(119 days)
No
The device description focuses on a galvanic fuel cell sensor and a microprocessor converting a linear signal. There is no mention of AI, ML, or complex algorithms beyond basic signal processing and control functions.
No.
The device is used to measure and display the concentration of oxygen in breathing gas mixtures and monitor oxygen concentrations provided by other medical devices; it does not provide any therapeutic effect itself.
No
Explanation: The device measures oxygen concentration in breathing gas mixtures and monitors it. Its purpose is to verify, spot check, or continuously monitor oxygen levels, not to diagnose a medical condition. It explicitly states its role is in circumstances where "oxygen concentration is controlled and set by other medical devices."
No
The device description clearly states it includes hardware components such as an oxygen sensor (galvanic fuel cell), a microprocessor, a keypad, and an LCD display. While it contains software, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to measure oxygen concentration in breathing gas mixtures. This is a measurement of a gas, not a biological sample (like blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Device Description: The device analyzes a gas stream using a sensor. It does not interact with or analyze biological specimens.
- Lack of Biological Sample Analysis: There is no mention of the device being used to test or analyze any biological material from a patient.
IVDs are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device measures the composition of a gas being delivered to a patient, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The AII 2000 Series Oxygen Analyzers & Monitor are intended to measure and display the concentration of oxygen in breathing gas mixtures. The intended use is only to verify, spot check or continuously monitor, oxygen concentrations in circumstances where the oxygen concentration is controlled and set by other medical devices such as oxygen/air blenders, flow meters or other control devices.
Product codes
73 CCL
Device Description
The AII 2000 Series Oxygen Analyzers and Monitor can be positioned on a table top or pole (tripod wire stand and V-mount dovetail attachments are mounted on the back of the unit) and are readily portable from one location to another. They provide continuous, fast, reliable and accurate oxygen measurements of up to 100% oxygen levels delivered by medical oxygen delivery equipment and respiratory care systems. The heart of each unit is the oxygen sensor, a self-contained galvanic fuel cell sensor. The sensor is specific to oxygen and The relationship between the sensor's signal and changes with the oxygen concentration is both proportional and linear. A battery powered state-of-the-art micro-processor converts the sensor's signal output representing the partial pressure of oxygen in the gas stream being analyzed. The resulting oxygen reading is displayed by a large easy to read backlit liquid crystal display (LCD) that has a resolution of 0.1% oxygen. The microprocessor is controlled from a keypad and provides features like system diagnostics, warning indicators, controls and an alarm capability for continuous monitoring that enhance both safety and effectiveness.
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)
Verification and validation of the software design and analyzer performance was conducted and documentation of both the bench testing and third party testing can be found in Section 9. The bench testing was based on the guidance document "Software Validation per General Principles of Software Validation; Final Guidance for Industry and FDA Staff" issued January 11, 2002.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Analytical Industries Inc.
Tel: 909-392-6900, Fax: 909-392-3665, e-mail: info@aii1.com 2855 Metropolitan Place, Pomona, CA 91767 USA
relationship between the sensor's signal and changes with the
oxygen concentration is both proportional and linear.
10
10 510(k) Summary
[As Required by 21 CFR 807.92]
| Owner / Submitter of 510(k): | Analytical Industries Inc.
2855 Metrolpolitan Place
Pomona, CA 91767
Tel: 909-392-6900, fax: 909-392-3665
e-mail: prindiblepj@earthlink.net; prindiblepj@aii1.com |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No.: | 9021044 |
| Contact: | Patrick J. Prindible |
| Date of Summary: | November 30, 2005 |
| Trade Name: | Analytical Industries Inc. |
| Common Name: | Oxygen Analyzer/Monitor |
| Classification Name: | Oxygen Gas Analyzer/Monitor |
| Regulation Number: | 868.1720 |
| Classification Panel: | Anesthesiology |
| Regulatory Class: | IIb |
| Product Code: | 73 CCL |
| Predicate Device(s): | 510(k) #K002382 Analytical Industries AII 2000 Oxygen Analyzer
510(k) #K000700 Sensidyne Monitor Analyzer (add'l reference only) |
| Device Description: | The AII 2000 Series Oxygen Analyzers and Monitor can be
positioned on a table top or pole (tripod wire stand and V-mount
dovetail attachments are mounted on the back of the unit) and are
readily portable from one location to another. They provide
continuous, fast, reliable and accurate oxygen measurements of up
to 100% oxygen levels delivered by medical oxygen delivery
equipment and respiratory care systems.
The heart of each unit is the oxygen sensor, a self-contained
galvanic fuel cell sensor. The sensor is specific to oxygen and The |
1
2855 Metropolitan Place, Pomona, CA 91767 USA Tel: 909-392-6900, Fax: 909-392-3665, e-mail: info@aii1.com
A battery powered state-of-the-art micro-processor converts the sensor's signal output representing the partial pressure of oxygen in the gas stream being analyzed. The resulting oxygen reading is displayed by a large easy to read backlit liquid crystal display (LCD) that has a resolution of 0.1% oxygen. The microprocessor is controlled from a keypad and provides features like system diagnostics, warning indicators, controls and an alarm capability for continuous monitoring that enhance both safety and effectiveness.
- Intended Use: The AII 2000 Series Oxygen Analyzers & Monitor are intended to measure and display the concentration of oxygen in breathing gas mixtures. The intended use is only to verify, spot check or continuously monitor, oxygen concentrations in circumstances where the oxygen concentration is controlled and set by other medical devices such as oxygen/air blenders, flow meters or other control devices.
Comparison of Technological Characteristics:
| Feature | AII 2000A/HC
Analyzer | AII 2000M
Monitor | AII 2000
Analyzer
#K002382 | Sensidyne
Analyzer
#K000700 | Sensidyne
Monitor
#K000700 |
|------------------------|--------------------------|-------------------------|----------------------------------|-----------------------------------|----------------------------------|
| Intended Use | Spot check | Continuously
monitor | Spot check | Spot check | Continuously
monitor |
| Oxygen Sensor | Galvanic | Galvanic | Galvanic | Galvanic | Galvanic |
| Range | 0-100% | 0-100% | 0-100% | 0-100% | 0-100% |
| Display Resolution | 0.1% | 0.1% | 0.1% | 0.1% | 0.1% |
| Controls | Keypad | Keypad/Menu | Pushbutton,
thumbwheel | Keypad | Keypad/Menu |
| Low Battery
Warning | Visual | Visual | Visual | Visual | Visual |
| Low Sensor Warning | Visual | Visual | NA | Unknown | Unknown |
| Alarms | NA | HI LO oxygen | NA | NA | HI LO oxygen |
| Alarm System | NA | Visual/Audible | NA | NA | Visual/Audible |
| Power Source | 2x AA Batteries | 2x AA Batteries | 1x 9V Battery | 2x AA Batteries | 2x AA Batteries |
(in)
Non-clinical Testing Data:
Verification and validation of the software design and analyzer performance was conducted and documentation of both the bench testing and third party testing can be found in Section 9. The bench testing was based on the guidance document "Software Validation per General Principles of Software Validation; Final Guidance for Industry and FDA Staff" issued January 11, 2002.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (USA). The seal features a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" arranged around the perimeter. Inside the circle, there is a stylized graphic of three human profiles facing to the right, with flowing lines representing hair or movement. The profiles are stacked vertically, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 4 2006
Mr. Patrick J. Prindible Analytical Industries, Incorporated 2855 Metropolitan Place Pomona, California 91767
Re: K053407
Trade/Device Name: Analytical Industries Incorporated AII 2000 Series Oxygen Analyzer/Monitor Regulation Number: 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: Class II Product Code: CCL Dated: March 27, 2006 Received: March 28, 2006
Dear Mr. Prindible:
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.
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
3
Page 2 -- Mr. Patrick J. Prindible
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- _ . 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Chiu-Lin, Ph.D.
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
4
Tel: 909-392-6900, Fax: 909-392-3665, e-mail: info@aii1.com 2855 Metropolitan Place, Pomona, CA 91767 USA
8 Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Analytical Industries Inc. AII 2000 Series Oxygen Analyzer/Monitor
Indications for Use:
The Analytical Industries Inc. AII 2000 Series Oxygen Analyzers & Monitors are intended to measure and display the concentration of oxygen in breathing gas mixtures. The intended use is only to verify, spot check or continuously monitor, oxygen concentrations in circumstances where the oxygen concentration is controlled and set by other medical devices such as oxygen/air blenders, flow meters or other control devices.
Prescription Use __ Yes
AND/OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
hueyfulcom
ology, General Hospital
Control Dental Devices
K053407