(567 days)
No
The description focuses on data transfer, storage, display, annotation, statistics, and printing, with no mention of AI or ML terms or functionalities.
No
The device is described as software that processes and displays data from a pulse oximeter, not directly providing therapy itself. Its intended use is as "an adjunct to traditional Pulse Oximetry" for observation and trend analysis, not for therapeutic intervention.
No
The device is described as software that assists in observing and managing data from traditional pulse oximetry, rather than directly diagnosing conditions itself. It provides data analysis and statistics for review by a caregiver, but does not offer a diagnosis.
Yes
The device description explicitly states that SatMaster is a "software-only 'device'" and lists only software components (Program Diskette, Software License, User Manual) and a Test Cable, which is likely for data transfer and not a core hardware component of the device itself. It relies on an end-user provided computer and a separate Pulse Oximeter.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SatMaster's Function: SatMaster is a software product that processes and displays data from a Pulse Oximeter. A Pulse Oximeter is a non-invasive device that measures oxygen saturation in the blood and pulse rate in vivo (within the living body).
- No Sample Analysis: SatMaster does not analyze biological samples taken from the patient. It works with data already generated by a separate medical device (the Pulse Oximeter) that performs the in vivo measurement.
Therefore, SatMaster falls under the category of a medical device, but specifically one that processes and manages data from another medical device, rather than performing an in vitro diagnostic test itself.
N/A
Intended Use / Indications for Use
Sathlaster is intended for use an adjunct to traditional Pulse Oximetry, in which the caregiver observes instantaneous Pulse Oximetry values as displayed on a Pulse Oximeter's face. SatMaster produces graphs and statistics describing a patient's Pulse Oximerry data trends over relatively long periods of time, including those times when the caregiver is not directly observing the Pulse Oximeter's display.
In a hospital setting. SalMaster would be used in association with ICU's. Operating and Recovery Rooms, Pulmonary Function Labs, Sleep Labs, and research.
In home-care settings. SatMaster would be used for sleep studies and home-oxygen evaluations.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
SatMaster is the name of EMG Scientific's Computerized Pulse Oximetry Software product. This product consists of a Program Diskette, a Software License, a User Manual, and a Test Cable. Thus, SatMaster is a software-only "device," intended for use with an MS-DOS, PC-type computer provided by the end-user.
Briefly, the SatMaster software provides a PC computer user the capability of transferring Pulse Oximetry data from a Pulse Oximeter, storing the data on the computer, displaying the data in various forms, annotating the data, calculating statistics, and printing the results.
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
Not Found
Intended User / Care Setting
Caregiver in hospital (ICU's, Operating and Recovery Rooms, Pulmonary Function Labs, Sleep Labs, and research) or home-care settings.
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)
The SatMaster software has been designed and extensively tested to insure the correctness and accuracy of SatMaster's data retrieval, data management, data storage, statistical calculations, and reports.
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.
Nellcor N-250 Pulse Oximeter (K863784, K901399)
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.
Nellcor N-200 Pulse Oximeter (K863784), Nellcor Symphony N-3000 Pulse Oximeter (K942347), Ohmeda Biox 3700 Pulse Oximeter (K850494), Ohmeda Biox 3740 Pulse Oximeter (K872772)
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).
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Image /page/0/Picture/0 description: The image shows handwritten text that appears to be a date and a series of numbers. The date reads "Dec. 4, 1796". Below the date, there is a sequence of numbers that reads "K952315".
Innovators of medical software solutions
Image /page/0/Picture/2 description: The image shows the word "SCIENTIFIC" in bold, black letters. The word is partially obscured by a black graphic to the left. The font is sans-serif and appears to be italicized.
1461 S. Livonia Avenue Los Angeles, California 90035-3317 FAX 310-551.1182 310-551.1181 shmuel@einstein.com Internet email:
510(k) Summary
| Contact Person | Shmuel Einstein |
|---|---|
| Date | August 5, 1996 |
| Device Name | "SatMaster," Computerized Pulse Oximetry Software |
| 510(k) File Number | K952315 |
The Device 1.
