Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a hyperbaric chamber system and its control/monitoring interface, with no mention of AI or ML capabilities. The performance studies focus on structural integrity and system functionality, not algorithmic performance.

Therapeutic

Yes

The intended use of the OxyHeal® 4000 is to administer hyperbaric oxygen therapy (HBOT) to treat patients with various medical conditions, clearly indicating a therapeutic purpose.

Diagnostic

No

The device is described as a hyperbaric chamber system used to administer hyperbaric oxygen therapy (HBOT) for various medical conditions, focusing on treatment rather than diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly states it is comprised of a multiplace hyperbaric chamber and major subsystems, which are physical components, not solely software. While it mentions a software validation test, this is part of the overall system validation, not indicative of a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to administer hyperbaric oxygen therapy (HBOT) to treat patients with specific medical conditions. This is a therapeutic treatment applied directly to the patient, not a diagnostic test performed on samples taken from the body.
Device Description: The device is a hyperbaric chamber, a pressure vessel designed for human occupancy. It's a piece of medical equipment used for treatment, not for analyzing biological samples.
Lack of IVD characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's condition based on sample analysis

Therefore, the OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family is a therapeutic medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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

Product codes (comma separated list FDA assigned to the subject device)

CBF

Device Description

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

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

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

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.
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.
Oxygen Delivery System: the primary source for supplying O2 to patients' breathing hoods inside the chamber.
Built-in Breathing System: capable of supplying each individually seated patient with breathing gas via standard oxygen hoods or free-flow masks.
Environmental Control System: used to manage the temperature (heating and cooling) and relative humidity (RH) of the hyperbaric chamber.
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. It features an HMI touch screen control system for initiating and monitoring HBOT treatments, manual back-up controls, and functions for controlling BIBS gasses, analyzing/monitoring O2 and CO2, monitoring relative humidity and temperature, door operations, lighting, and administrative functions. The FSS is activated from the control console, which also houses a communications system, gas analysis equipment, and patient entertainment systems (CCTV, audio/visual).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family provides hyperbaric oxygen therapy in a clinical setting. The Control Console is operated by a qualified hyperbaric chamber technician (CHT).

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing:

Non-destructive Testing: Four types of NDEs (Penetrant Examination, Ultrasonic Testing, Radiographic Examinations, Magnetic Particle Examination) are used to verify the integrity of structural welds. These tests are identical to those performed on the predicate device.
Hydrostatic Testing: A Standard Hydrostatic Test is conducted according to ASME Section VIII, Division 1 Code paragraph UG-99. The chamber is filled with water and pressure tested at 1.3 times the MAWP. Viewports are included in the test. This is identical to the tests performed on the predicate device.
Other V&V Testing:
- Fire Suppression System Testing: Confirmed compliance with NFPA 99.
- First Operational System Test (FOST): Verified system design met specification requirements, including pressurization/depressurization rates, ventilation rates, patient gas delivery, and gas quality (CGA Grade E).
- Software Validation Testing: Validated observed output of designated control functions, specifically pressurization/depressurization rates, ventilation rates, and patient gas delivery.
- Factory Acceptance Test (FAT): Verified all required operational functions.

Key Results: All tests demonstrated that the device performs as intended and conforms to the same standards as the predicate device, supporting the claim of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

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

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

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

Sincerely,

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

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K163109

Device Name

OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family

Indications for Use (Describe)

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

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

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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3

Section 008- 510(k) Summary for

OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family

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

1. Submission Sponsor

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

2. Submission Correspondent

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

3. Date Prepared

28 October 2016

4. Device Name

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

FDA Establishment Registration #: 1000519737

5. Predicate Device

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

6. Device Description

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.

4

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) .
1. ANSI/ASME PVHO-1 (2012 Edition): American National Standards Institute/American Society of Mechanical Engineers - Safety Standard for Pressure Vessels for Human Occupancy.
- FDA recognized consensus standard: (Recognition Number 1-78) ●
1. ISO 14971 (2012 Edition): International Standard Organization. Medical Devices Application of Risk Management to Medical Devices
- FDA recognized consensus standard: (Recognition Number 5-40) .

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

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).

5

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:

6

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.

