(332 days)
No
The document explicitly states "The software does not perform automatic scoring or diagnosis" and there are no mentions of AI, ML, or related concepts in the description, intended use, or testing sections.
No
The device is described as software that manages and transmits data and prescriptions for compatible therapy devices, rather than performing therapy itself.
No
The software states "The software does not perform automatic scoring or diagnosis." and its purpose is to "gather, store, manage, and view compliance data" and "create new or updated prescriptions and/or performance settings."
Yes
The device is described as "Care Orchestrator Essence software" and its function is to manage, store, and view data, as well as create and transmit prescriptions. While it interacts with compatible therapy devices, the description focuses solely on the software's capabilities and verification/validation testing is described as "Software verification and validation testing". The data transfer method via SD card is a mechanism for the software to receive and send information, not an indication that the device itself includes hardware beyond the computing platform it runs on.
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 the software is for gathering, storing, managing, and viewing compliance data from therapy devices. It also allows for creating and transmitting prescriptions and performance settings to these devices. This is related to managing patient therapy and device settings, not performing diagnostic tests on biological samples.
- Device Description: The description reinforces that the software is a desktop solution for managing patients, referrals, accessing patient information, viewing therapy and prescription data, and managing workflow. It focuses on data management and prescription updates for therapy devices.
- Lack of Diagnostic Functionality: The intended use explicitly states, "The software does not perform automatic scoring or diagnosis." This is a key indicator that it is not an IVD.
- Focus on Therapy Devices: The software interacts with and manages data from therapy devices (sleep therapy and respiratory devices), not devices used for in vitro diagnostic testing of biological samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This software does not perform any such function.
N/A
Intended Use / Indications for Use
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.
Product codes
BZD, MNS, MNT, CBK, NOU
Device Description
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.
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 professionals (e.g., Physicians, Durable Medical Equipment providers), 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, sample size, AUC, MRMC, standalone performance, key results)
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."
Non-Clinical Tests:
Software verification and validation testing was performed on Care Orchestrator Essence based on the product requirements. This testing included complete system testing to verify data transfer through an SD card from therapy devices to Care Orchestrator Essence. Once data was transferred, all tests confirmed that Care Orchestrator Essence can display patient and device information, display therapy data including summary and therapy reports and allow for a user to create and/or edit a patient's prescription for the supported therapy devices. Verification of cybersecurity requirements implemented within the software and system architecture were also confirmed for user authentication and encryption of data at rest. Labeling controls as identified in the risk and cybersecurity risk analysis were also verified. Unit verification and low level tests of prescription integrity checks were also completed.
The testing of Care Orchestrator Essence verified that all product requirements have been met with acceptable test results. The verification and validation testing demonstrated comparable safety and effectiveness of the Care Orchestrator Essence software in comparison to the predicate software, Care Orchestrator and DirectView.
Clinical Tests:
Clinical tests were not required to demonstrate the safety and effectiveness of Care Orchestrator Essence. Product functionality has been adequately assessed by non-clinical tests.
Conclusion:
Care Orchestrator Essence has demonstrated acceptable test results for all of the aforementioned nonclinical tests and required no clinical tests in order to demonstrate safety or effectiveness. It is therefore concluded that Care Orchestrator Essence is substantially equivalent to the predicate devices, Care Orchestrator (K152356) and DirectView (K083526).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
ATTACHMENT B
510(K) SUMMARY
Submitter I.
Official Contact
| Name | Amy Panzik |
|---|---|
| Title | Regulatory Affairs Project Manager |
| amy.panzik@philips.com | |
| Company | Respironics Inc. |
| Address | 1740 Golden Mile Highway |
| City, State, Zip | Monroeville, PA 15146 |
| Phone | (412) 542-3644 |
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/ | |
| Product Code: | Noncontinuous ventilator (21 CFR 868.5905, Product Code BZD) |
| Continuous ventilator (21 CFR 868.5895, Product Codes MNS, MNT, | |
| 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)
4
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
5
| 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 | ||||
| Orchestrator (Project | ||||
| Name: Sapphire) | Device Name: | |||
| DirectView | Device Name: Care | |||
| Orchestrator Essence | ||||
| (Project Name: Tonic) | ||||
| 510(k) Number: K152356 | 510(k) Number(s): | |||
| K083526 | ||||
| (also subsequent 510(k) | ||||
| K093416, K093905 and | ||||
| K111610) | 510(k) Number: | |||
| K183226 | ||||
| Manufacturer: Respironics | ||||
| Inc. | Manufacturer: | |||
| Respironics Inc. | Manufacturer: | |||
