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.

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

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. 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: Compressed Air System, Fire Suppression System, Bulk Oxygen System, Built-in Breathing System, HP Gas System, Environmental Control System (ECS), Control Console.

AI/ML Overview

The provided text details the 510(k) summary for the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family, demonstrating its substantial equivalence to predicate devices rather than proving it meets specific acceptance criteria through a "study" in the typical sense of a clinical trial or performance study comparing it against a predefined metric.

Instead, the "study" mentioned here refers to a comparison of the new device's technological characteristics, design, and operational parameters against those of legally marketed predicate devices. The acceptance criteria are implicit in meeting or exceeding the standards and performance of these predicate devices, as well as adherence to relevant industry standards like ASME and NFPA.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are the characteristics of the predicate devices and relevant standards (ASME, NFPA). The "reported device performance" is the OxyHeal® 5000's characteristics in comparison to these.

Characteristic	Acceptance Criteria (Predicate Devices & Standards)	Reported Device Performance (OxyHeal® 5000)
Product Code	CBF (Fink K031649, OxyHeal® 2000 K011866)	CBF
Regulation Number	21 CFR 868.5470 (Fink K031649, OxyHeal® 2000 K011866)	21 CFR 868.5470
Regulation Name	Hyperbaric Chamber (Fink K031649, OxyHeal® 2000 K011866)	Hyperbaric Chamber
Indications for Use	As defined in the Hyperbaric Oxygen Therapy Committee Report, dated 1999 (for predicates)	As defined in the Hyperbaric Oxygen Therapy Committee Report, dated 2008 (Substantially equivalent, updated report)
Hyperbaric Chamber Code Design	ASME Section VIII, Div. 1; ASME PVHO-1 (for predicates)	ASME: Boiler and Pressure Code; ASME PVHO-1: Safety Standard for Pressure Vessels for Human Occupancy (Substantially equivalent)
Hyperbaric Chamber System Design	NFPA 99, Chapter 19 – Hyperbaric Facilities (for predicates)	NFPA 99, Chapter 14 – Hyperbaric Facilities (Substantially equivalent – different chapter but same core standard)
Operating Pressure	3.0 ATA (OxyHeal® 2000) to 6.0 ATA (Fink DL8/TL20)	3.0ATA – 6.0ATA (Substantially equivalent to Fink DL8/TL20; OxyHeal 2000 is lower pressure range)
Operating Temperature	62°F - 100°F (Fink); Capable of operating within design temperature ranges based on patient comfort (OxyHeal® 2000)	50°F-125°F (Substantially equivalent, OxyHeal 2000 designed for lower pressure range)
Design Temperature	62°F - 100°F (Fink); 50°F - 120°F (OxyHeal® 2000)	50°F - 125°F (Substantially equivalent)
Design Pressure	30psig (OxyHeal® 2000) to 80.0 psi (Fink DL8/TL20)	30psig - 75psig (Substantially equivalent to Fink DL8/TL20; OxyHeal 2000 for lower pressure)
Design Life	≥ 30 years (Fink, OxyHeal® 2000)	90,000 cycles or 60 years, whichever happens first (≥ 30 years: Substantially equivalent)
Hydrostatic Pressure	45psi (OxyHeal® 2000) to 104.0 psi (Fink)	39psi - 97.5psi (Substantially equivalent to Fink DL8/TL20; OxyHeal 2000 for lower pressure)
Inspection Authority	ASME "U" Stamp (Fink); Independent 3rd Party ASME Authorized Inspector (AI) (OxyHeal® 2000)	Independent 3rd Party ASME Authorized Inspector (AI). Affix ASME Stamp on chamber data plate (Substantially equivalent)
Weight (lbs.)	~ 7,000 (OxyHeal® 2000) to ~110,231 (Fink)	15,000lbs to 120,000lbs (Substantially equivalent to Fink DL8/TL20; OxyHeal 2000 is smaller)
Dimensions (Main Compartment)	8.1'W x 7'H x 11'L to 10.3'W x 7'H x 19.3'L (Fink); Dia. = 6'; H = 7' (OxyHeal® 2000)	Min: 8' W x 7' H x 10'L; Max: 11'W x 8'H x 20'L (Substantially equivalent to Fink DL8/TL20; OxyHeal 2000 intentionally smaller)
Total Volume	197.8ft³ (OxyHeal® 2000) to 2,546.2ft³ (Fink)	600ft³ to 2,600ft³ (Substantially equivalent to Fink DL8/TL20; OxyHeal 2000 intentionally smaller)
