(127 days)
Not Found
No
The summary describes a software application for managing patient and device data from therapy devices, with no mention of AI or ML capabilities for analysis or decision support.
No
The device is described as software that allows clinicians to manage data and settings for ResMed compatible therapy devices, but it is not itself a therapeutic device. It indicates that it "augments the standard follow-up care of patients by providing transfer of machine and therapeutic information" and can "remotely change settings in non-life support devices only." The description states it "only obtains patient and machine information from therapeutic devices."
No
Explanation: ResScan is described as a tool for clinicians to download and view patient and machine data, store details, set machine parameters, and create reports. It is intended to augment standard follow-up care by transferring machine and therapeutic information. While it handles patient data, its primary function is data management and therapy adjustment rather than diagnosing a medical condition. The description specifically states it works with "therapeutic devices" and that "clinical testing was not deemed necessary... as ResScan only obtains patient and machine information from therapeutic devices for which clinical trials have already been conducted". This indicates it is not performing a diagnostic function itself.
No
The device description explicitly states it uses "Removal Media or PC direct connection as the interface between the flow generator and ResScan" and supports a "Data Card Reader," indicating reliance on physical hardware components for data transfer and interaction with the therapy devices.
Based on the provided information, ResScan is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that ResScan is for augmenting standard follow-up care by providing transfer of machine and therapeutic information and allowing remote setting changes in non-life support devices. It is used by clinicians in conjunction with therapy devices. This focuses on managing and monitoring therapy delivered by other devices, not on analyzing biological samples to diagnose or monitor a medical condition.
- Device Description: The description details functionalities related to downloading, viewing, storing, and setting parameters for flow generators. It also mentions creating reports and using interfaces for data transfer. None of these activities involve the analysis of biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis based on biological sample analysis.
ResScan appears to be a software tool used to manage and interact with therapeutic devices, specifically flow generators, for patient follow-up and therapy management. This falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
ResScan is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information. This includes the ability to remotely change settings in non-life support devices only.
It is intended to be used by Clinicians in conjunction with ResMed compatible therapy devices, using ResMed's proprietary communications protocol.
Product codes
BZD, MNS, MNT, CBK
Device Description
The performance and functional characteristics of ResScan includes all the user friendly features of the predicate device.
ResScan allows the clinician to:
- Download and view patient and machine data from ResMed flow generators
- Store patient details
- Set machine parameters (Using Removal Media or PC direct connection), non-life support devices only.
- Create and print reports
- Uses Removal Media or PC direct connection as the interface between the flow generator and ResScan
- Support for Data Card Reader
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
Clinicians, Hospital
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
Description of the test set, sample size, data source, and annotation protocol:
Design and Verification activities were performed on ResScan as a result of the risk analysis and design requirements. Verification testing included end-to-end testing to confirm that settings were successfully transferred between the flow generator and ResScan, and data captured by the flow generator was sent to ResScan. All tests confirmed the product met the predetermined acceptance criteria.
Non-Clinical Testing:
Design and non-clinical verification activities were performed on ResScan as a result of the updated risk analysis and design requirements. Verification testing included End-to-End bench testing to verify that ResScan, using only Removable Media, can receive patient usage, device settings, therapy summary data, detailed signal data and device log information from the flow generator (data). All tests confirmed the product met the predetermined acceptance criteria.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Design and non-clinical verification activities were performed on ResScan as a result of the updated risk analysis and design requirements. Verification testing included End-to-End bench testing to verify that ResScan, using only Removable Media, can receive patient usage, device settings, therapy summary data, detailed signal data and device log information from the flow generator (data). All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the new version of ResScan is substantially equivalent to the predicate device, ResScan (K113815).
ResScan met the predetermined pass/fail criteria as defined in the ResScan System Verification Report.
Clinical testing was not deemed necessary as identified in the Risk Analysis, as ResScan only obtains patient and machine information from therapeutic devices for which clinical trials have already been conducted, or compared with previous predicate comparison test results. Accordingly no clinical testing is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
KI40.054
RESMED
MAY 1 6 2014
ResScan Traditional 510(k)
510(k) SUMMARY
[As required by 21 CFR 807.92(c)]
| Date Prepared | 15 April 2014 |
|---|---|
| Submitter Name | Nicole Gaddi |
| Official Contact | Mr. Jim Cassi |
| Vice President - Quality Assurance Americas | |
| 9001 Spectrum Center Blvd | |
| San Diego CA 92123 USA | |
| Tel: (858) 836 6081 | |
| Device Trade Name | ResScan |
| Device Common Name | Continuous Ventilator |
| Classification/s & | |
| Classification Name/s | 21 CFR 868.5905, 73 BZD (Class II) |
| Non continuous ventilator (IPPB) | |
| 21 CFR 868.5895, 73 MNS (Class II) | |
| Continuous Ventilator | |
| 21 CFR 868.5895, 73 MNT (Class II) | |
| Continuous Ventilator | |
| 21 CFR 868.5895, 73 CBK (Class II) | |
| Ventilator, continuous, facility use | |
| Legally Marketed | |
| Predicate Device | |
| Reason for Submission | ResScan (K113815) |
| New Device |
Indication for Use
ResScan is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information. This includes the ability to remotely change settings in non-life support devices only.
It is intended to be used by Clinicians in conjunction with ResMed compatible therapy devices, using ResMed's proprietary communications protocol.
Device Description
The performance and functional characteristics of ResScan includes all the user friendly features of the predicate device.
ResScan allows the clinician to:
- Download and view patient and machine data from ResMed flow generators A
- Store patient details A
- Set machine parameters (Using Removal Media or PC direct connection), non-life support A devices only.
