Ventilator, Non-continuous (Respirator)

{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) 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. | 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 | Product<br>Code | Classification Name | Status | |---------------------|-----------------|-------------------------------------------------------------------------|-------------------------| | 21 CFR<br>§868.5905 | BZD | Ventilator, Non-Continuous<br>(Respirator) | Primary Product Code | | 21 CFR<br>§868.5895 | MNS | Ventilator, Continuous, Non-<br>life-supporting | Subsequent Product Code | | | MNT | Ventilator, Continuous,<br>Minimal Ventilatory Support,<br>Facility Use | Subsequent Product Code | | 21 CFR<br>§868.5895 | NOU | Continuous Ventilator, Home<br>Use | Subsequent Product Code | | | CBK | Ventilator, Continuous,<br>Facility Use | Subsequent Product Code | | 21 CFR<br>§868.5440 | CAW | Generator, Oxygen,<br>Portable | Subsequent Product Code | | 21 CFR<br>§868.2375 | MNR | Ventilatory Effort<br>Recorder | 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. 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. #### 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:<br>Care Orchestrator<br>K181053 | Reference Device:<br>Sleepware G3 with<br>Somnolyzer Inside,<br>K142988 | Subject Device:<br>Care Orchestrator with Home<br>Sleep Testing (Care Orchestrator<br>with HST) | Similarity to Predicate | | Device Type | Stand-alone software | Stand-alone software | Stand-alone software | Unchanged from predicate | | Classification | 21 CFR §868.5905<br>21 CFR §868.5895<br>21 CFR §868.5440 | 21 CFR §882.1400<br>21 CFR §868.2375 | 21 CFR §868.5905<br>21 CFR §868.5895<br>21 CFR §868.5440<br>21 CFR §868.2375 | The classification is<br>updated from the predicate<br>to reflect the additional<br>diagnostic functionality. | | Product Code | BZD, MNS, MNT,<br>NOU, CBK, CAW | OLZ, MNR, OLV | BZD, MNS, MNT, NOU, CBK,<br>CAW, MNR | Product codes are updated<br>to match new functionality | | Indications for<br>Use | Care Orchestrator is<br>intended to support<br>clinicians by tracking<br>data on patients who are<br>prescribed compatible<br>therapy devices in<br>accordance with the<br>intended use of those<br>therapy devices. Care<br>Orchestrator provides<br>remote patient data<br>collection & viewing<br>and is intended to be<br>used by healthcare<br>representatives (e.g.,<br>Physicians, Clinicians,<br>Durable Medical<br>Equipment providers) in<br>conjunction with | Sleepware G3 is a software<br>application used for<br>analysis (automatic and<br>manual scoring), display,<br>retrieval, summarization,<br>report generation and<br>networking of data<br>received from monitoring<br>devices used to categorize<br>sleep related events that<br>help aid in the diagnosis of<br>sleep related disorders. It is<br>indicated for use with<br>infant or adult patients in a<br>clinical environment by or<br>on the order of a physician.<br>The optional Somnolyzer<br>Inside scoring package has<br>the same intended use as | Care Orchestrator is intended to<br>support clinicians by tracking data<br>on patients who are prescribed<br>compatible therapy devices in<br>accordance with the intended use of<br>those therapy devices. Care<br>Orchestrator provides remote patient<br>data collection & viewing and is<br>intended to be used by healthcare<br>representatives (e.g., Physicians,<br>Clinicians, Durable Medical<br>Equipment providers) in conjunction<br>with compatible non-life support<br>therapy devices to adjust<br>prescription and/or performance<br>settings. In addition, Care<br>Orchestrator can be used for analysis<br>(automatic and manual scoring),<br>display, retrieval, summarization, | Existing functionality:<br>Unchanged from the<br>predicate device.<br>Diagnostic functionality:<br>Unchanged from the<br>reference device | | Feature/Function | Predicate Device:<br>Care Orchestrator<br>K181053 | Reference Device:<br>Sleepware G3 with<br>Somnolyzer Inside,<br>K142988 | Subject Device:<br>Care Orchestrator with Home<br>Sleep Testing (Care Orchestrator<br>with HST) | Similarity to Predicate | | | support therapy devices<br>to adjust prescription<br>and/or performance<br>settings. Care<br>Orchestrator allows<br>read-only access to<br>patients. Care<br>Orchestrator is intended<br>to be used in hospital,<br>institutional, provider,<br>and home care settings. | indicated for use with adult<br>patients only. | received from compatible<br>monitoring devices used to<br>categorize sleep-related events that<br>help aid in the diagnosis of sleep-<br>related disorders. The Home Sleep<br>Testing function of Care<br>Orchestrator is indicated for Adult<br>use only. Care Orchestrator allows<br>read-only access to patients. Care<br>Orchestrator is intended to be used<br>in hospital, institutional, provider,<br>and home care settings. | | | Manufacturer | Respironics, Inc. | Respironics, Inc. | Respironics, Inc. | Unchanged from Predicate<br>and reference. | | Location of Use | Hospital, institutional<br>provider, and home<br>settings. | Sleep laboratories | Hospital, institutional, provider,<br>home, and sleep laboratory settings. | In comparison to the<br>predicate device, the subject<br>devices add sleep laboratory<br>settings, which are included<br>in the reference device.<br>Only clinical providers will<br>have access to HST<br>functionality. | | Patient Population | Dependent on device<br>intended use | Adults only when using<br>scoring algorithms based<br>on the AASM guide. | Diagnostic HST use: Adults only,<br>remaining use dependent on device<br>intended use. | Unchanged from the<br>predicate and reference. | | User Population | Clinical Users,<br>Customer<br>Administrators, Product<br>Support Users | Clinical Users | Clinical users, Customer<br>administrators, Product Support<br>Users | Unchanged from the<br>predicate. | | Application Type | Cloud-based software<br>program | PC-based software<br>program | Cloud-based software program | Unchanged from the<br>predicate. | | Data Storage | Centralized Database | User PC | Centralized Database | Unchanged from the | | Feature/Function | Predicate Device:<br>Care Orchestrator<br>K181053 | Reference Device:<br>Sleepware G3 with<br>Somnolyzer Inside,<br>K142988 | Subject Device:<br>Care Orchestrator with Home<br>Sleep Testing (Care Orchestrator<br>with HST) | Similarity to Predicate | | | | | | predicate. | | Contraindications | No Contraindications | No contraindications | No Contraindications | Unchanged from the<br>predicate | | Software level of<br>concern | 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).