygen System

A bulk oxygen (Q2) system is the primary source for supplying O2 to the patients' breathing hoods inside the chamber. The bulk O2 is typically supplied by the end users of this device.

# 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.

# 6.5 HP Gas System

The HP gas system is used to supply O2 and medical air back-up in the event of an emergency resulting in the loss of primary breathing air and O2. Mixed gasses (e.g. helium, nitrogen, and helium-oxygen /nitrogen-oxygen mixes) may also be supplied as required by the end users. All gasses are connected to the hyperbaric chamber through appropriate piping, a gas manifold, and appropriately filtered.

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## 6.6 Environmental Control System (ECS)

The environmental control system is used to manage the temperature (heating and cooling) of the hyperbaric chamber.

### 6.7 Control Console

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:

- a. Administer BIBS gasses
- b. Analyze / monitor O2.
- Analyze/ monitor carbon dioxide (CO2) [option] C.
- Analyze / monitor relative humidity inside the hyperbaric chamber d.
- e. Control and monitor the temperature in the hyperbaric environment
- Open and close doors in any hyperbaric chamber compartment f.
- 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. 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).

# 7. Intended Use

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

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#### Technological Characteristics and Substantial Equivalence 8.

The following tables provide a comparison of OxyHeal's Rectangular Multiplace Hyperbaric Chamber Systems Family of Products to that of the predicate device with respect to intended use, technological characteristics and principles of operation; thereby providing more detailed information regarding the basis for the determination of substantial equivalence.

Table 1 compares the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family to the Fink Engineering PTY LTD Double Lock (DL8) and Tripe Lock (TL20) Hyperbaric Treatment Facility, and the OxyHeal® 2000 Hyperbaric Chamber System which are the predicate devices.

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# Comparison Table 1. OxyHeal 5000 Rectangular Multiplace Hyperbaric Chamber Product Family Compared to the Fink Engineering DL8 and TL20 Hyperbaric Treatment Facilities and the OxyHeal 2000 Hyperbaric Chamber System

