Care Orchestrator Essence

K183226 · Respironics, Inc. · BZD · Oct 18, 2019 · Anesthesiology

Device Facts

• Record ID: K183226
• Device Name: Care Orchestrator Essence
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Care Orchestrator Essence is intended for use by healthcare professionals (e.g., Physicians, Clinicians, Durable Medical Equipment providers) to gather, store, manage, and view compliance data for patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. The software also includes the ability to create new or updated prescriptions and/or performance settings, store them, and transmit them to compatible Respironics' non-life supporting therapy devices and Respironics Trilogy ventilator. Data and prescription settings are transferred between Care Orchestrator Essence and compatible devices via removable media. Care Orchestrator Essence is intended to be used in hospital, institutional, provider, and home care settings by healthcare representatives. The software does not perform automatic scoring or diagnosis. The data it provides are only one of several elements to consider when making decisions about patient therapy.

Device Story

Care Orchestrator Essence is a desktop software application for healthcare professionals (physicians, clinicians, DME providers) to manage patient therapy data. It functions as a data management system for sleep therapy and Trilogy respiratory devices. Input consists of therapy data and prescription settings transferred via SD card from compatible Respironics devices. The software allows users to view compliance data, generate reports, and create or update prescription/performance settings, which are then written back to the SD card for transfer to the therapy device. It operates on a PC in hospital, institutional, or home care settings. The software does not perform automated scoring or diagnosis; it serves as a tool to assist clinicians in therapy decision-making. It provides a centralized interface for managing patient referrals and therapy workflows without requiring internet connectivity.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated through non-clinical software verification and validation testing, including system testing for data transfer, display of therapy data, prescription integrity checks, and cybersecurity verification (authentication and encryption).

Technological Characteristics

Desktop software application for Windows 7 SP1 or newer. Connectivity via SD card (removable media) for data transfer; no wireless/internet required. Cybersecurity includes user authentication and data-at-rest encryption. Functionality includes data management, report generation, and prescription setting updates for Respironics therapy devices.

Indications for Use

Indicated for healthcare professionals managing patients prescribed compatible Respironics therapy devices (sleep therapy and Trilogy ventilators). Used to gather, store, manage, and view compliance data and update prescription/performance settings via removable media. Not for automatic scoring or diagnosis.

Regulatory Classification

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.

Predicate Devices

• Care Orchestrator (K152356)

Reference Devices

• Trilogy 100 Ventilator (DirectView) (K083526)
• DirectView (K093416)
• DirectView (K093905)
• DirectView (K111610)

Submission Summary (Full Text)

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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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 18, 2019

Respironics Inc. Jennifer Richardson Regulatory Affairs 1001 Murry Ridge Lane Murrysville, Pennsylvania 15642

Re: K183226

Trade/Device Name: Care Orchestrator Essence Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD, MNS, MNT, CBK, NOU Dated: September 17, 2019 Received: September 18, 2019

## Dear Jennifer Richardson:

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. 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 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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

James J. Lee, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K183226

Device Name Care Orchestrator Essence

### Indications for Use (Describe)

Care Orchestrator Essence is intended for use by healthcare professionals (e.g., Physicians, Durable Medical Equipment providers) to gather, store, manage, and view compliance data for patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. The software also includes the ability to create new or updated prescriptions and/or performance settings, store them, and transmit them to compatible Respironics' non-life supporting therapy devices and Respironics Trilogy ventilator. Data and prescription settings are transferred between Care Orchestrator Essence and compatible devices via removable media. Care Orchestrator Essence is intended to be used in hospital, institutional, provider, and home care settings by healthcare representatives.

The software does not perform automatic scoring or diagnosis. The data it provides are only one of several elements to consider when making decisions about patient therapy.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;"><b>X</b></span> |
|----------------------------------------------|------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span></span> |

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# ATTACHMENT B

# 510(K) SUMMARY

#### Submitter I.

Official Contact

| Name | Amy Panzik |
|------------------|--------------------------------------------------------------------|
| Title | Regulatory Affairs Project Manager |
| Email | <a href="mailto:[e-mail]">[e-mail]</a> |
| Company | Respironics Inc. |
| Address | 1740 Golden Mile Highway |
| City, State, Zip | Monroeville, PA 15146 |
| Phone | [phone] |

Date of Preparation September 17, 2019

#### Device II.

| Name of Device: | Care Orchestrator Essence |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Data Management System |
| Device Classification: | Class II |
| Classification Name/<br>Product Code: | Noncontinuous ventilator (21 CFR 868.5905, Product Code BZD)<br>Continuous ventilator (21 CFR 868.5895, Product Codes MNS, MNT,<br>CBK, NOU) |

#### Legally Marketed Predicate Device III.

Predicate: K152356 Sapphire, Respironics Inc. Trade Name: Care Orchestrator

Reference: K083526 Trilogy/DirectView, Respironics Inc. Trade Name: Trilogy 100 Ventilator (DirectView)

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#### Device Description IV.

