SUZANNE

K990565 · Nellcor Puritan Bennett, Inc. · MNR · Aug 18, 1999 · Anesthesiology

Device Facts

• Record ID: K990565
• Device Name: SUZANNE
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: MNR · Anesthesiology
• Decision Date: Aug 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nellcor Puritan Bennett Suzanne is intended for use in collecting and recording physiological data to be used in diagnosing sleep disorders. A pediatric through adult patient population is intended for the Suzanne, which can be used in either home or hospital environments.

Device Story

Suzanne is a portable polysomnograph system for sleep disorder diagnosis. It collects physiological inputs including EEG, ECG, pressure, thoracic/abdominal movements, breath detection (thermistor), airflow (pneumotachometer), ambient sound, body position, and ambient light. Signals are captured via headbox amplifiers and stored on a Flash card or transmitted to a computer via serial port. Used in home or clinical settings; operated by clinicians. In home environments, a setup unit verifies system function and timing. In clinical settings, data may be recorded directly to a computer via PC software. Output provides clinicians with physiological data to assist in diagnosing sleep disorders, facilitating patient management.

Clinical Evidence

No clinical studies were required. Bench testing confirmed functional performance specifications and signal readability. Software was validated per 1998 FDA guidance. Verification included connecting the device to a healthy person to confirm appropriate signal generation.

Technological Characteristics

Portable polysomnograph system; internal battery powered. Components include headboxes for signal amplification, Flash card storage, and serial communication port. Captures multi-modal physiological signals (EEG, ECG, respiratory, etc.). Software-based data recording and management. Complies with 1993 draft reviewer guidance for cardiovascular, respiratory, and neurological devices.

Indications for Use

Indicated for pediatric through adult patients requiring physiological data collection for the diagnosis of sleep disorders.

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 SleepWizard

Submission Summary (Full Text)

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AUG 1 8 1999

K990565

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in compliance with the requirements of the Safe Medical Device Act of 1990 and CFR 807.92.

10.0 - Manufacturer Name Nellcor Puritan Bennett (Mallinckrodt, Inc.) 2800 Northwest Blvd. Minneapolis, MN 55441 612-694-3500

#### 11.0 - Proprietary Name of Device

Suzanne

#### 12.0 - Common name of Device

Ventilatory Effort Recorder

#### 13.0 - Device Classification

Devices of this type have been class II by the Anesthesiology Devices Panel. Devices of this type have a classification code of MNR, Ventilatory Effort Recorder (21 CFR 868.2375).

#### 14.0 - Intended Use

The Nellcor Puritan Bennett Suzanne is intended for use in collecting physiological data to be used in diagnosing sleep disorders.

A pediatric through adult patient population is intended for the Suzanne, which can be used in either home or hospital environments.

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#### 15.0 - Device Description

The Suzanne System is composed of a data recorder that contains the electronics and software necessary to capture the physiological information of each sensor and to store this information in a Flash card it to a computer via a serial communication port.

The information that can be recorded by the Suzanne System is :

- · EEG signals
- · ECG signals
- · Pressure signals
- · Thoracic movements
- Abdominal movements .
- · Breath detection (through bucco-nasal thermistor)
- · Flow (through pneumotachometer)
- · Envelope of ambient sound
- · Body position
- · Ambient light detection

The signals are amplified by different amplifiers contained in elements of the system known as headboxes. When used in a home environment, the data is recorded in the flash card and the clinican uses a setup unit to check that the system works correctly and to set the recording starting time.

When used in a clinical environment, the system can be used as described above or data can be recorded to a computer with the use of a PC application software.

The system is powered by an internal battery.

#### 16.0 - Predicate Device Equivalence

The Nellcor Puritan Bennett SleepWizard is the predicate device for the Nellcor Puritan Bennett Suzanne.

#### 17.0 - Performance Testing

performed to confirm that the Suzann is capable of meeting its stated Functional testing v performances specifications and that the device output is readable. The Suzanne System passed all tests.

Testing was performed to confirm that the Suzanne System complies with the November 1993 draft "Reviewer Guidance for Premarket submissions" published by the Division of Cardiovascular, Respiratory, and Neurological Devices. The Suzanne System passed all tests.

All software was tested in accordance with the May 29, 1998 "Guidance for the Content of Picmarket Submissions for Software Contained in Medical Devices" published by the Office Evaluation. The Suzanne System passed all tests.

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 generated.

#### 18.0 - Conclusion

Nelloor Puritan Bennett concludes that the Suzanne meets its stated specifications, operates safely in its intended environment, and is effective in fulfilling its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1999

Mr. Darin L. Busch Requlatory Affairs Project Manager Nellcor Puritan Bennett, Inc. Sleep & Ventilation Division 2800 Northwest Blvd. Minneapolis, MN 55441-2625

Re: K990565 Trade Name: Suzanne Regulatory Class: II Product Code: MNR Dated: June 14, 1999 Received: June 16, 1999

Dear Mr. Busch:

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 reqistration, 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements concerning action. your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation

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Page 2 - Mr. Darin Busch

vou 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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Intended Use

### Device Name :

Suzanne Portable Polysomnograph System

### Intended Use :

The Nellcor Puritan Bennett Suzanne is intended for use in collecting and recording physiological data to be used in diagnosing sleep disorders.

A pediatric through adult patient population is intended for the Suzanne, which can be used in either home or hospital environments.

## Concurence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

510(k) number: K990565

V. Qaytell

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K990565