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.

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

AI/ML Overview

The provided text describes the DeVilbiss Intellipap/SleepCube Model DV55 S Series CPAP and its regulatory submission. However, it does not contain information about acceptance criteria, device performance, a specific study proving the device meets acceptance criteria, or any of the detailed metrics requested in your prompt.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed performance study with acceptance criteria and results for the new device itself.

Here's what can be extracted and what is explicitly missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing. The document states that "This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols." and "The DeVilbiss Bilevel S/ST met the required performance criteria and functioned as intended." However, it does not provide a table outlining specific numerical acceptance criteria (e.g., pressure accuracy, trigger sensitivity thresholds) or the measured performance values of the device against those criteria.

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

Missing. No information on sample size or data provenance for any specific test set is provided. It mentions testing "according to guidance" and "applicable voluntary standards" but not details of the tests themselves.

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

Missing. This type of information is generally relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis), which is not detailed here. The testing described is primarily non-clinical/engineering.

4. Adjudication Method for the Test Set:

Missing. Not applicable given the lack of detail on the test set and ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

Missing. An MRMC study involves human readers, and no such study is described. The document focuses on the device's technical characteristics and comparison to predicate devices, not human-in-the-loop performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Partially Addressed (implied, but without specifics): The document implies standalone (non-clinical/engineering) testing was done. It states: "This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols." and "The DeVilbiss Bilevel S/ST met the required performance criteria and functioned as intended." This refers to the device's inherent performance. However, there are no specific performance metrics or studies detailed.

7. The type of ground truth used:

Implied (Engineering Standards): For the non-clinical testing mentioned, the "ground truth" would be the specifications and requirements defined by the referenced ISO, ASTM, IEC standards, and other applicable regulatory guidance. No specific "ground truth" like pathology or outcomes data is relevant or mentioned.

8. The Sample Size for the Training Set:

Not Applicable / Missing: This device is a CPAP machine, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "development" would involve engineering design and validation, not model training.

9. How the Ground Truth for the Training Set was Established:

Not Applicable / Missing: As above, this concept doesn't apply to this type of medical device submission.

In summary, the provided document is a regulatory filing focused on establishing substantial equivalence for a medical device (a CPAP machine). It confirms that testing was performed according to standards and that the device met required performance criteria, but it does not provide the granular detail about specific acceptance criteria, test results, study methodology, or sample sizes for performance evaluation that your questions request. To obtain that information, one would typically need access to the full test reports or design validation documentation, which are not part of this publicly available 510(k) summary.

Summary

{0}------------------------------------------------

SEP 2-8 2009

Section 5.0 510(k) Summary

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:
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 - K080131DeVilbiss 9055 Bilevel - K032056DeVilbiss Intellipap - K071689

K691919

{1}------------------------------------------------

Description of Device:

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:

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 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,

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:

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

Regulation Number and Section

§ 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).