The Respironics CoughAssist T70 assists patients in clearing retained bronchopulmonary secretions by gradually applying a positive pressure to the airway, then rapidly shifting to a negative pressure. This rapid shift in pressure, via a facemask, mouthpicce or an endotracheal or tracheostomy tube, produces a high expiratory flow rate from the lungs, simulating a cough.

The Philips Respironics CoughAssist T70 is intended for use on adult or pediatric patients unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home.

Device Description

The Philips Respironics CoughAssist T70 is a portable electric device which utilizes a blower and a valve to apply alternating positive and then a negative pressure to a patient's airway in order to assist the patient in clearing retained bronchopulmonary secretions by simulating a cough. It includes a means to adjust the pressure and suction levels applied, a pressure gauge to measure the pressures, and a means (optional) to reduce the positive pressure (inhale) flow. The air is delivered to and from the patient via a breathing circuit incorporating a flexible tube, a bacterial filter and either a facemask, a mouthpiece or an adapter to a tracheostomy or endotracheal tube.

AI/ML Overview

The Philips Respironics CoughAssist T70 device is a noncontinuous ventilator designed to assist patients in clearing bronchopulmonary secretions by simulating a cough. The device applies alternating positive and negative pressure to the airway. This summary describes its acceptance criteria and the studies performed to demonstrate its performance and substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Philips Respironics CoughAssist T70 are primarily based on meeting product specifications through non-clinical testing and demonstrating substantial equivalence to its predicate devices, Emerson CoughAssist, Model CA-3000 (K002598) and Dima Italia Negavent DA-3 Plus Pegaso (K072292). The device performance was verified through various engineering tests. While specific quantitative acceptance criteria (e.g., precise pressure tolerances, flow rates, or triggering times) are not explicitly numerical values in the provided text, the document details functional and safety requirements that the device's performance was verified against.

Feature/Characteristic	Acceptance Criteria (Implied from testing/description)	Reported Device Performance
User Interface	To meet product requirements for the CoughAssist T70 UI, ensuring all display functions, user controls, and informational messages perform as intended, and proper data and therapy information are displayed.	Verified to meet product requirements through bench testing, code reviews, and software unit testing. All display functions, user controls, and informational messages performed as intended, displaying proper data and expected therapy information.
Delivered Pressure	To deliver accurate pressure for the intended duration of insufflation, exsufflation, and pause phases, and demonstrate pressure and flow stability across all patient test cases, including extreme flow rates and sensor malfunctions. Inhale (0 to 70 cmH2O) and Exhale (0 to -70 cmH2O) pressures should be maintained.	Verification testing confirmed accurate pressure delivery for the intended duration of all therapy phases. Demonstrated pressure and flow stability across all patient test cases, including extreme flow rates and sensor malfunctions (inaccuracies and/or complete dropout).
CoughTrak	To meet product specifications with each defined patient case simulation, ensuring availability, operation, and triggering performance across the range of patient cases. The device should trigger the insufflation phase when patient effort (pressure decrease below threshold) is detected.	Verified to meet product specifications with each defined patient case simulation. Availability, operation, and triggering performance were verified across the range of patient cases.
Data Management	To meet product specifications for SD card data integrity, including proper storage of therapy data, and compatibility with DirectView and Encore.	Verified to meet product specifications for SD card data integrity through software verification, code reviews, and testing.
Oximetry Accessory	To verify the behavior of pulse oximetry data and proper display of data received from the oximetry accessory (current SpO2 and heart rate).	Tested to verify the behavior of pulse oximetry data and the proper display of data received by the oximetry accessory.
Wired Remote Control	To verify the availability and operation of the remote-control device (foot pedal) to initiate manual therapy.	Verification testing conducted to verify the availability and operation of the CoughAssist T70 wired remote control device.
External Suctioning Accessory Interface	To demonstrate that the device provides power to an external suctioning accessory as specified.	Verified to demonstrate that the device provides power to a suctioning accessory as specified.
Power Management	To properly interface with a detachable battery, display battery information, charge the battery, indicate low battery charge, maintain compatibility with an external DC power supply, display power supply information, and 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 compatibility with an external DC power supply, proper display of power supply information, and indication of low external battery.
Software Algorithms	To function safely and effectively under worst-case scenarios, including stability throughout the operating flow range, steady-state stability with open and occluded patient circuits, disturbance rejection at rapid flow transitions, and avoiding instability during extreme flow rates.	Black-box and white-box performance testing, including open and closed loop conditions and worst-case scenario inputs (extreme flow rates, sensor malfunctions, inaccurate or complete sensor dropout), demonstrated that the software algorithms functioned safely and effectively.
General Safety & Effectiveness	To meet all applicable ISO, ASTM, and IEC standards and regulatory guidance and perform equivalently to predicate devices.	Successfully passed all test protocols for relevant ISO, ASTM, and IEC standards (ISO 14971, ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60068, IEC 62304) and FDA guidance documents. Confirmed to perform equivalently to predicate devices.

