(67 days)
Not Found
No
The summary describes a standard CPAP device and does not mention any AI or ML capabilities. The performance studies focus on standard device testing and comparison to a predicate device, not on the performance of any AI/ML algorithm.
Yes
The device is described as delivering Continuous Positive Airway Pressure (CPAP) therapy to treat Obstructive Sleep Apnea (OSA), which is a medical condition. It is intended for non-invasive use and functions as a pressure-supported and pressure-controlled ventilator, all pointing to a therapeutic purpose.
No
The device is a CPAP machine intended to deliver therapy for Obstructive Sleep Apnea, not to diagnose the condition.
No
The device description explicitly mentions physical components like a housing, power supply, and an airflow outlet tube, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA). This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a pressure-supported and pressure-controlled ventilator with a CPAP function. It delivers airflow to the patient's airway. This is consistent with a respiratory therapy device, not an IVD.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Breas iSleep 20+ System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
The Breas iSleep 20+ System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the . treatment of adult Obstructive Sleep Apnea (OSA).
Product codes (comma separated list FDA assigned to the subject device)
BZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults (who weigh more than 30 kg)
Intended User / Care Setting
trained users and qualified personnel.
clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. It must always be prescribed by a licensed physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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.
- 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.
- 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
- t Particle matter testing
The device passed all tests.
- 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.
- Clinical studies were not required to support a substantial equivalence determination.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Breas PV10i (K030985)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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1
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.
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.
2
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:
-
- 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.
-
- 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.
-
- 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
-
t Particle matter testing
The device passed all tests. -
- 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.
-
- 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.
4
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.
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 (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
6
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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