The BiPAP S/T-D System is intended for hospital or institutional use for treatment of obstructive sleep apnea, respiratory failure, or respiratory insufficiency.

Device Description

The BiPAP S/T-D System is a ventilation support system designed to augment a patient's ability to breathe on a spontaneous basis. It is not intended for life support situations. The BiPAP S/T-D System is intended for hospital or institutional use for treatment of obstructive sleep apnea, respiratory failure, or respiratory insufficiency. The BiPAP S/T- D offers four modes of operation: Continuous Positive Airway Pressure (CPAP), Spontaneous (S) mode, Spontaneous/Timed (S/T) mode, and Timed (T) mode. The BiPAP S/T-D System provides ventilation support by applying a positive pressure (IPAP) during the inspiratory seqment of a breathing cycle, and subsequently cycling to a lower pressure level (EPAP) during the expiratory seqment of the cycle for spontaneous breaths. The transition point between inspiration and expiration is sensed by the BiPAP S/T-D System as a function of a decrease in patient flow demand. The BiPAP S/T-D System also senses the transition point between expiration and inspiration. As the patient begins to inhale, the BiPAP S/T-D System senses the increase and transitions from EPAP to IPAP. These points are called the trigger thresholds. The BiPAP S/T-D System has the capability of monitoring delivered pressure and adjusting flow as applied to the patient circuit to maintain set IPAP and EPAP pressures. The System is also capable of compensating for air leakage around the patient interface.

AI/ML Overview

The provided text describes the BiPAP S/T-D System, a ventilation support system. Here's a breakdown of the acceptance criteria and the studies conducted to demonstrate its performance:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Specification)	Reported Device Performance	Environmental Conditions
Pressure Regulation/Flow Levels	+0.8, -1.5 cm H2O above setpoint over flow rates of -60 to 100 LPM	Nominal 115 VAC, 132 VAC, 100 VAC, 72-75°F Nominal, 105°F High
Control Accuracy, IPAP and EPAP Settings	±2 cm H2O of setting in the range of 4 to 20 cm H2O	Nominal temperature and input voltage
Control Setting Accuracy, Breaths Per Minute (BPM)	±2 BPM over range of 4 to 30 BPM, or ±10% of setpoint, whichever is greater	Nominal temperature and input voltage
Control Setting Accuracy %IPAP	±10% of setpoint measured at 90% and 10% IPAP settings	Nominal temperature and input voltage

Additional Safety and Environmental Criteria:

The device also met various national and international standards for electrical safety, electromagnetic compatibility, shock, and vibration:

Canadian Standards Association (CSA) C22.2 125
UL544 Medical and Dental Equipment Standards
German Postal Law Requirements for Conducted and Radiated Emissions per VFG 234/1991
IEC 68-2-6 (sinusoidal vibration), IEC 68-2-27 Shock, and IEC 68-34 Random Wide Band Vibration
Shock and vibration for the final packaged configuration per National Safe Transit Association Test Labs
Electromagnetic compatibility testing to IEC 601-1-2 (including IEC 801-1, -2, -3 and CISPIR 14)
MIL-STD-461D and MIL-STD-462D for magnetic field susceptibility
FCC Class B, Part 15.J Emissions

2. Sample Size Used for the Test Set and Data Provenance:

Test Set (Clinical Data):
- Prospective, Randomized, Controlled Clinical Studies: 31 adult patients with acute respiratory failure.
- Prospective, Non-Randomized Studies: 81 patients.
Data Provenance: The document does not explicitly state the country of origin for the clinical data. It describes them as "clinical studies" without further geographical details. The studies were prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not provided in the document. The text refers to "clinical data" and "statistical basis" but does not detail how the outcome measures (e.g., intubation avoidance) were assessed or validated by specific medical experts for the studies.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. The BiPAP S/T-D System is described as a medical device for ventilation support, not an AI-powered diagnostic or assistive tool that would involve human "readers" interpreting output.

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

Yes, a form of standalone performance assessment was done. The "technical data presented" and "functional testing" against published specifications (pressure regulation, control accuracy, etc.) represent the device's standalone performance. The device's ability to maintain set pressures and respond to patient flow patterns is a function of its internal design and algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the technical specifications (pressure, flow, accuracy), the "ground truth" would be established by precise measurement instruments and calibrated standards.
For the clinical studies, the primary outcome measure was whether the BiPAP System could "successfully avoid the need for intubation." This would fall under outcomes data.

