BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER

K993010 · Environmental Tectonics Corp. · CBF · May 30, 2000 · Anesthesiology

Device Facts

• Record ID: K993010
• Device Name: BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
• Applicant: Environmental Tectonics Corp.
• Product Code: CBF · Anesthesiology
• Decision Date: May 30, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To promote the movement of oxygen into a patient's tissues by causing him to resvire oxygen at a pressure that is greater than that of the earth's atmosphere (i.e., 1 ATA). Specifically, the BARA-MED® and the predicate devices are indicated for air or gas embolism; carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning; clostridial 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; refractory osteomyelitis; delayed radiation injury (soft tissue and bony necrosis); compromised skin grafts and flaps; thermal burns.

Device Story

BARA-MED® is an acrylic monoplace hyperbaric chamber; provides hyperbaric oxygen therapy by pressurizing and ventilating the chamber with pure oxygen. Patient breathes chamber atmosphere at pressures >1 ATA. Operator controls pressure-time profiles and oxygen ventilation rates via pneumatic or electronic systems. Used in clinical settings to promote tissue oxygenation for various medical conditions. Output is the controlled hyperbaric environment; allows physician-prescribed treatment delivery. Benefits include enhanced healing and treatment of specific ischemic or toxic conditions.

Clinical Evidence

Bench testing only. Device performance demonstrated through compliance with ASME Boiler and Pressure Vessel Code, ASME PVHO-1, and NFPA 99 standards.

Technological Characteristics

Acrylic monoplace hyperbaric chamber. Materials and construction comply with ASME Boiler and Pressure Vessel Code Section VIII, ASME PVHO-1-1997, and NFPA 99. Operates via pneumatic or electronic pressure/ventilation control systems. Standalone device.

Indications for Use

Indicated for patients requiring hyperbaric oxygen therapy for conditions including air/gas embolism, carbon monoxide poisoning, gas gangrene, crush injury/acute traumatic ischemia, decompression sickness, problem wounds, anemia, intracranial abscess, necrotizing soft tissue infections, refractory osteomyelitis, radiation injury, compromised skin grafts/flaps, and thermal burns.

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

• Dixie Manufacturing Co.'s Dixie 800-45
• Perry Baromedical's Sigma I
• Sechrist Industry's Sechrist 2500
• Sechrist Industry's Sechrist 2500E (K934164)
• Sechrist Industry's Sechrist 3200 (K950386)

Submission Summary (Full Text)

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K993010

# 510(k) SUMMARY

# Environmental Tectonics Corporation's BARA-MED® Acrylic Monoplace Hyperbaric Chamber

### SUBMITTER'S NAME AND ADDRESS

Environmental Tectonics Corporation ("ETC") Hyperbaric Division 125 James Way Southampton, PA 18966

# CONTACT PERSON AND TELEPHONE/FACSIMILE NUMBERS

Micheal W. Allen Director, Hyperbaric Division Environmental Tectonics Corporation 125 James Way Southampton, PA 18966

Phone: [phone]. Ext. 373 Facsimile: [phone]

## DATE PREPARED: September 3, 1999

## NAME OF DEVICE

Trade of Proprietary Name: BARA-MED® Clinical Acrylic Monoplace Hyperbarid Chamber

Common Name: Hyperbaric Chamber

Classification Name: Hyperbaric chamber, 21 C.F.R. § 868.5470

#### PREDICATE DEVICES

- Dixie Manufacturing Co.'s Dixie 800-45 (pre-amendment device) �
- Perry Baromedical's Sigma I (pre-amendment device) �
- Sechrist Industry's Sechrist 2500 (pre-amendment device) �
- Sechrist Industry's Sechrist 2500E (K934164) �
- Sechrist Industry's Sechrist 3200 (K950386) �

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# DEVICE DESCRIPTION/SUBSTANTIAL EQUIVALENCE

The BARA-MED® and its predicate devices have the same intended use: to promote the movement of oxygen into a patient's tissues by causing him to resvire oxygen at a pressure that is greater than that of the earth's atmosphere (i.e., 1 ATA). Specifically, the BARA-MED® and the predicate devices are indicated for air or gas embolism; carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning; clostridial 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; refractory osteomyelitis; delayed radiation injury (soft tissue and bony necrosis); compromised skin grafts and flaps; thermal burns. These indications for use are in accordance with the recommendations made by the Undersea and Hyperbaric Medical Society for the medical application of hyperbaric chambers.

