BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER

K020974 · Environmental Tectonics Corp. · CBF · Jun 26, 2002 · Anesthesiology

Device Facts

• Record ID: K020974
• Device Name: BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER
• Applicant: Environmental Tectonics Corp.
• Product Code: CBF · Anesthesiology
• Decision Date: Jun 26, 2002
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BARA-MED Monoplace Hyperbaric Chamber is a prescription device intended for the whole body administration of oxygen to a patient at pressures not exceeding 3 ATA (Atmospheres Absolute).

Device Story

BARA-MED® is an acrylic monoplace hyperbaric chamber for whole-body oxygen administration at pressures up to 3 ATA. Device operates by pressurizing and ventilating the chamber with pure oxygen, which the patient breathes. Chamber pressure-time profiles and oxygen ventilation rates are managed by an operator via pneumatic or electronic controls. Used in clinical settings to deliver prescribed hyperbaric oxygen therapy. Output allows physicians to conduct controlled, safe, and comfortable treatments for specific medical conditions, enabling effective responses to clinical contingencies.

Clinical Evidence

Bench testing only. Testing demonstrated compliance with ASME Boiler and Pressure Vessel Code Section VIII, ASME PVHO-1 (Safety Standard for Pressure Vessels for Human Occupancy), and NFPA 99 (Standard for Health Care Facilities).

Technological Characteristics

Acrylic monoplace hyperbaric chamber; operates at pressures up to 3 ATA. Construction adheres to ASME Boiler and Pressure Vessel Code Section VIII (1998), ASME PVHO-1 (1997), and NFPA 99 Chapter 19 (1999). Features pneumatic or electronic control systems for pressure-time profiles and oxygen ventilation rates.

Indications for Use

Indicated for patients requiring hyperbaric oxygen therapy for: air/gas embolism, carbon monoxide poisoning (including cyanide-complicated), 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

• 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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# JUN 2 6 2002

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## 510(K) SUMMARY

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

#### SUBMITTER'S NAME AND ADDRESS

Environmental Tectonics Corporation ("ETC") BioMedical Systems Group 125 James Way Southampton, PA 18966-3877

#### CONTACT PERSON AND TELEPHONE / FACSIMILE NUMBERS

Michael W. Allen Vice-President, BioMedical Systems Group Environmental Tectonics Corporation 125 James Way Southampton, PA 18966-3877

#### DATE PREPARED: 26 March 2002

#### NAME OF DEVICE

Trade of Proprietary Name: BARA-MED® Acrylic Monoplace Hyperbaric 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) �
- Scchrist Industry's Sechrist 2500E (K934164) �
- Sechrist Industry's Sechrist 3200 (K950386) > �

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Image /page/1/Picture/0 description: The image shows a logo for BioMedical Systems. The logo features the letters "E", "B", and "C" arranged in a triangular formation. Above the letters is a medical symbol with a staff and snakes. The text "BioMedical Systems" is written below the letters.

## DEVICE DESCRIPTION / SUBSTANTIAL EQUIVALENCE

The BARA-MED® and its predicate devices have the same intended use: as a prescription device intended for the whole-body administration of oxygen to a patient at pressures not exceeding 3 ATA.

The BARA-MED® and its predicate devices have very similar general principles of operation. All of these chambers are pressurized and ventilated continuously with purc oxygen, and the patient breathes the chamber atmosphere. Also, in cach of the chambers, the pressure-time profile (i.e. the rate and direction of pressure change and the time hold 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 purpose of such controls are to be able to conduct the particular hyperbaric oxygen treatment prescribed by the physician in a way that is sale 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 Pressure Vessel Code, Section VIII, Rules For Construction . of Pressure Vessels, Division 1, 1998 Edition,
- ASME PVHO-1, Safety Standard For Pressure Vessets For Human . Occupancy, 1997 Edition
- NFPA 99, Standard For Health Care Facilities, Chapter 19, Hyperbaric . Facilities, 1999 Edition.

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

#### PERFORMANCE DATA

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

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2002

Environmental Tectonics Corporation c/o Mr. Michael W. Allen BioMedical Systems Group 125 James Way Southampton, PA 18966-3877

Re: K020974

BARA-MED® Acrylic Monoplace Hyperbaric Chamber Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II (two) Product Code: 73 CBF Dated: March 26, 2002 Received: March 26, 2002

Dear Mr. Allen:

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), You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. While this concern has existed with devices of this type prior to the submission of this premarket notification, we believe that eliminating references to the specific medical conditions for which this device is to be used, from the indications for use statement, could exacerbate the situation. Although, we could attempt to address this concern by identifying and requiring a limitation on the use of the device to appear in the device labeling, this would require that we identify each use that could result in patient harm; a task that is clearly not

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# Page 2 - Mr. Michael W. Allen

practical. To more effectively address this concern, in accordance with Section 513(i)(1)(E), if you label this device for any specific indications for use, your labeling, instructions for use (including company sponsored training programs), as well as any bibliography that accompanies vour device. is limited to the following medical conditions:

- 1. 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 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 bone necrosis)
- 11. Skin grafts and flaps (compromised)
- 12. Thermal burns
- 13. Intracranial abscess.

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); 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.

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

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 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" (21 CFR 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.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Bernard E. Statland, M.D.,Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure Indications for Use

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Indications for Use Page 1 of 1 510 (k) Number (if known) : _ K020974 Device Name: BARA-MED Acrylic Monoplace Hyperbaric Chamber Indications for Use:

The BARA-MED Monoplace Hyperbaric Chamber is a prescription device intended for the whole body administration of oxygen to a patient at pressures not exceeding 3 ATA (Atmospheres Absolute).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98) (Posted July 1, 1998) Back to the Indications for Use Page

foAnknor

of Cardiovascular & Respiratory Devices 510(K) Number

**Prescription Use**
(Per 21 CFR 801.109)