SatMaster is the name of EMG Scientific's Computerized Pulse Oximetry Software product. This product consists of a Program Diskette, a Software License, a User Manual, and a Test Cable. Thus, SatMaster is a software-only "device," intended for use with an MS-DOS, PC-type computer provided by the end-user.
Briefly, the SatMaster software provides a PC computer user the capability of transferring Pulse Oximetry data from a Pulse Oximeter, storing the data on the computer, displaying the data in various forms, annotating the data, calculating statistics, and printing the results.
Sathlaster has been in use outside the US for over 5 years. Prominent foreign users include the Queen Mary Hospital at the University of Hong Kong, Osaka Medical & Health Center for Mothers & Children, Adelaide Children's Hospital, Royal University Hospital, National University of Singapore, Helsingborgs Lasarett (Sweden), Royal Brisbanc Hospital (Australia), University of Malaysia -Department of Anaesthesiology, Universitair Zickenhuis Antwerpen, University of Calgary, Forschungsinstitut fur klinische Medizintchnik (Germany), Broadgreen Hospital NHS Trust (United Kingdom).
2. An Accessory
SatMaster is designed to be an accessory to enhance a caregiver's use of Pulse Oximeters. Pulse Oximeters, approved. Class II devices manufactured by several companies, are used to measure a patient's Oxygen Saturation (SaO2) and Pulse Rate. The current values of these clinical parameters are displayed on the Pulse Oximeter's front pancl. Many Pulse Oximeters contain a memory to store numerous hours of oximetry trend data.
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August 5, 1996
Likewise, many Pulse Oximeters contain a Scrial Communications Port, so that the Pulse Oximeter may transfer data to a computer, a printer, or some other device. SatMaster would only be useful in conjunction with an oximeter having a Serial Communications Port, since SatMaster receives data from the Pulse Oximeter via a connection between the computer and the Pulse Oximeter's Serial Communications Port.
Some Pulse Oximeter's can be connected to various types of printing devices. These Pulse Oximeters, when connected to a printer, can produce graphs of SaO2 vs. time, histograms, and certain statistics.
Here is a list of the Pulse Oximeters that SatMaster has been designed to work with:
| Manufacturer | Model | Stock Number | Clearance Date |
|---|---|---|---|
| Nellcor | N-200 Pulse Oximeter | K863784 | 21 November 1986 |
| Nellcor | Symphony N-3000 Pulse Oximeter | K942347 | 12 May 1995 |
| Ohmeda | Biox 3700 Pulse Oximeter | K850494 | 28 March 1985 |
| Ohmeda | Biox 3740 Pulse Oximeter | K872772 | 7 October 1987 |
The Predicate Device 3.
The Predicate Device that SatMaster resembles is a Nelloor N-250 Pulse Oximeter. The Nellcor N-250 Pulse Oximeter is actually a composite device obtained by connecting a Nellcor N-200 Pulse Oximeter to the Nellcor N-50 Powerbase. The combination of these two devices is known as the N-250 Pulse Oximeter.
The FDA 510(k) clearances for these two Nelloor products are:
| Nellcor N-200 Pulse Oximeter | K863784 (21 November 1986) |
|---|---|
| Nellcor N-50 Powerbase | K901399 (12 June 1990) |
The features of these two devices that arc relevant to this discussion are as follows. The Nellcor N-200 Pulse Oximeter performs Pulse Oximetry monitoring on the patient, displays instantaneous values of the SaO2 and Pulse Rate, and stores the Pulse Oximetry data in its trend memory at 5 second intervals. The N-200 also produces audible alarms for conditions such as high and low SaO2, high and low Pulse Rate, etc.
2
Trend (see Figure 12), shows SaOt levels
The Nellcor N-50 Powerbase contains an LCD scroen, and a strip-chart printer. The unit can access the connected Nellcor N-200's trend memory and display a graph of SaO2 vs. time on the LCD screen. Using the N-50's built-in printer, the following graphs and statistics can be output:
- Trend Graph of SaO2 and Pulse Rate vs. time 1.
