The DeVilbiss Healthcare DV6WM Wireless Modem is intended to be used as a data collection tool for DeVilbiss IntelliPAP Series with SmartLink II Bluetooth module, IntelliPAP2, and DeVilbiss Blue Series CPAPs for patients in a home or healthcare environment. It is not intended to be used as a diagnostic tool.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DeVilbiss DV6WM Wireless Modem. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria for a new medical device function. Therefore, much of the requested information regarding specific performance metrics, sample sizes for test/training sets, expert adjudication, or MRMC studies for AI performance is not present.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish safety and effectiveness.

Here's a breakdown of the available information structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

This device is a wireless modem for CPAPs, not a diagnostic or therapeutic AI device. Its performance is evaluated against technical standards and the functionality of its predicate devices. The "acceptance criteria" here are compliance with relevant standards and functional equivalence.

Acceptance Criteria (Compliance/Functionality)	Reported Device Performance
Adherence to Standards:
IEC 60601-1-2:2007 Ed. 3.0 (EMC)	Device designed and tested to demonstrate compliance and passed all test protocols.
IEC 60601-1-11:2010 Ed. 1.0 (Home Use ME)	Device designed and tested to demonstrate compliance and passed all test protocols. Operating/Storage humidity/temperature ranges comply with this standard.
FCC Regulation 47 CFR Part 15 Radio Freq.	Device designed and tested to demonstrate compliance and passed all test protocols.
Wireless Standards (FCC Part 15, IC RSP-100,	Device designed and tested to demonstrate compliance and passed all test protocols.
RTTE 1999/5/EC)
IEC 62133 (LiPo Battery)	Internal LiPo battery certified to IEC 62133.
UN 38.3 (LiPo Battery)	Internal LiPo battery certified to UN 38.3.
Functional Equivalence:
Intended Use	Similar to predicate device (DeVilbiss DV5M SmartLink System K082209): Data collection tool for CPAPs, not for diagnosis.
Operating Principle	Similar to predicate device (Resmed EasyCare Online K093684): Wireless data transfer from CPAP to a secure data server using cellular technology. Uses Bluetooth for CPAP connection.
Operating Modes	Similar to predicate device (Resmed EasyCare Online K093684): Wake (read data, send data), Low Power Sleep. Functions include searching for Bluetooth devices, reading data, switching to GSM, contacting server, uploading data, and data integrity checks.
Compliance Monitoring	Similar to predicate device (Resmed EasyCare Online K093684): Reads data recorded by host CPAP and transfers to a secure data server. Does not record data itself.
Remote Settings Change Function	Similar to predicate devices: Accommodates wireless prescription settings updates from SmartLink Desktop software, relayed via secure data server and modem to the CPAP. Includes verification.
Power Requirements	Change from predicate (internally powered by rechargeable LiPo battery) allows for modem placement to optimize cellular signal. Safety of battery certified to IEC 62133 and UN 38.3.
User Interface	Modified to indicate new functions (three status LEDs for battery, Bluetooth, GSM; one pushbutton for test call). Status also displayed on host CPAP for IntelliPAP2/Blue Series. Considered to have "no impact on safety or effectiveness."
Environmental Ranges	Operating Temperature, Humidity, and Storage Temperature/Atmospheric Pressure ranges are within regulatory/standard limits (IEC 60601-1-11) and comparable/broader than predicate.
Physical Characteristics (Dimensions, Weight)	Similar to predicate device DeVilbiss DV5M SmartLink System (K082209).
Electrical Safety (IEC 60601-1 Classification)	Change in classification to "Internally Powered ME Equipment" with "No applied part" due to internal battery, no impact on safety or effectiveness. Degree of Protection against Ingress of Water is IP21 (Drip Proof).
Shock and Vibration	States "Same as predicate," implying it meets standards for a 30" drop, IEC 68, and ASTM D-4169.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable/not provided. The submission describes non-clinical engineering and usability testing, not performance on a dataset of clinical cases.
Data Provenance: Not applicable. The device's function is data transmission, not analysis of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not an AI/diagnostic device requiring expert ground truth for clinical cases.

