The Philips Respironics SimplyClear device promotes airway clearance by gradually applying air pulse generated high frequency oscillatory vibrations on the positive and negative pressures applied to the chest wall via the airways. The high frequency oscillatory vibrations release mucus from the bronchial walls, increasing mobilization. The shift in pressure produces a high expiratory flow from the lungs, promoting the clearance of the mobilized secretions via coughing.

The Philips Respironics SimplyClear device may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. It is for use on adult or pediatric patients having difficulty with secretion clearance and/or inability to cough.

The SimplyClear device is for use in a hospital, institutional environment or in the home.

Device Description

The Philips Respironics SimplyClear device promotes airway clearance by loosening, mobilizing and clearing secretions. The loosening and mobilization occurs by gradually applying air pulse generated high frequency oscillatory vibrations on the positive and negative pressures applied to the chest wall via the airways. The high frequency oscillatory vibrations release mucus from the bronchial walls, increasing mobilization. The positive to negative shift in pressure produces a high expiratory flow from the lungs, promoting the clearance of the mobilized secretions via coughing.

The SimplyClear device combines the loosening and mobilization functionality of the Vest Airway Clearance System (K024309) with the secretion clearance functionality of the CoughAssist device (K002598), Dima Italia Negavent DA-3 Plus Pegaso (K072292) and the CoughAssist T70 device (K121955).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Philips Respironics SimplyClear device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in the format requested. Instead, it describes various "performance testing" and "verification activities" against "design input specifications" and "product requirements." The acceptance criteria are broadly implied by the successful completion of these tests.

However, based on the Testing Summary table and the Performance Data section, we can infer the tested features and their successful verification:

Device Feature	Acceptance Criteria (Implied)	Reported Device Performance
User Interface	Meet product requirements; proper display functions, user controls, and informational messages; display correct data and therapy information.	Verified to meet product requirements. All display functions, user controls, and informational messages performed as intended. Displayed proper data and expected therapy information.
Delivered Pressure & Flow Stability	Deliver accurate pressure for intended duration (insufflation, exsufflation, pause); demonstrate pressure and flow stability across all patient test cases, including extreme flow rates and sensor malfunctions.	Verified to deliver accurate pressure for the intended duration. Demonstrated pressure and flow stability across all patient test cases, including extreme flow rates and sensor malfunctions (inaccuracies and/or complete drop out).
CoughTrak	Meet product specifications with defined patient case simulations; availability, operation, and triggering performance across patient cases.	Verified to meet product specifications with each defined patient case simulation. Availability, operation, and triggering performance verified across the range of patient cases.
Oscillations	Meet product specifications; bench testing at extreme therapy settings (waveform testing on maximum duration, extreme settings).	Verified to meet product specifications. Bench testing at extreme therapy settings conducted, including waveform testing on maximum duration of therapy at extreme therapy settings. Oscillations waveforms compared against predicate device waveforms with no oscillations.
Data Management	Meet product specifications for SD card data integrity.	Verified to meet product specifications for SD card data integrity through software verification, code reviews, and software verification testing.
Oximetry Accessory	Proper display of SpO2 and heart rate data received.	Tested to verify the behavior of pulse oximetry data and proper display of data received.
Wired Remote Control	Availability and operation of the device.	Verification testing conducted to verify availability and operation.
External Suctioning Accessory Interface	Provide power to a suctioning accessory as specified.	Verified to demonstrate that the device provides power to a suctioning accessory as specified.
Power Management	Properly interface with detachable battery; display battery information; charge battery; indicate low battery; compatible with external DC power supply; display power supply information; indicate low external battery.	Verified to properly interface with the detachable battery, properly display battery information, properly charge the battery, and indicate a low battery charge. Verified to be compatible with an external DC power supply, to properly display the power supply information, and to properly indicate a low external battery.

