(53 days)
Not Found
Not Found
No
The summary describes a modification to existing oxygen systems involving cylinder fittings, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is described as a "Complete Home Oxygen System," which is used to provide oxygen therapy, making it a therapeutic device.
No
Explanation: The "Intended Use / Indications for Use" states that the device is for converting existing home oxygen systems to proprietary cylinder fittings. This description indicates a function related to the delivery or management of oxygen, not the identification or diagnosis of medical conditions.
No
The 510(k) summary describes a modification to existing hardware (Invacare IHO 100 Complete Home Oxygen Systems) involving physical fittings, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "convert existing Invacare IHO 100 Complete Home Oxygen Systems to proprietary type cylinder fittings." This describes a modification to a medical device (an oxygen system) that is used in vivo (on a living person) to deliver oxygen.
- Lack of IVD Characteristics: IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with biological specimens or diagnostic purposes.
Therefore, this device falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This 510(k) is to convert existing Invacare IHO 100 Complete Home Oxygen Systems to proprietary type cylinder fittings.
Product codes (comma separated list FDA assigned to the subject device)
73 CAW
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
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(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 and Human Services. The logo features a stylized eagle or bird-like figure with its wings spread, symbolizing protection and care. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the organization's name and country.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 1998
Mr. Edward A. Kroll Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, OH 44036-2125
K983777 Re: Venture Homefill Retrofit Kit Requlatory Class: II (two) Product Code: 73 CAW Dated: October 23, 1998 Received: October 26, 1998
Dear Mr. Kroll:
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, Drug, 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 Requlation (QS) for Medical Devices: General requlation (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 regulation 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.
1
Page 2 - Mr. Edward A. Kroll
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 regulation (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,
Thomas J. Callahon
Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known); K983777
Device Name: Modification To Venture IHO 100 Complete Home Oxygen System Cylinder Fitting
This 510(k) is to convert existing Invacare IHO 100 Complete Home Oxygen Indications For Use: Systems to proprietary type cylinder fittings.
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
:
..
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kramer
(Division Sign-Off) Prescription Use Prescription Use ) > (Division of Cardiovascular, Respiratory, >
(Per 21 CFR 801.109 and Neurological Devices
510(k) Number ...
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)