PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2

K021689 · Pan-America Hyperbarics, Inc. · CBF · Oct 24, 2002 · Anesthesiology

Device Facts

• Record ID: K021689
• Device Name: PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
• Applicant: Pan-America Hyperbarics, Inc.
• Product Code: CBF · Anesthesiology
• Decision Date: Oct 24, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

It is the expressed, intended use of the Pan-America Hyperbarics, Inc., PAH-M10+2 Hyperbaric Chamber System is 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 its 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 UHMS Hyperbaric Oxygen Therapy Committee Report (1999) are as follows: - Air or gas embolism 1. - Carbon monoxide poisoning and carbon monoxide poisoning complicated by 2. cyanide poisoning - 3. Clostridial myositis and myonecrosis - 4. Crush injury, compartment syndrome, and other acute traumatic ischemias - 5. Decompression sickness - 6. Enhanced healing 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 The Pan-America Hyperbarics, Inc., PAH-M10+2 Hyperbaric Chamber System is designed to be installed and operated in medical facilities as defined by the NFPA 99, Health Care Facilities, Chapter 19, Hyperbaric Facilities (Chapter 20, 2002 Edition). Further, this system is intended to be operated only by medical personnel specifically trained in the appropriate use of HBO and the safe operations of all related equipment such as the hyperbaric chamber.

Device Story

Multiplace hyperbaric chamber system; treats up to 12 patients; max operating pressure 6 ATA. Uses compressed air for pressurization; 100% oxygen delivered via oronasal masks or head tents. Operated by trained medical personnel in clinical facilities. Features main and transfer compartments; rectangular door for gurney access; manual pneumatic pressure control. Includes Teledyne TED-191 oxygen analyzer for continuous monitoring; low-voltage intercommunication system for patient-operator contact; dual fire suppression (water deluge and handline). Provides hyperbaric oxygen therapy to facilitate healing or treat specific medical conditions; physician-prescribed. Benefits patients by providing controlled hyperbaric environment for approved clinical indications.

Clinical Evidence

No clinical data. Device relies on established clinical indications for hyperbaric oxygen therapy as defined by the Undersea & Hyperbaric Medical Society (UHMS) and adherence to recognized safety standards (ASME/NFPA).

Technological Characteristics

Class A multiplace hyperbaric chamber; 7025mm length, 2500mm diameter. Materials/fabrication per ANSI/ASME Boiler and Pressure Vessel Code Section VIII Div 1 and ANSI/ASME-PVHO-1. Pressurization via compressed air; oxygen delivery via masks/tents. Includes Teledyne TED-191 oxygen analyzer. Fire suppression: water deluge and handline per NFPA 99. Manual pneumatic pressure control. Penetrator plate for external monitoring leads.

Indications for Use

Indicated for patients requiring hyperbaric oxygen therapy for conditions including air/gas embolism, carbon monoxide poisoning (with/without cyanide poisoning), clostridial myositis/myonecrosis, crush injury, compartment syndrome, acute traumatic ischemias, decompression sickness, problem wound healing, 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

• Engineered Medical Technology OASIS Hyperbaric System (K001121)
• Perry Sigma MP Multiplace Hyperbaric Chamber (K930748)
• Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber (K950957)
• Reimers T Class Hyperbaric Facility (K95438)

Submission Summary (Full Text)

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OCT 2 4 2002

K 021689

# 510(k) NOTIFICATION SUMMARY (Per 21 CFR 807.92)

Prepared: May 20, 2002

TRADE NAME: Pan-America Hyperbarics, Inc., PAH-M10+2 Hyperbaric Chamber System

COMMON NAME OF DEVICE: Multiplace Hyperbaric Chamber

CLASSIFICATION: 73 CBF, 21 CFR 868.5470

ESTABLISHMENT REGISTRATION NUMBER: Pending

### CLAIMED PREDICATE DEVICE(S):

Engineered Medical Technology OASIS Hyperbaric System - K001121 Perry Sigma MP Multiplace Hyperbaric Chamber – K930748 Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber - K 950957 Reimers T Class Hyperbaric Facility - K95438

### ADDRESS OF MANUFACTURER:

CONTACT PERSON: Cheng, Kuo-Chung

### EXECUTIVE SUMMARY

The PAH-M10+2 Hyperbaric Chamber System is a Class A multiplace hyperbaric chamber designed to treat up to 12 patients at up to a maximum operating pressure of 6 Atmospheres Absolute (ATA) or 73.5 pounds per square inch qauge (psig). The chamber uses compressed air as the pressurization gas and 100% oxygen as the hyperbaric treatment gas.