4. Adjudication method for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a data collection tool, not an AI-powered diagnostic aid for human readers.

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

The device's standalone function is to wirelessly collect and transfer CPAP usage/performance data to a secure server. This function was confirmed through non-clinical testing against relevant standards. The "performance testing" section indicates this was verified by passing test protocols for communication, electrical safety, EMC, and environmental factors.

7. The type of ground truth used:

Not applicable. For a device like this, the "ground truth" would be the successful and accurate transmission of data from the CPAP to the server, and compliance with all technical safety standards. This is verified through engineering testing and certification rather than clinical ground truth like pathology or outcome data.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that uses a training set.

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

Not applicable.

Summary

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

January 21, 2016

DeVilbiss Healthcare, LLC c/o Paul Dryden President, ProMedic, Inc. 100 Devilbiss Drive Somerset. Pennsylvania 15501

Re: K152810

Trade/Device Name: DeVilbiss DV6WM Wireless Modem Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 20, 2015 Received: December 22, 2015

Dear Paul Dryden:

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K152810

Device Name

DeVilbiss DV6WM Wireless Modem

Indications for Use (Describe)

The DeVilbiss Healthcare DV6WM Wireless Modem is intended to be used as a data collection tool for DeVilbiss IntelliPAP Series with SmartLink II Bluetooth module. IntelliPAP2. and DeVilbiss Blue Series CPAPs for patients in a home or healthcare environment. It is not intended to be used as a diagnostic tool.

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Administrative Information and Device Identification

Name and address of the manufacturer andsponsor of the 510(k) submission:	DeVilbiss Healthcare LLC100 DeVilbiss DriveSomerset, PA 15501
Official contact person for allcorrespondence:	Betty MillerRegulatory/Compliance ManagerPhone: 814-443-7606Fax: 814-443-7575
Date Prepared:	December 20, 2015
Device Name:	DeVilbiss DV6WM Wireless Modem
Proprietary name of new device:	DeVilbiss DV6WM Wireless Modem
Common or usual name of the device:	ventilator, non-continuous (respirator)
DeVilbiss Model Number	DV6WM-NA, DV6WM-EU, DV6WM-UK
Classification	Class II
Panel Code:	73 BZD
CFR Regulation Number:	21 CFR 868.5905
Predicate Device Name(s) and 510(k)number(s):	K082209 – DeVilbiss DV5M SmartlinkSystemK093684 Resmed EasyCare Online

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Description of Device:

The proposed DeVilbiss DV6WM Wireless Modem is an accessory to a DeVilbiss CPAP machine. The proposed device provides automatic wireless telemetry of CPAP usage and performance data to a healthcare provider. Predicate devices DeVilbiss DV5M Smartlink System (K082209) and Resmed EasyCare Online (K093684) operate by the same basic principal of transferring CPAP data from a therapy device to a PC program for storing and reporting patient usage and machine performance. Predicate device Resmed EasyCare Online (K093684) is used for comparison of data transfer through a cellular data network.

The proposed DeVilbiss DV6WM Wireless Modem is similar in size, shape and functionality to the predicate with the following modifications

Bluetooth wireless communication
Cellular wireless communication ●
Rechargeable Lithium Polymer battery power

Indications for Use:

Comparison of Device Technological Characteristics to Predicate Devices:

The proposed DeVilbiss DV6WM Wireless Modem has the following similarities to those which previously received 510(k) concurrence:

. Has the same intended use
Uses the same operating principle

Modifications that were made:

Bluetooth wireless communication ●
Cellular wireless communication .
Rechargeable Lithium Polymer battery power ●

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Comparison of Similarities and Differences:

