BIPAP HARMONY S/T, MODEL 1001445

K984407 · Respironics, Inc. · MNS · May 19, 1999 · Anesthesiology

Device Facts

• Record ID: K984407
• Device Name: BIPAP HARMONY S/T, MODEL 1001445
• Applicant: Respironics, Inc.
• Product Code: MNS · Anesthesiology
• Decision Date: May 19, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BiPAP Harmony S/T is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient.

Device Story

BiPAP Harmony S/T is a non-invasive, electromechanical pressure support ventilator for home and institutional use. Device delivers bi-level positive airway pressure to augment patient breathing. Operates in Spontaneous/Timed (S/T) mode; clinician sets IPAP/EPAP, rate, and inspiratory time. System utilizes Respironics Auto-Trak Sensitivity for spontaneous triggering; compensates for circuit leaks and flow-based pressure drops. Provides patient-triggered breaths if rate exceeds setting; machine-triggered, time-cycled breaths if rate falls below setting. Includes alarms for high/low pressure, pressure regulation, and patient disconnect. Intended to maintain airway patency and assist respiration; does not provide total ventilatory requirements. Clinicians configure settings; patients use device for respiratory support.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness verified through performance-related testing, electrical safety, electromagnetic compatibility, mechanical, and environmental testing in accordance with FDA reviewer guidance.

Technological Characteristics

Electromechanical non-invasive pressure support ventilator. Features include Auto-Trak Sensitivity for triggering, leak compensation, and flow-based pressure drop compensation. Includes built-in alarms (high/low pressure, disconnect) and optional oxygen valve. Device is standalone; no software utilized. Intended for adult patients >30kg.

Indications for Use

Indicated for adult patients (>30kg) with acute or chronic respiratory insufficiency or obstructive sleep apnea requiring non-invasive ventilatory support. Not intended for total ventilatory support.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• Respironics Quantum PSV (K962517)

Submission Summary (Full Text)

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## MA

Premarket Notification Section 510(k) Section 1 - Summary of Safety and Effectiveness

# SECTION 1

# EXECUTIVE SUMMARY / SUMMARY OF SAFETY & EFFECTIVENESS

Image /page/0/Picture/5 description: The image shows the logo for Respironics Inc. The logo consists of a triangle with a stylized figure inside, above the text "RESPIRONICS INC." Below the company name is the address "1001 Murry Ridge Drive, Murrysville, PA 156".

1001 Murry Ridge Drive, Murrysville, PA 15668

| Official Contact | David J. Vanella<br>Manager, Regulatory Affairs<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|
| Classification Reference | 21 CFR 868.5895 |
| Common/Usual Name | continuous ventilator, non-life-supporting |
| Proprietary Name | BiPAP Harmony S/T |
| Internal Project Name | Harmony LS |
| Predicate Device | Respironics Quantum PSV (K#962517) |
| Reason for submission | New Device |

# Substantial Equivalence

This premarket notification section 510(k) submission demonstrates that the BiPAP Harmony S/T is substantially equivalent to, and has the same intended use as, the Respironics Quantum PSV.

Testing was performed to demonstrate that the performance of the BiPAP Harmony S/T in its intended environment is as safe and effective as that of the legally marketed predicate device. The safety and effectiveness of BiPAP Harmony S/T were verified through performance-related testing in addition to electrical safety, electromagnetic compatibility, mechanical and environmental testing. The BiPAP Harmony S/T was tested and found compliant (as applicable for Code MNS) with the

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standards referenced in the "Draft FDA Reviewer Guidance for Ventilators," July 1995 as well as with the "Draft Reviewer Guidance for Premarket Notifications, "November 1993.

## Intended Use/Indications for Use

The BiPAP Harmony S/T is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea.

It is not intended to provide the total ventilatory requirements of the patient.

## Environment of Use/Patient Population

The BiPAP Harmony S/T is intended predominantly for use in the home, but may also be used in the hospital or other institutional settings.

The BiPAP Harmony S/T is intended for adult patients (>30kg).

# Brief Device Description

The BiPAP Harmony S/T is a noninvasive pressure support ventilator and is classified under product code MNS (ventilator, continuous, non-life supporting). It is an electromechanical device and contains no software.

The BiPAP Harmony S/T ventilator provides therapy in a Spontaneous/Timed (S/T) mode. A clinician sets IPAP/EPAP, Rate and Inspiratory Time.

. The device delivers patient triggered, pressure limited, patient cycled breaths if the patient's breathing rate is above the rate setting.

. The device delivers machine triggered, pressure limited, time cycled breaths if the patient's breathing rate falls below the rate setting. The inspiratory time setting controls the duration of the inspiratory phase. The inspiratory time setting does not affect the cycling of a spontaneous breath.

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## Features

#### PERFORMANCE

- Provides non-invasive application of bi-level and continuous positive airway pressure I support ventilation.
- Provides spontaneous triggering based on the Respironics Auto-Trak™ Sensitivity system. ■
- Compensates for most leaks in the patient circuit and patient interface. ■
- 발 Compensates the unit outlet pressure for flow based pressure drops in the patient circuit.

#### SAFETY

- Provides built-in alarms for high pressure, low pressure, and pressure regulation. 트
- Provides internal circuit monitoring for safety. 트
- Provides an optional oxygen valve that closes, preventing oxygen flow, when the unit is ■ turned off or power fails.
- 프 Provides a patient disconnect alarm with a time delay that is set by trained personnel.

Figure 1 shows the BiPAP Harmony S/T system, which includes:

- BiPAP Harmony S/T unit
- Circuit tubing I
- Patient interface I
- l Exhalation port

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Image /page/3/Figure/2 description: This image shows a BiPAP Harmony S/T device with its various components labeled. The device includes user controls, prescription controls, and a pressure display. The device is connected to a circuit tubing, which leads to an exhalation port and a patient interface. The image also indicates the presence of an optional bacteria filter and oxygen valve.

Figure 1. BiPAP Harmony S/T System.

# BiPAP Harmony S/T Accessories

The BiPAP Harmony S/T can be used with various combinations of Respironics-approved patient circuit accessories, such as patient interface devices (masks and headgear assemblies), humidifier, and circuit tubing.

(End of Section.)

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Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 19 1999

Mr. David J. Vanella Manager, Regulatory Affairs RESPIRONICS®, Inc. 1001 Murry Ridge Dr. Murrysville, PA 15668

Re: K984407 BiPAP Harmony S/T, Model 1001445 Trade Name: Regulatory Class: II Product Code: MNS Dated: February 23, 1999 February 25, 1999 Received:

Dear Mr. Vanella:

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 registration, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices

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Page 2 – Mr. David J. Vanella

under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 regulation (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 [phone]. Also, please note the regulation entitled, "Misbranding by 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. Callahon

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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Page 1 of 1

510(k) Number (if known): _K904407

Device Name: BiPAP Harmony S/T

#### Intended Use/Indications for Use

The BiPAP Harmony S/T is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient.

#### Environment of Use/Patient Population

The BiPAP Harmony S/T is intended predominantly for use in the home, but may also be used in the hospital or other institutional settings.

The BiPAP Harmony S/T is intended for adult patients (>30 kg).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">X</span> |
|----------------------|---------------------------------------------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |

(Division Sign-Off)

Division of Cardiovascular, Respiratory,

510(k) Number K984407

and Neurological Devices