HYPERBARIC CHAMBER

K960389 · Tampa Hyperbaric Ent. · CBF · Dec 5, 1996 · Anesthesiology

Device Facts

• Record ID: K960389
• Device Name: HYPERBARIC CHAMBER
• Applicant: Tampa Hyperbaric Ent.
• Product Code: CBF · Anesthesiology
• Decision Date: Dec 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of this device is discussed by the "Indications for Use" section and includes: Decompression sickness; Carbon monoxide with or without cyanide poisoning; Smoke inhalation; Exceptional blood loss; Clostridial myonecrosis; Crush injury, compartment syndrome and acute traumatic ischemias; Selected Problem Wounds; Compromised skin grafts; Osteomyelitis; Osteoradionecrosis; Thermal burns; Necrotizing soft tissue infections.

Device Story

Tampa Hyperbaric Chamber is a steel pressure vessel used to increase partial pressure of oxygen in body tissues. Device operates by raising absolute air pressure to 15 psig; oxygen delivered via oronasal mask. Chamber features in-swinging hatch, manual air pressure valves, and internal emergency release. Operated by attendant at external workstation monitoring occupants via audio-video system. Provides therapeutic environment for patients seated or supine. Pressure limited to 21 psig via relief valve. Benefits include treatment of ischemic and infectious conditions by enhancing tissue oxygenation. Safety features include water deluge system, gas analysis meters, and hydrostatic testing.

Clinical Evidence

Device passed clinical trial tests verifying ability to raise partial pressure of oxygen in body tissues. No specific quantitative metrics (e.g., p-values, CIs) provided. Safety supported by documented performance within decompression table parameters and hydrostatic testing.

Technological Characteristics

Carbon steel pressure vessel; 3/8 inch thick walls. Operates via manual brass valves and direct pressure gauges. Certified to ASME Pressure Vessel for Human Occupancy standards. Includes internal emergency release, viewports, and water deluge system. No high voltage devices or electronic software control. Sterilization/cleaning via standard protocols for hyperbaric environments.

Indications for Use

Indicated for patients requiring hyperbaric oxygen therapy for decompression sickness, CO/cyanide poisoning, smoke inhalation, blood loss, clostridial myonecrosis, crush injury, compartment syndrome, acute traumatic ischemia, problem wounds, compromised skin grafts, osteomyelitis, osteoradionecrosis, thermal burns, and necrotizing soft tissue infections.

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

• Proteus Dual-Place Hyperbaric Chamber (K862198)
• Proteus Multi-Place Hyperbaric Chamber (K930748)

Submission Summary (Full Text)

{0}

From: Michael Cupria To: Joanna Weilershausen
Date: 2/4/96 Time: 1:44:00
Page 4 of 7

Tampa Hyperbaric Enterprise
700 West Waters Avenue
Tampa, Florida 33604
Phone [phone]
FAX [phone]

Office of Device Evaluation
Division of Cardiovascular, Respiratory, and Neurological Devices
9200 Corporate Blvd.
Rockville, MD 20850

updated December 4, 1996

Trade name: Tampa Hyperbaric Chamber
Common Name of device: Hyperbaric Chamber (or Recompression Chamber)
Classification: 21 CFR 868.5470 Pro code #73CBF
Establishment registration number: 9024206
Address of Manufacturer: 700 West Waters Avenue, Tampa, FL 33604
Contact person: Michael Capria
DEC - 5 1996
510(k) Number K960389

## Section 2

Summary of device effectiveness: This device raises the absolute air pressure to a level that has been documented to double the partial pressure of oxygen in breathing quality air. This effectively raises the available partial pressure of oxygen during normal inspiration. With the addition of higher percentages of oxygen via oronasal mask the partial pressure of oxygen in body tissues can be increased 10 times above natural atmospheric conditions. This hyperbaric device has passed clinical trial tests to verify that it does indeed raise the available partial pressure of oxygen in body tissues.

Safety and effectiveness: This hyperbaric chamber is generally safe and effective when used within documented parameters relative to decompression table times for repetitive use. The intake and exhaust valves are sized (½") to slow the time required for full compression and decompression. This provides a fail-safe method for filling the chamber with air and alternately releasing the air prior to egress. It requires 15 minutes to fill the chamber to the optimum working pressure (15 psig) and 8 minutes to depressurize the chamber. While this is slower than most chambers already on the market the longer time is actually more comfortable for the patients. Incidental temporary side-effects (i.e. eardrum pain or damage and psychological anxiety) are rare if contraindications are screened and the attendant monitors the

# K960389 faxed page 4

{1}

From: Michael Capria To: Joanna Weller-Hauser
Date: 12/4/96 Time: 16:44:25
Page 5 of 7

occupant. While some more serious side-effects (i.e. collapsed lung and oxygen toxicity) were documented in other similar hyperbaric chambers, those problems were evoked at greater pressures with the increased risk of those type medical misadventures. On the other hand, this device has the relief valve designed to limit pressure to 21 psig. This added feature effectively limits risk and assures overall safety to hyperbaric chambers already in commercial use.

The chamber uses an in-swinging steel hatch door with a rubber "O" ring in the contacting face. There is no latch or other device to lock. A reasonable push against the hatch while the air pressure rises will initiate hatch closure. Air pressure holds the hatch securely closed. There are no high voltage devices placed inside this hyperbaric chamber. There are no new technological materials used. There are manual air pressure valves to prevent inadvertent or unauthorized changes. There are no exposed sharp edges in tank construction. The construction is mechanically stable and has no exposed moving parts. The hyperbaric chamber is secure from vibration and offers 3/8 inch thick steel protection to the occupants in the unlikely event of an outside catastrophe. The occupants have an internal emergency release valve for additional security. The tank construction is coated to withstand fluid spills. The chamber is certified to operate within specifications up to 150° F and has been hydrostatically tested to assure performance. The surface temperature of the chamber does not increase during its operation. No toxic materials come into contact with the patient, operator or attendant. The air is certified pure breathing quality. There are no wires in the device that could risk strangulation. This device is intended to have operator assistance to monitor the activity inside and outside the hyperbaric chamber.

