(90 days)
Not Found
No
The description mentions a digital signal processor performing filtering, calculations, and noise reduction using existing algorithms, but does not mention AI or ML.
No
The device is a pulse oximeter intended for monitoring functional arterial oxygen saturation and pulse rate, not for providing therapy.
Yes
Explanation: The device provides continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate, which are physiological parameters used to assess a patient's health status, thereby aiding in diagnosis or guiding medical interventions.
No
The device description explicitly states that the Model 2001 Pulse Oximeter "consists of a dual microprocessor based data acquisition system" and mentions "firmware for the primary microprocessor" and "firmware for the second microprocessor". This indicates the presence of hardware components beyond just software.
Based on the provided information, the Model 2001 Pulse Oximeter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the Model 2001 is a non-invasive device that monitors functional arterial oxygen saturation and pulse rate directly from the patient's pulsating vascular bed (finger or toe). It does not analyze samples like blood, urine, or tissue.
- The device description focuses on measuring physiological parameters directly from the patient. It describes the use of light absorption and time between pulses to determine oxygen saturation and pulse rate, which are in-vivo measurements.
Therefore, the Model 2001 Pulse Oximeter falls under the category of in-vivo diagnostic or monitoring devices, not in-vitro diagnostics.
N/A
Intended Use / Indications for Use
The Model 2001 Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units. The Model 2001 Pulse Oximeter and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgement of a physician.
Product codes (comma separated list FDA assigned to the subject device)
74 DQA
Device Description
The Model 2001 Pulse Oximeter is designed for continuous, non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoqlobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as accessories to the Model 520A monitor. The Model 2001 displays digital values of SpO2 and pulse rate as well as a graphic display of the plethysmogram. The Model 2001 monitor consists of a dual microprocessor based data acquisition system that measures oxygen saturation data. The firmware for the primary microprocessor performs the functions of the existing Model 520A including data acquisition, display, trending and communications with external devices. The firmware for the second microprocessor, a digital signal processor, performs the filtering, pulse rate and saturation calculations of the existing algorithms and additional calculations which analyze the incoming signals and perform noise reduction on that signal when the presence of noise is detected. The Model 2001 can be powered by either an internal power supply operating on AC or by a sealed rechargeable lead-acid gel battery. Audible and visual alarms for high/low saturation and pulse rate are available. The Model 2001 also includes a temporary (2 minute) and permanent alarm silence and other configurable settings. The Model 2001 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The Model 2001 Pulse Oximeter has visual indicators for pulse error conditions, power mode (i.e. AC vs. battery) and alarm silence. There is also a serial port that provides user configurable data output capable of communicating with printers and other devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal, pediatric and adult patients
Intended User / Care Setting
trained operators; hospital, hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units.
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)
Inter-device comparison studies and non-invasive controlled hypoxia studies were conducted to establish the Model 2001 accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 2001.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
510(K) Summary
November 17, 1999
-
Applicant's Name and Address a.
Novametrix Medical Systems, Inc. 5 Technology Drive Wallingford, CT 06492 -
b. Contact Person
Robert H. Schiffman, R.A.C. Q.A. and Regulatory Manager (203) 284-2542 (203) 284-0753 (facsimile) -
Name of Device ﻥ ﻧ
Device Names (Proprietary/Trade Names):
Device Name (Common Name):
Classification:
Pulse Oximeter Class II, 21 C.F.R. 870.2700 /74DQA
Model 2001 MARSpO2 Pulse Oximeter
d. Equivalent Devices
Substantial equivalence to the following legally marketed predicate devices with the same or similar indications for use has been demonstrated by a comparison of product features as described in the labeling and promotional literature for predicate devices and for the Model 2001, as well as testing to accepted industry standards. In addition, inter-device comparison studies and non-invasive controlled hypoxia studies were conducted to establish the Model 2001 accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 2001. The predicate devices are as follows:
- Model 520A Pulse Oximeter, Novametrix Medical Systems, Inc., K913516 1.
-
- Model 2000 Pulse Oximeter, Ivy Biomedical Systems, Inc., K982255
- N-395 Pulse Oximeter, Nellcor Puritan Bennett Inc., K991823 3.
Device Description e.
