(140 days)
The Precision Medical Oxygen Monitor is intended to measure the concentration of oxygen being delivered to the patient. The oxygen monitor is not intended as a life supporting device.
The Precision Medical, Inc. Oxygen monitor is made of two components, the monitor, and the sensor, attached by a coiled cable. The monitor houses the LCD screen, circuit board, key pad, and batteries. The sensor is a galvanic oxygen sensor that produces a millivolt signal that is proportional to partial pressure of oxygen being measured. The monitor converts the millivolt signal sent from the sensor to a percent oxygen concentration displayed on the LCD screen.
Here's a breakdown of the acceptance criteria and the study information for the Precision Medical, Inc. Oxygen Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Maxtec) | Reported Device Performance (Precision Medical) | Test Method/Report |
|---|---|---|---|
| Measurement Range | 0.0 - 100% | 0.0 - 100% | Not specified |
| Resolution | 0.10% | 0.10% | Not specified |
| Accuracy & Linearity | ±1% of full scale at constant temperature, R.H. and pressure when calibrated at full scale. | ±1% of full scale at constant temperature, R.H. and pressure when calibrated at full scale. | Precision Medical Test # 699-1 |
| Total Accuracy | ±3% Actual Oxygen Level over full operating temperature range | ±3% Actual Oxygen Level over full operating temperature range | Not explicitly listed as a separate test, but implied by specs |
| Response Time | 90% of final value in approximately 15 seconds at 23°C | 90% of final value in approximately 12 seconds at 25°C | Not specified |
| Operating Temperature | 15°C - 40°C [59°F - 104°F] | 10°C - 45°C [50°F - 113°F] | Precision Medical Test # 699-4 |
| Storage Temperature | -15°C - 50°C [5°F - 122°F] | -15°C - 50°C [5°F - 122°F] | Not specified |
| Humidity | 0 - 95% [non-condensing] | 0 - 95% [non-condensing] | Precision Medical Test # 699-4 |
| Power Requirements | 2, AA Alkaline Batteries [2 x 1.5 Volts] | 4, AA Alkaline Batteries [4 x 1.5 Volts] | Not specified |
| Battery Life | Approximately 3000 hours in typical use | Approximately 1500 hours in continuous use. Non alarm condition | Not specified |
| Low Battery Indication | "LOW BAT" icon displayed on screen | "LOW BAT" icon displayed on screen | Not specified |
| Sensor Type | Maxtec MAX-250E galvanic fuel cell | Precision Medical 504877 Galvanic fuel cell | Not specified |
| Expected Sensor Life | >900,000% O2 Hours | >1,000,000% O2 Hours | Not specified |
| Alarm System | high/low alarms, flashing red LEDs, audible alarm beeper | high/low alarms, flashing red LEDs, audible alarm beeper | Not specified |
| Low Alarm Range | 18% - 99% | 18% - 99% | Not specified |
| High Alarm Range | 19% - 99% | 19% - 99% | Not specified |
| Alarm Accuracy | Exact to displayed alarm value | Exact to displayed alarm value | Not specified |
| Dimensions | 3.5"[W] x 5.5"[H] x 1.5"[D] [89mm x 140mm x 38mm] | 3.6"[W] x 5.4"[H] x 1.5"[D] [89mm x 140mm x 38mm] | Not specified |
| Weight | Approximately 0.92 lbs. [417g] | Approximately 1.11 lbs. [430g] | Not specified |
| Cable Length | 10 ft. [3m] | 10 ft. [3m] | Not specified |
| Diverter Fitting | fits industry standard, 15 mm "T" adapter | fits industry standard, 15 mm "T" adapter | Not specified |
| Electromagnetic Compatibility | Not explicitly stated as acceptance criteria, but tested for predicate | Complied with IEC 60601-1-2:2004 | Retlif Testing Laboratories Test Report No. R-2915P |
| Software Validation | Compliance with Guidance document: General Principles of Software Validation | Complied with Guidance document: General Principles of Software Validation, Final Guidance for Industry and FDA Staff | Not specified |
| Mechanical / Climatic | Not explicitly stated as acceptance criteria, but tested for predicate | Passed | Precision Medical Test # 699-4 |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only lists the tests performed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests performed are engineering and performance validation tests on the physical device itself (e.g., accuracy, temperature range), not on interpretations by experts.
