The DeVilbiss Intellipap2/DeVilbiss BLUE Series is intended for use in treating OSA in spontaneously breathing patients 30 Kg (66 lbs) and above by means of application of positive air pressure. The Device is to be used in Home and Healthcare Environments.

Device Description

The proposed DeVilbiss Intellipap2/DeVilbiss BLUE are devices for treating obstructive sleep apnea by means of applied airway pressure. Predicates devices DeVilbiss IntelliPAP DV5 Series (K071689), and Respironics, Inc, Remstar Auto A-Flex HT (K113068) operate by the same basic principal of creating pressurized air that is delivered to the patient's airway by a nasal or oralnasal mask. The devices maintain a set pressure, prescribed by a physician, at the patient's mask for flow rates up to approximately 100 L/m.

AI/ML Overview

The document K143677 describes the DeVilbiss Intellipap2/DeVilbiss BLUE device, which is intended for use in treating Obstructive Sleep Apnea (OSA). A clinical study was performed to validate the respiratory event detection and pressure change decisions made by the proposed device.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or a direct comparison of the device performance against specific numerical targets for the respiratory event detection algorithm. Instead, it states the study's primary objective was to "demonstrate effectiveness of therapy provided by the DeVilbiss AutoAdjust CPAP device as reported by an expert human reviewer" and to determine "whether the machine results are equivalent to hand scores." The conclusion states that the device is "substantially equivalent to the predicate devices in terms of meeting performance criteria and functioning as intended."

Acceptance Criteria (Inferred from study objective)	Reported Device Performance (Summary)
Effectiveness of therapy as reported by expert human reviewer	Demonstrated an effectiveness of therapy. (Specific metrics not provided)
Equivalence of machine results to hand-scored PSG	Machine results were determined to be equivalent to hand scores. (Specific metrics not provided)

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

Sample size for the test set: 28 subjects
Data provenance: A single-center, prospective, controlled study in the U.S.

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

Number of experts: The document mentions "an expert human reviewer" (singular) for assessing therapy effectiveness and "hand-scored PSG" for equivalence, implying one or more experts for scoring. However, a specific number and detailed qualifications are not provided beyond "expert."

4. Adjudication method for the test set

The document implies that the "expert human reviewer" or "hand-scored PSG" served as the reference standard against which the device was compared. The method for resolving discrepancies among multiple experts, if multiple were involved, is not explicitly stated.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not described. The study focused on validating the device's algorithm against human-scored PSG.

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

Yes, a standalone study of the algorithm's performance was done. The study "compared to hand-scored PSG to determine whether the machine results are equivalent to hand scores," which indicates an evaluation of the device's algorithm performance directly.

7. The type of ground truth used

Type of ground truth: Expert human reviewer and hand-scored Polysomnography (PSG).

8. The sample size for the training set

The document does not provide information on the sample size used for the training set.

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

The document does not specify how the ground truth for any training set was established. It only describes the validation study for the "new Respiratory event detection algorithm."

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 a stylized symbol of 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

September 18, 2015

DeVilbiss Healthcare, LLC Betty Miller Regulatory/compliance Manager 100 DeVilbiss Drive Somerset, PA 15501

Re: K143677

Trade/Device Name: DeVilbiss Intellipap2/DeVilbiss BLUE Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (Ippb) Regulatory Class: Class II Product Code: BZD Dated: August 19, 2015 Received: August 20, 2015

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.

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. Division 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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Indications for Use

510(k) Number: (if known): K143677

DeVilbiss Intellipap2/DeVilbiss BLUE Device Name: Indications For Use:

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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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:	December 23, 2014
Device Name:	DeVilbiss Intellipap2/DeVilbiss BLUE
Proprietary name of new device:	DeVilbiss Intellipap2/DeVilbiss BLUE
Common or usual name of the device:	DV63 Series and DV64 Series
DeVilbiss Model Number	DV63 Series Standard Plus and DV64Series AutoAdjust/AutoPlus
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-continuos respirator
Predicate Device Name(s) and 510(k)number(s):	DeVilbiss Intellipap DV5 Series clearedunder K071689 and Respironics, Inc,Remstar Auto A-Flex HT cleared underK113068

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Description of Device:

The proposed DeVilbiss Intellipap2/DeVilbiss BLUE is similar in size, shape and functionality to the predicate with the following modifications

Bluetooth wireless communication ●
. PulseDose Humidity option
New Respiratory event detection algorithm
Serial Communication was changed from RS232 serial to USB serial .
An encoded method of prescription setting change, SmartCode Rx ●

Predicate device Respironics, Inc, Remstar Auto A-Flex HT (K113068) is used for comparison of respiratory event detection.