Care Orchestrator Essence software is a desktop solution that allows healthcare representatives (e.g., physicians, clinicians, durable medical equipment providers) involved in a patient's therapy lifecycle the ability to manage patients and referrals; control access to patient information; view and interact with therapy and prescription data from Respironics devices; enhance the patient compliance management workflow; and gain efficiencies in the overall patient therapy workflow.

Care Orchestrator Essence supports patient data management and prescription updates for sleep therapy devices (BZD, MNS, MNT) and Trilogy respiratory devices (CBK, NOU) through an SD card.

#### Indications for Use V.

Care Orchestrator Essence is intended for use by healthcare professionals (e.g., Physicians, Clinicians, Durable Medical Equipment providers) to gather, store, manage, and view compliance data for patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. The software also includes the ability to create new or updated prescriptions and/or performance settings, store them, and transmit them to compatible Respironics' non-life supporting therapy devices and Respironics Trilogy ventilator. Data and prescription settings are transferred between Care Orchestrator Essence and compatible devices via removable media. Care Orchestrator Essence is intended to be used in hospital, institutional, provider, and home care settings by healthcare representatives.

The software does not perform automatic scoring or diagnosis. The data it provides are only one of several elements to consider when making decisions about patient therapy.

## Comparison of Technological Characteristics with the Predicate VI. Device

Care Orchestrator Essence has the following similarities to the legally marketed predicate device:

## Predicate: Care Orchestrator

Similar indications for use Same environment of use Similar functionality Same report capabilities

## Reference: DirectView Software

Similar indications for use Same environment of use Same functionality Same report capabilities

