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

The iSleep10 and 20 are intended to be operated by trained users and qualified personnel.

Device Description

The iSleep 10 and 20 systems are pressure-supported and pressure-controlled ventilator with a CPAP function intended for spontaneous breathing patients who require longterm support by mechanical ventilation during the night.

The iSleep 10 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 10 and 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 10 and 20 housing are 6.8 x 6.8 x 8.2 inches, and the device weighs 2.8 pounds (iSleep 20 including empty humidifier 3.1 pounds).

AI/ML Overview

Acceptance Criteria and Device Performance Study for Breas iSleep 10 and 20 System

This document outlines the acceptance criteria and the studies conducted to demonstrate that the Breas iSleep 10 and 20 Systems meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard Adhered To	Reported Device Performance
Non-clinical Performance	Meeting stated performance specifications	Device passed all tests.
Comparative Performance	Substantial equivalence in waveform, Work of Breathing, and Pressure Dynamic regulation compared to predicate device (Breas PV100, K001553).	Bench testing confirmed substantial equivalence.
Regulatory Compliance (General)	Compliance with November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" and July 1995 "Draft Reviewer Guidance for Ventilators" by FDA's Division of Cardiovascular, Respiratory, and Neurological Devices.	Device passed all tests for applicable requirements.
Electrical Safety	IEC 60601-1	Device passed all tests.
Safety and Performance	ISO 17510-1	Device passed all tests.
Electromagnetic Compatibility (EMC)	EMC testing	Device passed all tests.
Mechanical Safety	Mechanical Safety testing	Device passed all tests.
Environmental	Environmental testing	Device passed all tests.
Functional	Functional testing	Device passed all tests.
Particle Matter	Particle matter testing	Device passed all tests.
Software Validation	FDA's May 11, 2005 "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices"	Device passed all tests.

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

The provided documentation does not specify a "test set" in the context of human subject data. The testing mentioned is primarily bench-testing (non-clinical, comparative, and compliance testing) and software testing. Therefore, the concept of sample size and data provenance as typically applied to clinical studies with patient data does not directly apply here.

Sample Size for Bench/Non-Clinical Testing: Not explicitly stated, but these typically involve multiple units to ensure reproducibility and robustness of results. The testing was conducted by or on behalf of the manufacturer, Breas Medical AB.
Data Provenance: The data originates from the manufacturer's internal testing and validation processes in Sweden (Breas Medical AB, Företagsvägen 1, SE 435 33 Mölnlycke, Sweden). This is prospective testing conducted specifically for regulatory submission.

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

As the primary testing was non-clinical bench testing and software validation, the concept of "experts establishing ground truth for a test set" in the context of clinical interpretation (e.g., radiologist for imaging) is not applicable.

Experts for Bench Testing: The experts involved would be engineers, quality assurance personnel, and regulatory affairs specialists at Breas Medical AB, with expertise in medical device design, testing, and regulatory standards. Their qualifications would be relevant to these technical fields.
Ground Truth for Non-Clinical Data: The "ground truth" for the bench tests is defined by the technical specifications of the device and the objective performance requirements of the relevant industry and regulatory standards (e.g., IEC 60601-1, ISO 17510-1, FDA guidance documents).

4. Adjudication Method for the Test Set

Given that the testing described is non-clinical and technical, an adjudication method (like 2+1 or 3+1 for clinical disagreements) is not relevant. The "adjudication" in this context would be the successful verification and validation of the device's technical specifications and adherence to standards, as determined by internal quality control processes and regulatory submissions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. The submission explicitly states: "Clinical studies were not required to support a substantial equivalence determination."

Therefore, there is no effect size reported for how much human readers improve with AI vs. without AI assistance, as the device does not incorporate AI for diagnostic or interpretative assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study in the context of an algorithm's performance without human interaction was not conducted. The device is a CPAP system, a hardware medical device with embedded software. Its performance is assessed as a system, not as a standalone AI algorithm that provides outputs for human interpretation. The software aspects were validated in accordance with FDA guidance for software in medical devices, but this refers to the functionality and safety of the embedded control software, not an independent interpretive algorithm.

