(266 days)
Not Found
No
The document describes a hyperbaric chamber system and its components, focusing on mechanical and control systems. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a hyperbaric chamber system used to deliver hyperbaric oxygen therapy for various medical conditions, indicating it is a therapeutic device.
No
The device description clearly states it is a "Hyperbaric Chamber System" used for administering hyperbaric oxygen therapy. Its operation involves providing a specific environment for treatment, not diagnosing conditions. The "Intended Use / Indications for Use" section lists various conditions that can be treated with hyperbaric oxygen therapy, not diagnosed by the device.
No
The device description clearly details a physical hyperbaric chamber system with multiple hardware components and subsystems, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the treatment of various medical conditions using hyperbaric oxygen therapy. This is a therapeutic intervention applied directly to the patient, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a hyperbaric chamber system designed to create a high-pressure environment for patients. 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 components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
In summary, the OxyHeal® 5000, Rectangular Multiplace Hyperbaric Chamber System is a therapeutic device used for delivering hyperbaric oxygen therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The following indications which are listed on the Undersea and Hyperbaric Medical Society (UHMS) website: www.uhms.org are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric Oxygen Therapy Committee.
-
- 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
Product codes (comma separated list FDA assigned to the subject device)
CBF
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:
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.
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).
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
Not Found
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:
- Structural Testing: Penetrant Examination (PE), Ultrasonic Testing (UT), Radiographic Examinations (RT), and Magnetic Particle Examination (MT) were used for certifying weld integrity and pressure vessel integrity. The PVHO was hydrostatically pressure tested at 1.3 times the maximum allowable working pressure (MAWP).
- Fire Suppression System Testing: A Fire Suppression System (FSS) test was conducted to ensure the fire deluge system and hand line met NFPA 99 requirements.
- First Operational System Test (FOST): Performed to verify system design met specification requirements, including testing of minimum and maximum pressurization rates, depressurization rates, ventilation rates, conditions for maintaining these rates, patient gas delivery systems and flow meter range, and chamber pressurization and ventilation gas meeting CGA Grade E requirements.
- Software Validation Testing: Conducted to validate that observed output of designated hyperbaric chamber control functions met their designed output, ensuring they are consistently safe and effective. This included testing of minimum and maximum pressurization rates, depressurization rates, ventilation rates, conditions for maintaining these rates, and patient gas delivery systems and flow meter range.
- Factory Acceptance Test (FAT): Performed to verify the system's ability to perform all required operational functions. This included pneumatic testing of the low pressure air supply system, BIBS, and FSS at 1.2 times above MAWP; leak testing on all joints and connections; pressure relief valve testing; and relative humidity (RH) and temperature monitoring testing.
Clinical Testing:
There was no clinical testing required to support the OxyHeal 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family.
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.
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
§ 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).
0
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
1
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
2
Indications for Use
510(k) Number (if known) K152223
Device Name
OxyHeal 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family
Indications for Use (Describe)
The following indications which are listed on the Undersea and Hyperbaric Medical Society (UHMS) website: www.uhms.org are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric Oxygen Therapy Committee.
-
- 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
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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3
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
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.
4
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.
5
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.
-
- 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
6
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.
7
Comparison Table 1. OxyHeal 5000 Rectangular Multiplace Hyperbaric Chamber Product Family Compared to the Fink Engineering DL8 and TL20 Hyperbaric Treatment Facilities and the OxyHeal 2000 Hyperbaric Chamber System
| Manufacturer | OxyHeal® Medical
Systems, Inc. | Fink Engineering PTY
LTD | OxyHeal® Medical
Systems, Inc. | OxyHeal® 5000 Rectangular
Multiplace Hyperbaric
Chamber Product Family
Summary Comparison to
Predicates |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | OxyHeal® 5000 Two &
Three Compartment
Hyperbaric Chamber
System | DL8 Hyperbaric
Treatment Facility &
TL20 Hyperbaric
Treatment Facility | OxyHeal® 2000
Hyperbaric Chamber
System | |
| 510(k) Number | K152223 | K031649 | K011866 | K152223 |
| Product Code | CBF | CBF | CBF | Identical |
| Regulation Number | 21 CFR 868.5470 | 21 CFR 868.5470 | 21 CFR 868.5470 | Identical |
| Regulation Name | Hyperbaric Chamber | Hyperbaric Chamber | Hyperbaric Chamber | Identical |