Characteristics	Predicate Device:Resmed EasyCare Online(K093684)	Predicate Device:DeVilbiss DV5M SmartLinkSystem (K082209)	Modified Device:DeVilbiss DV6WM WirelessModem	Nature ofChange
Indications forUse Statement	EasyCare Online is intended toaugment the standard follow-up care of patients diagnosedwith obstructive sleep apneaby displaying usage andtherapeutic information thathas been transmitted fromthe patient's flow generatorlocated in the home to thecare giver. EasyCare Onlinealso provides remote settingscapabilities.It is intended to be used byClinicians in conjunction withResMed compatible flowgenerators.	The DeVilbiss DV5M SmartLinkSystem in conjunction with aDeVilbiss CPAP Unit is intendedfor use in treating obstructivesleep apnea in patients 30 Kgand above. The system is notintended to be used as a tool fordiagnosis of obstructive sleepapnea (OSA) or relateddisorders. It is intended to beused to follow up the progressof a patients previouslydiagnosed with OSA or relateddisorders treated with nasalCPAP. The system is to beused in home and clinicalenvironments.	The DeVilbiss HealthcareDV6WM Wireless Modem isintended for use as anaccessory to DeVilbissIntelliPAP Series with SmartLinkII Bluetooth module, IntelliPAP2,and DeVilbiss Blue SeriesCPAPs for patients in a home orhealthcare environment.	Similar topredicate.no impact onsafety oreffectiveness
OperatingPrinciple	Device reads data recordedand stored in the Resmed S9or higher Series CPAP,encodes the data and transfersdata to a secure data server.Data is viewed using an on-line data management andreport generator web portal.	Device records data from aDeVilbiss DV5 Series CPAPwhile the CPAP is operating.Internal storage of recordeddata is transferred to SmartLinkDesktop software via SD cardand stored in a local database.SmartLink Desktop softwarecreates reports of CPAP usageand performance.	Device reads data recorded andstored in the DV6 Series CPAP,encodes the data and sends toa secure data server. Data isdownloaded into SmartLinkDesktop software from securedata server and stored in a localdatabase. SmartLink Desktopsoftware creates reports ofCPAP usage and performance.	Similar topredicate.no impact onsafety oreffectiveness
OperatingModes	Acts as a data transfer device,transfers data from ResmedS9 CPAP to a secure dataserver.	Records data from CPAP,1. Transfers data to2. SmartLink Desktopsoftware via SD card.	Acts as a data transfer device.Three modes of operation:1. Wake, talking to CPAP,reads recorded usage datafrom CPAP2. Wake, talking to server,transfers CPAP data to asecure data server3. Sleep, low power mode,waiting for next scheduledcall time	Similar topredicate.no impact onsafety oreffectiveness
510(k) ProductCode	BZD (Ventilator, non-continuous (respirator))	BZD (Ventilator, non-continuous(respirator))	BZD (Ventilator, non-continuous(respirator))	Same aspredicate
PowerRequirements	Powered from host CPAP	Powered from host CPAP	Powered by internalrechargeable Lithium Polymerbattery	Change tointernallypowereddevice
ComplianceMonitoring	Transfers data recorded andstored in the CPAP wirelesslyto a secure data server	Records 3 years of "whilebreathing" ON/OFF compliance,120 days of Daily Performance,Rx change, approximately 72hours of Oximetry, and Faultlogs	Transfers data recorded andstored in the CPAP wirelessly toa secure data server	Similar topredicate.no impact onsafety oreffectiveness
User interface	Shows info on host CPAP LCDdisplay	Shows info on host CPAP LCDdisplay	Shows status info on host CPAPdisplayOn proposed device: three LEDstatus indicators for battery,Bluetooth and GSM (cellular);One pushbutton to initiate a testcall	Change toindicate newfunctions.no impact onsafety oreffectiveness
Characteristics	Predicate Device:	Predicate Device:	Modified Device:	Nature of Change
	Resmed EasyCare Online(K093684)	DeVilbiss DV5M SmartLinkSystem (K082209)	DeVilbiss DV6WM WirelessModem
Remotesettings changefunction	Can change CPAPprescription settings throughWireless Modem fromEasyCare Online Software	Can change CPAP prescriptionsettings through SD Card fromSmartLink Desktop Software	Can change CPAP prescriptionsettings through WirelessModem from SmartLink DesktopSoftware	Similar topredicate.no impact onsafety oreffectiveness
OperatingTemperatureRange	Operating Temperature:+5° to +35° C(+41° to +95° F)	Operating Temperature:+5 to +40 °C.(+41°F to +104°F)	Operating Temperature:+5 °C to +40 °C(+41°F to +104°F)	Same aspredicate.
OperatingHumidityRange	Relative Humidity:15 to 95% (non-condensing)	Relative Humidity:0 to 95% (non-condensing)	Relative Humidity:15 % to 93 % (non-condensing)
StorageTemperatureRange	Storage Temperature:-20° to 60°C(-4° to 140° F)	Storage Temperature:- 40°C to + 70°C(-40 to +158 °F)	Storage Temperature:- 25°C to + 70°C(-13 to +158 °F)
	Relative Humidity:15 to 95% (non-condensing)	Relative Humidity:0% to 95% (non-condensing)	Relative Humidity:15% to 93% (non-condensing)
Operatingatmosphericpressure range	101 to 77 kPa(0 - 2286 m / 0 - 7500 ft)	101 kPa to 74 kPaSea level to 9,000 feet(0 to 2743 m)	700 hPa to 1060 hPa(~9800 ft to ~ 1400ft below sealevel)
Shock andVibration	Not published	Unit shall be able to withstand adrop from a height of 30"IEC 68 Environmental TestingASTM D-4169 Testing ofShipping Containers	Unit shall be able to withstand adrop from a height of 30"IEC 68 Environmental TestingASTM D-4169 Testing ofShipping Containers	Same aspredicate.
IEC 60601-1Classification	Type of Protection AgainstElectric Shock: Class IIEquipment	Type of Protection AgainstElectric Shock: Class IIEquipment	Type of Protection AgainstElectric Shock: InternallyPowered ME Equipment	Change inclassificationto internallypowereddevice, noapplied parts
	Degree of Protection AgainstElectric Shock: Type BFApplied Part	Degree of Protection AgainstElectric Shock: Type BF AppliedPart	Degree of Protection AgainstElectric Shock: N/A, No appliedpart	no impact onsafety oreffectiveness
	Degree of Protection againstIngress of Water (device & ACpower supply): Drip Proof,IPX1	Degree of Protection againstIngress of Water (device & ACpower supply): Drip Proof, IPX1	Degree of Protection againstIngress of Water (device & ACpower supply): Drip Proof, IP21
	Mode of Operation:Continuous Electrical	Mode of Operation: ContinuousElectrical	Mode of Operation:Non-Continuous
Standards			IEC 60601-1EN ISO 17510-1EN 60601-1-2RTCA/DO-160 section 21,category M
Dimensions	39.6mm x 54.1mm x 125.0mm	3.9" H x 3.1" W x 1.4" D(9.9cm H x 7.9cm W x 3.6cm D)	4.4"H x 3"W x 1"D(11.2cm x 7.6cm x 2.5cm)
Weight	< 100 g	0.30 lbs. (0.14 Kg)	0.35 lbs. (158.8 g)

