The new DeVilbiss Model 9055 Bilevel CPAP is an AC powered, dual-pressure blower designed to be used in providing CPAP therapy to the spontaneously breathing adult patient population with Obstructive Sleep Apnea. Rapid changes in pressure between EPAP (Expiratory Positive Airway Pressure) and IPAP (Inspiratory Positive Airway Pressure) will be achieved by changing the operating speed of the blower. The bilevel device will have two primary prescription settings: IPAP pressure and EPAP pressure. Electrical power is supplied to the unit using an AC line cord (100 – 240 VAC, 50/60Hz, 400 Hz). The AC input voltage is converted to a DC voltage by an internal switch-mode power supply. The DC voltage is used to power the internal electronics of the product (microcontroller, motor control circuitry, blower, LCD display, etc.). Positive pressure is produced by spinning a reverse-curved impeller with a brushless DC motor. Room air is drawn into the blower through a filter, pressurized in the blower, and then discharged through a 22 mm ID tube.

AI/ML Overview

This 510(k) summary does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) that would typically be found in a study report for a diagnostic device utilizing AI.

This document describes a Bilevel CPAP device (DeVilbiss Model 9055), which is a medical device for treating Obstructive Sleep Apnea. The FDA cleared this device based on substantial equivalence to existing predicate devices, not on a new clinical study assessing its performance against specific acceptance criteria in the way you've outlined for things like diagnostic accuracy.

Therefore, many of your specific questions cannot be answered from this document. I will answer what is available and explain why other information is not present.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

For this type of device, "acceptance criteria" are related to performance characteristics and safety, demonstrating that the new device performs as well as, or equivalently to, the predicate devices. The "study" for this submission is a comparison to legally marketed predicate devices, not a new clinical trial generating performance metrics like sensitivity/specificity for a diagnostic AI.

Criteria Category	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as stated in the 510(k))
Intended Use	The device must be intended for use in treating Obstructive Sleep Apnea (OSA) in spontaneously breathing adult patients by applying positive air pressure.	"The DeVilbiss Model 9055 Bilevel CPAP is intended for use in treating OSA in spontaneously breathing adult patients by means of application of positive air pressure." "The Model 9055 Bilevel CPAP is intended for use in treating obstructive sleep apnea in adult patients." This matches the predicate devices.
Functional Equivalence	The device must provide dual pressures (IPAP and EPAP) for OSA treatment and achieve rapid changes in pressure between EPAP and IPAP, functioning similarly to predicate devices.	"The new dual pressure level CPAP is designed to provide rapid changes in air pressure between EPAP (expiratory positive airway pressure) and IPAP (inspiratory positive airway pressure)." "The DeVilbiss Model 9055 Bilevel CPAP is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all utilize a microprocessor controlled system to provide a range of dual pressures (IPAP and EPAP) for the treatment of Obstructive Sleep Apnea." This matches the predicate devices.
Technological Equivalence	The device must not introduce new technologies compared to predicate devices and utilize similar or identical materials and construction.	"No new technologies have been introduced in the Model 9055 Bilevel CPAP device." "The compressor is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices."
Safety and Standards Compliance	The device must comply with applicable electrical and mechanical safety standards for this type of device.	"The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device." "All of the devices are tested and approved to recognized agency safety standards." (Implies compliance, but specific standards not listed in the provided text).

Detailed Study Information (Not Present in the Provided Document):

This submission is a 510(k) for a medical device (Bilevel CPAP machine), not an AI/diagnostic software. Therefore, the concepts of "test sets," "ground truth," "expert consensus," "MRMC studies," or "training sets" as they apply to AI/machine learning studies are not applicable here and are not mentioned in the provided text.