| Indications for use: | As defined in the
Hyperbaric Oxygen
Therapy Committee
Report, dated 2008 | As defined in the
Hyperbaric Oxygen
Therapy Committee Report,
dated 1999 | As defined in the
Hyperbaric Oxygen
Therapy Committee
Report, dated 1999 | Substantially equivalent |
| Hyperbaric
Chamber Code
Design | 1. ASME: Boiler and
Pressure Code
2. ASME PVHO-1:
Safety Standard for
Pressure Vessels for
Human Occupancy | 1. ASME Section VIII,
Div. 1
2. ASME PVHO-1. Safety
Standard for Pressure
Vessels for Human
Occupancy | 1. ASME Section VIII,
Div. 1
2. ASME PVHO-1.
Safety Standard for
Pressure Vessels for
Human Occupancy | Substantially equivalent |
| Hyperbaric
Chamber System
Design | 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 Family
Chambers and the Fink DL8
and TL20 are substantially
equivalent. |
| Manufacturer | OxyHeal® Medical
Systems, Inc. | Fink Engineering PTY
LTD | OxyHeal® Medical
Systems, Inc. | OxyHeal® 5000 Rectangular
Multiplace Hyperbaric
Chamber Product Family
Summary Comparison to
Predicates |
| Trade Name | OxyHeal® 5000 Two &
Three Compartment
Hyperbaric Chamber
System | DL8 Hyperbaric
Treatment Facility &
TL20 Hyperbaric
Treatment Facility | OxyHeal® 2000
Hyperbaric Chamber
System | |
| Operating
Temperature | 50°F-125°F | 62°F - 100°F | Capable of operating
within design temperature
ranges; however from a
practical standpoint,
ranges based on
maintaining patient
comfort. | The OxyHeal 2000 is designed
to operate at the lower pressure
range 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 Family
Chambers and the Fink DL8
and TL20 are substantially
equivalent.
The OxyHeal 2000 is designed
to operate at the lower pressure
range as noted. |
| Design Life | 90,000 cycles or 60 years,
which ever happens first | ≥ 30 years | ≥ 30 years | All hyperbaric chambers listed
have life expectancy of ≥ 30
years: Substantially equivalent |
| Hydrostatic
Pressure | 39psi - 97.5psi | 104.0 psi | 45psi | OxyHeal 5000 Product Family
Chambers and the Fink DL8
and TL20 are substantially
equivalent.
The OxyHeal 2000 is designed
to operate at the lower pressure
range noted. |
| Manufacturer | OxyHeal® Medical
Systems, Inc. | Fink Engineering PTY
LTD | OxyHeal® Medical
Systems, Inc. | OxyHeal® 5000 Rectangular
Multiplace Hyperbaric
Chamber Product Family
Summary Comparison to
Predicates |
| Trade Name | OxyHeal® 5000 Two &
Three Compartment
Hyperbaric Chamber
System | DL8 Hyperbaric
Treatment Facility &
TL20 Hyperbaric
Treatment Facility | OxyHeal® 2000
Hyperbaric Chamber
System | |
| Inspection Authority | Independent 3rd Party
ASME Authorized
Inspector (AI).
Affix ASME Stamp on
chamber data plate | ASME "U" Stamp | Independent 3rd Party
ASME Authorized
Inspector (AI).
Affix ASME Stamp on
chamber data plate | Substantially equivalent |
| Weight (lbs.) | 15,000lbs to 120,000lbs | Ranges Stated:
~26,400 to
~110,231 | ~ 7,000 | Weights of the OxyHeal 5000
Product Family Chambers and
the Fink DL8 and TL20 are
substantially equivalent.
The OxyHeal 2000 is a
significantly smaller chamber. |
| Dimensions | For all compartments, the
following min/max apply | | Dia. = 6'; H = 7' | The dimensions of the OxyHeal
5000 Product Family chamber
and the Fink DL8 and TL20 are
substantially equivalent.
