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 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. Sapphire allows read-only access to patients. Sapphire is intended to be used in hospital, institutional, provider, and home care settings.

Device Description

Sapphire is a web application that is used to manage patients utilizing compatible sleep and respiratory devices, view therapy data, generate reports and update device settings for applicable therapy devices. Sapphire is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in hospital, institutional, provider and home settings. Device data is transferred either wirelessly or from an SD card to a centralized database. A user can view this data through a web based application on their computer.

AI/ML Overview

The provided document, a 510(k) summary for the Sapphire device, offers limited details regarding specific acceptance criteria and detailed study results. Based on the available information, here's a breakdown:

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

The document does not provide a formal table of acceptance criteria with corresponding performance metrics. Instead, it broadly states that "The testing of Sapphire verified that all product requirements have been met with passing test results." The description of "product requirements" is general and includes:

Displaying patient and device information.
Displaying therapy data, including compliance and therapy reports.
Allowing a user to create and/or edit a patient's prescription for applicable therapy devices.
Verification of cybersecurity requirements (encryption of data at rest and in transit).

The "reported device performance" is a high-level statement that these requirements were met. No quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific error rates) are provided.

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

The document does not explicitly state the sample size used for the test set or the data provenance. It mentions "complete system testing to verify data transfer from therapy devices to Sapphire, through both wireless data transfer." This implies patient data was used, but the quantity, origin, or retrospective/prospective nature of that data is not specified.

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)

This information is not provided. The testing described appears to be software verification and validation, not a study involving expert-adjudicated ground truth data for diagnostic performance.

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

No adjudication method is mentioned, as the nature of the testing described does not involve expert adjudication of diagnostic outcomes.

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

No MRMC comparative effectiveness study was done. The Sapphire device is a data management system, not an AI-powered diagnostic tool that assists human readers in interpreting medical images or data from that perspective.

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

The testing performed was standalone in the sense that it verified the software's ability to correctly process and display data, and manage settings, without explicitly assessing human interaction improvements. However, it's a data management system, so its "standalone performance" refers to its functional correctness in handling data and settings as intended, not diagnostic accuracy.

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

The document does not detail how "ground truth" was established for the data processed by Sapphire. Given the functionality (data transfer, display, report generation, setting adjustment), the "ground truth" would likely refer to the accuracy of the transferred data matching the source device data and the correct application of prescribed settings. This would be established through comparison with the original therapy device data and verification of setting changes.

8. The sample size for the training set

The document does not mention a training set, as Sapphire is a data management system and not explicitly described as having a machine learning component that would require a distinct training set (in the typical AI/ML sense).

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

Not applicable, as a training set is not mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8, 2016

Respironics Inc. Colleen Witt Manager, Regulatory Affairs 1740 Golden Mile Highway Monroeville, Pennsylvania 15146

Re: K152356

Trade/Device Name: Sapphire Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: Class II Product Code: BZD, MNS, MNT, CBK, NOU Dated: December 4, 2015 Received: December 5, 2015

Dear Colleen Witt:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152356

Device Name Sapphire

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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TAB 5

510(K) SUMMARY

I. Submitter

Official Contact	Colleen WittManager, Regulatory Affairscolleen.witt@philips.comRespironics Inc.1740 Golden Mile HighwayMonroeville, PA 15146
	Phone: 724-387-4870
	Fax: 724-387-7490

Date of Preparation January 8, 2016

II. Device

Name of Device:	Sapphire
Common/Usual Name:	Data Management System
Device Classification:	Class II
Classification Name/Product Code:	Non-continuous ventilator (21 CFR 868.5905, Product Code BZD)Continuous ventilator (21 CFR 868.5895, Product Codes MNS, MNT,CBK, NOU)

Legally Marketed Predicate Devices III.

K140054 ResScan, ResMed LTD.
. K132371 EasyCare Online, ResMed LTD.

IV. Device Description

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Specific roles are assigned within Sapphire. Based on these roles and access rights, users can perform the following tasks within Sapphire:

Add new users with an assigned role to Sapphire ●
Add new patients, along with applicable device information, to Sapphire
Therapy Data Management (including viewing and generating therapy data reports) ●
. Update a patient's prescription/device settings for non-life support devices
Configure compliance rules associated with a patient .

V. Indications for Use

Comparison of Technological Characteristics with the Predicate VI.

