(108 days)
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No
The description focuses on data collection, display, analysis of trend data, and report generation with user-defined event definitions. There is no mention of AI, ML, or related concepts like training/test sets, which are typical indicators of AI/ML use.
No.
The device is described as "an accessory to two NPB pulse oximeters" and its function is to "collect, edit, and analyze trend data recorded" by these pulse oximeters. It does not provide any treatment or therapeutic intervention.
No
The "Intended Use / Indications for Use" section explicitly states that the software "provides general functions that are not intended to diagnose any specific disease." It serves to collect, edit, and analyze trend data from pulse oximeters, which is supportive information for clinicians but not for direct diagnosis.
Yes
The device is explicitly described as "Score Software" and its function is to collect, edit, analyze, and display data from existing pulse oximeters. It does not include any hardware components itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is an "accessory to two NPB pulse oximeters" and is for "collecting, editing, and analyzing trend data recorded by a Nellcor Symphony™ N-3000 pulse oximeter or a Nellcor Puritan Bennett™ N-200 pulse oximeter." It explicitly states it "provides general functions that are not intended to diagnose any specific disease."
- Device Description: The description focuses on retrieving, displaying, analyzing, and reporting data from pulse oximeters. This is data collected from the patient by the pulse oximeter, not data derived from a sample in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the software processes data from a medical device that measures physiological parameters in vivo (within the body). It does not perform tests on samples in vitro.
N/A
Intended Use / Indications for Use
Score Software is an accessory to two NPB pulse oximeters. It is intended to provide clinicians with the ability to collect, edit, and analyze trend data recorded by a Nellcor Symphony™ N-3000 pulse oximeter or a Nellcor Puritan Bennett™ N-200 pulse oximeter. It provides general functions that are not intended to diagnose any specific disease.
Product codes
74 DQA
Device Description
Score Software retrieves data from certain pulse oximeters such as the Nellcor Puritan Bennett Models N-200 and N-3000, displays recorded data, analyzes the data, and generates a report for the user to review. The report includes both raw wave forms and summary statistics such as number desaturations. The event definitions are defined by the user.
Depending on which pulse oximeter the clinician uses and how the pulse oximeter parameters are set, the Score Software analysis function provides the following results:
- Pulse rate and standard deviation .
- SpO2 analysis and study information
- Alarm and desaturation event log (only N-3000 records alarm data) .
- Pulse search and motion indication (N-3000 only) .
- Percentage of time spent in motion (N-3000 only)
- Percentage of time spent in pulse search (N-3000 only) .
Analysis results are intended to be used within the context of the fully disclosed trend data.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
13.9 Testing was performed to confirm that Score Software is capable of meeting its intended functional requirements. Score Software passed all tests.
13.9 All software was tested in compliance with the Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) review published by the Office of Device Evaluation within the CDRH. Score passed all tests.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
13.0 510(k) Summary
13.1 General Information
Nellcor Puritan Bennett 10200 Valley View Road Eden Prairie, MN 55344
| Submitter's Name: | Chris Hadland |
|---|---|
| Phone: | (612) 941-3006 |
| Fax Number: | (612) 829-5423 |
| Summary Preparation Date: | April 16, 1996 |
13.2 Proprietary Name of the Device
Score Software (Models 4520 and 4530)
13.3 Common Name of the Device
Pulse Oximeter Display Software
13.4 Device Classification
Devices of this generic type have been classified as class II by the Respiratory Devices Panel. Devices of this type have a classification code of 74 DQA, Oximeter (21CFR 870.2700).
13.5 Intended Use
Score Software is an accessory to two NPB pulse oximeters. It is intended to provide clinicians with the ability to collect, edit, and analyze trend data recorded by a Nellcor Symphony™ N-3000 pulse oximeter or a Nellcor Puritan Bennett™ N-200 pulse oximeter. It provides general functions that are not intended to diagnose any specific disease.
13.6 Predicate Device Equivalence
We are claiming substantial equivalence Nellcor P200S Thermal Printer first described in cleared 510(k) K913695
13.7 Device Description
Depending on which pulse oximeter the clinician uses and how the pulse oximeter parameters are set, the Score Software analysis function provides the following results:
1
- Pulse rate and standard deviation .
- . SpO2 analysis and study information
- Alarm and desaturation event log (only N-3000 records alarm data) .
- Pulse search and motion indication (N-3000 only) .
- . Percentage of time spent in motion (N-3000 only)
- Percentage of time spent in pulse search (N-3000 only) .
Analysis results are intended to be used within the context of the fully disclosed trend data.
Score Software retrieves data from certain pulse oximeters such as the Nellcor Puritan Bennett Models N-200 and N-3000, displays recorded data, analyzes the data, and generates a report for the user to review. The report includes both raw wave forms and summary statistics such as number desaturations. The event definitions are defined by the user.
13.8 Comparison of Technologic Characteristics
Score Software produces reports that contain similar information and have a similar report format to the P200S predicate device. Score is different than the P200S Thermal Printer in that the P200S Thermal Printer is a self-contained instrument with intrinsic ability to perform all functions using its internal circuitry, microprocessing power and hardware capability, while Score Software is designed to run on standard IBM compatible computers using a Windows operating system. Score relies upon the computer microprocessor and standard printers driven by Windows print drivers.
13.9 Summary of Performance Testing
- 13.9 Testing was performed to confirm that Score Software is capable of meeting its intended functional requirements. Score Software passed all tests.
- 13.9 All software was tested in compliance with the Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) review published by the Office of Device Evaluation within the CDRH. Score passed all tests.
13.10 Conclusions
We conclude that the Score Software meets its stated performance specifications and criteria outlined in the Reviewers Guidance publication referenced above. We conclude that Score Software will operate safely in its intended environment and be effective in fulfilling its intended use. The safety and effectiveness of Score Software features are as safe and effective as the respective features provided on the predicate device.