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. In addition, Care Orchestrator can be used for analysis (automatic and manual scoring), display, retrieval, summarization, and report generation of data received from compatible monitoring devices used to categorize sleep-related events that help aid in the diagnosis of sleep-related disorders. The Home Sleep Testing function of Care Orchestrator is indicated for Adult use only. 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 cloud-based software platform that allows entities including physicians, other professional home and clinical staff, and durable medical equipment providers in a patient's therapy lifecycle the ability to manage patients and referrals, control access to patient information and therapy data, enhance patient compliance management workflow, and gain efficiencies in the overall patient therapy workflow. Care Orchestrator also provides a method for sleep data acquired from a supported home sleep test (HST) devices to be imported, scored and reviewed by a qualified user. The HST function of Care Orchestrator is for adult use only.

The intent of the Care Orchestrator sleep diagnostic functionality is to provide a capability that allows users to analyze, score, review and generate clinical reports for HST acquisitions (i.e. sleep studies) from within a web browser. Users can upload acquisitions to Care Orchestrator and perform these actions all from within the browserbased Care Orchestrator Client application.

Care Orchestrator software has undergone no significant changes since in K181053. The addition of the Home Sleep Testing features, subject of this submission, add a sub-set of Home Sleep Testing functionality.

AI/ML Overview

The provided document is a 510(k) summary for the "Care Orchestrator with Home Sleep Testing" device. It outlines the device's indications for use, its comparison to a predicate device, and a brief statement about performance data. However, it does not contain a detailed study proving the device meets specific acceptance criteria, nor does it provide a table of acceptance criteria with reported device performance.

The document states:

"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."
"Software verification and validation included software code reviews, automated testing, bench verification testing and labeling review."

This indicates that general software V&V activities were performed, but the specific details requested in your prompt (acceptance criteria table, sample sizes, ground truth establishment, MRMC studies, etc.) are not included in this summary.

Therefore, many of your questions cannot be answered from the provided text.

Here's a breakdown of what can be inferred or directly stated, and what information is missing:

1. A table of acceptance criteria and the reported device performance

Missing from the document. The document states that software verification and validation testing was done, but it does not provide a table of specific acceptance criteria or quantitative performance metrics for those criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing from the document. The summary mentions "bench verification testing" but does not detail the sample size of the test set, the nature of the data (e.g., patient data, synthetic data), its origin, or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing from the document. The document does not specify if experts were used to establish ground truth for a test set, nor their number or qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing from the document. There is no information provided regarding any adjudication methods for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Missing from the document. The document does not mention any MRMC comparative effectiveness studies. The device's function involves automatic and manual scoring to aid in the diagnosis of sleep-related disorders, but how it impacts human reader performance through such studies is not discussed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Partially addressed. The device performs "analysis (automatic and manual scoring)". The "automatic scoring" component implies standalone algorithmic functionality. However, the document does not provide specific performance metrics for this standalone component.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Missing from the document. The type of ground truth used for any validation of the automatic scoring algorithm is not specified.

8. The sample size for the training set

Missing from the document. This document focuses on the regulatory submission and does not disclose details about the training set size for any machine learning components.

9. How the ground truth for the training set was established

Missing from the document. Similar to the test set, the method for establishing ground truth for any potential training set is not provided.

Summary

{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.

September 25, 2020

Respironics, Inc. Jennifer Richardson Senior Regulatory Affairs Engineer 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K201439

Trade/Device Name: Care Orchestrator with Home Sleep Testing Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: August 21, 2020 Received: August 24, 2020

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

{1}------------------------------------------------

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

for Malvina B. Eydelman, M.D. Director 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) K201439

Device Name Care Orchestrator with Home Sleep Testing

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

SECTION 5 510(K) SUMMARY Submitter I.

Official Contact	Jennifer Richardson	Senior Regulatory Affairs Engineer
	jennifer.richardson@philips.com
	1740 Golden Mile Highway
	Monroeville, PA 15146
	Phone: 812-322-1116
Manufacturing Facility	Respironics Inc.
	1001 Murry Ridge Ln
	Murrysville, Pennsylvania 15668
Date of Preparation	25 September 2020

II. Device

Name of Device:	Care Orchestrator with Home Sleep Testing
Common/Usual Name:	Data collection and patient management software
Regulatory Class:	II

Regulation	ProductCode	Classification Name	Status
21 CFR§868.5905	BZD	Ventilator, Non-Continuous(Respirator)	Primary Product Code
21 CFR§868.5895	MNS	Ventilator, Continuous, Non-life-supporting	Subsequent Product Code
	MNT	Ventilator, Continuous,Minimal Ventilatory Support,Facility Use	Subsequent Product Code
21 CFR§868.5895	NOU	Continuous Ventilator, HomeUse	Subsequent Product Code
	CBK	Ventilator, Continuous,Facility Use	Subsequent Product Code
21 CFR§868.5440	CAW	Generator, Oxygen,Portable	Subsequent Product Code
21 CFR§868.2375	MNR	Ventilatory EffortRecorder	Subsequent Product Code

{4}------------------------------------------------

III. Legally Marketed Predicate Device

Primary predicate: K181053, Care Orchestrator, Respironics Inc. ● The predicate has not been subject to any design-related recalls.

Reference device: Sleepware G3 with Somnolyzer Inside, K142988. ●

Device Description IV.