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Discussion of Substantial Equivalence and Differences:

Indications for Use

Similar to predicate device DeVilbiss DV5M SmartLink System (K082209). The proposed DeVilbiss DV6WM Wireless Modem is intended to be used as a data collection tool for DeVilbiss IntelliPAP Series with SmartLink II Bluetooth module, IntelliPAP2, and DeVilbiss Blue Series CPAPs and is not intended to be used as a diagnostic tool. Although the method of data retrieval is different, the purpose of collecting data is the same.

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Operating Principle

Similar to predicate device Resmed EasyCare Online (K093684). The proposed DeVilbiss DV6WM Wireless Modem operates as a wireless data transfer device, similar to the predicate Resmed EasyCare Online (K093684). Both devices use GSM cellular telephone technology to send data recorded by the patient's CPAP to a remote data server for access by a healthcare provider. The proposed DeVilbiss DV6WM Wireless Modem uses a wireless link to the patient's CPAP device whereas the predicate Resmed EasyCare Online (K093684) physically and electrically attaches to the patient's CPAP device. The physical separation of the proposed DeVilbiss DV6WM Wireless Modem allows the user to locate the modem where it can get a sufficient cellular signal to connect to the remote data server, and still be in Bluetooth range of the patient's CPAP device. The proposed DeVilbiss DV6WM Wireless Modem completes a data transfer once per day.