The BARA-MED® and its predicate devices have very similar general principles of operation. All of these chambers are pressurized and ventilated continuously with pure oxygen, and the patient breathes the chamber atmosphere. Also, in each of the chambers, the pressure-time profile i.e., the rate and direction of pressure change and the time held at any particular pressure), as well as the oxygen ventilation rate of any treatment, are controlled by the chamber's operator, either directly by means of a pneumatic or electronic system, or indirectly by means of an automatic electronic system. The purposes of such controls are to be able to conduct the particular hyperbaric oxygen treatment prescribed by the physician in a way that is save and comfortable for the patient, and to be able to respond appropriately and effectively to any contingency circumstance.

The ETC BARA-MED® is designed and manufactured in accordance with the applicable sections of:

- ASME Boiler and Presser Vessel Code, Section VII, Rules for ● Construction of Pressure Vessels, Division 1, 1998 Edition.
- . ASME PVHO-1-1997, Safety Standard for Pressure Vessels for Human Occupancy.
- NFPA 99, Standard for Health Care Facilities, Chapter 19, 199 . Edition.

In all respects, the BARA-MED® is substantially equivalent to one or more clinical monoplace hyperbaric chambers that are legally marketed for the conduct of hyperbaric oxygen therapy.

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# PERFORMANCE DATA

Testing was indicated to demonstrate that the device meets the standards referenced above.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2000

Environmental Tectonics Corp. C/O Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004

Re: K993010 Rasa-Med, Acrylic Monoplace Hyperbaric Chamber Regulatory Class: II (two) 73 CBF Product Code: Dated: February 28, 2000 Received: March 1, 2000

Dear Mr. Holstein:

We have reviewed your Section 510(k) notification of intent to market we nave reviewed your beceien drown have determined the device is the device fereiched above and indications for use stated in the Substantially equivalence (essent to the devices marketed in encrosure) to regarif marito May 28, 1976, the enactment date of the Interstate Commerce prior co the devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and In accordance with the provident of ce, market the device, subject to the general controls provisions of the Act. The general controls che general conclude requirements for annual registration, pisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device ID Class III (Premarket Approval), it may be subject to such controls) of Craco - Existing major regulations affecting your device aan be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. ed 653. If babbandad in the Practice requirements, as set with the Ourchio System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ocheral regaracton od Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in assumptions. Turrare of comp-in, FDA may publish further announcements regaratory acurrently in the Federal Register. Please note: this concerning your dovemarket notification submission does not affect any reopone of your pat have under sections 531 through 542 of the Act obrigation you might have andric Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Mr. Howard Holstein

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N Millenson

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):

Device Name: BARA-MED® ACRYLIC MONOPLACE CHAMBER

Indications For Use:

All of the contemporary substantially equivalent systems listed in Attachment 12 are used for the same indications as listed in the Hyperbaric Oxygen Therapy: Committee Report, Undersea and Hyperbaric Medical Society, Inc., Revised 1999.

- Air or Gas Embolism .
- Carbon Monoxide Poisoning and Carbon Monoxide Poisoning complicated by Cyanide . Poisoning
- Clostridial 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 .
- Osteomyelitis (Refractory) .
- Delayed Radiation Injury (Soft Tissue and Bony Necrosis) .
- Skin Grafts and Flaps (Compromised) ●
- Thermal Burns .

# (PLEASE DO NOT WRITEW BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mcllven K993610
Division Sign Off

Division of Cardiovascular, Respiratory, and Neurological Devices 93010 519(k) Number _

(Optional Format 3-10-98)