(726 days)
No
The summary describes a hyperbaric chamber and its physical specifications, operational parameters, and safety certifications. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is designed for hyperbaric oxygen therapy (HBO), which is a medical treatment with specific indications for various medical conditions, indicating its therapeutic intent.
No
This device is a hyperbaric chamber used for treatment (therapy), not for diagnosing conditions. Its indications for use are for treating various medical conditions.
No
The device description clearly details a physical hyperbaric chamber constructed of steel with windows, pressure monitoring, communication systems, and electrical components, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a medical treatment (hyperbaric oxygen therapy) applied directly to a patient to treat various conditions. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details the physical construction and features of a hyperbaric chamber, which is a piece of medical equipment used for treatment. It does not describe a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition based on in vitro analysis.
Therefore, the Wright 1000 Mono Hyperbaric Chamber is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Hyperbaric oxygen therapy (HBO)is a medical treatment where a patient is placed in a specially designed vessel and placed under pressure greater then sea level and breathes 100% oxygen intermittently. Alveolar oxygen pressure is increased causing a rise in plasma oxygen content which results in enhanced tissue oxygen delivery. the amount of pressure increases and the length of time under pressure are determined by the condition being treated. Treatment pressures are usually between 2 and 3 times atmospheric. treatment usually lasts from 1 to 2 hours at full pressure.
The following are approved indications:
- l: Air or gas embolism.
- 2: Carbon monoxide poisoning and smoke inhalation. Carbon monoxide complicated by cyanide poisoning.
- 3: Clostridial myonecrosis (Gas gangrene).
- 4: Crush injury, Compartment syndrome, and other acute traumatic ischemias .
- 5: Decompression sickness.
- 6: Enhancement of healing in selected problem wounds.
- 7: Exceptional blood loss (Anemia)
- 8: Necrotizing soft tissue infections (Subcutaneous tissue, Muscle, Fascia).
- 9: Osteomyelitis (Refractory).
- 10: Radiation tissue damage (Osteoradionecrosis).
- ll. Skin grafts and flaps (Compromised).
-
- Thermal burns.
-
- Adjunctive hyperbaric oxygen in intracranial abscess.
Product codes
73 CBF
Device Description
The Wright 1000 Mono Hyperbaric Camber:
*Max operational pressure 30 PSIG.
*Constructed out of SA516-70N steel
*The 4 Large 14" Windows Constructed out of PVO Acrylic
*Hydrostatic tested at 45 PSIG.
*Welds are X-rayed
*Welds magna Flux tested after hydrostatic test.
*Manufactured by a ASME approved house and certified by ASME. Certification No. 28,352
*Manufactured under PVHO guidelines
*Manufactured under NFPA Guidelines
*Registered with National Board Of Pressure Vessel Inspectors.
*Wiring to National Electrical code.
*Electrical Testing: Electromagnetic and Safety testing Conducted.
*Spacious interior
*2 Way Communications
*Pressure and Oxygen monitoring With alarms.
*Programmable Treatment Pressure Alarms
*Variable ventilation
*Comfortable reclining chair
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
MAY 28 1997
Image /page/0/Picture/1 description: The image contains a handwritten string of characters and numbers. The string begins with the letter 'K', followed by the numbers '95', '25', and '45'. The string also contains a fraction, with '5' as the numerator and '3' as the denominator, separated by a diagonal line.
Image /page/0/Picture/2 description: The image shows a logo for Wright. The logo consists of a stylized letter "W" that is connected to the word "right". The logo is black and white, and it is surrounded by a circle. The logo is simple and modern.
INDUSTRIES
C. Wright Industries 13760 S. Gramercy PL. Gardena, CA. 90249 Phone: 310-523-5132 310-523-1825 Fax: Contact: Charles Wright Date:4-15-1997
RECEIVED
21 APR 97 13 56
FDA/CDRH/ODE/DH
510(k) Summery
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFC-401) 9200 Corporate Boulevard Rockville, Maryland 20850
Re: 510 (k) Notification Re: 510 (K) Notification # K95245 K952545 Proprietary Name: Wright 1000 Mono Hyperbaric Chamber. Common Name: Hyperbaric Chamber. ochanes craner arressure Vessel for Human Occupancy.
Calssification Name: (PVHO) Pressure Vessel for Human Occupancy.
Predicate Device: HYOX System Limited 510(k) No. K874107
Attention: Christy Foreman
Sincerely Yours
Charles Wright
Charles Wright Owner/Operator C. Wright Industries
1
HYPERBARIC TREATMENT:
Hyperbaric oxygen therapy (HBO)is a medical treatment where a patient is placed in a specially designed vessel and placed under pressure greater then sea level and breathes 100% oxygen intermittently. Alveolar oxygen pressure is increased causing a rise in plasma oxygen content which results in enhanced tissue oxygen delivery. the amount of pressure increases and the length of time under pressure are determined by the condition being treated. Treatment pressures are usually between 2 and 3 times atmospheric. treatment usually lasts from 1 to 2 hours at full pressure.
The following are approved indications:
- l: Air or gas embolism.
- 2: Carbon monoxide poisoning and smoke inhalation. Carbon monoxide complicated by cyanide poisoning.
- 3: Clostridial myonecrosis (Gas gangrene).
- 4: Crush injury, Compartment syndrome, and other acute traumatic ischemias .
- 5: Decompression sickness.
- 6: Enhancement of healing in selected problem wounds.
- 7: Exceptional blood loss (Anemia)
- 8: Necrotizing soft tissue infections (Subcutaneous tissue, Muscle, Fascia).
- 9: Osteomyelitis (Refractory).
- 10: Radiation tissue damage (Osteoradionecrosis).
- ll. Skin grafts and flaps (Compromised).
-
- Thermal burns.
-
- Adjunctive hyperbaric oxygen in intracranial abscess.
2
CONTRAINDICATIONS:
Only previously listed indications are approved all others are considered contraindications.
REFERANCES :
:
l: HYPERBARIC MEDICINE PROCEDURES. 1996
2: HYPERBARIC OXYGEN THERAPY: A COMMITTEE REPORT. 1996
3: MONOPLACE HYPERBARIC CHAMBER SAFTY GUIDELINES. 1991
3
The Wright 1000 Mono Hyperbaric Camber:
*Max operational pressure 30 PSIG.
*Constructed out of SA516-70N steel
*The 4 Large 14" Windows Constructed out of PVO Acrylic
*Hydrostatic tested at 45 PSIG.
*Welds are X-rayed
*Welds magna Flux tested after hydrostatic test.
*Manufactured by a ASME approved house and certified by ASME. Certification No. 28,352
*Manufactured under PVHO guidelines
*Manufactured under NFPA Guidelines
*Registered with National Board Of Pressure Vessel Inspectors.
*Wiring to National Electrical code.
*Electrical Testing: Electromagnetic and Safety testing Conducted.
*Spacious interior
*2 Way Communications
*Pressure and Oxygen monitoring With alarms.
*Programmable Treatment Pressure Alarms
*Variable ventilation
*Comfortable reclining chair
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles a stylized caduceus or a representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 28 1997
Mr.. Charles Wright Wright Industries 13760 South Gramercy Place Gardena, California 90249
Re: K952545 Wright 1000 Mono Hyperbaric Chamber Regulatory Class: II (two) Product Code: 73 CBF Dated: April 15, 1997 Received: April 21, 1997
Dear Mr. Wright:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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 provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 620) and that, through periodic GMP 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 requlations.
5
Page 2 - Mr. Charles Wright
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) 594-4646. 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 qeneral 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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