(119 days)
Not Found
No
The device description focuses on data collection and wireless transmission, with no mention of AI/ML algorithms for analysis or interpretation.
No.
The device is described as an accessory that collects usage and performance data from a CPAP system, not as a device that delivers therapy itself.
No
This device is described as an accessory that collects usage and performance data from a CPAP system for follow-up of obstructive sleep apnea. It does not perform a diagnosis itself but aids in monitoring therapy.
No
The device description explicitly states it is a physical accessory that connects electrically to a CPAP system and includes a Bluetooth module with a built-in antenna, indicating it is a hardware device with software components, not a software-only device.
Based on the provided information, the DeVilbiss DV5MB SmartLink II System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to collect usage and performance data from a CPAP system for follow-up of obstructive sleep apnea. This is related to monitoring the performance of a therapeutic device and patient adherence to therapy, not performing a diagnostic test on a biological sample.
- Device Description: The device is described as an accessory that connects to a CPAP to collect data. It does not interact with biological samples or perform any analysis on them.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information based on laboratory testing
The device's function is purely data collection and transmission related to the operation of the CPAP machine.
N/A
Intended Use / Indications for Use
The DeVilbiss DV5MB SmartLink II System can only be used in conjunction with the DeVilbiss DV51, DV53, DV54, DV55, DV56, and DV57 Series CPAP Systems for follow up of obstructive sleep apnea in patients weighing above 30 kg on nasal CPAP therapy. The system is to be used in home and healthcare environments.
Product codes
BZD
Device Description
The proposed DeVilbiss DV5MB SmartLink II System is an accessory to DeVilbiss IntelliPAP DV5x Series CPAPs, models DV51, DV53, DV54, DV55, DV56 and DV57. The proposed DeVilbiss DV5MB SmartLink II System connects physically and electrically to a DV5x Series CPAP for the purpose of collecting usage and performance data from the CPAP for subsequent download to PC software for storage, viewing and reporting.
The proposed DeVilbiss DV5MB SmartLink II System is identical to the predicate device with the addition of a Bluetooth Wireless connection. The Bluetooth radio used is a complete Bluetooth module with built in antenna and Bluetooth v2.1 + EDR. The maximum output power of the Bluetooth radio is +2.5 dBm, has a maximum range of 10 meters. The DeVilbiss DV5MB SmartLink II System wireless feature can be used in the home or in a healthcare setting.
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
patients weighing above 30 kg
Intended User / Care Setting
home and healthcare environments
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 and IEC standards and other applicable requirements passing all test protocols. The proposed DeVilbiss DV5MB SmartLink II has been fully tested to demonstrate compliance with the applicable sections of the following standards:
-
- IEC 60601-1-1:2000 Medical Electrical Equipment—Part 1: General Requirements for Safety; Safety Requirements for Medical Electrical Systems
-
- IEC 60601–1–2:2007 Ed 3.0 Medical Electrical Equipment—Part 1: General Requirements for Safety; Electromagnetic Compatibility Requirements and Tests
-
- IEC 60601-1-4:2000 Consol. Ed. 1.1. Medical electrical equipment Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems, edition 1.1.
-
- ISO 14971:2012 Medical devices Application of risk management to medical devices
-
- EN55011:2007 Industrial, scientific and medical (ISM) radio-frequency equipment -Radio disturbance characteristics - Limits and methods of measurements
-
- IEC 529 (1989): Classification of Degrees of Protection Provided by Enclosures
-
- IEC 68 (1988): Environmental Testing
-
- ISTA Procedure 3A Package –Products for Parcel Delivery System Shipments 70kg (150lb) or less
-
- FCC Requlation 47 CFR Part 15 Radio Frequency Devices, Class B
Additional design considerations were applied based on published quidance and draft quidance documents from FDA:
-
- FDA Reviewer Guidance for Premarket Notification Submissions (Anesthesiology and Respiratory Device Branches, November 1993)
-
- DRAFT FDA Guidance Design Considerations for Devices Intended for Home Use Dec 12- 2012
-
- DRAFT FDA Guidance Cybersecurity in Medical Devices 6-13-13
-
- FDA Guidance Radio Frequency Wireless Technology in Medical Devices Aug 14-2013
The proposed DeVilbiss DV5MB SmartLink II System in conjunction with a DeVilbiss CPAP Unit meets the required performance criteria and functioned as intended. See Section 12.0 and Section 9.0.
