(324 days)
Hyox Systems, Ltd.'s, HTU2 Hyperbaric Chamber (1), Sechrist Industries's Sechrist 2500E Hyperbaric Chamber (2), Sechrist Industries's Sechrist 3200 Hyperbaric Chamber (3)
Not Found
No
The document describes a hyperbaric chamber and its modifications to meet safety standards. There is no mention of AI or ML technology in the intended use, device description, or any other section.
Yes
The "Intended Use / Indications for Use" section explicitly lists various treatments for which the device is used. This directly defines its purpose as a therapeutic device.
No
The device is described as a "hyperbaric therapy unit" used for "treatment" of various conditions, indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly details physical modifications to a hyperbaric chamber, including changes to steel thickness, window thickness, and compressor type. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a hyperbaric therapy unit. Its function is to deliver oxygen at increased pressure to a patient's body. This is a therapeutic intervention applied directly to the patient, not a test performed on a sample outside the body.
- Intended Use: The intended uses listed are all clinical conditions treated by delivering hyperbaric oxygen therapy directly to the patient. None of them involve analyzing biological samples.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
To promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure, with non critical patients for the treatment of:
-
- Air or Gas Embolism;
- Carbon Monoxide Poisoning and Smoke Inhalation, 2. Carbon Monoxide Poisoning Complicated by Cyanide Poisoning;
- Clostridal Myonecrosis; 3.
- Crush Injury, Compartment Syndrome, Acute Traumatic 4. Ischemias;
- Decompression Sickness; 5.
- Enhancement of Healing in Selected Problem Wounds; 6.
- Exceptional Blood Loss; 7.
- Necrotizing Soft Tissue Infections; 8.
- Osteomyelitis (Refractory); 9.
-
- Radiation Tissue Damage;
- 11, Skin Grafts & Flaps (Compromised);
-
- Thermal Burns; and
-
- Adjunctive Hyperbaric Oxygen in Intracranial Abscess.
Product codes (comma separated list FDA assigned to the subject device)
73 CBF
Device Description
The HTU3 is a modified version of the HTU2. To comply with the ASME/PVHO-1 safety standard for pressure vessels for human occupancy, Hyox increased the operating pressure of the Company's hyperbaric therapy unit from two times atmospheric pressure to three times atmospheric pressure, the operating pressure of the Sechrist devices. To facilitate this change, certain minor modifications to the HTU2 were necessary to configure the HTU3. including: (1) an increase in the compression time, as well as an increase in the slow, fast, and emergency decompression times (although the compression and the decompression rates remain unchanged); (2) an increase in the thickness of steel used to manufacture the hyperbaric chamber: (3) an increase in thickness of the device's acrylic windows; and (4) a change from a compressor that functions using a diaphragm unit to a compressor that works using a free piston mechanism. Finally, also to comply with the ASME/PVHO-1 safety standard for pressure vessels for human occupancy, Hyox has made two additional modifications. Hyox has modified the shape of the chamber's acrylic windows and the grade of steel from which the hyperbaric chamber is manufactured.
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): 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.