| Manufacturer | OxyHeal® Medical<br>Systems, Inc. | Fink Engineering PTY<br>LTD | OxyHeal® Medical<br>Systems, Inc. | OxyHeal® 5000 Rectangular<br>Multiplace Hyperbaric<br>Chamber Product Family<br>Summary Comparison to<br>Predicates |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | OxyHeal® 5000 Two &<br>Three Compartment<br>Hyperbaric Chamber<br>System | DL8 Hyperbaric<br>Treatment Facility &<br>TL20 Hyperbaric<br>Treatment Facility | OxyHeal® 2000<br>Hyperbaric Chamber<br>System | |
| 510(k) Number | K152223 | K031649 | K011866 | K152223 |
| Product Code | CBF | CBF | CBF | Identical |
| Regulation Number | 21 CFR 868.5470 | 21 CFR 868.5470 | 21 CFR 868.5470 | Identical |
| Regulation Name | Hyperbaric Chamber | Hyperbaric Chamber | Hyperbaric Chamber | Identical |
| Indications for use: | As defined in the<br>Hyperbaric Oxygen<br>Therapy Committee<br>Report, dated 2008 | As defined in the<br>Hyperbaric Oxygen<br>Therapy Committee Report,<br>dated 1999 | As defined in the<br>Hyperbaric Oxygen<br>Therapy Committee<br>Report, dated 1999 | Substantially equivalent |
| Hyperbaric<br>Chamber Code<br>Design | 1. ASME: Boiler and<br>Pressure Code<br>2. ASME PVHO-1:<br>Safety Standard for<br>Pressure Vessels for<br>Human Occupancy | 1. ASME Section VIII,<br>Div. 1<br>2. ASME PVHO-1. Safety<br>Standard for Pressure<br>Vessels for Human<br>Occupancy | 1. ASME Section VIII,<br>Div. 1<br>2. ASME PVHO-1.<br>Safety Standard for<br>Pressure Vessels for<br>Human Occupancy | Substantially equivalent |
| Hyperbaric<br>Chamber System<br>Design | NFPA 99, Chapter 14 –<br>Hyperbaric Facilities | NFPA 99, Chapter 19 –<br>Hyperbaric Facilities | NFPA 99, Chapter 19 –<br>Hyperbaric Facilities | Substantially equivalent |
| Operating Pressure | 3.0ATA – 6.0ATA | 6.0 ATA | 3.0 ATA | OxyHeal 5000 Product Family<br>Chambers and the Fink DL8<br>and TL20 are substantially<br>equivalent. |
| Manufacturer | OxyHeal® Medical<br>Systems, Inc. | Fink Engineering PTY<br>LTD | OxyHeal® Medical<br>Systems, Inc. | OxyHeal® 5000 Rectangular<br>Multiplace Hyperbaric<br>Chamber Product Family<br>Summary Comparison to<br>Predicates |
| Trade Name | OxyHeal® 5000 Two &<br>Three Compartment<br>Hyperbaric Chamber<br>System | DL8 Hyperbaric<br>Treatment Facility &<br>TL20 Hyperbaric<br>Treatment Facility | OxyHeal® 2000<br>Hyperbaric Chamber<br>System | |
| Operating<br>Temperature | 50°F-125°F | 62°F - 100°F | Capable of operating<br>within design temperature<br>ranges; however from a<br>practical standpoint,<br>ranges based on<br>maintaining patient<br>comfort. | The OxyHeal 2000 is designed<br>to operate at the lower pressure<br>range as noted.<br>Substantially equivalent |
| Design Temperature | 50°F - 125°F | 62°F - 100°F | 50°F - 120°F | Substantially equivalent |
| Design Pressure | 30psig - 75psig | 80.0 psi | 30psig | OxyHeal 5000 Product Family<br>Chambers and the Fink DL8<br>and TL20 are substantially<br>equivalent.<br>The OxyHeal 2000 is designed<br>to operate at the lower pressure<br>range as noted. |