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

The provided text indicates that the testing was non-clinical bench testing.

Sample size: The document does not specify a quantitative sample size for the test set in terms of human subjects or distinct physical devices tested. Instead, it refers to testing across "all patient test cases identified in the Product Requirements Document" and "defined patient case simulations" for features like CoughTrak. It also mentions "worst-case scenario inputs." This indicates a comprehensive set of simulated conditions rather than a traditional human subject sample size.
Data Provenance: The data provenance is entirely retrospective and non-clinical. The testing involved "side by side bench testing methodologies," "open and closed loop conditions," and "software unit testing and code reviews." No human or animal data were used in this specific submission. The data is generated from laboratory and engineering verification activities.

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

Not applicable. This was a non-clinical bench study. The "ground truth" for the test set was defined by the product requirements and technical specifications of the device and its predicate, verified by engineering and software testing. There were no human experts establishing ground truth for patient outcomes or diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. As a non-clinical bench study, there was no adjudication method involving multiple human reviewers or experts. The "ground truth" was based on engineering specifications and direct measurement/observation of device behavior against those specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This submission focuses on the engineering and software modifications and their performance relative to predefined specifications and predicate devices, not on human reader performance with or without AI assistance. The device is a secretion clearance device, not an interpretative AI system.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a form of standalone performance was conducted, as the entire evaluation was non-clinical bench testing without human-in-the-loop performance. The "black-box performance testing" and "white-box testing" of the software algorithms specifically assessed the device's (and its algorithms') ability to function according to specifications in various simulated patient scenarios and extreme conditions. This directly evaluates the device's intrinsic functional performance.

7. Type of Ground Truth Used

The ground truth used for the non-clinical testing was based on:

Engineering Specifications/Product Requirements: The device's performance was compared against predetermined design input specifications and product requirements defined in the Product Requirements Document. These specifications dictated expected pressure delivery, flow stability, trigger performance, data integrity, and compliance with various standards.
Predicate Device Performance: Equivalence to predicate devices (Emerson CoughAssist CA-3000 and Dima Italia Negavent DA-3 Plus Pegaso) was a key ground truth criterion, implying that the new device should perform at least as well as the established, legally marketed devices.
Regulatory Standards: Compliance with relevant ISO, ASTM, and IEC standards (e.g., IEC 60601-1 for safety) formed another layer of ground truth, where successful adherence to these standards demonstrated acceptable performance.

8. Sample Size for the Training Set

Not applicable. The provided document concerns a 510(k) submission for device modifications based on non-clinical bench testing. It describes the verification of engineering design and software algorithms, which involve empirical tuning of PID gains during development, but does not refer to a "training set" in the context of machine learning or AI models with external data. The device's control algorithms were "empirically tuned to achieve the necessary response and stability," implying an iterative development and testing process, but not a distinct training set.

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

Not applicable, as there was no explicit "training set" in the context of machine learning. The "ground truth" during development, influencing the empirical tuning of control algorithms, would have been derived from desired physical performance characteristics (e.g., pressure response, stability, flow rates) under various simulated conditions, established through engineering principles, system modeling, and iterative bench testing.

