(206 days)
Not Found
Not Found
No
The summary describes a device for measuring oxygen concentration and does not mention any AI or ML related terms, image processing, or performance studies typically associated with AI/ML devices.
No.
The device measures oxygen concentration in gas mixtures, which is a diagnostic or monitoring function, not a therapeutic intervention.
No
The device measures oxygen concentration in gas mixtures, which is a measurement function, not a diagnostic one. It does not identify or characterize diseases or conditions in a patient.
No
The description focuses on measuring oxygen concentration in gas mixtures, which strongly implies a hardware sensor is involved. There is no mention of the device being software-only.
Based on the provided information, the AX300 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device measures the concentration of oxygen in gas mixtures. IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information about a person's health.
- Device Description: While the description is "Not Found," the intended use is the primary indicator.
- Other Sections: The lack of information about image processing, AI/ML, imaging modality, anatomical site, training/test sets, performance studies, and key metrics further supports that this is not an IVD device, as these are often relevant for devices that analyze biological samples or medical images.
The AX300 appears to be a device used in a clinical setting to monitor the composition of gases being administered to patients, which falls under the category of a medical device, but not specifically an IVD.
N/A
Intended Use / Indications for Use
The AX300 is intended to accurately measure (spot check) 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
medical applications such as anesthesia, respiratory therapy
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 U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2003
Mr. Ray Khajavi Director Teledyne Instruments 16830 Chestnut Street City of Industry, California 91748-1020
Re: K024228
Trade/Device Name: AX300 Oxygen Analyzer 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,
Susan Ruart
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
AX300 Indications for Use
510(k) Number: KO24228
The AX300 is intended to accurately measure (spot check) 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 V
OR
Over the Counter Use
Susa Burns
计) sthesiology, General Hospital,
S101(k) Number