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| Table 10-1: Comparison of Care Orchestrator Essence to Care Orchestrator (K152356) | | | | |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature/Function | Predicate Device: | Reference Device: | Subject Device: | Similarity to Predicate |
| | Device Name: Care<br>Orchestrator (Project<br>Name: Sapphire) | Device Name:<br>DirectView | Device Name: Care<br>Orchestrator Essence<br>(Project Name: Tonic) | |
| | 510(k) Number: K152356 | 510(k) Number(s):<br>K083526<br>(also subsequent 510(k)<br>K093416, K093905 and<br>K111610) | 510(k) Number:<br>K183226 | |
| | Manufacturer: Respironics<br>Inc. | Manufacturer:<br>Respironics Inc. | Manufacturer:<br>Respironics Inc. | |
| Indications for Use | Sapphire is intended to<br>support clinicians by tracking<br>data on patients who are<br>prescribed compatible therapy<br>devices in accordance with<br>the intended use of those<br>therapy devices. Sapphire<br>provides remote patient data<br>collection & viewing and is<br>intended to be used by | DirectView is a data<br>assessment tool for use by<br>physicians, clinicians, and<br>home care providers to<br>receive and report stored<br>data from an SD data card<br>and select Philips<br>Respironics devices.<br>DirectView can be used to<br>manage a patient's<br>prescription. It provides | Care Orchestrator Essence<br>is intended for use by<br>healthcare professionals<br>(e.g., Physicians,<br>Clinicians, Durable Medical<br>Equipment providers) to<br>gather, store, manage, and<br>view compliance data for<br>patients who are prescribed<br>compatible therapy devices | Similar to predicate<br>devices, K083526 &<br>K152356.<br>Different from K152356 in<br>that Care Orchestrator |
| | healthcare representatives<br>(e.g., Physicians, Clinicians,<br>Durable Medical Equipment<br>providers) in conjunction with<br>compatible non-life support | the trained clinical<br>professional with the<br>ability to transfer new or<br>updated prescriptions to<br>the device via an SD card,<br>but does not allow the | in accordance with the<br>intended use of those<br>therapy devices. The<br>software also includes the<br>ability to create new or | Essence adds adjustment<br>to prescriptions and/or<br>performance settings via<br>removable media for |
| Table 10-1: Comparison of Care Orchestrator Essence to Care Orchestrator (K152356) | | | | |
| Feature/Function | Predicate Device: | Reference Device: | Subject Device: | Similarity to Predicate |
| | Device Name: Care<br>Orchestrator (Project<br>Name: Sapphire) | Device Name:<br>DirectView | Device Name: Care<br>Orchestrator Essence<br>(Project Name: Tonic) | |
| | 510(k) Number: K152356 | 510(k) Number(s):<br>K083526<br>(also subsequent 510(k)<br>K093416, K093905 and<br>K111610) | 510(k) Number:<br>K183226 | |
| | Manufacturer: Respironics<br>Inc. | Manufacturer:<br>Respironics Inc. | Manufacturer:<br>Respironics Inc. | |
| | therapy devices to adjust<br>prescription and/or<br>performance settings.<br>Sapphire allows read-only<br>access to patients. Sapphire<br>is intended to be used in<br>hospital, institutional, provider,<br>and home care settings. | clinician to remotely<br>change a prescription.<br>DirectView does not<br>perform any automatic<br>scoring or diagnosing of a<br>patient's therapy data. | updated prescriptions<br>and/or performance<br>settings, store them, and<br>transmit them to compatible<br>Respironics' non-life<br>supporting therapy devices<br>and Respironics Trilogy<br>ventilator. Data and<br>prescription settings are<br>transferred between Care<br>Orchestrator Essence and<br>compatible devices via<br>removable media. Care<br>Orchestrator Essence is<br>intended to be used in | Trilogy (NOU, CBK)<br>therapy devices.<br>Different from K152356 in<br>that Care Orchestrator<br>Essence does not provide<br>read-only access to<br>patients.<br>Different from K083526 in |
| | | | | that Care Orchestrator<br>Essence's indication for |
| Table 10-1: Comparison of Care Orchestrator Essence to Care Orchestrator (K152356) | | | | |
| Feature/Function | Predicate Device: | Reference Device: | Subject Device: | Similarity to Predicate |
| | Device Name: Care<br>Orchestrator (Project<br>Name: Sapphire) | Device Name:<br>DirectView | Device Name: Care<br>Orchestrator Essence<br>(Project Name: Tonic) | |
| | 510(k) Number: K152356 | 510(k) Number(s):<br>K083526<br>(also subsequent 510(k)<br>K093416, K093905 and<br>K111610) | 510(k) Number:<br>K183226 | |
| | Manufacturer: Respironics<br>Inc. | Manufacturer:<br>Respironics Inc. | Manufacturer:<br>Respironics Inc. | |
| | | | hospital, institutional,<br>provider, and home care<br>settings by healthcare<br>representatives.<br><br>The software does not<br>perform automatic scoring<br>or diagnosis. The data it<br>provides are only one of<br>several elements to<br>consider when making<br>decisions about patient<br>therapy. | use statement specifically<br>identifies prescription<br>and/or performance<br>settings update via<br>removable media for<br>Trilogy life-support therapy<br>devices. The K083526<br>predicate had this same<br>functionality but did not<br>specifically identify Trilogy<br>in the indication. |
| Table 10-1: Comparison of Care Orchestrator Essence to Care Orchestrator (K152356) | | | | |