7

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
Systems, Inc.	OxyHeal® Medical
Systems, Inc.	OxyHeal® 4000 Family
Summary Comparison to
Predicate (K152223)
Trade Name	OxyHeal® 4000 Family
(K163109)	OxyHeal® 5000 Family
(K152223)
510(k) Number	K163109	K152223	Unique K numbers for each
product family have been
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
Hyperbaric Oxygen
Therapy Committee Report,
dated 2008	As defined in the
Hyperbaric Oxygen
Therapy Committee
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

ASME PVHO-1: Safety Standard for Pressure Vessels for Human Occupancy.
FDA consensus standard recognition no. 1-78. | 1. ASME: Boiler and Pressure Code
ASME PVHO-1: Safety Standard for Pressure Vessels for Human Occupancy.
FDA consensus standard recognition no. 1-78. | Regardless of PVHO geometry:
Rectangular: OxyHeal® 5000 [non-uniform distribution of pressure (worst case)] Cylindrical: OxyHeal® 4000 [uniform distribution of pressure] Codes and standards defining requirements for PVHO materials, design, fabrication, and testing are identical. |
| Calculations | ASME Section VIII, Div. 1 | ASME Section VIII, Div. 1 | Identical |
| 1-2 Hyperbaric Chamber | | | |
| Manufacturer
Trade Name | OxyHeal® Medical
Systems, Inc.
OxyHeal® 4000 Family
(K163109) | OxyHeal® Medical
Systems, Inc.
OxyHeal® 5000 Family
(K152223) | OxyHeal® 4000 Family
Summary Comparison to
Predicate (K152223) |
| Joint Design

                             | Design and fabrication

shall be in accordance
with specified Divisions of
Section VIII of the ASME
Code and the following
requirements of
ASME/PVHO-1, para. 1-
7.1 (a) through (c) | Design and fabrication shall
be in accordance with
specified Divisions of
Section VIII of the ASME
Code and the following
requirements of
ASME/PVHO-1, para. 1-
7.1 (a) through (c) | Identical |
| ASME PVHO-1

                         | Per ASME Section II                                                                                                                                                                                      | Per ASME Section II                                                                                                                                                                                      | Identical                                                                                                                                                                                                                                                                                               |

| Non-Destructive

                         | Hydrostatic testing to be

8

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

9

10

flow meters. Minimum

11

| nsmitter | Minimum = 0 psig
Maximum = 75 psig | Minimum = 0 psig
Maximum = 75 psig | |
|-----------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------|
| perature Sensor | 75°F ± 5°F | 75°F ± 5°F | Identical |
| ative Humidity
sor | 0% - 100% | 0% - 100% | Identical |
| vision (TV)
em | 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 |

1-3 Compressed Air System
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)
Air Compressors	Qty. two (2) rotary screw
Operating range:
Rated Power:
208V ±10%, 3-ph, 60Hz -
460V ±10%, 3-ph, 60Hz
Max Working Pressure:
125psig - 217psig
Air Delivery
155 CFM - 288 CFM	Qty. two (2) rotary screw
Operating range:
Rated Power:
208V ±10%, 3-ph, 60Hz -
460V ±10%, 3-ph, 60Hz
Max Working Pressure:
125psig - 217psig
Air Delivery
155 CFM - 288 CFM	Identical
Air Receiver	Ranges: Qty. 1 – Qty.5
depending on space and
location within client
facility.	Ranges: Qty. 1 – Qty.5
depending on space and
location within client
facility.	Substantially equivalent
- Design Code	ASME Boiler and Pressure
Code	ASME Boiler and Pressure
Code	Identical
- Calculations	ASME Section VIII, Div. 1	ASME Section VIII, Div. 1	Identical
- Joint Design	Joint design and fabrication
shall be performed in	Joint design and fabrication
shall be performed in	Identical
1-3 Compressed Air System
Manufacturer	OxyHeal® Medical
Systems, Inc.
OxyHeal® 4000 Family
(K163109)	OxyHeal® Medical
Systems, Inc.
OxyHeal® 5000 Family
(K152223)	OxyHeal® 4000 Family
Summary Comparison to
Predicate (K152223)
Trade Name	accordance with UW-12
and Table UW-12 of
ASME Boiler and Pressure
Vessel Code, Division, I,
Section VIII	accordance with UW-12
and Table UW-12 of
ASME Boiler and Pressure
Vessel Code, Division, I,
Section VIII	Identical
Non-