Summary

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K121955

Philips Respironics CoughAssist T70

Premarket Notification -- Traditional 510(k)

Section 4 - 510(k) Summary

Administrative Information and Device Identification

DEC 1 4 2012

Name and address of themanufacturer and sponsor of the510(k) submission:	Manufacturer:
	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 themanufacturer of the new device:	Manufacturer: 1040777 (Establishmentregistration number)
	Sponsor: 2518422 (Establishment registrationnumber)
Official contact person for allcorrespondence:	Colleen Witt, RAC
	Senior Regulatory Affairs Engineer
	Philips Respironics
	1740 Golden Mile HighwayMonroeville, PA 15146
	Office: 724-387-4870
	Fax: 724-387-7490
	Email: colleen.witt@philips.com
Date Prepared:	June 29, 2012
Device Name:	Philips Respironics CoughAssist T70
Proprietary name of new device:	Philips Respironics CoughAssist T70
Common or usual name of thedevice:	Secretion Clearance Device
Philips/Respironics model number:	Philips Respironics CoughAssist T70
Classification of new device:	Class II
Classification of the predicatedevice:	Class II
Classification Panel:	Anesthesiology
Panel Code:	NHJ - noncontinuous ventilator (IPPB)
CFR Regulation Number:	21 CFR 868.5905
	a) Identification. A noncontinuous ventilator(intermittent positive pressure breathing – IPPB)is a device intended to deliver intermittently anaerosol to a patient's lungs or to assist a patient'sbreathing.
	(b) Classification. Class II (performancestandards).
Predicate Device Name(s) and510(k) numbers:	Emerson CoughAssist, Model CA-3000 –K002598
	Dima Italia Negavent DA-3 Plus Pegaso -K072292
Reason for submission:	Device modifications

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Description of Device

Like its predicates, the Respironics CoughAssist T70 device is for use on any adult or pediatric patient unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. Operators of the device are expected to be patients, lay caregivers (family members), clinicians, home nurses, homecare provider technicians, physicians and service personnel. The environment of use for the device will be for use in the hospital, institutional environment or in the home.

The CoughAssist T70 device is designed to deliver a cough cycle to a patient. A cough cycle includes a positive pressure inhale phase, a negative pressure exhale phase and a near zero pressure pause phase.

The CoughAssist T70 engineering design incorporates closed loop control algorithms through the motor controller and valve controller software algorithms. Block diagrams and a stability analysis have been provided for these closed loop algorithms.

The motor and valve controller utilize PID controllers. The PID gains are empirically tuned to achieve the necessary response and stability of the system to give best performance for all patient cases identified in the Product Requirements Document (provided in Attachment A of

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the original submission). Additionally, adaptive gain changes are implemented in the Valve Controller to reject any external disturbance and to account for process and condition changes.

The CoughAssist T70 Valve (Pressure) Control system is designed to maintain stability throughout the operating flow range of the device. This includes steady-state stability with open and occluded patient circuit as well as disturbance rejection stability in cases where the device rapidly transitions from high flow to no flow and back to high flow again (open patient circuit to occluded patient circuit back to open patient circuit). Additionally, when in the inhale and exhale phases, the device pressure is continuously monitored to ensure that the pressure being delivered is the same polarity as the set point pressure. In the event of extreme flow rates (if the patient becomes disconnected from the device during therapy), the motor and valve controllers are designed to avoid any controller instability.

If the device is in Auto mode, the device will continuously trigger and cycle. If CoughTrak is enabled, the device will stay in the Pause waiting for the patient to trigger (which will not happen if the patient is not connected). In the Pause phase, the pressure is limited in order to minimize flow; a standby state is provided to preserve motor operation.

Statement of Intended Use

Indications for Use

The Respironics CoughAssist T70 is intended for use on adult or pediatric patients unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home.

Comparison of Device Technological Characteristics to Predicate Device

Substantial Equivalence

The Respironics CoughAssist T70 device has the following similarities to the previously cleared predicate devices:

D Same intended use.
Same operating principle.
Same technology.
D Same manufacturing process.

