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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for the DeVilbiss DV5MB Smartlink II System, which is an accessory to CPAP systems. It aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with corresponding device performance metrics in the way one might expect for a diagnostic or therapeutic medical device. Instead, the "acceptance criteria" are implied by the conformance to various international and national standards, and the "device performance" is stated as having "met the required performance criteria and functioned as intended."

Acceptance Criteria Category (Implied)	Specific Standard / Requirement	Reported Device Performance
Electrical Safety	IEC 60601-1-1:2000 (Medical Electrical Equipment—Part 1: General Requirements for Safety; Safety Requirements for Medical Electrical Systems)	"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 System in conjunction with a DeVilbiss CPAP Unit meets the required performance criteria and functioned as intended."
Electromagnetic Compatibility (EMC)	IEC 60601–1–2:2007 Ed 3.0 (Medical Electrical Equipment—Part 1: General Requirements for Safety; Electromagnetic Compatibility Requirements and Tests)	"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 System in conjunction with a DeVilbiss CPAP Unit meets the required performance criteria and functioned as intended."
Software Safety/Programmable Medical Systems	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.)	"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 System in conjunction with a DeVilbiss CPAP Unit meets the required performance criteria and functioned as intended."
Risk Management	ISO 14971:2012 (Medical devices Application of risk management to medical devices)	"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 System in conjunction with a DeVilbiss CPAP Unit meets the required performance criteria and functioned as intended."
Radio Disturbance Characteristics	EN55011:2007 (Industrial, scientific and medical (ISM) radio-frequency equipment -Radio disturbance characteristics - Limits and methods of measurements)	"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 System in conjunction with a DeVilbiss CPAP Unit meets the required performance criteria and functioned as intended."
Ingress Protection	IEC 529 (1989) (Classification of Degrees of Protection Provided by Enclosures)	"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 System in conjunction with a DeVilbiss CPAP Unit meets the required performance criteria and functioned as intended."
Environmental Testing	IEC 68 (1988) (Environmental 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 System in conjunction with a DeVilbiss CPAP Unit meets the required performance criteria and functioned as intended."
Package Testing	ISTA Procedure 3A Package –Products for Parcel Delivery System Shipments 70kg (150lb) or less	"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 System in conjunction with a DeVilbiss CPAP Unit meets the required performance criteria and functioned as intended."
Radio Frequency Devices	FCC Regulation 47 CFR Part 15 Radio Frequency Devices, Class B	"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 System in conjunction with a DeVilbiss CPAP Unit meets the required performance criteria and functioned as intended."
Guidance Document Compliance	FDA Reviewer Guidance (Nov 1993), DRAFT FDA Guidance for Home Use (Dec 2012), DRAFT FDA Guidance Cybersecurity (June 2013), FDA Guidance Wireless Technology (Aug 2013)	"Additional design considerations were applied based on published guidance and draft guidance documents from FDA." "The proposed DeVilbiss DV5MB SmartLink II System in conjunction with a DeVilbiss CPAP Unit meets the required performance criteria and functioned as intended."
Functional Equivalence to Predicate	Data collection, software display, remote settings change, remote control, data transfer (wired/wireless)	"The proposed DeVilbiss DV5MB SmartLink II System is identical to the predicate device with the addition of a Bluetooth Wireless connection." and "operates same as wired RS232 connection. No impact on safety or effectiveness." (Regarding added Bluetooth).

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

This document describes a premarket notification for a medical device accessory (SmartLink II System) that collects usage and performance data from CPAP machines and adds Bluetooth wireless communication.

Sample Size for Test Set: The document does not specify sample sizes related to patient data or clinical datasets for testing. The testing described is primarily non-clinical (bench testing, electrical safety, EMC, risk management, environmental, package, and RF compliance).
Data Provenance: Not applicable in the context of this submission, as no clinical data or patient-specific data derived from human subjects is presented as a test set for the device's functionality. The "data" concerns the device's adherence to engineering and safety standards.

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

Number of Experts: Not applicable. The ground truth for the non-clinical testing (e.g., whether a device complies with IEC 60601-1-1 or FCC Part 15) is established by the specifications of the standards themselves and the objective measurements performed by certified testing bodies or internal engineering teams.
Qualifications of Experts: Not detailed, but implied to be qualified engineers and technicians performing the standard-based testing.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "test set" here refers to non-clinical tests against engineering and safety standards. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic outputs by human readers, which is not the nature of the testing described.

