(571 days)
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.
As an accessory to a pulse oximeter monitoring module in a Spacelabs Medical Patient Care Information System (PCIS), a Spacelabs Medical Disposable SpO2 sensor provides the means to noninvasively acquire SpO2 signals from the patient's fingertip or for the continuous monitoring 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.
I'm sorry, but relevant information is not found in the provided text to generate a response. The document mostly focuses on the regulatory aspects of the device, such as its classification, predicate devices, and FDA approval, rather than detailed performance study data.
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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/Contact Person:Company: | Irene JaworskiDirector of Regulatory Affairs and QualitySpacelabs Medical Inc.15220 N.E. 40th StreetRedmond, WA 98073 |
|---|---|---|
| Telephone:Facsimile: | (425) 882-3913(425) 867-3550 | |
| 2. | Name of Device: | Spacelabs Medical Disposable SpO2 Sensor |
| Classification: | Oximeter74DQA; 21 CFR 870.2700Class II | |
| 3. | Predicate Device(s): | We consider the Spacelabs Medical family ofDisposable SpO2 Sensors to be substantiallyequivalent to features offered by currently-marketeddevices with identical intended uses. Specifically,these sensors are substantially equivalent todisposable sensors marketed by Nellcor PuritanBennett (510(k) reference K915699), Novamterix(K893643) and Ohmeda (K962127) for monitoringpulse oxygen saturation. |
| 4. | Device Description: | As an accessory to a pulse oximeter monitoringmodule in a Spacelabs Medical Patient CareInformation System (PCIS), a Spacelabs MedicalDisposable SpO2 sensor provides the means tononinvasively acquire SpO2 signals from thepatient's fingertip or for the continuous monitoringof 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.
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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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
§ 870.2700 Oximeter.
(a)
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.(b)
Classification. Class II (performance standards).