(146 days)
No
The description mentions "Micro-processor controlled blower" and "automatically adjusts pressure in response to inspiratory flow limitation, snore and apnea" and "automatically adjusts pressure in response female-specific OSA characteristics". While these are automated responses based on inputs, the language used ("automatically adjusts pressure") and the lack of any mention of AI, ML, deep learning, training data, or complex algorithms beyond simple response logic suggests it's a rule-based or algorithmic system, not AI/ML. The clinical trial focuses on the efficacy of the "modified AutoSet algorithm," further supporting a traditional algorithmic approach.
Yes
The device is indicated for the treatment of mild to moderate obstructive sleep apnea (OSA), which is a medical condition, making it a therapeutic device.
No
The device is a self-adjusting CPAP system intended for the treatment of obstructive sleep apnea (OSA). While it adjusts pressure in response to patient characteristics, its primary function is therapeutic (delivering positive airway pressure) rather than diagnostic (identifying or characterizing a medical condition).
No
The device description explicitly states it contains a "Micro-processor controlled blower (flow generator) system" and includes hardware components like patient tubing, mask, and humidifier. While it has software components (therapy modes), it is not solely software.
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 positive airway pressure. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a flow generator that delivers air pressure. It does not perform any tests on biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
The device is a medical device used for therapy, specifically for treating a respiratory condition.
N/A
Intended Use / Indications for Use
The S9 Cronulla for Her self-adiusting system is indicated for the treatment of mild to moderate obstructive sleep apnea (OSA) in female patients weighing more than 66 lb (30 kg).
The S9 Cronulla for Her self-adjusting system is intended for home and hospital use.
Product codes
BZD
Device Description
The 'S9 Cronulla for Her' contains a Micro-processor controlled blower (flow generator) system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing (standard, or heated), mask (patient interface) and humidifier. The 'S9 Cronulla for Her' System (S9 Cronulla for Her with HumidAire 5i) retains all the same hardware and performance features of the predicate device. Key features include in-line power supply, HumidAire 5i, tubing (heated and standard options) and colour LCD for better user interface.
The 'S9 Cronulla for Her' flow generator includes three therapy modes. These include:
- CPAP mode - the device delivers a continuous positive airway pressure throughout the entire therapy session
- AutoSet mode the device automatically adjusts pressure in response to inspiratory flow . limitation, snore and apnea.
- AutoSet for Her mode -- the device automatically adjusts pressure in response female-specific OSA characteristics.
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)
Clinical Testing:
A clinical trial demonstrated that the modified AutoSet algorithm performed as expected in treating female patients in a single-blind, randomised, cross-over non-inferiority study comparing the efficacy of the new AfH algorithm to the standard AutoSet algorithm (K091947).
The primary endpoints were met in the AfH clinical trial. The trial showed that the AfH algorithm effectively treated female OSA patients as reflected by the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) outcomes. Furthermore, investigation of sleep parameters showed that flow limitation was significantly decreased with the AfH algorithm compared to the standard AutoSet algorithm. Whilst no other statistically significant results were found in these parameters, there were the following improvements:
- REM sleep percentage
- RERAs .
Subjective feedback also showed no significant differences between the AfH and standard AutoSet algorithms with all outcomes' median subjective ratings remaining "above average".
No adverse event or complications occurred as a result of the trial.
Non-Clinical Testing:
Verification activities were performed to verify that the software change to include an additional treatment mode ('AutoSet for Her') did not affect the safety and effectiveness of the subject device.
Side-by-Side bench testing was performed to verify that the S9 Cronulla for Her with H5i humidifier and heated tubing met the requirements of the S9 Cronulla System Specification, and compare the results to the predicate device (S8 Aspen with H4i Plus humidifier and heated tubinq (K091947)). This bench testing included testing the performance of each therapy mode which included:
- Pressure stability
- Response to apneas
- Response to flow limitations and snore.
A breathing machine was used to simulate patient breathing patterns resulting in the Flow Generator responding in a manner consistent with maintaining the CPAP treatment pressure (CPAP mode) or adjusting the CPAP pressure based upon the patient's condition in real-time (self-adjusting mode). The clinical Pass/Fail requirements are traced to the S9 Cronulla for Her System Specification and to the predicate device's performance. The S9 Cronulla for Her met the predefined Clinical Pass/Fail criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
S8 Aspen (K091947)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K132606
JAN 1 3 2014
| Required | By section 807.92 (c) |
|---|---|
| Date Prepared | 10th Jan, 2014 |
| Owners Name | ResMed Ltd |
| 1 Elizabeth Macarthur Drive | |
| Bella Vista, NSW 2153, Australia | |
| Submitter | Greg Dockar |
- 61 2 8884 2157 (Phone)
- 61 2 8884 2000 (FAX)
GregD@resmed.com.au |
| Official Contact | Mr Jim Cassi - Vice President - Quality Assurance Americas
ResMed Corp.
