(141 days)
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No
The summary describes a web application for managing patient data from compatible therapy devices, viewing therapy data, generating reports, and updating device settings. There is no mention of AI or ML capabilities, image processing, or any description of training or test sets typically associated with AI/ML development. The focus is on data transfer, display, and basic reporting/setting adjustments.
No
No
Sapphire is intended to track patient data and adjust therapy device settings, but it does not diagnose medical conditions. Its function is to support clinicians by providing remote patient data collection and viewing, and adjusting prescriptions and/or performance settings of compatible therapy devices.
Yes
The device is described as a "web application" and its function is to manage patients, view data, generate reports, and update settings for compatible therapy devices. It receives data wirelessly or via SD card, but the core functionality and interaction are through the web application itself, which is software. The description focuses on software verification and validation, not hardware.
Based on the provided information, Sapphire is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Sapphire's Function: Sapphire's intended use and description clearly state that it is a web application used to manage patients using compatible sleep and respiratory devices, view therapy data, generate reports, and update device settings. It collects data from therapy devices, not from human specimens.
- No Specimen Analysis: There is no mention of Sapphire analyzing any biological samples or performing any tests on bodily fluids or tissues.
Therefore, Sapphire falls under the category of a medical device, but not specifically an In Vitro Diagnostic device. It's a system for managing and interacting with data from other medical devices.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD, MNS, MNT, CBK, NOU
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.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in hospital, institutional, provider, and home care settings.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing: Non-clinical tests were performed based on product requirements. This testing included complete system testing to verify data transfer from therapy devices to Sapphire, through both wireless 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 requirements within the system architecture were also confirmed for encryption of data at rest and in transit. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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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
1
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
2
Indications for Use
510(k) Number (if known) K152356
Device Name Sapphire
Indications for Use (Describe)
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.
| 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 Witt
Manager, Regulatory Affairs
colleen.witt@philips.com
Respironics Inc.
1740 Golden Mile Highway
Monroeville, 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.
IV. 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.
4
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
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.
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 be
used by Clinicians
in conjunction with
ResMed
compatible
therapy devices,
using ResMed's
proprietary
communications
protocol. | by an
EasyCare
Online
compatible
home sleep
test device.
Transfer and
display, usage
and
therapeutic
information
that has been
transmitted
remotely from
the patient's
therapy device
located in the
home. It is
intended to
support the
standard
follow-up care
of patients
that have
been
prescribed a
compatible
ResMed
therapy device
for the
treatment of
obstructive
sleep apnea
or respiratory
insufficiency.
EasyCare
Online also
provides
remote
settings
capabilities. | 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. | |
| Application | PC based
application | Web based
application | Web based
application | Equivalent to
K132371 |
| Data storage | Data stored on
Clinician's
computer | Data stored on
centralized
database | Data stored on
centralized
database | Equivalent to
K132371. |
| Functionality | Patient
management
• Display
therapy data
• Generate
reports
• Settings
management
(remote | Patient
• management
• Display
therapy data
• Compliance
reports
• Therapy
reports | Patient
• management
• Display
therapy data
• Generate
reports
• Settings
management
for non-life | Equivalent to
K140051
Similar to
K132371.
Sapphire has the
same
functionality as
K132371 with
respect to patient
management, |
| | setting change
functionality
only applies to
non-life
support
devices) | Settings management Diagnostic Home Sleep Test Reports | supporting
devices | data display,
report generating and settings
management.
Sapphire does not create
diagnostic home sleep test reports
as was cleared in
K132371. |
| Settings
management | Ability to remotely
change device
settings in non-life
support devices
only. | Ability to remotely
change device
settings. | Ability to remotely
change device
settings in non-life
support devices
only. | Equivalent to
K140051 and
K132371. |
| Reports | Summary report Detailed report Compliance report | Detailed report Compliance report Therapy report | Detailed Report
(includes compliance
information) | Similar to
K140051 and
K132371. |
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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.
7
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.