| Feature/Function | Predicate Device: | Reference Device: | Subject Device: | Similarity to Predicate |
| | Device Name: Care<br>Orchestrator (Project<br>Name: Sapphire) | Device Name:<br>DirectView | Device Name: Care<br>Orchestrator Essence<br>(Project Name: Tonic) | |
| | 510(k) Number: K152356 | 510(k) Number(s):<br>K083526<br>(also subsequent 510(k)<br>K093416, K093905 and<br>K111610) | 510(k) Number:<br>K183226 | |
| | Manufacturer: Respironics<br>Inc. | Manufacturer:<br>Respironics Inc. | Manufacturer:<br>Respironics Inc. | |
| Product Code | BZD, MNS, MNT, NOU, CBK | MNS, MNT, CBK, NOU | BZD, MNS, MNT, NOU,<br>CBK | Equivalent to K083526<br>and K152356.<br>Care Orchestrator<br>Essence supports<br>prescription and/or<br>performance settings<br>update via removable<br>media for CBK/NOU<br>Trilogy life-support therapy<br>devices only. It is not<br>intended for use with any<br>other life-supporting<br>devices. |
| Table 10-1: Comparison of Care Orchestrator Essence to Care Orchestrator (K152356) | | | | |
| Feature/Function | Predicate Device: | Reference Device: | Subject Device: | Similarity to Predicate |
| | Device Name: Care<br>Orchestrator (Project<br>Name: Sapphire) | Device Name:<br>DirectView | Device Name: Care<br>Orchestrator Essence<br>(Project Name: Tonic) | |
| | 510(k) Number: K152356 | 510(k) Number(s):<br>K083526<br>(also subsequent 510(k)<br>K093416, K093905 and<br>K111610) | 510(k) Number:<br>K183226 | |
| | Manufacturer: Respironics<br>Inc. | Manufacturer:<br>Respironics Inc. | Manufacturer:<br>Respironics Inc. | |
| Environment of Use | Care Orchestrator is intended<br>to be used in hospital,<br>institutional, provider and<br>home care settings | DirectView is intended to<br>be used in hospital,<br>institutional, provider and<br>home care settings | Care Orchestrator Essence<br>is intended to be used in<br>hospital, institutional,<br>provider and home care<br>settings | Equivalent to K152356 &<br>K083526. |
| User Population | Healthcare representatives<br>(e.g., Physicians, Clinicians,<br>Durable Medical Equipment<br>providers) and patients | Healthcare<br>representatives (e.g.,<br>Physicians, Clinicians,<br>Durable Medical<br>Equipment providers) | Healthcare representatives<br>(e.g., Physicians,<br>Clinicians, Durable Medical<br>Equipment providers) | Similar to K152356.<br>Care Orchestrator<br>Essence does not provide<br>read-only access to<br>patients.<br>Equivalent to K083526 |
| Table 10-1: Comparison of Care Orchestrator Essence to Care Orchestrator (K152356) | | | | |
| Feature/Function | Predicate Device: | Reference Device: | Subject Device: | Similarity to Predicate |
| | Device Name: Care<br>Orchestrator (Project<br>Name: Sapphire) | Device Name:<br>DirectView | Device Name: Care<br>Orchestrator Essence<br>(Project Name: Tonic) | |
| | 510(k) Number: K152356<br>Manufacturer: Respironics<br>Inc. | 510(k) Number(s):<br>K083526<br>(also subsequent 510(k)<br>K093416, K093905 and<br>K111610)<br>Manufacturer:<br>Respironics Inc. | 510(k) Number:<br>K183226<br>Manufacturer:<br>Respironics Inc. | |
| Application Type | Web-based application | Desktop application | Desktop application | Different from K152356.<br>Care Orchestrator<br>requires internet access;<br>Care Orchestrator<br>Essence requires a PC<br>running Windows 7<br>Service Pack 1 or newer.<br>Equivalent to K083526<br>Care Orchestrator<br>Essence does not require<br>the internet |
| Table 10-1: Comparison of Care Orchestrator Essence to Care Orchestrator (K152356) | | | | |
| Feature/Function | Predicate Device: | Reference Device: | Subject Device: | Similarity to Predicate |
| | Device Name: Care<br>Orchestrator (Project<br>Name: Sapphire) | Device Name:<br>DirectView | Device Name: Care<br>Orchestrator Essence<br>(Project Name: Tonic) | |
| | 510(k) Number: K152356 | 510(k) Number(s):<br>K083526<br>(also subsequent 510(k)<br>K093416, K093905 and<br>K111610) | 510(k) Number:<br>K183226 | |
| | Manufacturer: Respironics<br>Inc. | Manufacturer:<br>Respironics Inc. | Manufacturer:<br>Respironics Inc. | |
| Data transfer<br>technology from<br>therapy device | Wireless (Bluetooth or<br>cellular modem) SD Card | SD Card | SD Card | Similar to K152356 with<br>regard to data transfer<br>with an SD card.<br>Equivalent to K083526 |
| Data storage | Data is stored on a<br>centralized database | Data is stored on a single<br>PC | Data is stored on a single<br>PC | Different from K152356<br>Equivalent to K083526 |
| Functionality | Patient management Display therapy data Generate reports Prescription Settings<br>management for non-life<br>supporting devices (BZD,<br>MNS, MNT) | Patient management Display therapy data Generate reports Settings management<br>for non-life supporting<br>and life supporting<br>devices | Patient management Display therapy data Generate reports Prescription Settings<br>management for non-<br>life supporting devices | Similar to K152356<br>Care Orchestrator<br>Essence has additional<br>functionality for<br>Prescription Settings |
| Table 10-1: Comparison of Care Orchestrator Essence to Care Orchestrator (K152356) | | | | |
| Feature/Function | Predicate Device: | Reference Device: | Subject Device: | Similarity to Predicate |
| | Device Name: Care<br>Orchestrator (Project<br>Name: Sapphire) | Device Name:<br>DirectView | Device Name: Ca…