The BiPAP A40 ventilator is intended to provide invasive and non-invasive ventilatory support to treat adulate and pediatric weighing over 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA), Respiratory Insufficiency, or Respiratory Failure. It is intended to be used in the home, institutional/hospital, and portable applications such as wheelchairs and gurneys.

Device Description

The Respironics BiPAP A40 Ventilatory Support System is a microprocessor controlled blower and valve based positive pressure ventilatory system. The device can provide non-invasive or invasive ventilation. The device augments patient breathing by supplying pressurized air through a patient circuit. It senses the patients breathing effort by monitoring airflow in the patient circuit and adjusts its output to assist in inhalation and exhalation. This therapy is known as Bi-level ventilation. Bi-level ventilation provides a higher pressure, known as IPAP (Inspiratory Positive Airway Pressure), when you inhale, and a lower pressure, known as EPAP (Expiratory Positive Airway Pressure), when you exhale. The higher pressure makes it easier for you to inhale, and the lower pressure makes it easier for you to exhale. This device can also provide a single pressure level, known as CPAP (Continuous Positive Airway Pressure).

The BiPAP A40 Ventilator is compatible with the System One Heated Humidifier. The System One heated humidifier, previously cleared for use in K113053, is an accessory for the Philips Respironics A Series therapy devices to provide moisture to the circuit.

The BiPAP A40 ventilator introduces a new therapy mode called AVAPS-AE. This therapy mode combines an improved AVAPS algorithm with an auto-back up to treat hypoventilation. An auto-EPAP algorithm runs simultaneously with the bi-level therapy to deliver the pressure support at the optimal PEEP. Additionally the ventilator can be operated using AC power, a detachable battery, or an external battery.

A Graphical user interface displays device data and device settings.

The BIPAP A40 Ventilatory Support System is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable,

Like its predicates, the BiPAP A40 Ventilatory Support System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask or trach). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen tubing, an exhalation device, and a patient interface device.

AI/ML Overview

This document describes the BiPAP A40 Ventilatory Support System, a continuous ventilator intended for invasive and non-invasive ventilatory support in both adult and pediatric patients weighing over 10 kg. It's meant for use in various settings, including home, hospital, and portable applications.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing that confirmed the product met "predetermined acceptance criteria" (Page 5). However, specific numerical acceptance criteria (e.g., "Pressure Accuracy: +/- X cmH2O") are not explicitly listed in a table format alongside specific numerical performance results. Instead, the document generally states that "All tests confirmed the product met the predetermined acceptance criteria."

The closest information to acceptance criteria is found in the "Technological Characteristic" table on page 3, which lists specifications for pressure accuracy and alarm indicators. The document then states that "Performance testing comprises pressure performance, trigger and cycling, as well as volume assured pressure support ventilation" and "All tests confirmed the product met the predetermined acceptance criteria." This implies that the device's performance aligned with these listed characteristics.

The "Pressure Accuracy" is stated as "+/- 2.5 cmH2O of the setting". The document does not provide a separate table of specific acceptance criteria values versus reported performance values with numerical results for each test. It simply states that the device "passing all test protocols" and "All tests confirmed the product met the predetermined acceptance criteria."