4. Adjudication Method for the Test Set
This is not applicable as the tests described are technical performance measurements of the device, not analyses requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device. The device is an oxygen monitor, which provides a direct measurement, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a physical oxygen monitor, not an algorithm. Its performance is inherent to its physical and electronic design. The data provided describes standalone device performance.
7. Type of Ground Truth Used
The ground truth used for these performance tests would be calibrated reference standards or known environmental conditions. For example, for "Accuracy & Linearity," the ground truth would be precisely measured oxygen concentrations and controlled temperature/humidity. For "Electromagnetic Emissions & Immunity," the ground truth would be established by the testing standards themselves.
8. Sample Size for the Training Set
This is not applicable as the Precision Medical, Inc. Oxygen Monitor is a hardware device that measures oxygen concentration using a galvanic fuel cell. It does not employ machine learning or AI models that require a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
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510(k) Summary
FEB 27 2007
Precision Medical, Inc. Oxygen Monitor
Submitter Information
| Submitter | Precision Medical, Inc.300 Held DriveNorthampton, Pa.18067 |
|---|---|
| Contact | James ParkerQuality Assurance Manager |
| Tel: | (610)-262-6090 Extensions 228 |
| Fax: | (610)-262-6080 |
| Preparation Date: | October 2, 2006 |
| Device Name | |
| Proprietary Name: | Precision Oxygen Monitor |
| Common Name: | Oxygen Analyzer |
| Classification Name: | Analyzer, Gas Oxygen as per CFR 868.1720 |
| Classification Product Code | CCL |
| Device Classification | Class II |
Predicate Device Equivalence
Precision Medical, Inc. is claiming substantial equivalence to the Cerion Hand Held Oxygen Analyzer. Now (Maxtec) 510K number K911344
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Device Description
The Precision Medical, Inc. Oxygen monitor is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where monitoring of oxygen levels are required. Additional information:
The Precision Medical, Inc. Oxygen monitor is made of two components, the monitor, and the sensor, attached by a coiled cable. The monitor houses the LCD screen, circuit board, key pad, and batteries. The sensor is a galvanic oxygen sensor that produces a millivolt signal that is proportional to partial pressure of oxygen being measured. The monitor converts the millivolt signal sent from the sensor to a percent oxygen concentration displayed on the LCD screen.
Precision Medical, Inc. will purchase the Sensor from IT Dr. Gambert Gmbh Hinter dem Chor 21 23966 Wismar Germany 510K number K002384
Intended Use
The oxygen monitor provides continuous, direct monitoring of oxygen mixtures in a wide variety of medical applications such as anesthesiology [e.g. anesthesia machines], respiratory devices [e.g. respirators, ventilators, pediatric incubators], and oxygen therapy [e.g., oxygen tents]. The oxygen monitor is to be used by trained healthcare professionals under the supervision, or on the order, of a physician in a hospital [ or other clinical setting. The Precision Medical, Inc. oxygen monitor is not intended for transport use, This device is not an oxygen supply source.