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

Sample Size: Not explicitly stated as a number of devices or patient cases. The testing involved "defined patient test cases" but the quantity isn't specified.
Data Provenance: The study was a non-clinical bench testing study. It used simulated patient test cases and "worst-case scenario inputs" rather than actual patient data. Therefore, there's no country of origin for patient data (as none was used) and it is not retrospective or prospective in the human-subjects sense.

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

Not applicable. This was a non-clinical bench testing study where "ground truth" was established by the device's design input specifications and expected performance, rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. As a non-clinical bench testing study, there was no need for adjudication by experts to establish a ground truth. Performance was assessed against predefined engineering specifications.

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

Not applicable. This device is a powered percussor for airway clearance, not an AI-assisted diagnostic or interpretation tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The "performance data" describes standalone validation of the device's algorithms and hardware performance against specifications using "black-box" and "white-box" bench testing. This confirms the algorithm and system's functional integrity independent of a human operator's assessment of patient outcomes during therapy, although a human is operating the device.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical testing was based on the device's design input specifications and product requirements. This would include engineering specifications for pressure, flow, timing, oscillation parameters, user interface functionality, data integrity, and power management.

8. The Sample Size for the Training Set

Not applicable. This document describes a traditional medical device (hardware and embedded software) verification and validation process, not a machine learning or artificial intelligence (AI) device that would involve a "training set" for an algorithm. The software algorithms were designed and tested, not "trained" on data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Summary

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K 122111

Philips Respironics SimplyClear

Premarket Notification -- Abbreviated 510(k)

Section 5.0 510(k) Summary

DEC 3 1 2012

Administrative Information and Device Identification

Name and address of the	Manufacturer:
manufacturer and sponsor of the
510(k) submission:	Respironics, Inc.
	175 Chastain Meadows Court
	Kennesaw, GA 30144-3714
	Office: (770) 423-2322
	Fax: (770) 423-2300

	Sponsor:

	Respironics
	1740 Golden Mile Highway
	Monroeville, PA 15146
	Office: 724-387-7562
	Fax: 724-387-7490

FDA registration number of the	Manufacturer: 1040777 (Establishment
manufacturer of the new device:	registration number)

	Sponsor: 2518422 (Establishment registration
	number)
Official contact person for all	Colleen Witt, RAC
correspondence:	Senior Regulatory Affairs Engineer

	Philips Respironics
	1740 Golden Mile Highway
	Monroeville, PA 15146
	Office: 724-387-4870
	Fax: 724-387-7490
	Email: colleen.witt(@)philips.com

Date Prepared:	July 16, 2012
Device Name:	Philips Respironics SimplyClear Device
Proprietary name of new device:	Philips Respironics SimplyClear Device
Common or usual name of the	Percussor, Powered-Electric
device:
Philips/Respironics model number:	Philips Respironics SimplyClear Device
Classification of new device:	Class II
Classification of the predicate	Class II
device:
Classification Panel:	Anesthesiology
Panel Code:	BYI - powered percussor
	NHJ - noncontinuous ventilator (IPPB)

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CFR Regulation Number:	21 CFR 868.5665
	a) Identification. A powered percussor is a
	device that is intended to transmit vibration
	through a patient's chest wall to aid in freeing
	mucus deposits in the lung in order to improve
	bronchial drainage and that may be powered by
	electricity or compressed gas
	(b) Classification. Class II (performancestandards).
Predicate Device Name(s) and510(k) numbers:	Modified Vest Airway™ Clearance System -K024309
	Emerson CoughAssist, Model CA-3000 -K002598
	Dima Italia Negavent DA-3 Plus Pegaso -K072292
	Philips Respironics CoughAssist T70 - K121955
Reason for submission:	New Device

Description of Device:

The key benefits of this device are:

Oscillations .
Simplicity of Use .
- Common User Interface across product platforms

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Philips Respironics SimplyClear