The OxyHeal 2000 is
intentionally designed as a
smaller cylindrical hyperbaric
chamber and no transfer
compartment. |
| Main Compartment
(Lock) (ML) | Min: 8' W x 7' H x 10'L
Max: 11'W x 8'H x 20'L
Flat Heads, Rectangular
Shell, and Rectangular
Door Frames. | Ranges stated:
8.1'W x 7'H x 11'L to
10.3'W x 7'H x 19.3'L | | |
| Transfer
Compartment
(Lock) (EL) | | Ranges stated:
8.1'W x 7'H x 4.5'L to
7.8'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 Product
Family chamber volumes and
the Fink DL8 and TL20 are
substantially equivalent. |
| Main Compartment
(Lock) (ML) | Rectangular geometry
from 600ft³ to 2600ft³ | Ranges stated:
614.5ft³ to 1,536.2ft³ | 197.8ft³ | |
| Manufacturer | OxyHeal® Medical
Systems, Inc. | Fink Engineering PTY
LTD | OxyHeal® Medical
Systems, Inc. | OxyHeal® 5000 Rectangular
Multiplace Hyperbaric |
| Trade Name | OxyHeal® 5000 Two &
Three Compartment
Hyperbaric Chamber
System | DL8 Hyperbaric
Treatment Facility &
TL20 Hyperbaric
Treatment Facility | OxyHeal® 2000
Hyperbaric Chamber
System | Chamber Product Family
Summary Comparison to
Predicates |
| Transfer
Compartment
(Lock) (EL)
Inner Compartment
(Lock) (IL) | | Ranges stated:
254.3ft³ to 529.7ft³
480.3ft³ | | The OxyHeal 2000 is
intentionally designed as a
smaller cylindrical hyperbaric
chamber. |
| Total Volume | 6,000ft³ to 2,600ft ³ | Ranges stated:
868.7ft³ to 2,546.2ft³ | 197.8ft³ | Total volumes of the OxyHeal
5000 Product Family chamber
and the Fink DL8 and TL 20
are substantially equivalent.
The OxyHeal 2000 is
intentionally designed as a
smaller cylindrical hyperbaric
chamber with much smaller
total volumes. |
| Medical Lock | Cylindrical
Min: 10 inch diameter
Max: 16 inch diameter | 13.8" x 13.8" x 19.7" | 10" ID x 10"L | Substantially equivalent |
| Main Doorway Size | Minimum door frame
size: 44" x 80, Maximum
52" x 80" | 39.4" x 75.6" | 32" x 83" | The OxyHeal 5000 Product
Family and the Fink DL8 and
TL20 chamber main doorway
sizes are substantially
equivalent.
The doorways of the OxyHeal
5000 compared to the 2000
Product Family chambers and
the Fink DL8 and TL20 |
| Manufacturer | OxyHeal® Medical
Systems, Inc.
OxyHeal® 5000 Two &
Three Compartment
Hyperbaric Chamber
System | Fink Engineering PTY
LTD
DL8 Hyperbaric
Treatment Facility &
TL20 Hyperbaric
Treatment Facility | OxyHeal® Medical
Systems, Inc.
OxyHeal® 2000
Hyperbaric Chamber
System | OxyHeal® 5000 Rectangular
Multiplace Hyperbaric
Chamber Product Family
Summary Comparison to
Predicates |
| Trade Name | | | | |
| | | | | predicate chambers are
substantially equivalent in
terms of safety and
effectiveness of operation. |
| Penetrators | Maximum of 30
Penetrations of 2" x 12"
blocks. | | | |
| Lighting | LED lights
Min: 4
Max: 15 | Ranges stated:
Six (6) to fourteen (14)
external dimmable lights | One (1) internally
mounted light. | The OxyHeal 5000 Product
Family chamber lights, the Fink
DL8 and TL20 chamber lights,
and the OxyHeal 2000 chamber
light comply with NFPA-99
and are substantially equivalent
in terms of safety and
effectiveness of operation. |
| Viewports (PVHO-
-
| Minimum: One (1) per
hyperbaric chamber.
Maximum: Six (6) per
compartment.
Minimum: 8" Diameter,
Maximum: 30" Diameter. | Ranges stated:
Main Lock (ML):
13.8" ID - Qty. 2 each to
23.6" ID - Qty. 4 each
Transfer Lock (TL):
5.9" ID - Qty. 1 each to
13" ID - Qty. 3 each
Inner Lock (IL):
6" ID - Qty. 2 each | 16" ID - Qty. 2 each | The OxyHeal 5000 Product
Family and the Fink DL8 and
TL20 chamber, and the
OxyHeal 2000 viewports are
substantially equivalent. |
| Capacity Main
Compartment | 4 Patients Up to 24
Patients | Ranges stated:
From eight (8) seated
patients
Four (4) wheelchairs | Capable of
accommodating up to six
(6) upright seated patients | The OxyHeal 5000 Product
Family and the Fink DL8 and
TL20 chamber main |
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| Manufacturer | OxyHeal® Medical
Systems, Inc. | Fink Engineering PTY
LTD | OxyHeal® Medical
Systems, Inc. | OxyHeal® 5000 Rectangular
Multiplace Hyperbaric
Chamber Product Family
Summary Comparison to
Predicates |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | OxyHeal® 5000 Two &
Three Compartment
Hyperbaric Chamber
System | DL8 Hyperbaric
Treatment Facility &
TL20 Hyperbaric
Treatment Facility | OxyHeal® 2000
Hyperbaric Chamber
System | |
| | | One (1) hospital gurney to -
up to twenty (20) patients | or four (4) upright seated
patients and two (2)
gurneys. | compartments are substantially
equivalent.
