(158 days)
Breas PV100 (K001553)
Not Found
No
The summary does not mention any terms related to AI or ML, and the device description focuses on standard ventilator and CPAP functions.
Yes
The device is described as delivering "continuous positive airway pressure therapy for the treatment of obstructive sleep apnea in adults," which indicates a therapeutic purpose.
No
Explanation: The device is a CPAP machine and ventilator intended for treatment of obstructive sleep apnea, not for diagnosis.
No
The device description explicitly details physical components like a housing, power supply, and airflow delivery system, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for delivering continuous positive airway pressure therapy for the treatment of obstructive sleep apnea. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a pressure-supported and pressure-controlled ventilator with a CPAP function. This describes a device that provides respiratory support, not one that analyzes biological samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
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 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).
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.
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 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.
- 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.
- 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
- 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 PV100 (K001553)
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
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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) |
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:
-
- 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.
-
- 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.
-
- 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. -
- 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 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 (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
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 |
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