| Design Life | 90,000 cycles or 60 years,<br>which ever happens first | ≥ 30 years | ≥ 30 years | All hyperbaric chambers listed<br>have life expectancy of ≥ 30<br>years: Substantially equivalent |
| Hydrostatic<br>Pressure | 39psi - 97.5psi | 104.0 psi | 45psi | OxyHeal 5000 Product Family<br>Chambers and the Fink DL8<br>and TL20 are substantially<br>equivalent.<br>The OxyHeal 2000 is designed<br>to operate at the lower pressure<br>range noted. |
| Manufacturer | OxyHeal® Medical<br>Systems, Inc. | Fink Engineering PTY<br>LTD | OxyHeal® Medical<br>Systems, Inc. | OxyHeal® 5000 Rectangular<br>Multiplace Hyperbaric<br>Chamber Product Family<br>Summary Comparison to<br>Predicates |
| Trade Name | OxyHeal® 5000 Two &<br>Three Compartment<br>Hyperbaric Chamber<br>System | DL8 Hyperbaric<br>Treatment Facility &<br>TL20 Hyperbaric<br>Treatment Facility | OxyHeal® 2000<br>Hyperbaric Chamber<br>System | |
| Inspection Authority | Independent 3rd Party<br>ASME Authorized<br>Inspector (AI).<br>Affix ASME Stamp on<br>chamber data plate | ASME "U" Stamp | Independent 3rd Party<br>ASME Authorized<br>Inspector (AI).<br>Affix ASME Stamp on<br>chamber data plate | Substantially equivalent |
| Weight (lbs.) | 15,000lbs to 120,000lbs | Ranges Stated:<br>~26,400 to<br>~110,231 | ~ 7,000 | Weights of the OxyHeal 5000<br>Product Family Chambers and<br>the Fink DL8 and TL20 are<br>substantially equivalent.<br>The OxyHeal 2000 is a<br>significantly smaller chamber. |
| Dimensions | For all compartments, the<br>following min/max apply | | Dia. = 6'; H = 7' | The dimensions of the OxyHeal<br>5000 Product Family chamber<br>and the Fink DL8 and TL20 are<br>substantially equivalent.<br>The OxyHeal 2000 is<br>intentionally designed as a<br>smaller cylindrical hyperbaric<br>chamber and no transfer<br>compartment. |
| Main Compartment<br>(Lock) (ML) | Min: 8' W x 7' H x 10'L<br><br>Max: 11'W x 8'H x 20'L<br>Flat Heads, Rectangular<br>Shell, and Rectangular<br>Door Frames. | Ranges stated:<br>8.1'W x 7'H x 11'L to<br>10.3'W x 7'H x 19.3'L | | |
| Transfer<br>Compartment<br>(Lock) (EL) | | Ranges stated:<br>8.1'W x 7'H x 4.5'L to<br>7.8'W x 7'H x 10.8'L | | |
| Inner Compartment<br>(Lock) (IL) | | 7.8'W x 7'H x 10.8'L | | |
| Volume | | | | The OxyHeal 5000 Product<br>Family chamber volumes and<br>the Fink DL8 and TL20 are<br>substantially equivalent. |
| Main Compartment<br>(Lock) (ML) | Rectangular geometry<br>from 600ft³ to 2600ft³ | Ranges stated:<br>614.5ft³ to 1,536.2ft³ | 197.8ft³ | |
| Manufacturer | OxyHeal® Medical<br>Systems, Inc. | Fink Engineering PTY<br>LTD | OxyHeal® Medical<br>Systems, Inc. | OxyHeal® 5000 Rectangular<br>Multiplace Hyperbaric |
| Trade Name | OxyHeal® 5000 Two &<br>Three Compartment<br>Hyperbaric Chamber<br>System | DL8 Hyperbaric<br>Treatment Facility &<br>TL20 Hyperbaric<br>Treatment Facility | OxyHeal® 2000<br>Hyperbaric Chamber<br>System | Chamber Product Family<br>Summary Comparison to<br>Predicates |