The OxyHeal 2000 is
intentionally designed as a
smaller cylindrical hyperbaric
chamber with less capacity;
however, substantially
equivalent in terms of safety
and effectiveness of operation. |
| Fire Suppression | IAW NFPA 99 | IAW NFPA 99 | IAW NFPA 99 | Substantially equivalent |
| Finish - Chamber | Sandblasted and finished
with 2-part high quality
epoxy paint with glossy
finish. | Shot blasted & painted | | Substantially equivalent |
| Life Support
Controls | Automatic pressurization
& depressurization with
manual back-up from
both inside and outside
each chamber
compartment. | Manual electropneumatic
(pressurization)
Manual electropneumatic
(depressurization) | Automatic pressurization
& depressurization with
manual back-up from both
inside and outside the
chamber. | The OxyHeal 5000 Product
Family and the OxyHeal 2000
life support controls are
substantially equivalent. |
| Environmental
Control | Heating & cooling | Heating | Heating and cooling | The OxyHeal 5000 Product
Family and the OxyHeal 2000
environmental controls are
substantially equivalent. |
| Ventilation | Automatic chamber
ventilation with manual
back-up. Min 6 cfm, Max | Constant air flow | Automatic chamber
ventilation with manual
back-up. | The OxyHeal 5000 Product
Family and the OxyHeal 2000 |
| Manufacturer | OxyHeal® Medical | Fink Engineering PTY | OxyHeal® Medical | OxyHeal® 5000 Rectangular |
| | Systems, Inc. | LTD | Systems, Inc. | Multiplace Hyperbaric |
| Trade Name | OxyHeal® 5000 Two &
Three Compartment
Hyperbaric Chamber
System | DL8 Hyperbaric
Treatment Facility &
TL20 Hyperbaric
Treatment Facility | OxyHeal® 2000
Hyperbaric Chamber
System | Chamber Product Family
Summary Comparison to
Predicates |
| | 48cfm with a +/- 1 fsw
stability. | | | ventilation are substantially
equivalent. |
| BIBS with
Overboard Dump | Four (4) to Twenty-Four
(24), on demand gas
delivery. | Ranges stated:
Two (2) - Four (4) | Four (4) | The BIBS overboard dump
system for the OxyHeal 5000
Product Family, the Fink DL8
and TL20 chambers, and the
OxyHeal 2000 chamber are
substantially equivalent in
terms of safety and
effectiveness of operation. |
| Hoods with
Overboard Dump | Four (4) to Twenty-Four
(24) 1-100LPM delivery
flow meters. Minimum
flow for hoods: 40-lpm. | Ranges stated:
Six (6) to Twenty two (22) | Four (4) | The hood overboard dump
system for the OxyHeal 5000
Product Family, the Fink DL8
and TL20 chambers, and the
OxyHeal 2000 chamber are
substantially equivalent in
terms of safety and
effectiveness of operation. |
| Depth Measurement | Digital with analog
backup | Digital with analog backup | Digital with analog backup | Substantially equivalent |
| Gas Analysis | Oxygen (O2) 1-100% and
carbon dioxide (CO2) 0-
5000ppm | Oxygen (O2) and carbon
dioxide (CO2) | Oxygen (O2) and carbon
dioxide (CO2) | Substantially equivalent |
| Communications | Primary: Wireless
telephone
Secondary: Intercom
Tertiary: Sound powered
backup | Internal/external PA system
Sound powered backup | Primary: Wireless
telephone
Secondary: Intercom | Substantially equivalent |
| Manufacturer | OxyHeal® Medical
Systems, Inc. | Fink Engineering PTY
LTD | OxyHeal® Medical
Systems, Inc. | OxyHeal® 5000 Rectangular
Multiplace Hyperbaric |
| Trade Name | OxyHeal® 5000 Two &
Three Compartment
Hyperbaric Chamber
System | DL8 Hyperbaric
Treatment Facility &
TL20 Hyperbaric
Treatment Facility | OxyHeal® 2000
Hyperbaric Chamber
System | Chamber Product Family
Summary Comparison to
Predicates |
| Entertainment | Individual up to 4-
channels. Varies based on
customer specification for
number of compartments
and number of patients to
be treated. | Individual 4-channel
selection for eight (8)
persons | Individual 4-channel
selection for up to six (6)
persons. | Substantially equivalent |
| TV System | 24VDC LED TV
Monitor. AM/FM
Tuner/CD, DVD, and
Cable TV Tuner. . | External color with remote
control AM/FM tuner/CD
& DVD player | One (1) internally
mounted TV System.
