(212 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any related concepts. The device description is not available, and there is no information about training or test sets, which are typically associated with AI/ML development.
No
The device measures and displays oxygen concentration, which is a diagnostic or monitoring function, not a therapeutic one. It provides information for medical applications but does not directly treat a condition.
No
Explanation: The device measures and displays oxygen concentration, which is a monitoring function, not a diagnostic one that identifies a disease or condition.
No
The device description is not found, but the intended use clearly describes a device that measures the concentration of oxygen in gas mixtures. This function typically requires hardware sensors and measurement components, not just software.
Based on the provided information, the MX300 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure oxygen concentration in gas mixtures used in medical applications like anesthesia and respiratory therapy. This involves analyzing gases, not biological samples (like blood, urine, or tissue) which are the focus of IVDs.
- Device Description: While the description is "Not Found," the intended use clearly points to a device that interacts with gases, not biological specimens.
- No mention of biological samples: The entire description focuses on gas mixtures and their use in medical procedures. There is no mention of analyzing any type of biological sample.
IVDs are specifically designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The MX300's function falls outside of this definition.
N/A
Intended Use / Indications for Use
The MX300 is intended to continuously measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and is intended for adult, pediatric and neonatal populations.
Product codes
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
adult, pediatric and neonatal populations
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
§ 868.1720 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 U.S. Department of Health and 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 resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 2003
Mr. Ray Khajavi Director Teledyne Instruments 16830 Chestnut Street City of Industry, California 91748-1020
Re: K024155
Trade/Device Name: MX300 Oxygen Monitor Regulation Number: 21 CFR 868.1720 Regulation Name: Analyzer, Gas, Oxygen, Gaseous Phase Regulatory Class: II Product Code: CCL Dated: June 24, 2003 Received: June 25, 2003
Dear Mr. Khajavi:
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. Ray Khajavi
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,
Susa Russer
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
MX300 Indications for Use
510(k) Number: KO24155
The MX300 is intended to continuously measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and is intended for adult, pediatric and neonatal populations.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 4
OR
Over the Counter Use ______
Susan Rury
(Division Sign-Off) (Division Sign-Old)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K024155