(332 days)
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.
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.
I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) premarket notification for a medical device called "Care Orchestrator Essence," which is a software for managing patient compliance data and therapy settings for compatible Respironics devices.
While it mentions software verification and validation testing and non-clinical tests were conducted, it does not provide details on:
- A table of acceptance criteria and reported device performance. It broadly states that "all product requirements have been met with acceptable test results," but no specific criteria or performance metrics are listed.
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study. The device does not perform automatic scoring or diagnosis, so this type of study would not be applicable.
- Standalone (algorithm-only) performance. The device is intended to be used by healthcare professionals.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document emphasizes that clinical tests were not required and that the effectiveness was demonstrated through non-clinical testing and comparison to predicate devices. It focuses on the functional similarities and differences between the new device and previously cleared predicate devices rather than providing detailed performance metrics from a study that fits the criteria of your request (e.g., studies involving ROC curves, sensitivity, specificity, etc., which are common for diagnostic or AI-driven systems).
{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) |
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}------------------------------------------------
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: CareOrchestrator (ProjectName: Sapphire) | Device Name:DirectView | Device Name: CareOrchestrator Essence(Project Name: Tonic) | ||
| 510(k) Number: K152356 | 510(k) Number(s):K083526(also subsequent 510(k)K093416, K093905 andK111610) | 510(k) Number:K183226 | ||
| Manufacturer: RespironicsInc. | Manufacturer:Respironics Inc. | Manufacturer:Respironics Inc. | ||
| Indications for Use | Sapphire is intended tosupport clinicians by trackingdata on patients who areprescribed compatible therapydevices in accordance withthe intended use of thosetherapy devices. Sapphireprovides remote patient datacollection & viewing and isintended to be used by | DirectView is a dataassessment tool for use byphysicians, clinicians, andhome care providers toreceive and report storeddata from an SD data cardand select PhilipsRespironics devices.DirectView can be used tomanage a patient'sprescription. It provides | Care Orchestrator Essenceis intended for use byhealthcare professionals(e.g., Physicians,Clinicians, Durable MedicalEquipment providers) togather, store, manage, andview compliance data forpatients who are prescribedcompatible therapy devices | Similar to predicatedevices, K083526 &K152356.Different from K152356 inthat Care Orchestrator |
| healthcare representatives(e.g., Physicians, Clinicians,Durable Medical Equipmentproviders) in conjunction withcompatible non-life support | the trained clinicalprofessional with theability to transfer new orupdated prescriptions tothe device via an SD card,but does not allow the | in accordance with theintended use of thosetherapy devices. Thesoftware also includes theability to create new or | Essence adds adjustmentto prescriptions and/orperformance settings viaremovable 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: CareOrchestrator (ProjectName: Sapphire) | Device Name:DirectView | Device Name: CareOrchestrator Essence(Project Name: Tonic) | ||
| 510(k) Number: K152356 | 510(k) Number(s):K083526(also subsequent 510(k)K093416, K093905 andK111610) | 510(k) Number:K183226 | ||
| Manufacturer: RespironicsInc. | Manufacturer:Respironics Inc. | Manufacturer:Respironics Inc. | ||
| therapy devices to adjustprescription and/orperformance settings.Sapphire allows read-onlyaccess to patients. Sapphireis intended to be used inhospital, institutional, provider,and home care settings. | clinician to remotelychange a prescription.DirectView does notperform any automaticscoring or diagnosing of apatient's therapy data. | updated prescriptionsand/or performancesettings, store them, andtransmit them to compatibleRespironics' non-lifesupporting therapy devicesand Respironics Trilogyventilator. Data andprescription settings aretransferred between CareOrchestrator Essence andcompatible devices viaremovable media. CareOrchestrator Essence isintended to be used in | Trilogy (NOU, CBK)therapy devices.Different from K152356 inthat Care OrchestratorEssence does not provideread-only access topatients.Different from K083526 in | |
| that Care OrchestratorEssence'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: CareOrchestrator (ProjectName: Sapphire) | Device Name:DirectView | Device Name: CareOrchestrator Essence(Project Name: Tonic) | ||
| 510(k) Number: K152356 | 510(k) Number(s):K083526(also subsequent 510(k)K093416, K093905 andK111610) | 510(k) Number:K183226 | ||
| Manufacturer: RespironicsInc. | Manufacturer:Respironics Inc. | Manufacturer:Respironics Inc. | ||
| hospital, institutional,provider, and home caresettings by healthcarerepresentatives.The software does notperform automatic scoringor diagnosis. The data itprovides are only one ofseveral elements toconsider when makingdecisions about patienttherapy. | use statement specificallyidentifies prescriptionand/or performancesettings update viaremovable media forTrilogy life-support therapydevices. The K083526predicate had this samefunctionality but did notspecifically identify Trilogyin 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: CareOrchestrator (ProjectName: Sapphire) | Device Name:DirectView | Device Name: CareOrchestrator Essence(Project Name: Tonic) | ||
