(233 days)
Not Found
Not Found
No
The provided 510(k) summary focuses solely on the intended uses of a hyperbaric chamber and does not mention any AI or ML components in the device description, performance studies, or key metrics.
Yes
The "Intended Use / Indications for Use" section lists multiple medical conditions and injuries the device is designed to treat, such as "Carbon Monoxide Poisoning," "Decompression Sickness," and "Enhancement of Healing in Selected Problem Wounds," which are all therapeutic in nature.
No
The provided text lists medical conditions that the device is intended to treat (e.g., carbon monoxide poisoning, gas gangrene, problem wounds), not conditions it is designed to diagnose. Diagnostic devices are used to identify or detect medical conditions, whereas this device is used for treatment.
Unknown
The provided text only lists intended uses and mentions predicate devices. It lacks a device description, which is crucial for determining if the device is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The listed intended uses are all related to treating various medical conditions within the human body (e.g., air embolism, carbon monoxide poisoning, wound healing, infections). IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: While the description is "Not Found," the intended uses strongly suggest a therapeutic device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The intended uses clearly point towards a device used for hyperbaric oxygen therapy, which is a treatment method, not a diagnostic test.
N/A
Intended Use / Indications for Use
- 1 Air or Gas Embolism
- 2 Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
- 3 Clostridal Myositis and Myonecrosis (Gas Gangrene)
- Crush Injury, Compartment Syndrome, and other Acute 4 Traumatic Ischemias
- 5 Decompression Sickness
- 6 Enhancement of Healing in Selected Problem Wounds
- 7 Exceptional Blood Loss (Anemia)
- 8 Intracranial Abscess
- 9 Necrotizing Soft Tissue Infections
- 10 Osteomyelitis (Refractory)
- 11 Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
- 12 Skin Grafts & Flaps (Compromised)
- 13 Thermal Burns
These are the indicated uses by the Undersea & Hyperbaric Medical Society.
The device is designed to be used for the indicated uses only.
Product codes
CBF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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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.
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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).
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 black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The profiles are stacked on top of each other, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2003
Mr. Audley L. Aaron President Mechidyne Systems, Incorporated 16840 Clay Road Houston, Texas 77084
Re: K022214
Trade/Device Name: MSI i2010 Dual Place Hyperbaric Chamber Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: October 21, 2002 Received: December 2, 2002
Dear Mr. Aaron:
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. Aaron
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 (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.
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K022214 Device Name: MSI i2010 Dual Place Hyperbaric Chamber Indications for Use:
- 1 Air or Gas Embolism
- 2 Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
- 3 Clostridal Myositis and Myonecrosis (Gas Gangrene)
- Crush Injury, Compartment Syndrome, and other Acute 4 Traumatic Ischemias
- 5 Decompression Sickness
- Enhancement of Healing in Selected Problem Wounds റ
- 7 Exceptional Blood Loss (Anemia)
- 8 Intracranial Abscess
- 9 Necrotizing Soft Tissue Infections
- 10 Osteomyelitis (Refractory)
- 11 Delayed Radiation Injury (Soft Tissue and Bony Necrosis
- 12 Skin Grafts & Flaps (Compromised)
- 13 Thermal Burns
These are the indicated uses by the Undersea & Hyperbaric Medical Society.
The device is designed to be used for the indicated uses only.
Susa Rumpf
on of Anesthesiology, General Hospitzl, ection Control, Dental Devices
510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)