Clinical Testing:
No clinical testing or clinical performance evaluations were conducted on the proposed DeVilbiss DV5MB SmartLink II relating to clinical studies to demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DeVilbiss DV5M SmartLink System (K082209)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms, possibly representing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2014
DeVilbiss Healthcare LLC Ms. Betty Miller Regulatory/Compliance Manager 100 DeVilbiss Drive Somerset, PA 15501
Re: K140880
Trade/Device Name: DeVilbiss DV5MB Smartlink II System Regulation Number: 21 CFR 868.5905 Regulation Name: Ventilator, Non-Continuous Respirator Regulatory Class: II Product Code: BZD Dated: July 1, 2014 Received: July 3, 2014
Dear Ms. Miller:
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.
1
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 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 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/Resourcesfor You/Industry/default.htm. 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 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. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number: (if known):_
Device Name: DeVilbiss DV5MB Smartlink II Svstem
The DeVilbiss DV5MB SmartLink II System can only be used in conjunction with the DeVilbiss DV51, DV53, DV54, DV55, DV56, and DV57 Series CPAP Systems for follow up of obstructive sleep apnea in patients weighing above 30 kg on nasal CPAP therapy. The system is to be used in home and healthcare environments.
| Prescription Use _____________________________________________________________________________________________________________________________________________________________ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/2/Picture/7 description: The image shows the FDA logo. The logo is a stylized version of the letters "FDA". The letters are white and are outlined in a slightly darker shade of white. The logo is simple and modern.
Anya C. Harry -S 2014.08.01 14:18:20 -04'00'
Page of of a
3
Section 5.0 510(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 |
|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA registration number of the manufacturer
of the new device: | 2515872 |
| Official contact person for all
correspondence: | Betty Miller
Regulatory/Compliance Manager
DeVilbiss Healthcare LLC
100 DeVilbiss Drive
Somerset, PA 15501
Phone: 814-443-7606
Fax: 814-443-7575
Email: betty.miller@devilbisshc.com |
| Date Prepared: | 03/21/2014 |
| Device Name: | DeVilbiss DV5MB SmartLink II |
| Proprietary name of new device: | DeVilbiss DV5MB SmartLink II System |
| Common or usual name of the device: | SmartLink II |
| DeVilbiss Model Number | DV5MB |
| Classification of the predicate device: | Class II |
| Classification of new device: | Class II |
| Classification Panel: | Anesthesiology |
| Panel Code: | BZD |
| CFR Regulation Number: | 21 CFR 868.5905 Ventilator, non-
continuous respirator |
| Predicate Device Name(s) and 510(k)
number(s): | DeVilbiss DV5M SmartLink System
(K082209) |
4
Description of Device:
The proposed DeVilbiss DV5MB SmartLink II System is an accessory to DeVilbiss IntelliPAP DV5x Series CPAPs, models DV51, DV53, DV54, DV55, DV56 and DV57. The proposed DeVilbiss DV5MB SmartLink II System connects physically and electrically to a DV5x Series CPAP for the purpose of collecting usage and performance data from the CPAP for subsequent download to PC software for storage, viewing and reporting.
The proposed DeVilbiss DV5MB SmartLink II System is identical to the predicate device with the addition of a Bluetooth Wireless connection. The Bluetooth radio used is a complete Bluetooth module with built in antenna and Bluetooth v2.1 + EDR. The maximum output power of the Bluetooth radio is +2.5 dBm, has a maximum range of 10 meters. The DeVilbiss DV5MB SmartLink II System wireless feature can be used in the home or in a healthcare setting.