Operating Modes

Similar to predicate device Resmed EasyCare Online (K093684). The proposed DeVilbiss DV6WM Wireless Modem has three modes of operation; 1) Wake, reading data from a CPAP, 2) Wake, sending data to secure data server, 3) Low Power Sleep. The proposed DeVilbiss DV6WM Wireless Modem is normally in a low power sleep mode. The proposed DeVilbiss DV6WM Wireless Modem wakes from low power sleep mode by either user pressing the Test Call button or at a scheduled call time. When the proposed DeVilbiss DV6WM Wireless Modem wakes to begin a call cycle, it searches for new Bluetooth devices in range, searches for the target device and processes any new pair requests. Data is read from any paired CPAP devices in range, up to ten devices. After all CPAP data has been read, the Bluetooth radio is switched off and the GSM cellular radio is switched on. The proposed DeVilbiss DV6WM Wireless Modem proceeds to find cellular service, contact the secure data server and upload data read from the CPAPs to the secure data server. The secure data server receives and checks the data integrity and responds to the proposed DeVilbiss DV6WM Wireless Modem that the data was received or has errors. If the data was received without errors, the modem clears data on the CPAP. If the data was received with errors, the modem does not clear data on the CPAP so it is available for the next call. The proposed DeVilbiss DV6WM Wireless Modem cannot be contacted through the cellular phone system, it only makes outgoing calls, and it does not receive calls.

The predicate device Resmed EasyCare Online (K093684) wireless modem device attached to a host Resmed CPAP and is powered by the host CPAP. The wireless modem sends CPAP data to a secure data server. The data is stored in an online data base and viewed online using a web browser and login credentials.

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Power Requirements

The proposed DeVilbiss DV6WM Wireless Modem is internally powered by a rechargeable Lithium Polymer (LiPo) battery. The internal LiPo battery is certified to IEC 62133 and UN 38.3, as required by IEC 60601-1 3rd Edition. The LiPo battery allows placement of the modem where it can place cellular calls while in Bluetooth range of the target CPAP.

The predicate devices Resmed EasyCare Online (K093684) and DeVilbiss DV5M SmartLink System (K082209) are physically and electrically attached to the host CPAP device, receiving power from the host CPAP device.

Compliance Monitoring

Similar to predicate device Resmed EasyCare Online (K093684). The proposed DeVilbiss DV6WM Wireless Modem reads data recorded by the host CPAP and transfers the data to a secure data server. The proposed DeVilbiss DV6WM Wireless Modem does not record data and only stores data temporarily during transfer to the secure data server. The predicate device Resmed EasyCare Online (K093684) performs the same function, transferring data recorded by the host CPAP to a secure data server.

User interface

Changed to indicate new functions on proposed device. The proposed DeVilbiss DV6WM Wireless Modem user interface consists of three status LEDs and one pushbutton. The status LEDs indicate status of battery and activity of Bluetooth and GSM (cellular) radio. The proposed DeVilbiss DV6WM Wireless Modem sends status information to a DeVilbiss IntelliPAP2/DeVilbiss Blue Series CPAP during a call sequence. The status information tells the user the battery charge level, Bluetooth signal strength and cellular signal strength. It also indicates the modem serial number and number of days since the last time data was sent to the server. DeVilbiss IntelliPAP Series CPAPs do not display modem status information, this information is available in patient records and reports in DeVilbiss SmartLink Desktop Software.

Functions of the predicate device DeVilbiss DV5M SmartLink System (K082209) that display usage summary information are built into the DV6x Series CPAP.

Remote settings change function

Similar to predicate device Resmed EasyCare Online (K093684) and predicate device DeVilbiss DV5M SmartLink System (K082209). The predicate device Resmed EasyCare Online (K093684) accommodates a similar method of updating CPAP settings. A healthcare provider can modify the CPAP settings on the EasyCare Online web interface. The Resmed wireless modem receives the setting update from the EasyCare Online secure data server and applies them to the patient's CPAP.