| Transfer<br>Compartment<br>(Lock) (EL)<br>Inner Compartment<br>(Lock) (IL) | | Ranges stated:<br>254.3ft³ to 529.7ft³<br>480.3ft³ | | The OxyHeal 2000 is<br>intentionally designed as a<br>smaller cylindrical hyperbaric<br>chamber. |
| Total Volume | 6,000ft³ to 2,600ft ³ | Ranges stated:<br>868.7ft³ to 2,546.2ft³ | 197.8ft³ | Total volumes of the OxyHeal<br>5000 Product Family chamber<br>and the Fink DL8 and TL 20<br>are substantially equivalent.<br>The OxyHeal 2000 is<br>intentionally designed as a<br>smaller cylindrical hyperbaric<br>chamber with much smaller<br>total volumes. |
| Medical Lock | Cylindrical<br>Min: 10 inch diameter<br>Max: 16 inch diameter | 13.8" x 13.8" x 19.7" | 10" ID x 10"L | Substantially equivalent |
| Main Doorway Size | Minimum door frame<br>size: 44" x 80, Maximum<br>52" x 80" | 39.4" x 75.6" | 32" x 83" | The OxyHeal 5000 Product<br>Family and the Fink DL8 and<br>TL20 chamber main doorway<br>sizes are substantially<br>equivalent.<br>The doorways of the OxyHeal<br>5000 compared to the 2000<br>Product Family chambers and<br>the Fink DL8 and TL20 |
| Manufacturer | OxyHeal® Medical<br>Systems, Inc.<br>OxyHeal® 5000 Two &<br>Three Compartment<br>Hyperbaric Chamber<br>System | Fink Engineering PTY<br>LTD<br>DL8 Hyperbaric<br>Treatment Facility &<br>TL20 Hyperbaric<br>Treatment Facility | OxyHeal® Medical<br>Systems, Inc.<br>OxyHeal® 2000<br>Hyperbaric Chamber<br>System | OxyHeal® 5000 Rectangular<br>Multiplace Hyperbaric<br>Chamber Product Family<br>Summary Comparison to<br>Predicates |
| Trade Name | | | | |
| | | | | predicate chambers are<br>substantially equivalent in<br>terms of safety and<br>effectiveness of operation. |
| Penetrators | Maximum of 30<br>Penetrations of 2" x 12"<br>blocks. | | | |
| Lighting | LED lights<br><br>Min: 4<br><br>Max: 15 | Ranges stated:<br>Six (6) to fourteen (14)<br>external dimmable lights | One (1) internally<br>mounted light. | The OxyHeal 5000 Product<br>Family chamber lights, the Fink<br>DL8 and TL20 chamber lights,<br>and the OxyHeal 2000 chamber<br>light comply with NFPA-99<br>and are substantially equivalent<br>in terms of safety and<br>effectiveness of operation. |
| Viewports (PVHO-<br>1) | Minimum: One (1) per<br>hyperbaric chamber.<br>Maximum: Six (6) per<br>compartment.<br>Minimum: 8" Diameter,<br>Maximum: 30" Diameter. | Ranges stated:<br><b>Main Lock (ML):</b><br>13.8" ID - Qty. 2 each to<br>23.6" ID - Qty. 4 each<br><b>Transfer Lock (TL):</b><br>5.9" ID - Qty. 1 each to<br>13" ID - Qty. 3 each<br><b>Inner Lock (IL):</b><br>6" ID - Qty. 2 each | 16" ID - Qty. 2 each | The OxyHeal 5000 Product<br>Family and the Fink DL8 and<br>TL20 chamber, and the<br>OxyHeal 2000 viewports are<br>substantially equivalent. |
| Capacity Main<br>Compartment | 4 Patients Up to 24<br>Patients | Ranges stated:<br>From eight (8) seated<br>patients<br>Four (4) wheelchairs | Capable of<br>accommodating up to six<br>(6) upright seated patients | The OxyHeal 5000 Product<br>Family and the Fink DL8 and<br>TL20 chamber main |

