IM2001 PULSE OXIMETER

K012706 · Imagyn Medical Technologies, Inc. · DQA · Mar 7, 2003 · Cardiovascular

Device Facts

• Record ID: K012706
• Device Name: IM2001 PULSE OXIMETER
• Applicant: Imagyn Medical Technologies, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The IM2001 Pulse Oximeter is indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with pediatric and adult population, in hospitals, hospital-type facilities and intra-hospital transport environment. The IM2001 is intended for prescription use with adult and pediatric patients in hospitals. hospital-type facilities, and intra-hospital transport environments.

Device Story

IM2001 Pulse Oximeter provides continuous, non-invasive monitoring of SpO2 and pulse rate. Device utilizes reflection-based sensing via a forehead-mounted sensor; sensor emits and detects red and infrared light. Signal Processing Unit (microprocessor-controlled console) processes light signals to calculate and display digital SpO2 and pulse rate values. Intended for use in hospitals, hospital-type facilities, and intra-hospital transport environments by clinicians. Provides real-time physiological data to assist healthcare providers in patient monitoring and clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence based on performance testing and validation results.

Technological Characteristics

Reflection-based pulse oximetry sensor; microprocessor-controlled monitoring console; red and infrared light source; digital display of SpO2 and pulse rate; forehead-mounted sensor configuration.

Indications for Use

Indicated for continuous, non-invasive monitoring of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in pediatric and adult patients. For prescription use in hospitals, hospital-type facilities, and intra-hospital transport.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• N-395 Pulse Oximeter (K991823, K993637) with RS-10 sensor (K904039)

Submission Summary (Full Text)

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K012706

#### 510(K) SUMMARY

# IM2001 Pulse Oximeter

MAR 0 7 2003

#### 510(k) Number K012706 (Revised 7-22-02)

E-Mail: [e-mail]

| Applicant's Name: | Cybro Medical Ltd. (Subsidiary of Imagyn, Inc.)<br>Matam, Bldg. 30,<br>Haifa 31905, Israel<br>Tel: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Powell<br>Imagyn Medical Technologies, Inc. |
| | 8850 M-89, P.O. Box 351<br>Richland, MI 49083 |
| | Tel: [phone] |
| | Fax: [phone] |

Trade Name: IM2001 Pulse Oximeter

Classification Name: Oximeter

#### Classification:

The FDA has classified pulse oximeters as class II devices (product code 74DQA, Regulation No. 870.2700) and they are reviewed by the Cardiovascular Panel.

## Predicate Device:

N-395 Pulse Oximeter (Nellcor Puritan Bennett, Inc) cleared under K991823 and K993637 when operates with its RS-10 sensor (Nellcor Puritan Bennett, Inc) cleared under K904039.

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## Intended Use:

The IM2001 Pulse Oximeter is indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with pediatric and adult population, in hospitals, hospital-type facilities and intra-hospital transport environment.

## Device Description:

The IM-2001 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate based on the principal of Reflection. The device consists of a small and light-weight sensor and is intended to monitor arterial SaO2 from the forehead.

IM2001 Pulse Oximeter consists of a sensor that emits and detects red and infrared light, a holder, a connecting cable, and a microprocessorcontrolled monitoring console Signal Processing Unit (monitor). The monitor displays digital values of Sp02 and Pulse Rate.

The IM2001 is intended for prescription use with adult and pediatric patients in hospitals. hospital-type facilities, and intra-hospital transport environments.

## Substantial Equivalence:

Cybro Medical Ltd. believes that, based on calculations, validations, and performance testing results, the IM2001 Pulse Oximeter is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 7 2003

Cybro Medical, Ltd. c/o Ms. Julie Powell Vice President of Quality Assurance and Regulatory Affairs Imagyn Medical Technologies, Inc. 8850 M-89 Box 351 Richland, Michigan 49083-9416

Re: K012706

Trade/Device Name: IM2001 Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: 74 DQA Dated: December 6, 2002 Received: December 9, 2002

Dear Ms. Powell:

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

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Page 2 -- Ms. Julie Powell

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/dsma/dsmamain.html

Sincerely yours,

Susan Runser

Susan Runner, DDS, MA Interim 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 STATEMENT

# 510(k) Number (if known):_)(△l2706

Device Name: IM2001 Pulse Oximeter

#### Indications for Use:

The IM2001 Pulse Oximeter is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with pediatric and adult population, in hospitals, hospital-type facilities and intra-hospital transport environment. For prescription use only.

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KO12706 510(k) Number _

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use_____________

(Division Sign-Off)

OR

510(k) Number: k012706
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