(90 days)
Not Found
No
The description mentions a "Micro-processor controlled blower system" but does not include any terms or descriptions indicative of AI or ML, such as "adaptive algorithm," "learning," "predictive," or analysis of complex data patterns beyond basic pressure control. The "self-adjusting" aspect likely refers to standard auto-CPAP functionality based on pressure feedback, not AI/ML.
Yes
The device is indicated for the treatment of obstructive sleep apnea (OSA), which is a medical condition, making it a therapeutic device.
No
Explanation: The device is described as a "self-adjusting system" that "generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHz as required for the treatment of OSA." This indicates that it provides therapy (treatment), rather than diagnosing a condition.
No
The device description explicitly states the system comprises a flow generator, patient tubing, mask, and humidifier, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of obstructive sleep apnea (OSA) by providing Continuous Positive Airway Pressure (CPAP). This is a therapeutic intervention, not a diagnostic test performed on in vitro samples.
- Device Description: The device is described as a blower system that generates air pressure. This is consistent with a respiratory therapy device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver air pressure to treat a condition, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The S8 Aspen self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). The S8 Aspen self-adjusting system is intended for home and hospital use.
Product codes (comma separated list FDA assigned to the subject device)
73 BZD
Device Description
The S8 Aspen System (S8 Aspen with HumidAire 4i Plus) is similar to the predicate device(s), with a new and improved power supply and heater controller for the HumidAire 4i Plus. The S8 Aspen contains a Micro-processor and a blower system that is capable of continuous positive airway Pressure (CPAP) from 4-20 cmHz as required for the treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.
The functional characteristics of the S8 Aspen system includes all the clinician and user friendly features of the predicate devices.
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
Not Found
Intended User / Care Setting
home and hospital use.
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)
Not Found
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.
VPAP ST (K080131), VPAP Auto (K082605)
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
510(k) Summary ~ S8 Aspen
Date Prepared
25th June, 2009
Official Contact
Dr Lionel King V.P., Quality Assurance & Regulatory Affairs ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
Tel: +61 (2) 8884 2243 +61 (2) 8884 2000 Fax:
| Classification Reference | 21 CFR 868.5905 |
|---|---|
| Product Code | 73 BZD |
| Common/Usual Name | Non continuous ventilator (IPPB). |
| Proprietary Name | S8 Aspen |
| Predicate Device(s) | VPAP ST (K080131) VPAP Auto (K082605) |
Reason for submission
New Device
25th June, 2009
Page 17
1
ResMed
Indication for Use
The S8 Aspen self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg).
The S8 Aspen self-adjusting system is intended for home and hospital use.
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate devices.
- Same intended use >
- Similar operating principle A
- Similar technologies >
- Same manufacturing process >
Design and Verification activities were performed on the S8 Aspen System as a result of the risk and vis and Design and VChildullion activities were performed the predetermined acceptance critieria. Resided has design requirements. An ests commod the probably and effectiveness of CPAP treatment for patients with delething that the new device has not not allor of the new device complies with the applicable requirements referenced in the FDA guidance documents:
- FDA Draft Reviewer Guidance for Ventilators (July 1995) >
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May * 11, 2005)
Device Description
The S8 Aspen System (S8 Aspen with HumidAire 4i Plus) is similar to the predicate device(s), with a new and The So Aspen Oyellen (OO Aspon Min HumidAire 4) Plus. The S8 Aspen contains a Micro-processor
improved power supply and heater controller for the HumidAire 4i Plus. The S8 As illiproved power supply and neater of the Pressure (CPAP) from 4-20 cmHz as required commond blover system that goneration of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.
The functional characteristics of the S8 Aspen system includes all the clinician and user friendly features of the predicate devices.
Conclusion
The S8 Aspen is substantially equivalent to the Predicate devices.
25th June, 2009
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is left-aligned. The background is plain and white, providing a clear contrast for the text.
Image /page/2/Picture/2 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. In the center of the seal is an emblem that appears to be an eagle or some other bird-like figure. The image is black and white and appears to be a scan or photocopy of an official document.
SEP 2 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
ResMed Limited C/O Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 9001 Spectrum Center Boulevard Kearny Mesa, California 92123
Re: K091947
Trade/Dévice Name: S8 Aspen Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 25, 2009 Received: June 30, 2009
Dear Mr. D'Cruz:
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 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.
3
Page 2- Mr. D'Cruz
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH /CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known):
Device Name: S8 Aspen
Indication for Use
The S8 Aspen self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 Ib (>30 kg).
The S8 Aspen self-adjusting system is intended for home and hospital use.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K091947
25th June, 2009
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