9001 Spectrum Center Boulevard,
San Diego, CA 92123 - 1 (858) 836 6081 (Phone)
+1 (858) 836 5519 (FAX) |
| Classification Reference | 21 CFR 868.5905 (Class II) |
| Product Code | 73 BZD |
| Common/Usual Name | Non continuous ventilator (IPPB). |
| Proprietary Name | S9 Cronulla for Her |
| Predicate Device(s) | S8 Aspen (K091947) |
510(k) Summary – S9 Cronulla for Her
Reason for submission
.
New Device
1
Indication for Use
The S9 Cronulla for Her self-adiusting system is indicated for the treatment of mild to moderate obstructive sleep apnea (OSA) in female patients weighing more than 66 lb (30 kg).
The S9 Cronulla for Her 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.
t
- . Similar intended use
- . Same operating principle
- Same technologies ●
- . Same manufacturing process
The S9 Cronulla for Her retains all the same operating/technologies/manufacturing characteristics as the S8 Aspen (K091947). The S9 Cronulla for Her includes an additional treatment mode (software) called AutoSet for Her (AfH) which provides equivalent responses to apneas, snore and flattening breathing events for females in comparison to standard AutoSet mode. The S9 Cronulla for Her is indicated for a subset of the patient population when compared to the predicate S8 Aspen (K091947). Therefore this difference (subset) does not affect safety and effectiveness which remains unchanged from the predicate (K091947).
Design and Verification activities were performed on the S9 Cronulla for Her System as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the new device has not altered the safety and effectiveness of CPAP treatment. The S9 Cronulla for Her 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)
- FDA Draft Guidance for Industry and FDA Staff Design Considerations for Devices Intended . for Home Use
Clinical Testing:
A clinical trial demonstrated that the modified AutoSet algorithm performed as expected in treating female patients in a single-blind, randomised, cross-over non-inferiority study comparing the efficacy of the new AfH algorithm to the standard AutoSet algorithm (K091947).
The primary endpoints were met in the AfH clinical trial. The trial showed that the AfH algorithm effectively treated female OSA patients as reflected by the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) outcomes. Furthermore, investigation of sleep parameters showed that flow limitation was significantly decreased with the AfH algorithm compared to the standard AutoSet algorithm. Whilst no other statistically significant results were found in these parameters, there were the following improvements:
- . REM sleep percentage
- RERAs .
2
Subjective feedback also showed no significant differences between the AfH and standard AutoSet algorithms with all outcomes' median subjective ratings remaining "above average".
No adverse event or complications occurred as a result of the trial.
Non-Clinical Testing:
Verification activities were performed to verify that the software change to include an additional treatment mode ('AutoSet for Her') did not affect the safety and effectiveness of the subject device.
Side-by-Side bench testing was performed to verify that the S9 Cronulla for Her with H5i humidifier and heated tubing met the requirements of the S9 Cronulla System Specification, and compare the results to the predicate device (S8 Aspen with H4i Plus humidifier and heated tubinq (K091947)). This bench testing included testing the performance of each therapy mode which included:
- . Pressure stability
- . Response to apneas
- . Response to flow limitations and snore.
A breathing machine was used to simulate patient breathing patterns resulting in the Flow Generator responding in a manner consistent with maintaining the CPAP treatment pressure (CPAP mode) or adjusting the CPAP pressure based upon the patient's condition in real-time (self-adjusting mode). The clinical Pass/Fail requirements are traced to the S9 Cronulla for Her System Specification and to the predicate device's performance. The S9 Cronulla for Her met the predefined Clinical Pass/Fail criteria.
The S9 Cronulla for Her with and without the integrated heated humidifier (H5i) was designed and tested according to:
- . IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests ،
- IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for safety . Medical electrical equipment - General requirements for basic safety and essential performance
Software regression testing was also conducted.
Device Description
The 'S9 Cronulla for Her' contains a Micro-processor controlled blower (flow generator) system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing (standard, or heated), mask (patient interface) and humidifier. The 'S9 Cronulla for Her' System (S9 Cronulla for Her with HumidAire 5i) retains all the same hardware and performance features of the predicate device. Key features include in-line power supply, HumidAire 5i, tubing (heated and standard options) and colour LCD for better user interface.