Comparison of Device Technological Characteristics to Predicate Devices:

The proposed DeVilbiss Intellipap2/DeVilbiss BLUE have the following similarities to those which previously received 510(k) concurrence:

Has the same intended use, ●
Use the same operating principle. .
Incorporates similar materials, and ●
Is manufactured and packaged using similar materials and processes. ●

Modifications that were made:

Bluetooth wireless communication ●
PulseDose Humidity option ●
New Respiratory event detection algorithm ●
Serial Communication was changed from RS232 serial to USB serial .
An encoded method of prescription setting change, SmartCode Rx ●

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Comparison of Similarities and Differences:

Feature	PredicateDevice:Respironics A-Flex HT(K113068)	Predicate Device:DeVilbiss DV53Standard PlusCPAP, DeVilbissDV54 Auto CPAP(K071689)	Modified Device:DeVilbissIntellipap2/DeVilbissBLUE	Remarks:
Statement ofIntended Use	The RemstarAuto A-Flex HTdelivers positiveairway pressuretherapy for thetreatment ofObstructiveSleep Apnea inspontaneouslybreathingpatientweighing over30kg (66 lbs. Itis for use in thehome orhospital/institutional environment	The DeVilbissIntelliPAP/SleepCube CPAP Pro(Model DV53Series) andAutoAdjust (ModelDV54 Series) areintended for use intreating OSA inspontaneouslybreathing patients30 kg and above bymeans ofapplication ofpositive airpressure. Thedevice is to beused in home andclinicalenvironments.	The DeVilbissIntellipap2/DeVilbissBLUE Series isintended for use intreating OSA inspontaneouslybreathing patients 30Kg (66 lbs) and aboveby means ofapplication of positiveair pressure. TheDevice is to be used inHome and HealthcareEnvironments.	Similar topredicatesPatientpopulation isthe same.Conditiontreated (OSA)is the same.References toinstitutional,clinical, andhealthcareenvironmentsare allconsidered tobe the sameenvironment.No impact onsafety oreffectiveness

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Feature	PredicateDevice:Respironics A-Flex HT(K113068)	Predicate Device:DeVilbiss DV53Standard PlusCPAP, DeVilbissDV54 Auto CPAP(K071689)	Modified Device:DeVilbissIntellipap2/DeVilbissBLUE	Remarks:
OperatingPrinciple	The CPAPmachinepressurizesroom air andapplies thepressurized airto the user'sairway throughthe hose andnasal mask.Breathing thepressurized airflow keeps theairway open,preventing theuser fromexperiencingbreaks inbreathing whilesleeping.	The CPAP machinepressurizes roomair and applies thepressurized air tothe user's airwaythrough the hoseand nasal mask.Breathing thepressurized air flowkeeps the airwayopen, preventingthe user fromexperiencingbreaks in breathingwhile sleeping.	The CPAP machinepressurizes room airand applies thepressurized air to theuser's airway throughthe hose and nasalmask. Breathing thepressurized air flowkeeps the airwayopen, preventing theuser fromexperiencing breaks inbreathing whilesleeping.	Same aspredicate.
OperatingModes	CPAPAutoAdjust	CPAPAutoAdjust	СРАРAutoAdjust	Same aspredicate.
510(k) ProductCode	BZD (Ventilator,non-continuous(respirator))	BZD (Ventilator,non-continuous(respirator))	BZD (Ventilator, non-continuous(respirator))	Same aspredicate.
Feature	PredicateDevice:Respironics A-Flex HT(K113068)	Predicate Device:DeVilbiss DV53Standard PlusCPAP, DeVilbissDV54 Auto CPAP(K071689)	Modified Device:DeVilbissIntellipap2/DeVilbissBLUE	Remarks:
RespiratoryEventDetection	ObstructiveApnea, CentralApnea,Hypopnea,Flow Limitation,PeriodicBreathing,RERA,SnoringLeak	Apnea, Hypopnea,Snoring, ExhalePuffingLeak	Obstructive Apnea,Central Apnea,Hypopnea,Flow Limitation,Periodic Breathing,RERA,Snoring,Exhale PuffingLeak	Similar topredicates.Added CentralApnea, FlowLimitation,PeriodicBreathing andRERA toDeVilbisspredicateNo impact onsafety oreffectiveness
HeatedHumidifier	Optional heatedhumidifier,connects toCPAPelectrically andpneumatically	Optional heatedhumidifier,connects to CPAPelectrically andpneumatically	Optional heatedhumidifier, connects toCPAP electrically andpneumatically	Same aspredicate.
PulseDosehumidifieroption	Optional HeatedTube for usewith heatedhumidifier toreduce rainout inpatient tube	Optional heatedhumidifier,connects to CPAPelectrically andpneumatically	Optional PulseDosehumidifier module,connects to heatedhumidifier electricallyand pneumatically toreduce rainout inpatient tube	Similar topredicate.PulseDosehumidifieroption reducesrainout, similarto heated tube.No impact onsafety oreffectiveness