Medical Lock	10" ID x 10"L (OxyHeal® 2000) to 13.8" x 13.8" x 19.7" (Fink)	Cylindrical Min: 10 inch diameter; Max: 16 inch diameter (Substantially equivalent)
Main Doorway Size	32" x 83" (OxyHeal® 2000) to 39.4" x 75.6" (Fink)	Minimum door frame size: 44" x 80"; Maximum 52" x 80" (Substantially equivalent in terms of safety and effectiveness of operation)
Lighting	One (1) internally mounted light (OxyHeal® 2000) to Six (6) to fourteen (14) external dimmable lights (Fink)	LED lights Min: 4; Max: 15 (Comply with NFPA-99 and are substantially equivalent in terms of safety and effectiveness of operation)
Viewports (PVHO-1)	16" ID - Qty. 2 each (OxyHeal® 2000) to various (Fink)	Minimum: One (1) per hyperbaric chamber. Maximum: Six (6) per compartment. Minimum: 8" Diameter, Maximum: 30" Diameter (Substantially equivalent)
Capacity Main Compartment	From eight (8) seated patients / Four (4) wheelchairs (Fink) to Six (6) upright seated patients (OxyHeal® 2000)	4 Patients Up to 24 Patients (Substantially equivalent to Fink DL8/TL20; OxyHeal 2000 is smaller)
Fire Suppression	IAW NFPA 99 (Fink, OxyHeal® 2000)	IAW NFPA 99 (Substantially equivalent)
Life Support Controls	Manual electropneumatic (pressurization/depressurization) (Fink); Automatic pressurization & depressurization with manual back-up from both inside and outside the chamber (OxyHeal® 2000)	Automatic pressurization & depressurization with manual back-up from both inside and outside each chamber compartment (Substantially equivalent to OxyHeal 2000)
Environmental Control	Heating (Fink); Heating and cooling (OxyHeal® 2000)	Heating & cooling (Substantially equivalent to OxyHeal 2000)
Ventilation	Constant air flow (Fink); Automatic chamber ventilation with manual back-up (OxyHeal® 2000)	Automatic chamber ventilation with manual back-up. Min 6 cfm, Max 48cfm with a +/- 1 fsw stability (Substantially equivalent)
BIBS with Overboard Dump	Two (2) - Four (4) (Fink); Four (4) (OxyHeal® 2000)	Four (4) to Twenty-Four (24), on demand gas delivery (Substantially equivalent in terms of safety and effectiveness)
Hoods with Overboard Dump	Six (6) to Twenty two (22) (Fink); Four (4) (OxyHeal® 2000)	Four (4) to Twenty-Four (24) 1-100LPM delivery flow meters. Minimum flow for hoods: 40-lpm (Substantially equivalent in terms of safety and effectiveness)
Depth Measurement	Digital with analog backup (Fink, OxyHeal® 2000)	Digital with analog backup (Substantially equivalent)
Gas Analysis	Oxygen (O2) and carbon dioxide (CO2) (Fink, OxyHeal® 2000)	Oxygen (O2) 1-100% and carbon dioxide (CO2) 0-5000ppm (Substantially equivalent)
Communications	Internal/external PA system, Sound powered backup (Fink); Primary: Wireless telephone, Secondary: Intercom (OxyHeal® 2000)	Primary: Wireless telephone, Secondary: Intercom, Tertiary: Sound powered backup (Substantially equivalent)
Entertainment	Individual 4-channel selection for eight (8) persons (Fink); Individual 4-channel selection for up to six (6) persons (OxyHeal® 2000)	Individual up to 4-channels. Varies based on customer specification for number of compartments and number of patients to be treated (Substantially equivalent)
TV System	External color with remote control AM/FM tuner/CD & DVD player (Fink); One (1) internally mounted TV System. AM/FM tuner/CD & DVD player (OxyHeal® 2000)	24VDC LED TV Monitor. AM/FM Tuner/CD, DVD, and Cable TV Tuner (Comply with NFPA-99 and are substantially equivalent in terms of safety and effectiveness of operation)
Compartment Relief	ASME certified pressure relief valve (Fink, OxyHeal® 2000)	One (1) ASME certified pressure relief valve per compartment. 30 psig to 75 psig (Substantially equivalent)
Compartment Drain	One (1) manual drain in each compartment (Fink, OxyHeal® 2000)	Minimum One (1) manual drain in each compartment (Substantially equivalent)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document describes engineering tests and a comparison to predicate devices, not a clinical study on a patient test set in the conventional sense. The "test set" for the non-clinical testing comprises the physical components and integrated system of the OxyHeal® 5000 chamber itself.

