Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a wireless modem for data collection and transmission, with no mention of AI/ML capabilities or related concepts like algorithms, training data, or performance metrics typically associated with AI/ML.

Therapeutic

No
The device is described as a data collection tool and an accessory to a CPAP machine, providing wireless telemetry of usage and performance data. Its intended use explicitly states it is "not intended to be used as a diagnostic tool" and it doesn't directly treat or mitigate a disease or condition.

Diagnostic

No

The 'Intended Use / Indications for Use' section explicitly states: "It is not intended to be used as a diagnostic tool."

SaMD (Software as a Medical Device)

No

The device is described as a "Wireless Modem" and an "accessory to a DeVilbiss CPAP machine," which are hardware components. The performance studies also mention testing to hardware standards (ISO, ASTM, IEC, FCC).

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states it is a "data collection tool" and "It is not intended to be used as a diagnostic tool." IVDs are specifically designed for diagnostic purposes, typically involving the examination of samples from the human body.
Device Description: The description highlights its function as an "accessory to a DeVilbiss CPAP machine" for "automatic wireless telemetry of CPAP usage and performance data." This is related to monitoring and managing a pre-existing condition (sleep apnea, treated by CPAP), not diagnosing a condition.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or other processes typically associated with in vitro diagnostics.

Therefore, the DeVilbiss Healthcare DV6WM Wireless Modem falls outside the scope of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

BZD

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

home or healthcare environment.

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: 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:

Not specified (likely refers to general safety standards)
IEC 60601-1-2:2007 Ed. 3.0,
IEC 60601-1-11:2010 Ed. 1.0 + Corrigendum 1.0 (4-2011)
FCC Regulation 47 CFR Part 15 Radio Frequency Devices, Class B
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.

Key results: 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. 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.

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.

K082209 – DeVilbiss DV5M Smartlink System, K093684 Resmed EasyCare Online

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

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

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, stacked on top of each other.

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

1

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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FORM FDA 3881 (8/14)

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510(k) Summary

Administrative Information and Device Identification

| Name and address of the manufacturer and
sponsor of the 510(k) submission: | DeVilbiss Healthcare LLC
100 DeVilbiss Drive
Somerset, PA 15501 |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Official contact person for all
correspondence: | Betty Miller
Regulatory/Compliance Manager
Phone: 814-443-7606
Fax: 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 Smartlink
System
K093684 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:

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.

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 SmartLink
System (K082209) | Modified Device:
DeVilbiss DV6WM Wireless
Modem | Nature of
Change |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Indications for
Use Statement | EasyCare Online is intended to
augment the standard follow-
up care of patients diagnosed
with obstructive sleep apnea
by displaying usage and
therapeutic information that
has been transmitted from
the patient's flow generator
located in the home to the
care giver. EasyCare Online
also provides remote settings
capabilities.
It is intended to be used by
Clinicians in conjunction with
ResMed compatible flow
generators. | The DeVilbiss DV5M SmartLink
System in conjunction with a
DeVilbiss CPAP Unit is intended
for use in treating obstructive
sleep apnea in patients 30 Kg
and above. The system is not
intended to be used as a tool for
diagnosis of obstructive sleep
apnea (OSA) or related
disorders. It is intended to be
used to follow up the progress
of a patients previously
diagnosed with OSA or related
disorders treated with nasal
CPAP. The system is to be
used in home and clinical
environments. | The DeVilbiss Healthcare
DV6WM Wireless Modem is
intended for use as an
accessory to DeVilbiss
IntelliPAP Series with SmartLink
II Bluetooth module, IntelliPAP2,
and DeVilbiss Blue Series
CPAPs for patients in a home or
healthcare environment. | Similar to
predicate.
no impact on
safety or
effectiveness |
| Operating
Principle | Device reads data recorded
and stored in the Resmed S9
or higher Series CPAP,
encodes the data and transfers
data to a secure data server.
Data is viewed using an on-
line data management and
report generator web portal. | Device records data from a
DeVilbiss DV5 Series CPAP
while the CPAP is operating.
Internal storage of recorded
data is transferred to SmartLink
Desktop software via SD card
and stored in a local database.
SmartLink Desktop software
creates reports of CPAP usage
and performance. | Device reads data recorded and
stored in the DV6 Series CPAP,
encodes the data and sends to
a secure data server. Data is
downloaded into SmartLink
Desktop software from secure
data server and stored in a local
database. SmartLink Desktop
software creates reports of
CPAP usage and performance. | Similar to
predicate.
no impact on
safety or
effectiveness |
| Operating
Modes | Acts as a data transfer device,
transfers data from Resmed
S9 CPAP to a secure data
server. | Records data from CPAP,

