(318 days)
K862198, K9300748
Not Found
No
The device description focuses on mechanical and pressure-based operation, with no mention of AI or ML components. The performance studies also describe a physical effect (raising oxygen partial pressure) rather than an algorithmic one.
Yes
The device is intended to treat various medical conditions such as decompression sickness, carbon monoxide poisoning, difficult-to-heal wounds, and burns, indicating a therapeutic purpose.
No
The device description and intended use indicate that this hyperbaric chamber is used for treatment by raising oxygen levels in body tissues, not for diagnosing conditions.
No
The device description clearly details a physical hyperbaric chamber with hardware components like valves, a hatch door, chairs, and viewports. It is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a hyperbaric chamber. Its function is to increase the air pressure around a patient's entire body to increase the partial pressure of oxygen in their tissues. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
- Intended Use: The listed intended uses are all medical conditions treated by hyperbaric oxygen therapy, which is a treatment method, not a diagnostic method.
- No Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
73CBF
Device Description
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 avaiiable partial pressure of oxygen during normal inspiration. With the addition of higher percentages of oxygen via oronasal mask the partial pressure of oxygen in hody tissues can he 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.
This hyperbaric chamber is generally safe and effective when used within documented parameters relative to decompression table times for repeitive 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.
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 No toxic materials come into contact with the patient, operator or attendant. its operation. 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Entire body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This hyperbaric device has passed clinical trial tests to verify that it does indeed raise the available partial pressure of oxygen in body tissues.
Performance Testing: Certified by the American Society of Mechanical Engineers - Pressure Vessel for Human occupancy Safety Characteristics
Includes hydrostatic pressure testing to 1½ working pressure, tank magnaflux testing, and X-ray testing of all welds .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K862198, K9300748
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5470 Hyperbaric chamber.
(a)
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).(b)
Classification. Class II (performance standards).
0
From: Michael Capria To: Joanna Weitershausen
Image /page/0/Picture/1 description: The image shows a machine with a cylindrical body and a control panel attached to its side. The cylindrical body is supported by a stand, and there are some markings on its surface. The control panel has a display screen and some buttons, suggesting it is used to operate or monitor the machine. The machine appears to be industrial or scientific equipment.
Tampa Hyperbaric Enterprise 700 West Waters Avenue Tampa, Florida 33604 Phone 813-935-4404 FAX 813-932-5392
Jate: 224/96 Time: 14:400 0
Image /page/0/Picture/3 description: The image shows a piece of machinery with a cylindrical body. The cylinder is supported by two stands. A box-shaped control panel with a digital display is positioned next to the cylinder. The image is a black and white drawing.
Office of Device Evaluation Division of Cardiovascular, Respiratory, and Neurological Devices 9200 Corporate Blvd. Rockville, MD 20850
updated December 4, 1996
DEC - 5 1996
'l'rade 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
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 hody tissues can he 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 repeitive 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 anxicty) arc rare if contraindications are screened and the attendant monitors the
1
occupant. While some more serious side-effects (i.e. collapsed lung and oxygen toxicity) were documented in other similar hyperharic 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 No toxic materials come into contact with the patient, operator or attendant. its operation. 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.
2
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【Jse
IIas 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 hottled 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 Tosting
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 s wung 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 # K9300748 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
3
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
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 Certified by the American Society of Mechanical Engineers - Pressure Vessel for Human occupancy 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 insidc to manually scal itsclf 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 scal itsclf 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 four signature for fax transmission)