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| Manufacturer | OxyHeal® Medical<br>Systems, Inc. | Fink Engineering PTY<br>LTD | OxyHeal® Medical<br>Systems, Inc. | OxyHeal® 5000 Rectangular<br>Multiplace Hyperbaric<br>Chamber Product Family<br>Summary Comparison to<br>Predicates |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | OxyHeal® 5000 Two &<br>Three Compartment<br>Hyperbaric Chamber<br>System | DL8 Hyperbaric<br>Treatment Facility &<br>TL20 Hyperbaric<br>Treatment Facility | OxyHeal® 2000<br>Hyperbaric Chamber<br>System | |
| | | One (1) hospital gurney to -<br>up to twenty (20) patients | or four (4) upright seated<br>patients and two (2)<br>gurneys. | compartments are substantially<br>equivalent.<br>The OxyHeal 2000 is<br>intentionally designed as a<br>smaller cylindrical hyperbaric<br>chamber with less capacity;<br>however, substantially<br>equivalent in terms of safety<br>and effectiveness of operation. |
| Fire Suppression | IAW NFPA 99 | IAW NFPA 99 | IAW NFPA 99 | Substantially equivalent |
| Finish - Chamber | Sandblasted and finished<br>with 2-part high quality<br>epoxy paint with glossy<br>finish. | Shot blasted & painted | | Substantially equivalent |
| Life Support<br>Controls | Automatic pressurization<br>& depressurization with<br>manual back-up from<br>both inside and outside<br>each chamber<br>compartment. | Manual electropneumatic<br>(pressurization)<br>Manual electropneumatic<br>(depressurization) | Automatic pressurization<br>& depressurization with<br>manual back-up from both<br>inside and outside the<br>chamber. | The OxyHeal 5000 Product<br>Family and the OxyHeal 2000<br>life support controls are<br>substantially equivalent. |
| Environmental<br>Control | Heating & cooling | Heating | Heating and cooling | The OxyHeal 5000 Product<br>Family and the OxyHeal 2000<br>environmental controls are<br>substantially equivalent. |
| Ventilation | Automatic chamber<br>ventilation with manual<br>back-up. Min 6 cfm, Max | Constant air flow | Automatic chamber<br>ventilation with manual<br>back-up. | The OxyHeal 5000 Product<br>Family and the OxyHeal 2000 |
| Manufacturer | OxyHeal® Medical | Fink Engineering PTY | OxyHeal® Medical | OxyHeal® 5000 Rectangular |
| | Systems, Inc. | LTD | Systems, Inc. | Multiplace Hyperbaric |
| Trade Name | OxyHeal® 5000 Two &<br>Three Compartment<br>Hyperbaric Chamber<br>System | DL8 Hyperbaric<br>Treatment Facility &<br>TL20 Hyperbaric<br>Treatment Facility | OxyHeal® 2000<br>Hyperbaric Chamber<br>System | Chamber Product Family<br>Summary Comparison to<br>Predicates |
| | 48cfm with a +/- 1 fsw<br>stability. | | | ventilation are substantially<br>equivalent. |
| BIBS with<br>Overboard Dump | Four (4) to Twenty-Four<br>(24), on demand gas<br>delivery. | Ranges stated:<br>Two (2) - Four (4) | Four (4) | The BIBS overboard dump<br>system for the OxyHeal 5000<br>Product Family, the Fink DL8<br>and TL20 chambers, and the<br>OxyHeal 2000 chamber are<br>substantially equivalent in<br>terms of safety and<br>effectiveness of operation. |
| Hoods with<br>Overboard Dump | Four (4) to Twenty-Four<br>(24) 1-100LPM delivery<br>flow meters. Minimum<br>flow for hoods: 40-lpm. | Ranges stated:<br>Six (6) to Twenty two (22) | Four (4) | The hood overboard dump<br>system for the OxyHeal 5000<br>Product Family, the Fink DL8<br>and TL20 chambers, and the<br>OxyHeal 2000 chamber are<br>substantially equivalent in<br>terms of safety and<br>effectiveness of operation. |
| Depth Measurement | Digital with analog<br>backup | Digital with analog backup | Digital with analog backup | Substantially equivalent |
| Gas Analysis | Oxygen (O2) 1-100% and<br>carbon dioxide (CO2) 0-<br>5000ppm | Oxygen (O2) and carbon<br>dioxide (CO2) | Oxygen (O2) and carbon<br>dioxide (CO2) | Substantially equivalent |
| Communications | Primary: Wireless<br>telephone<br>Secondary: Intercom<br>Tertiary: Sound powered<br>backup | Internal/external PA system<br>Sound powered backup | Primary: Wireless<br>telephone<br>Secondary: Intercom | Substantially equivalent |
| Manufacturer | OxyHeal® Medical<br>Systems, Inc. | Fink Engineering PTY<br>LTD | OxyHeal® Medical<br>Systems, Inc. | OxyHeal® 5000 Rectangular<br>Multiplace Hyperbaric |
| Trade Name | OxyHeal® 5000 Two &<br>Three Compartment<br>Hyperbaric Chamber<br>System | DL8 Hyperbaric<br>Treatment Facility &<br>TL20 Hyperbaric<br>Treatment Facility | OxyHeal® 2000<br>Hyperbaric Chamber<br>System | Chamber Product Family<br>Summary Comparison to<br>Predicates |
| Entertainment | Individual up to 4-<br>channels. Varies based on<br>customer specification for<br>number of compartments<br>and number of patients to<br>be treated. | Individual 4-channel<br>selection for eight (8)<br>persons | Individual 4-channel<br>selection for up to six (6)<br>persons. | Substantially equivalent |
| TV System | 24VDC LED TV<br>Monitor. AM/FM<br>Tuner/CD, DVD, and<br>Cable TV Tuner. . | External color with remote<br>control AM/FM tuner/CD<br>& DVD player | One (1) internally<br>mounted TV System.<br>AM/FM tuner/CD & DVD<br>player. | The OxyHeal 5000 Product<br>Family TV systems and the<br>Fink DL8 and TL20 TV<br>systems comply with NFPA-99<br>and are substantially equivalent<br>in terms of safety and<br>effectiveness of operation.<br>The OxyHeal 2000 is<br>intentionally designed as a<br>smaller cylindrical hyperbaric<br>chamber with a TV system that<br>complies with NFPA-99 and is<br>substantially equivalent in<br>terms of safety and<br>effectiveness of operation. |
| Compartment Relief | One (1) ASME certified<br>pressure relief valve per<br>compartment.<br>30 psig to 75 psig | ASME certified pressure<br>relief valve | One (1) ASME certified<br>pressure relief valve | Substantially equivalent |
| Manufacturer | OxyHeal® Medical<br>Systems, Inc. | Fink Engineering PTY<br>LTD | OxyHeal® Medical<br>Systems, Inc. | OxyHeal® 5000 Rectangular<br>Multiplace Hyperbaric |
| Trade Name | OxyHeal® 5000 Two &<br>Three Compartment<br>Hyperbaric Chamber<br>System | DL8 Hyperbaric<br>Treatment Facility &<br>TL20 Hyperbaric<br>Treatment Facility | OxyHeal® 2000<br>Hyperbaric Chamber<br>System | Chamber Product Family<br>Summary Comparison to<br>Predicates |
| Compartment Drain | Minimum One (1)<br>manual drain in each<br>compartment | One (1) manual drain in<br>each compartment | One (1) manual drain | Substantially equivalent |