The 'S9 Cronulla for Her' flow generator includes three therapy modes. These include:
- . CPAP mode - the device delivers a continuous positive airway pressure throughout the entire therapy session
3
- AutoSet mode the device automatically adjusts pressure in response to inspiratory flow . limitation, snore and apnea.
- AutoSet for Her mode -- the device automatically adjusts pressure in response female-specific ● OSA characteristics.
The functional characteristics of the S9 Cronulla for Her system includes all the clinician and user friendly features of the predicate device which have been verified during usability studies in accordance with IEC 62366 Medical devices - Application of usability engineering to medical devices.
Characteristics between predicate and modified device
| Characteristic Predicate Device S8 Aspen (K091947) | Modified device S9 Cronulla for Her | Comments | |
|---|---|---|---|
| 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. | The S9 Cronulla for Her self-adjusting system is indicated for the treatment of mild to moderate obstructive sleep apnea (OSA) in female patients weighing more than 66 lb (30 kg). | ||
| The S9 Cronulla for Her self-adjusting system is intended for home and hospital use. | Equivalent | ||
| Only name change- and reduced patient population from predicate | |||
| Location of use (primary) | Hospital/Home | Hospital/Home | Equivalent |
| Performance | |||
| Pressure range | 4-20 cm H2O (CPAP Mode) EPR +3 cm H2O | ||
| 4-20 cm H2O (AutoSet Mode) EPR +3 cm H2O | 4-20 cm H2O (CPAP Mode) EPR +3 cm H2O | ||
| 4-20 cm H2O (AutoSet Mode) EPR +3 cm H2O | |||
| 4-20 cm H2O (AutoSet AfH Mode) EPR +3 cm H2O | Equivalent: | ||
| Addition of treatment mode indicated for females | |||
| Ramp | User selected as "Off" to 45 minutes in 5 minute increments Max Ramp time set at clinician's discretion | User selected as "Off" to 45 minutes in 5 minute increments Max Ramp time set at clinician's discretion | Equivalent |
| Modes of operation | CPAP Mode (Fixed-pressure) AutoSet Mode (maximum to 20cm H2O with CAD) CPAP and AutoSet with EPR (maximum to 20cm H2O with CAD) | CPAP Mode (Fixed-pressure) AutoSet Mode (maximum to 20cm H2O with CAD) AutoSet for Her (AfH) (maximum to 20cm H2O with CAD) CPAP, AutoSet with EPR(maximum to 20cm H2O with CAD) | Equivalent: |
| Addition of treatment mode indicated for females | |||
| System Components | Flow generator Integrated humidifier (HumidAire 4i Plus) Mask, air tubing and heated tubing | Flow generator Integrated humidifier (H5i) Mask, air tubing and heated tubing | Equivalent |
| Name change only from predicate (K091947)- same performance |
Conclusion
Based on the clinical and non-clinical results, the S9 Cronulla for Her is substantially equivalent to the Predicate device (S8 Aspen K091947).
4
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2014
ResMed Corporation Mr. Jim Cassi Vice President - Quality Assurance Americas 9001 Spectrum Center Boulevard San Diego, CA 92123
Re: K132606
Trade/Device Name: ResMed™ S9 Cronulla for Her Regulation Number: 21 CFR 868.5905 Regulation Name: Non-continuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 5, 2013 Received: December 9, 2013
Dear Mr. Cassi:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
5
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address .
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 yours,
Image /page/5/Picture/8 description: The image contains a combination of text and graphic elements. The text includes the name "Tejashri Purohit-Sheth, M.D." followed by the title "Clinical Deputy Director" and the acronym "DAGRID". There is also a decorative graphic element on the left side of the image, and the word "FOR" is present in the bottom right corner.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K132606
Davice Name S9 Cronulla for Her
Indications for Use (Describe)
The S9 Crowle for Her self-adjusting system is indicated for the treatment of mild to moderate obstructive sleep apress (OSA) in female patients weighing more than 66 lb (30 kg).
The S9 Cronulla for Her self-adjusting system is intended for home and hospital usc.
Type of Use (Select one or both, as applicable)
🇿 Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 801 Subpart C)
Please do not write below this line -- continue on a separate page if needed.
FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Anya C. Harry -S 2014.01.10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16:06:27 -05'00'
FORM FDA 3881 (1/14)
7
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