(259 days)
Not Found
No
The summary describes a data management and workflow solution for therapy devices, focusing on data collection, viewing, and prescription adjustments. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
Care Orchestrator is a software solution that supports clinicians by tracking data, managing patients, and adjusting prescription/performance settings for compatible non-life support therapy devices, rather than providing therapy itself.
No
The device collects and displays patient data from compatible therapy devices, and allows healthcare representatives to adjust prescription and/or performance settings or manage referrals, but it does not diagnose medical conditions.
Yes
The device description and performance studies focus solely on software verification and validation, data transfer, and display/editing functionalities within a software platform. While it interacts with therapy devices, the submission describes the "Care Orchestrator" itself as a software solution for managing patient data and prescriptions, without mentioning any hardware components of the Care Orchestrator system itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Care Orchestrator is for tracking data on patients using compatible therapy devices and supporting clinicians in adjusting prescription and/or performance settings. It focuses on managing patient therapy workflow and data from external therapy devices.
- Device Description: The description reinforces this by detailing its functions related to patient and referral management, access control, billing interaction, compliance management, and resupply of medical equipment. It specifically mentions supporting data management for sleep and respiratory therapy devices.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any interaction with biological specimens or any diagnostic testing performed by the device itself.
Care Orchestrator is a software solution designed to manage data and workflow related to patient therapy using external medical devices, not to perform in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Care Orchestrator is intended to support clinicians by tracking data on patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. Care Orchestrator provides remote patient data collection & viewing and is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in conjunction with compatible non-life support therapy devices to adjust prescription and/ or performance settings. Care Orchestrator allows read-only access to patients. Care Orchestrator is intended to be used in hospital, institutional, provider, and home care settings.
Product codes
BZD, MNS, MNT, CBK, NOU, CAW
Device Description
Care Orchestrator is a solution that will provide entities involved in a patient's therapy lifecycle with the ability to manage patients and referrals, control access to patient information and theract with billing information, enhance patient compliance management workflow, manage the resupply of medical equipment, and gain efficiencies in the overall Patient Therapy Workflow.
Care Orchestrator will support patient data management for sleep therapy devices (BZD, MNS, MNT) and respiratory devices (CBK, NOU, CAW). Care Orchestrator will support prescription updates for sleep therapy devices. There are no input flows to the respiratory device interfaces (Bluetooth and SD Card). Device prescription and settings are read-only for these respiratory device types.
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
Intended User: healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers)
Care Setting: hospital, institutional, provider, and home care settings.
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: Software verification and validation testing, Non-Clinical Tests. Clinical tests were not required.
Sample Size: Not specified
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key Results: The testing of Care Orchestrator verified that all product requirements have been met with passing test results. The verification and validation testing demonstrated the overall substantial equivalence of the Care Orchestrator system.
Key Metrics
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 4, 2019
Respironics Inc. Ankitha Rao Regulatory Project Manager 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K181053
Trade/Device Name: Care Orchestrator Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD, MNS, MNT, CBK, NOU, CAW Dated: December 5, 2018 Received: December 6, 2018
Dear Ankitha Rao:
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 Mav 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
James J. Lee -S
for Tina Kiang, Ph.D. Acting 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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Indications for Use
510(k) Number (if known) K181053
Device Name Care Orchestrator
Indications for Use (Describe)
Care Orchestrator is intended to support clinicians by tracking data on patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. Care Orchestrator provides remote patient data collection & viewing and is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in conjunction with compatible non-life support therapy devices to adjust prescription and/ or performance settings. Care Orchestrator allows read-only access to patients. Care Orchestrator is intended to be used in hospital, institutional, provider, and home care settings.
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) |
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TAB 5 510(K) SUMMARY
Submitter I.
| Official Contact | Ankitha Rao
Regulatory Project Manager
ankitha.rao@philips.com
Respironics Inc.
1740 Golden Mile Highway
Monroeville, PA 15146
Phone: 724-387-7442
Fax: 724-387-7490 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation | April 18, 2018 |
| II. Device | |
| Name of Device: | Care Orchestrator |
| Common/Usual Name: | Data Management System |
| Device Classification: | Class II |
| Classification Name/
Product Code: | Non-continuous ventilator (21 CFR 868.5905, Product Code BZD)
Continuous ventilator (21 CFR 868.5895, Product Codes MNS, MNT, CBK, NOU) |
Portable oxygen generator (21CFR868.5440, Product Code CAW)
III. Legally Marketed Predicate Device
K152356 Sapphire, Respironics Inc. Trade Name: Care Orchestrator
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Device Description IV.
Care Orchestrator is a solution that will provide entities involved in a patient's therapy lifecycle with the ability to manage patients and referrals, control access to patient information and theract with billing information, enhance patient compliance management workflow, manage the resupply of medical equipment, and gain efficiencies in the overall Patient Therapy Workflow.
