The Breas iSleep 20+ System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA).

The iSleep20+ is intended for non-invasive use.

The iSleep20+ shall only be used by patients with spontancous breathing.

The CPAP function is intended to deliver continuous positive airway pressure therapy for the treatment of obstructive sleep apnea in adults (who weigh more than 30 kg).

The iSleep 20+ is intended to be operated by trained users and qualified personnel.

Device Description

The iSleep 20+ system is pressure-supported and pressure-controlled ventilator with a CPAP function intended for spontaneous breathing patients who require long-term support by mechanical ventilation during the night.

In the treatment of chronic respiratory failure, positive airway pressure ventilation is well established and common practice as a mean to assure sufficient gas exchange. There are a number of devices legally marketed in the United States for this application.

The iSleep 20+ system can be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. It must always be prescribed by a licensed physician.

It is not intended for life support applications or for transport of critical care patients.

The therapy delivered by the Breas iSleep 20+ System is Constant Positive Airway Pressure (CPAP)

The iSleep 20+ airflow is delivered via a single lumen outlet tube that may be connected to various non-invasive patient interfaces, such as nasal masks. To minimize CO2 rebreathing, masks or other interfaces permitting a leak flow of at least 12 liters/minute at the output pressure setting of 4 cmH20 are recommended.

The iSleep 20+ systems have an auto-switching power supply that facilitates use in conjunction with international travel (100 - 240 VAC). It can also be used with an external 12.5/ 24 VDC power source when AC mains line voltage is not available.

The outer dimensions of the iSleep 20+ housing is 6.8 x 6.8 x 8.2 inches, and the device weighs 3.1 pounds including empty humidifier.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for the Breas iSleep 20+ System, a CPAP device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials. Therefore, much of the information typically found in acceptance criteria and detailed study designs for new medical device performance validation is not present or not applicable in this context.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission are generally derived from recognized standards and the performance of the predicate device. The text does not explicitly list quantitative acceptance criteria in a table format with corresponding reported values. Instead, it states that the device passed various tests designed to demonstrate safety, performance, and substantial equivalence to the predicate device.

Table 1: Implied Acceptance Criteria and Reported Device Performance

Acceptance Criterion Category	Source of Criteria (Implied)	Reported Device Performance
Performance Specifications	Stated performance specifications of the Breas iSleep 20+ System	"The Breas 20+ System is capable of meeting its stated performance specifications" (Passed)
Risk Analysis Issues	Addressed risk analysis issues	"Jul Risk Analysis issues have been appropriately addressed" (Passed)
Wave-form performance	Performance of predicate device (Breas PV10i)	"substantial equivalent with regards to Wave-form performance" (Passed)
Work of Breathing	Performance of predicate device (Breas PV10i)	"substantial equivalent with regards to... Work of Breathing" (Passed)
Pressure Dynamic regulation	Performance of predicate device (Breas PV10i)	"substantial equivalent with regards to... Pressure Dynamic regulation" (Passed)
Electrical Safety	IEC 60601-1 standard	"Passed all applicable tests." (Compliant)
Safety and Performance	ISO 17510-1 standard	"Passed all applicable tests." (Compliant)
Electromagnetic Compatibility (EMC)	EMC testing standards	"Passed all applicable tests." (Compliant)
Mechanical Safety	Relevant mechanical safety standards	"Passed all applicable tests." (Compliant)
Environmental Performance	Relevant environmental testing standards	"Passed all applicable tests." (Compliant)
Functional Performance	Functional requirements of the device	"Passed all applicable tests." (Compliant)
Particle Matter	Relevant particle matter testing standards	"The device passed all tests." (Compliant)
Software Documentation & Testing	FDA's May 11, 2005 "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices"	"The device passed all tests." (Compliant)

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable. The submission refers to "non-clinical testing" and "bench-testing" rather than human subject testing with a "test set" in the context of AI/diagnostic device validation. The "test set" here refers to the device itself and its components undergoing engineering and performance evaluations.
Data Provenance: Not applicable. The testing described is laboratory/bench testing of the device and its components. No human data (e.g., patient records, images) is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for device performance in this 510(k) context is established by engineering standards, specifications, and comparison to the predicate device's measured performance on a test bench, not by expert human interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept is relevant for clinical studies where human interpretation or outcomes need to be adjudicated. The testing here is against objective engineering and performance standards.

5. 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. A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical studies were not required to support a substantial equivalence determination." The device is a CPAP system, not an AI-assisted diagnostic or interpretation tool.

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

Not applicable. This device is a CPAP system, not an algorithm, and its performance is assessed as a standalone electromechanical device against specified engineering and safety standards, and in comparison to a predicate device's physical output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is established by engineering specifications, recognized international standards (e.g., IEC 60601-1, ISO 17510-1), and the measured performance of the legally marketed predicate device (Breas PV10i). This is a technical, objective ground truth based on physical measurements and compliance, not clinical or interpretative "ground truth" as might be used for diagnostic algorithms.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device. The "training" here would refer to the device's design and manufacturing processes meeting the required specifications.