Sample size used for the test set and the data provenance: Not applicable. This is a hardware device; testing would involve engineering, performance, electrical safety, and biocompatibility, not analysis of a "test set" of patient data for diagnostic accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is not an AI for human reader assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device would be its ability to consistently deliver specified pressures and its compliance with safety standards, evaluated through engineering tests and comparison to predicate devices, not clinical pathology or outcomes data in the context of an AI study.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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K032056

FEB 2 0 2004

16.0	510(k) Summary

Submitter's Name:	Sunrise Medical HHG, Inc.Respiratory Products Division100 DeVilbiss DriveSomerset PA 15501
Contact Person:	Stephen F. KrepelkaPhone: 814-443-7671Fax: 814-443-7571Email: steve.krepelka@sunmed.com
Date Prepared:	July 1, 2003
Device Name:	Bilevel CPAP
Common or Usual Name:	Bilevel Nasal CPAP with Remote Control Module and AnalogBreakout Box
DeVilbiss Model Number:	Model 9055
Trade Proprietary Name:	DeVilbiss Bilevel CPAP with Remote Control Module and AnalogBreakout Box
Established RegistrationNumber:	2515872
Classification Panel:	Anesthesiology
FDA Classification:	Class II
CFR Section:	868.5905
Product Code:	BZD
Legally Marketed Predicate Devices:
Device Name	510(k) Notification
DeVilbiss Model 7355 Bilevel CPAP with RemoteControl ModuleResmed Sullivan VPAP II	K952491 K961783
DeVilbiss 9001 Series CPAP	K011229

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Description of Device:

The bilevel device will have two primary prescription settings: IPAP pressure and EPAP pressure.

Electrical power is supplied to the unit using an AC line cord (100 – 240 VAC, 50/60Hz, 400 Hz). The AC input voltage is converted to a DC voltage by an internal switch-mode power supply. The DC voltage is used to power the internal electronics of the product (microcontroller, motor control circuitry, blower, LCD display, etc.). Positive pressure is produced by spinning a reverse-curved impeller with a brushless DC motor. Room air is drawn into the blower through a filter, pressurized in the blower, and then discharged through a 22 mm ID tube.

Statement of intended Use:

The DeVilbiss Model 9055 Bilevel CPAP is intended for use in treating OSA in spontaneously breathing adult patients by means of application of positive air pressure. The device is to be used in home and clinical environments.

Statement of Safety and Effectiveness:

The DeVilbiss Model 9055 Bilevel CPAP is equivalent in both function and indications for use to the DeVilbiss Model 7355 and Resmed Sullivan VPAP II Bilevel CPAP legally marketed predicate devices. Displays and constructional details are equivalent to the DeVilbiss Model 9001 CPAP.

The DeVilbiss Model 9055 Bilevel CPAP is designed for use on the order of a physician for the treatment of Obstructive Sleep Apnea. The compressor is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device.

The new dual pressure level CPAP is designed to provide rapid changes in air pressure between EPAP (expiratory positive airway pressure) and IPAP (inspiratory positive airway pressure). The method of making this pressure change and other characteristics of the Model 9055 Bilevel CPAP are substantially equivalent to other legally marketed devices.

Technological Characteristics:

The DeVilbiss Model 9055 Bilevel CPAP is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all utilize a microprocessor controlled system to provide a range of dual pressures (IPAP and EPAP) for the treatment of Obstructive Sleep Apnea. All of the devices are tested and approved to recognized agency safety standards. No new technologies have been introduced in the Model 9055 Bilevel CPAP device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized symbol that resembles an abstract bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

Mr. Stephen F. Krepelkea Project Engineer Sunrise Medical 100 DeVilbiss Drive Somersrt, Pennsylvania 15501-2125

Re: K032056

Trade/Device Name: DeVilbiss Model 9055 Bilevel CPAP Regulation Number: 868-5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 5, 2004 Received: February 6, 2004

Dear Mr. Krepelka:

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 nay, 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 such 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 Eederal Register.

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Page 2 - Ms. Falk

Please be advised that FDA's issuance of a substantial equivalence determination does not I Toast that FDA has made a determination that your device complies with other requirements moan that it 27 mas made a actes and regulations administered by other Federal agencies. of the Act of ally I oderal two Act's requirements, including, but not limited to: registration r ou inust comply with are research many (21 CFR Part 801); good manufacturing practice allo listing (21 CF R Part 067), absiting 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter wifi and in Jo The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desite special the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph. D.

Chiu Lin, Ph., D. 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): K032056

Device Name:

DeVilbiss Model 9055 Bilevel CPAP

Indications For Use:

The Model 9055 Bilevel CPAP is intended for use in treating obstructive sleep apnea in adult patients.

Vttach

(Sylision Sign-Off) (Owlsion Sign-Off)
Division of Anesthesiology, General Hospital, Division of Antool, Dental Devices

510(k) Number: K032056

Yes Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

No Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _ 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).