Triggering adjustments (Cough-Trak)
Data storage, transfer and reporting (DirectView and Encore)
Portability ●
- Maintains patient lifestyle
- Smaller size and decreased weight
Accessory Options ●
- Oximetry Accessory ·
- Remote Control Accessory (foot pedal)
- External Suctioning Accessory Interface
Power Management Options
- Detachable battery
- External DC battery
- Universal Battery pack

Statement of Intended Use:

The Philips Respironics SimplyClear device assists patients in loosening, mobilizing and clearing secretions by providing high frequency oscillatory vibrations while gradually applying a positive pressure to the airway, then rapidly shifting to a negative pressure. The oscillatory vibrations assist in loosening and mobilizing the secretions while the rapid shift in pressure produces a high expiratory flow rate from the lungs, which promotes the clearance of secretions.

Indications for Use:

The SimplyClear device may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. It is for use on adult or pediatric patients having difficulty with secretion clearance and/or inability to cough. The SimplyClear device is for use in a hospital. institutional environment or in the home.

Comparison of Device Technological Characteristics to Predicate Device

Substantial Equivalence

The submitted SimplyClear device has the following similarities to the predicate devices listed in this submission which previously received 510(k) concurrence; the SimplyClear device:

Has the same intended use, .
. Uses the same operating principle,
Incorporates the same basic system requirements including, but not limited to: physical . interfaces; modes of operation; therapy controls; and
Incorporates similar materials ●
Is manufactured utilizing the same manufacturing processes .

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The table below summarizes the key technical characteristics between the SimplyClear device to those of the predicate devices listed in the submission:

Technological	SimplyClear	The Vest	Emerson	Negavent DA-3	CoughAssist T70
Characteristic		Airway	CoughAssist	Plus Pegaso
		Clearance
		System
Patient	Adult or	Adult and	Adult or	Adult or	Adult or pediatric
Population	pediatric	pediatric	pediatric patient	pediatric patient	patient unable to
	patients having	patients with	with an	unable to cough	cough or clear
	difficulty with	evidence or	ineffective	or clear	secretions
	secretion	suggestion of	cough due to	secretions effectively	effectively
	clearance	retained	muscular	effectively
	and/or inability	secretions,	dystrophy,
	to cough.	evidence that	myasthenia
		the patient is	gravis,
		having	poliomyelitis, or
		difficulty withsecretion	other neurologicdisorder with
		clearance or	some paralysis
		presence of	of the
		atelectasis	respiratory
		caused by	muscles, such as
		mucus	spinal cord
		plugging.	injury.
Delivery Type	Non Invasive	Non-Invasive,Inflatable Vest	Non Invasive orInvasive	Non Invasive orInvasive	Non Invasive orInvasive
Modes of	Manual and	Auto	Manual and	Manual and Auto	Manual and Auto
Operation	Auto		Auto
Inhalation	0 to 70 cmH2O	Pressuresetting 1-10	0 to 60 cmH2O	+5 to 70 cmH2O	0 to 70 cmH2O
Pressure
Exhalation	0 to -70	Pressuresetting 1-10	0 to -60 cmH2O	-5 to -70 cmH2O	0 to -70 cmH2O
Pressure	cmH2O
Inhale Flow	Low, Medium,High	N/A	Low and High	Low, Medium,High	Low, Medium,High
Pause Time	0 to 5 seconds	N/A	0 to 5 seconds	0.1 - 9.9 seconds	0 to 5 seconds
Phases of	Insufflation,Exsufflation,Pause	N/A	Insufflation,Exsufflation,Pause	Insufflation,Exsufflation,Pause	Insufflation,Exsufflation,Pause
Therapy Features	CoughTrak,Oscillations	Oscillations	N/A	N/A	CoughTrak
Software	DynamicStabilityAnalysisFlow andPressure BasedOscillationDetectionExtreme FlowRate Controland ResponseSensorMalfunctionStability	N/A	N/A	N/A	DynamicStability AnalysisFlow andPressure BasedOscillationDetectionExtreme FlowRate Control andResponseSensorMalfunctionStability
Oscillations	1 to 20 cmH2O	N/A	N/A	N/A	N/A
Amplitude
OscillationFrequency	0 to 20 Hz	5 to 20 cyclesper second(Hz)	N/A	N/A	N/A
Remote DataAccess	A securedigital (SD)card providesmeans for dataaccess		N/A	N/A	A secure digital(SD) cardprovides meansfor data access

