(288 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, or related technologies, nor does it describe any functionality that would typically involve such technologies (like image processing or data analysis beyond standard medical device operation). The intended uses listed are for a hyperbaric oxygen therapy device, which does not inherently require AI/ML.
Yes
The listed indications for use, such as treating carbon monoxide poisoning, healing wounds, and addressing infections, are all therapeutic applications.
No
The "Intended Use / Indications for Use" lists various medical conditions that the device is used to treat, not to diagnose. There is no mention of the device performing any diagnostic functions like analyzing images, patient data, or biological samples to identify a condition.
Unknown
The provided text only lists intended uses and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Intended Use: The listed intended uses are all clinical conditions treated directly in or on the patient's body (e.g., air embolism, carbon monoxide poisoning, wound healing, burns). These are not conditions diagnosed or monitored through laboratory testing of samples.
- Lack of IVD characteristics: The description lacks any mention of analyzing biological samples, laboratory procedures, or diagnostic testing.
Therefore, this device appears to be a therapeutic device used for treating various medical conditions, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
Indications For Use:
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- Air or gas embolism
-
- Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
-
- Clostridial myositis and myonecrosis
-
- Crush injury, compartment syndrome or other acute traumatic ischemias
-
- Decompression sickness
-
- Enhanced healing of selected problem wounds
-
- Exceptional blood loss anemia
-
- Necrotizing soft tissue infections
-
- Osteomyelitis (refractory)
-
- Delaved radiation injury (soft tissue and bone necrosis)
-
- Skin grafts and flaps (compromised)
-
- Thermal burns
-
- Intracranial abscesses
Product codes
CBF
Device Description
Multiplace Hyperbaric Chamber
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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.
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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.
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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).
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§ 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 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" around the perimeter. Inside the circle is an abstract symbol that resembles three human figures or stylized birds in flight, arranged in a layered or overlapping manner.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2003
Dr. Edward F. Good Bay Area Hypersciences, LLC 18312 Sandy Cove Houston, TX 77058
Re: K030713
Trade/Device Name: BAH-6P Multiplace Hyperbaric Chamber Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: December 5, 2003 Received: December 9, 2003
Dear Dr. Good:
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 - Dr. Edward F. Good
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 vour 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 (301) 594-4646. 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,
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
Indications for Use
510(k) Number: K030713
Device Name: Multiplace Hyperbaric Chamber
Indications For Use:
-
- Air or gas embolism
-
- Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
-
- Clostridial myositis and myonecrosis
-
- Crush injury, compartment syndrome or other acute traumatic ischemias
-
- Decompression sickness
-
- Enhanced healing of selected problem wounds
-
- Exceptional blood loss anemia
-
- Necrotizing soft tissue infections
-
- Osteomyelitis (refractory)
-
- Delaved radiation injury (soft tissue and bone necrosis)
-
- Skin grafts and flaps (compromised)
-
- Thermal burns
-
- Intracranial abscesses
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stuh
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices |
510(k) Number: Ka302713
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