(162 days)
Not Found
Not Found
Unknown
The provided 510(k) summary lacks detailed information about the device description, image processing, or any explicit mention of AI/ML terms. Without this information, it's impossible to determine if AI/ML is incorporated.
No.
The provided text does not contain enough information to determine if the device is a therapeutic device. The "Predicate Device(s)" mentions devices marketed before May 1976, which is not indicative of current therapeutic classification.
No
The provided text does not contain enough information to determine if the device is a diagnostic device. The "Predicate Device(s)" mentions "legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976," which is a general statement about pre-amendment devices and does not describe the specific function of this device or its predicate.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, it is not possible to definitively determine if this device is an IVD.
Here's why:
- The "Intended Use / Indications for Use" section is the most crucial for determining if a device is an IVD. It states "for the indications for use stated in the enclosure". Without the content of this enclosure, we cannot see if the device is intended for the examination of specimens derived from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of disease or other conditions. This is the core definition of an IVD.
- The other sections are "Not Found". While the absence of information about image processing, AI, anatomical site, etc., might suggest it's less likely to be a complex imaging-based IVD, it doesn't rule out other types of IVDs (e.g., a simple test kit).
To determine if this device is an IVD, you would need to review the "indications for use stated in the enclosure". If those indications involve testing human specimens for diagnostic or related purposes, then it is likely an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
73 CCL
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 22 1999
Mr. Donald W. Morrow, III Medical Technology Specialists 6290-D Warwick Road Richmond, VA 23224
Re: K983500 PRO2 Check Oxygen Indicator Regulatory Class: II (two) Product Code: 73 CCL Dated: February 25, 1999 Received: February 26, 1999
Dear Mr. Morrow:
This letter corrects our substantially equivalent letter of March 17, 1999, regarding the error in your 510(k) number.
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 leqally 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 requlations 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 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
1
Page 2 - Mr. Donald W. Morrow, III
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.
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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure