The BiPAP Focus ventilator is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or respiratory failure, or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient.

Device Description

The BiPAP Focus is a non-invasive ventilator which has two (2) ventilation modes:

Continuous positive airway pressure (CPAP) which provides a single level of positive pressure to the patient
Spontaneous/Timed (S/T) which provides two levels of positive pressure (one during inspiration - IpAp and one during expiration - EvAp) and delivers timed breaths if the patient does not initiate a breath.

AI/ML Overview

I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification for a medical device called "BiPAP Focus." It details the regulatory approval process, classification, and a summary of the device and its intended use, as well as a comparison to predicate devices.

However, it does not contain any information about specific acceptance criteria (performance metrics with thresholds) or the results of any study (clinical or technical) that would demonstrate the device meets such criteria. The document focuses on demonstrating substantial equivalence to previously approved devices, rather than presenting a performance study against specific acceptance metrics.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes, data provenance.
Number and qualifications of experts for ground truth.
Adjudication method.
MRMC comparative effectiveness study or human reader improvement effect size.
Standalone performance study.
Type of ground truth used.
Training set sample size.
How ground truth for the training set was established.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 2006

Dr. John O'Dea General Manager Respironics (Ireland) Limited Parkmore Business Park, Parkmore West Galway, Ireland

Re: K053168

Trade/Device Name: BiPAP Focus Regulation Number: 21 CFR 868.5895 Regulation Name: Ventilator, Continuous, Non-Life-Supporting Regulatory Class: II Product Code: MNS Dated: November 10, 2005 Received: November 14, 2005

Dear Dr. O'Dea:

This letter corrects our substantially equivalent letter of January 4, 2006.

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 narketed 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 (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 Dr. O'Dea

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. 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), please contact the Office of Compliance at (240) 276-0120. 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 Division 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.

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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Premarket Notification 510(k) Section 4 - Indications for Use Statement Respironics BiPAP Focus

Page 1 of i

510(k) Number: (To be assigned)

Device Name:

BiPAP Focus

Indications for Use:

Intended Population

Adults > 30 kg

Environments of use

Hospital, sub-acute and intra-hospital transport under qualified clinician direction and supervision

Prescription Use XX (Part 21 CFR 80 ! Subpart D)

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)

Tim Johnson

K053168

Page 4.1

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Premarket Notification 510(k) Section 5 - 510(k) Summary

JAN 4 2006

Non-Confidential Summary of Safety and Effectiveness Page 1 of 2

10-Nov-05 Respironics Ireland Ltd. Parkmore Business Centre Tel - [353] (91) 709011 Parkmore West Fax - [353] (91) 758929 Galway, Ireland Official Contact: John O'Dea, Ph.D. - General Manager Proprietary or Trade Name: BiPAP Focus Common/Usual Name: Noninvasive ventilator Classification Name: ventilator, continuous, minimal ventilatory support, facility use (MNT) Device: Model - BiPAP Focus Predicate Devices: Respironics - Vision - K982454 Harmony K984407 and K031656

Device Description:

The BiPAP Focus is a non-invasive ventilator which has two (2) ventilation modes:

Continuous positive airway pressure (CPAP) which provides a single level of positive 1. pressure to the patient
Spontaneous/Timed (S/T) which provides two levels of positive pressure (one during 2. inspiration - IpAp and one during expiration - EvAp) and delivers timed breaths if the patient does not initiate a breath.

Image /page/3/Picture/9 description: The image shows a piece of medical equipment sitting on a stand. The equipment has a screen and several buttons. The stand has wheels, which makes it easy to move the equipment around. The equipment is likely used to monitor a patient's vital signs.

Indications for use - The BiPAP Focus ventilator is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or respiratory failure, or to maintain airway patency and provide ventil support to patients who experience obstructive sleep apnea. It is not intended to romaid? } ventilatory requirements of the patient.

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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 10-Nov-05

Patient Population - For use with patients > 30 kg

Environment of Use - Home, Hospital, Sub-acute Institutions

Differences Between Other Legally Marketed Predicate Devices

The differences between the new device, BiPAP Focus, and the predicate devices are -

An Internal battery and associated charging circuit is being added; .
. The existing Buzzer on Harmony 2 will become the backup Buzzer;
The existing Remote Alarm will be reconfigured to go through an internal relay to isolate t the circuit. A ¼ Screen VGA will be used instead of the current LCD;
The Alarm LEDs will be supplemented with Battery Status LEDs; .
The "Vent Inop" LED will be replaced by a High Priority Text based alarm; and .
The Industrial Design of the unit will cater for additional GUI circuitry. .

The BiPAP Focus is viewed as having a non-invasive ventilation capability substantially equivalent to the following predicate devices -

Respironics - Vision - K982454 and Harmony K984407 and K031656

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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).