RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER

K082455 · Gulf Coast Hyperbarics, Inc. · CBF · May 22, 2009 · Anesthesiology

Device Facts

• Record ID: K082455
• Device Name: RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
• Applicant: Gulf Coast Hyperbarics, Inc.
• Product Code: CBF · Anesthesiology
• Decision Date: May 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

It is the expressed, intended use of the Gulf Coast Hyperbaric rectangular hyperbaric chamber to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in their procurement and routine use.

Device Story

Rectangular multiplace hyperbaric chamber designed for clinical hospital environments; accommodates up to 12 seated patients. Device provides hyperbaric oxygen therapy at pressures up to 3.0 ATA. Features include walk-through sliding doors, oxygen hood supply/exhaust system, and integrated air conditioning. Operated by trained personnel via a control console displaying chamber functions, temperature, and humidity. Includes internal/external communication systems, CCTV, and entertainment systems. Designed to simulate a clinical room to reduce patient anxiety. Safety features include fire suppression per NFPA 99 and manual-electric life support controls. Benefits include controlled delivery of hyperbaric oxygen for validated medical conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, manufacturing standards (ASME/NFPA), and comparison to legally marketed predicate devices.

Technological Characteristics

Pressure vessel constructed per ASME Section VIII, Div. 1 and ASME PVHO-1. Operating pressure 3.0 ATA; design pressure 32.3 PSI. Dimensions 9.3'W x 8.3'H x 32'L. Features manual-electric life support, dual oxygen/CO2 gas analysis, and environmental control (heating/cooling). Fire suppression per NFPA 99. Connectivity includes internal/external PA, sound power phones, and CCTV. Lighting is external/dimmable.

Indications for Use

Indicated for patients with conditions responsive to hyperbaric oxygen therapy, including: air/gas embolism, carbon monoxide poisoning (with/without cyanide poisoning), clostridial myositis/myonecrosis, crush injury/compartment syndrome/acute traumatic ischemias, decompression sickness, problem wounds, exceptional blood loss anemia, necrotizing soft tissue infections, refractory osteomyelitis, delayed radiation injury, compromised skin grafts/flaps, thermal burns, and intracranial abscess.

Regulatory Classification

Identification

A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).

Predicate Devices

• Fink Engineering Multiplace Hyperbaric Chamber (K031649)
• Perry Baromedical Multiplace Hyperbaric Chamber (K930748)
• Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber (K950957)

Submission Summary (Full Text)

{0}------------------------------------------------

MAY 22 2009

K082455

Gulf Coast Hyperbarics, Inc.

1100 W. 26* St. Lynn Haven, FL 32444 [phone]

### 510(K) Summary for Gulf Coast Hyperbarics, Inc. Rectangular Multiplace Hyperbaric Chamber (K082455)

Date: May 22, 2009

To:

Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, MD. 20850

- Gulf Coast Hyperbarics, Inc. Submitter: 1100 W. 26th Street Lynn Haven, FL 32444 Telephone: [phone] Fax: [phone] Email: [e-mail] [e-mail]
Name of Device:

Proprietary name: Rectangular Multiplace Hypebaric Chamber Common/Usual Name: Hypebaric Chamber

{1}------------------------------------------------

Gulf, Coast Hyperbasics, Inc.

1100 W. 26* St.

Lynn Haven, FL 32444 [phone]

Equivalent Devices:

Fink Engineering Multiplace Hyperbaric Chamber- K031649 Perry Baromedical Multiplace Hyperbaric Chamber- K930748 Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber - K950957

Device Description

The Gulf Coast Hyperbarics rectangular multiplace hyperbaric chambers are designed and manufactured in accordance with the requirements of the ANSI/ASME Boiler and Pressure Vessel code, Section VIII, Division 1, Pressure Vessels ANSVASME-PVHO-1 (American Society of Mechanical Engineers- Pressure Vessels for Human Occupancy. and NFPA 99, Health Care Facilities; Chapter 20, Hyperbaric Facilities, 2005 Edition. The new Gulf Coast Hyperbaric multiplace rectangular chambers (K082455) are designed and manufactured using the same major components as in the cleared Gulf Coast Hyperbarics multiplace cylindrical chamber (K950957). The rectangular multiplace chamber includes as a key component, a new and user friendly rectangular design which is simple and simulates as closely as possible the clinical conditions found elsewhere in their working environment.