8. The sample size for the training set:

The document describes a medical device, not a machine learning model. Therefore, there is no concept of a "training set" in the context of this submission. The device's operational parameters and algorithms are based on engineering design and physiological principles, not on data training in the AI sense.

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

As there is no "training set" for an AI model in this context, this question is not applicable. The device's design and functionality are based on established engineering and medical principles for ventilator operation.

Summary

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K95/264

Premarket Notification, Part A Section 16, 510(k) Summary

BiPAP S/T-D System

JUL 2 9 1996

Section 16 - 510(k) Summary

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, and the text "RESPIRONICS INC." below it. Underneath the company name is the address "1001 Murry Ridge Drive, Murrysville, PA 15668".

Date:
July 22, 1996
Respironics Inc. Manufacturer: 1001 Murry Ridge Drive Murrysville, PA 15668 Phone: (412) 733-0200
Francis X. Dobscha Official Contact: Manager, Regulatory Affairs
BiPAP® S/T-D Device Name: Continuous Ventilator, Passive Common Name: Exhalation Port, Critical Care

Classification: 868.5895

BiPAP® (K883825) Predicate Device:
Detachable Control Panel (K905540)

Siemens Servo 900 (K81102)

Puritan Bennett 7200 (K823958/B and K833786)

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Description of the BiPAP S/T-D System

The BiPAP S/T- D offers four modes of operation:

· Continuous Positive Airway Pressure (CPAP)
· Spontaneous (S) mode. The unit cycles between Inspiratory Positive Airway Pressure (IPAP) and Expiratory Positive Airway Pressure (EPAP) in response to the patient rate. The difference between IPAP and EPAP is the delivered pressure support level.
Spontaneous/Timed (S/T) mode. The unit cycles between Inspiratory Positive Airway Pressure (IPAP) and Expiratory Positive Airway Pressure (EPAP) in response to the patient rate. The difference between IPAP and EPAP is the delivered pressure support level.
· Timed (T) mode. The unit cycles between Inspiratory Positive Airway Pressure (IPAP) and Expiratory Positive Airway Pressure (EPAP) levels based solely on set breaths per minute (BPM) and %IPAP Time Controls.

The BiPAP S/T-D System provides ventilation support by applying a positive pressure (IPAP) during the inspiratory seqment of a breathing cycle, and subsequently cycling to a lower pressure level (EPAP) during the expiratory seqment of the cycle for spontaneous breaths. The transition point between inspiration and expiration is sensed by the BiPAP S/T-D System as a function of a decrease in patient flow demand. The BiPAP S/T-D System also senses the transition point between expiration and inspiration. As the patient begins to inhale, the BiPAP S/T-D System senses the increase and transitions from EPAP to IPAP. These points are called the trigger thresholds.

Levels of IPAP and EPAP can be adjusted by the clinician for individual patient requirements. The IPAP control setting is prohibited from being greater than EPAP by design of the control system. IPAP settings are always set equal to or greater than EPAP. By setting IPAP and EPAP levels the same, CPAP therapy is applied. If the EPAP level is set greater than the ambient atmospheric pressure (greater than 0), then a level of positive end expiratory pressure (PEEP) is applied to the patient's airway. The BiPAP S/T-D System is a prescription device. IPAP and EPAP levels are determined by a physician or by a clinician under the direction of a physician.

The BiPAP S/T-D System has the capability of monitoring delivered pressure and adjusting flow as applied to the patient circuit to maintain set IPAP and EPAP pressures. The System is also capable of compensating for air

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leakage around the patient interface. Patient interfaces include nasal masks, full face masks covering both the mouth and nose, and a mouthpiece that is used to apply pressures orally.

Each patient interface system uses an exhalation leak to direct the patient's exhaled gasses to the atmosphere. This leak is incorporated either as an accessory valve or bleed port.

Intended Uses of the BiPAP S/T-D System

The BiPAP S/T-D System is intended for hospital or institutional use for treatment of obstructive sleep apnea, respiratory failure, or respiratory insufficiency.

The BiPAP S/T-D System can be used to administer oxygen by using an external oxygen tank and bleeding oxygen into the patient circuit. This therapy is not metered or otherwise requlated. Patient monitoring must be performed to ensure effective administration of oxygen therapy.