The Model 2001 Pulse Oximeter is designed for continuous, non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoqlobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as accessories to the Model 520A monitor. The Model 2001 displays digital values of SpO2 and pulse rate as well as a graphic display of the plethysmogram. The Model 2001 monitor consists of a dual microprocessor based data acquisition system that measures oxygen saturation data. The firmware for the primary microprocessor performs the functions of the existing Model 520A including data acquisition, display, trending and communications with external devices. The firmware for the second microprocessor, a digital signal processor, performs the filtering, pulse rate and saturation calculations of the existing algorithms and additional calculations which analyze the incoming signals and perform noise reduction on that signal when the presence of noise is detected.
1
The Model 2001 can be powered by either an internal power supply operating on AC or by a sealed rechargeable lead-acid gel battery. Audible and visual alarms for high/low saturation and pulse rate are available. The Model 2001 also includes a temporary (2 minute) and permanent alarm silence and other configurable settings. The Model 2001 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The Model 2001 Pulse Oximeter has visual indicators for pulse error conditions, power mode (i.e. AC vs. battery) and alarm silence. There is also a serial port that provides user configurable data output capable of communicating with printers and other devices.
Intended Use f.
The Model 2001 Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care The Model 2001 Pulse Oximeter and its sensors are intended to be used by units. trained operators when pulse oximetry monitoring is required in the judgement of a physician. The intended use, patient population and environments of use are the same or similar to the predicate devices, the Novametrix Model 520A Pulse Oximeter, Ivy Biomedical Model 2000 Oximeter, and the Nellcor Puritan Bennett N-395 Pulse Oximeter.
Technological Characteristics q.
The Model 2001 Pulse Oximeter measures functional oxygen saturation and pulse rate with sensors that contain red and infrared light sources. Since oxygen saturated blood absorbs different amounts of light at each wavelength (red and infrared) as compared with unsaturated blood, the amount of light absorbed at each wavelength by the blood in each pulse can be used to calculate oxygen saturation. The light energy from red and infrared LEDs is beamed through a sample cell- a pulsating vascular bed, the patient's finger or toe for example. The remaining light energy not absorbed by the sample cell reaches a photodiode, on the opposing side of the sensor. The signal received by the photodiode is split into its red and infrared components, sampled, software filtered, processed using proprietary algorithms and displayed as a numerical value for functional oxygen saturation and as a waveform, the plethysogram.
The Model 2001 uses a similar SpO2 and pulse rate software algorithm to process the information from the sensor as the predicate device, Model 520A Pulse Oximeter, cleared under K913516. In addition, the Model 2001 possesses artifact filtering software that reduces the effects of artifact such as patient/sensor motion. This allows the Model 2001 to provide valid SpO2 and pulse rate readings for increased levels of artifact as compared to previous generations. With this capability the Model 2001 provides a decrease in false/nuisance alarms due to the effect of motion artifact.
h. Certification Statement
In accordance with the requirements of 21 CFR 807.87(i), the following certification is provided:
Novametrix Medical Systems, Inc. believes that all data and information submitted in this premarket notification are truthful and accurate and no material fact has been omitted.
Robert H. Schiffman
Robert H. Schiffman, R.A.C. Q.A. and Regulatory Manager
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right, resembling an abstract bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2000
Mr. Robert H. Schiffman Novametrix Medical Systems, Inc. 5 Technology Drive P.O. Box 690 Wallingford, CT 06492-1926
K993979 Re: Model 2001 MARSpO2 Requlatory Class: II (two) Product Code: 74 DQA Dated: November 17, 1999 Received: November 24, 1999
Dear Mr. Schiffman:
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 A substantially equivalent determination assumes compliance to 895. 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 Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this 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.
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Page 2 - Mr. Robert H. Schiffman
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 requlation (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,
for
Witten, Ph.D., M.D. SECTION N Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K993979 |
|---|---|
| --------------------------- | --------- |
Model 2001 Pulse Oximeter_ Device Name: __
Indications For Use:
The Model 2001 Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate units in neonatal, pediatric and adult patients in hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units. The Model 2001 and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgement of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/4/Picture/6 description: The image shows a black and white abstract drawing. The drawing consists of a series of interconnected lines and shapes, forming a complex and somewhat chaotic pattern. The lines vary in thickness and direction, creating a sense of movement and energy within the composition. There are no recognizable objects or figures within the drawing, making it purely abstract in nature.
Prescription Use_ (Per 21 CFR 801.109)
(Division Sign-Off) (Striaton Sign-OII)
Division of Cardiovascular, Respiratory Over-The-Counter Use_ 510(k) Number_
(Optional Format 1-2-96)