Destructive
Examinations
(NDE) | Radiographic examination
and ultrasonic examination
shall be performed in
accordance with UW-51 of
ASME Boiler and Pressure
Vessel Code, Division, I,
Section VIII | Radiographic examination
and ultrasonic examination
shall be performed in
accordance with UW-51 of
ASME Boiler and Pressure
Vessel Code, Division, I,
Section VIII | Identical |
| | Ultrasonic examination
shall be performed in
accordance with UW-53
and Appendix 12 of ASME
Boiler and Pressure Vessel
Code, Division, I, Section
VIII | Ultrasonic examination
shall be performed in
accordance with UW-53
and Appendix 12 of ASME
Boiler and Pressure Vessel
Code, Division, I, Section
VIII | Identical |
| Hydrostatic

Test | Hydrostatic testing to be
performed in accordance
with ASME Boiler and
Pressure Vessel Code,
Section UG-99 @ 1.3 times
maximum allowable
working pressure. | Hydrostatic testing to be
performed in accordance
with ASME Boiler and
Pressure Vessel Code,
Section UG-99 @ 1.3 times
maximum allowable
working pressure. | Identical |
| Pressure Vessel
Relief | One (1) pressure relief
satisfying the requirements
of ASME Boiler and
Pressure Vessel Code,
Section UG-125.
Rated at 200 psig | One (1) pressure relief
satisfying the requirements
of ASME Boiler and
Pressure Vessel Code,
Section UG-125.
Rated at 200 psig | Identical |
| Filters | | | Identical |
| Liquid Separator

                        | Removes moisture from air

using centrifugal force | Removes moisture from air
using centrifugal force | Identical |
| Prefilter Filter

                        | 5 micron element                                                                                                                                                                                     | 5 micron element                                                                                                                                                                                     | Identical                                                            |

| Coalescing Filter

                       | 1 micron element                                                                                                                                                                                     | 1 micron element                                                                                                                                                                                     | Identical                                                            |

