K Number

Device Name

COUGHASSIST T70 DEVICE

Manufacturer

RESPIRONICS, INC.

Date Cleared

2012-12-14

(164 days)

Product Code

NHJ

Regulation Number

868.5905

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K002598, K072292

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and software control of pressure and flow, with no mention of AI/ML terms or learning capabilities. The performance testing described is standard software and hardware verification, not AI/ML model validation.

Therapeutic

Yes.
The device's intended use is to assist patients in clearing bronchopulmonary secretions by simulating a cough, which is a therapeutic action.

Diagnostic

Explanation: The device is described as assisting patients in clearing secretions by simulating a cough, which is a therapeutic function. It is not used to identify, diagnose, or monitor a medical condition, disease, or injury.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "portable electric device which utilizes a blower and a valve" and includes hardware components like a pressure gauge and a breathing circuit. While it mentions software algorithms, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Respironics CoughAssist T70 is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body. The CoughAssist T70 works by applying pressure directly to the patient's airway to assist with coughing and clearing secretions. It does not analyze any biological samples.
The intended use and device description clearly describe a mechanical device for respiratory assistance. The focus is on simulating a cough through pressure changes, not on diagnostic testing of bodily fluids or tissues.

Therefore, the CoughAssist T70 falls under the category of a therapeutic or assistive medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes (comma separated list FDA assigned to the subject device)

NHJ

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

airway, lungs

Indicated Patient Age Range

adult or pediatric patients

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key results: 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. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Emerson CoughAssist, Model CA-3000 – K002598, Dima Italia Negavent DA-3 Plus Pegaso - K072292

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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 the
manufacturer and sponsor of the

510(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 the
manufacturer of the new device:	Manufacturer: 1040777 (Establishment
registration number)
	Sponsor: 2518422 (Establishment registration
number)
Official contact person for all
correspondence:	Colleen Witt, RAC
	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:	June 29, 2012
Device Name:	Philips Respironics CoughAssist T70
Proprietary name of new device:	Philips Respironics CoughAssist T70
Common or usual name of the
device:	Secretion Clearance Device
Philips/Respironics model number:	Philips Respironics CoughAssist T70
Classification of new device:	Class II
Classification of the predicate
device:	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 an
aerosol to a patient's lungs or to assist a patient's
breathing.
	(b) Classification. Class II (performance
standards).
Predicate Device Name(s) and
510(k) numbers:	Emerson CoughAssist, Model CA-3000 –
K002598
	Dima Italia Negavent DA-3 Plus Pegaso -
K072292
Reason for submission:	Device modifications

Description of Device

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

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

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.

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

| Characteristic
CoughAssist
Pegaso
Adult or pediatric patient
Patient
Adult or pediatric
Adult or pediatric
Population
unable to cough or clear
patient unable to
patient with an
secretions effectively
cough or clear
ineffective cough
scretions effectively

due 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 Type
Non Invasive or Invasive
Non Invasive or
Non Invasive or
Invasive
Invasive
Modes of
Manual and Auto
Manual and Auto
Manual and Auto
Operation
0 to 70 cmH2O
Inhalation
0 to 60 cmH2O
+5 to 70 cmH2O
Pressure
0 to -70 cmH2O
Exhalation
0 to -60 cmH2O
-5 to -70 cmH2O
Pressure
Inhale Flow
Low, Medium, High
Low and High
Low, Medium, High
Pause Time
0 to 5 seconds
0.1 - 9.9 seconds
0 to 5 seconds
Phases of
Insufflation, Exsufflation,
Insufflation,
Insufflation,
Therapy Cycle
Pause
Exsufflation, Pause
Exsufflation, Pause
Therapy
CoughTrak
N/A
N/A
Features
CoughAssist,
Dynamic Stability Analysis
N/A
N/A
including
Flow and Pressure Based
CoughTrak
Oscillation Detection
Safety Protocols
Extreme Flow Rate Control
and Response
Sensor Malfunction Stability
Remote Data
A secure digital (SD) card
N/A
N/A
provides means for data access
Access

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
User Interface	A new graphical user interface with hierarchal menu system	User Interface including
displayed therapy
parameters	Has been verified to meet product requirements defined for the
CoughAssist T70 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	The device Inhale pressure is 0 to 70 cmH2O and Exhale pressure is
0 to -70 cmH2O	Delivered Pressure and
Flow Stability	Verification testing has verified that the CoughAssist T70 device
delivers accurate pressure for the intended duration of the
insufflation, exsufflation and pause phases of therapy. The
CoughAssist T70 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	A feature for patients who can provide a spontaneous breathing
effort to trigger the cough sequence, instead of using manual or auto
modes of therapy. This software feature monitors the device outlet
pressure and initiates the Insufflation phase of therapy delivery
when the pressure decreases below a set threshold indicative of
patient effort.	CoughTrak	The CoughTrak feature of the CoughAssist T70 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.
Displayed Therapy
Parameters	The device displays outlet pressure, measured peak cough flow and
measured inhaled tidal volume	Data Management	Data management of the CoughAssist T70 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.
Data Management	Therapy data will be stored on an SD card, which will be
compatible with both DirectView and Encore	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.
Oximetry Accessory	Device shall interface with the Oximetry accessory to display
current SpO2 and heart rate data received from the oximeter	Wired Remote Control	Verification testing has been conducted to verify the availability and
operation of the CoughAssist T70 wired remote control device.
Wired Remote Control	A remote control accessory (foot pedal) is provided to initiate
manual therapy by means of a wired remote control interface	External Suctioning
Accessory Interface	The CoughAssist T70 device has been verified to demonstrate that
the device provides power to a suctioning accessory as specified.
External Suctioning
Accessory Interface	Device shall provide a DC output intended to power an external
suctioning accessory	Power Management	The CoughAssist T70 has been verified to properly interface with
the detachable battery, properly display the battery information,
properly charge the battery and indicate a low battery charge. The
CoughAssist T70 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.
Power Management	Options include a Detachable battery, External DC battery and
Universal 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.

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:

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.

	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
Technological
characteristics
if 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

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.

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

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

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.

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:_

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