(115 days)
EasyCare Online is a web based solution for healthcare specialists intended to:
• assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded by an EasyCare Online compatible home sleep test device.
• transfer and display, usage and therapeutic information that has been transmitted remotely from the patient's therapy device located in the home. It is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed therapy device for the treatment of obstructive sleep apnea or respiratory insufficiency. EasyCare Online also provides remote settings capabilities
EasyCare Online is a web application that can transfer, store, manage and display usage and therapy data from (ResMed compatible flow generators) and diagnostic data from (ResMed compatible sleep study devices). The data is transferred from the device either wirelessly through a communications module, or with the aid of an SD card and internet technology, to a central database and then displayed on the clinician's/DME's computer, through a web based application such as internet Explorer.
EasyCare Online is used to monitor and optimize the therapy of patients diagnosed with sleep apnea or respiratory insufficiency, who are using a ResMed therapy device or home sleep test study device. The application enables patient usage data to be shared across several different user groups for the primary purpose of monitoring patient compliance and home sleep studies. Clinical users. Home Medical Equipment (DME) providers and other healthcare specialists can access data with ResMed approved user accounts. Also, clinical users and DMEs are able to address any clinical issues in a timely manner and provide the necessary patient support, including the modification of device settings. EasyCare Online supports physicians in the diagnosis Sleep Disordered Breathing, by reviewing home sleep test results via their web browser or download the clinical data to their PC for further analysis.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EasyCare Online device:
This 510(k) submission is for an expanded intended use of an existing device (EasyCare Online, K123557) by integrating functionality from another predicate device (ApneaLink Plus, K083575). Therefore, the "study" primarily focuses on demonstrating that the new integration does not negatively impact the existing functionality and accurately displays data from the newly integrated device. It does not involve a traditional clinical study for the diagnostic accuracy of the device itself.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to the predicate devices and the successful completion of non-clinical testing. The "reported device performance" is essentially the successful completion of verification activities.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Software Verification: Changes introduced in the code did not impact previous EasyCare Online (K123557) functionality and the addition of ApneaLink Plus (K083575) functionality into EasyCare Online was verified. | PASS: Regression and End-to-End system testing confirmed that changes did not impact previous ECO functionality and verified the addition of ApneaLink Plus functionality into ECO. |
| Side-by-Side Testing: EasyCare Online (modified) correctly and accurately displayed home sleep test data belonging to ApneaLink Plus devices, producing the same data as the predicate ApneaLink Plus PC software (K083575). | PASS: Side-by-side testing using three patient breathing pattern scripts demonstrated that ECO (modified) and ApneaLink Plus PC software produced the same home sleep test data and met predetermined pass/fail criteria. |
| General Performance: The device functions correctly with ResMed compatible devices (73 MNS and 73 MNR). | PASS: Confidence system level testing ensured integration of ALC was conducted and found not to change the performance of EasyCare Online, confirming correct function with compatible devices. |
| Safety and Efficacy: Changes do not affect the safety and efficacy of the device. | PASS: The EasyCare Online uses existing data types and communication mechanisms between therapy devices as supported by the predicate device (K123557), indicating no negative impact on safety and efficacy. |
Study Details
1. A table of acceptance criteria and the reported device performance:
Provided above.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: "Three patient breathing pattern scripts" were used for the side-by-side testing.
- Data Provenance: Not explicitly stated. The scripts likely represent simulated or standardized data rather than individual patient data from a specific country or collected prospectively/retrospectively in a clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This submission does not involve human expert adjudication of diagnostic outcomes. The "ground truth" for the side-by-side testing was the output of the predicate ApneaLink Plus PC software. The study's goal was to ensure the modified EasyCare Online replicated this known output accurately. Therefore, no external experts were used to establish ground truth in the traditional sense of a clinical diagnostic study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None (in the context of human adjudication). The "adjudication" was a direct comparison of output data between the modified device and the predicate device's software.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This was not an MRMC study. The device is a data management and display system, not a diagnostic AI system intended for direct human assistance in interpretation in the way a typical diagnostic image analysis AI would be.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The core of the "testing" was comparing the data processing and display capabilities of the modified EasyCare Online (algorithm/software only) against the known output of the predicate ApneaLink Plus PC software (also algorithm/software only). The "standalone" performance here refers to the software's ability to process and present data identically to an established, cleared device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the side-by-side testing was the output of the predicate ApneaLink Plus PC software (K083575). This means the existing, cleared device's performance served as the benchmark for accuracy for the data processing and display component. This is often referred to as "reference standard" or "comparator device" in such equivalence studies.
8. The sample size for the training set:
- Not applicable / Not explicitly stated. This submission does not describe the development of a novel algorithm that requires a "training set" in the machine learning sense. The changes primarily involved integrating existing functionalities and ensuring data integrity.
9. How the ground truth for the training set was established:
- Not applicable. As no training set for a novel algorithm was described, this question is not relevant to this submission. The "ground truth" for the device's expanded functionality was anchored to the performance of its predicate devices.
