(399 days)
Not Found
No
The document describes a hyperbaric chamber and its intended uses, but there is no mention of AI or ML technology in the device description, intended use, or any other section. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used to correct tissue hypoxia for the treatment of various medical conditions, indicating its therapeutic purpose.
No
The device is a treatment device, specifically a hyperbaric chamber designed to deliver hyperbaric oxygenation as a primary or adjunctive therapy for various conditions. It does not perform any diagnostic functions.
No
The device description clearly describes a physical hyperbaric chamber made of stainless steel with acrylic viewports, indicating 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:
- Intended Use: The intended use clearly describes the device as a therapeutic treatment for various medical conditions by correcting tissue hypoxia. This involves directly treating a patient's body.
- Device Description: The description details a hyperbaric chamber designed to house a human patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other health information. This device is a therapeutic device used to treat a patient directly.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
73 CBF
Device Description
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.
Variable control from maximum 7 psi @ minute slower for less adaptable patients,
§ 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).
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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
1
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.
2
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 (