Acceptance Criteria Category	Specific Criteria (from Technological Characteristics)	Reported Device Performance
Pressure Accuracy	+/- 2.5 cmH2O of the setting	"All tests confirmed the product met the predetermined acceptance criteria." "The BiPAP A40 testing showed the device functions safely and effectively under worst case clinical scenarios (i.e. providing adequate pressure to maintain patent airway for a patient and avoiding over pressurization under defined clinical scenarios. The device adjusted to inter as well as intra patient variability."
Alarm / Power Control Panel Indicators	LED / Audible Alarm indicators, Red High Priority and Yellow Low Priority alarm LED indicators, various system error alarms, required FDA alarms	"All tests confirmed the product met the predetermined acceptance criteria." The device is "fitted with alarms to alert the user to changes that will affect the treatment."
Ventilation Modes	CPAP, Spontaneous / Timed, Spontaneous, Pressure Control, Timed	"All tests confirmed the product met the predetermined acceptance criteria." These modes and therapy features are "also included in the BiPAP A40 Ventilatory Support System."
Pressure Ranges	CPAP: 4 to 20 cmH2O; IPAP: 4 to 40 cmH2O (S, S/T, T, PC) and 4 to 25 cmH2O (S mode with BiFlex); EPAP: 4 to 25 cmH2O (S, S/T, T, PC) and 4 to 20 cmH2O (S mode with BiFlex)	"All tests confirmed the product met the predetermined acceptance criteria." Device provides up to 40 cmH2O pressure.
AVAPS (Average Volume Assured Pressure Support)	Available in S, S/T, PC, and T modes; Rate: 0.5 to 5 cmH2O / minute	"All tests confirmed the product met the predetermined acceptance criteria." "Bench test data demonstrated the algorithm's ability to safely change pressure support to maintain a target tidal volume in response to varying lung conditions."
AVAPS-AE Mode	Combines AVAPS with auto-back up and auto-EPAP algorithm for hypoventilation. EPAP adjustments and auto back-up rate algorithm "validated using non-clinical tests and have been determined to be substantially equivalent."	"All tests confirmed the product met the predetermined acceptance criteria." "Bench test data demonstrated the algorithm's ability to safely adjust the EPAP setting within the prescription settings of EPAP minimum and maximum in response to changes in upper airway resistance."
Triggering	AutoTrak and Flow Trigger (cleared on predicates); Sensitive AutoTrak (extension of AutoTrak)	"All tests confirmed the product met the predetermined acceptance criteria." Sensitive AutoTrak allows algorithms to run independently to "more accurately detect a patient trigger in certain cases."

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

The document describes "bench testing" and "non-clinical tests" (Page 4, 5, 6, 7). No specific sample size (e.g., number of patients or patient data sets) for a test set is provided. The testing appears to be primarily focused on the device's functional performance in a laboratory setting, rather than with a human patient test set.

The data provenance is from non-clinical bench testing rather than human subject data. There is no mention of country of origin of data or whether it was retrospective or prospective, as it pertains to bench testing.

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

This information is not applicable as the testing described is non-clinical bench testing, not involving human experts for ground truth establishment of a medical condition. The "ground truth" for the device's performance was established by its design input specifications and engineering verification.

4. Adjudication Method for the Test Set

This information is not applicable as the testing was non-clinical bench testing and did not involve expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes "comparative testing" (Page 5) and "side-by-side bench testing methodologies" (Page 6) with predicate devices to demonstrate substantial equivalence, but this refers to comparing the device's technical performance against other devices, not a study involving human readers with and without AI assistance.

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

The testing described is primarily standalone in nature for the device itself (algorithm only without human-in-the-loop performance in a clinical context). The device is a ventilatory support system, not an AI diagnostic tool requiring human interpretation. The "algorithms" mentioned (AVAPS, AVAPS-AE, Trigger Type Options) are intrinsic to the device's operation. The bench testing verified their functional performance.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical testing was based on design input specifications, engineering principles, and validated test protocols for ventilator performance (e.g., pressure accuracy, breath rates, tidal volume delivery). For the algorithms, the ground truth was their ability to perform to these specifications, to "safely change pressure support to maintain a target tidal volume" and "safely adjust the EPAP setting" under varying conditions (Page 6).

8. The Sample Size for the Training Set

The document does not describe a training set in the context of machine learning. The device's algorithms (like AVAPS-AE) appear to be rule-based or control-loop systems, rather than trained machine learning models requiring a distinct "training set." Therefore, this information is not applicable in the conventional sense of machine learning.

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

As there is no mention of a training set for machine learning, this information is not applicable. The "ground truth" for the device's operational parameters would have been established through engineering design, physiological models, and clinical requirements and specifications for ventilator performance.

Summary

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Section 05: 510(k) Summary

DEC 1 4 2012

Premarket Notification – Abbreviated 510(k)

Name and address of the manufacturerand sponsor of the 510(k) submission:	Manufacturer:
	Respironics, Inc.
	1001 Murry Ridge Lane
	Murrysville, PA 15668
	Sponsor:
	Respironics
	1740 Golden Mile Highway
	Monroeville, PA 15146
	Office: 724-387-7562
	Fax: 724-387-7490
Date of Submission	05/29/2012
FDA registration number of themanufacturer of the new device:	2518422
Official contact person for allcorrespondence:	Joseph E. Olsavsky
	Senior Manager, Regulatory Affairs, Home
	Respiratory Care
	Respironics
	1740 Golden Mile Highway
	Monroeville, PA 15146
	Office: 724-387-7562
	Fax: 724-387-7490
	Email: joseph.olsavsky@philips.com
Classification Reference	21 CFR 868.5895
	a) Identification. A continuous ventilator(respirator) is a device intended to mechanicallycontrol or assist patient breathing by delivering apredetermined percentage of oxygen in thebreathing gas. Adult, pediatric, and neonatalventilators are included in this generic type ofdevice.
	(b) Classification. Class II (performance standards).
Panel Code/Classification Name:	MNT – ventilator, continuous, minimal ventilatorysupport, facility use
Classification Panel:	Anesthesiology

