DeVilbiss Intellipap2/DeVilbiss BLUE
Device Facts
| Record ID | K143677 |
|---|---|
| Device Name | DeVilbiss Intellipap2/DeVilbiss BLUE |
| Applicant | Devilbiss Healthcare, LLC |
| Product Code | BZD · Anesthesiology |
| Decision Date | Sep 18, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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 Story
DeVilbiss Intellipap2/DeVilbiss BLUE is a CPAP/Auto-CPAP device for treating obstructive sleep apnea (OSA). It pressurizes room air, delivering it to the patient's airway via a nasal or oral-nasal mask to keep the airway open during sleep. Used in home and healthcare environments by patients under physician prescription. Features include Bluetooth connectivity, PulseDose humidity, USB serial communication, and SmartCode Rx for prescription settings. The device monitors respiratory events (apnea, hypopnea, snoring, flow limitation, etc.) and adjusts pressure accordingly. It can connect to an optional Nonin 3150 WristOx2 oximeter to log SpO2 and pulse rate. Data is transferred via SD card or USB. The device provides therapy to maintain prescribed pressure, helping prevent breathing interruptions and improving patient outcomes.
Clinical Evidence
Single-center, prospective, controlled study (n=28) comparing the revised respiratory event detection algorithm to hand-scored PSG. Subjects (mean age 54, 57% male) with moderate-to-severe OSA on stable therapy acted as their own controls. Primary objective: demonstrate effectiveness of therapy as reported by expert human reviewer. Results showed the device algorithm is equivalent to hand-scored PSG for sleep event analysis and pressure titration. No device-related adverse events reported.
Technological Characteristics
Materials: Sabic PC Lexan HP1R 8H8D331 (UL94 V-0). Sensing: Pressure/flow monitoring, optional Bluetooth oximetry. Energy: 100-240 VAC, 50/60 Hz; 12.5 VDC. Connectivity: Bluetooth, USB, SD card. Sterilization: N/A (non-sterile). Software: Respiratory event detection algorithm. Standards: IEC 60601-1, IEC 60601-1-2, ISO 17510-1, ISO 14971, IEC 60601-1-6, IEC 62366.
Indications for Use
Indicated for spontaneously breathing patients 30 kg (66 lbs) and above with obstructive sleep apnea (OSA).
Regulatory Classification
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.
Predicate Devices
Reference Devices
Submission Summary (Full Text)
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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:
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.
| 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 and<br>sponsor of the 510(k) submission: | DeVilbiss Healthcare LLC<br>100 DeVilbiss Drive<br>Somerset, PA 15501 |
|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA registration number of the manufacturer<br>of the new device: | 2515872 |
| Official contact person for all<br>correspondence: | Betty Miller<br>Regulatory/Compliance Manager<br>DeVilbiss Healthcare LLC<br>100 DeVilbiss Drive<br>Somerset, PA 15501<br>Phone: 814-443-7606<br>Fax: 814-443-7575<br>Email: 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 DV64<br>Series 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-<br>continuos respirator |
| Predicate Device Name(s) and 510(k)<br>number(s): | DeVilbiss Intellipap DV5 Series cleared<br>under K071689 and Respironics, Inc,<br>Remstar Auto A-Flex HT cleared under<br>K113068 |
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# Description of Device:
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.
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 | Predicate<br>Device:<br>Respironics A-<br>Flex HT<br>(K113068) | Predicate Device:<br>DeVilbiss DV53<br>Standard Plus<br>CPAP, DeVilbiss<br>DV54 Auto CPAP<br>(K071689) | Modified Device:<br>DeVilbiss<br>Intellipap2/DeVilbiss<br>BLUE | Remarks: |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement of<br>Intended Use | The Remstar<br>Auto A-Flex HT<br>delivers positive<br>airway pressure<br>therapy for the<br>treatment of<br>Obstructive<br>Sleep Apnea in<br>spontaneously<br>breathing<br>patient<br>weighing over<br>30kg (66 lbs. It<br>is for use in the<br>home or<br>hospital/institutio<br>nal environment | The DeVilbiss<br>IntelliPAP/SleepCu<br>be CPAP Pro<br>(Model DV53<br>Series) and<br>AutoAdjust (Model<br>DV54 Series) are<br>intended for use in<br>treating OSA in<br>spontaneously<br>breathing patients<br>30 kg and above by<br>means of<br>application of<br>positive air<br>pressure. The<br>device is to be<br>used in home and<br>clinical<br>environments. | The DeVilbiss<br>Intellipap2/DeVilbiss<br>BLUE Series is<br>intended for use in<br>treating OSA in<br>spontaneously<br>breathing patients 30<br>Kg (66 lbs) and above<br>by means of<br>application of positive<br>air pressure. The<br>Device is to be used in<br>Home and Healthcare<br>Environments. | Similar to<br>predicates<br>Patient<br>population is<br>the same.