Sample Size: The sample size is essentially one (the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family, representing its design). The testing applies to the specific device models being submitted. The document evaluates the design and performance characteristics of new models within this product family against established standards and predicate devices.
Data Provenance: The testing details suggest that tests were conducted by the manufacturer (OxyHeal Medical Systems, Inc.) or by independent bodies (like ASME authorized inspectors) as part of the manufacturing and verification process. This is prospective testing for the submitted device design. The origin would be the manufacturing site or testing facilities. No country of origin for specific testing data is explicitly mentioned, but the manufacturer is based in National City, CA, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as this is a device engineering and performance validation against standards and predicate devices, not an AI or diagnostic device requiring expert interpretation for "ground truth" establishment in a clinical imaging context. The "ground truth" for compliance to standards comes from the ASME and NFPA codes themselves, and expert judgment is inherent in the design, engineering, and inspection processes by qualified engineers and ASME authorized inspectors.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of device submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving multiple readers interpreting data where a consensus or tie-breaking mechanism is needed to establish ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was conducted.

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

Not applicable. This is not an algorithm-based device. The device itself is the hyperbaric chamber system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context refers to established engineering standards, safety requirements, and the validated performance of predicate devices. Specifically:

Engineering Standards: ASME/PVHO-1 for pressure vessels, NFPA 99 for health care facilities (including fire suppression, electrical design, etc.).
Performance Specifications: User Design Specifications for the OxyHeal® 5000, which are verified through various tests (structural, fire suppression, operational, software validation, factory acceptance).
Predicate Device Characteristics: The established and legally marketed performance and design features of the Fink Engineering PTY LTD SL8, DL8, and TL20 Hyperbaric Oxygen Facility (K031649) and the OxyHeal Health Group®, Inc. OxyHeal® 2000 Hyperbaric Chamber Series (K011866).

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device that requires a training set.

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

Not applicable. There is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

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

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)

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)

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: 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.com

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

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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
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