The BiPAP S/T-D System is similar to the BiPAP described in K883825, and other continuous ventilators, such as the Siemens Servo 900 and the Puritan Bennett 7200. However, there are specific differences between the BiPAP S/T-D and these traditional life-support ventilators as noted below.

Comparison of the BiPAP to Predicate Devices

The maior technical difference between the BiPAP S/T-D System and most continuous ventilators is in the technical approach used to achieve patient support ventilation.

The BiPAP S/T-D System has a self-contained, internal blower assembly to generate airway pressure. Most comparable predicate devices utilize an external pressure source.

The BiPAP S/T-D System is an electromechanically controlled system that controls the pressure applied to the patient based on patient demand, while the flow is adjusted to maintain a set inspiratory and expiratory pressure. Changes between inspiratory phases and expiratory phases are determined by changes in patient flow patterns.

The BiPAP S/T-D System has an electronic mechanism for compensating for leaks around the patient's mask or in the patient circuit supplying positive pressure to the patient. The pressure supplied by the BiPAP S/T-D System is constant within +0.8 to -1.5 cm H2O in the flow ranges of -60 to 100 Liters per Minute (LPM). (The -60 LPM designation represents patient exhalation into the BiPAP S/T-D patient circuit.) Most comparable continuous ventilators require a

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manual operator adjustment to the flow rate control to compensate for leaks in the masks and other areas of the patient circuit.

There are differences in operational characteristics between the BiPAP S/T-D system and predicate devices that are fully compliant with ASTM F 1100-90. the voluntary standard for critical care ventilators:

The BiPAP S/T-D System provides continuous positive airway pressure . (CPAP) and positive pressure ventilation and is indicated for assisted ventilation of adults. This system does not provide mandatory ventilation with quaranteed tidal volume delivery. Patients requiring mandatory ventilation at predetermined tidal volumes are not candidates for pressure support or pressure-limited ventilation.
The BiPAP S/T-D System requires an intentional leak port, instead of an . actively controlled exhalation valve to remove exhaled air from the circuit. Therefore, specific masks and circuits using an intentional leak port are required for normal operation. The pressurized air from the BiPAP S/T-D System causes a continuous flow of air to exhaust from the leak port to flush the exhaled air from the circuit. The machine should be turned on and the intentional leak port should be checked before the mask is applied.
Pressurized air from the BiPAP S/T-D System causes a continuous flow of . air to exhaust from the leak port to flush exhaled air from the circuit. The ability to completely exhaust exhaled air from the circuit is dependent upon the EPAP setting and I:E ratio. At low EPAP settings or with short expiratory times (e.g., high breathing rates) the leak rate through the intentional leak port may be inadequate to clear all exhaled gas from the circuit. Some rebreathing may occur.
. র্ব controlled method for setting and measuring inspired oxygen concentrations cannot be accomplished while using the BiPAP S/T-D System. Instead, oxygen administration is accomplished by using an external low flow oxygen source that is titrated into the mask. At a fixed flow rate of supplemental oxygen, the inspired oxygen concentration will vary, depending on the IPAP and EPAP settings, patient breathing pattern, mask fit and the leak rate. Continuous patient monitoring is recommended while administering oxygen.
. The Airway Pressure Monitor is recommended for use while operating the BiPAP S/T-D System. The Airway Pressure Monitor will monitor proximal airway pressures and provide audible and visual alerts for high and low pressure conditions, and alert the user to a low internal battery, and incidents when the monitor's power switch is inadvertently turned OFF while the BiPAP S/T-D System is in use. Each alarm function should be checked before use by performing the Performance Verification procedure described in Chapter 8 of the Clinical Manual.

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The BiPAP alarm system differs from some ventilators in the following . respects:
- Although the low pressure alarm on the Airway Pressure Monitor will Λ sound in the event of a power failure, the BiPAP System does not have an independent loss-of-power alarm.
- The Airway Pressure Monitor cannot detect complete or partial Λ obstruction of the exhalation port.
- The Airway Pressure Monitor will sound if pressures exceed the Λ user-set threshold, but there is no mechanism to relieve excess pressures generated in the event of a ventilator control system failure.
- The BiPAP's alarms provide indication only while the alarm > condition exists. There is no mechanism to retain the alarm message after a transient alarm condition returns to normal.
Unlike most ventilators, the oxygen inlet (located on the mask) will . accept general purpose tubing. Caution must be exercised to ensure that only oxygen is connected to the oxygen inlet.
. The BiPAP System can be set to extreme inverse I:E ratios. Use of such ratios may have adverse physiological consequences and are not recommended.