| 510(k) Number: K152356 | 510(k) Number(s):K083526(also subsequent 510(k)K093416, K093905 andK111610) | 510(k) Number:K183226 | ||
| Manufacturer: RespironicsInc. | Manufacturer:Respironics Inc. | Manufacturer:Respironics Inc. | ||
| Product Code | BZD, MNS, MNT, NOU, CBK | MNS, MNT, CBK, NOU | BZD, MNS, MNT, NOU,CBK | Equivalent to K083526and K152356.Care OrchestratorEssence supportsprescription and/orperformance settingsupdate via removablemedia for CBK/NOUTrilogy life-support therapydevices only. It is notintended for use with anyother life-supportingdevices. |
| 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: CareOrchestrator (ProjectName: Sapphire) | Device Name:DirectView | Device Name: CareOrchestrator Essence(Project Name: Tonic) | ||
| 510(k) Number: K152356 | 510(k) Number(s):K083526(also subsequent 510(k)K093416, K093905 andK111610) | 510(k) Number:K183226 | ||
| Manufacturer: RespironicsInc. | Manufacturer:Respironics Inc. | Manufacturer:Respironics Inc. | ||
| Environment of Use | Care Orchestrator is intendedto be used in hospital,institutional, provider andhome care settings | DirectView is intended tobe used in hospital,institutional, provider andhome care settings | Care Orchestrator Essenceis intended to be used inhospital, institutional,provider and home caresettings | Equivalent to K152356 &K083526. |
| User Population | Healthcare representatives(e.g., Physicians, Clinicians,Durable Medical Equipmentproviders) and patients | Healthcarerepresentatives (e.g.,Physicians, Clinicians,Durable MedicalEquipment providers) | Healthcare representatives(e.g., Physicians,Clinicians, Durable MedicalEquipment providers) | Similar to K152356.Care OrchestratorEssence does not provideread-only access topatients.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: CareOrchestrator (ProjectName: Sapphire) | Device Name:DirectView | Device Name: CareOrchestrator Essence(Project Name: Tonic) | ||
| 510(k) Number: K152356Manufacturer: RespironicsInc. | 510(k) Number(s):K083526(also subsequent 510(k)K093416, K093905 andK111610)Manufacturer:Respironics Inc. | 510(k) Number:K183226Manufacturer:Respironics Inc. | ||
| Application Type | Web-based application | Desktop application | Desktop application | Different from K152356.Care Orchestratorrequires internet access;Care OrchestratorEssence requires a PCrunning Windows 7Service Pack 1 or newer.Equivalent to K083526Care OrchestratorEssence does not requirethe 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: CareOrchestrator (ProjectName: Sapphire) | Device Name:DirectView | Device Name: CareOrchestrator Essence(Project Name: Tonic) | ||
| 510(k) Number: K152356 | 510(k) Number(s):K083526(also subsequent 510(k)K093416, K093905 andK111610) | 510(k) Number:K183226 | ||
| Manufacturer: RespironicsInc. | Manufacturer:Respironics Inc. | Manufacturer:Respironics Inc. | ||
| Data transfertechnology fromtherapy device | Wireless (Bluetooth orcellular modem) SD Card | SD Card | SD Card | Similar to K152356 withregard to data transferwith an SD card.Equivalent to K083526 |
| Data storage | Data is stored on acentralized database | Data is stored on a singlePC | Data is stored on a singlePC | Different from K152356Equivalent to K083526 |
| Functionality | Patient management Display therapy data Generate reports Prescription Settingsmanagement for non-lifesupporting devices (BZD,MNS, MNT) | Patient management Display therapy data Generate reports Settings managementfor non-life supportingand life supportingdevices | Patient management Display therapy data Generate reports Prescription Settingsmanagement for non-life supporting devices | Similar to K152356Care OrchestratorEssence has additionalfunctionality forPrescription 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: CareOrchestrator (ProjectName: Sapphire) | Device Name:DirectView | Device Name: CareOrchestrator Essence(Project Name: Tonic) | ||
| 510(k) Number: K152356 | 510(k) Number(s):K083526(also subsequent 510(k)K093416, K093905 andK111610) | 510(k) Number:K183226 | ||
| Manufacturer: RespironicsInc. | Manufacturer:Respironics Inc. | Manufacturer:Respironics Inc. | ||
| and Trilogy lifesupporting device | management for Trilogy(NOU/CBK) devices.Equivalent to K083526 | |||
| Settings management | Ability to change devicesettings wirelessly or via aSecure Digital (SD) card innon-life support devices only. | Ability to change devicesettings in all supportedRespironics devices via aSecure Digital (SD) card.No wireless access. | Ability to change devicesettings in all supportedRespironics devices via aSecure Digital (SD) card.No wireless access. | Similar to K152356.Equivalent to K083526 |
| Reports | Detailed Report (includescompliance information) | Detailed Report (includescompliance information) | Detailed Report (includescompliance 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: CareOrchestrator (ProjectName: Sapphire) | Device Name:DirectView | Device Name: CareOrchestrator Essence(Project Name: Tonic) | ||
| 510(k) Number: K152356 | 510(k) Number(s):K083526(also subsequent 510(k)K093416, K093905 andK111610) | 510(k) Number:K183226 | ||
| Manufacturer: RespironicsInc. | Manufacturer:Respironics Inc. | Manufacturer:Respironics Inc. | ||
| Labeling | Online help file within theapplication | Online help file within theapplication | Online help file within theapplication | Equivalent to K152356 &K083526. |
| Viewing of data | Rendered, static PDF basedon user selected date range. | Interactive viewing of databased on user selecteddate range. | Interactive viewing of databased on user selecteddate range. | Different from K152356.Equivalent to K083526 |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
{13}------------------------------------------------
{14}------------------------------------------------
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).
§ 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).