(210 days)
Not Found
Not Found
No
The provided text describes a hyperbaric oxygen therapy device and its intended uses, which are standard medical conditions treated with this therapy. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The "Not Found" entries for sections like "Mentions AI, DNN, or ML," "Description of the training set," and "Summary of Performance Studies" further indicate the absence of AI/ML components.
Yes
The "Intended Use / Indications for Use" section lists multiple medical conditions for which Hyperbaric Oxygen Therapy is considered appropriate, indicating that the device is used to treat or manage these conditions.
No.
The 'Intended Use' section describes Hyperbaric Oxygen Therapy (a treatment), not a device used to diagnose conditions.
Unknown
The provided text only describes the intended use of a hyperbaric oxygen therapy device. It does not contain any information about the device itself, its components, or whether it is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the treatment of various medical conditions using Hyperbaric Oxygen Therapy. This is a therapeutic intervention applied directly to the patient, not a test performed on a sample taken from the patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, the device described is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The conditions listed as appropriate for the use of Hyperbaric Oxygen Therapy in the current Undersea and Hyperbariac Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1998) are as follows: Air or gas embolism Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning or 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 bone necrosis) Skin grafts and flaps (compromised) Thermal burns Intracranial abscess
Product codes
CBF
Device Description
Not Found
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.
Not Found
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
Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of three stylized wavy lines, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the logo in a circular fashion. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 5 2004
Mr. Rick Ryder Owner Hyperbaric for Life, LLC 3206 West State Avenue Phoenix, Arizona 85051
Re: K041007
Trade/Device Name: Millennium 2000, 2001, 2002, 2003, 2004, 2005 Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: October 25, 2004 Received: October 25, 2004
Dear Mr. Ryder:
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.
1
Page 2 - Mr. Ryder
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Carls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 2
Indications for Use
(To be assigned) K 041007 _____________________________________________________________________________________________________________________________________________________________________ 510(k) Number:
Millennium 2000,2001,2002,2003,2004,2005 Device Name:
Indications for Use:
The conditions listed as appropriate for the use of Hyperbaric Oxygen Therapy in the current The conditions instou as upprophato sic and Medical Society (UHMS)Hyperbaric Oxygen Therapy Committee Report (1998) are as follows
Air or gas embolism
Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
or
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 bone necrosis)
Skin grafts and flaps (compromised)
Thermal burns
Intracranial abscess
Prescription Use X (Per CFR 801.109)
Wigin
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anton Dental Devices KO41007
510(k) Number:_
Over-the-counter use __
12