| Active Carbon

12

13

1-4 Fire Suppression System
Manufacturer	OxyHeal® Medical
Systems, Inc.	OxyHeal® Medical
Systems, Inc.	OxyHeal® 4000 Family
Summary Comparison to
Trade Name	OxyHeal® 4000 Family
(K163109)	OxyHeal® 5000 Family
(K152223)	Predicate (K152223)
Fire Suppression
System Design
Code	Fire Protection complies
with paragraph 14.2.5 of
NFPA 99 (FDA consensus
std. recognition no. 1-67).	Fire Protection complies
with paragraph 14.2.5 of
NFPA 99 (FDA consensus
std. recognition no. 1-67).	Identical
Fire Deluge Tank	Quantity ranges based on
number of chamber
compartments:
1 Compartment: Qty. 1
2 Compartment: Qty. 2
3 Compartment: Qty. 3
Fire deluge system
complies with paragraph
14.2.5.2 of NFPA 99 (FDA
consensus std. recognition
no. 1-67).	Quantity ranges based on
number of chamber
compartments:
1 Compartment: Qty. 1
2 Compartment: Qty. 2
3 Compartment: Qty. 3
Fire deluge system
complies with paragraph
14.2.5.2 of NFPA 99 (FDA
consensus std. recognition
no. 1-67).	Identical
Design Code	-	ASME Boiler and Pressure
Code, Section VIII Division
I	ASME Boiler and Pressure
Code, Section VIII Division
I	Identical
Calculations	-	ASME Section VIII, Div. 1	ASME Section VIII, Div. 1	Identical
Joint Design	-	Joint design and fabrication
shall be performed in
accordance with UW-12
and Table UW-12 of	Joint design and fabrication
shall be performed in
accordance with UW-12
and Table UW-12 of	Identical
1-4 Fire Suppression System
Manufacturer
Trade Name	OxyHeal® Medical
Systems, Inc.
OxyHeal® 4000 Family
(K163109)	OxyHeal® Medical
Systems, Inc.
OxyHeal® 5000 Family
(K152223)	OxyHeal® 4000 Family
Summary Comparison to
Predicate (K152223)
	ASME Boiler and Pressure
Vessel Code, Division, I,
Section VIII	ASME Boiler and Pressure
Vessel Code, Division, I,
Section VIII
Non-
Destructive
Examinations
(NDE)	Radiographic examination
and ultrasonic examination
shall be performed in
accordance with UW-51 of
ASME Boiler and Pressure
Vessel Code, Division, I,
Section VIII	Radiographic examination
and ultrasonic examination
shall be performed in
accordance with UW-51 of
ASME Boiler and Pressure
Vessel Code, Division, I,
Section VIII	Identical
	Ultrasonic examination
shall be performed in
accordance with UW-53
and Appendix 12 of ASME
Boiler and Pressure Vessel
Code, Division, I, Section
VIII	Ultrasonic examination
shall be performed in
accordance with UW-53
and Appendix 12 of ASME
Boiler and Pressure Vessel
Code, Division, I, Section
VIII
Hydrostatic
Test	Hydrostatic testing to be
performed in accordance
with ASME Boiler and
Pressure Vessel Code,
Section VIII, UG-99 @ 1.3
times max. allowable
working pressure.	Hydrostatic testing to be
performed in accordance
with ASME Boiler and
Pressure Vessel Code,
Section VIII, UG-99 @ 1.3
times max. allowable
working pressure.	Identical
Pressure Vessel
Relief	One (1) pressure relief
satisfying the requirements
of ASME Boiler and
Pressure Vessel Code,
Section UG-125.
Rated at 200 psig	One (1) pressure relief
satisfying the requirements
of ASME Boiler and
Pressure Vessel Code,
Section UG-125.
Rated at 200 psig	Identical
Hand Line Tank	Hand Line system complies
with paragraph 14.2.5.3 of
NFPA 99 (FDA consensus
std. recognition no. 1-67).	Hand Line system complies
with paragraph 14.2.5.3 of
NFPA 99 (FDA consensus
std. recognition no. 1-67).	Identical
-
Design Code	ASME Boiler and Pressure
Code, Section VIII Division
I	ASME Boiler and Pressure
Code, Section VIII Division
I	Identical
-
Calculations	ASME Section VIII, Div. 1	ASME Section VIII, Div. 1	Identical
-
Design Code	Joint design and fabrication
shall be performed in	Joint design and fabrication
shall be performed in	Identical
1-4 Fire Suppression System
Manufacturer	OxyHeal® Medical Systems, Inc.
OxyHeal® 4000 Family	OxyHeal® Medical Systems, Inc.
OxyHeal® 5000 Family	OxyHeal® 4000 Family Summary Comparison to Predicate (K152223)
Trade Name	(K163109)	(K152223)
	accordance with UW-12
and Table UW-12 of ASME Boiler and Pressure Vessel Code, Division, I, Section VIII	accordance with UW-12
and Table UW-12 of ASME Boiler and Pressure Vessel Code, Division, I, Section VIII
- Joint Design	Radiographic examination and ultrasonic examination shall be performed in accordance with UW-51 of ASME Boiler and Pressure Vessel Code, Division, I, Section VIII

Ultrasonic examination shall be performed in accordance with UW-53 and Appendix 12 of ASME Boiler and Pressure Vessel Code, Division, I, Section VIII | Radiographic examination and ultrasonic examination shall be performed in accordance with UW-51 of ASME Boiler and Pressure Vessel Code, Division, I, Section VIII

Ultrasonic examination shall be performed in accordance with UW-53 and Appendix 12 of ASME Boiler and Pressure Vessel Code, Division, I, Section VIII | Identical | |
| - Non-Destructive Examinations (NDE) | NDE shall be performed in accordance with ASME/PVHO-1, para. 1-7.3 | NDE shall be performed in accordance with ASME/PVHO-1, para. 1-7.3 | Identical | |
| - Hydrostatic Test | Hydrostatic testing to be performed in accordance with ASME Boiler and Pressure Vessel Code, Section UG-99 @ 1.3 times max. allowable working pressure. | Hydrostatic testing to be performed in accordance with ASME Boiler and Pressure Vessel Code, Section UG-99 @ 1.3 times max. allowable working pressure. | Identical | |
| - Pressure Vessel Relief | One (1) pressure relief satisfying the requirements of ASME Boiler and Pressure Vessel Code, Section UG-125.
Rated at 200 psig | One (1) pressure relief satisfying the requirements of ASME Boiler and Pressure Vessel Code, Section UG-125.
Rated at 200 psig | Identical | |
| - Piping | ASTM B88 | ASTM B88 | Identical | |
| - Testing | OMS Factory Acceptance Test (FAT) | OMS Factory Acceptance Test (FAT) | Substantially Equivalent | |