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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® MedicalSystems, Inc.	Fink Engineering PTYLTD	OxyHeal® MedicalSystems, Inc.	OxyHeal® 5000 RectangularMultiplace HyperbaricChamber Product FamilySummary Comparison toPredicates
Trade Name	OxyHeal® 5000 Two &Three CompartmentHyperbaric ChamberSystem	DL8 HyperbaricTreatment Facility &TL20 HyperbaricTreatment Facility	OxyHeal® 2000Hyperbaric ChamberSystem
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 theHyperbaric OxygenTherapy CommitteeReport, dated 2008	As defined in theHyperbaric OxygenTherapy Committee Report,dated 1999	As defined in theHyperbaric OxygenTherapy CommitteeReport, dated 1999	Substantially equivalent
HyperbaricChamber CodeDesign	1. ASME: Boiler andPressure Code2. ASME PVHO-1:Safety Standard forPressure Vessels forHuman Occupancy	1. ASME Section VIII,Div. 12. ASME PVHO-1. SafetyStandard for PressureVessels for HumanOccupancy	1. ASME Section VIII,Div. 12. ASME PVHO-1.Safety Standard forPressure Vessels forHuman Occupancy	Substantially equivalent
HyperbaricChamber SystemDesign	NFPA 99, Chapter 14 –Hyperbaric Facilities	NFPA 99, Chapter 19 –Hyperbaric Facilities	NFPA 99, Chapter 19 –Hyperbaric Facilities	Substantially equivalent
Operating Pressure	3.0ATA – 6.0ATA	6.0 ATA	3.0 ATA	OxyHeal 5000 Product FamilyChambers and the Fink DL8and TL20 are substantiallyequivalent.
Manufacturer	OxyHeal® MedicalSystems, Inc.	Fink Engineering PTYLTD	OxyHeal® MedicalSystems, Inc.	OxyHeal® 5000 RectangularMultiplace HyperbaricChamber Product FamilySummary Comparison toPredicates
Trade Name	OxyHeal® 5000 Two &Three CompartmentHyperbaric ChamberSystem	DL8 HyperbaricTreatment Facility &TL20 HyperbaricTreatment Facility	OxyHeal® 2000Hyperbaric ChamberSystem
OperatingTemperature	50°F-125°F	62°F - 100°F	Capable of operatingwithin design temperatureranges; however from apractical standpoint,ranges based onmaintaining patientcomfort.	The OxyHeal 2000 is designedto operate at the lower pressurerange as noted.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 FamilyChambers and the Fink DL8and TL20 are substantiallyequivalent.The OxyHeal 2000 is designedto operate at the lower pressurerange as noted.
Design Life	90,000 cycles or 60 years,which ever happens first	≥ 30 years	≥ 30 years	All hyperbaric chambers listedhave life expectancy of ≥ 30years: Substantially equivalent
HydrostaticPressure	39psi - 97.5psi	104.0 psi	45psi	OxyHeal 5000 Product FamilyChambers and the Fink DL8and TL20 are substantiallyequivalent.The OxyHeal 2000 is designedto operate at the lower pressurerange noted.
Manufacturer	OxyHeal® MedicalSystems, Inc.	Fink Engineering PTYLTD	OxyHeal® MedicalSystems, Inc.	OxyHeal® 5000 RectangularMultiplace HyperbaricChamber Product FamilySummary Comparison toPredicates
Trade Name	OxyHeal® 5000 Two &Three CompartmentHyperbaric ChamberSystem	DL8 HyperbaricTreatment Facility &TL20 HyperbaricTreatment Facility	OxyHeal® 2000Hyperbaric ChamberSystem
Inspection Authority	Independent 3rd PartyASME AuthorizedInspector (AI).Affix ASME Stamp onchamber data plate	ASME "U" Stamp	Independent 3rd PartyASME AuthorizedInspector (AI).Affix ASME Stamp onchamber data plate	Substantially equivalent
Weight (lbs.)	15,000lbs to 120,000lbs	Ranges Stated:~26,400 to~110,231	~ 7,000	Weights of the OxyHeal 5000Product Family Chambers andthe Fink DL8 and TL20 aresubstantially equivalent.The OxyHeal 2000 is asignificantly smaller chamber.