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The table below summarizes the key technical characteristics between the CoughAssist T70 to
those of the predicate devices listed in the submission:

CharacteristicCoughAssistPegasoAdult or pediatric patientPatientAdult or pediatricAdult or pediatricPopulationunable to cough or clearpatient unable topatient with ansecretions effectivelycough or clearineffective coughscretions effectivelydue to muscular	Technological	Description	Emerson	Negavent DA-3 Plus





			dystrophy,
myasthenia gravis,
poliomyelitis, or
other neurologic
disorder with some
paralysis of the
respiratory muscles,
such as spinal cord
injury.
Delivery TypeNon Invasive or InvasiveNon Invasive orNon Invasive or
InvasiveInvasive
Modes ofManual and AutoManual and AutoManual and Auto
Operation
0 to 70 cmH2OInhalation0 to 60 cmH2O+5 to 70 cmH2O
Pressure
0 to -70 cmH2OExhalation0 to -60 cmH2O-5 to -70 cmH2O
Pressure
Inhale FlowLow, Medium, HighLow and HighLow, Medium, High
Pause Time0 to 5 seconds0.1 - 9.9 seconds0 to 5 seconds
Phases ofInsufflation, Exsufflation,Insufflation,Insufflation,
Therapy CyclePauseExsufflation, PauseExsufflation, Pause
TherapyCoughTrakN/AN/A
Features
CoughAssist,Dynamic Stability AnalysisN/AN/A
includingFlow and Pressure Based
CoughTrakOscillation Detection
Safety ProtocolsExtreme Flow Rate Control
and ResponseSensor Malfunction Stability
Remote DataA secure digital (SD) cardN/AN/A
provides means for data accessAccess

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The table below provides a description of the modifications to the Respironics CoughAssist T70 device that are the subject of this 510(k) submission:

Device Modification	Description	Device Modification	Testing Summary
User Interface	A new graphical user interface with hierarchal menu system	User Interface includingdisplayed therapyparameters	Has been verified to meet product requirements defined for theCoughAssist T70 UI. Bench testing, code reviews and software unittesting was performed to ensure that all display functions, usercontrols and informational messages performed as intended. TheUser Interface was verified to ensure that it displayed the properdata and expected therapy information.
Delivered Pressure	The device Inhale pressure is 0 to 70 cmH2O and Exhale pressure is0 to -70 cmH2O	Delivered Pressure andFlow Stability	Verification testing has verified that the CoughAssist T70 devicedelivers accurate pressure for the intended duration of theinsufflation, exsufflation and pause phases of therapy. TheCoughAssist T70 has been verified to demonstrate pressure andflow stability across all patient test cases, including extreme flowrates and sensor malfunctions (i.e. sensor inaccuracies and / orcomplete sensor drop out).
CoughTrak	A feature for patients who can provide a spontaneous breathingeffort to trigger the cough sequence, instead of using manual or automodes of therapy. This software feature monitors the device outletpressure and initiates the Insufflation phase of therapy deliverywhen the pressure decreases below a set threshold indicative ofpatient effort.	CoughTrak	The CoughTrak feature of the CoughAssist T70 device has beenverified to meet product specifications with each defined patientcase simulation. The availability, operation and triggeringperformance has been verified to operate across the range of patientcases.
Displayed TherapyParameters	The device displays outlet pressure, measured peak cough flow andmeasured inhaled tidal volume	Data Management	Data management of the CoughAssist T70 device has been verifiedto meet product specifications for SD card data integrity. Softwareverification, including code reviews and software verificationtesting was conducted to verify the expected results with the SDcard.
Data Management	Therapy data will be stored on an SD card, which will becompatible with both DirectView and Encore	Oximetry Accessory	The Oximetry Accessory has been tested to verify the behavior ofthe pulse oximetry data and the proper display of data received bythe oximetry accessory.
Oximetry Accessory	Device shall interface with the Oximetry accessory to displaycurrent SpO2 and heart rate data received from the oximeter	Wired Remote Control	Verification testing has been conducted to verify the availability andoperation of the CoughAssist T70 wired remote control device.
Wired Remote Control	A remote control accessory (foot pedal) is provided to initiatemanual therapy by means of a wired remote control interface	External SuctioningAccessory Interface	The CoughAssist T70 device has been verified to demonstrate thatthe device provides power to a suctioning accessory as specified.
External SuctioningAccessory Interface	Device shall provide a DC output intended to power an externalsuctioning accessory	Power Management	The CoughAssist T70 has been verified to properly interface withthe detachable battery, properly display the battery information,properly charge the battery and indicate a low battery charge. TheCoughAssist T70 has also been verified to be compatible with anexternal DC power supply, to properly display the power supplyinformation and to properly indicate a low external battery.
Power Management	Options include a Detachable battery, External DC battery andUniversal Battery pack

The software design and algorithm descriptions for each of these modifications to the CoughAssist T70 device have been provided as part of this 510(k) submission.

