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.

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

AI/ML Overview

This 510(k) submission describes the DeVilbiss IntelliPAP/SleepCube Bilevel ST device, intended for treating Obstructive Sleep Apnea (OSA). The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific acceptance criteria (e.g., numerical thresholds for accuracy, sensitivity, or specificity) or detailed reported device performance in a quantitative way for the DeVilbiss IntelliPAP/SleepCube Bilevel ST device.

Instead, the submission states that:

Acceptance Criteria (Implicit)	Reported Device Performance
Compliance with appropriate ISO, ASTM, and IEC standards and other applicable requirements.	"This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols."
Adherence to FDA's Draft Reviewer Guidance for Premarket Notification Submissions - Anesthesiology and Respiratory Devices.	"The DeVilbiss DV56 ST Series Bilevel CPAP was designed and tested according to guidance outlined in: 1. FDA's Draft Reviewer Guidance for Premarket Notification Submissions -Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices (November 1993)... As suggested by FDA's November 1993 publication... 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."
Adherence to FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."	"The DeVilbiss DV56 ST Series Bilevel CPAP was designed and tested according to guidance outlined in: ...2. FDA 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (May 11, 2005)." (Implied compliance by testing according to guidance).
Substantial equivalence to predicate devices in terms of meeting performance criteria and functioning as intended.	"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." The submission also notes the device "met the required performance criteria and functioned as intended." and "does not raise any new issues of safety and effectiveness." The device's technological characteristics are similar (same intended use, operating principle, basic Bilevel modes, and materials). The market dictates a need for "increased" triggering sensitivity "to be competitive".
To provide a continuous source of bilevel positive airway pressure for the treatment of sleep apnea effectively.	"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." (Functionality is implicitly met through testing and substantial equivalence).

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a test set (e.g., number of patients or clinical cases). The testing described is "Non-Clinical Testing" and refers to compliance with standards and guidance documents. There is no mention of data provenance (e.g., country of origin, retrospective or prospective) as it pertains to patient data, because this was not a clinical study involving patients for direct performance evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the provided text. The device underwent non-clinical standard testing and comparison to predicate devices, not evaluation against expert-established ground truth in a clinical setting.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this submission. The submission focuses on demonstrating substantial equivalence through engineering and standards compliance, not on comparing human reader performance with or without AI assistance. The device is a medical device (CPAP machine), not an AI-powered diagnostic tool for interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable in the context of this device. The DeVilbiss IntelliPAP/SleepCube Bilevel ST is a therapeutic device that delivers positive airway pressure, not an algorithm, and it always operates with a "human-in-the-loop" (the patient and prescribing clinician). The testing focused on the device's mechanical and software performance against established engineering standards and specifications.

7. Type of Ground Truth Used

The ground truth used for this submission's non-clinical testing was based on engineering specifications, regulatory guidance, and performance criteria outlined in applicable ISO, ASTM, and IEC standards. The device's functionality was evaluated against these predefined technical benchmarks and its ability to act as a therapeutic device for OSA, consistent with the intended use. It was also compared to the performance and characteristics of predicate devices. There is no mention of pathology, expert consensus (in a clinical interpretation sense), or patient outcomes data from a study for establishing ground truth.

8. Sample Size for the Training Set

This information is not applicable. The Device is not an AI/ML device that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there was no training set for an AI/ML algorithm.

Summary

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KC093070

Section 5.0 510(k) Summary

JAN 2 6 2010

Administrative Information and Device Identification

Name and address of the manufacturer andsponsor of the 510(k) submission:	DeVilbiss Healthcare100 DeVilbiss DriveSomerset, PA 15501
FDA registration number of the manufacturerof the new device:	2515872
Official contact person for all correspondence:	Betty Lou MillerRegulatory Affairs CoordinatorDeVilbiss Healthcare100 DeVilbiss DriveSomerset, PA 15501Phone: 814-443-7602Fax: 814-443-7571Email:betty.miller@devilbisshc.com
Date Prepared:	September 29, 2009
Device Name:	DeVilbiss Intellipap/SleepCubeBilevel ST
Proprietary name of new device:	DeVilbiss Intellipap/SleepCubeBilevel 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 - K080131DeVilbiss 9055 Bilevel - K032056DeVilbiss Intellipap - K071689

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Description of Device:

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.

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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. The DeVilbiss DV56 ST Series Bilevel CPAP was designed and tested according to guidance outlined in:

1. FDA's Draft Reviewer Guidance for Premarket Notification Submissions -Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices (November 1993); and
1. 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.

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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.

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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

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Indications for Use

Not yet assigned 510(k) Number: (if known):

DeVilbiss IntelliPAP/SleepCube DV56 ST Series Bilevel CPAP Device Name:

Indications For Use:

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

Regulation Number and Section

§ 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).