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Premarket Notification - Abbreviated 510(k)

Philips Respironics BiPAP A40 Ventilator Support System

Common/Usual Name	Ventilatory Support System
Proprietary/Trade name of new device:	BiPAP A40 Ventilatory Support System
Predicate Device Name(s) and 510(k)numbers:	• BiPAP A30 Ventilatory Support System(K113053)• Trilogy 200 Ventilatory Support System(K093416)
Reason for submission:	New Device

Intended Use

Device Description

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BiPAP A40 Ventilatory Support System

A Graphical user interface displays device data and device settings.

The BIPAP A40 Ventilatory Support System is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable,

Technological Characteristics Compared to Predicate

The primary device platform being used as the key topic for this submission, the BiPAP A30 Ventilatory Support System was previously cleared in K113053. The same ventilation modalities and therapy features, previously cleared in K113053 are also included in the BiPAP A40 Ventilatory Support System, which is the topic of this submission. These modes and therapy features include: CPAP, Spontaneous, Spontaneous/Timed, Timed, Pressure Control modes with Bi-Flex or the AVAPS therapy features available if enabled by the health care professional.

The secondary device predicate, the Trilogy 200 was previously cleared in K093416. Similar to the Trilogy 200, the BiPAP A40 can provide pressure up to 40cm, provide invasive support if prescribed, be used in mobile applications such as wheelchairs, and provides an optional detachable battery.

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Comparison of Device Technological Characteristics to Predicate Devices

The BiPAP A40 Ventilatory Support System has the following similarities to those predicate devices listed in this submission which previously received 510(k) concurrence; the BiPAP A40 ventilator:

Has the same/similar intended use, .
. Uses the same operating principle,
· Incorporates the same basic ventilator system requirements including, but not limited to: physical interfaces; visual, audible and remote alarm system; modes of operation; performance settings:
Incorporates similar materials; and .
Uses the same manufacturing processes. .

The table below summarizes the technical characteristics between the BiPAP A40 Ventilatory Support System to those that are similar to the predicate devices listed in the submission:

Technological Characteristic	Description
Patient Population	Patients weighing over 10kg (22lbs)
Ventilation Type	Non Invasive or Invasive Support
Design	Microprocessor valve controlled DC blower motor design
Pressure Regulation Method	Pressure feedback, motor speed and valve
Modes of Operation	CPAP, Spontaneous / Timed, Spontaneous, Pressure Control, Timed
CPAP Pressure	4 to 20 cmH2O
IPAP Pressure	4 to 40 cmH2O for S, S/T, T and PC (IPAP Min/Max)4 to 25 cmH2O for S mode with BiFlex enabled
EPAP Pressure	4 to 25 cmH2O for S, S/T, T and PC (EPAP Min/Max)4 to 20 cmH2O for S mode with BiFlex enabled
BiFlex	User settable parameter that has 3 flex settings and is enabled in S mode up to 25 cmH2O
AVAPS	Average volume assured pressure support available in S, S/T, PC and T modes
AVAPS Rate	0.5 to 5 cmH2O / minute
Ramp	User settable; Linear time based
Rise Time	User settable parameter that has 6 settings; not available in CPAP mode
Inspiratory Time	0.5 to 3.0 sec available in S/T, PC and T modes
Breath Rate	0 to 40 bpm in S/T and PC modes4 to 40 bpm in T mode
Triggering	AutoTrak and Flow Trigger
Pressure Accuracy	+ 2.5 cmH2O of the setting
Alarm / Power Control Panel Indicators	LED / Audible Alarm indicatorsTwo alarm LED indicators: Red High Priority and Yellow Low Priority