- A histogram showing percent of time at various SaO2 levels 2.
- A Tabular list of SaO2 values at 30 second intervals 3.
Here is an example of the graphs and statistics produced by the Nellcor N-50:
Tabular printout (see Figure 11) provides a histogram for SaO2 and other tabular data for saturation and out
Image /page/2/Figure/8 description: The image shows a series of six different charts or diagrams, labeled 62 through 67. The first few charts, 62 through 66, appear to be some sort of data representation, possibly related to signal processing or data analysis. The last chart, 67, is a bar graph with values on the x-axis ranging from 70 to 100, and the y-axis labeled as 'STREK'.
Flours 11: N-90 Tabular Printout Ex
Image /page/2/Figure/10 description: The image shows a medical chart with the word "NELLCOR" vertically oriented on the left side. The chart includes numerical data, such as 68, 69, and 70, along with labels like "11/29", "100K", "50K", "RATE", and "00:59". The chart also contains a series of horizontal lines and vertical dotted lines, suggesting a graphical representation of patient data or monitoring information.
n (see Figure 13), shows a maximum of 12 hours of trend data
Image /page/2/Figure/13 description: The image shows two separate figures. The figure on the left has the word "NELLCOR" written vertically. The figure on the right is a bar graph that shows the percentage of time spent in a given range. The x-axis ranges from 70 to 100, and the y-axis ranges from 0 to 100k.
Image /page/2/Figure/14 description: The image contains text that appears to be from the Nello N-500 Operators Manual. The text indicates that the content is reproduced with permission from Nello. The text is in a dark font and is set against a light background, making it readable. The overall layout suggests it may be a header or source attribution for a document or excerpt.
Figure 13: N-50 Histogram Printout Ex
4. SatMaster's Equivalence to Predicate Device
SatMaster is substantially equivalent to the Predicate Device in the following areas:
- The ability to extract Pulse Oximetry data from a Pulse Oximeter and to display Pulse Oximetry 1. trend information on the screen and in printed reports
- The ability to produce a tabular list of Pulse Oximetry data values at various time intervals 2.
- The ability to generate histograms showing percent of time at various SaO2 levels 3.
SatMaster is not intended to be a patient monitor. Therefore. SatMaster does not perform the functions of the Nellcor N-200 Pulse Oximeter. Rather, a computer running the SatMaster software performs some of the same functions a Nellcor N-50 Powerbase. Thus, a computer running the SatMaster software. when used with a Pulse Oximeter, provides some of the capabilities of the Nellcor N-250.
5. Differences between SatMaster and the Predicate Device
Although SatMaster is substantially equivalent to the Predicate Device, certain important differences should be noted:
-
- Whereas the N-250 combination serves as a patient oxygenation monitor, SatMaster performs no monitoring of the patient. Rather, SatMaster presents the user with reports based on the data
3leo
- Whereas the N-250 combination serves as a patient oxygenation monitor, SatMaster performs no monitoring of the patient. Rather, SatMaster presents the user with reports based on the data
3
that has been collected by the Pulse Oximeter, which is, of course, an approved monitoring device. Thus, by design, SatMaster does not perform the functions of the Nellcor N-200 Pulse Oximeter.
- Since SatMaster is not intended to be a patient monitor, SatMaster has no provisions for 2. reporting of the Pulse Oximeter's alarms.
- Although the Nellcor N-250 can be connected to an external ECG synchronization source, 3. SatMaster does not produce an ECG or Pleth waveform output, as the N-250 does.
- The Nellcor N-50 Powerbase acts as a dock into which the Nellcor N-200 Pulse Oximeter is 4. inserted. The N-50 provides electrical power to the Nellcor N-200 Pulse oximeter. Likewise, several connectors are present in the N-50 to allow connection of the composite N-250 device to a variety of external devices.