Tab 5 Page 4 of 8

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The table below provides a description of the features of the SimplyClear device that are the subject of this 510(k) submission:

Device Feature	Description
User Interface	A new graphical user interface with hierarchal menu system
Delivered Pressure	The device Inhale pressure is 0 to 70 cmH2O and Exhale pressure is 0 to -70 cmH2O
CoughTrak	A feature for patients who can provide a spontaneous breathing effort to triggerthe cough sequence, instead of using manual or auto modes of therapy. Thissoftware feature monitors the device outlet pressure and initiates the Insufflationphase of therapy delivery when the pressure decreases below a set thresholdindicative of patient effort.
Oscillations	A feature that delivers an oscillation on the pressure signal based on frequencyand amplitude set points
Displayed TherapyParameters ·	The device displays outlet pressure, measured peak cough flow and measuredinhaled tidal volume
Data Management	Therapy data will be stored on an SD card, which will be compatible with bothDirectView and Encore
Oximetry Accessory	Device shall interface with the Oximetry accessory to display current SpO2 andheart rate data received from the oximeter
Wired Remote Control	A remote control accessory (foot pedal) is provided to initiate manual therapy bymeans of a wired remote control interface
External SuctioningAccessory Interface	Device shall provide a DC output intended to power an external suctioningaccessory
Power Management	Options include a Detachable battery, External DC battery and Universal Batterypack

The software design and algorithm descriptions for each of these features of the SimplyClear device have been provided as part of this 510(k) submission.

Performance Data

Non-Clinical Testing

Black-box performance testing was conducted for the SimplyClear device using side by side bench testing methodologies to demonstrate that the SimplyClear device performs to design input specifications and is equivalent to the predicate devices. This bench testing included both open and closed loop conditions from the defined patient test cases to verify that the SimplyClear software algorithms performed to specification. Bench testing conducted for the SimplyClear device characterized the types of worst case scenario inputs that would be experienced in the intended use environment such as extreme flow rates. Additional white-box

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testing verified proper operation under conditions of sensor malfunctions and inaccurate or complete sensor dropout. This combination of testing demonstrated that the SimplyClear devices' closed loop control algorithms function safely and effectively under worst case scenarios.

Device Testing Summary

Verification activities have been performed to verify that the device features stated above did not affect the safety and effectiveness of the subject device. This included bench testing, software unit testing and code reviews. A control system analysis was completed and submitted as part of this 510(k) submission.

The table below provides a summary of the testing that was conducted on the features of the Philips Respironics SimplyClear device that are the subject of this 510(k) submission:

Device Feature	Testing Summary
User Interface includingdisplayed therapyparameters	Has been verified to meet product requirements defined for the SimplyClear UI. Bench testing, code reviews and software unit testing was performed to ensure that all display functions, user controls and informational messages performed as intended. The User Interface was verified to ensure that it displayed the proper data and expected therapy information.
Delivered Pressure andFlow Stability	Verification testing has verified that the SimplyClear device delivers accurate pressure for the intended duration of the insufflation, exsufflation and pause phases of therapy. The SimplyClear device has been verified to demonstrate pressure and flow stability across all patient test cases, including extreme flow rates and sensor malfunctions (i.e. sensor inaccuracies and / or complete sensor drop out).
CoughTrak	The CoughTrak feature of the SimplyClear device has been verified to meet product specifications with each defined patient case simulation. The availability, operation and triggering performance has been verified to operate across the range of patient cases.
Oscillations	The Oscillation feature of the SimplyClear device has been verified to meet product specifications. Bench testing at extreme therapy settings has been provided, which includes waveform testing conducted on maximum duration of therapy at extreme therapy settings. Oscillation waveforms were also compared against the predicate device waveforms with no oscillations.
Data Management	Data management of the SimplyClear device has been verified to meet product specifications for SD card data integrity. Software verification, including code reviews and software verification testing was conducted to verify the expected results with the SD card.
Oximetry Accessory	The Oximetry Accessory has been tested to verify the behavior of the pulse oximetry data and the proper display of data received by the oximetry accessory.
Wired Remote Control	Verification testing has been conducted to verify the availability and operation of the SimplyClear wired remote control device.
External SuctioningAccessory Interface	The SimplyClear device has been verified to demonstrate that the device provides power to a suctioning accessory as specified.
Power Management	The SimplyClear device has been verified to properly interface with the