There are four small chairs bolted inside the chamber along a certified welded angle iron. This allows patients to sit during the hyperbaric sessions. There is adequate room for these four chairs to be removed and replaced with two cots bolted along the same angle iron without welding any new metal to the chamber (new welds would void certification). There are two certified viewports for visual inspection of the occupants.

The intended use of this device is discussed by the "Indications for Use" section and includes: Decompression sickness; Carbon monoxide with or without cyanide poisoning; Smoke inhalation; Exceptional blood loss; Clostridial myonecrosis; Crush injury, compartment syndrome and acute traumatic ischemias; Selected Problem Wounds; Compromised skin grafts; Osteomyelitis; Osteoradionecrosis; Thermal burns; Necrotizing soft tissue infections.

# K960389 faxed page 5

{2}

From: Michael Capria To: Joanna Weitershausen
Date: 12/4/96 Time: 19:00:00
Page 6 of 7

# 1st Comparison Table Information:

## Predicate Device
Proteus Dual-Place Hyperbaric Chamber # K862198
Perry Baromedical, Inc. FDA # 1036464

## Labeling
Has required labels along with control panel labels

## Intended Use
Has all the prior listed indications
plus air or gas embolism

## Physical Characteristics
Stainless steel; supine patient position on gurney; airlock for a seated attendant; pressurized with a combination of bottled oxygen and nitrogen; gas analysis meters to monitor environment; viewports to directly see interior / exterior activity with audio system for communication.

## Anatomical Sites
Entire body

## Performance Testing
Certified by the American Society of Mechanical Engineers - Pressure Vessel for Human occupancy

## Safety Characteristics
Direct monitoring at a work station attached to the device. Electric controls to valves with electric meters to regulate pressure. Externally swung hatch with auto-clave type secure closure. Warning alarms for toxic gas or fire hazards.

## Our Device
Tampa Hyperbaric Chamber #K960389
Tampa Hyperbaric Enterprise FDA # 9024206

## Labeling
Has required labels along with control panel labels

## Intended Use
All the prior listed indications
except air or gas embolism

## Physical Characteristics
Carbon steel; seated or supine patient position; seated attendant without airlock; pressurized with compressed air derived from oil-less compressed certified pure, filtered air; gas analysis meters to monitor environment; audio-video system to see interior / exterior activity for communication.
Water deluge system for fire safety.

## Anatomical Sites
Entire body

## Performance Testing
Certified by the American Society of Mechanical Engineers - Pressure Vessel for Human occupancy

## Safety Characteristics
Direct monitoring at a work station attached to the device. Manual control valves with direct pressure meters to regulate pressure. Internally swung hatch manually seals itself against inside of tank.
Warning alarms for toxic gas or fire hazards.
Water deluge system for fire safety.

# 2nd Comparison Table Information:

## Predicate Device
Proteus Multi-Place Hyperbaric Chamber # K930748
Perry Baromedical, Inc. FDA # 1036464

## Labeling
Has required labels along with control panel labels

## Intended Use
Has all the prior listed indications
plus air or gas embolism

## Our Device
Tampa Hyperbaric Chamber #K960389
Tampa Hyperbaric Enterprise FDA # 9024206

## Labeling
Has required labels along with control panel labels

## Intended Use
All the prior listed indications
except air or gas embolism

# K960389 faxed page 6

{3}

From: Michael Capria To: Joanna Weitershausen
Date: 12/4/96 Time: 15:49:23
Page 7 of 7

## Physical Characteristics

Stainless steel; standing, seated or supine patient positions with airlock for attendant; pressurized with a combination of bottled oxygen, nitrogen and compressed air derived from oil-less compressed certified pure, filtered air; gas analysis meters to monitor environment; viewports and audio-video system to directly see interior / exterior activity for communication. Water deluge system for fire safety.

## Anatomical Sites

Entire body

## Performance Testing

Certified by the American Society of Mechanical Engineers - Pressure Vessel for Human occupancy

## Physical Characteristics

Carbon steel; seated or supine patient position; seated attendant without airlock; pressurized with compressed air derived from oil-less compressed certified pure, filtered air; gas analysis meters to monitor environment; audio-video system to see interior / exterior activity with audio system for communication. Water deluge system for fire safety.

## Anatomical Sites

Entire body

## Performance Testing

Certified by the American Society of Mechanical Engineers - Pressure Vessel for Human occupancy

Includes hydrostatic pressure testing to 1½ working pressure, tank magnaflux testing, and X-ray testing of all welds.

## Safety Characteristics

Direct monitoring at a work station attached outside the device. Electric controlled valves with electric meters to regulate pressure. Tank hatch swing inside to manually seal itself against tank.

## Safety Characteristics

Direct monitoring work station attached outside the device. Manual control brass valves, direct pressure gas gauges to regulate pressure. Tank hatch swings inside to manually seal itself against tank.

**Truth and Accuracy Statement:** The undersigned certifies the statements made in this submission are true and accurate with respect to his knowledge of the facts contained herein.

signed **Michael Capria**

Michael Capria (computer font signature for fax transmission)

# K960389 faxed page 7