SPACELABS MEDICAL DISPOSABLE SP02 SENSOR

K981655 · Spacelabs Medical, Inc. · DQA · Dec 3, 1999 · Cardiovascular

Device Facts

• Record ID: K981655
• Device Name: SPACELABS MEDICAL DISPOSABLE SP02 SENSOR
• Applicant: Spacelabs Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Dec 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Spacelabs Medical Disposable SpO2 Sensor is intended as a disposable, single-patient use accessory to a PCIS system for the acquisition of oxygen saturation signals from adult, pediatric and infant populations. The sensors may be used in a clinical environment where noninvasive monitoring oxygen saturation for the detection of of desaturation due to abnormal pulmonary/circulatory functions is required. Acquired data communicated via a sensor adapter cable to an information network for display recording, editing and analysis.

Device Story

Disposable SpO2 sensor accessory for Spacelabs Medical Patient Care Information System (PCIS). Device converts optical signals from patient's fingertip or foot into electrical signals. Signals transmitted via adapter cable to pulse oximeter monitor. Used in clinical environments by healthcare providers for continuous monitoring of oxygen saturation. Output displayed as numeric values and waveforms on bedside or central monitoring systems; enables alarm generation. Benefits include noninvasive detection of desaturation caused by abnormal pulmonary or circulatory function. Features smaller photo-detector to reduce signal saturation on translucent skin and clear bandage material for site inspection.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Disposable pulse oximetry sensor. Materials include clear bandage material. Sensing principle: photoelectric pulse oximetry. Form factor: sized for adult, pediatric, and infant use on fingertip or foot. Connectivity: wired via adapter cable to PCIS monitoring module. Available in sterile and non-sterile configurations.

Indications for Use

Indicated for noninvasive, continuous monitoring of oxygen saturation to detect desaturation due to abnormal pulmonary/circulatory function in adult, pediatric, and infant populations. Applied to sites including fingertip and foot.

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

• Nellcor Puritan Bennett (K915699)
• Novamterix (K893643)
• Ohmeda (K962127)

Submission Summary (Full Text)

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98 16.55-

DEC - 3 1999

# 510(k) SAFETY AND EFFECTIVENESS SUMMARY

## Spacelabs Medical Disposable SpO2 Sensors

| 1. | Submitter's Name/<br>Contact Person:<br>Company: | Irene Jaworski<br>Director of Regulatory Affairs and Quality<br>Spacelabs Medical Inc.<br>15220 N.E. 40th Street<br>Redmond, WA 98073 |
|----|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Telephone:<br>Facsimile: | [phone]<br>[phone] |
| 2. | Name of Device: | Spacelabs Medical Disposable SpO2 Sensor |
| | Classification: | Oximeter<br>74DQA; 21 CFR 870.2700<br>Class II |
| 3. | Predicate Device(s): | We consider the Spacelabs Medical family of<br>Disposable SpO2 Sensors to be substantially<br>equivalent to features offered by currently-marketed<br>devices with identical intended uses. Specifically,<br>these sensors are substantially equivalent to<br>disposable sensors marketed by Nellcor Puritan<br>Bennett (510(k) reference K915699), Novamterix<br>(K893643) and Ohmeda (K962127) for monitoring<br>pulse oxygen saturation. |
| 4. | Device Description: | As an accessory to a pulse oximeter monitoring<br>module in a Spacelabs Medical Patient Care<br>Information System (PCIS), a Spacelabs Medical<br>Disposable SpO2 sensor provides the means to<br>noninvasively acquire SpO2 signals from the<br>patient's fingertip or for the continuous monitoring<br>of pulse saturation signals. |

The SpO2 sensor converts optical signals into electrical signals from common monitoring sites. The acquired signals are transferred via an adapter cable to a pulse oximeter monitor for subsequent display, review, and editing by the care provider.

Sensors are available for specific monitoring sites, including the fingertip and foot, and are sized to meet various adult, pediatric and infant patient needs.

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The Spacelabs Medical Disposable SpO2 Sensor is Intended Use: intended as a disposable, single-patient use accessory to a PCIS system for the acquisition of oxygen saturation signals from adult, pediatric and infant populations. The sensors may be used in a clinical environment where noninvasive monitoring oxygen saturation for the detection of of desaturation due to abnormal pulmonary/circulatory functions is required. Acquired data communicated via a sensor adapter cable to an information network for display recording, editing and analysis.

> Spacelabs Medical intends to sell the Disposable SpO2 Sensor in two basic configurations: (1) sterile and (2) non-sterile.

Comparison of We consider the family of Spacelabs Medical 6. Technological Disposable SpO2 Sensors to be substantially equivalent to sensors currently marketed by Nellcor Characteristics Puritan Bennett, Novamterix, and Ohmeda.

> The design, materials, methods of skin application, cable connections to a display unit, and SpO2 signal acquisition technology are similar to the predicate sensors. Sensors from all these manufacturers provide the means for interfacing with a patient to acquire SpO2 physiologic data and forwarding it via a sensor cable interface to a monitor for alarm generation and display of numeric values and waveforms on a bedside or central monitoring system.

> The only significant differences between the Spacelabs Medical and the predicate devices are in the design of the photo-detector sensor and the selection of the bandage material in the Spacelabs Spacelabs has selected a Medical sensors. smaller photo-detector to reduce signal saturation on patients with translucent skin. The photodetector on the sensor is slightly raised when positioned on the patient to improve the quality of the signal. The adult and pediatric Spacelabs Medical sensors also incorporate a clear bandage material to facilitate the visual inspection of the sensor site when attached to the patient.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of three thick, curved lines.

:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 1999

Ms. Irene Jaworski Spacelabs Medical, Inc. 15220 N.E. 40th Street P.O. Box 97013 Redmond, WA 98073-9713

Re: K981655 Spacelabs Medical Disposable Pulse Oximeter (SpO2) Sensors Models 703-0002-00, 703-0003-00 and 703-0004-00 Regulatory Class: II (two) Product Code: 74 DQA October 22, 1999 Dated: Received: November 1, 1999

Dear Ms. Irene Jaworski:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this

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Page 2 - Ms. Irene Jaworski

response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

tcammo A Walter-Sh- 65,

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

Page 1 of 1

510(k) Number (if known): K981655

Device Name: Spacelabs Medical Disposable SpO2 Sensors

Indications for Use:

#### Physiological purpose.

An accessory to an SpO2 monitoring system for use in noninvasive, continuous monitoring of oxygen saturation for the detection of desaturation due to abnormal pulmonary/circulatory function in adult, pediatric or infant population by the standard photoelectric pulse of oximetric technique.

## Parts of body applied to:

Sensors are available for common monitoring sites, including the fingertip and foot.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

OR

Over-The-Counter Use __

(Optional Format 1-2-96)

A Westerholm
(Division Sign-Off)

Division of Cardiovascular, Respiratory,
Division of Cardiovascular, Respiratory, and Neurological Devices and Neurological Device 510(k) Number