- メ Create and print reports
-
. Uses Removal Media or PC direct connection as the interface between the flow generator and ResScan
- 大 Support for Data Card Reader
1
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device.
- 入 Similar intended use
-
Same operating principle
- Same technologies ★
-
Same manufacturing process
Design and Verification activities were performed on ResScan as a result of the risk analysis and design requirements. Verification testing included end-to-end testing to confirm that settings were successfully transferred between the flow generator and ResScan, and data captured by the flow generator was sent to ResScan. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the new device is substantially equivalent to the predicate device and any changes do not raise new questions of safety and effectiveness when used for patient compliance management as an adjunct with ResMed flow generators. The new device complies with the applicable requirements referenced in the FDA guidance documents:
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical > Devices (May 11, 2005)
-
FDA Off-the-Shelf Software Use in Medical Devices (September 9, 1999)
| Feature | ResScan predicate(K113815) | ResScan (modified) | Comments |
|---|---|---|---|
| Intended Use | ResScan™ is intended to | ||
| augment the standard follow-up care of patients by | |||
| providing transfer of machine and therapeutic information, | |||
| including the ability to remotely change settings. |
It is intended to be used by
Clinicians in conjunction with
ResMed compatible flow
generators, using ResMed's
proprietary communications protocol. | ResScan™ is intended to
augment the standard
follow-up care of patients by
providing transfer of
machine and therapeutic
information. This includes
the ability to remotely
change settings in non-life
support devices only.
It is intended to be used by
Clinicians in conjunction
with ResMed compatible
therapy devices, using
ResMed's proprietary
communications protocol. | Equivalent:
Remote setting change
functionality is not
applicable to ResMed
CBK therapy devices. |
| Location of use | • Hospital | • Hospital | Equivalent |
| Functionality | • Display of therapy data
• Generate reports
• Settings management
• Patient management | • Display of therapy data
• Generate reports
• Settings management
• Patient management | Equivalent:
Remote setting change
functionality only
applies to non-life
support devices |
| Compatible
flow generators | • Resmed compatible
therapy devices (73 BZD,
73 MNS and 73 MNT ) | • Resmed compatible
therapy devices (73 BZD,
73 MNS, 73 MNT and 73
CBK ) | Equivalent:
Remote setting change
functionality only
applies to non-life
support devices |
2
| Feature | ResScan predicate(K113815) | ResScan (modified) | Comments |
|---|---|---|---|
| Communication | |||
| medium | • Serial connection | ||
| • Removable medium | • Serial connection | ||
| • Removable medium | Equivalent: | ||
| Serial connection only | |||
| applies to non-life | |||
| support devices | |||
| Patient | |||
| information | • Mask Leak | ||
| • AHI | |||
| • Pressure | |||
| • Minute Ventilation | |||
| • Respiratory rate | • Mask Leak | ||
| • AHI | |||
| • Pressure | |||
| • Minute Ventilation | |||
| • Respiratory rate | Equivalent | ||
| Changeable | |||
| settings | • Start Pressure | ||
| • Set Pressure | |||
| • Ramp time | |||
| • Setting time | • Start Pressure | ||
| • Set Pressure | |||
| • Ramp time | |||
| • Setting time | Equivalent: | ||
| Remote setting change | |||
| functionality only | |||
| applies to non-life | |||
| support devices |
Non-Clinical Testing
Design and non-clinical verification activities were performed on ResScan as a result of the updated risk analysis and design requirements. Verification testing included End-to-End bench testing to verify that ResScan, using only Removable Media, can receive patient usage, device settings, therapy summary data, detailed signal data and device log information from the flow generator (data). All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the new version of ResScan is substantially equivalent to the predicate device, ResScan (K113815).
ResScan met the predetermined pass/fail criteria as defined in the ResScan System Verification Report.
Clinical Testing
Clinical testing was not deemed necessary as identified in the Risk Analysis, as ResScan only obtains patient and machine information from therapeutic devices for which clinical trials have already been conducted, or compared with previous predicate comparison test results. Accordingly no clinical testing is required.
Summary of additional features from the ResScan (K113815)
-
ResMed compatible therapy devices include, e.g. VPAP Bilevel devices (73 MNS).
- Life support therapy device (73 CBK). A
- Display/reporting of multiple therapy programs for life support therapy devices. メ
- Display/reporting of additional modes such as ASVAuto, ACV, PACV, V-SIMV, P-SIMV, & PS. A
- A Support for Windows Remote Desktop Environments.
The inclusion of these features has been assessed within the risk analysis and no additional safety risks have been found as a result of the inclusion of these features.
Conclusion
The modified ResScan is as safe and as effective as the predicate device, ResScan (K113815) and is deemed substantially equivalent to the predicate device, ResScan (K113815).
3
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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
May 16, 2014
Resmed Corporation Mr. Jim Cassi Vice President, Quality Assurance Americas 9001 Spectrum Center Blvd. San Diego, CA 92123
Re: K140054
Trade/Device Name: ResScan Regulation Number: 21 CFR 868.5905 Regulation Name: Non-continuous Ventilator Regulatory Class: II Product Code: BZD, MNS, MNT, CBK Dated: April 16, 2014 Received: April 18, 2014
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.
4
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 (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/McdicalDevices/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 Industry and Consumer Education 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
DAGRID/ODE/CDRH FOR
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
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K140054
Device Name ResScan
Indications for Use (Describe)
ResScan is intended to augment the standard follow-up care of patients by providing transfer of machine and thermation. This includes the ability to remotely change settings in non-life support devices only.
It is intended to be used by Clinicians in conjunction with ResMed compatible therapy devices, using
ResMed's proprietary communications protocol.
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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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