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Feature	PredicateDevice:Respironics A-Flex HT(K113068)	Predicate Device:DeVilbiss DV53Standard PlusCPAP, DeVilbissDV54 Auto CPAP(K071689)	Modified Device:DeVilbissIntellipap2/DeVilbissBLUE	Remarks:
OximeterFunction	No oximeteroption available	The DeVilbissDV53 StandardPlus CPAP,DeVilbiss DV54Auto CPAP usesthe DeVilbissDV5M SmartLinkComplianceModule (K082209)to connect anoptional Noninoximeter to logSpO2 and PulseRate at 4-secondintervals. Not fordiagnosticpurposes.	The modifiedDeVilbissIntellipap2/DeVilbissBLUE connectswirelessly (Bluetooth)to an optional NoninModel 3150 WristOx2oximeter (K102350) tolog SpO2 and PulseRate at 1-secondintervals. Not fordiagnostic purposes.	Similar topredicate.Records SpO2and PulseRate fromNoninOximeter,validatedchange towirelessconnection.No impact onsafety oreffectiveness
Data Transfer	SD CardWireless Modem(via EncoreAnywhere)	SD CardRS232 SerialInterface	SD CardUSB Serial Interface	Similar topredicate.Change toUSB serialinterface,validatedcommunicationNo impact onsafety oreffectiveness

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Feature	Predicate Device:Respironics A-Flex HT(K113068)	Predicate Device:DeVilbiss DV53 Standard PlusCPAP, DeVilbiss DV54 Auto CPAP(K071689)	Modified Device:DeVilbissIntellipap2/DeVilbissBLUE	Remarks:
Remote settingschangefunction	CPAP Settingscan be remotelychanged throughEncoreAnywheresoftware viaWireless Modem	CPAP Settings canbe remotelychanged throughSmartLink Desktopsoftware via SDcard transfer	CPAP Settings can beremotely changedthrough SmartLinkDesktop software viaSD card transfer.CPAP Settings can beremotely changedthrough SmartLinkDesktop software viaSmartCode Rx feature	Similar topredicate.SD cardsetting updatessame aspredicate.SmartCode Rxsetting updatesvalidated.No impact onsafety oreffectiveness
OperatingTemperature /HumidityRange	OperatingTemperature: 5°to 35° C(41° to 95° F)RelativeHumidity:15 to 95% (non-condensing)	OperatingTemperature: +5 to+40 °C.(+41°F to +104°F)Relative Humidity:0 to 95% (non-condensing)	OperatingTemperature: +5 °C to+40 °C(+41°F to +104°F)Relative Humidity:15% to 93%, (non-condensing)	Similar topredicate.Changedoperatingrelativehumidity rangeto comply withIEC 60601-1-11No impact onsafety oreffectiveness

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Feature	PredicateDevice:Respironics A-Flex HT(K113068)	Predicate Device:DeVilbiss DV53Standard PlusCPAP, DeVilbissDV54 Auto CPAP(K071689)	Modified Device:DeVilbissIntellipap2/DeVilbissBLUE	Remarks:
PowerRequirements	AC Input Power:100 – 240 VAC,50/60 Hz,2.1 ADC Input Power:12 VDC, 5.0 A	AC Input Power:100 - 240 VAC,50/60 Hz,0.65 ADC Input Power:12 VDC, 5.0 A	AC Input Power:100 - 240 VAC,50/60 Hz,1.25 ADC Input Power:12.5 VDC, 5.2 A	Similar topredicate.Same AC inputvoltage range.DC inputrequirementslightly higher.No impact onsafety oreffectivenesspasses IEC60601-1
Materialscomparison
Enclosure	Not Published	GE PlasticsCycoloyCX2244MEPC/ABS BlendFR30U - MeetsUL94 V-0 flameretardant spec.(P/N: 420-0200-004)	Sabic PC LexanHP1R 8H8D331Bright White,Meets UL94 V-0 flameretardant spec.	Similar topredicate.Same flamerating, differentmaterial andcolor.No impact onsafety oreffectivenessmeets the ULFlame Rating

Statement of Intended Use:

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Non-Clinical Testing:

This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols. DeVilbiss Intellipap2/DeVilbiss BLUE Series was designed and tested to demonstrate compliance with the applicable standards.