14

15

-て . (

16

1-5 Oxygen Delivery Requirements
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)
Facility Supplied
Ground Storage and
Bulk Liquid O2	(Customer Provided)
Ranges:
Gallons: 500-13,000
SCF: 50K - 1.3M
100psi - 150PSI
Permitted by Authority
Having Jurisdiction (AHJ)	(Customer Provided)
Ranges:
Gallons: 500-13,000
SCF: 50K - 1.3M
100psi - 150PSI
Permitted by Authority
Having Jurisdiction (AHJ)	Identical
or
Microbulk	(Customer Provided)
Ranges:
Gallons: 230-715
SCF: 5,658 - 66,592
100psi - 150PSI
Permitted by Authority
Having Jurisdiction (AHJ)	(Customer Provided)
Ranges:
Gallons: 230-715
SCF: 5,658 - 66,592
100psi - 150PSI
Permitted by Authority
Having Jurisdiction (AHJ)	Identical
Piping	ASTM B819	ASTM 819	Identical

1-6 Built In Breathing System (BIBS)
Manufacturer	OxyHeal® Medical
Systems, Inc.	OxyHeal® Medical
Systems, Inc.	OxyHeal® 4000 Family
Summary Comparison to
Trade Name	OxyHeal® 4000 Family
(K163109)	OxyHeal® 5000 Family
(K152223)	Predicate (K152223)
HP Oxygen	Cylinder Size: K
Pressure: 3000 psig
CGA 346	Cylinder Size: K
Pressure: 3000 psig
CGA 346	Identical
HP Medical Air	Cylinder Size: K
Pressure: 3000 psig
CGA 346	Cylinder Size: K
Pressure: 3000 psig
CGA 346	Identical
HP Mixed Gas (e.g.)

Nitrogen
Nitrox
Helium | Cylinder Size: K
Pressure: 3000 psig
CGA 580
CGA 326
CGA 580 | Cylinder Size: K
Pressure: 3000 psig
CGA 580
CGA 326
CGA 580 | Identical |
| Piping | ASTM B819 | ASTM B819 | Identical |
| Testing | OMS Factory Acceptance
Test (FAT) | OMS Factory Acceptance
Test (FAT) | Substantially Equivalent |

17

1-7 Environmental Control System (ECS)
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)
Environmental
Control System	Chamber temperature and
humidity control complies
with paragraph 14.2.4.3 of
NFPA 99 (FDA consensus
std. recognition no. 1-67).	Chamber temperature and
humidity control complies
with paragraph 14.2.4.3 of
NFPA 99 (FDA consensus
std. recognition no. 1-67).	Identical
Environmental
Control Unit (ECU)	Quantity ranges based on
number of chamber
compartments:
1 Compartment: Qty. 1
2 Compartment: Qty. 2
3 Compartment: Qty. 3	Quantity ranges based on
number of chamber
compartments:
1 Compartment: Qty. 1
2 Compartment: Qty. 2
3 Compartment: Qty. 3	Identical
ECU Physical
Dimensions	24"L X 24"W X 36"H	24"L X 24"W X 36"H	Identical
ECU Heat Load
(Heat Mode)	~ 12000 BTU/HR	~ 12000 BTU/HR	Identical
ECU Heat Load
(Heat Mode)	~ 16000 BTU/HR	~ 16000 BTU/HR	Identical
ECU Coolant Pump
Motor	2.2 AMPS	2.2 AMPS	Identical
ECU Coolant Pump
Flow Rate	4.2 GPM @ 24 FT HEAD	4.2 GPM @ 24 FT HEAD	Identical
Testing	OMS Factory Acceptance
Test (FAT)	OMS Factory Acceptance
Test (FAT)	Substantially Equivalent
1-8 Control Console
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)
HMI Touchscreen
Monitor	Quantity ranges based on
number of chamber
compartments (Comp):
1 Comp: Qty. 1
2 Comp: Qty. 1-2
3 Comp: Qty. 2-3	Quantity ranges based on
number of chamber
compartments (Comp):
1 Comp: Qty. 1
2 Comp: Qty. 1-2
3 Comp: Qty. 2-3	Identical
	Primary method of
controlling chamber Primary means for
monitoring chamber
system status	Primary method of
controlling chamber Primary means for
monitoring chamber
system status
Life Support
Controls	Automatic pressurization &
depressurization with
manual back-up from both
inside and outside each
chamber compartment.	Automatic pressurization &
depressurization with
manual back-up from both
inside and outside each
chamber compartment.	Identical
Emergency
Depressurization	Chamber depressurization
complies with paragraph
14.2.4.5 of NFPA 99 (FDA
consensus std. recognition
no. 1-67).	Chamber depressurization
complies with paragraph
14.2.4.5 of NFPA 99 (FDA
consensus std. recognition
no. 1-67).	Identical
Ventilation	Automatic chamber
ventilation with manual
back-up. Ranges are as
follows:

