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.

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.

AI/ML Overview

The provided text does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics typically associated with medical device studies (e.g., sensitivity, specificity, accuracy against a referent standard).

Instead, the document is a 510(k) Premarket Notification for a device called "Care Orchestrator," which is a data management system for therapy devices. The key focus of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (also named Care Orchestrator, K152356).

Here's a breakdown of what the document does state, and why it doesn't fit the requested criteria:

Device Type: Care Orchestrator is a software-based data management system for tracking and managing patient data from therapy devices (e.g., sleep therapy, respiratory devices). It's not a diagnostic device or one that performs a specific measurement or medical interpretation that would require traditional performance metrics like sensitivity or specificity.
Purpose: Its primary functions are remote patient data collection and viewing, managing patient and referral information, controlling access to patient data, handling billing information, managing medical equipment resupply, and allowing clinicians to adjust prescription/performance settings for compatible non-life support therapy devices.
"Study" type: The relevant section is "VII. Performance Data: Software Verification and Validation Testing." This section describes non-clinical tests focused on verifying the software's functionality and ensuring it meets product requirements. It explicitly states, "Clinical tests were not required to demonstrate the safety and effectiveness of Care Orchestrator. Product functionality has been adequately assessed by non-clinical tests."

Therefore, I cannot provide the requested table or detailed information because the provided text does not include:

A table of acceptance criteria and reported device performance for specific medical metrics. The "performance data" refers to software verification and validation against product requirements, not medical diagnostic or treatment efficacy metrics.
Sample size for a test set in a medical performance study.
Data provenance (country of origin, retrospective/prospective).
Number of experts and their qualifications for ground truth.
Adjudication method.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
Standalone algorithm performance (as it's a data management system, not an AI for diagnosis/treatment).
Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
Sample size for a training set.
How ground truth for a training set was established.

Summary of available information related to "performance":

The document focuses on demonstrating that the software functions as intended and is equivalent to the predicate device.

Non-Clinical Tests: Software verification and validation testing was conducted.
- Focus: Complete system testing to verify data transfer from therapy devices to Care Orchestrator (wireless and SD card), display of patient and device information, display of therapy data (including compliance and therapy reports), and the ability for a user to create/edit patient prescriptions for applicable therapy devices.
- Outcome: "The testing of Care Orchestrator verified that all product requirements have been met with passing test results." And "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."

In essence, the "study" described is a software verification and validation process to ensure the data management system functions correctly and securely, rather than a clinical study evaluating diagnostic accuracy or therapeutic outcomes.

Summary

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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

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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)

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 RaoRegulatory Project Managerankitha.rao@philips.comRespironics Inc.1740 Golden Mile HighwayMonroeville, PA 15146Phone: 724-387-7442Fax: 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 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 DeviceDevice Name: CareOrchestrator (Project: Sapphire)510(k) Number: K152356Manufacturer: Respironics Inc.	Subject DeviceDevice Name: CareOrchestrator (modified)510(k) Number: TBDManufacturer: RespironicsInc.	Comments
Indications forUse	Sapphire is intended to supportclinicians by tracking data onpatients who are prescribedcompatible therapy devices in	Care Orchestrator isintended to supportclinicians by tracking data onpatients who are prescribed	Equivalent toK152356.
	accordance with the intendeduse of those therapy devices.Sapphire provides remotepatient data collection & viewingand is intended to be used byhealthcare representatives (e.g.,Physicians, Clinicians, DurableMedical Equipment providers) inconjunction with compatiblenon-life support therapy devicesto adjust prescription and/orperformance settings. Sapphireallows read-only access topatients. Sapphire is intended tobe used in hospital, institutional,provider, and home caresettings.	compatible therapy devicesin accordance with theintended use of thosetherapy devices. CareOrchestrator providesremote patient datacollection & viewing and isintended to be used byhealthcare representatives(e.g., Physicians, Clinicians,Durable Medical Equipmentproviders) in conjunctionwith compatible non-lifesupport therapy devices toadjust prescription and/orperformance settings. CareOrchestrator allows read-only access to patients. CareOrchestrator is intended tobe used in hospital,institutional, provider, andhome care settings.	Remote settingchangefunctionality isnot applicableto RespironicsCBK, NOU andCAW therapydevices.
Application	Web based application	Web based application	Equivalent toK152356.
Data storage	Data stored on centralizeddatabase	Data stored on centralizeddatabase	Equivalent toK152356.
Functionality	Patient management Display therapy data Generate reports Settings management fornon-life supporting devices	Patient management Display therapy data Generate reports Settings managementfor non-life supportingdevices	Equivalent toK152356.Remote settingchangefunctionality isnot applicableto RespironicsCBK, NOU andCAW therapydevices or anyRespironicsdevices thatare intendedfor life-support.
Settingsmanagement	Ability to remotely changedevice settings in non-lifesupport devices only.	Ability to remotely changedevice settings in non-lifesupport devices only.	Equivalent toK152356.
Reports	Detailed Report (includescompliance information)	Detailed Report (includescompliance information)	Equivalent toK152356.

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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).

Regulation Number and Section

§ 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).