Hyox Systems, Ltd.'s, HTU2 Hyperbaric Chamber (1), Sechrist Industries's Sechrist 2500E Hyperbaric Chamber (2), Sechrist Industries's Sechrist 3200 Hyperbaric Chamber (3)
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 22 1999
510(k) SUMMARY
Hyox Systems, Ltd.'s HTU3 Hyperbaric Chamber
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hyox Systems, Ltd. Pressure Products House Westhill Industrial Estate, Westhill Aberdeen, AB32 6TQ Scotland, United Kingdom
Contact Person:
Ms. Kathleen Scanlan Quality Assurance Manager Hyox Systems, Ltd. Pressure Products House Westhill Industrial Estate, Westhill Aberdeen, AB32 6TQ Scotland, United Kingdom
Date Prepared: February 3, 1999
Name of Device
HTU3 Hyperbaric Chamber
Common or Usual Name
Hyperbaric Chamber
Classification Name
Hyperbaric Chamber
Predicate Devices
- Hyox Systems, Ltd.'s, HTU2 Hyperbaric Chamber (1)
- Sechrist Industries's Sechrist 2500E Hyperbaric Chamber (2)
- Sechrist Industries's Sechrist 3200 Hyperbaric Chamber (3)
1
Substantial Equivalence
The HTU3 Hyperbaric Chamber and the predicate devices listed above have the same intended use and very similar principles of operation and technological characteristics. Specifically, the HTU3 and the predicate devices are intended to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. The HTU3 is indicated for use in treating: (1) Air or Gas Embolism; (2) Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Poisoning Complicated by Cyanide Poisoning; (3) Clostridal Myonecrosis; (4) Crush Injury, Compartment Syndrome. Acute Traumatic Ischemias; (5) Decompression Sickness: (6) Enhancement of Healing in Selected Problem Wounds; (7) Exceptional Blood Loss: (8) Necrotizing Soft Tissue Infections: (9) Osteomvelitis (Refractory): (10) Radiation Tissue Damage; (11) Skin Grafts & Flaps (Compromised); (12) Thermal Burns; and (13) Adjunctive Hyperbaric Oxygen in Intracranial Abscess.
Moreover, the HTU3 is a modified version of the HTU2. To comply with the ASME/PVHO-1 safety standard for pressure vessels for human occupancy, Hyox increased the operating pressure of the Company's hyperbaric therapy unit from two times atmospheric pressure to three times atmospheric pressure, the operating pressure of the Sechrist devices. To facilitate this change, certain minor modifications to the HTU2 were necessary to configure the HTU3. including: (1) an increase in the compression time, as well as an increase in the slow, fast, and emergency decompression times (although the compression and the decompression rates remain unchanged); (2) an increase in the thickness of steel used to manufacture the hyperbaric chamber: (3) an increase in thickness of the device's acrylic windows; and (4) a change from a compressor that functions using a diaphragm unit to a compressor that works using a free piston mechanism. Finally, also to comply with the ASME/PVHO-1 safety standard for pressure vessels for human occupancy, Hyox has made two additional modifications. Hyox has modified the shape of the chamber's acrylic windows and the grade of steel from which the hyperbaric chamber is manufactured.
None of these differences raises new questions of safety or effectiveness. Thus, the HTU3 Hyperbaric Chamber is substantially equivalent to the HTU2, the Sechrist 2500E, and the Sechrist 3200 hyperbaric chambers,
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the symbol in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 22 1999
Mr. Edward C. Wilson, Jr. Hyox Systems, Ltd. c/o Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109
K984313 Re: HTU3 Hyperbaric Therapy Unit Regulatory Class: II (two) Product Code: 73 CBF Dated: July 27, 1999 Received: July 27, 1999
Dear Mr. Wilson:
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 (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, Druq, 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, 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 requlation 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.
3
Page 2 - Mr. Edward C. Wilson, Jr.
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 requlation (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,
teanne Bi Wentworth-
- fri, Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_ K984313
Device Name: Hyox Systems Ltd.'s HTU3 Hyperbaric Chamber
Indications for Use:
To promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure, with non critical patients for the treatment of:
-
- Air or Gas Embolism;
- Carbon Monoxide Poisoning and Smoke Inhalation, 2. Carbon Monoxide Poisoning Complicated by Cyanide Poisoning;
- Clostridal Myonecrosis; 3.
- Crush Injury, Compartment Syndrome, Acute Traumatic 4. Ischemias;
- Decompression Sickness; 5.
- Enhancement of Healing in Selected Problem Wounds; 6.
- Exceptional Blood Loss; 7.
- Necrotizing Soft Tissue Infections; 8.
- Osteomyelitis (Refractory); 9.
-
- Radiation Tissue Damage;
- 11, Skin Grafts & Flaps (Compromised);
-
- Thermal Burns; and
-
- Adjunctive Hyperbaric Oxygen in Intracranial Abscess.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
to Hillelth
(Division Sign-Off) Division of Cardiovascular. Respiratory, and Neurological Devices
510(k) Number K984313
Prescription Use
(Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)