Comparison of Device Technological Characteristics to Predicate Devices:
The proposed DeVilbiss DV5MB SmartLink II Module has the following similarities to those which previously received 510(k) concurrence:
- Has the same intended use
- Uses the same operating principle
- Incorporates similar materials ●
The only modifications that were made are:
- . Added Bluetooth Wireless communication interface
| Feature | Predicate Device:
DeVilbiss DV5M SmartLink
System (K082209) | Modified Device:
DeVilbiss DV5MB SmartLink
II System | Nature of
Change |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Statement | 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 to be
used in home and healthcare
environments. | The DeVilbiss DV5MB
SmartLink II 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 to be
used in home and healthcare
environments. | Same as
predicate. |
| Feature | Predicate Device:
DeVilbiss DV5M SmartLink
System (K082209) | Modified Device:
DeVilbiss DV5MB SmartLink
II System | Nature of
Change |
| Indications for
Use Statement | The DeVilbiss DV5M
SmartLink System can only
be used in conjunction with
the DeVilbiss DV51, and
DV54 Series CPAP Systems
for follow up of obstructive
sleep apnea in patients
weighing above 30 kg on
nasal CPAP therapy | The DeVilbiss DV5MB
SmartLink II System can
only be used in conjunction
with the DeVilbiss DV51,
DV53, DV54, DV55, DV56,
and DV57 Series CPAP
Systems for follow up of
obstructive sleep apnea in
patients weighing above 30
kg on nasal CPAP therapy.
The system is to be used in
home and healthcare
environments. | Add
compatibility
with additional
DV5x Series
CPAP models.
No impact on
safety or
effectiveness. |
| Compliance
recording | Records 3 years of "while
breathing" ON/OFF
compliance, 120 days of Daily
Performance, Rx change,
approximately 72 hours of
Oximetry, and Fault logs | Records 3 years of "while
breathing" ON/OFF
compliance, 120 days of Daily
Performance, Rx change,
approximately 72 hours of
Oximetry, and Fault logs | Same as
predicate. |
| User interface | The DeVilbiss DV5M
SmartLink Module is
designed to mechanically and
electrically attach to a DV5x
series CPAP. The module
uses the onboard Keypad/
Display of the DV5x CPAP as
the user interface. The user
interface is located on the top
of the DV5x CPAP and
consists of a 6 button keypad
and a 2x16 LCD Display. | The DeVilbiss DV5MB
SmartLink II System is
designed to mechanically and
electrically attach to a DV5x
series CPAP. The module
uses the onboard Keypad/
Display of the DV5x CPAP as
the user interface. The user
interface is located on the top
of the DV5x CPAP and
consists of a 6 button keypad
and a 2x16 LCD Display. | Same as
predicate. |
| Oximeter
Function | The DeVilbiss DV5M
SmartLink Module uses an
optional Nonin oximeter to log
SpO2 and Pulse Rate at 4-
second intervals. | The DeVilbiss DV5MB
SmartLink II System uses an
optional Nonin oximeter to log
SpO2 and Pulse Rate at 4-
second intervals. | Same as
predicate. |
| Feature | Predicate Device:
DeVilbiss DV5M SmartLink
System (K082209) | Modified Device:
DeVilbiss DV5MB SmartLink
II System | Nature of
Change |
| Software
Function | The SmartLink software is
used to display data as it is
recorded from the module.
The software stores data in a
data based structure and has
querying and reporting
functionality. | The SmartLink software is
used to display data as it is
recorded from the module.
The software stores data in a
data based structure and has
querying and reporting
functionality. (See Section
16.0 software section) | Improvements
to user interface
and
performance.
No impact on
safety or
effectiveness. |
| Remote settings
change function | CPAP Settings can be
changed through an SD card,
settings are programmed
through SmartLink Desktop
software. | CPAP Settings can be
changed through an SD card,
settings are programmed
through SmartLink Desktop
software. | Same as
predicate. |
| Remote control
function | Wired RS232 connection to a
distance of up to 200 feet. | Wired RS232 connection to a
distance of up to 200 feet.
Wireless Bluetooth
connection to a distance of up
to 33 feet. | Added
Bluetooth
wireless
communication,
operates same
as wired RS232
connection.
No impact on
safety or
effectiveness. |
| Means of Data
Transfer | Memory card or
wired RS232 connection | Memory card or
wired RS232 connection | Same as
predicate. |
| Environmental
Specifications | Operating temperature:
5 to +40 °C.
Operating humidity range: 0
to 95% R.H. non condensing
Storage temperature range:
-40 to +70 °C
Storage humidity range: 0 to
95% R.H. non-condensing | Operating temperature:
5 to +40 °C.