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

MRMC Study: No. The document explicitly states: "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." Therefore, no MRMC study or assessment of human reader improvement with or without AI assistance was performed or is relevant to this submission.

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

Standalone Performance: Not applicable in the traditional sense of an AI algorithm's diagnostic or predictive performance. The SmartLink II system is an accessory for data collection and communication from a CPAP device; it does not perform diagnostic algorithms itself in a standalone capacity that would require such an evaluation. Its "performance" refers to its ability to reliably collect, transfer, and store data, and its compliance with safety and environmental standards.

7. The Type of Ground Truth Used

Type of Ground Truth: For the non-clinical testing, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced international standards (e.g., IEC 60601 series, ISO 14971, EN55011, IEC 529, IEC 68, ISTA Procedure 3A, FCC Part 15) and FDA guidance documents. Compliance is measured against these established technical benchmarks.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set of data. It is a hardware accessory with embedded software for data collection and communication.

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

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.

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 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.

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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

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Indications for Use

510(k) Number: (if known):_

Device Name: DeVilbiss DV5MB Smartlink II Svstem

	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'

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Section 5.0 510(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
FDA registration number of the manufacturerof the new device:	2515872
Official contact person for allcorrespondence:	Betty MillerRegulatory/Compliance ManagerDeVilbiss Healthcare LLC100 DeVilbiss DriveSomerset, PA 15501Phone: 814-443-7606Fax: 814-443-7575Email: 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)

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Description of Device:

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

Comparison of Similarities and Differences:

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Statement of Intended Use:

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:

1. IEC 60601-1-1:2000 Medical Electrical Equipment—Part 1: General Requirements for Safety; Safety Requirements for Medical Electrical Systems
1. IEC 60601–1–2:2007 Ed 3.0 Medical Electrical Equipment—Part 1: General Requirements for Safety; Electromagnetic Compatibility Requirements and Tests
1. 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.
1. ISO 14971:2012 Medical devices Application of risk management to medical devices
1. EN55011:2007 Industrial, scientific and medical (ISM) radio-frequency equipment -Radio disturbance characteristics - Limits and methods of measurements
1. IEC 529 (1989): Classification of Degrees of Protection Provided by Enclosures
1. IEC 68 (1988): Environmental Testing

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1. ISTA Procedure 3A Package –Products for Parcel Delivery System Shipments 70kg (150lb) or less
1. 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:

1. FDA Reviewer Guidance for Premarket Notification Submissions (Anesthesiology and Respiratory Device Branches, November 1993)
1. DRAFT FDA Guidance Design Considerations for Devices Intended for Home Use Dec 12- 2012
1. DRAFT FDA Guidance Cybersecurity in Medical Devices 6-13-13
1. 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.

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).