Performance Data

Non-Clinical Testing

Black-box performance testing was conducted for the CoughAssist T70 device using side by side bench testing methodologies to demonstrate that the CoughAssist T70 device performs to design input specifications and is equivalent to the predicate device. This bench testing included both open and closed loop conditions from the defined patient test cases to verify that the CoughAssist T70 software algorithms performed to specification. Bench testing conducted for the CoughAssist T70 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 testing verified proper operation under conditions of sensor malfunctions and inaccurate or complete sensor dropout. This combination of testing demonstrated that the CoughAssist T70 closed loop control algorithms function safely and effectively under worst case scenarios.

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Device Modification Testing Summary

Verification activities have been performed to verify that the device modifications stated above did not affect the safety and effectiveness of the subject device. This included bench testing, software unit testing and code reviews.

The table below provides a summary of the testing that was conducted on the modifications to the Respironics CoughAssist T70 device that are the subject of this 510(k) submission:

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Standards Evaluation

This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols. The Respironics CoughAssist T70 device was designed and tested according to:

I. 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
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 CoughAssist T70 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 Respironics CoughAssist T70 device was tested in accordance with the applicable voluntary standards. The Respironics CoughAssist T70 met the required performance criteria and functioned as intended.

Conclusion

The CoughAssist T70 modifications that are the subject of this 510(k) submission have been validated using non-clinical tests and have been determined to be substantially equivalent. In summary, bench testing (black-box and white-box) and software code reviews have confirmed that the CoughAssist T70 device performs equivalently to the cited predicate devices. I The indications for use, technological characteristics, and principles of operation are similar to the predicate devices. The Respironics CoughAssist T70 device is substantially equivalent to the predicate devices and the device, as changed, does not raisc any new issues of safety and effectiveness.

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	YES	NO	N/A
tronics CoughAssist T70 (K121055)Required Elements for 510(k) Summary (21 CFR 807.92)
Clearly labeled "510(k) Summary"	page 1
Submitter' s name, address, phone #, a contact person	page 1
Date the summary was prepared	page 1
The name of the device/trade name/common name/classification name	page 1
An identification of the legally marketed Predicate	page 2
Description of the subject device	page 2-3
Statement of intended use(identical to indications for use)	page 3
Technologicalcharacteristicsif same, a summary of comparison of technological characters	page 4
	If different, a summary of how do they compare to the Predicate	page 4
Performance Data	Brief discussion of non-clinical data submitted, referenced, or relied on	page 5-7
	Brief discussion of clinical data submitted, referenced, or relied on, including:Description upon whom the device was tested,Data obtained from the tests and especially:Adverse events and complicationsOther information for SE determinationConclusion that data demonstrate SE			X
Gred Elements for 510(k) Statement (21 CFR 807.93)
Signed verbatim statement			page 7

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 14, 2012

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

Re: K121955

Trade/Device Name: Philips Respironics CoughAssist T70 Device Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NHJ Dated: October 31, 2012 Received: November 1, 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 I ou may controls provisions of the Act include requirements for annual registration, listing 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 havinged a determination that your device complies with other requirements of the Act that I Drims Intacted and regulations administered by other Federal agencies. You must or any I odetail 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 forth in the quality by every of 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 11 You donte speefice aav/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 vours.

2012.12.14 Susan Runner DDS, MA 1 5:34:55 -05'00'

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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Premarket Notification -- Special 510(k)

Section 6.0 Indications for Use

Indications for Use

510(k) Number (if known): 121 955

Device Name: Philips Respironics CoughAssist T70 device

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lester W. Schultheis Jr 2012.12.14,15:41:43 -05'00'

(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices

×121955 510(k) Number:_

Tab 6 Page 1 of 1

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).