PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE

K040178 · S.P.O. Medical Equipment, Ltd. · DQA · Sep 10, 2004 · Cardiovascular

Device Facts

• Record ID: K040178
• Device Name: PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE
• Applicant: S.P.O. Medical Equipment, Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The SPO PulseOx 5500 Pulse Oximeter is indicated for use for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospitals, medical facilities, home care, transport and sub-acute environments. The SPO PulseOx 7500 Pulse Oximeter, a small, wrist-worn device, is indicated for use in measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It may be used for spot checking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, sub-acute and sleep study environments.

Device Story

PulseOx 5500 (finger) and 7500 (wrist-worn) pulse oximeters; monitor arterial hemoglobin oxygen saturation (SpO2) and pulse rate. Reflective pulse oximetry principle; sensor emits light at visible and infrared wavelengths; measures reflected light intensity changes to calculate oxygen saturation. Components: sensor block, analog block, controller, LCD display, battery. Used by clinicians or patients in hospitals, medical facilities, home care, transport, sub-acute, ambulatory, and sleep study environments. Output displayed on LCD; 7500 model includes data storage. Provides non-invasive monitoring to assist clinical decision-making regarding patient oxygenation status.

Clinical Evidence

Validated via three clinical studies: comparison of PulseOx vs. Masimo/Radical vs. arterial blood sampling; comparison of PulseOx 5500/7500 vs. Masimo/Radical; and comparison of reflectance pulse oximeter accuracy vs. standard pulse oximeter in adults. Meta-analysis performed comparing device performance to blood sampling results; results showed sufficient correlation to gold standard.

Technological Characteristics

Reflective pulse oximetry; visible and infrared light sources. Components: sensor block, analog block, controller, LCD display, battery. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC). Software validation per IEC 60601-1-4 and FDA software guidance.

Indications for Use

Indicated for spot-checking and/or data collection/recording of SpO2 and pulse rate in adult and pediatric patients in clinical, home, transport, ambulatory, and sleep study settings.

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

• Onyx 9700 (Nonin Medical Inc.)
• Pulsox-3 (Minolta, K984570)
• Masimo Radical Pulse Oximeter (Masimo Corp., K992340)
• 3100 WristOx Wrist Pulse Oximeter (Nonin Medical Inc., K030668)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SPO Medical Equipment Limited C/O Ms. Ahava M. Stein Consulting 20 Hata'as Street, Suite 213 44425 Kfar Saba ISRAEL

Re: K040178

Trade/Device Name: PulseOx 7500 WristWatch Device, PulseOx 5500 Finger Device Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 17, 2004 Received: August 23, 2004

Dear Ms. Stein:

This letter corrects our substantially equivalent letter of September 10, 2004.

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 (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 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.

SEP 2 8 2004

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o 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,

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 Statement

510(k) Number (if known): K040178

Device Name:

PulseOx 5500 Finger Device

Indications For Use:

The SPO PulseOx 5500 Pulse Oximeter is indicated for use for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospitals, medical facilities, home care, transport and sub-acute environment.

Com Suom

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K040178

AND/OR

Prescription Use _ V (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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## Indications for Use Statement

510(k) Number (if known): K040178

Device Name:

PulseOx 7500 WristWatch Device

Indications For Use:

The SPO PulseOx 7500 Pulse Oximeter, a small, wrist-worn device, is indicated for use in measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It may be used for spot checking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, sub-acute and sleep study environments.

Cune Suliom

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

K 040 178 510(k) Number:

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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K040178

SEP 1 0 2004

# SECTION 7 - SUMMARY OF SAFETY AND EFFECTIVENESS

### Applicant: 1.

SPO Medical Equipment Ltd. Kfir Barkan Bldg. 3 Hagavish Str. P.O.B. 2454 Kfar Saba 44425 ISRAEL Tel: [phone] Fax: [phone]

### Corresponding Official: 2.

Ahava M. Stein, Consultant A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as Str., Suite 213 44425 Kfar Saba, ISRAEL Tel: [phone] Fax: [phone]

### Device Name and Classification 3.

Pulse Oximeter, CFR classification section 870.2700

#### Device trade or proprietary name: 4.

PulseOx 5500 Finger Device PulseOx 7500 WristWatch Device

#### Common Name: 5.

Pulse Oximeter

#### Classification Name: 6.

CFR classification section 870.2700 and product code DQA, Class II.