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KJSZ371 NOV 2 2 2013
ResMed
ECO Traditional 510(k) Premarket
Notification
Jul 2013
4A 510(k) Summary
| 510(k) Summary | |||||
|---|---|---|---|---|---|
| Date Prepared | 26 Jul, 2013 | ||||
| Submitter | Greg DockarSenior Regulatory Affairs ManagerResMed Ltd, Australia1 Elizabeth Macarthur DriveBella Vista, NSW 2153, Australia+ 61 2 8884 2157 (Phone)+ 61 2 8884 2000 (FAX)GregD@resmed.com.au | ||||
| Official Contact | Jim CassiVice President Quality Assurance AmericasResMed Corp9001 Spectrum Center BoulevardSan Diego, CA 92123+1 858 836 6081+1 858 836 5519Jim. Cassi@resmed.com | ||||
| Device name | EasyCare Online | ||||
| Product codes | 73 MNS73 MNR | ||||
| Classification reference | Ventilator, Continuous, Non-Life-Supporting (21 CFR 868.5895,Product Code 73 MNS)Breathing Frequency Monitor (21CFR 868.2375 product code 73MNR) | ||||
| Predicate device(s) | EasyCare Online (510(k) number (K123557)ApneaLink Plus (510(k) number (K083575) | ||||
| Reason for submission | Expanded Intended for Use. |
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EasyCare Online is a web based solution for healthcare specialists intended to:
- assist in the diagnosis of sleep disordered breathing in adult patients through analysis of . data recorded by an EasyCare Online compatible home sleep test device.
- transfer and display, usage and therapeutic information that has been transmitted . remotely from the patient's therapy device located in the home. It is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed therapy device for the treatment of obstructive sleep apnea or respiratory insufficiency. EasyCare Online also provides remote settings capabilities
Device Description
EasyCare Online is a web application that can transfer, store, manage and display usage and therapy data from (ResMed compatible flow generators) and diagnostic data from (ResMed compatible sleep study devices). The data is transferred from the device either wirelessly through a communications module, or with the aid of an SD card and internet technology, to a central database and then displayed on the clinician's/DME's computer, through a web based application such as internet Explorer.
EasyCare Online is used to monitor and optimize the therapy of patients diagnosed with sleep apnea or respiratory insufficiency, who are using a ResMed therapy device or home sleep test study device. The application enables patient usage data to be shared across several different user groups for the primary purpose of monitoring patient compliance and home sleep studies. Clinical users. Home Medical Equipment (DME) providers and other healthcare specialists can access data with ResMed approved user accounts. Also, clinical users and DMEs are able to address any clinical issues in a timely manner and provide the necessary patient support, including the modification of device settings. EasyCare Online supports physicians in the diagnosis Sleep Disordered Breathing, by reviewing home sleep test results via their web browser or download the clinical data to their PC for further analysis.
Basis for Determination of Substantial Equivalence
The modified EasyCare Online has the following similarities to the previously cleared predicated device:
- Similar intended use .
- Same operating principle .
- 0 Same technology
- Same manufacturing (deployment) process 0
EasyCare Online modifications provide additional features for collection, storage and reporting of respiratory nasal airflow, respiratory effort, pulse rate and oxygen saturation during sleep studies which is used to assist the physician in diagnosis sleep disordered breathing. The physician prescribed device will help to recognize sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy.
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With the ApneaLink Plus (also referred to as ApneaLink to Cloud - ALC) Software integration with EasyCare Online, a regression analysis showed that minimal affect on the existing system would occur. Confidence system level testing was conducted to ensure integration of ALC was conducted and found not to change the performance of EasyCare Online. Accordingly, 73 MNS and 73 MNR ResMed compatible devices function correctly with EasyCare Online. These changes do not affect the safety and efficacy of the device, as the EasyCare Online uses the existing data types and communications mechanisms between therapy devices as supported by the predicate device (K123557).
