(357 days)
Not Found
No
The device description focuses on the mechanical and control systems of a hyperbaric chamber and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is designed to treat various medical conditions, such as air or gas embolism, carbon monoxide poisoning, and problem wounds, by administering hyperbaric oxygen therapy. This directly indicates a therapeutic purpose.
No
The device description indicates it is a "multiplace hyperbaric chamber system designed to treat up to 12 patients." The "Intended Use / Indications for Use" section lists various conditions for which hyperbaric oxygen (HBO) therapy is appropriate, all of which are treatment-oriented. There is no mention of the device being used to diagnose conditions or process diagnostic information.
No
The device description clearly details a physical hyperbaric chamber system with various hardware components (chamber vessel, windows, doors, control systems, communication system, penetrator plate). It is not solely software.
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 about a person's health. This testing is done outside the body (in vitro).
- Device Description: The OxyHeal 2000 series is a hyperbaric chamber. It's a physical enclosure designed to treat patients by exposing them to increased atmospheric pressure and oxygen. This is a therapeutic device used on the patient's body, not for testing specimens from the patient's body.
- Intended Use: The listed conditions are all medical conditions treated by exposing the patient to a specific environment (high pressure and oxygen). There is no mention of analyzing biological samples.
Therefore, the OxyHeal 2000 series is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OxyHeal 2000 hyperbaric chamber series is intended to be procured and used by physicians to treat a variety of medical conditions that respond to hyperbaric oxygen. The Undersea and Hyperbaric Medical Society (UHMS) produces a list of medical conditions that have been identified for the appropriate primary or adjunctive use of hyperbaric oxygen. These approved conditions include: air or gas embolism; carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning; clostridial myositis and myonecrosis (gas gangrene); crush injury, compartment syndrome and other acute traumatic ischemias; decompression sickness; enhanced healing of selected problem wounds; exceptional blood loss anemia; necrotizing soft tissue infections; osteomyelitis (refractory); delayed radiation injury (soft tissue and bony necrosis); compromised skin flaps and graffs; thermal burns; and, intracranial abscess. Aggressive research into the beneficial effects of hyperbaric oxygen, when appropriately applied, will result in additional medical conditions being added to the list of indications by the UHMS.
It is the expressed, intended use of the OxvHeal 2000 hyperbaric chamber series to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in its procurement and routine use.
The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:
-
- Air or gas embolism
-
- Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
-
- Clostridial myositis and myonecrosis
-
- Crush injury, compartment syndrome, and other acute traumatic ischemias
-
- Decompression sickness
-
- Enhanced healing of selected problem wounds
-
- Exceptional blood loss anemia
-
- Necrotizing soft tissue infections
-
- Osteomyelitis (refractory)
-
- Delayed radiation injury (soft tissue and bony necrosis)
-
- Skin grafts and flaps (compromised)
-
- Thermal burns
-
- Intracranial abscess
Product codes
CBF
Device Description
The OxyHeal 2000 series is a Class A multiplace hyperbaric chamber system designed to treat up to 12 patients to a maximum operating pressure of 6 Atmospheres Absolute (ATA) or 73.5 pounds per square inch gauge (psig). The chamber uses compressed air as the pressurization gas and 100% oxygen as the hyperbaric treatment gas.
The OxyHeal 2000 hyperbaric chamber series is designed and fabricated in accordance with the requirements of the ANSI/ASME Boiler and Pressure Vessel Code, Section VIII, Division 1. Pressure Vessels: ANSI/ASME-PVHO-1 (American Society of Mechanical Engineers-Pressure Vessels for Human Occupancy); and, NFPA 99, Health Care Facilities, Chapter 19, Hyperbaric Facilities. The overall external length of the chamber can range from 12 feet to 20 feet. Its internal diameter can range from 72 inches to 180 inches. When combined, these features allow for the state of the art, hands on treatment of one (1) to 12 ambulatory patients in comfort. Large circular windows create a more open atmosphere and help reduce patient claustrophobia. Pressurization is provided by compressed air with 100% oxygen administered to the patient by using properly fitting oro-nasal masks or head tents.
A low-voltage patient intercommunication system designed and installed in accordance with NFPA 99. Chapter 19 and provides communications between the patients in the chamber and the outside chamber operator. It also provides patients with audio program content from external sources such as TV's, cassette players, radios, etc. The system consists of a master station mounted on the chamber operator's control console that contains all of the controls and connection points.