<br>Condition<br>treated (OSA)<br>is the same.<br>References to<br>institutional,<br>clinical, and<br>healthcare<br>environments<br>are all<br>considered to<br>be the same<br>environment.<br>No impact on<br>safety or<br>effectiveness |
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| Feature | Predicate<br>Device:<br>Respironics A-<br>Flex HT<br>(K113068) | Predicate Device:<br>DeVilbiss DV53<br>Standard Plus<br>CPAP, DeVilbiss<br>DV54 Auto CPAP<br>(K071689) | Modified Device:<br>DeVilbiss<br>Intellipap2/DeVilbiss<br>BLUE | Remarks: |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating<br>Principle | The CPAP<br>machine<br>pressurizes<br>room air and<br>applies the<br>pressurized air<br>to the user's<br>airway through<br>the hose and<br>nasal mask.<br>Breathing the<br>pressurized air<br>flow keeps the<br>airway open,<br>preventing the<br>user from<br>experiencing<br>breaks in<br>breathing while<br>sleeping. | The CPAP machine<br>pressurizes room<br>air and applies the<br>pressurized air to<br>the user's airway<br>through the hose<br>and nasal mask.<br>Breathing the<br>pressurized air flow<br>keeps the airway<br>open, preventing<br>the user from<br>experiencing<br>breaks in breathing<br>while sleeping. | The CPAP machine<br>pressurizes room air<br>and applies the<br>pressurized air to the<br>user's airway through<br>the hose and nasal<br>mask. Breathing the<br>pressurized air flow<br>keeps the airway<br>open, preventing the<br>user from<br>experiencing breaks in<br>breathing while<br>sleeping. | Same as<br>predicate. |
| Operating<br>Modes | CPAP<br>AutoAdjust | CPAP<br>AutoAdjust | СРАР<br>AutoAdjust | Same as<br>predicate. |
| 510(k) Product<br>Code | BZD (Ventilator,<br>non-continuous<br>(respirator)) | BZD (Ventilator,<br>non-continuous<br>(respirator)) | BZD (Ventilator, non-<br>continuous<br>(respirator)) | Same as<br>predicate. |
| Feature | Predicate<br>Device:<br>Respironics A-<br>Flex HT<br>(K113068) | Predicate Device:<br>DeVilbiss DV53<br>Standard Plus<br>CPAP, DeVilbiss<br>DV54 Auto CPAP<br>(K071689) | Modified Device:<br>DeVilbiss<br>Intellipap2/DeVilbiss<br>BLUE | Remarks: |
| Respiratory<br>Event<br>Detection | Obstructive<br>Apnea, Central<br>Apnea,<br>Hypopnea,<br>Flow Limitation,<br>Periodic<br>Breathing,<br>RERA,<br>Snoring<br>Leak | Apnea, Hypopnea,<br>Snoring, Exhale<br>Puffing<br>Leak | Obstructive Apnea,<br>Central Apnea,<br>Hypopnea,<br>Flow Limitation,<br>Periodic Breathing,<br>RERA,<br>Snoring,<br>Exhale Puffing<br>Leak | Similar to<br>predicates.<br>Added Central<br>Apnea, Flow<br>Limitation,<br>Periodic<br>Breathing and<br>RERA to<br>DeVilbiss<br>predicate<br>No impact on<br>safety or<br>effectiveness |
| Heated<br>Humidifier | Optional heated<br>humidifier,<br>connects to<br>CPAP<br>electrically and<br>pneumatically | Optional heated<br>humidifier,<br>connects to CPAP<br>electrically and<br>pneumatically | Optional heated<br>humidifier, connects to<br>CPAP electrically and<br>pneumatically | Same as<br>predicate. |
| PulseDose<br>humidifier<br>option | Optional Heated<br>Tube for use<br>with heated<br>humidifier to<br>reduce rainout in<br>patient tube | Optional heated<br>humidifier,<br>connects to CPAP<br>electrically and<br>pneumatically | Optional PulseDose<br>humidifier module,<br>connects to heated<br>humidifier electrically<br>and pneumatically to<br>reduce rainout in<br>patient tube | Similar to<br>predicate.<br>PulseDose<br>humidifier<br>option reduces<br>rainout, similar<br>to heated tube.<br>No impact on<br>safety or<br>effectiveness |
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| Feature | Predicate<br>Device:<br>Respironics A-<br>Flex HT<br>(K113068) | Predicate Device:<br>DeVilbiss DV53<br>Standard Plus<br>CPAP, DeVilbiss<br>DV54 Auto CPAP<br>(K071689) | Modified Device:<br>DeVilbiss<br>Intellipap2/DeVilbiss<br>BLUE | Remarks: |