Min = 6 cfm/min
Max = 48 cfm/min ± 1
FSW stability
Chamber ventilation
complies with paragraph
14.2.4.1 of NFPA 99 (FDA
consensus std. recognition
no. 1-67). | Automatic chamber
ventilation with manual
back-up. Ranges are as
follows:
Min = 6 cfm/min
Max = 48 cfm/min ± 1
FSW stability
Chamber ventilation
complies with paragraph
14.2.4.1 of NFPA 99 (FDA
consensus std. recognition
no. 1-67). | Identical |
| Programmable
Logic Controller
(PLC) | Controls the operator
initiated actions at the HMI
touch screen by
communicating with various | Controls the operator
initiated actions at the HΜΙ
touch screen by
communicating with various | Identical |
| 1-8 Control Console | | | |
| 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) | |
| | devices managing the
performance of chamber
subsystems | devices managing the
performance of chamber
subsystems | |
| Keyboard and
Mouse #1 and #2 | Alternate method for
providing input to control
hyperbaric chamber | Alternate method for
providing input to control
hyperbaric chamber | Identical |
| | Quantity ranges based on
number of chamber
compartments (Comp):
1 Comp: Qty. 1
2 Comp: Qty. 1-2
3 Comp: Qty. 2-3 | Quantity ranges based on
number of chamber
compartments (Comp):
1 Comp: Qty. 1
2 Comp: Qty. 1-2
3 Comp: Qty. 2-3 | |
| Patient Monitor,
Quad Screen | Visual method for
monitoring patients
undergoing HBOT | Visual method for
monitoring patients
undergoing HBOT | Identical |
| | Quantity ranges based on
number of chamber
compartments (Comp):
1 Comp: Qty. 1
2 Comp: Qty. 1-2
3 Comp: Qty. 2-3 | Quantity ranges based on
number of chamber
compartments (Comp):
1 Comp: Qty. 1
2 Comp: Qty. 1-2
3 Comp: Qty. 2-3 | |
| Fire Suppression
System (FSS)
Activation
Pushbutton | When depressed, activates
FSS and illuminates green | When depressed, activates
FSS and illuminates green | Identical |
| | Quantity ranges based on
number of chamber
compartments (Comp):
1 Comp: Qty. 1
2 Comp: Qty. 2
3 Comp: Qty. 3 | Quantity ranges based on
number of chamber
compartments (Comp):
1 Comp: Qty. 1
2 Comp: Qty. 2
3 Comp: Qty. 3 | |
| Communications
System | Primary: Wireless telephone
Secondary: Intercom
Tertiary: (OPTION) Sound
powered backup | Primary: Wireless telephone
Secondary: Intercom
Tertiary: (OPTION) Sound
powered backup | Identical |
| Gas Analysis System | Determines the O2 and CO2
from within a treatment
compartment or from the
BIBS gases. | Determines the O2 and CO2
from within a treatment
compartment or from the
BIBS gases. | Identical |
| 1-8 Control Console | | | |
| Manufacturer | OxyHeal® Medical Systems, Inc.
OxyHeal® 4000 Family (K163109) | OxyHeal® Medical Systems, Inc.
OxyHeal® 5000 Family (K152223) | OxyHeal® 4000 Family Summary Comparison
to Predicate (K152223) |
| Trade Name | | | |
| | Monitor w/
SDA Carbon Dioxide
Monitor (OPTION add on) | Monitor w/
SDA Carbon Dioxide
Monitor (OPTION add on) | |
| | O₂ @ 0% - 100% ± 1%
CO₂ @ 0 – 5250
NOTE parts per million
(ppm) ± 25ppm. | O₂ @ 0% - 100% ± 1%
CO₂ @ 0 – 5250
NOTE parts per million
(ppm) ± 25ppm. | |
| | Oxygen monitoring
complies with paragraph
14.2.8.4 of NFPA 99 (FDA
consensus std. recognition
no. 1-67). | Oxygen monitoring
complies with paragraph
14.2.8.4 of NFPA 99 (FDA
consensus std. recognition
no. 1-67). | |
| Flowmeters | Controls the flow of gas to
the gas analyzer so as not to
damage the analyzers
internal parts. | Controls the flow of gas to
the gas analyzer so as not to
damage the analyzers
internal parts. | Identical |
| Selector Switch | Two (2) per compartment
User adjustable and used for
selecting between zero gas,
calibration gas or gas flow
from the chamber
compartment. | Two (2) per compartment
User adjustable and used for
selecting between zero gas,
calibration gas or gas flow
from the chamber
compartment. | Identical |
| | One (1) per compartment | One (1) per compartment | |
