(118 days)
Not Found
No
The document describes a standard bilevel positive airway pressure device with adjustable trigger sensitivity, which is a common feature in such devices and does not indicate the use of AI/ML. There are no mentions of AI, ML, or related concepts like deep learning or neural networks.
Yes
The device is intended for use in treating Obstructive Sleep Apnea (OSA) by applying positive air pressure to prevent airway collapse, which is a therapeutic function.
No
The device is described as providing positive air pressure for the treatment of sleep apnea, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a hardware device that provides positive air pressure, including components like a pneumatic splint and mechanisms for adjusting pressure and triggering sensitivity. While it contains software, it is not solely software.
Based on the provided text, 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 air pressure to prevent airway collapse. It does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body.
- Detecting or measuring substances in those samples.
- Providing information for diagnosis, monitoring, or screening.
The device is clearly described as a therapeutic device for treating a respiratory condition.
N/A
Intended Use / Indications for Use
The DeVilbiss Intellipap/SleepCube Model DV56 ST 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)
MNS
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 ST product will replace the 9055D in the sleep product line as well as provide a new product offering where time backup rate is necessary. The product will have a reduced manufactured cost, primarily derived from reduced material costs and improved engineering design associated with the existing IntelliPAP/SleepCube product platform. The market has dictated a need for lower cost and smaller sized bilevel units as well as improved functionality such as timed backup rate and manually adjustable inhale/exhale triggering sensitivity.
The triggering sensitivity overall must be increased as much as possible to be competitive with other bilevel ST 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 ST 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
Not Found
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)
This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols. The DeVilbiss DV56 ST 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.
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
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
KC093070
Section 5.0 510(k) Summary
.
JAN 2 6 2010
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: | September 29, 2009 |
| Device Name: | DeVilbiss Intellipap/SleepCube
Bilevel ST |
| Proprietary name of new device: | DeVilbiss Intellipap/SleepCube
Bilevel ST |
| Common or usual name of the device: | DeVilbiss Bilevel ST |
| DeVilbiss Model Number | DV56 ST Series |
| Classification of the predicate device: | Class II |
| Classification of new device: | Class II |
| Classification Panel: | Anesthesiology |
| Panel Code: | MNS |
| CFR Regulation Number: | 21 CFR 868.5895 ventilator,
continuous, non-life-supporting |
| 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 ST product will replace the 9055D in the sleep product line as well as provide a new product offering where time backup rate is necessary. The product will have a reduced manufactured cost, primarily derived from reduced material costs and improved engineering design associated with the existing IntelliPAP/SleepCube product platform. The market has dictated a need for lower cost and smaller sized bilevel units as well as improved functionality such as timed backup rate and manually adjustable inhale/exhale triggering sensitivity.
The triggering sensitivity overall must be increased as much as possible to be competitive with other bilevel ST 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 ST 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 ST 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 DV56 ST 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 DV56 ST 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 ST 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 IntelliPAP/SleepCube Bilevel ST 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes above a pair of legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Ms. Betty Lou Miller Regulatory Affairs Coordinator Sunrise Medical 100 DeVilbiss Drive Somerset, Pennsylvania 15501
JAN 2 6 2010
Rc: K093070
Trade/Device Name: DeVilbiss IntelliPAP/SleepCube DV56 ST Series Bilevel CPAP Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: January 21, 2010 Received: January 22 , 2010
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Wh fo
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices
Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
5
Indications for Use
Not yet assigned 510(k) Number: (if known):
DeVilbiss IntelliPAP/SleepCube DV56 ST Series Bilevel CPAP Device Name:
Indications For Use:
The DeVilbiss IntelliPAP/SleepCube Model DV56 ST Series Bilevel 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 (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)
L. Schultze
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page of
30 70 510(k) Number: KR) 9
Section 4.0-1