The rectangular chamber(s) place major emphasis on patient and operator safety, and user-friendly operator controls and includes several unique features including:

- A large, comfortable rectangular hyperbaric chamber that has been 0 outfitted to appear like any other clinical room in a hospital to reduce patient anxiety
- o Large walk-through rectangular sliding doors that fit flush with the floor so that patients can be wheeled into the chamber without bumping over the doorjamb.
- A large and easy to use control console designed to display all functions of o the chamber

{2}------------------------------------------------

Gulf, Coast Hyperbaries, Inc.

1100 W. 26" Sz Lynn Haven, FL 32444

## [phone]

- An oxygen hood supply and exhaust system designed for easy use and O eliminates over or under pressurization of the hood and eliminates the possibility of "shrink wrapping" the patient hood.
- Air conditioning system providing controllable cooling and heating of the o chamber interior. The temperature and humidity is monitored at the control console.

Specification of the Rectangular Multiplace Hyperbaric Chamber System is as follows:

| Design Code | ASME Section VIII, Div. 1 & ASME PVHO |
|-----------------------|---------------------------------------|
| Operating Pressure | 3.0 ATA |
| Operating Temperature | 62 degrees F to 100 degrees F |
| Design Pressure | 32.3 PSI |
| Design Temperature | 62 degrees F to 100 degrees F |
| Design Life | 70,000 Cycles/30 yrs |
| Hydrostatic Pressure | 42.0 PSI |
| Inspection Authority | ASME “U” Stamp |
| Weight | 113,000 lbs |
| Dimensions | 9.3'w x 8.3'H x 32'L |
| Volume | 2,423.8f3 |
| Medical Lock | 13"dia x 14" long |
| Doors (all 3) | 48"w x 76"H |
| Lighting | 10 External0Dimmable |
| Viewports/Chamber | 18"dia (9 ea) |
| Viewports (3 doors) | 8" dia. (3 ea) |
| Capacity | 12-seated patients |
| Fire Suppression | Iaw NFPA99- 2005 Edition |
| Finish | Sand blasted & painted |

{3}------------------------------------------------

Gulf, Coast Hyperbaries, Inc.

1100 W. 26* St. Lynn Haven, FL 32444 [phone]

| Life Support Controls | Manual-Electric |
|------------------------|-----------------------------------------------|
| Environmental Control | Cooling & Heating |
| Ventilation | As Required |
| BIB w/overboard Dump | 3 |
| Hoods w/overboard Dump | 12 |
| Depth Measurement | Dual analog both chambers |
| Gas Analysis | Dual oxygen and single |
| | Carbon dioxide analyzers |
| Communications | Internal/External PA system |
| | Open/Closed communication system |
| | Sound power phones (3) |
| | Closed Circuit Television (3) |
| Entertainment | Individual four-channel Audio for 12 Patients |
| Television System | Color television-purged |
| | Main chamber, AM/FM Receiver |
| | CD & DVD |

Gulf Coast Hyperbarics, Inc. has concluded the general design approach, method of pressure control, and intended use of the rectangular chamber multiplace hyperbaric chamber is substantially equivalent to the Perry Baromedical multiplace chamber (K930748), The Fink Engineering multiplace hyperbaric chamber (K031649) and the Gulf Coast Hyperbarics multiplace chamber (K950957) and is proposing them as predicate devices for the Gulf Coast Hyperbarics rectangular multiplace hyperbaric chamber (K085455).

{4}------------------------------------------------

#### Indications for use:

It is the expressed, intended use of the Gulf Coast Hyperbaric rectangular hyperbaric chamber to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in their procurement and routine use.

The UHMS is the professional medical organization chartered with setting the standards of care defining the appropriate use of hyperbaric oxygen. More specifically, the UHMS publishes a listing of medical conditions that have been clearly established as appropriate primary or adjunctive use of hyperbaric oxygen (HBO). The disorders on the list have been scientifically validated and verified through extensive data collection. It should be noted that the list is dynamic. Based on the strength of the scientific data, disorders are both added and removed from the list, depending on the outcomes of scientific pursuit.

The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) is as follows:

- l. Air or gas embolism
- 2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
- 3. Clostridial myositis and myonecrosis
- 4. Crush injury, compartment syndrome, and other acute traumatic ischemias
- 5. Decompression sickness
- 6. Enhanced of selected problem wounds
- 7. Exceptional blood loss anemia
- 8. Necrotizing soft tissue infections
- 9. Osteomyelitis (refractory)
- 10. Delayed radiation injury (soft tissue and bony necrosis)
- 11. Skin grafts and flaps (compromised)
- 12. Thermal burns
- 13. Intracranial abscess

{5}------------------------------------------------

## INDICATIONS FOR USE: (As stated on the UHMS website)

The following indications are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric Oxygen Therapy Committee. The Committee Report can be purchased directly through the UHMS.