Dimensions	For all compartments, thefollowing min/max apply		Dia. = 6'; H = 7'	The dimensions of the OxyHeal5000 Product Family chamberand the Fink DL8 and TL20 aresubstantially equivalent.The OxyHeal 2000 isintentionally designed as asmaller cylindrical hyperbaricchamber and no transfercompartment.
Main Compartment(Lock) (ML)	Min: 8' W x 7' H x 10'LMax: 11'W x 8'H x 20'LFlat Heads, RectangularShell, and RectangularDoor Frames.	Ranges stated:8.1'W x 7'H x 11'L to10.3'W x 7'H x 19.3'L
TransferCompartment(Lock) (EL)		Ranges stated:8.1'W x 7'H x 4.5'L to7.8'W x 7'H x 10.8'L
Inner Compartment(Lock) (IL)		7.8'W x 7'H x 10.8'L
Volume				The OxyHeal 5000 ProductFamily chamber volumes andthe Fink DL8 and TL20 aresubstantially equivalent.
Main Compartment(Lock) (ML)	Rectangular geometryfrom 600ft³ to 2600ft³	Ranges stated:614.5ft³ to 1,536.2ft³	197.8ft³
Manufacturer	OxyHeal® MedicalSystems, Inc.	Fink Engineering PTYLTD	OxyHeal® MedicalSystems, Inc.	OxyHeal® 5000 RectangularMultiplace Hyperbaric
Trade Name	OxyHeal® 5000 Two &Three CompartmentHyperbaric ChamberSystem	DL8 HyperbaricTreatment Facility &TL20 HyperbaricTreatment Facility	OxyHeal® 2000Hyperbaric ChamberSystem	Chamber Product FamilySummary Comparison toPredicates
TransferCompartment(Lock) (EL)Inner Compartment(Lock) (IL)		Ranges stated:254.3ft³ to 529.7ft³480.3ft³		The OxyHeal 2000 isintentionally designed as asmaller cylindrical hyperbaricchamber.
Total Volume	6,000ft³ to 2,600ft ³	Ranges stated:868.7ft³ to 2,546.2ft³	197.8ft³	Total volumes of the OxyHeal5000 Product Family chamberand the Fink DL8 and TL 20are substantially equivalent.The OxyHeal 2000 isintentionally designed as asmaller cylindrical hyperbaricchamber with much smallertotal volumes.
Medical Lock	CylindricalMin: 10 inch diameterMax: 16 inch diameter	13.8" x 13.8" x 19.7"	10" ID x 10"L	Substantially equivalent
Main Doorway Size	Minimum door framesize: 44" x 80, Maximum52" x 80"	39.4" x 75.6"	32" x 83"	The OxyHeal 5000 ProductFamily and the Fink DL8 andTL20 chamber main doorwaysizes are substantiallyequivalent.The doorways of the OxyHeal5000 compared to the 2000Product Family chambers andthe Fink DL8 and TL20
Manufacturer	OxyHeal® MedicalSystems, Inc.OxyHeal® 5000 Two &Three CompartmentHyperbaric ChamberSystem	Fink Engineering PTYLTDDL8 HyperbaricTreatment Facility &TL20 HyperbaricTreatment Facility	OxyHeal® MedicalSystems, Inc.OxyHeal® 2000Hyperbaric ChamberSystem	OxyHeal® 5000 RectangularMultiplace HyperbaricChamber Product FamilySummary Comparison toPredicates
Trade Name
				predicate chambers aresubstantially equivalent interms of safety andeffectiveness of operation.
Penetrators	Maximum of 30Penetrations of 2" x 12"blocks.
Lighting	LED lightsMin: 4Max: 15	Ranges stated:Six (6) to fourteen (14)external dimmable lights	One (1) internallymounted light.	The OxyHeal 5000 ProductFamily chamber lights, the FinkDL8 and TL20 chamber lights,and the OxyHeal 2000 chamberlight comply with NFPA-99and are substantially equivalentin terms of safety andeffectiveness of operation.
Viewports (PVHO-1)	Minimum: One (1) perhyperbaric chamber.Maximum: Six (6) percompartment.Minimum: 8" Diameter,Maximum: 30" Diameter.	Ranges stated:Main Lock (ML):13.8" ID - Qty. 2 each to23.6" ID - Qty. 4 eachTransfer Lock (TL):5.9" ID - Qty. 1 each to13" ID - Qty. 3 eachInner Lock (IL):6" ID - Qty. 2 each	16" ID - Qty. 2 each	The OxyHeal 5000 ProductFamily and the Fink DL8 andTL20 chamber, and theOxyHeal 2000 viewports aresubstantially equivalent.
Capacity MainCompartment	4 Patients Up to 24Patients	Ranges stated:From eight (8) seatedpatientsFour (4) wheelchairs	Capable ofaccommodating up to six(6) upright seated patients	The OxyHeal 5000 ProductFamily and the Fink DL8 andTL20 chamber main

