(90 days)
Not Found
No
The description focuses on providing positive airway pressure and adjustable triggering sensitivity, with no mention of AI or ML capabilities. The performance studies reference standard testing and guidance documents that predate widespread AI/ML in medical devices.
Yes
The device is intended for "treating OSA in spontaneously breathing patients," which is a medical condition, making it a therapeutic device.
No
This device is intended for treating OSA by applying positive air pressure, not for diagnosing it.
No
The device description clearly outlines a physical device that provides positive air pressure, indicating it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat OSA by applying positive air pressure to the oropharynx. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the mechanical function of providing positive airway pressure to prevent airway collapse. It does not mention analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a therapeutic device used to manage a diagnosed condition (OSA) by providing mechanical support to the airway.
N/A
Intended Use / Indications for Use
The DeVilbiss IntelliPAP/SleepCube Model DV55 S Series is 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The role of the product from a patient's point of view is to provide a continuous source of bilevel positive airway pressure for the treatment of sleep apnea. Positive airway pressure is applied to the oropharynx to act as a pneumatic splint to prevent the collapse of the pharyngeal muscle, which occludes the patient airway during sleep. Bilevel units are used over conventional CPAP units due to high pressures and/or patient intolerance to continuous pressure, making exhalation difficult.
The DeVilbiss Bilevel S product will replace the 9055D in the sleep product line as well as provide a new product offering. The product will have a reduced manufactured cost, primarily derived from reduced material costs and improved engineering design associated with the existing Intellipan/SleepCube product platform. The market has dictated a need for lower cost and smaller sized bilevel units as well as improved functionality such as manually adjustable inhale/exhale triggering sensitivity.
The triggering sensitivity overall must be increased as much as possible to be competitive with other bilevel devices currently available. Automatic and manual inhale/exhale trigger sensitivity is to be provided to allow the clinician to customize trigger parameters for specific operating conditions. The DeVilbiss Intellipap/SleepCube Bilevel S product is not intended to meet the needs for the "ventilator" market, which necessitates features such as alarms, higher operating pressures and other ventilator specific functions
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oropharynx
Indicated Patient Age Range
patients 30 Kg and above
Intended User / Care Setting
home and clinical environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols. The DeVilbiss DV55 S Series Bilevel CPAP was designed and tested according to guidance outlined in:
-
- FDA's Draft Reviewer Guidance for Premarket Notification Submissions -Anesthesiology and Respiratory Devices Branch: Division of Cardiovascular, Respiratory, and Neurological Devices (November 1993); and
-
- FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005),
As suggested by FDA's November 1993 publication entitled "Reviewer Guidance for Premarket Notification Submissions - Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices" the DeVilbiss Bilevel S/ST was tested in accordance with the applicable voluntary standards. The DeVilbiss Bilevel S/ST met the required performance criteria and functioned as intended.
See Section 16.7 Validation. Verification Testing, Section 17.0 Electromagnetic Compatibility and Electrical Safety, Section 18.0 Performance Testing and Attachment B.
- FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005),
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.
Resmed VPAP ST - K080131, DeVilbiss 9055 Bilevel - K032056, DeVilbiss Intellipap - K071689
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
SEP 2-8 2009
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
100 DeVilbiss Drive
Somerset, PA 15501 |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA registration number of the manufacturer
of the new device: | 2515872 |
| Official contact person for all correspondence: | Betty Lou Miller
Regulatory Affairs Coordinator
DeVilbiss Healthcare
100 DeVilbiss Drive
Somerset, PA 15501
Phone: 814-443-7602
Fax: 814-443-7571
Email:
betty.miller@devilbisshc.com |
| Date Prepared: | |
| Device Name: | DeVilbiss Intellipap/SleepCube S |
| Proprietary name of new device: | DeVilbiss Intellipap/SleepCube S |
| Common or usual name of the device: | DeVilbiss S |
| DeVilbiss Model Number | DV55 S Series |
| 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): | Resmed VPAP ST - K080131
DeVilbiss 9055 Bilevel - K032056
DeVilbiss Intellipap - K071689 |
..
