SCORE SOFTWARE

K961450 · Nellcor Puritan Bennett, Inc. · DQA · Aug 1, 1996 · Cardiovascular

Device Facts

• Record ID: K961450
• Device Name: SCORE SOFTWARE
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Score Software functions as accessory to Nellcor N-3000 and N-200 pulse oximeters; retrieves recorded trend data from devices. Software runs on IBM-compatible PCs using Windows OS; processes data to generate reports including raw waveforms and summary statistics. Analysis outputs include pulse rate/standard deviation, SpO2 analysis, alarm/desaturation event logs, pulse search/motion indicators, and percentage of time in motion/pulse search. Clinicians review reports to assess patient trends; software does not provide diagnostic conclusions. Intended for clinical use to support data review and analysis.

Clinical Evidence

Bench testing only. Software verified against functional requirements and tested in compliance with FDA Reviewers Guidance for Computer Controlled Medical Devices. No clinical data provided.

Technological Characteristics

Software-based analysis tool for IBM-compatible PCs running Windows. Relies on host computer microprocessor and standard Windows print drivers. Processes data retrieved from Nellcor N-200 and N-3000 pulse oximeters.

Indications for Use

Indicated for clinicians using Nellcor N-3000 or N-200 pulse oximeters to collect, edit, and analyze recorded trend data. No specific patient population or contraindications specified.

Regulatory Classification

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.

Predicate Devices

• Nellcor P200S Thermal Printer (K913695)

Submission Summary (Full Text)

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AUG 1 1996
K961450

## 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: [phone]
Fax Number: [phone]
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:

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- Pulse rate and standard deviation
- $\mathrm{SpO}_2$ 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.

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