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### Description of the Device 7.

The SPO PulseOx pulse oximeter devices monitor the oxygen saturation levels in the blood I no or oximetry, i.e., changes in light intensity as the light is reflected back from human of purse onlinery, now different wavelengths (in the visible and infrared wavelength) are used. Comparisons between the standard signal and the variances can be used to calculate the oxygen saturation of arterial blood. The SPO PulseOx pulse oximeter devices are based the onygon battlizes the reflective method whereby the sensor is located on one side of the relevant body part so as to measure the necessary parameters.

The main components of the SPO pulse oximeter devices are a sensor block, analog block, controller, LCD display and battery.

#### Intended Use: 8.

### PulseOx 5500

The SPO PulseOx 5500 Pulse Oximeter is indicated for use for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospitals, medical facilities, home care, transport and sub-acute environments.

### PulseOx 7500

The SPO PulseOx 7500 Pulse Oximeter, a small, wrist-worn device, is indicated for use is measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It may be used for spot checking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, subacute and sleep study environments.

#### Performance Data: 9.

The following performance tests have been performed on the SPO pulse oximeter devices:

### Bench Studies

Bench studies were performed to verify that the PulseOx devices meet their specifications. Tests results showed that the devices perform within their specification and according to the requirements of FDA Draft Guidance Document of the Non-Invasive Pulse Oximeter.

### Software Validation

Software Validation according to the IEC60601-1-4 standard and the FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices.

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## Electrical Safety and Electromagnetic Compliance

The device was tested according to the following recognized standards:

IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety;

IEC 60601-1-2 Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

Test results showed that the PulseOx device meet the requirements of these standards.

## Environmental Testing

The PulseOx device will undergo environmental and mechanical testing in accordance With FDA Reviewer Guidance for Premarket Notification Submissions; November 1993; With I DA Reviewer Gallanov Tor Free Branch; Division of Cardiovascular, Respiratory and Neurological Devices.

### Clinical Studies

The performance of the PulseOx devices was validated by three clinical studies:

- A comparison of PulseOx, Masimo/Radical and Arterial Blood Sampling. .
- A comparison of PulseOx 5500/7500 models to Masimo/Radical. .
- A comparison of Palse and accuracy of a reflectance pulse oximeter in comparison to . a standard pulse oximeter in adult patients.

In addition, a meta-analysis was performed to compare the performance of the PulseOx m uddition, a mone anding testing results in accordance with FDA Draft Guidance de rices to orood sampling results results show a sufficient correlation to the Gold Standard.

#### Predicate Devices 10.

The PulseOx pulse oximeter devices are substantially equivalent to the combination of the The I dise Oximetry device (manufactured by Nonin Medical Inc., and subject of Onlyx 9700 I also Oximely at 1100 (the PulSox-3 (manufactured by Minolta and the subject of 510(k) document no. K984570), the Masimo Radical Pulse Oximeter (manufactured by Masimo Corp. and the subject of 510(k) document no. K992340) and to the 3100 WristOx Wrist Pulse Oximeter (manufactured by Nonin Medical Inc. and subject of 510(k) document no. K030668).

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### Technological Characteristics Compared to Predicate Device 11.

The technological characteristics, e.g., overall design, materials, mechanism of action, The toolmological enaracteristics, etc., and the intended use of the PulseOx mode of operation, performance entiraly equivalent to the predicate devices cited above as demonstrated in Section 3 of the 510(k) submission.