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The proposed DeVilbiss DV6WM Wireless Modem accommodates wireless prescription settings updates in the same manner that the predicate device DeVilbiss DV5M SmartLink System (K082209) accommodates prescription setting updates via SD card. The healthcare provider modifies CPAP settings for the patient's assigned CPAP device within SmartLink Desktop software. When saving the setting changes, the SmartLink Desktop software provides 3 ways to update settings on the patient's CPAP device; 1) direct wired connection of CPAP to PC, 2) SD card transfer, 3) Wireless Modem. Options 1) and 2) are part of predicate device DeVilbiss DV5M SmartLink System (K082209). Option 3) is new for the wireless modem, settings are sent to the secure data server and relayed to the wireless modem that is associated with the patient's CPAP serial number. When the modem makes a connection to the CPAP, the settings are updated by the modem and verified. New settings are sent back to the secure data server and a notification is posted for the patient's CPAP serial number that the new settings were applied. The setting update is acknowledged in SmartLink Desktop software on the next download form the secure data server for the healthcare provider to verify that the patient's device has been updated.

Operating Humidity Range

Similar to predicate device DeVilbiss DV5M SmartLink System (K082209). The proposed DeVilbiss DV6WM Wireless Modem complies with requirements IEC 60601-1-11 Medical Devices intended for Home Use. The operating humidity range is more narrow and within the range of the predicate device DeVilbiss DV5M SmartLink System (K082209)

Storage Temperature Range

Changed storage temperature range to comply with IEC 60601-1-11. The proposed DeVilbiss DV6WM Wireless Modem complies with requirements IEC 60601-1-11 Medical Devices intended for Home Use. The storage temperature range is more narrow and within the range of the predicate device DeVilbiss DV5M SmartLink System (K082209)

Operating atmospheric pressure range

Changed atmospheric pressure range to comply with IEC 60601-1-11. The proposed DeVilbiss DV6WM Wireless Modem complies with requirements IEC 60601-1-11 Medical Devices intended for Home Use. The atmospheric pressure range is broader than the predicate device DeVilbiss DV5M SmartLink System (K082209).

Dimensions

The proposed DeVilbiss DV6WM Wireless Modem is similar in size to the predicate device DeVilbiss DV5M SmartLink System (K082209).

Weight

The proposed DeVilbiss DV6WM Wireless Modem is similar in weight to the predicate device DeVilbiss DV5M SmartLink System (K082209).

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Performance Testing

Non-Clinical Testing:

This device has been tested to appropriate ISO. ASTM. and IEC standards and other applicable requirements passing all test protocols. The proposed DeVilbiss DV6WM Wireless Modem was designed and tested to demonstrate compliance with the applicable sections of the following standards:

1. IEC 60601-1-2:2007 Ed. 3.0,
1. IEC 60601-1-11:2010 Ed. 1.0 + Corrigendum 1.0 (4-2011)
1. FCC Regulation 47 CFR Part 15 Radio Frequency Devices, Class B
1. Wireless Standards
- FCC Part 15 .
  - Industry Canada RSP-100
  - European wireless standard RTTE directive 1999/5/EC ●

Human usability validation was conducted with lay users and clinical users to focus on critical and essential tasks as per analysis of user tasks, and evaluation of use reports for similar devices. Any harm that could result from task failures is described in the usability report. Subjective assessments from all participants, particularly in the case of task failures, were collected and analyzed as part of the usability validation.

Clinical Testing:

No clinical testing was necessary to demonstrate the safety and effectiveness of the proposed DV6WM Wireless Modem.

Statement of Safety and Effectiveness:

Analysis of comparison of design, function and features of the proposed DV6WM Wireless Modem to the predicates DV5M SmartLink System (K082209) and Resmed EasyCare Online (K093684), together with the results of testing demonstrate the device to be substantially equivalent to the predicate devices in terms of meeting performance criteria and functioning as intended.

Conclusion:

The test methods used are the similar to those submitted in the original predicate device submission, updated to reflect new versions of standards and FDA quidance. The proposed DeVilbiss DV6WM Wireless Modem meets all applicable FDA recognized consensus standards. Based on these results, the proposed device, as changed, is substantially equivalent to the following predicate devices: DeVilbiss DV5M SmartLink System (K082209) and Resmed EasyCare Online (K093684) and does not raise any new issues of safety and effectiveness.

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).