Since SatMaster is a software system, SatMaster does not provide the Pulse Oximeter with electrical power, nor does it provide the Pulse Oximeter with any connections to external devices. Rather, the user's computer is connected to the Pulse Oximeter's Serial Data Port via a simple RS-232 cable.
- SatMaster gencrates additional reports not provided by the N-250. Morcover, SatMaster-5. generated versions of the N-250's reports contain various enhancements.
- SatMaster performs various data-management functions to aid in storing and organizing the 6. Pulse Oximetry data that has been obtained from the Pulse Oximeter. These-data management functions are designed to be easy for the user to use, and at the same time to increase patient safety.
6. Intended Use of SatMaster
Sathlaster is intended for use an adjunct to traditional Pulse Oximetry, in which the caregiver observes instantaneous Pulse Oximetry values as displayed on a Pulse Oximeter's face. SatMaster produces graphs and statistics describing a patient's Pulse Oximerry data trends over relatively long periods of time, including those times when the caregiver is not directly observing the Pulse Oximeter's display.
In a hospital setting. SalMaster would be used in association with ICU's. Operating and Recovery Rooms, Pulmonary Function Labs, Sleep Labs, and research.
In home-care settings. SatMaster would be used for sleep studies and home-oxygen evaluations.
It is expected that the Pulse Oximeter itself will be operated by competent personnel in accordance with the Pulse Oximcter manufacturer's FDA-approved instructions.
Once the patient monitoring process is complete, cither in the hospital or home setting, the Pulse Oximeter unit would normally be brought to the office where the computer resides. (Alternatively, a portable computer would be brought to the Pulse Oximeter.) After connecting the serial oximeter tocomputer data cable and invoking the SatMaster software, the accumulated Pulse Oximetry data would be transferred from the Pulse Oximeter to the computer. Once the data transfer is complete, it is no longer necessary for the computer to be connected to the Pulse Oximeter. The caregiver may now view the Pulse Oximetry data and statistics on the computer screen, annotate the data, and print various reports.
7. Safety and Effectiveness of SatMaster Compared to the Predicate Device
As noted above, SatMaster is not a patient monitor Rather, SatMaster is intended to be an Accessory to the use of Pulse Oximeters. It is expected that the Pulse Oximeter itself will be operated by competent personnel in accordance with the Pulse Oximeter manufacturer's FDA-approved instructions.
4
The safe and effective monitoring of a patient by a Pulse Oximeter while connected to an external device, such as a computer running SatMaster, is a documented feature of an approved Pulse Oximeter. Thus, the Pulse Oximeter-to-patient connection, and the Pulse Oximetry monitoring process, is unaffected by whether will be used to display or calculate statistics on the data. Therefore, using SatMaster should have no impact on the safety of the Pulse Oximetry monitoring process
The SatMaster software has been designed and extensively tested to insure the correctness and accuracy of SatMaster's data retrieval, data management, data storage, statistical calculations, and reports.
As mentioned above, certain features of SatMaster represent enhancements of safety and effectiveness when compared with the predicate device. For example, a strip chart generated by the predicate device does not bear the patient's name or ID number; the possibility exists that it could be mixed up with that of another patient. When using SatMaster, however, before any oximetry data is transferred to the computer, the operator must enter the patient's name and ID number into SatMaster's Patient Data Management facility. This identification information is then prominently shown on every subsequent screen and report.
Another example: the extensive reports and statistics generated by SatMaster can provide additional information to the caregiver over that produced by the predicate device.
SatMaster serves to cnhance the usage of Pulse Oximcers. Provided that a Pulse Oximeter is operated in accordance with the Pulse Oximeter's Manufacturer's instructions, SatMaster reports and statistics provide a convenient "bicture" of the data collected by Pulse Oximeters. In the opinion of a number of researchers, SatMaster's functionality may have clinical value in several areas, as can be seen from the following list of published articles describing research performed using SatMaster:
Durand M. McEvoy C. MacDonald K. Spontaneous desaturations in intubated very low birth weight infants (