Operating humidity range: 0
to 95% R.H. non condensing
Storage temperature range:
-40 to +70 °C
Storage humidity range: 0 to
95% R.H. non-condensing | Same as
predicate. |
| Power
Requirements | The DeVilbiss DV5M
SmartLink Module is not
equipped with an on-board
power supply. It only
receives its power (12 VDC)
from the DV5x Series CPAP
device during operation. | The DeVilbiss DV5MB
SmartLink II System is not
equipped with an on-board
power supply. It only
receives its power (12 VDC)
from the DV5x Series CPAP
device during operation. | Same as
predicate. |
| Feature | Predicate Device:
DeVilbiss DV5M SmartLink
System (K082209) | Modified Device:
DeVilbiss DV5MB SmartLink
II System | Nature of
Change |
| 510(k) Product
Code | BZD (Ventilator, non-
continuous (respirator)) | BZD (Ventilator, non-
continuous (respirator)) | Same as
predicate. |
| Materials
comparison | | | |
| Enclosure | GE Plastics Cycoloy
CX2244ME PC/ABS Blend
FR30U - Meets UL94 V-0
flame retardant spec. (P/N:
420-0200-004) | GE Plastics Cycoloy
CX2244ME PC/ABS Blend
FR30U - Meets UL94 V-0
flame retardant spec. (P/N:
420-0200-004) | Same as
predicate. |
Comparison of Similarities and Differences:
5
6
7
Statement of Intended Use:
The DeVilbiss DV5MB SmartLink II System can only be used in conjunction with the DeVilbiss DV51, DV53, DV54, DV55, DV56, and DV57 Series CPAP Systems for follow up of obstructive sleep apnea in patients weighing above 30 kg on nasal CPAP therapy. The system is to be used in home and healthcare environments.
Non-Clinical Testing:
This device has been tested to appropriate ISO and IEC standards and other applicable requirements passing all test protocols. The proposed DeVilbiss DV5MB SmartLink II has been fully tested to demonstrate compliance with the applicable sections of the following standards:
-
- IEC 60601-1-1:2000 Medical Electrical Equipment—Part 1: General Requirements for Safety; Safety Requirements for Medical Electrical Systems
-
- IEC 60601–1–2:2007 Ed 3.0 Medical Electrical Equipment—Part 1: General Requirements for Safety; Electromagnetic Compatibility Requirements and Tests
-
- IEC 60601-1-4:2000 Consol. Ed. 1.1. Medical electrical equipment Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems, edition 1.1.
-
- ISO 14971:2012 Medical devices Application of risk management to medical devices
-
- EN55011:2007 Industrial, scientific and medical (ISM) radio-frequency equipment -Radio disturbance characteristics - Limits and methods of measurements
-
- IEC 529 (1989): Classification of Degrees of Protection Provided by Enclosures
-
- IEC 68 (1988): Environmental Testing
8
-
- ISTA Procedure 3A Package –Products for Parcel Delivery System Shipments 70kg (150lb) or less
-
- FCC Requlation 47 CFR Part 15 Radio Frequency Devices, Class B
Additional design considerations were applied based on published quidance and draft quidance documents from FDA:
-
- FDA Reviewer Guidance for Premarket Notification Submissions (Anesthesiology and Respiratory Device Branches, November 1993)
-
- DRAFT FDA Guidance Design Considerations for Devices Intended for Home Use Dec 12- 2012
-
- DRAFT FDA Guidance Cybersecurity in Medical Devices 6-13-13
-
- FDA Guidance Radio Frequency Wireless Technology in Medical Devices Aug 14-2013
The proposed DeVilbiss DV5MB SmartLink II System in conjunction with a DeVilbiss CPAP Unit meets the required performance criteria and functioned as intended. See Section 12.0 and Section 9.0.
Clinical Testing:
No clinical testing or clinical performance evaluations were conducted on the proposed DeVilbiss DV5MB SmartLink II relating to clinical studies to demonstrate substantial equivalence to the predicate device.
Conclusion:
The proposed DeVilbiss DV5MB SmartLink II System is substantially equivalent to the predicate DV5M SmartLink Compliance Module (K082209) and the device, as changed, does not raise any new issues of safety and effectiveness.
Analysis of comparison of design, function and features of the proposed DeVilbiss DV5MB SmartLink II System to the predicate DV5M SmartLink Compliance Module (K082209), 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.