Feature	Predicate Device:DeVilbiss DV5M SmartLinkSystem (K082209)	Modified Device:DeVilbiss DV5MB SmartLinkII System	Nature ofChange
Intended UseStatement	The DeVilbiss DV5MSmartLink System inconjunction with a DeVilbissCPAP Unit is intended for usein treating obstructive sleepapnea in patients 30 Kg andabove. The system is to beused in home and healthcareenvironments.	The DeVilbiss DV5MBSmartLink II System inconjunction with a DeVilbissCPAP Unit is intended for usein treating obstructive sleepapnea in patients 30 Kg andabove. The system is to beused in home and healthcareenvironments.	Same aspredicate.
Feature	Predicate Device:DeVilbiss DV5M SmartLinkSystem (K082209)	Modified Device:DeVilbiss DV5MB SmartLinkII System	Nature ofChange
Indications forUse Statement	The DeVilbiss DV5MSmartLink System can onlybe used in conjunction withthe DeVilbiss DV51, andDV54 Series CPAP Systemsfor follow up of obstructivesleep apnea in patientsweighing above 30 kg onnasal CPAP therapy	The DeVilbiss DV5MBSmartLink II System canonly be used in conjunctionwith the DeVilbiss DV51,DV53, DV54, DV55, DV56,and DV57 Series CPAPSystems for follow up ofobstructive sleep apnea inpatients weighing above 30kg on nasal CPAP therapy.The system is to be used inhome and healthcareenvironments.	Addcompatibilitywith additionalDV5x SeriesCPAP models.No impact onsafety oreffectiveness.
Compliancerecording	Records 3 years of "whilebreathing" ON/OFFcompliance, 120 days of DailyPerformance, Rx change,approximately 72 hours ofOximetry, and Fault logs	Records 3 years of "whilebreathing" ON/OFFcompliance, 120 days of DailyPerformance, Rx change,approximately 72 hours ofOximetry, and Fault logs	Same aspredicate.
User interface	The DeVilbiss DV5MSmartLink Module isdesigned to mechanically andelectrically attach to a DV5xseries CPAP. The moduleuses the onboard Keypad/Display of the DV5x CPAP asthe user interface. The userinterface is located on the topof the DV5x CPAP andconsists of a 6 button keypadand a 2x16 LCD Display.	The DeVilbiss DV5MBSmartLink II System isdesigned to mechanically andelectrically attach to a DV5xseries CPAP. The moduleuses the onboard Keypad/Display of the DV5x CPAP asthe user interface. The userinterface is located on the topof the DV5x CPAP andconsists of a 6 button keypadand a 2x16 LCD Display.	Same aspredicate.
OximeterFunction	The DeVilbiss DV5MSmartLink Module uses anoptional Nonin oximeter to logSpO2 and Pulse Rate at 4-second intervals.	The DeVilbiss DV5MBSmartLink II System uses anoptional Nonin oximeter to logSpO2 and Pulse Rate at 4-second intervals.	Same aspredicate.
Feature	Predicate Device:DeVilbiss DV5M SmartLinkSystem (K082209)	Modified Device:DeVilbiss DV5MB SmartLinkII System	Nature ofChange
SoftwareFunction	The SmartLink software isused to display data as it isrecorded from the module.The software stores data in adata based structure and hasquerying and reportingfunctionality.	The SmartLink software isused to display data as it isrecorded from the module.The software stores data in adata based structure and hasquerying and reportingfunctionality. (See Section16.0 software section)	Improvementsto user interfaceandperformance.No impact onsafety oreffectiveness.
Remote settingschange function	CPAP Settings can bechanged through an SD card,settings are programmedthrough SmartLink Desktopsoftware.	CPAP Settings can bechanged through an SD card,settings are programmedthrough SmartLink Desktopsoftware.	Same aspredicate.
Remote controlfunction	Wired RS232 connection to adistance of up to 200 feet.	Wired RS232 connection to adistance of up to 200 feet.Wireless Bluetoothconnection to a distance of upto 33 feet.	AddedBluetoothwirelesscommunication,operates sameas wired RS232connection.No impact onsafety oreffectiveness.
Means of DataTransfer	Memory card orwired RS232 connection	Memory card orwired RS232 connection	Same aspredicate.
EnvironmentalSpecifications	Operating temperature:5 to +40 °C.Operating humidity range: 0to 95% R.H. non condensingStorage temperature range:-40 to +70 °CStorage humidity range: 0 to95% R.H. non-condensing	Operating temperature:5 to +40 °C.Operating humidity range: 0to 95% R.H. non condensingStorage temperature range:-40 to +70 °CStorage humidity range: 0 to95% R.H. non-condensing	Same aspredicate.
PowerRequirements	The DeVilbiss DV5MSmartLink Module is notequipped with an on-boardpower supply. It onlyreceives its power (12 VDC)from the DV5x Series CPAPdevice during operation.	The DeVilbiss DV5MBSmartLink II System is notequipped with an on-boardpower supply. It onlyreceives its power (12 VDC)from the DV5x Series CPAPdevice during operation.	Same aspredicate.
Feature	Predicate Device:DeVilbiss DV5M SmartLinkSystem (K082209)	Modified Device:DeVilbiss DV5MB SmartLinkII System	Nature ofChange
510(k) ProductCode	BZD (Ventilator, non-continuous (respirator))	BZD (Ventilator, non-continuous (respirator))	Same aspredicate.
Materialscomparison
Enclosure	GE Plastics CycoloyCX2244ME PC/ABS BlendFR30U - Meets UL94 V-0flame retardant spec. (P/N:420-0200-004)	GE Plastics CycoloyCX2244ME PC/ABS BlendFR30U - Meets UL94 V-0flame retardant spec. (P/N:420-0200-004)	Same aspredicate.