(268 days)
Not Found
No
The document mentions a "revised algorithm" for respiratory event detection and pressure changes, but there is no explicit mention of AI, ML, or related terms like DNN. The description of the clinical study focuses on comparing the device's algorithm to hand-scored PSG, which is a standard validation method for non-AI algorithms in this domain.
Yes
The device is intended for treating Obstructive Sleep Apnea (OSA) by applying positive air pressure, which directly addresses a medical condition.
No
The "Intended Use / Indications for Use" states that the device is "intended for use in treating OSA", and "Device Description" also says it is "for treating obstructive sleep apnea", indicating a therapeutic purpose rather than a diagnostic one. While it performs "respiratory event detection and pressure change decisions", this is for the purpose of adjusting therapy, not for diagnosing the condition initially.
No
The device description explicitly states it is a device for treating obstructive sleep apnea by means of applied airway pressure, which involves hardware components to generate and deliver pressurized air. While it mentions a revised software algorithm, the core device is a physical CPAP machine.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "treating OSA in spontaneously breathing patients... by means of application of positive air pressure." This describes a therapeutic device that delivers physical treatment (pressurized air) to the patient's airway.
- Device Description: The description reinforces this by stating the device "are devices for treating obstructive sleep apnea by means of applied airway pressure."
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze biological samples (blood, urine, tissue, etc.), or provide information for diagnostic purposes. While it detects respiratory events and adjusts pressure, this is part of the therapy delivery, not a standalone diagnostic test.
- Clinical Study Focus: The clinical study focuses on validating the effectiveness of therapy and the accuracy of the device's event detection and pressure changes during therapy, not on its ability to diagnose sleep apnea.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
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.
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 ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
30 Kg (66 lbs) and above
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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
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: | 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
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-
continuos respirator |
| Predicate Device Name(s) and 510(k)
number(s): | DeVilbiss Intellipap DV5 Series cleared
under K071689 and Respironics, Inc,
Remstar Auto A-Flex HT cleared under
K113068 |
4
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 ●
5
Comparison of Similarities and Differences:
| Feature | Predicate
Device:
Respironics A-
Flex HT
(K113068) | Predicate Device:
DeVilbiss DV53
Standard Plus
CPAP, DeVilbiss
DV54 Auto CPAP
(K071689) | Modified Device:
DeVilbiss
Intellipap2/DeVilbiss
BLUE | Remarks: |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement of
Intended Use | The Remstar
Auto A-Flex HT
delivers positive
airway pressure
therapy for the
treatment of
Obstructive
Sleep Apnea in
spontaneously
breathing
patient
weighing over
30kg (66 lbs. It
is for use in the
home or
hospital/institutio
nal environment | The DeVilbiss
IntelliPAP/SleepCu
be CPAP Pro
(Model DV53
Series) and
AutoAdjust (Model
DV54 Series) are
intended for use in
treating OSA in
spontaneously
breathing patients
30 kg and above by
means of
application of
positive air
pressure. The
device is to be
used in home and
clinical
environments. | 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. | Similar to
predicates
Patient
population is
the same.
Condition
treated (OSA)
is the same.
References to
institutional,
clinical, and
healthcare
environments
are all
considered to
be the same
environment.
No impact on
safety or
effectiveness |
6
| Feature | Predicate
Device:
Respironics A-
Flex HT
(K113068) | Predicate Device:
DeVilbiss DV53
Standard Plus
CPAP, DeVilbiss
DV54 Auto CPAP
(K071689) | Modified Device:
DeVilbiss
Intellipap2/DeVilbiss
BLUE | Remarks: |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
Principle | The CPAP
machine
pressurizes
room air and
applies the
pressurized air
to the user's
airway through
the hose and
nasal mask.
Breathing the
pressurized air
flow keeps the
airway open,
preventing the
user from
experiencing
breaks in
breathing while
sleeping. | The CPAP machine
pressurizes room
air and applies the
pressurized air to
the user's airway
through the hose
and nasal mask.
Breathing the
pressurized air flow
keeps the airway
open, preventing
the user from
experiencing
breaks in breathing
while sleeping. | The CPAP machine
pressurizes room air
and applies the
pressurized air to the
user's airway through
the hose and nasal
mask. Breathing the
pressurized air flow
keeps the airway
open, preventing the
user from
experiencing breaks in
breathing while
sleeping. | Same as
predicate. |
| Operating
Modes | CPAP
AutoAdjust | CPAP
AutoAdjust | СРАР
AutoAdjust | Same as
predicate. |
| 510(k) Product
Code | BZD (Ventilator,
non-continuous
(respirator)) | BZD (Ventilator,
non-continuous
(respirator)) | BZD (Ventilator, non-
continuous
(respirator)) | Same as
predicate. |
| Feature | Predicate
Device:
Respironics A-
Flex HT
(K113068) | Predicate Device:
DeVilbiss DV53
Standard Plus
CPAP, DeVilbiss
DV54 Auto CPAP
(K071689) | Modified Device:
DeVilbiss
Intellipap2/DeVilbiss
BLUE | Remarks: |
| Respiratory
Event
Detection | Obstructive
Apnea, Central
Apnea,
Hypopnea,
Flow Limitation,
Periodic
Breathing,
RERA,
Snoring
Leak | Apnea, Hypopnea,
Snoring, Exhale
Puffing
Leak | Obstructive Apnea,
Central Apnea,
Hypopnea,
Flow Limitation,
Periodic Breathing,
RERA,
Snoring,
Exhale Puffing
Leak | Similar to
predicates.
