SLEEPWIZARD

K964494 · Nellcor Puritan Bennett, Inc. · MNR · Feb 4, 1997 · Anesthesiology

Device Facts

• Record ID: K964494
• Device Name: SLEEPWIZARD
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: MNR · Anesthesiology
• Decision Date: Feb 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended Use

The SleepWizard is intended for use in collecting, recording and displaying physiological data to be used in diagnosing sleep disorders such as obstructive sleep apnea in patients weighing over 20kg in a clinical or home environment.

Device Story

SleepWizard is a sleep disorders data recorder used in clinical or home settings. It collects physiological signals via patient-attached sensors; signals are amplified to ±3 volts and stored on a Flashcard within a Data Collector. Clinicians set up the system via computer (RS232 or modem connection). Data can be monitored in real-time if modems are used. Post-study, the Flashcard is inserted into a computer for processing, analysis, and printing. The device aids clinicians in diagnosing sleep disorders by providing recorded physiological data for review.

Clinical Evidence

No clinical studies were required. Bench testing confirmed the device meets performance specifications, produces readable output, and complies with FDA reviewer guidance for cardiovascular, respiratory, and neurological devices and computer-controlled medical devices. Verification included connecting the device to a healthy person to ensure signal generation.

Technological Characteristics

Battery-powered sleep disorders data recorder. Includes Data Collector, Extension Box, and sensors. Features RS232 and modem connectivity for computer interface. Optically isolated circuitry. Signals amplified to ±3 volts. Data storage via Flashcard.

Indications for Use

Indicated for patients weighing over 20kg for the collection, recording, and display of physiological data to assist in the diagnosis of sleep disorders, including obstructive sleep apnea.

Regulatory Classification

Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

Predicate Devices

• Nellcor Puritan Bennett SANDMAN (K934599, K943673)

Submission Summary (Full Text)

{0}

NELLCOR PURITAN BENNETT
K964494
Nellcor Puritan Bennett Inc.
10200 Valley View Road
Eden Prairie, MN 55344
612 94 3006
612 929.5423 Fax

FEB - 4 1997

# 510(k) SUMMARY

## NELLCOR PURITAN BENNETT SleepWizard

### November 7, 1996

#### 1.0 Submitter 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: October 25, 1996

#### 2.0 Device Name

Proprietary Name: Nellcor Puritan Bennett SleepWizard
Common Name: Sleep Disorders Data Recorder
Classification Name: MNR, Ventilatory Effort Recorder, per 21 CFR 868.2375

#### 3.0 Predicate Device Equivalence

We are claiming substantial equivalence to the Nellcor Puritan Bennett SANDMAN, cleared for commercial distribution per K934599 and K943673.

#### 4.0 Device Description

The system is set up by the clinician using the computer, which is connected to the Data Collector by a cable connecting to the RS232 port, or by a modem. The computer is optically isolated from the Data Collector by circuitry on the Power Board. The patient is prepared for the sleep study as described in the Clinician's Guide and Patient's Guide (Attachments 1 and 3, respectively). A Ground Electrode is connected to the Data Collector and the patient to ensure that the signals collected all are at the same ground potential. Various sensors are connected to the patient and either directly to the Data Collector or to the Extension Box which in turn is connected to the Data Collector.

{1}

During the study itself, physiologic signals are detected by the sensors. Except for the pulse oximeter, these signals are then amplified by amplifiers. Each amplifier is designed so that it is dedicated to a specific sensor so that all signals are at $\pm 3$ volts after amplification. The signals are then sent to the Data Collector, where they are stored and periodically written on the Flashcard. If the Data Collector and computer are both connected to modems, the clinician can view the data on the computer screen while it is being collected from the patient.

At the conclusion of data collection (i.e., at the end of the sleep study) the Flashcard is removed from the Data Collector and inserted into the computer so that the data may be processed and printed out for analysis purposes.

## 5.0 Intended Use

The SleepWizard is intended for use in collecting, recording and displaying physiological data to be used in diagnosing sleep disorders such as obstructive sleep apnea in patients weighing over $20\mathrm{kg}$ in a clinical or home environment.

## 6.0 Comparison of Technological Characteristics

The device has the same technological characteristics as the predicate device, except that the SleepWizard is battery powered and the SANDMAN is powered by AC Mains. This clearly raises no new concerns regarding safety and effectiveness as both technologies are well understood.

## 7.0 Summary of Performance Testing

7.1 Functional testing was performed to confirm that SleepWizard is capable of meeting its stated performance specifications and that the device output is readable. SleepWizard passed all tests.

7.2 Testing was performed to confirm that SleepWizard complies with the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" published by the Division of Cardiovascular, Respiratory, and Neurological Devices. SleepWizard passed all tests.

7.3 All software was tested in accordance with the August 29, 1991 "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k)Review" published by the Office of Device Evaluation. SleepWizard passed all tests.

7.4 No clinical studies were required to support a substantial equivalence determination, except for connecting the device to a healthy person and running the system to verify that readable, appropriate signals were being generated.

## 8.0 Conclusions

We conclude that the SleepWizard meets its stated performance specifications and criteria outlined in the Reviewers Guidance publications referenced above. We conclude that the SleepWizard will operate safely in its intended environment and be effective in fulfilling its intended use.

TOTAL P.05