(105 days)
NotFound
No
The summary describes a standard oxygen analyzer using a sensor, with no mention of AI, ML, or related concepts.
No
The device measures oxygen concentration but does not deliver or alter the air/oxygen mixture, nor does it continuously monitor a patient. Therefore, it is not a therapeutic device.
Yes
The device is intended to "spot-check or measure oxygen concentration of a delivered air/oxygen mixture," which is a measurement taken to assess a physiological parameter. Even though it is not for continuous monitoring, it provides specific information about oxygen levels, qualifying it as a diagnostic tool.
No
The device description explicitly states it utilizes a "MAX-250 oxygen sensor" and is part of a line of "oxygen analyzers and monitors," indicating it includes hardware components beyond just software.
Based on the provided information, the MAXO2+ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "spot-check or measure oxygen concentration of a delivered air/ oxygen mixture." This is a measurement of a gas mixture, not a biological sample taken from the human body.
- Device Description: The device description focuses on the oxygen sensor and its engineering for measuring oxygen concentration.
- Lack of Biological Sample Analysis: IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease. The MAXO2+ does not interact with or analyze any biological samples.
The MAXO2+ is a device used to measure the composition of a gas mixture being delivered, likely for respiratory support or other medical applications where controlling oxygen levels is important. This falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The MAXO2+ is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/ oxygen mixture.
The MAXO2+ is not intended for use in continuous monitoring of oxygen delivery to a patient.
Product codes
CCL
Device Description
The MAXO2+ A(E) oxygen analyzer is a member of Maxtec's MAXO2 analyzer line of oxygen analyzers and monitors. It utilizes the MAX-250 oxygen sensor and is engineered for long life, maximum reliability and stable performance.
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
qualified personnel
Hospitals, Home Care, Transport, and Sub-acute Institutions.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
Maxtec, Inc
K040484
MAXO₂
510(k) NOTIFICATION - 9 2004
Section 1 - 510(k) Summary of Safety and Effectiveness
Non-Confidential Summary of Safety and Effectiveness February 19, 2004 Page 1 of 3
Maxtec, Inc 6526 S. Cottonwood Street Salt Lake City, UT 84107 U.S.A. Phone: (801) 266-5300 (801) 270-5590 Fax:
| Official Contact: | Gordon R. Roth - Quality System Manager |
|---|---|
| Proprietary or Trade Name: | MAXO2+ |
| Common/Usual Name: | Oxygen Analyzer |
| Classification Name: | Analyzer, Gas, Oxygen, Gaseous Phase |
| Predicate Device: | Caradyne - OxiCheck - K023565 |
Device Description:
The MAXO2+ A(E) oxygen analyzer is a member of Maxtec's MAXO2 analyzer line of oxygen analyzers and monitors. It utilizes the MAX-250 oxygen sensor and is engineered for long life, maximum reliability and stable performance.
Intended Use:
The MAXO2+ is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/ oxygen mixture.
The MAXO2+ is not intended for use in continuous monitoring of oxygen delivery to a patient.
Environment of Use:
The MAXO2+ is intended for use in Hospitals, Home Care, Transport, and Sub-acute Institutions. The MAXO2+ is not intended for use in a MRI environment.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged 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
JUN - 9 2004
Mr. Gordon R. Roth Quality System Manager Maxtec. Incorporated 6526 South Cottonwood Street Salt Lake City, Utah 84107
Re: K040484
Trade/Device Name: MAX02+ Model "A" and "AE" Regulation Number: 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: II Product Code: CCL Dated: May 25, 2004 Received: May 26, 2004
Dear Mr. Roth:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined 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 mendments, or to devices that have been reclassified in accordance with the provisions of /incentinents, or to are rood Cosmetic Act (Act) that do not require approval of a premarket the redelar 1 000; Drag). You may, therefore, market the device, subject to the general approvial applicans of the Act. The general controls provisions of the Act include controls providens of an 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 (1 Mrx), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Roth
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 Incan that I DA mas made a statutes and regulations administered by other Federal agencies. of the Act of ally I outeral timated including, but not limited to: registration r ou intist comply wan and 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CF Real 80%), systems (QS) regulation (21 CFR Part 820); and if requirenches as bet form inroduct 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) This letter wifi and in J . The FDA finding of substantial equivalence of your device to a premaired 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), If you desire specific at 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 may obtain 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,
Carls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Maxtec, Inc
Statement of Indications for Use
MAXO2+
510(k) Number (if known): _ Ko4 o 40 40 4
Device Name: -----------------------------------------------------------------------------------------------------------------------------------------------------------------
Indications for Use: -------------------------------------- The MAXO2+ is intended as a tool for use by
qualified personnel to spot-check or measure oxygen concentration of a delivered air/ oxygen mixture
The MAXO2+ is not intended for use in continuous monitoring of oxygen delivery to a patient.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quytlepour
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:________________________________________________________________________________________________________________________________________________________________