The DeVilbiss IntelliPAP/SleepCube Model DV57 Series Auto 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. Auto Bilevel units are used over conventional CPAP units due to high pressures and/or patient intolerance to continuous pressure, making exhalation difficult.

The proposed DeVilbiss DV57 Auto Bilevel product is an addition to the sleep product line. The proposed Auto Bilevel device combines the functions of traditional (predicate) Bilevel and (predicate) Auto Adjust CPAP to provide bilevel pressure support therapy that responds to detected events and adjusts the IPAP pressure setting as the patient demand requires. The level of pressure support, difference between IPAP and EPAP is maintained at a level prescribed by a doctor.

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 Auto Bilevel 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the DeVilbiss Intellipap/SleepCube Auto Bilevel device:

Important Note: The provided document is a 510(k) Summary, which is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device. It typically focuses on design, function, and performance comparisons to predicates rather than presenting detailed, comprehensive clinical study results for novel acceptance criteria. Therefore, much of the requested information (like specific effect sizes from MRMC studies, detailed training set information with ground truth establishment, or specific sample sizes for tests) is not explicitly present in this type of document.

Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of precise, quantifiable acceptance criteria with corresponding performance metrics like you might find for a novel device. Instead, it relies on demonstrating substantial equivalence to predicate devices. The acceptance is implicitly tied to meeting the performance characteristics and safety profiles of the already-cleared predicate devices.

Implicit Acceptance Criteria and Reported Performance (derived from the text):

Acceptance Criteria Category	Reported Device Performance
Intended Use Equivalence	Device has the "same intended use" as predicate. Intended to treat OSA in spontaneously breathing patients 30 Kg and above in home and clinical environments.
Operating Principle Equivalence	Uses the "same operating principle" (bilevel positive airway pressure, responding to detected events, adjusting IPAP while maintaining pressure support).
Bilevel Modes and Settings Equivalence	Incorporates the "same basic Bilevel modes and settings" as predicate.
Material Equivalence	Incorporates "similar materials" as predicate.
Safety and Effectiveness Equivalence	"Analysis of comparison of design, function and features...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."
Standard Compliance (Non-Clinical)	"Tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols." Met "required performance criteria and functioned as intended."
Software Compliance (if applicable)	Tested according to FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
Regulatory Framework (Non-Continuous Ventilator)	Classified as a Class II device under 21 CFR 868.5905 Noncontinuous Ventilator (IPPB).
Human Trigger Sensitivity	Automatic and manual inhale/exhale trigger sensitivity provided to allow clinician customization.

Study Details

The document describes non-clinical testing rather than a clinical study with human patients comparing the device's diagnostic or therapeutic efficacy against a gold standard or human readers.

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The testing described is non-clinical (bench testing) against standards and performance characteristics of predicate devices.
- Data Provenance: Not applicable as it's non-clinical testing. It's likely internal laboratory testing data from DeVilbiss Healthcare LLC.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) summary for a CPAP-like device. Ground truth for performance would be based on engineering specifications and adherence to standards, which typically do not involve expert medical readers for establishing the truth, but rather engineers and quality control personnel for verification.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is non-clinical testing against engineering specifications and standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study described. This device is a therapeutic device (CPAP-like) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, this type of study is not relevant to its clearance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone performance testing was done in the sense that the device's operational performance was tested independently against engineering specifications and standards. The device itself operates autonomously to deliver therapy based on pre-programmed algorithms for auto-adjustment and bilevel pressure delivery. However, this is not "standalone algorithm performance" in the context of an AI diagnostic that might be compared to human performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" would be the established engineering specifications, regulatory standards (ISO, ASTM, IEC), and the known performance characteristics of the predicate devices. Essentially, the device was required to perform according to its design and functional requirements, which were verified against these benchmarks.
The sample size for the training set:
- Not applicable. This device is not an AI/ML device that requires a "training set" in the context of machine learning model development. Its algorithms are likely rule-based or control-loop-based, developed through engineering design and testing, not by training on large datasets in the way an image recognition algorithm would be.
How the ground truth for the training set was established:
- Not applicable. (See point 7).

In Summary:

The K112220 510(k) submission for the DeVilbiss Intellipap/SleepCube Auto Bilevel focuses on demonstrating substantial equivalence to existing predicate devices (Resmed VPAP Auto - K082605, DeVilbiss Intellipap Bilevel S - K091919, DeVilbiss IntelliPAP Auto Adjust - K071689). The "acceptance criteria" are intrinsically linked to meeting the performance, safety, and functional characteristics of these predicates, as well as adherence to relevant industry standards. The testing described is primarily non-clinical bench testing to verify these characteristics, not clinical studies involving patient populations, expert readers, or AI algorithm training.

Summary

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K112220

NOV 22222011

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 LLC100 DeVilbiss DriveSomerset, PA 15501
FDA registration number of the manufacturer of the new device:	2515872
Official contact person for all correspondence:	James P. FroehlichQuality ManagerDeVilbiss Healthcare LLC100 DeVilbiss DriveSomerset, PA 15501Phone: 814-443-7692Fax: 814-443-7571Email: jim.froehlich@devilbisshc.com
Date Prepared:	June 27, 2011
Device Name:	DeVilbiss Intellipap/SleepCube Auto Bilevel
Proprietary name of new device:	DeVilbiss Intellipap/SleepCube Auto Bilevel
Common or usual name of the device:	DeVilbiss Auto Bilevel
DeVilbiss Model Number	DV57 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 Auto - K082605DeVilbiss Intellipap Bilevel S - K091919DeVilbiss IntelliPAP Auto Adjust - K071689

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Description of Device:

Comparison of Device Technological Characteristics to Predicate Devices:

The submitted DeVilbiss DV57 Auto Bilevel 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 DV57 Series Auto 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.

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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 DV57 Auto Bilevel 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 DV57 Auto Bilevel was tested in accordance with the applicable voluntary standards. The DeVilbiss DV57 Auto Bilevel 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 proposed DeVilbiss DV57 Auto Bilevel to the predicates Resmed VPAP Auto (K082605), DeVilbiss DV55 Bilevel S (K091919) and DeVilbiss IntelliPAP/SleepCube DV54 AutoAdjust (# 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 DV57 Auto Bilevel 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is centered in the image. There is a logo to the left of the text.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV 222 2011

Mr. James P. Froehlich Quality Manager DeVilbiss Healthcare LLC 100 DeVilbiss Drive Somerset, Pennsylvania 15501

Re: K112220

Trade/Device Name: DeVilbiss IntelliPAP/SleepCube Model DV57 Series Auto Bilevel CPAP Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 15, 2011 Received: November 16, 2011

Dear Mr. Froehlich:

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.

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Page 2 - Mr. Froehlich

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Nh for

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

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

DeVilbiss IntelliPAP/SleepCube Model DV57 Series Auto 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)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

1112220 510(k) Number:

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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).