| Respironics Inc. | ||||
| Indications for Use | Sapphire 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. Sapphire | ||||
| provides remote patient data | ||||
| collection & viewing and is | ||||
| intended to be used by | DirectView is a data | |||
| assessment tool for use by | ||||
| physicians, clinicians, and | ||||
| home care providers to | ||||
| receive and report stored | ||||
| data from an SD data card | ||||
| and select Philips | ||||
| Respironics devices. | ||||
| DirectView can be used to | ||||
| manage a patient's | ||||
| prescription. It provides | 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 | Similar to predicate | |||
| devices, K083526 & | ||||
| K152356. | ||||
| Different from K152356 in | ||||
| that Care Orchestrator | ||||
| healthcare representatives | ||||
| (e.g., Physicians, Clinicians, | ||||
| Durable Medical Equipment | ||||
| providers) in conjunction with | ||||
| compatible non-life support | the trained clinical | |||
| professional with the | ||||
| ability to transfer new or | ||||
| updated prescriptions to | ||||
| the device via an SD card, | ||||
| but does not allow the | in accordance with the | |||
| intended use of those | ||||
| therapy devices. The | ||||
| software also includes the | ||||
| ability to create new or | Essence adds adjustment | |||
| to prescriptions and/or | ||||
| performance settings via | ||||
| 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 | ||||
| Orchestrator (Project | ||||
| Name: Sapphire) | Device Name: | |||
| DirectView | Device Name: Care | |||
| Orchestrator Essence | ||||
| (Project Name: Tonic) | ||||
| 510(k) Number: K152356 | 510(k) Number(s): | |||
| K083526 | ||||
| (also subsequent 510(k) | ||||
| K093416, K093905 and | ||||
| K111610) | 510(k) Number: | |||
| K183226 | ||||
| Manufacturer: Respironics | ||||
| Inc. | Manufacturer: | |||
| Respironics Inc. | Manufacturer: | |||
| Respironics Inc. | ||||
| 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. | clinician to remotely | |||
| change a prescription. | ||||
| DirectView does not | ||||
| perform any automatic | ||||
| scoring or diagnosing of a | ||||
| patient's therapy data. | 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 | Trilogy (NOU, CBK) | |||
| therapy devices. | ||||
| Different from K152356 in | ||||
| that Care Orchestrator | ||||
| Essence does not provide | ||||
| read-only access to | ||||
| patients. | ||||
| Different from K083526 in | ||||
| that Care Orchestrator | ||||
| 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 | ||||
| Orchestrator (Project | ||||
| Name: Sapphire) | Device Name: | |||
| DirectView | Device Name: Care | |||
| Orchestrator Essence | ||||
| (Project Name: Tonic) | ||||
| 510(k) Number: K152356 | 510(k) Number(s): | |||
| K083526 | ||||
| (also subsequent 510(k) | ||||
| K093416, K093905 and | ||||
| K111610) | 510(k) Number: | |||
| K183226 | ||||
| Manufacturer: Respironics | ||||
| Inc. | Manufacturer: | |||
| Respironics Inc. | Manufacturer: | |||
| Respironics Inc. | ||||
| 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. | use statement specifically
identifies prescription
and/or performance
settings update via
removable media for
Trilogy life-support therapy
devices. The K083526
predicate had this same
functionality but did not
specifically identify Trilogy
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
Orchestrator (Project
Name: Sapphire) | Device Name:
DirectView | Device Name: Care
Orchestrator Essence
(Project Name: Tonic) | |
| | 510(k) Number: K152356 | 510(k) Number(s):
K083526
(also subsequent 510(k)
K093416, K093905 and
K111610) | 510(k) Number:
K183226 | |
| | Manufacturer: Respironics
Inc. | Manufacturer:
Respironics Inc. | Manufacturer:
Respironics Inc. | |
| Product Code | BZD, MNS, MNT, NOU, CBK | MNS, MNT, CBK, NOU | BZD, MNS, MNT, NOU,
CBK | Equivalent to K083526
and K152356.
Care Orchestrator
Essence supports
prescription and/or
performance settings
update via removable
media for CBK/NOU
Trilogy life-support therapy
devices only. It is not
intended for use with any
other life-supporting
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
Orchestrator (Project
Name: Sapphire) | Device Name:
DirectView | Device Name: Care
Orchestrator Essence
(Project Name: Tonic) | |
| | 510(k) Number: K152356 | 510(k) Number(s):
K083526
(also subsequent 510(k)
K093416, K093905 and
K111610) | 510(k) Number:
K183226 | |
| | Manufacturer: Respironics
Inc. | Manufacturer:
Respironics Inc. | Manufacturer:
Respironics Inc. | |
| Environment of Use | Care Orchestrator is intended
to be used in hospital,
institutional, provider and
home care settings | DirectView is intended to
be used in hospital,
institutional, provider and
home care settings | Care Orchestrator Essence
is intended to be used in
hospital, institutional,
provider and home care
settings | Equivalent to K152356 &
K083526. |
| User Population | Healthcare representatives
(e.g., Physicians, Clinicians,
Durable Medical Equipment
providers) and patients | Healthcare
representatives (e.g.,
Physicians, Clinicians,
Durable Medical
Equipment providers) | Healthcare representatives
(e.g., Physicians,
Clinicians, Durable Medical
Equipment providers) | Similar to K152356.
Care Orchestrator
Essence does not provide
read-only access to
patients.
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
Orchestrator (Project
Name: Sapphire) | Device Name:
DirectView | Device Name: Care
Orchestrator Essence
(Project Name: Tonic) | |
| | 510(k) Number: K152356
Manufacturer: Respironics
Inc. | 510(k) Number(s):
K083526
(also subsequent 510(k)
K093416, K093905 and
K111610)
Manufacturer:
Respironics Inc. | 510(k) Number:
K183226
Manufacturer:
Respironics Inc. | |
| Application Type | Web-based application | Desktop application | Desktop application | Different from K152356.