The BiPAP Systems have been functionally tested to meet their published specifications for applied pressure, patient airflow, under varying environmental conditions. Specifications that were met include:

	BiPAP S/T-D System	EnvironmentalConditions
Pressure Regulation/Flow Levels	+.8, -1.5 cm H2O abovesetpoint over flow rates of -60to 100 LPM	Nominal 115 VAC132 VAC, 100 VAC,72-75° F Nominal105° F High
Control Accuracy, IPAPand EPAP Settings	±2 cm H2O of setting in therange of 4 to 20 cm H2O	Nominal temperatureand input voltage
Control SettingAccuracy, Breaths PerMinute (BPM)	±2 BPM over range of 4 to 30BPM, or ±10 of setpoint,whichever is greater	Nominal temperatureand input voltage

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Control Setting Accuracy%IPAP	±10% of setpoint measured at90% and 10% IPAP settings	Nominal temperatureand input voltage
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Electromagnetic environmental testing, and shock and vibration testing were conducted by independent laboratories to the following National and International Standards for electrical safety for medical devices:

· Canadian Standards Association (CSA) C22.2 125, as tested by CSA.
· UL544 Medical and Dental Equipment Standards, as tested by the City of LA Test Labs.
· German Postal Law Requirements for Conducted and Radiated Emissions per VFG 234/1991, as tested by EMACO for TüV.
· Shock and Vibration testing per IEC 68-2-6 (sinusoidal vibration), IEC 68-2-27 Shock, and IEC 68-34 Random Wide Band Vibration, as tested by East West Labs.
· Shock and vibration for the final packaged configuration per National Safe Transit Association Test Labs.
· Electromagnetic compatibility testing to IEC 601-1-2 for medical electrical equipment. This is a standard that includes IEC 801-1, -2, -3 and CISPIR 14 requirements identified in the FDA Reviewer's Guidance Document. The BiPAP S/T-D System was also tested to MIL-STD-461D and MIL-STD-462D for magnetic field susceptibility. EMI and magnetic field testing was conducted by Canadian Standards Association.
· FCC Class B, Part 15.J Emissions.

Results of the performance testing indicate that the BiPAP S/T-D System will operate within its specifications.

Results of environmental testing indicate that the BiPAP S/T-D System will continue to function after being subjected to shock and vibration, and electromagnetic interference.

Radiation emissions meet the requirement of FCC Class B, Part 15.J.

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Clinical Study Summary

Clinical data are presented that verify the suitability of BiPAP Systems for use in treating adult patients with obstructive sleep apnea, respiratory insufficiency, or respiratory failure. These data indicate that the BiPAP System can be used in critical care situations with these patients to manage their acute respiratory condition. Data and analysis presented indicate with a high confidence (p≤ 0.05) that there is a statistical basis to indicate that the use of the BiPAP System, like other devices of this type, will help to avoid the need for intubation of these patients.

The clinical data includes 31 adult patients with acute respiratory failure who were enrolled in prospective, randomized, controlled clinical studies to determine, as a primary outcome measure, if the BiPAP System can be used to treat these patients and successfully avoid the need for intubation. Additional data concerning 81 patients enrolled in prospective, non-randomized studies were included to substantiate the conclusions drawn from the controlled studies.

Adverse Effects

Adverse effects identified during the clinical studies include abrasions on the bridge of the nose due to tight fitting masks. These were resolved by readjusting the mask, using foam spacers, or a skin barrier.

There was one report of a patient who had respiratory failure as a result of being taken off of the BiPAP S/T-D System to enable transport to another procedure. It is advised that an alternate method of ventilation be available when patients are transported.

Conclusions

The technical data presented indicate that the BiPAP S/T-D System is compatible with typical environment found in the home and hospital. They have been tested to meet technical safety and performance specifications for medical equipment as established by Canadian Standards Association and IEC.

Clinical data demonstrate that the BiPAP S/T-D System can be used in the hospital environment and other institutional settings to provide ventilation to spontaneously breathing adult patients who suffer from obstructive sleep apnea. are in acute respiratory failure, or have acute respiratory insufficiency.

When used with standard medical care, devices like the BiPAP S/T-D System can help reduce the need to intubate patients with respiratory failure or respiratory insufficiency.

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).