Transfers data to
SmartLink Desktop
software via SD card. | Acts as a data transfer device.
Three modes of operation:
Wake, talking to CPAP,
reads recorded usage data
from CPAP
Wake, talking to server,
transfers CPAP data to a
secure data server
Sleep, low power mode,
waiting for next scheduled
call time | Similar to
predicate.
no impact on
safety or
effectiveness |
| 510(k) Product
Code | BZD (Ventilator, non-
continuous (respirator)) | BZD (Ventilator, non-continuous
(respirator)) | BZD (Ventilator, non-continuous
(respirator)) | Same as
predicate |
| Power
Requirements | Powered from host CPAP | Powered from host CPAP | Powered by internal
rechargeable Lithium Polymer
battery | Change to
internally
powered
device |
| Compliance
Monitoring | Transfers data recorded and
stored in the CPAP wirelessly
to a secure data server | Records 3 years of "while
breathing" ON/OFF compliance,
120 days of Daily Performance,
Rx change, approximately 72
hours of Oximetry, and Fault
logs | Transfers data recorded and
stored in the CPAP wirelessly to
a secure data server | Similar to
predicate.
no impact on
safety or
effectiveness |
| User interface | Shows info on host CPAP LCD
display | Shows info on host CPAP LCD
display | Shows status info on host CPAP
display
On proposed device: three LED
status indicators for battery,
Bluetooth and GSM (cellular);
One pushbutton to initiate a test
call | Change to
indicate new
functions.
no impact on
safety or
effectiveness |
| Characteristics | Predicate Device: | Predicate Device: | Modified Device: | Nature of Change |
| | Resmed EasyCare Online
(K093684) | DeVilbiss DV5M SmartLink
System (K082209) | DeVilbiss DV6WM Wireless
Modem | |
| Remote
settings change
function | Can change CPAP
prescription settings through
Wireless Modem from
EasyCare Online Software | Can change CPAP prescription
settings through SD Card from
SmartLink Desktop Software | Can change CPAP prescription
settings through Wireless
Modem from SmartLink Desktop
Software | Similar to
predicate.

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) | |
| Operating
atmospheric
pressure range | 101 to 77 kPa
(0 - 2286 m / 0 - 7500 ft) | 101 kPa to 74 kPa
Sea level to 9,000 feet
(0 to 2743 m) | 700 hPa to 1060 hPa
(~9800 ft to ~ 1400ft below sea
level) | |
| Shock and
Vibration | Not published | Unit shall be able to withstand a
drop from a height of 30"
IEC 68 Environmental Testing
ASTM D-4169 Testing of
Shipping Containers | Unit shall be able to withstand a
drop from a height of 30"
IEC 68 Environmental Testing
ASTM D-4169 Testing of
Shipping Containers | Same as
predicate. |
| IEC 60601-1
Classification | Type of Protection Against
Electric Shock: Class II
Equipment | Type of Protection Against
Electric Shock: Class II
Equipment | Type of Protection Against
Electric Shock: Internally
Powered ME Equipment | Change in
classification
to internally
powered
device, no
applied parts |
| | Degree of Protection Against
Electric Shock: Type BF
Applied Part | Degree of Protection Against
Electric Shock: Type BF Applied
Part | Degree of Protection Against
Electric Shock: N/A, No applied
part | no impact on
safety or
effectiveness |
| | Degree of Protection against
Ingress of Water (device & AC
power supply): Drip Proof,
IPX1 | Degree of Protection against
Ingress of Water (device & AC
power supply): Drip Proof, IPX1 | Degree of Protection against
Ingress of Water (device & AC
power supply): Drip Proof, IP21 | |
| | Mode of Operation:
Continuous Electrical | Mode of Operation: Continuous
Electrical | Mode of Operation:
Non-Continuous | |
| Standards | | | IEC 60601-1
EN ISO 17510-1
EN 60601-1-2
RTCA/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 |