Single operator chamber pressure control is achieved via a simple industrial adjustable controller with output and input feedback. A pneumatic and manually operated control system is provided for triple control redundancy.
A penetrator plate is provided in the vessel wall to allow user supplied intravenous lines, medical monitoring leads, etc., to be used as required. The large rectangular door allows a normal size patient gurney or wheelchair to be used to transport nonambulatory patients without having to transfer the patient to a smaller transport device. This feature greatly improves patient handling safety.
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
The OxyHeal 2000 hyperbaric chamber series is designed to be installed and operated in medical facilities as defined by the NFPA 99, Health Care Facilities, Chapter 19, Hyperbaric Facilities. Further, this system is intended to be operated only by medical personnel specifically trained in the appropriate use of HBO and the safe operations of all related equipment such as the hyperbaric chamber.
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)
K960389, K930748, K950957, K95438
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
OxyHeal Health Group, Inc. OxyHeal 2000 Hyperbaric Chamber Series 510(K) NOTIFICATION SUMMARY
OxyHeal Health Group, Inc. P.O. Box 1987 La Jolla, CA 92038
1
510(k) NOTIFICATION SUMMARY (Per 21 CFR 807.92)
Prepared: 10 June 2001
TRADE NAME: OxyHeal 2000 Hyperbaric Chamber Series
COMMON NAME OF DEVICE: Multiplace Hyperbaric Chamber
CLASSIFICATION: 73 CBF, 21 CFR 868.5470
ESTABLISHMENT REGISTRATION NUMBER: 2029408
CLAIMED PREDICATE DEVICE(S):
Tampa Hyperbaric Enterprises' Multiplace Hyperbaric Chamber - K960389 Perry Sigma MP Multiplace Hyperbaric Chamber - K930748 Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber - K 950957 Reimers T Class Hyperbaric Facility - K95438
ADDRESS OF MANUFACTURER:
OxyHeal Health Group, Inc. P.O. Box 1987 La Jolla, CA 92038
CONTACT PERSON: Dave Heaney
EXECUTIVE SUMMARY
The Undersea and Hyperbaric Medical Society (UHMS) defines hyperbaric oxygen therapy as breathing 100% oxygen at pressures higher than atmospheric in a hyperbaric chamber. Accordina to the National Fire Protection Association (NFPA), hyperbaric chambers are classified into two categories: Class A (multi-occupant) and Class B (single occupant). The OxyHeal 2000 series is a Class A multiplace hyperbaric chamber system designed to treat up to 12 patients to a maximum operating pressure of 6 Atmospheres Absolute (ATA) or 73.5 pounds per square inch gauge (psig). The chamber uses compressed air as the pressurization gas and 100% oxygen as the hyperbaric treatment gas.
The OxyHeal 2000 hyperbaric chamber series is intended to be procured and used by physicians to treat a variety of medical conditions that respond to hyperbaric oxygen. The Undersea and Hyperbaric Medical Society (UHMS) produces a list of medical conditions that have been identified for the appropriate primary or adjunctive use of hyperbaric oxygen. These approved conditions include: air or gas embolism; carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning; clostridial myositis and myonecrosis (gas gangrene); crush injury, compartment syndrome and other acute traumatic ischemias; decompression sickness; enhanced healing of selected problem wounds; exceptional blood loss anemia; necrotizing soft tissue infections; osteomyelitis (refractory);
2
delaved radiation injury (soft tissue and bony necrosis); compromised skin flaps and graffs; thermal burns; and, intracranial abscess. Aggressive research into the beneficial effects of hyperbaric oxygen, when appropriately applied, will result in additional medical conditions being added to the list of indications by the UHMS.
The OxyHeal 2000 hyperbaric chamber series is designed and fabricated in accordance with the requirements of the ANSI/ASME Boiler and Pressure Vessel Code, Section VIII, Division 1. Pressure Vessels: ANSI/ASME-PVHO-1 (American Society of Mechanical Engineers-Pressure Vessels for Human Occupancy); and, NFPA 99, Health Care Facilities, Chapter 19, Hyperbaric Facilities. The overall external length of the chamber can range from 12 feet to 20 feet. Its internal diameter can range from 72 inches to 180 inches. When combined, these features allow for the state of the art, hands on treatment of one (1) to 12 ambulatory patients in comfort. Large circular windows create a more open atmosphere and help reduce patient claustrophobia. Pressurization is provided by compressed air with 100% oxygen ( administered to the patient by using properly fitting oro-nasal masks or head tents.