9. How the ground truth for the training set was established

Not applicable, as there is no training set in the context of an AI/machine learning device.

Summary

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2006 7 ਤੋਂ 510(k) Premarket Notification

Breas iSleep 20+ System

Breas Medical AB

510(k) SUMMARY

Submitter

Breas Medical AB

Företagsvagen 1

Karl-Johan Holm

SE 435 33 Molnlycke

Sweden

Contact Person

Quality Assurance and Regulatory Affairs Manager

Phone: +46 31 868830

Breas iSleep 20+ System

Fax: +46 31 868810

Summary Date

Name of Device

Common Name

Classification Name

Product Code

Predicate Device

CPAP system

April 11, 2006

Non-continuous ventilator (21 CFR 868.5905)

BZD

Breas PV10i (K030985)

Page 3.1

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Device Description:

The iSleep 20+ system can be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. It must always be prescribed by a licensed physician.

It is not intended for life support applications or for transport of critical care patients.

The therapy delivered by the Breas iSleep 20+ System is Constant Positive Airway Pressure (CPAP)

The outer dimensions of the iSleep 20+ housing is 6.8 x 6.8 x 8.2 inches, and the device weighs 3.1 pounds including empty humidifier.

Intended Use:

The iSleep20+ is intended for non-invasive use.

The iSleep20+ shall only be used by patients with spontancous breathing.

The CPAP function is intended to deliver continuous positive airway pressure therapy for the treatment of obstructive sleep apnea in adults (who weigh more than 30 kg).

The iSleep 20+ is intended to be operated by trained users and qualified personnel.

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Comparison of Use and Technological Characteristics:

The iSleep 20+ system can be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. They must always be prescribed by a licensed physician.

As compared with the cited predicate device, the Breas iSleep 20+ Systems have:

Same intended uses

Same environments of use

Similar design (microprocessor-controlled blower as air source)

Same fundamental scientific technology

The functions that are available in iSleep 20+ are also available in the predicate device. The differences that do exist are minimal and involve primarily additional functionality in the predicate device and additional display indicator possibilities in the iSleeen 20+ system. The features are described in the modified device information section 6 and appendix 6 (draft manuals and sellsheets).

Summary of Performance Testing:

1. Non-clinical testing was conducted to verify that the Breas 20+ System is capable of meeting its stated performance specifications and that Jul Risk Analysis issues have been appropriately addressed. The device passed all applicable tests.
1. Comparative testing to predicate device was performed. This bench- testing confirmed that the Breas iSleep 20+ System is substantial equivalent with regards to Wave-form performance as well as Work of Breathing and Pressure Dynamic regulation.
1. Testing was conducted to demonstrate compliance with applicable requirements in the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" published by the FDA's Division of Cardiovascular, Respiratory, and Neurological Devices and the July 1995 "Draft Reviewer Guidance for Ventilators". The testing included but was not limited to:
Electrical Safety testing per IEC 60601-1 .
Safety and Performance testing per ISO 17510-1 �
Electromagnetic Compatibility testing (EMC testing) .
. Mechanical Safety testing
Environmental testing
. Functional testing

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t Particle matter testing
The device passed all tests.
1. All device softwares were documented and tested in accordance with the FDA's May 11, 2005 "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices". The device passed all tests.
1. Clinical studies were not required to support a substantial equivalence determination.

Conclusions:

The Breas iSleep 20+ System meets its stated performance specifications and criteria outlined in the Reviewer Guidance publications referenced above. We conclude that the device is capable of operating safely in their intended environments and will be effective in fulfilling its intended use.

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JUN 2 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Karl-Johan Holm Quality Assurance & Regulatory Affairs Manager Breas Medical AB Foretagsvagen 1 Molnlycke, SWEDEN 43533

Re: K061057

Trade/Device Name: Breas iSleep 20+ System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 9, 2006 Received: June 14, 2006

Dear Mr. Holm:

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 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 Federal Register.

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Page 2 - Mr. Holm

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 begin 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/industry/support/index.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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510(k) Premarket Notification ________________________________________________________________________________________________________________________________________________

Breas iSleep 20+ System

Breas Medical AB

510(k) Number (if known):

Device Name:

Breas iSleep 20+ System

Indications for Use:

. .

The Breas iSleep 20+ System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the . treatment of adult Obstructive Sleep Apnea (OSA).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	X	OR	Over-the-Counter Use
---------------------------------------	---	----	----------------------

Division Sign-Off

Division of Anesthesiology, General Hospital,

Infection Control, Dental Devices

K() Number:	5061057
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Page 3.5

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).