|----------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Oximeter<br>Function | No oximeter<br>option available | The DeVilbiss<br>DV53 Standard<br>Plus CPAP,<br>DeVilbiss DV54<br>Auto CPAP uses<br>the DeVilbiss<br>DV5M SmartLink<br>Compliance<br>Module (K082209)<br>to connect an<br>optional Nonin<br>oximeter to log<br>SpO2 and Pulse<br>Rate at 4-second<br>intervals. Not for<br>diagnostic<br>purposes. | The modified<br>DeVilbiss<br>Intellipap2/DeVilbiss<br>BLUE connects<br>wirelessly (Bluetooth)<br>to an optional Nonin<br>Model 3150 WristOx2<br>oximeter (K102350) to<br>log SpO2 and Pulse<br>Rate at 1-second<br>intervals. Not for<br>diagnostic purposes. | Similar to<br>predicate.<br><br>Records SpO2<br>and Pulse<br>Rate from<br>Nonin<br>Oximeter,<br>validated<br>change to<br>wireless<br>connection.<br><br>No impact on<br>safety or<br>effectiveness |
| Data Transfer | SD Card<br><br>Wireless Modem<br>(via Encore<br>Anywhere) | SD Card<br><br>RS232 Serial<br>Interface | SD Card<br><br>USB Serial Interface | Similar to<br>predicate.<br><br>Change to<br>USB serial<br>interface,<br>validated<br>communication<br><br>No impact on<br>safety or<br>effectiveness |
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| Feature | Predicate Device:<br>Respironics A-Flex HT<br>(K113068) | Predicate Device:<br>DeVilbiss DV53 Standard Plus<br>CPAP, DeVilbiss DV54 Auto CPAP<br>(K071689) | Modified Device:<br>DeVilbiss<br>Intellipap2/DeVilbiss<br>BLUE | Remarks: |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Remote settings<br>change<br>function | CPAP Settings<br>can be remotely<br>changed through<br>Encore<br>Anywhere<br>software via<br>Wireless Modem | CPAP Settings can<br>be remotely<br>changed through<br>SmartLink Desktop<br>software via SD<br>card transfer | CPAP Settings can be<br>remotely changed<br>through SmartLink<br>Desktop software via<br>SD card transfer.<br>CPAP Settings can be<br>remotely changed<br>through SmartLink<br>Desktop software via<br>SmartCode Rx feature | Similar to<br>predicate.<br>SD card<br>setting updates<br>same as<br>predicate.<br>SmartCode Rx<br>setting updates<br>validated.<br>No impact on<br>safety or<br>effectiveness |
| Operating<br>Temperature /<br>Humidity<br>Range | Operating<br>Temperature: 5°<br>to 35° C<br>(41° to 95° F)<br>Relative<br>Humidity:<br>15 to 95% (non-<br>condensing) | Operating<br>Temperature: +5 to<br>+40 °C.<br>(+41°F to +104°F)<br>Relative Humidity:<br>0 to 95% (non-<br>condensing) | Operating<br>Temperature: +5 °C to<br>+40 °C<br>(+41°F to +104°F)<br>Relative Humidity:<br>15% to 93%, (non-<br>condensing) | Similar to<br>predicate.<br>Changed<br>operating<br>relative<br>humidity range<br>to comply with<br>IEC 60601-1-<br>11<br>No impact on<br>safety or<br>effectiveness |
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| Feature | Predicate<br>Device:<br>Respironics A-<br>Flex HT<br>(K113068) | Predicate Device:<br>DeVilbiss DV53<br>Standard Plus<br>CPAP, DeVilbiss<br>DV54 Auto CPAP<br>(K071689) | Modified Device:<br>DeVilbiss<br>Intellipap2/DeVilbiss<br>BLUE | Remarks: |
|-------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power<br>Requirements | AC Input Power:<br>100 – 240 VAC,<br>50/60 Hz,<br>2.1 A<br>DC Input Power:<br>12 VDC, 5.0 A | AC Input Power:<br>100 - 240 VAC,<br>50/60 Hz,<br>0.65 A<br>DC Input Power:<br>12 VDC, 5.0 A | AC Input Power:<br>100 - 240 VAC,<br>50/60 Hz,<br>1.25 A<br>DC Input Power:<br>12.5 VDC, 5.2 A | Similar to<br>predicate.<br>Same AC input<br>voltage range.<br>DC input<br>requirement<br>slightly higher.<br>No impact on<br>safety or<br>effectiveness<br>passes IEC<br>60601-1 |
| Materials<br>comparison | | | | |
| Enclosure | Not Published | GE Plastics<br>Cycoloy<br>CX2244ME<br>PC/ABS Blend<br>FR30U - Meets<br>UL94 V-0 flame<br>retardant spec.<br>(P/N: 420-0200-<br>004) | Sabic PC Lexan<br>HP1R 8H8D331<br>Bright White,<br>Meets UL94 V-0 flame<br>retardant spec. | Similar to<br>predicate.<br>Same flame<br>rating, different<br>material and<br>color.<br>No impact on<br>safety or<br>effectiveness<br>meets the UL<br>Flame Rating |
## Statement of Intended Use:
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.
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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.