| Patient
Entertainment
System | Components as listed below. | Components as listed below. | Identical |
| Television (TV)
—
System | Displays digital video on
chamber interior mounted
TVs | Displays digital video on
chamber interior mounted
TVs | Identical |
| DVD Player
— | Provides digital video to
patient entertainment
monitor inside chamber | Provides digital video to
patient entertainment
monitor inside chamber | Identical |
| CD Player
— | Provides digital audio to
speaker of patient
headphones inside chamber | Provides digital audio to
speaker of patient
headphones inside chamber | Identical |
| AM/FM Tuner
— | Provides audio to patient
headphones inside chamber | Provides audio to patient
headphones inside chamber | Identical |
| 1-8 Control Console | | | |
| 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) | |
| 4-Zone Mixer | Individual up to 4-channels.
Varies based on customer
specification for number of
compartments and number
of patients to be treated. | Individual up to 4-channels.
Varies based on customer
specification for number of
compartments and number
of patients to be treated. | Identical |
| Amplifier | Amplifies the outputs of the
AM/FM tuner, CD/DVD to
the chamber interior and the
patient headsets | Amplifies the outputs of the
AM/FM tuner, CD/DVD to
the chamber interior and the
patient headsets | Identical |
| Audio / Video
Recorder | Permits customer ability to
record patient video and / or
audio from within a
compartment. | Permits customer ability to
record patient video and / or
audio from within a
compartment. | Identical |
| Uninterrupted
Power Supply (UPS) | OPTION - Customer
Meets NFPA-99, para.
14.2.5.4.3 for automatic
battery back-up.
See also NFPA-99:
14.2.5.1.3 (3) for emergency
communications and
emergency lighting. 14.2.3.3
for emergency lighting.
14.2.5.4.3 for fire deluge | OPTION - Customer
Meets NFPA-99, para.
14.2.5.4.3 for automatic
battery back-up.
See also NFPA-99:
14.2.5.1.3 (3) for emergency
communications and
emergency lighting. 14.2.3.3
for emergency lighting.
14.2.5.4.3 for fire deluge | Identical |
| Testing | OMS Factory Acceptance
Test (FAT) | OMS Factory Acceptance
Test (FAT) | Substantially Equivalent |

18

T

19

I

20

Г

21

7. Intended Use and indications for 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
1. Carbon Monoxide Poisoning
- a. Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
1. Clostridial Myositis and Myonecrosis (Gas Gangrene)

22

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

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

8. Technological Characteristics and Substantial Equivalence

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

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

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

9. Non-Clinical Testing

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

23

9.1 Non-destructive Testing

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

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

Hydrostatic Testing 9.2

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

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

9.3 Other V&V Testing

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

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

24

9.3.1 Fire Suppression System Testing

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

First Operational System Test 9.3.2

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

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

9.3.3 Software Validation Testing.

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

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

9.3.4 Factory Acceptance Test

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

10 Conclusion

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