A low-voltage patient intercommunication system designed and installed in accordance with NFPA 99. Chapter 19 and provides communications between the patients in the chamber and the outside chamber operator. It also provides patients with audio program content from external sources such as TV's, cassette players, radios, etc. The system consists of a master station mounted on the chamber operator's control console that contains all of the controls and connection points.
Single operator chamber pressure control is achieved via a simple industrial adjustable controller with output and input feedback. A pneumatic and manually operated control system is provided for triple control redundancy.
A penetrator plate is provided in the vessel wall to allow user supplied intravenous lines, medical monitoring leads, etc., to be used as required. The large rectangular door allows a normal size patient gurney or wheelchair to be used to transport nonambulatory patients without having to transfer the patient to a smaller transport device. This feature greatly improves patient handling safety. OxyHeal has concluded that the general design approach, method of pressure control, and intended use of the OxyHeal 2000 hyperbaric chamber series is substantially equivalent to the Tampa Hyperbaric Enterprises' Hyperbaric Chamber (K960389). the Perry Baromedical Services Sigma MP Multiplace Hyperbaric Chamber (K930748), the Gulf Coast Hyperbarics, Inc. Multiplace Hyperbaric Treatment System (K950957), the Reimers Engineering T Class Hyperbaric Facility (K954387) and is proposing them as predicate devices for the OxyHeal 2000.
Intended Use:
It is the expressed, intended use of the OxvHeal 2000 hyperbaric chamber series to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in its procurement and routine use.
The UHMS is the professional medical organization chartered with setting the standards of care defining the appropriate use of hyperbaric oxygen. More specifically, the UHMS publishes a listing of medical conditions that have been clearly established as appropriate primary or adjunctive use of hyperbaric oxygen (HBO). The disorders on the list have been scientifically validated and verified through extensive data collection. It should be noted that the list is dynamic. Based on the strength of the scientific data, disorders are both added and removed from the list, depending on the outcomes of scientific pursuit.
3
The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:
-
- Air or gas embolism
-
- Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
-
- Clostridial myositis and myonecrosis
-
- Crush injury, compartment syndrome, and other acute traumatic ischemias
-
- Decompression sickness
-
- Enhanced of selected problem wounds
-
- Exceptional blood loss anemia
-
- Necrotizing soft tissue infections
- တ် Osteomyelitis (refractory)
-
- Delayed radiation injury (soft tissue and bony necrosis)
-
- Skin grafts and flaps (compromised)
-
- Thermal burns
-
- Intracranial abscess
The OxyHeal 2000 hyperbaric chamber series is designed to be installed and operated in medical facilities as defined by the NFPA 99, Health Care Facilities, Chapter 19, Hyperbaric Facilities. Further, this system is intended to be operated only by medical personnel specifically trained in the appropriate use of HBO and the safe operations of all related equipment such as the hyperbaric chamber.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, represented by a series of curved lines.
Public Health Service
JUN : 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hyperbaric Technologies, Inc c/o Mr. Dave Heaney 3224 Hoover Avenue National City, CA 91950
Re: K011866
Oxyheal 2000 Hyperbaric Chamber Series Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II (two) Product Code: CBF Dated: March 7, 2002 Received: March 13, 2002
Dear Mr. Heaney:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (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) that do not require approval of a premarket approval application (PMA). 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, 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2 - Mr. Dave Heaney
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Da Tule
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Page 1 of 1
510(k) Number (if known): Koll Blo ها
Device Name: OxyHeal 2000 Hyperbaric Chamber Series
Indications for Use:
The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:
-
- Air or gas embolism
-
- Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
-
- Clostridial myositis and myonecrosis
-
- Crush injury, compartment syndrome, and other acute traumatic ischemias
-
- Decompression sickness
-
- Enhanced healing of selected problem wounds
-
- Exceptional blood loss anemia
-
- Necrotizing soft tissue infections
-
- Osteomyelitis (refractory)
-
- Delayed radiation injury (soft tissue and bony necrosis)
-
- Skin grafts and flaps (compromised)
-
- Thermal burns
-
- Intracranial abscess
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K011866
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)