1
Description of Device:
The role of the product from a patient's point of view is to provide a continuous source of bilevel positive airway pressure for the treatment of sleep apnea. Positive airway pressure is applied to the oropharynx to act as a pneumatic splint to prevent the collapse of the pharyngeal muscle, which occludes the patient airway during sleep. Bilevel units are used over conventional CPAP units due to high pressures and/or patient intolerance to continuous pressure, making exhalation difficult.
The DeVilbiss Bilevel S product will replace the 9055D in the sleep product line as well as provide a new product offering. The product will have a reduced manufactured cost, primarily derived from reduced material costs and improved engineering design associated with the existing Intellipan/SleepCube product platform. The market has dictated a need for lower cost and smaller sized bilevel units as well as improved functionality such as manually adjustable inhale/exhale triggering sensitivity.
The triggering sensitivity overall must be increased as much as possible to be competitive with other bilevel devices currently available. Automatic and manual inhale/exhale trigger sensitivity is to be provided to allow the clinician to customize trigger parameters for specific operating conditions. The DeVilbiss Intellipap/SleepCube Bilevel S product is not intended to meet the needs for the "ventilator" market, which necessitates features such as alarms, higher operating pressures and other ventilator specific functions
Comparison of Device Technological Characteristics to Predicate Devices:
The submitted DeVilbiss Bilevel S has the following similarities to those which previously received 510(k) concurrence:
- Has the same intended use, .
- . Uses the same operating principle,
- Incorporates the same basic Bilevel modes and settings, .
- Incorporates similar materials .
Statement of Intended Use:
The DeVilbiss Intellipap/SleepCube Model DV55 S Series is 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.
2
Non-Clinical Testing:
This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols. The DeVilbiss DV55 S Series Bilevel CPAP was designed and tested according to guidance outlined in:
-
- FDA's Draft Reviewer Guidance for Premarket Notification Submissions -Anesthesiology and Respiratory Devices Branch: Division of Cardiovascular, Respiratory, and Neurological Devices (November 1993); and
-
- FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005),
As suggested by FDA's November 1993 publication entitled "Reviewer Guidance for Premarket Notification Submissions - Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices" the DeVilbiss Bilevel S/ST was tested in accordance with the applicable voluntary standards. The DeVilbiss Bilevel S/ST met the required performance criteria and functioned as intended.
See Section 16.7 Validation. Verification Testing, Section 17.0 Electromagnetic Compatibility and Electrical Safety, Section 18.0 Performance Testing and Attachment B.
Statement of Safety and Effectiveness:
Analysis of comparison of design, function and features of the DeVilbiss Bilevel S to the Resmed VPAP ST (K080131). DeVilbiss 9055 Bilevel (K032056) and DeVilbiss Intellipap (K071689). 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.
Conclusion:
The DeVilbiss Intellipan/SleepCube Bilevel S 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.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
SEP 2 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Betty Lou Miller Regulatory Affairs Coordinator Sunrise Medical 100 DeVilbiss Drive Somerset, Pennsylvania 15501
Re: K091919
Trade/Device Name: DeVilbiss IntelliPAP/SleepCube Model DV55 S Series CPAP Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 26, 2009 Received: June 30, 2009
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.
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.
4
Page 2 - Ms. Miller
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
fo
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number: (if known): Not yet assigned
DeVilbiss IntelliPAP/SleepCube Model DV55 S Series CPAP Device Name:
Indications For Use:
The DeVilbiss IntelliPAP/SleepCube Model DV55 S Series is 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.
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)
Raul Robles for L. Schulteis
(Division Sign-Off) Division of Anesthestology, General Hospital Intection Control, Dental Devices
510(k) Number: K0911
Page
Section 4.0-1