(571 days)
Not Found
No
The description focuses on standard pulse oximetry technology and signal processing, with no mention of AI or ML.
No
This device is an accessory to a monitoring system used for noninvasive, continuous monitoring of oxygen saturation and pulse signals. It provides diagnostic information rather than directly treating or preventing a disease or condition.
Yes
The device is described as continuously monitoring oxygen saturation for the "detection of desaturation due to abnormal pulmonary/circulatory function," which is a diagnostic purpose to identify a medical condition. It's an accessory to a pulse oximeter monitoring system, which itself is a diagnostic tool.
No
The device description explicitly states it is a "Spacelabs Medical Disposable SpO2 sensor" which is a hardware component that converts optical signals into electrical signals. It is an accessory to a pulse oximeter monitoring module, which is also hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "noninvasive, continuous monitoring of oxygen saturation" by detecting desaturation due to abnormal pulmonary/circulatory function. This is a physiological measurement taken directly from the patient's body.
- Device Description: The device is described as an "accessory to a pulse oximeter monitoring module" that "noninvasively acquire SpO2 signals from the patient's fingertip or for the continuous monitoring of pulse saturation signals." It converts "optical signals into electrical signals from common monitoring sites." This is a direct measurement of a physiological parameter.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. This device does not involve the analysis of any bodily specimens outside the body.
The device is a sensor that is applied directly to the patient to measure a physiological parameter (oxygen saturation) in real-time. This falls under the category of physiological monitoring devices, not in vitro diagnostics.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
74DQA
Device Description
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.
Spacelabs Medical intends to sell the Disposable SpO2 Sensor in two basic configurations: (1) sterile and (2) non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, foot
Indicated Patient Age Range
adult, pediatric, infant
Intended User / Care Setting
clinical environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Jaworski
Director of Regulatory Affairs and Quality
Spacelabs Medical Inc.
15220 N.E. 40th Street
Redmond, WA 98073 |
|----|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Telephone:
Facsimile: | (425) 882-3913
(425) 867-3550 |
| 2. | Name of Device: | Spacelabs Medical Disposable SpO2 Sensor |
| | Classification: | Oximeter
74DQA; 21 CFR 870.2700
Class II |
| 3. | Predicate Device(s): | We consider the Spacelabs Medical family of
Disposable SpO2 Sensors to be substantially
equivalent to features offered by currently-marketed
devices with identical intended uses. Specifically,
these sensors are substantially equivalent to
disposable sensors marketed by Nellcor Puritan
Bennett (510(k) reference K915699), Novamterix
(K893643) and Ohmeda (K962127) for monitoring
pulse oxygen saturation. |
| 4. | Device Description: | 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.
1
ട്.
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.
2
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
3
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
4
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