AM/FM tuner/CD & DVD
player. | The OxyHeal 5000 Product
Family TV systems and the
Fink DL8 and TL20 TV
systems comply with NFPA-99
and are substantially equivalent
in terms of safety and
effectiveness of operation.
The OxyHeal 2000 is
intentionally designed as a
smaller cylindrical hyperbaric
chamber with a TV system that
complies with NFPA-99 and is
substantially equivalent in
terms of safety and
effectiveness of operation. |
| Compartment Relief | One (1) ASME certified
pressure relief valve per
compartment.
30 psig to 75 psig | ASME certified pressure
relief valve | One (1) ASME certified
pressure relief valve | Substantially equivalent |
| Manufacturer | OxyHeal® Medical
Systems, Inc. | Fink Engineering PTY
LTD | OxyHeal® Medical
Systems, Inc. | OxyHeal® 5000 Rectangular
Multiplace Hyperbaric |
| Trade Name | OxyHeal® 5000 Two &
Three Compartment
Hyperbaric Chamber
System | DL8 Hyperbaric
Treatment Facility &
TL20 Hyperbaric
Treatment Facility | OxyHeal® 2000
Hyperbaric Chamber
System | Chamber Product Family
Summary Comparison to
Predicates |
| Compartment Drain | Minimum One (1)
manual drain in each
compartment | One (1) manual drain in
each compartment | One (1) manual drain | Substantially equivalent |
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9. Non-Clinical Testing
Refer to paragraphs 9.1 - 9.5
9.1 Structural Testing
The following testing and /or examinations were used in whole or in part for certifying the weld integrity and the integrity of the entire pressure vessel for human occupancy (PVHO) (the hyperbaric chamber):
- Penetrant Examination (PE) a.
- b. Ultrasonic Testing (UT)
- C. Radiographic Examinations (RT)
- d. Magnetic Particle Examination (MT)
In accordance with ASME requirements, the entire PVHO is pressure tested hydrostatically. This entails filling the PVHO with water and pressure testing at 1.3 times the maximum allowable working pressure (MAWP) of the PVHO. Each viewport is installed in its location and hydrostatically tested as part of the overall structural test.
9.2 Fire Suppression System Testing
A Fire Suppression System (FSS) test was conducted at the completion of the hydrostatic test to ensure that the fire deluge system water spray system and the hand line met the requirements of the National Fire Protection Agency (NFPA) 99, Chapter 14 - Hyperbaric facilities.
9.3 First Operational System TestA first operational system test (FOST) was performed to verify that the system design met each of the specification requirements. This testing includes the following items specified in the OxyHeal 5000 hyperbaric chamber system product family as defined in the User Design Specification.
- a. Testing of the minimum and maximum pressurization rates
- b. Testing of the minimum and maximum depressurization rates
- Testing of the minimum and maximum ventilation rates C.
- d. Testing of the conditions under which these rates are to be maintained
- Testing of the patient gas delivery systems and flow meter range e.
- Testing of the chamber pressurization and ventilation gas for meeting requirements for CGA f. Grade E
9.4 Software Validation Testing.
A software validation test was conducted to validate that observed output of designated hyperbaric chamber control functions met the output that they were designed to perform to ensure they are consistently safe and effective and operate. This testing includes the following items specified in the OxyHeal 5000 hyperbaric chamber system product family as defined in the User Design Specification.
- Testing of the minimum and maximum pressurization rates a.
- b. Testing of the minimum and maximum depressurization rates
- C. Testing of the minimum and maximum ventilation rates
- Testing of the conditions under which these rates are to be maintained d.
- Testing of the patient gas delivery systems and flow meter range e.
તે. તે રે Factory Acceptance Test
17
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.