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detachable battery, properly display the battery information, properly
charge the battery and indicate a low battery charge. The SimplyClear
device has also been verified to be compatible with an external DC power
supply, to properly display the power supply information and to properly
indicate a low external battery.

Standards Evaluation

This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols. The Philips Respironics SimplyClear device was designed and tested according to:

ISO 14971 Medical devices - Application of risk management to medical devices
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements of Safety
IEC 60601-1-2 Medical Electrical Equipment -- Part 1-2: Electromagnetic Compatibility

1. IEC 60601-1-6 Medical Electrical Equipment Part 1-6: Usability

IEC 60068 Environmental Testing (Part 2-6, 2-27, 2-64): Mechanical Vibration and Shock Resistance testing
IEC 62304 Medical device software - Software life cycle processes

The SimplyClear device complies with the applicable requirements referenced in the FDA guidance documents:

FDA's Draft Reviewer Guidance for Premarket Notification Submissions -. Anesthesiology and Respiratory Devices Branch: Division of Cardiovascular. Respiratory, and Neurological Devices (November 1993); and
FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).

As suggested by FDA's November 1993 publication entitled "Reviewer Guidance for Premarket Notification Submissions - Anesthesiology and Respiratory Devices Branch: Division of Cardiovascular, Respiratory, and Neurological Devices" the Philips Respironics SimplyClear device was tested in accordance with the applicable voluntary standards. The Philips Respironics SimplyClear met the required performance criteria and functioned as intended.

Conclusion

The SimplyClear device that is the subject of this 510(k) submission has been validated using non-clinical tests and has been determined to be substantially equivalent to the predicate devices. In summary, bench testing (black-box and white-box) and software code reviews have

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Philips Respironics SimplyClear

confirmed that the SimplyClear device performs equivalently to the cited predicate devices. The indications for use, technological characteristics, and principles of operation are similar to the predicate devices. The Philips Respironics SimplyClear device is substantially equivalent to the predicate devices listed in this summary and the new device does not raise any new issues of safety and effectiveness.

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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a series of waving lines, representing health and human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 31, 2012

Ms. Colleen Witt, RAC Senior Regulatory Affairs Engineer Respironics 1740 Golden Mile Highway MONROEVILLE PA 15146

Re: K122111

Trade/Device Name: Phillips Respironics SimplyClear Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: II Product Code: BYI, NHJ Dated: December 28, 2012 Received: December 31, 2012

Dear Ms. Witt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

. Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Philips Respironics SimplyClear

Section 4.0 Indications for Use

Indications for Use

Device Name: Philips Respironics SimplyClear

The SimplyClear device is for use in a hospital, institutional environment or in the home.

Prescription Use X (Part 21 CFR 801 Subpart D)

. . . . . .

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Paul H. Shin -S	For L.S.
2012.12.31 11:39:21
-05'00'	Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)Division of Anesthesiology, General HospitalInfection Control, Dental Devices	Page 1 of 1

K122111 510(k) Number:

Regulation Number and Section

§ 868.5665 Powered percussor.

(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).