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Manufacturer	OxyHeal® MedicalSystems, Inc.	Fink Engineering PTYLTD	OxyHeal® MedicalSystems, Inc.	OxyHeal® 5000 RectangularMultiplace HyperbaricChamber Product FamilySummary Comparison toPredicates
Trade Name	OxyHeal® 5000 Two &Three CompartmentHyperbaric ChamberSystem	DL8 HyperbaricTreatment Facility &TL20 HyperbaricTreatment Facility	OxyHeal® 2000Hyperbaric ChamberSystem
		One (1) hospital gurney to -up to twenty (20) patients	or four (4) upright seatedpatients and two (2)gurneys.	compartments are substantiallyequivalent.The OxyHeal 2000 isintentionally designed as asmaller cylindrical hyperbaricchamber with less capacity;however, substantiallyequivalent in terms of safetyand effectiveness of operation.
Fire Suppression	IAW NFPA 99	IAW NFPA 99	IAW NFPA 99	Substantially equivalent
Finish - Chamber	Sandblasted and finishedwith 2-part high qualityepoxy paint with glossyfinish.	Shot blasted & painted		Substantially equivalent
Life SupportControls	Automatic pressurization& depressurization withmanual back-up fromboth inside and outsideeach chambercompartment.	Manual electropneumatic(pressurization)Manual electropneumatic(depressurization)	Automatic pressurization& depressurization withmanual back-up from bothinside and outside thechamber.	The OxyHeal 5000 ProductFamily and the OxyHeal 2000life support controls aresubstantially equivalent.
EnvironmentalControl	Heating & cooling	Heating	Heating and cooling	The OxyHeal 5000 ProductFamily and the OxyHeal 2000environmental controls aresubstantially equivalent.
Ventilation	Automatic chamberventilation with manualback-up. Min 6 cfm, Max	Constant air flow	Automatic chamberventilation with manualback-up.	The OxyHeal 5000 ProductFamily 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 &Three CompartmentHyperbaric ChamberSystem	DL8 HyperbaricTreatment Facility &TL20 HyperbaricTreatment Facility	OxyHeal® 2000Hyperbaric ChamberSystem	Chamber Product FamilySummary Comparison toPredicates
	48cfm with a +/- 1 fswstability.			ventilation are substantiallyequivalent.
BIBS withOverboard Dump	Four (4) to Twenty-Four(24), on demand gasdelivery.	Ranges stated:Two (2) - Four (4)	Four (4)	The BIBS overboard dumpsystem for the OxyHeal 5000Product Family, the Fink DL8and TL20 chambers, and theOxyHeal 2000 chamber aresubstantially equivalent interms of safety andeffectiveness of operation.
Hoods withOverboard Dump	Four (4) to Twenty-Four(24) 1-100LPM deliveryflow meters. Minimumflow for hoods: 40-lpm.	Ranges stated:Six (6) to Twenty two (22)	Four (4)	The hood overboard dumpsystem for the OxyHeal 5000Product Family, the Fink DL8and TL20 chambers, and theOxyHeal 2000 chamber aresubstantially equivalent interms of safety andeffectiveness of operation.
Depth Measurement	Digital with analogbackup	Digital with analog backup	Digital with analog backup	Substantially equivalent
Gas Analysis	Oxygen (O2) 1-100% andcarbon dioxide (CO2) 0-5000ppm	Oxygen (O2) and carbondioxide (CO2)	Oxygen (O2) and carbondioxide (CO2)	Substantially equivalent
Communications	Primary: WirelesstelephoneSecondary: IntercomTertiary: Sound poweredbackup	Internal/external PA systemSound powered backup	Primary: WirelesstelephoneSecondary: Intercom	Substantially equivalent
Manufacturer	OxyHeal® MedicalSystems, Inc.	Fink Engineering PTYLTD	OxyHeal® MedicalSystems, Inc.	OxyHeal® 5000 RectangularMultiplace Hyperbaric
Trade Name	OxyHeal® 5000 Two &Three CompartmentHyperbaric ChamberSystem	DL8 HyperbaricTreatment Facility &TL20 HyperbaricTreatment Facility	OxyHeal® 2000Hyperbaric ChamberSystem	Chamber Product FamilySummary Comparison toPredicates
Entertainment	Individual up to 4-channels. Varies based oncustomer specification fornumber of compartmentsand number of patients tobe treated.	Individual 4-channelselection for eight (8)persons	Individual 4-channelselection for up to six (6)persons.	Substantially equivalent
TV System	24VDC LED TVMonitor. AM/FMTuner/CD, DVD, andCable TV Tuner. .	External color with remotecontrol AM/FM tuner/CD& DVD player	One (1) internallymounted TV System.AM/FM tuner/CD & DVDplayer.	The OxyHeal 5000 ProductFamily TV systems and theFink DL8 and TL20 TVsystems comply with NFPA-99and are substantially equivalentin terms of safety andeffectiveness of operation.The OxyHeal 2000 isintentionally designed as asmaller cylindrical hyperbaricchamber with a TV system thatcomplies with NFPA-99 and issubstantially equivalent interms of safety andeffectiveness of operation.
Compartment Relief	One (1) ASME certifiedpressure relief valve percompartment.30 psig to 75 psig	ASME certified pressurerelief valve	One (1) ASME certifiedpressure relief valve	Substantially equivalent
Manufacturer	OxyHeal® MedicalSystems, Inc.	Fink Engineering PTYLTD	OxyHeal® MedicalSystems, Inc.	OxyHeal® 5000 RectangularMultiplace Hyperbaric
Trade Name	OxyHeal® 5000 Two &Three CompartmentHyperbaric ChamberSystem	DL8 HyperbaricTreatment Facility &TL20 HyperbaricTreatment Facility	OxyHeal® 2000Hyperbaric ChamberSystem	Chamber Product FamilySummary Comparison toPredicates
Compartment Drain	Minimum One (1)manual drain in eachcompartment	One (1) manual drain ineach 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.

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).