Verification Activities to demonstrate the performance, effectiveness and safety include:

Controls and indicators

Controls, display and user interface have been verified to function as intended. Application of usability was applied to the design per IEC 60601-1-6 and IEC 62366 (excluding section D4.3.1).

Performance

The performance of the CPAP and Heated Humidifier with PulseDose module has been verified to function as intended and meets the requirements of ISO 17510-1 Sleep Apnea Breathing Therapy Equipment.

Materials

Materials of the device and components have been verified to provide the required level of safety and strength. Materials in the medical gas path have been tested for biocompatibility and air purity to verify that gas pathway is biocompatible. The materials utilized in the design do not raise any new issues of safety and effectiveness.

Safety Evaluation

Safety has been verified to meet the requirements of IEC 60601-1 (Medical Electrical Equipment-Part 1: General Requirements for Safety) and has been designed following ISO 14971 Medical devices - Application of Risk Management to Medical Devices.

Electromagnetic Compatibility

Electromagnetic Compatibility has been tested and verified to meet the requirements of IEC 60601-1-2 (Medical Electrical Equipment - Part 1-2 Electromagnetic Compatibility) and FDA Draft Reviewer Guidance for Premarket Notification Submissions (1993).

Mechanical Stress

Mechanical stress has been tested and verified to meet the requirements of FDA Reviewer Guidance for Premarket Notification Submissions (1993), IEC 60068-2-6, IEC 60068-2-27 and IEC 60068-2-64.

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Transportation

Transportation shipping and storage has been tested and verified to meet the requirements of ISTA Procedure 3A: Packaged-Products for Parcel Delivery.

See Section 16.7 Validation, Verification Testing, Section 17.0 Electromagnetic Compatibility and Electrical Safety, Section 18.0 Performance Testing and Attachment B.

Clinical Testing:

Clinical testing was performed to validate the respiratory event detection and pressure change decisions made by the proposed device during therapy. A single-center, prospective, controlled study was designed to validate improvements to the predicate software algorithm in the DeVilbiss AutoAdjust CPAP flow generator, a device that is already FDA-cleared under K071689 and in use in the U.S. The revised algorithm is intended to improve precision of treatment and phenotyping of residual disease.

Subjects with a sleep apnea diagnosis who were on stable therapy enrolled in a one-night PSG titration study. DeVilbiss AutoAdjust CPAP device with revised algorithm was compared to hand-scored PSG to determine whether the machine results are equivalent to hand scores. Each subject acted as their own control for assessing accuracy of sleep event analysis and prescribed CPAP pressure.

The primary objective of the study was to demonstrate effectiveness of therapy provided by the DeVilbiss AutoAdjust CPAP device as reported by an expert human reviewer. A total of 28 subjects, with a diagnosis of moderate to severe sleep apnea on stable therapy, completed the study. 57% of subjects were male and 43% were female. Subject ages ranged from 27 to 75 years, with a mean age of 54.0 years. Twenty six of the subjects completing the study were diagnosed with Obstructive Sleep Apnea, and 2 with Mixed Sleep Apnea. Three (3) adverse events were reported for one subject. All the events consisted of mild digestive distress and were unrelated to the study device. No safety concerns were raised in the course of the study.

Statement of Safety and Effectiveness:

Analysis of comparison of design, function and features of the proposed DeVilbiss Intellipap2/DeVilbiss BLUE Series to the predicates DeVilbiss IntelliPAP DV5 Series cleared under K071689, and substantially equivalent to Respironics, Inc, Remstar Auto A-Flex HT cleared under K113068, together with the results of testing demonstrates the device to be substantially equivalent to the predicate devices in terms of meeting performance criteria and functioning as intended.

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Conclusion:

The DeVilbiss Intellipap2/DeVilbiss BLUE Series is substantially equivalent to the predicate device listed in this Summary and the device, as changed, 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).