ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.

K060657 · Breas Medical AB · BZD · Aug 18, 2006 · Anesthesiology

Device Facts

• Record ID: K060657
• Device Name: ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.
• Applicant: Breas Medical AB
• Product Code: BZD · Anesthesiology
• Decision Date: Aug 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Microprocessor-controlled CPAP system; delivers continuous positive airway pressure via single lumen tube and non-invasive patient interface (e.g., nasal mask). Used in clinical settings (hospitals, sleep labs) and home environments; requires physician prescription. Operated by trained users/qualified personnel. Auto-switching power supply (100–240 VAC) or external 12.5/24 VDC source. Provides pressure-supported/pressure-controlled ventilation for spontaneous breathing patients. Output monitored via display indicators. Benefits patients by ensuring sufficient gas exchange for chronic respiratory failure/obstructive sleep apnea treatment.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical safety (IEC 60601-1), performance (ISO 17510-1), EMC, mechanical safety, environmental, and functional testing. Comparative bench testing against predicate confirmed equivalent waveform performance and pressure regulation.

Technological Characteristics

Microprocessor-controlled blower; CPAP therapy; 100-240 VAC or 12.5/24 VDC power; single lumen outlet tube; dimensions 6.8 x 6.8 x 8.2 inches; weight 2.8-3.1 lbs. Software-controlled pressure regulation. Compliant with IEC 60601-1 and ISO 17510-1.

Indications for Use

Indicated for adults (>30 kg) with obstructive sleep apnea who are spontaneously breathing. For non-invasive use only. Contraindicated for life support or transport of critical care patients.

Regulatory Classification

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.

Predicate Devices

• Breas PV100 (K001553)

Submission Summary (Full Text)

{0}------------------------------------------------

:

:

r

{

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: [phone] |
| | Fax: [phone] |
| 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) |

{1}------------------------------------------------

## 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.

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 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).

## 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.

{2}------------------------------------------------

## 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.
- 2. 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.
- 3. 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 ●

{3}------------------------------------------------

- . Particle matter testing
The device passed all tests.

- 4. 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.
- 5. 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.

{4}------------------------------------------------

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.

{5}------------------------------------------------

### 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 [phone]. 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 [phone] or [phone] 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

{6}------------------------------------------------

# 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 |

Page*1*of*1*