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 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.

AI/ML Overview

This document describes the BiPAP Harmony S/T, a non-invasive pressure support ventilator. The submission focuses on demonstrating substantial equivalence to a predicate device through performance testing and compliance with relevant standards, rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the way a diagnostic AI device submission might.

Therefore, many of the requested categories for AI device evaluation are not applicable or cannot be extracted directly from this document.

Here's the information that can be extracted or derived:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific, quantifiable acceptance criteria. Instead, it states:

Acceptance Criteria Category	Reported Device Performance
Overall Safety & Effectiveness	"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."
Compliance with Standards	"The BiPAP Harmony S/T was tested and found compliant (as applicable for Code MNS) with the 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."
Performance Features	The device "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." "Compensates the unit outlet pressure for flow based pressure drops in the patient circuit."
Safety Features	"Provides built-in alarms for high pressure, low pressure, and pressure regulation." "Provides internal circuit monitoring for safety." "Provides an optional oxygen valve that closes, preventing oxygen flow, when the unit is turned off or power fails." "Provides a patient disconnect alarm with a time delay that is set by trained personnel."

2. Sample size used for the test set and the data provenance

This information is not provided. The document refers to "performance-related testing" and "electrical safety, electromagnetic compatibility, mechanical and environmental testing" but does not detail the nature or sample size of these tests in relation to a "test set" of patient data. Given this is a hardware ventilator, "data provenance" in the context of patient data for AI model validation is not relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a ventilator, not an AI diagnostic tool requiring expert ground truth for a test set.

4. Adjudication method for the test set

Not applicable for a hardware device described in this context.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable. This is a hardware device, not an AI assistance system requiring a human-in-the-loop study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is described as an electromechanical device containing no software.

7. The type of ground truth used

Not applicable in the context of clinical "ground truth" for diagnostic or AI performance. The "truth" for this device relates to engineering specifications, physical performance (e.g., pressure delivery, leak compensation), and safety feature functionality, which would be verified through specific engineering and bench testing rather than patient outcome or expert consensus data in the traditional sense of "ground truth" for AI.

8. The sample size for the training set

Not applicable. This device is an electromechanical ventilator with no software; therefore, there is no "training set" in the context of AI or machine learning.

9. How the ground truth for the training set was established

Not applicable for the same reasons as above.

Summary

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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. VanellaManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, 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

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 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 (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801.109)

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

(Division Sign-Off)

Division of Cardiovascular, Respiratory,

510(k) Number K984407

and Neurological Devices

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
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.(b)
Classification. Class II (performance standards).