Added Central
Apnea, Flow
Limitation,
Periodic
Breathing and
RERA to
DeVilbiss
predicate
No impact on
safety or
effectiveness |
| Heated
Humidifier | Optional heated
humidifier,
connects to
CPAP
electrically and
pneumatically | Optional heated
humidifier,
connects to CPAP
electrically and
pneumatically | Optional heated
humidifier, connects to
CPAP electrically and
pneumatically | Same as
predicate. |
| PulseDose
humidifier
option | Optional Heated
Tube for use
with heated
humidifier to
reduce rainout in
patient tube | Optional heated
humidifier,
connects to CPAP
electrically and
pneumatically | Optional PulseDose
humidifier module,
connects to heated
humidifier electrically
and pneumatically to
reduce rainout in
patient tube | Similar to
predicate.
PulseDose
humidifier
option reduces
rainout, similar
to heated tube.
No impact on
safety or
effectiveness |
7
8
| Feature | Predicate
Device:
Respironics A-
Flex HT
(K113068) | Predicate Device:
DeVilbiss DV53
Standard Plus
CPAP, DeVilbiss
DV54 Auto CPAP
(K071689) | Modified Device:
DeVilbiss
Intellipap2/DeVilbiss
BLUE | Remarks: |
|----------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Oximeter
Function | No oximeter
option available | The DeVilbiss
DV53 Standard
Plus CPAP,
DeVilbiss DV54
Auto CPAP uses
the DeVilbiss
DV5M SmartLink
Compliance
Module (K082209)
to connect an
optional Nonin
oximeter to log
SpO2 and Pulse
Rate at 4-second
intervals. Not for
diagnostic
purposes. | The modified
DeVilbiss
Intellipap2/DeVilbiss
BLUE connects
wirelessly (Bluetooth)
to an optional Nonin
Model 3150 WristOx2
oximeter (K102350) to
log SpO2 and Pulse
Rate at 1-second
intervals. Not for
diagnostic purposes. | Similar to
predicate.
Records SpO2
and Pulse
Rate from
Nonin
Oximeter,
validated
change to
wireless
connection.
No impact on
safety or
effectiveness |
| Data Transfer | SD Card
Wireless Modem
(via Encore
Anywhere) | SD Card
RS232 Serial
Interface | SD Card
USB Serial Interface | Similar to
predicate.
Change to
USB serial
interface,
validated
communication
No impact on
safety or
effectiveness |
9
| Feature | Predicate Device:
Respironics A-Flex HT
(K113068) | Predicate Device:
DeVilbiss DV53 Standard Plus
CPAP, DeVilbiss DV54 Auto CPAP
(K071689) | Modified Device:
DeVilbiss
Intellipap2/DeVilbiss
BLUE | Remarks: |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Remote settings
change
function | CPAP Settings
can be remotely
changed through
Encore
Anywhere
software via
Wireless Modem | CPAP Settings can
be remotely
changed through
SmartLink Desktop
software via SD
card transfer | CPAP Settings can be
remotely changed
through SmartLink
Desktop software via
SD card transfer.
CPAP Settings can be
remotely changed
through SmartLink
Desktop software via
SmartCode Rx feature | Similar to
predicate.
SD card
setting updates
same as
predicate.
SmartCode Rx
setting updates
validated.
No impact on
safety or
effectiveness |
| Operating
Temperature /
Humidity
Range | Operating
Temperature: 5°
to 35° C
(41° to 95° F)
Relative
Humidity:
15 to 95% (non-
condensing) | Operating
Temperature: +5 to
+40 °C.
(+41°F to +104°F)
Relative Humidity:
0 to 95% (non-
condensing) | Operating
Temperature: +5 °C to
+40 °C
(+41°F to +104°F)
Relative Humidity:
15% to 93%, (non-
condensing) | Similar to
predicate.
Changed
operating
relative
humidity range
to comply with
IEC 60601-1-
11
No impact on
safety or
effectiveness |
10
| Feature | Predicate
Device:
Respironics A-
Flex HT
(K113068) | Predicate Device:
DeVilbiss DV53
Standard Plus
CPAP, DeVilbiss
DV54 Auto CPAP
(K071689) | Modified Device:
DeVilbiss
Intellipap2/DeVilbiss
BLUE | Remarks: |
|-------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power
Requirements | AC Input Power:
100 – 240 VAC,
50/60 Hz,
2.1 A
DC Input Power:
12 VDC, 5.0 A | AC Input Power:
100 - 240 VAC,
50/60 Hz,
0.65 A
DC Input Power:
12 VDC, 5.0 A | AC Input Power:
100 - 240 VAC,
50/60 Hz,
1.25 A
DC Input Power:
12.5 VDC, 5.2 A | Similar to
predicate.
Same AC input
voltage range.
DC input
requirement
slightly higher.
No impact on
safety or
effectiveness
passes IEC
60601-1 |
| Materials
comparison | | | | |
| Enclosure | Not Published | GE Plastics
Cycoloy
CX2244ME
PC/ABS Blend
FR30U - Meets
UL94 V-0 flame
retardant spec.
(P/N: 420-0200-
004) | Sabic PC Lexan
HP1R 8H8D331
Bright White,
Meets UL94 V-0 flame
retardant spec. | Similar to
predicate.
Same flame
rating, different
material and
color.
No impact on
safety or
effectiveness
meets the UL
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.
11
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.
12
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.
13
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.