The PAH-M10+2 Hyperbaric Chamber System is intended to be procured and used by physicians to treat a variety of medical conditions that respond to hyperbaric oxygen. The Undersea & Hyperbaric Medical Society (UHMS) produces a list of medical conditions that have been identified for the appropriate primary or adjunctive use of hyperbaric oxygen. These approved conditions include: air or gas embolism; carbon monoxide poisoning and smoke inhalation; clostridial myonecrosis (gas gangrene); crush injury, compartment syndrome and other acute traumatic ischemias; decompression sickness; enhanced healing of selected problem wounds; exceptional blood loss anemia; necrotizing soft tissue infections; osteomyelitis (refractory); radiation tissue damage (osteoradionecrosis); compromised skin flaps and grafts; thermal burns; and, intracranial abscess. Aggressive research into the beneficial effects of hyperbaric oxygen, when appropriately applied, will result in additional medical conditions being added to the list of indications by the UHMS.

The PAH-M10+2 Hyperbaric Chamber System is designed and fabricated in accordance with the requirements of the ANSI/ASME Boiler and Pressure Vessel Code, Section VIII, Division 1, Pressure Vessels; ANSI/ASME-PVHO-1 (American Society of Mechanical Engineers-Pressure Vessels for Human Occupancy); and, NFPA 99, Health Care Facilities, Chapter 19, Hyperbaric Facilities (Chapter 20, 2002 Edition). The overall external length of the chamber is 7025mm (approx. 23 ft). Its internal diameter is 2500mm (approx. 8.2 ft). There are two compartments: main compartment and transfer compartment. Ten (10) seats and two (2) seats are installed in main compartment and transfer compartment respectively. Besides, there is one (1) additional seat installed in the main compartment for attendant. Two independent fire suppression systems, water deluge system and handline system, are

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installed in accordance with the requirement of NFPA 99, Chapter 19 (Chapter 20, 2002 Edition). Pressurization is provided by compressed air with 100% oxygen administered to the patient by using properly fitting oronasal masks or head tents. A low-voltage patient intercommunication system designed and installed in accordance with NFPA 99, Chapter 19 (Chapter 20, 2002 Edition) and provides communications between the patients in the chamber and the outside chamber operator. It also provides patients with audio program content from external sources such as CD players, radios, etc. A Teledyne TED-191 oxygen analyzer is installed to monitor the concentration of oxygen inside the chamber continually. The system consists of an operator control console that contains all of the controls and connection points. Single operator chamber pressure control is achieved via a simple manual pneumatic control. A penetrator plate is provided in the vessel wall to allow user supplied medical monitoring leads, etc., to be used as required. The rectanqular door allows a normal size patient gurney to be used to transport nonambulatory patients into the chamber. This feature greatly improves patient handling safety.

### INTENDED USE

It is the expressed, intended use of the Pan-America Hyperbarics, Inc., PAH-M10+2 Hyperbaric Chamber System is 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 its 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 UHMS Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:

- Air or gas embolism 1.
- Carbon monoxide poisoning and carbon monoxide poisoning complicated by 2. cyanide poisoning
- က် Clostridial myositis and myonecrosis
- Crush injury, compartment syndrome, and other acute traumatic ischemias ধ
- ട. Decompression sickness
- Enhanced healing of selected problem wounds റ.
- Exceptional blood loss anemia 7.
- Necrotizing soft tissue infections 8.
- Osteomyelitis (refractory) တဲ
- 10. Delayed radiation injury (soft tissue and bony necrosis)
- 11. Skin grafts and flaps (compromised)
- 12. Thermal burns
- 13. Intracranial abscess

The Pan-America Hyperbarics, Inc., PAH-M10+2 Hyperbaric Chamber System is designed to be installed and operated in medical facilities as defined by the NFPA 99, Health Care Facilities, Chapter 19, Hyperbaric Facilities (Chapter 20, 2002 Edition). Further, this system is intended to be operated only by medical personnel specifically trained in the appropriate use of HBO and the safe operations of all related equipment such as the hyperbaric chamber.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

200 Corporate Boulevard Bockville MD 20850

Pan-America Hyperbarics. Incorporated C/O Mr. W. T. Workman Workman Hyperbaric Services, Incorporated 18111 Copper Ridge Drive San Antonio, Texas 78259-3612

Re: K021689

Trade/Device Name: Hyperbaric Chamber System, Model PAH-M10+2 Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: September 5, 2002 Received: September 6, 2002

Dear Mr. Workman:

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 such additional controls. Existing major regulations affecting vour 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.

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Page 2 - Mr. Workman

. . . .

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Device Name: Pan-America Hyperbarics, Inc., PAH-M10+2 Hyperbaric Chamber System

Indications for Use:

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:

- 1. Air or gas embolism
- Carbon monoxide poisoning and carbon monoxide poisoning complicated by 2. cyanide poisoning
- 3. Clostridial myositis and myonecrosis
- Crush injury, compartment syndrome, and other acute traumatic ischemias 4.
- 5. Decompression sickness
- Enhanced healing of selected problem wounds 6.
- 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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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ision Sign-Off) ision of Anesthesiology, General Hosp Infection Control, Dental Devices

(Optional Format 3-10-98)

510(k) Number: