(119 days)
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.
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.
This document describes the Analytical Industries Inc. AII 2000 Series Oxygen Analyzer/Monitor, a device designed to measure oxygen concentration in breathing gas mixtures. The provided information primarily focuses on the device's technological characteristics, intended use, and regulatory clearance. It does not contain acceptance criteria for performance metrics based on a specific study, nor does it provide details of a clinical study to prove such criteria were met.
Here’s a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria or numerical performance targets are stated in the provided documentation. The document focuses on regulatory equivalence to predicate devices and general functional descriptions.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy | Not specified | "continuous, fast, reliable and accurate oxygen measurements" (qualitative) |
| Range | Not specified | 0-100% Oxygen |
| Resolution | Not specified | 0.1% Oxygen |
| Response Time | Not specified | "fast" (qualitative) |
| Power Source | Not specified | 2x AA Batteries |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific clinical "test set" or data provenance in the context of device performance validation. It refers to "bench testing" and "third-party testing" for software design and analyzer performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No clinical test set with human expert-adjudicated ground truth is described.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set with ground truth adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document does not discuss human reader performance, AI assistance, or an effect size.
6. Standalone Performance Study (Algorithm Only)
The document refers to software validation and "bench testing" and "third-party testing" for analyzer performance. While this implies a standalone assessment of the device, specific details about a formal standalone study with quantifiable results against predefined acceptance criteria are not provided. The focus is on the software, sensor, and overall analyzer function in relation to regulatory guidelines.
7. Type of Ground Truth Used
For the "bench testing" and "third-party testing" mentioned, the ground truth would most likely be established by controlled laboratory conditions using calibrated gas mixtures with known oxygen concentrations. This is an objective, quantitative ground truth.
8. Sample Size for the Training Set
Not applicable. The device is an oxygen analyzer, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. Its function is based on a galvanic fuel cell sensor and a microprocessor converting a signal.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no training set for an AI/ML algorithm. The device's operation relies on established physical principles and calibration against known standards. Calibration of the oxygen sensor and the analyzer to known oxygen concentrations would establish the "ground truth" for ensuring the device's accuracy.
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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 PlacePomona, CA 91767Tel: 909-392-6900, fax: 909-392-3665e-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 Analyzer510(k) #K000700 Sensidyne Monitor Analyzer (add'l reference only) |
| Device Description: | The AII 2000 Series Oxygen Analyzers and Monitor can bepositioned on a table top or pole (tripod wire stand and V-mountdovetail attachments are mounted on the back of the unit) and arereadily portable from one location to another. They providecontinuous, fast, reliable and accurate oxygen measurements of upto 100% oxygen levels delivered by medical oxygen deliveryequipment and respiratory care systems.The heart of each unit is the oxygen sensor, a self-containedgalvanic fuel cell sensor. The sensor is specific to oxygen and The |
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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/HCAnalyzer | AII 2000MMonitor | AII 2000Analyzer#K002382 | SensidyneAnalyzer#K000700 | SensidyneMonitor#K000700 |
|---|---|---|---|---|---|
| Intended Use | Spot check | Continuouslymonitor | Spot check | Spot check | Continuouslymonitor |
| 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 BatteryWarning | 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.
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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
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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
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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
§ 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).