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		minute ventilation and Low tidal volume alarm
System Error Alarms		Loss of power, Ventilator inoperative, Low Battery, Pressureregulation, Low Circuit Leak, High Temperature, AC PowerDisconnect, Keypad Stuck, Replace Detachable Battery, InsertSD Card, Card Error Info message, Start on Battery InfoMessage, Check AC Power Supply Info message, BatteryDisconnect Info message, Battery Discharging Stopped Due toTemperature, Battery not charging due to temperature, Batterynot charging, Battery depleted and Detachable batterydisconnected info message
Required FDA alarms based onFDA Reviewers Guidance forVentilators		Loss of main power supply, Breathing circuit integrity, Highairway pressure and Alarm Battery Power Supplies
Humidifier Interface		The base unit and humidifier are connected through a hardwireconnection and the base unit contains the control circuitrynecessary for the operation of the humidifier. Setting controlsreside on the base unit.
Humidifier Chamber and Volume		Polycarbonate chamber with stainless steel heater plate; 325mlvolume
Remote Data Access		A secure digital (SD) card provides means for data accessand/or serial communications.

The modifications to the Respironics BiPAP A40 Ventilatory Support system that are the subject of this Abbreviated 510(k) submission consist of the following:

1. IPAP Pressure of 40 cmH2O pressure is comparable to the cited device predicates. The BiPAP A30 provides up to 30 cmH2O whereas the Trilogy 200 device provides up to 50 cmH2O
1. AVAPS AE Mode, which incorporates the existing cleared AVAPS therapy feature and adjusts EPAP based on upper airway resistance and incorporates an automatic back-up rate algorithm. This mode is comparable to the cited device predicates which both offer AVAPS therapy feature. The EPAP adjustments and auto back-up rate algorithm have been validated using non-clinical tests and have been determined to be substantially equivalent.
Detachable Battery Accessory includes the detachable battery module. Li-lon battery and 3. operating instructions. The Detachable Battery accessory is comparable to the cited device predicate, Trilogy 200. The same detachable battery is used for both devices.
1. Added invasive system one resistance to increase sensitivity of circuit disconnect alarm to ensure accuracy of the alarm when used with a high resistance circuit, which is similar to the Trilogy 200 alarm system.
1. Trigger Type Options available on the BiPAP A40 device include AutoTrak, Sensitive AutoTrak and Flow Trigger. AutoTrak and Flow Trigger are cleared on the device predicate, BiPAP A30 and Trilogy 200. Sensitive AutoTrak allows each algorithm to run

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independently in order to more accurately detect a patient trigger in certain cases. Sensitive AutoTrak is an extension of the currently cleared AutoTrak.

1. Labeling Update to remove the current warning, "The AVAPS and Bi-Flex features are for adult patients only" from the User Manual for the BiPAP A40 device. There is adequate supporting literature for the use of Bi-Flex and AVAPS in the pediatric population weighing over 10kg ..

Performance Data

Design and Verification activities were performed on the BiPAP A40 as a result of the risk analysis and product design requirements. All tests confirmed the product met the predetermined acceptance criteria. Performance testing comprises pressure performance, trigger and cycling, as well as volume assured pressure support ventilation. In addition to system verification testing, comparative testing was performed using common protocols for BiPAP A40 and the predicate device. The side-by-side testing demonstrated that the BiPAP A40 is Substantially Equivalent to the predicate devices.

This device has been tested to appropriate ISO and IEC standards and other applicable requirements passing all test protocols. The BIPAP A40 was designed and tested according to:

. IEC 60601-1:1988, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and its Amendments All:1991 and A2:1 995
IEC 60601-1-2:2007, Medical electrical equipment -Part 1-2: General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
· EN ISO 8185 Humidifiers for Medical Use General Requirements for Humidification Systems
ISO 10651-6:2004; Lung ventilators for medical use Particular requirements for basic . safety and essential performance. Part 6: Home care ventilatory support devices.

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

FDA Draft Reviewer Guidance for Ventilators (July 1995) .
. FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical

Devices (May 11, 2005)

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Support System

Non-Clinical Testing

This device has been tested to appropriate collateral and particular ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols. The Respironics BiPAP A40 Ventilatory Support Systems was designed and tested according to guidance outlined in:

1. FDA Draft Reviewer Guidance for Premarket Notification Submissions Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and . Neurological Devices (November 1993);
1. FDA Draft Reviewer Guidance for Ventilators July 1995; and
1. FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).