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, Clinicians, Durable Medical Equipment providers) in conjunction with compatible non-life support therapy devices to adjust prescription and/or performance settings. In addition, Care Orchestrator can be used for analysis (automatic and manual scoring), display, retrieval, summarization, and report generation of data received from compatible monitoring devices used to categorize sleep-related events that help aid in the diagnosis of sleep-related disorders. The Home Sleep Testing function of Care Orchestrator is indicated for Adult use only. Care Orchestrator allows read-only access to patients. Care Orchestrator is intended to be used in hospital, institutional, provider, and home care settings.

Respironics Inc.

25 September 2020

Page 5-2

{5}------------------------------------------------

Traditional 510(k)

Section 5 – 510(k) Summary

compatible non-life

VI. Comparison of Technological Characteristics with the Predicate Device
Feature/Function	Predicate Device:Care OrchestratorK181053	Reference Device:Sleepware G3 withSomnolyzer Inside,K142988	Subject Device:Care Orchestrator with HomeSleep Testing (Care Orchestratorwith HST)	Similarity to Predicate
Device Type	Stand-alone software	Stand-alone software	Stand-alone software	Unchanged from predicate
Classification	21 CFR §868.590521 CFR §868.589521 CFR §868.5440	21 CFR §882.140021 CFR §868.2375	21 CFR §868.590521 CFR §868.589521 CFR §868.544021 CFR §868.2375	The classification isupdated from the predicateto reflect the additionaldiagnostic functionality.
Product Code	BZD, MNS, MNT,NOU, CBK, CAW	OLZ, MNR, OLV	BZD, MNS, MNT, NOU, CBK,CAW, MNR	Product codes are updatedto match new functionality
Indications forUse	Care Orchestrator isintended to supportclinicians by trackingdata on patients who areprescribed compatibletherapy devices inaccordance with theintended use of thosetherapy devices. CareOrchestrator providesremote patient datacollection & viewingand is intended to beused by healthcarerepresentatives (e.g.,Physicians, Clinicians,Durable MedicalEquipment providers) inconjunction with	Sleepware G3 is a softwareapplication used foranalysis (automatic andmanual scoring), display,retrieval, summarization,report generation andnetworking of datareceived from monitoringdevices used to categorizesleep related events thathelp aid in the diagnosis ofsleep related disorders. It isindicated for use withinfant or adult patients in aclinical environment by oron the order of a physician.The optional SomnolyzerInside scoring package hasthe same intended use as	Care Orchestrator is intended tosupport clinicians by tracking dataon patients who are prescribedcompatible therapy devices inaccordance with the intended use ofthose therapy devices. CareOrchestrator provides remote patientdata collection & viewing and isintended to be used by healthcarerepresentatives (e.g., Physicians,Clinicians, Durable MedicalEquipment providers) in conjunctionwith compatible non-life supporttherapy devices to adjustprescription and/or performancesettings. In addition, CareOrchestrator can be used for analysis(automatic and manual scoring),display, retrieval, summarization,	Existing functionality:Unchanged from thepredicate device.Diagnostic functionality:Unchanged from thereference device
Feature/Function	Predicate Device:Care OrchestratorK181053	Reference Device:Sleepware G3 withSomnolyzer Inside,K142988	Subject Device:Care Orchestrator with HomeSleep Testing (Care Orchestratorwith HST)	Similarity to Predicate
	support therapy devicesto adjust prescriptionand/or performancesettings. CareOrchestrator allowsread-only access topatients. CareOrchestrator is intendedto be used in hospital,institutional, provider,and home care settings.	indicated for use with adultpatients only.	received from compatiblemonitoring devices used tocategorize sleep-related events thathelp aid in the diagnosis of sleep-related disorders. The Home SleepTesting function of CareOrchestrator is indicated for Adultuse only. Care Orchestrator allowsread-only access to patients. CareOrchestrator is intended to be usedin hospital, institutional, provider,and home care settings.
Manufacturer	Respironics, Inc.	Respironics, Inc.	Respironics, Inc.	Unchanged from Predicateand reference.
Location of Use	Hospital, institutionalprovider, and homesettings.	Sleep laboratories	Hospital, institutional, provider,home, and sleep laboratory settings.	In comparison to thepredicate device, the subjectdevices add sleep laboratorysettings, which are includedin the reference device.Only clinical providers willhave access to HSTfunctionality.
Patient Population	Dependent on deviceintended use	Adults only when usingscoring algorithms basedon the AASM guide.	Diagnostic HST use: Adults only,remaining use dependent on deviceintended use.	Unchanged from thepredicate and reference.
User Population	Clinical Users,CustomerAdministrators, ProductSupport Users	Clinical Users	Clinical users, Customeradministrators, Product SupportUsers	Unchanged from thepredicate.
Application Type	Cloud-based softwareprogram	PC-based softwareprogram	Cloud-based software program	Unchanged from thepredicate.
Data Storage	Centralized Database	User PC	Centralized Database	Unchanged from the
Feature/Function	Predicate Device:Care OrchestratorK181053	Reference Device:Sleepware G3 withSomnolyzer Inside,K142988	Subject Device:Care Orchestrator with HomeSleep Testing (Care Orchestratorwith HST)	Similarity to Predicate
				predicate.
Contraindications	No Contraindications	No contraindications	No Contraindications	Unchanged from thepredicate
Software level ofconcern	Moderate	Moderate	Moderate	Unchanged from predicate

and report generation of data

Sleepware G3, but is

{6}------------------------------------------------

{7}------------------------------------------------

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." The software for this device was considered to have a "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 included software code reviews, automated testing, bench verification testing and labeling review.

VIII. Conclusion

The modified Care Orchestrator with Home Sleep Testing software is substantially equivalent to Care Orchestrator (K181053).

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).