(399 days)
Intended use of our device is to correct tissue hypoxia for treatment of:
*Air or gas embolisms
*Decompression sickness
Carbon monoxide poisoning with or without cyanide complications
Smoke inhalation
Exceptional blood loss or anemia
Clostridial myonecrosis (gangrene)
Selected problem chronic wounds
Crush injury, compartment syndrome and acute traumatic ischemias
Compromised skin grafts
Osteomyelitis
Thermal burns
Osteoradionecrosis (radiation burns)
Necrotizing soft tissue infections
*In gas embolism and decompression sickness hyperbaric oxygenation van be used as a primary therapy. In the other indications hyperbaric oxygenation is an adjunctive treatment to further primary medical intervention.
Tampa Hyperbaric Monoplace Chamber
Stainless steel; supine patient position on gurney; eight acrylic viewports on 36" diameter chamber. All interior materials cleaned for oxygen service. Certified by the American Society of Mechanical Engineers - Pressure Vessel for Human occupancy.
The provided text is a 510(k) premarket notification letter and summary for a medical device, specifically a hyperbaric chamber. It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence.
However, the provided text does not contain any information about acceptance criteria, a study proving device performance against acceptance criteria, or any of the detailed diagnostic performance metrics (e.g., sample size, provenance, expert qualifications, study types like MRMC or standalone performance, ground truth methods, or training set details).
The document is a regulatory submission for premarket notification, focusing on establishing substantial equivalence to an existing device based on physical characteristics and intended use, rather than a clinical performance study demonstrating diagnostic efficacy using specific acceptance criteria.
Therefore, I cannot provide the requested information.
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Page 2 - Mr. Michael Capria
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan, Ph.D.
Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
2_
Enclosure
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 1999
Mr. Michael Capria Tampa Hyperbaric Enterprise 700 West Waters Avenue Tampa, FL 33604
K981938 Re : Tampa Hyperbaric Monoplace Chamber Requlatory Class: II (two) Product Code: 73 CBF Dated: April 12, 1999 Received: April 16, 1999
Dear Mr. Capria:
We have reviewed your Section 510(k) notification of intent to market whe device referenced above and we have determined the device is ene dovios in the indications 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. The general controls che general concrolo provide 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Image /page/1/Picture/9 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape and features the department's name around the perimeter. In the center of the logo is an abstract image of an eagle.
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Summary of 510(k) safety and effectiveness information substantial equivalence continued
Summary comparison of our device to the legally marketed predicate device (continued):
| Physical Characteristics | Physical Characteristics |
|---|---|
| Stainless steel; supine patient position on gurney; | Stainless steel; supine patient position on chamber floor; |
| eight acrylic viewports on 36" diameter chamber | two acrylic viewports on 30" diameter chamber |
| All interior materials cleaned for oxygen service. | All interior materials cleaned for oxygen service. |
| 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 |
Intended use of our device is to correct tissue hypoxia for treatment of:
*Air or gas embolisms
*Decompression sickness
Carbon monoxide poisoning with or without cyanide complications
Smoke inhalation
Exceptional blood loss or anemia
Clostridial myonecrosis (gangrene)
Selected problem chronic wounds
Crush injury, compartment syndrome and acute traumatic ischemias
Compromised skin grafts
Osteomyelitis
Thermal burns
Osteoradionecrosis (radiation burns)
Necrotizing soft tissue infections
*In gas embolism and decompression sickness hyperbaric oxygenation van be used as a primary therapy. In the other indications hyperbaric oxygenation is an adjunctive treatment to further primary medical intervention.
{3}------------------------------------------------
Increases the metabolic activity of the immune system for reducing hacterial infections such Increases the metabolic activity of the inficitions associated with clostridia myonerosis
as Actinomycosis; controlling bacterial infections associated with closes (gangrene) and necrotizing soft tissue infections (severe skin ulcers).
The mechanical effect of higher atmospheric pressure decreases the volume of size offending gas. The mechanical effect of higher aunospient presidents of the offending eas.
embolism gas trapped in body tissues (Boyle's Law) alowing edimination benefits stem This action can reduce air embolism from medical or diving accidents. Additional benefits stem. This action can reduce air embolism from nediting that hyperbario oxygenation provides to reduce
from the vasoconstriction and reduction of swelling that conditions. from the vasoconstriction and reacless.
histamine mediated inflammation scen with air embolism and while, at the same
ne mediated inflammation scen with an ennounce an the same time same time provides an
Hyperbaric oxygenation produces vasoconstriction while at the sums of crus Hyperbaric oxygen for cellular metabolism and thus reduces edema after hums on crush abundance of available oxygen to canalitain collular finaction. - This action has been
injuries while delivering extra oxygen to maintain collulation tissue damage) and documented to help reduce tissue damage in osteoradioncrosis (radiation tissue damage) and thermal burns.