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| 02 Monitor | Predicate (Maxtec) | Precision Medical |
|---|---|---|
| Specifications | ||
| Measurement | 0.0 - 100% | 0.0 - 100% |
| Range | ||
| Resolution | 0.10% | 0.10% |
| Accuracy & | ±1% of full scale at constant | ±1% of full scale at constant |
| Linearity | temperature, R.H. and pressure whencalibrated at full scale. | temperature, R.H. and pressure whencalibrated at full scale. |
| Total Accuracy | ±3% Actual Oxygen Level over fulloperating temperature range | ±3% Actual Oxygen Level over fulloperating temperature range |
| Response Time | 90% of final value in approximately 15seconds at 23°C | 90% of final value in approximately 12seconds at 25°C |
| Warm-up Time | none required | none required |
| OperatingTemperature | 15°C - 40°C [59°F - 104°F] | 10°C - 45°C [50°F - 113°F |
| StorageTemperature | -15°C - 50°C [5°F - 122°F] | -15°C - 50°C [5°F - 122°F] |
| Humidity | 0 - 95% [non-condensing] | 0 - 95% [non-condensing] |
| PowerRequirements | 2, AA Alkaline Batteries[2 x 1.5 Volts] | 4, AA Alkaline Batteries[4 x 1.5 Volts] |
| Battery Life | approximately 3000 hours in typical use | approximately 1500 hours in continuoususe. |
| Non alarm condition | ||
| Low BatteryIndication | "LOW BAT" icon displayed on screen | "LOW BAT" icon displayed on screen |
| Sensor Type | Maxtec MAX-250E galvanic fuel cell | Precision Medical 504877Galvanic fuel cell |
| Expected SensorLife | >900,000% O2 Hours | >1,000,000% O2 Hours |
| Alarm System | high/low alarms, flashing red LEDs,audible alarm beeper | high/low alarms, flashing red LEDs,audible alarm beeper |
| Low Alarm Range | 18% - 99% | 18% - 99% |
| High Alarm Range | 19% - 99% | 19% - 99% |
| Alarm Accuracy | exact to displayed alarm value | exact to displayed alarm value |
| Dimensions | 3.5"[W] x 5.5"[H] x 1.5"[D] [89mm x140mm x 38mm] | 3.6"[W] x 5.4"[H] x 1.5"[D] [89mm x140mm x 38mm] |
| Weight | approximately 0.92 lbs. [417g] | approximately 1.11 lbs. [430g] |
| Cable Length | 10 ft. [3m] | 10 ft. [3m] |
| Diverter Fitting | fits industry standard, 15 mm "T" adapter | fits industry standard, 15 mm "T" adapter |
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Summary of Performance Testing
The Precision Medical, Inc. Oxygen Monitor has successfully pass tests in the following areas:
Mechanical / Climatic
Operating, Temperature, and Humidity range of the PM5900 Oxygen Monitor Precision Medical Test # 699-4
Device Performance: Performance testing, Accuracy: +/- 1% of full scale @ constant temperature and pressure when calibrated at full scale. Precision Medical Test # 699-1
Electromagnetic Emissions & Immunity Tests per IEC 60601-1-2:2004 Performed by Retlif Testing Laboratories for Precision Medical, Inc. Test Report No. R-2915P
Soft ware validation: Following guidance document: General Principles of Software Validation, Final Guidance for Industry and FDA Staff,
Conclusions
In Summary, Precision Medical, Inc. has demonstrated that the Precision Medical, Inc. oxygen Monitor is safe and effective. The combined testing and analysis of results provides assurance that the device meets the specifications and is safe and effective for the intended use.
Risk Analysis
Precision Medical, Inc. is using International Standard ISO 14971 Medical Devices Application of Risk management to medical devices Risk analysis will be completed for this device, before the final release. This document will be updated and released as part of design control.
Design control
Precision Medical, Inc. is in compliance with 21 CFR 820.30 for design control. The design inputs/outputs matrix has been developed using form PMF 202. These documents will be completed before the release of the product.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James Parker Quality Assurance Manager Precision Medical, Incorporated 300 Held Drive Northampton, Pennsylvania 18067
FEB 2 7 2007
Re: K063096
Trade/Device Name: Precision Oxygen Monitor Regulation Number: 21 CFR 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: II Product Code: CCL Dated: January 29, 2007 Received: February 1, 2007
Dear Mr. Parker:
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.
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Page 2 -- Mr. Parker
Please be advised that FDA's issuance of a substantial equivalence determination docs 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clues
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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Indications for Use
510(k) Number : K063096
Device Name: Precision Medical, Inc. Oxygen Monitor
Indications for Use:
The Precision Medical Oxygen Monitor is intended to measure the concentration of oxygen being delivered to the patient. The oxygen monitor is not intended as a life supporting device.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
.
. lll. hhh
K06 3094
§ 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).