PRECISION OXYGEN MONITOR

K063096 · Precision Medical, Inc. · CCL · Feb 27, 2007 · Anesthesiology

Device Facts

• Record ID: K063096
• Device Name: PRECISION OXYGEN MONITOR
• Applicant: Precision Medical, Inc.
• Product Code: CCL · Anesthesiology
• Decision Date: Feb 27, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.1720
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Device monitors oxygen concentration in medical gas mixtures; inputs millivolt signal from galvanic fuel cell sensor proportional to partial pressure of oxygen; monitor converts signal to percent oxygen concentration displayed on LCD screen; used in hospitals/clinical settings by trained healthcare professionals; includes high/low alarm system with visual (flashing red LEDs) and audible alerts; provides continuous monitoring for anesthesia machines, ventilators, and oxygen therapy equipment; aids clinicians in verifying oxygen delivery; not for life support or transport.

Clinical Evidence

Bench testing only. Performance testing verified accuracy of ±1% of full scale at constant temperature and pressure. Electromagnetic emissions and immunity testing performed per IEC 60601-1-2:2004. Software validation conducted per FDA guidance.

Technological Characteristics

Galvanic fuel cell sensor; 4 AA alkaline batteries; LCD display; 10 ft cable; 15 mm 'T' adapter; dimensions 3.6" x 5.4" x 1.5"; weight 430g; operating temperature 10°C - 45°C; humidity 0-95% non-condensing; high/low alarm system; software validation per FDA guidance.

Indications for Use

Indicated for continuous, direct monitoring of oxygen concentration in medical gas mixtures for patients requiring oxygen therapy, anesthesia, or respiratory support (e.g., ventilators, incubators). Not for life support or transport use. For use by trained healthcare professionals under physician supervision.

Regulatory Classification

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.

Predicate Devices

• Cerion Hand Held Oxygen Analyzer (K911344)

Submission Summary (Full Text)

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K063096

# 510(k) Summary

# FEB 27 2007

# Precision Medical, Inc. Oxygen Monitor

## Submitter Information

| Submitter | Precision Medical, Inc.<br>300 Held Drive<br>Northampton, Pa.<br>18067 |
|-----------------------------|------------------------------------------------------------------------|
| Contact | James Parker<br>Quality 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 when<br>calibrated at full scale. | temperature, R.H. and pressure when<br>calibrated at full scale. |
| Total Accuracy | ±3% Actual Oxygen Level over full<br>operating temperature range | ±3% Actual Oxygen Level over full<br>operating temperature range |
| Response Time | 90% of final value in approximately 15<br>seconds at 23°C | 90% of final value in approximately 12<br>seconds at 25°C |
| Warm-up Time | none required | none required |
| Operating<br>Temperature | 15°C - 40°C [59°F - 104°F] | 10°C - 45°C [50°F - 113°F |
| Storage<br>Temperature | -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] |
| Power<br>Requirements | 2, AA Alkaline Batteries<br>[2 x 1.5 Volts] | 4, AA Alkaline Batteries<br>[4 x 1.5 Volts] |
| Battery Life | approximately 3000 hours in typical use | approximately 1500 hours in continuous<br>use. |
| | | Non alarm condition |
| Low Battery<br>Indication | "LOW BAT" icon displayed on screen | "LOW BAT" icon displayed on screen |
| Sensor Type | Maxtec MAX-250E galvanic fuel cell | Precision Medical 504877<br>Galvanic fuel cell |
| Expected Sensor<br>Life | >900,000% O2 Hours | >1,000,000% O2 Hours |
| Alarm System | high/low alarms, flashing red LEDs,<br>audible alarm beeper | high/low alarms, flashing red LEDs,<br>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 x<br>140mm x 38mm] | 3.6"[W] x 5.4"[H] x 1.5"[D] [89mm x<br>140mm 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 [phone]. 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 [phone] or [phone] 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

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K06 3094