Hyperbaric oxygen therapy improves the outcome of compromised skin grafts and can Hyperbaric oxygen therapy migro res are and of better gramulation thissue formation. enhance healing in selected problem woulds by the the plasma and can help the outcome i ne oxtra with exceptional blood loss and anemia problems.
Hyperbaric oxygen has an anti-bacterial effect on anaerobic bacteria. Also, white blood cells
Hyperbaric oxygen has an anti-bacterial effect on anaerobic are untimal, function more effectively to kill pathogenic microbes when oxygen concentrations are optimal.
function more effectively to kill pathogenic microbes when oxygen and have disea This action helps control infections such as osteomyclitis (unmanageable bone disease).
heips control meeting burner.
Summary comparison of our device to the legally marketed predicate device:
Predicate Device
Proteus Dual-Place Hyperbaric Chamber # K862198
Pressurization Rate
Variable control (from maximum 10 psi @ minute) slower for fess adaptable patients (<1 psi @) minute) Maximum intended clinical pressure 75 psi w/air
Depressurization Rate
Varied control (from 0 to 1 psi @ second) with an extra emergency (~10 second) release
Purge Flow Rate
Varied control (0 - 50 cfm) with diluent gas or oxygen through chamber using valve coordination; also, uses patient face mask.
Our Device
Tampa Monoplace Hyperbaric Chamber # K981938
Pressurization Rate
Variable control from maximum 7 psi @ minute slower for less adaptable patients, < I psi @ minute Maximum intended clinical pressure 29.4 psi w/oxygen
Depressurization Rate
Varied control (from 0 to 1 psi @ second) with
an extra emergency (--10 second) release
Purge Flow Rate
Varied control (0 - 1 cfin) with only oxygen through chamber using constant automatic pressure regulator; no use of face mask. Increased purge volume available (1 - 18 cfm) by coordinating intake and exhaust valves
m
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Summary of 510(k) safety and effectiveness information substantial equivalence
Tampa Hyperbaric Enterprise contact: Michael Capria 700 West Waters Avenue Tampa, Florida 33604 Phone 813-935-4404 Fax 813-932-5392
date prepared May 29, 1998, updated December 11, 1998
Tampa Hyperbaric Monoplace Chamber Name of Device:
This hyperbaric chamber is generally safe when used with professional supervision Safetv: within prescribed time limits. The intake and exhaust valves are designed to manage compression and decompression. This provides a reliable method for increasing chamber pressure with oxygen and alternately releasing the oxygen prior to egress. Incidental temporary side-effects (i.e. eardrum pain and psychological anxiety) should be limited by a trained professional monitoring the occupant.
Our monoplace chamber has the added safety feature of a relief valve designed to limit pressure to 30 psig. Normal operating pressure is between 7.5 psi and 22 psi. The stainless steel chamber is designed to support years of normal working pressure compression cycles without structural degradation. The acrylic viewports should be inspected annually and replaced at least every 10 years. The chamber should be hydro-tested when the viewports are replaced. This chamber should be operated in climate controlled room temperatures. Compression causes a slight 10° F rise in temperature that returns to normal once pressure rise ceases. Decompression causes a slight 10° F drop in temperature. These are normal temperature variations. There are no sharp exposed edges and there are no motorized moving parts. There are no toxic materials that come into contact with patients from this device. There are no materials used that could cause strangulation.
This device raises the absolute oxygen pressure to a level that has been Effectivencss: documented to raise the partial pressure of oxygen in body tissues. This effectively raises the available partial pressure of oxygen during normal inspiration between 10 to 20 times above natural atmospheric conditions. Hyperbaric oxygen therapy promotes several physiologic changes:
Displaces accumulated nitrogen in patients with decompression sickness.
Displaces accumulated toxic gases in patients with carbon monoxide poisoning and smoke inhalation with or without cyanide poisoning.
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510(k) Number (if known): K981938
Device Name: Tampa Hyperbaric Monoplace Chamber
Indications For Use:
- Carbon monoxide poisoning with or without cyanide complications .
- . Smoke inhalation
- . Decompression sickness
-
- Exceptional blood loss or anemia
- . Clostridial myonecrosis (gangrene)
- Selected problem chronic wounds .
- Crush injury, compartment syndrome and acute traumatic ischemias .
- . Compromised skin grafts
- . Osteomyclitis
- . Thermal burns
- . Osteoradionecrosis (radiation burns)
- . Necrotizing soft tissue infections
- ن Air or Gas Embolism
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
KAtte Werthausn
ision of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The_Counter Use
(Optional Format 1-2-96)
§ 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).