| Feature | EasyCare Online [Primary predicate(K123557)] | ApneaLink Plus [Secondary predicate(K083575)] | EasyCare Online (modified) | Comments |
|---|---|---|---|---|
| IntendedUse | EasyCare Onlinetransfers and displaysto physicians, usageand therapeuticinformation that hasbeen transmittedremotely from thepatient's flow generatorlocated in the home.EasyCare Online alsoprovides remotesettings capabilities.EasyCare Online isintended to support thestandard follow-up careof patients that havebeen prescribed acompatible ResMedflow generator for thetreatment of obstructivesleep apnea orrespiratory insufficiency | The ApneaLink Plusdevice is indicated foruse by Health CareProfessionals(HCP),where it may aid in thediagnosis of sleepdisordered breathing foradult patients.ApneaLink Plus recordsthe following data:patient respiratory nasalairflow, snoring, bloodoxygen saturation,pulse and respiratoryeffort during sleep. Thedevice uses theserecordings to produce areport for the HCP thatmay aid in the diagnosisof sleep disorderedbreathing or for furtherclinical investigation. | EasyCare Online is a webbased solution for healthcarespecialists intended to:• assist in the diagnosis ofsleep disordered breathing inadult patients throughanalysis of data recorded byan EasyCare Onlinecompatible home sleep testdevice.• transfer and display, usageand therapeutic informationthat has been transmittedremotely from the patient'stherapy device located in thehome. It is intended tosupport the standard follow-up care of patients that havebeen prescribed acompatible ResMed therapydevice for the treatment ofobstructive sleep apnea orrespiratory insufficiency.EasyCare Online alsoprovides remote settingscapabilities | EquivalentCombined andsimplified-same intent. |
| Functionality | • Centraliseddatabase• Compliance reports• Therapy reports.• Settingsmanagement• Patient management | • Diagnostic HomeSleep Test Reports(HSTR) | • Centralised database• Compliance reports• Therapy reports.• Settings management• Patient management• Diagnostic Home SleepTest Reports (HSTR) | EquivalentCombinedfeatures |
| DatatransferTechnology | • Wireless• SD Card/Internet | USB connection fromApneaLink Plus to thePersonal Computer | • Wireless• SD Card/Internet• File upload/Internet | Equivalent |
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ResMed
| Feature | EasyCare Online[Primarypredicate(K123557)] | ApneaLink Plus[Secondarypredicate(K083575)] | EasyCare Online (modified) | Comments |
|---|---|---|---|---|
| Therapysettings | • Pressure• Mode• Comfort | — | • Pressure• Mode• Comfort | Equivalent |
| Patientinformation | • Mask Leak• AHI• PrescriptionPressure• Start Pressure• Minute Ventilation• Respiratory rate• Mode• EPR Level• Pressure SupportLevel | — | • Mask Leak• AHI• Prescription Pressure• Start Pressure• Minute Ventilation• Respiratory rate• Mode• EPR Level• Pressure Support Level | Equivalent |
| Home SleepTestInformation(HSTI) | — | • Recording times• Event statistics(including AHI, apneaindex, hypopneaindex, apneaclassification)• Oxy statistics (ODI,oxygen saturation)• Pulse statistics• Breath statistics | • Recording times• Event statistics (includingAHI, apnea index,hypopnea index, apneaclassification)• Oxy statistics (ODI, oxygensaturation)• Pulse statistics• Breath statistics | EquivalentSide by sidetesting of ECO(modified) andApneaLinkPlus PCsoftwaredemonstratedthat ECOcorrectly andaccuratelydisplayedhome sleeptest databelonging toApneaLinkPlus devices. |
Non Clinical Testing
Design and non-clinical verification activities were performed on EasyCare Online as a result of the updated risk analysis and design requirements. Verification testing included end-to-end testing to verify data transfer integrity between end user browser PC and EasyCare Online was successfully implemented. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that new version of EasyCare Online is substantially equivalent to the predicate device, EasyCare Online (K123557).
Side-by-Side testing using the same data showed that both the predicate device ApneaLink Plus (K083575) and EasyCare Online produced the same home sleep test data. EasyCare Online met the predetermined pass/fail criteria.
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| Testing | Scope of testing | Result |
|---|---|---|
| Softwareverification | Regression and End-to-End system testing was conducted to confirm thatchanges introduced in the code did not impact on previous ECO functionality(K123557) and verify the addition of ApneaLink Plus (K083575) functionality intoECO. | PASS |
| Side-by-sidetesting | Three patient breathing pattern scripts were used for side by side testing of ECO(modified) and ApneaLink Plus PC software ((K083575) to verify that ECOcorrectly and accurately displayed home sleep test data belonging to ApneaLinkPlus devices. | PASS |
Clinical Testing
No clinical testing is required for EasyCare Online.
Conclusion
The modified version of EasyCare Online is substantially equivalent to the predicate device, EasyCare Online (K123557)
The modified version of EasyCare Online is as safe and as effective, and performs substantially equivalent to the predicate devices, EasyCare Online (K123557) and ApneaLink Plus (K083575).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
November 22, 2013
Resmed Corporation Jim Cassi Vice President, Quality Assurance Americas 9001 Spectrum Center Blvd. SAN DIEGO, CA 92123
Re: K132371 Trade Name: EasyCare Online Regulatory Class: III Product Code: MNS Dated: October 16, 2013 Received: October 21, 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.
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
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Page 2 - Mr. Jim Cassi
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 (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.
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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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Erin Keith Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
510(k) Number (if known) K132371
Device Name EasyCare Online
Indications for Use (Describe)
EasyCare Online is a web based solution for healthcare specialists intended to:
• assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded by an EasyCare Online compatible home sleep test device.
· transfer and display, usage and therapeutic information that has been transmitted remotely from the patient's therapy device located in the home. It is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed therapy device for the treatment of obstructive sleep apnea or respiratory insufficiency. EasyCare Online also provides remote settings capabilities
Type of Use (Select one or both, as applicable)
X 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 FOR FDA USE ONLY . . . . 1-2-2-2 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).