Care Orchestrator will support patient data management for sleep therapy devices (BZD, MNS, MNT) and respiratory devices (CBK, NOU, CAW). Care Orchestrator will support prescription updates for sleep therapy devices. There are no input flows to the respiratory device interfaces (Bluetooth and SD Card). Device prescription and settings are read-only for these respiratory device types.
V. Indications for Use
Care Orchestrator is intended to support clinicians by tracking data on patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. Care Orchestrator provides remote patient data collection & viewing and is intended to be used by healthcare representatives (e.g., Physicians, Durable Medical Equipment providers) in conjunction with compatible non-life support therapy devices to adjust prescription and/or performance settings. Care Orchestrator allows read-only access to patients. Care Orchestrator is intended to be used in hospital, institutional, provider, and home care settings.
Comparison of Technological Characteristics with the Predicate VI.
Device
The modified Care Orchestrator has the following similarities to the legally marketed predicate device:
- Similar intended use ●
- . Same operating principle
- . Same technoloqy
- Same manufacturing (deployment) process .
| Feature/Function | Predicate Device
Device Name: Care
Orchestrator (Project: Sapphire)
510(k) Number: K152356
Manufacturer: Respironics Inc. | Subject Device
Device Name: Care
Orchestrator (modified)
510(k) Number: TBD
Manufacturer: Respironics
Inc. | Comments |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Sapphire is intended to support
clinicians by tracking data on
patients who are prescribed
compatible therapy devices in | Care Orchestrator is
intended to support
clinicians by tracking data on
patients who are prescribed | Equivalent to
K152356. |
| | accordance with the intended
use of those therapy devices.
Sapphire provides remote
patient data collection & viewing
and is intended to be used by
healthcare representatives (e.g.,
Physicians, Clinicians, Durable
Medical Equipment providers) in
conjunction with compatible
non-life support therapy devices
to adjust prescription and/or
performance settings. Sapphire
allows read-only access to
patients. Sapphire is intended to
be used in hospital, institutional,
provider, and home care
settings. | compatible therapy devices
in accordance with the
intended use of those
therapy devices. Care
Orchestrator provides
remote patient data
collection & viewing and is
intended to be used by
healthcare representatives
(e.g., Physicians, Clinicians,
Durable Medical Equipment
providers) in conjunction
with compatible non-life
support therapy devices to
adjust prescription and/or
performance settings. Care
Orchestrator allows read-
only access to patients. Care
Orchestrator is intended to
be used in hospital,
institutional, provider, and
home care settings. | Remote setting
change
functionality is
not applicable
to Respironics
CBK, NOU and
CAW therapy
devices. |
| Application | Web based application | Web based application | Equivalent to
K152356. |
| Data storage | Data stored on centralized
database | Data stored on centralized
database | Equivalent to
K152356. |
| Functionality | Patient management Display therapy data Generate reports Settings management for
non-life supporting devices | Patient management Display therapy data Generate reports Settings management
for non-life supporting
devices | Equivalent to
K152356.
Remote setting
change
functionality is
not applicable
to Respironics
CBK, NOU and
CAW therapy
devices or any
Respironics
devices that
are intended
for life-support. |
| Settings
management | Ability to remotely change
device settings in non-life
support devices only. | Ability to remotely change
device settings in non-life
support devices only. | Equivalent to
K152356. |
| Reports | Detailed Report (includes
compliance information) | Detailed Report (includes
compliance information) | Equivalent to
K152356. |
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VII. Performance Data:
Software Verification and Validation Testing
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This software was considered to have a
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Moderate Level of Concern, since a failure or latent flaw in the software could result in minor harm to the patient.
Non-Clinical Tests
Software verification and validation testing was performed on Care Orchestrator based on the product requirements. This testing included complete system testing to verify data transfer from therapy devices to Care Orchestrator, through both wireless data transfer and SD card data transfer. Once data was transferred, all tests confirmed that Care Orchestrator can display patient and device information, display therapy data including compliance and therapy reports and allow for a user to create and/or edit a patients prescription for an applicable therapy device.
The testing of Care Orchestrator verified that all product requirements have been met with passing test results. The verification and validation testing demonstrated the overall substantial equivalence of the Care Orchestrator system.
Clinical Tests
Clinical tests were not required to demonstrate the safety and effectiveness of Care Orchestrator. Product functionality has been adequately assessed by non-clinical tests.
Summary of additional feature(s) from the Care Orchestrator (K152356)
- . Portable oxygen generator (Product Code CAW) Support
- Support of additional therapy device models (Product codes BZD, MNT, MNS, CBK/NOU) .
- . Therapy data download via removable media (SD card) for Product codes CBK/NOU
- . Task Management
- Configurable compliance and health rules .
- . Enhancements to user and organization management capability including external authorizations
- Enhancements to reporting capability including custom report templates .
- Patient management enhancements including search capability, activity log, notes, and document attachments
- . Display of device health information
- . Product support console
- . Legacy application data migration and synchronization
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.
VIII. Conclusion
The modified Care Orchestrator is as safe and as effective as the predicate device, Care Orchestrator (K152356) and is deemed substantially equivalent to the predicate device, Care Orchestrator (K152356).