Device

Sapphire has the following similarities to the legally marketed predicate devices:

Similar intended use
. Same operating principle
Similar technologies ●

Feature/Function	Predicate Device #1	Predicate Device #2	Subject Device	Comments
Indications for Use	Device Name:ResScan	Device Name:EasyCare Online	Device Name:Sapphire	Similar to K140054 and K132371.Intended uses have similar intent with respect to transferring device and therapeutic data and changing device settings in compatible non-life support therapy devices.
	510(k) Number:K140054	510(k) Number:K132371	510(k) Number:K152356
	Manufacturer:ResMed LTD	Manufacturer:ResMed LTD	Manufacturer:Respironics
	ResScan is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information. This includes the ability to remotely change settings in non-life support devices only.	EasyCare Online is a web based solution for healthcare specialists intended to:- Assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded	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 &
	It is intended to beused by Cliniciansin conjunction withResMedcompatibletherapy devices,using ResMed'sproprietarycommunicationsprotocol.	by anEasyCareOnlinecompatiblehome sleeptest device.Transfer anddisplay, usageandtherapeuticinformationthat has beentransmittedremotely fromthe patient'stherapy devicelocated in thehome. It isintended tosupport thestandardfollow-up careof patientsthat havebeenprescribed acompatibleResMedtherapy devicefor thetreatment ofobstructivesleep apneaor respiratoryinsufficiency.EasyCareOnline alsoprovidesremotesettingscapabilities.	viewing and isintended to beused byhealthcarerepresentatives(e.g., Physicians,Clinicians,Durable MedicalEquipmentproviders) inconjunction withcompatible non-life supporttherapy devices toadjust prescriptionand/orperformancesettings. Sapphireallows read-onlyaccess to patients.Sapphire isintended to beused in hospital,institutional,provider, andhome caresettings.
Application	PC basedapplication	Web basedapplication	Web basedapplication	Equivalent toK132371
Data storage	Data stored onClinician'scomputer	Data stored oncentralizeddatabase	Data stored oncentralizeddatabase	Equivalent toK132371.
Functionality	Patientmanagement• Displaytherapy data• Generatereports• Settingsmanagement(remote	Patient• management• Displaytherapy data• Compliancereports• Therapyreports	Patient• management• Displaytherapy data• Generatereports• Settingsmanagementfor non-life	Equivalent toK140051Similar toK132371.Sapphire has thesamefunctionality asK132371 withrespect to patientmanagement,
	setting changefunctionalityonly applies tonon-lifesupportdevices)	Settings management Diagnostic Home Sleep Test Reports	supportingdevices	data display,report generating and settingsmanagement.Sapphire does not creatediagnostic home sleep test reportsas was cleared inK132371.
Settingsmanagement	Ability to remotelychange devicesettings in non-lifesupport devicesonly.	Ability to remotelychange devicesettings.	Ability to remotelychange devicesettings in non-lifesupport devicesonly.	Equivalent toK140051 andK132371.
Reports	Summary report Detailed report Compliance report	Detailed report Compliance report Therapy report	Detailed Report(includes complianceinformation)	Similar toK140051 andK132371.

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Performance Data: VII.

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." This software 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 testing was performed on Sapphire based on the product requirements. This testing included complete system testing to verify data transfer from therapy devices to Sapphire, through both wireless data transfer. Once data transfer. Once data was transferred, all tests confirmed that Sapphire can display patient and device information, display therapy data including compliance and therapy reports and allow for a user to create and/or edit a patients prescription for applicable therapy device. Verification of cybersecurity requiremented within the system architecture were also confirmed for encryption of data at rest and in transit.

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The testing of Sapphire verified that all product requirements have been met with passing test results. The verification and validation testing demonstrated comparable safety and effectiveness of the Sapphire system in comparison to the predicate.

Clinical Tests

Clinical tests were not required to demonstrate the safety and effectiveness of Sapphire. Product functionality has been adequately assessed by non-clinical tests.

VIII. Conclusion

Sapphire has passed all of the aforementioned non-clinical tests and required no clinical tests in order to demonstrate safety or effectiveness. It is therefore concluded that Sapphire is substantially equivalent to the predicate devices ResScan, ResMed LTD. (K140054) and EasyCare Online, ResMed LTD. (K132371) in terms of safety and effectiveness.

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).