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## 9. Non-Clinical Testing

Refer to paragraphs 9.1 - 9.5

#### 9.1 Structural Testing

The following testing and /or examinations were used in whole or in part for certifying the weld integrity and the integrity of the entire pressure vessel for human occupancy (PVHO) (the hyperbaric chamber):

- Penetrant Examination (PE) a.
- b. Ultrasonic Testing (UT)
- C. Radiographic Examinations (RT)
- d. Magnetic Particle Examination (MT)

In accordance with ASME requirements, the entire PVHO is pressure tested hydrostatically. This entails filling the PVHO 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.

#### 9.2 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 National Fire Protection Agency (NFPA) 99, Chapter 14 - Hyperbaric facilities.

9.3 First Operational System TestA 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 5000 hyperbaric chamber system product family as defined in the User Design Specification.

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

#### 9.4 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 to ensure they are consistently safe and effective and operate. This testing includes the following items specified in the OxyHeal 5000 hyperbaric chamber system product family as defined in the User Design Specification.

- Testing of the minimum and maximum pressurization rates a.
- b. Testing of the minimum and maximum depressurization rates
- C. Testing of the minimum and maximum ventilation rates
- 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.

#### તે. તે રે Factory Acceptance Test

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A Factory Acceptance Test (FAT) was performed to verify that the system was able to perform all required operational functions. This testing includes the following items specified in the OxyHeal 5000 hyperbaric chamber system product family as defined in the User Design Specification.

- Pneumatic testing of the low pressure air supply system, Built-in Breathing System (BIBS), and a. fire suppression system (FSS) at 1.2 times above Maximum Operating Working Pressure
- b. Leak testing on all joints and connections
- Pressure relief valve testing C.
- d. Relative humidity (RH) and Temperature monitoring testing

# 10. Clinical Testing

There was no clinical testing required to support the OxyHeal 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family.

# 11. Conclusion

It has been shown in this 510(k) submission that the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family is substantially equivalent to the predicate devices.. The OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family, as designed, manufactured, and tested is determined to be substantially equivalent to the referenced predicate devices.