Care Orchestrator
requires internet access;
Care Orchestrator
Essence requires a PC
running Windows 7
Service Pack 1 or newer.
Equivalent to K083526
Care Orchestrator
Essence does not require
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
Orchestrator (Project
Name: Sapphire) | Device Name:
DirectView | Device Name: Care
Orchestrator Essence
(Project Name: Tonic) | |
| | 510(k) Number: K152356 | 510(k) Number(s):
K083526
(also subsequent 510(k)
K093416, K093905 and
K111610) | 510(k) Number:
K183226 | |
| | Manufacturer: Respironics
Inc. | Manufacturer:
Respironics Inc. | Manufacturer:
Respironics Inc. | |
| Data transfer
technology from
therapy device | Wireless (Bluetooth or
cellular modem) SD Card | SD Card | SD Card | Similar to K152356 with
regard to data transfer
with an SD card.
Equivalent to K083526 |
| Data storage | Data is stored on a
centralized database | Data is stored on a single
PC | Data is stored on a single
PC | Different from K152356
Equivalent to K083526 |
| Functionality | Patient management Display therapy data Generate reports Prescription Settings
management for non-life
supporting devices (BZD,
MNS, MNT) | Patient management Display therapy data Generate reports Settings management
for non-life supporting
and life supporting
devices | Patient management Display therapy data Generate reports Prescription Settings
management for non-
life supporting devices | Similar to K152356
Care Orchestrator
Essence has additional
functionality for
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
Orchestrator (Project
Name: Sapphire) | Device Name:
DirectView | Device Name: Care
Orchestrator Essence
(Project Name: Tonic) | |
| | 510(k) Number: K152356 | 510(k) Number(s):
K083526
(also subsequent 510(k)
K093416, K093905 and
K111610) | 510(k) Number:
K183226 | |
| | Manufacturer: Respironics
Inc. | Manufacturer:
Respironics Inc. | Manufacturer:
Respironics Inc. | |
| | | | and Trilogy life
supporting device | management for Trilogy
(NOU/CBK) devices.
Equivalent to K083526 |
| Settings management | Ability to change device
settings wirelessly or via a
Secure Digital (SD) card in
non-life support devices only. | Ability to change device
settings in all supported
Respironics devices via a
Secure Digital (SD) card.
No wireless access. | Ability to change device
settings in all supported
Respironics devices via a
Secure Digital (SD) card.
No wireless access. | Similar to K152356.
Equivalent to K083526 |
| Reports | Detailed Report (includes
compliance information) | Detailed Report (includes
compliance information) | Detailed Report (includes
compliance information) | Equivalent to K152356 &
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
Orchestrator (Project
Name: Sapphire) | Device Name:
DirectView | Device Name: Care
Orchestrator Essence
(Project Name: Tonic) | |
| | 510(k) Number: K152356 | 510(k) Number(s):
K083526
(also subsequent 510(k)
K093416, K093905 and
K111610) | 510(k) Number:
K183226 | |
| | Manufacturer: Respironics
Inc. | Manufacturer:
Respironics Inc. | Manufacturer:
Respironics Inc. | |
| Labeling | Online help file within the
application | Online help file within the
application | Online help file within the
application | Equivalent to K152356 &
K083526. |
| Viewing of data | Rendered, static PDF based
on user selected date range. | Interactive viewing of data
based on user selected
date range. | Interactive viewing of data
based on user selected
date range. | Different from K152356.
Equivalent to K083526 |
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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."
Non-Clinical Tests
Software verification and validation testing was performed on Care Orchestrator Essence based on the product requirements. This testing included complete system testing to verify data transfer through an SD card from therapy devices to Care Orchestrator Essence. Once data was transferred, all tests confirmed that Care Orchestrator Essence can display patient and device information, display therapy data including summary and therapy reports and allow for a user to create and/or edit a patient's prescription for the supported therapy devices. Verification of cybersecurity requirements implemented within the software and system architecture were also confirmed for user authentication and encryption of data at rest. Labeling controls as identified in the risk and cybersecurity risk analysis were also verified. Unit verification and low level tests of prescription integrity checks were also completed.
The testing of Care Orchestrator Essence verified that all product requirements have been met with acceptable test results. The verification and validation testing demonstrated comparable safety and effectiveness of the Care Orchestrator Essence software in comparison to the predicate software, Care Orchestrator and DirectView.
Clinical Tests
Clinical tests were not required to demonstrate the safety and effectiveness of Care Orchestrator Essence. Product functionality has been adequately assessed by non-clinical tests.
Conclusion VIII.
Care Orchestrator Essence has demonstrated acceptable test results for all of the aforementioned nonclinical tests and required no clinical tests in order to demonstrate safety or effectiveness. It is therefore concluded that Care Orchestrator Essence is substantially equivalent to the predicate devices, Care Orchestrator (K152356) and DirectView (K083526).