Performance testing was conducted for the BiPAP A40 device using side-by-side bench testing methodologies to demonstrate that the BiPAP A40 performs to design input specifications. Bench testing for the BiPAP A40 device was conducted using both closed-loop and open-loop applications from patient test cases to verify that the BiPAP AV APS AE algorithm performs to specification. Bench testing conducted for the BiPAP A40 device characterized the types of worst-case scenario inputs that would be experienced in the intended use environment such as extreme flow rates, functional sensor malfunction, inaccuracy or complete sensor drop out and successfully demonstrated that the BiPAP A40 system responded safely under these conditions. The BiPAP A40 testing showed the device functions safely and effectively under worst case clinical scenarios (i.e. providing adequate pressure to maintain patent airway for a patient and avoiding over pressurization under defined clinical scenarios. The device adjusted to inter as well as intra patient variability.

Stability and safety of the AVAPS-AE algorithms is established by exception handling in the software to account for extreme flow rates or other cases which may otherwise cause unintended outputs. Bench test data demonstrated the algorithm's ability to safely change pressure support to maintain a target tidal volume in response to varying lung conditions. These changing lung conditions may be inter as well as intra patient variability. The bench test data demonstrated the algorithm's ability to safely adjust the EPAP setting within the prescription settings of EPAP

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BiPAP A40 Ventilatory Support System

minimum and maximum in response to changes in upper airway resistance. These changing resistances may be inter as well as intra patient variability. The algorithm monitors the patient's spontaneous breath rate during therapy and sets a target backup rate below the patient's spontaneous rate. The algorithm reset accounts for variable breath rates from patient.

Adverse Event Summary Information

The cited device predicate for the electro-mechanical (EM) device platform used for this submission is unchanged from the original clearance of the BiP APA30 device (K113053). To date, there are no adverse events histories for this device platform in the Maude Database. A search of the Maude Database for Product Code: cok Brand Name: Trilogy Report Date From: 01/01/2000 Report Date To: 03/31/2012 resulted in 8 records.

Of the 8 records, none were identified as being related to the EM platform of the BiPAP A40 device.

Substantial Equivalence

The modified device has the following similarities to the previously cleared predicate devices:

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

Design verification tests were performed on the Respironics BiPAP A40 Ventilatory Support as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device.

In summary, bench testing and comparative analysis has confirmed that the BiPAP A40 Ventilatory Support System performs equivalently to the cited predicate devices. I The indications for use, technological characteristics, and principles of operation are similar to the predicate devices.

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Premarket Notification – Abbreviated 510(k)

Philips Respironics BiPAP A40 Ventilatory Support System

The modifications that are the subject of this 510(k) submission have been validated using nonclinical tests and have been determined to be substantially equivalent. The Respironics BiPAP A40 Ventilatory Support System is substantially equivalent to the predicate devices listed above and the device, as changed, does not raise any new issues of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Public Health Service

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

December 14, 2012

Mr. Joseph E. Olsavsky Senior Manager, Regulatory Affairs Respironics, Incorporated 1740 Golden Mile Highway MONROEVILLE PA 15146

Re: K121623

Trade/Device Name: BiPAP A40 Ventilatory Support System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNT Dated: November 9, 2012 Received: November 13, 2012

Dear Mr. Olsavsky:

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, 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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Page 2 - Mr. Olsavsky

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 loase oc actives that I Dr a resume that your device complies with other requirements of the Act that I Dr Har Intal statutes and regulations administered by other Federal agencies. You must or any I ederal blances and 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 also quarty by tool 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 10 a 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 1807.97). 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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Premarket Notification - Abbreviated 510(k)

Philips Respironics BiPAP A40 Ventilatory Support System

Section 4.0 Indications for Use

Indications for Use

510(k) Number (if known): 402/623

Device Name: BiPAP A40 Ventilatory Support System

The BiPAP A40 ventilator is intended to provide invasive and non-invasive ventilatory support to treat adult and pediatric patients weighing over 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA), Respiratory Insufficiency, or Respiratory Failure. It is intended to be used in the home, institutional/hospital, and portable applications such as wheelchairs and gurneys.

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)

ിറ്റുമ്പോ!

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Albert E. Moyal Albert E. Moyal 2012.12.14 11:05:59 -02.00. for LS

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

Page 1 of 1

510(k) Number;_

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).