- l Air or Gas Embolism Carbon Monoxide Poisoning and
- 2 Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
- Clostridal Myositis and Myonecrosis (Gas 3 Gangrene)
- Crush Injury, Compartment Syndrome, and other 4 Acute Traumatic Ischemias
- 5 Decompression Sickness
- Enhancement of Healing in Selected Problem б Wounds
- 7 Exceptional Blood Loss (Anemia)
- 8 Intracranial Abscess
- 9 Necrotizing Soft Tissue Infections
- Osteomyelitis (Refractory) 10
- Delayed Radiation Injury (Soft Tissue and Bony 11 Necrosis)
- Skin Grafts & Flaps (Compromised) 12
- Thermal Burns 13

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged around the top half of the circle. The eagle is facing to the right, and its wings are depicted with thick, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 2009

Mr. James W. McCarthy Owner Gulf Coast Hyperbarics, Incorporated 1100 West 26th Street Lynn Haven, Florida 32444

Re: K082455

Trade/Device Name: Multiplace Hyperbaric Chamber Regulation Number: 21 CFR 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: May 1, 2009 Received: May 12, 2009

Dear Mr. McCarthy:

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.

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

{7}------------------------------------------------

Page 2- Mr. McCarthy

and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sosen Rurose

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Image /page/8/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo includes the FDA acronym, the full name of the agency, and the logo of the Department of Health and Human Services. Below the logo, the text "CENTER FOR DEVICES AND RADIOLOGICAL HEALTH" is visible.

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH

# Indications for Use

510(k) Number (if known): _ KO82455

Device Name: MULTIPLACE HYPERBARIC CHAMBER

Indications for Use:

Sina Chase

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K052435

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

http://www.fda.gov/cdrh/ode/indicate.html

5/5/2009

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo and contact information for Gulf Coast Hyperbarics, Inc. The logo features a stylized, interconnected design to the left of the company name. The address is listed as 1100 W. 26th Street, Lynn Haven, FL 32444, and the phone number is [phone].

INDICATIONS FOR USE 510(K): KOB24455 Device Name: Rectangular Multiplace Hyperbario Chamber

Indications for Use:

Statement of Indications

It is the expressed intended use of the Gulf Coast Hyperbarics¬ Inc. Rectangular Hyperbaric Oxygen Treatment Facilities to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive devices it is further intended for physician involvement in their procurement and routine use

The UHMS is the professional medical organization chartered with setting the standards of care defining the appropriate use of hyperbaric oxygen. More specifically the UHMS publishes a listing of medical conditions that have been clearly established as appropriate primary or adjunctive use of hyperbaric oxygen (HB0). The disorders on the list have been scientifically validated and

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for Gulf Coast Hyperbarics, Inc. The logo includes a stylized graphic to the left of the company name. Below the company name is the address 1100 W. 26th Street, Lynn Haven, FL 32444.

[phone]

verified through extensive data collection. It should be noted that the list is dynamic. Based on the strength of the scientific data, disorders are both added and removed from the list, depending on the outcomes of scientific pursuit. The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:

- l Air or Gas Embolism
- Carbon Monoxide Poisoning and
- Carbon Monoxide Poisoning
- Complicated by Cyanide Poisoning
- Clostridal Myositis and Myonecrosis (Gas Gangrene)
- Crush Injury- Compartment Syndrome and other Acute Traumatic Ischemias Decompression Sickness
- Enhancement of Healing in Selected Problem Wounds
- Exceptional Blood Loss (Anemia)
- Intracranial Abscess
- Necrotizing Soft Tissue Infections
- 0steomyelitis (Refractory)
- Delayed Radiation Injury (Soft ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ
- Tissue and Bony Necrosis)
- Skin Grafts & Flaps (Compromised)
- Thermal Burns

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo and address of Gulf Coast Hyperbarics, Inc. The logo features an abstract design with three curved lines. The address is listed as 1100 W. 26th Street, Lynn Haven, FL 32444.

[phone]

In addition I have included a copy of the most current indications for hyperbaric oxygen therapy from the UHMS website.

Respectfully

Rhee Casey

James W. McCarthy, President Gulf Coast Hyperbarics, Inc