7. Type of Ground Truth Used

The "ground truth" used for this submission is based on:

Technical Specifications and Requirements: The manufacturer's defined performance specifications for the iSleep 10 and 20 systems.
Industry Standards: Compliance with established international standards such as IEC 60601-1 (electrical safety) and ISO 17510-1 (safety and performance for devices used for the treatment of sleep apnea).
Regulatory Guidance Documents: Adherence to FDA's "Reviewer Guidance for Premarket Notification Submissions," "Draft Reviewer Guidance for Ventilators," and "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."
Predicate Device Performance: The performance characteristics of the legally marketed predicate device (Breas PV100, K001553) served as a benchmark for comparative testing to establish substantial equivalence.

8. Sample Size for the Training Set

The concept of a "training set" as it relates to machine learning or AI models is not applicable to this submission. The device is a CPAP system, a hardware device with embedded control software, not an AI/ML device that requires a training set for model development. The software was documented and tested for functionality and safety, not "trained" on data.

9. How the Ground Truth for the Training Set Was Established

Since there was no "training set" in the context of AI/ML, there is no ground truth established for such a set. The "ground truth" relevant to the device's development and validation (as described in point 7) was inherent in the engineering design specifications, international standards, and regulatory requirements.

Summary

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{

K060657

Breas iSleep 10 and 20 System

Breas Medical AB

510(k) SUMMARY

AUG 1 8 2006

Submitter	Breas Medical AB
	Företagsvagen 1
	SE 435 33 Molnlycke
	Sweden
Contact Person	Karl-Johan Holm
	Quality Assurance and Regulatory Affairs Manager
	Phone: +46 31 868830
	Fax: +46 31 868810
Summary Date	March 06, 2006
Name of Device	Breas iSleep 10 and 20 Systems
Common Name	CPAP system
Classification Name	Non-continuous ventilator (21 CFR 868.5905)
Product Code	BZD
Predicate Device	Breas PV100 (K001553)

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Device Description:

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 10 and 20 systems 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 10 and 20 Systems is Constant Positive Airway Pressure (CPAP)

The outer dimensions of the iSleep 10 and 20 housing are 6.8 x 6.8 x 8.2 inches, and the device weighs 2.8 pounds (iSleep 20 including empty humidifier 3.1 pounds).

Intended Use:

The iSleep10 and 20 are intended for non-invasive use.

The iSleep10 and 20 shall only be used by patients with spontaneous breathing.

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

The iSleep10 and 20 are intended to be operated by trained users and qualified personnel.

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Comparison of Use and Technological Characteristics:

The iSleep 10 and 20 systems 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 10 and 20 Systems have:

Same intended uses

Same environments of use

Similar design (microprocessor-controlled blower as air source)

Same fundamental scientific technology

The differences that do exist are minimal and involve primarily user preference features. The iSleep 10 and 20 Systems have additional display indicator These features are described in the modified device information section 6 and appendix 6 (manuals and sellsheets).

Summary of Performance Testing:

1. Non-clinical testing was conducted to verify that the Breas iSleep 10 and 20 Systems are capable of meeting their stated performance specifications and that all Risk Analysis issues have been appropriately addressed. The device passed all tests.
1. Comparative testing to predicate device was performed. This bench- testing confirmed that the Breas iSleep 10 and 20 Systems are 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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. 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 10 and 20 Systems meet their stated performance specifications and criteria outlined in the Reviewer Guidance publications referenced above. We conclude that the devices are capable of operating safely in their intended environments and will be effective in fulfilling their intended use.

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2006

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

Re: K060657

Trade/Device Name: iSleep 10 and 20 Systems Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 24, 2006 Received: July 26, 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 vour 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,

Clive
Shin-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 iSleep 10 and 20

510(k) Number (if known): K060657

Device Names: iSleep 10, iSleep 20

Indications for Use:

The iSlcep10 and 20 are intended for non-invasive use.

The iSleep10 and 20 shall only be used by patients with spontaneous breathing.

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

The iSleep10 and 20 are intended to be operated by trained users and qualified personnel.

Environment of Use:

The iSleep10 and 20 can be used in clinical settings (e.g., hospitals, sleep laboratories, subacute care institutions) and home environments.

They must always be prescribed by a licensed physician.

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

Over-The-Counter Use No (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)

gn-Off
ion of Anesthesiology, General Hospital,
.:on Control, Dental Devices

Labels	Values
Number:	K060657

Page1of1

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).