Lumify Diagnostic Ultrasound System
Device Facts
| Record ID | K203406 |
|---|---|
| Device Name | Lumify Diagnostic Ultrasound System |
| Applicant | Philips Ultrasound, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Feb 23, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), and M modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung. Lumify is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
Device Story
Lumify Diagnostic Ultrasound System is a mobile, software-controlled ultrasound device. It acquires high-resolution ultrasound data via USB transducers (C5-2, L12-4, S4-1) connected to a COTS mobile device (iOS/Android). The system displays images in B, Color Doppler, Combined, and M modes. A new 'B-lines Feature' provides automated detection and counting of B-lines in lung ultrasound images to assist in assessing pulmonary conditions like pneumonia, pulmonary edema, and ARDS. Users can review and manually edit the automated B-line counts. The system is used by healthcare professionals in point-of-care settings. The Lumify Power Module enables connectivity and power for iOS devices. The output aids clinicians in diagnostic decision-making by quantifying lung artifacts.
Clinical Evidence
Bench testing only. Performance data provided to support the software algorithm for the B-lines Feature, including requirements review, risk analysis, and product performance testing. All pre-determined acceptance criteria were met.
Technological Characteristics
Mobile ultrasound system comprising COTS mobile device, Philips ultrasound app, and USB-based transducers (Curved, Linear, Sector arrays). Includes Lumify Power Module for iOS interface/power. Software-based image processing for B-mode, Color Doppler, and M-mode. Automated B-line detection algorithm added to existing software platform.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal/obstetric, abdominal, pediatric, cephalic, urological, gynecological, cardiac fetal echo, small organ, musculoskeletal, peripheral vessel, carotid, cardiac, and lung applications. Intended for use by healthcare professionals in clinical environments.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Lumify Diagnostic Ultrasound System (K192226)
Submission Summary (Full Text)
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February 23, 2021
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Philips Ultrasound, Inc. % Mr. Colin Jacob Senior Regulatory Affairs Specialist 22100 Bothell Everett Highway BOTHELL WA 98021
Re: K203406
Trade/Device Name: Lumify Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 15, 2021 Received: January 19, 2021
Dear Mr. Jacob:
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 801 and Part 809); 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)
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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
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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| | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2023<br>See PRA Statement below. | |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------|
| 510(k) Number (if known) | K203406 | | |
| Device Name | Lumify Diagnostic Ultrasound System | | |
| Indications for Use (Describe) | Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), and M modes. | | |
| | It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung. | | |
| | Lumify is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals. | | |
| Type of Use (Select one or both, as applicable) | <table style="display: inline-table;"><tr><td><span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</td><td>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="font-size: 16px;">☑</span> 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<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff<br>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." | | |
| FORM FDA 3881 (6/20) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | |
| | COMPANY CONFIDENTIAL<br>May Not Be Reproduced Without Written Permission | | |
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## 510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. Date Prepared: February 16, 2021
EMAIL: benny.lam@philips.com
### I. Submitter
| Manufacturer Name<br>and Address | Philips Ultrasound, Inc.<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact<br>Information | Colin S. Jacob<br>Senior Regulatory Affairs Specialist<br>TEL: +1 (425)-908-1209<br>EMAIL: colin.jacob@philips.com |
| Secondary Contact<br>Information | Benny Lam<br>Principal Regulatory Affairs Specialist<br>TEL: +1 (425)-215-3496 |
### II. Device
| Trade Name | Lumify Diagnostic Ultrasound System |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Common Name | Diagnostic ultrasound system and transducers |
| Regulation Description | Ultrasonic pulsed doppler imaging system<br>Ultrasonic pulsed echo imaging system<br>Diagnostic ultrasonic transducer |
| Regulation Number | 892.1550<br>892.1560<br>892.1570 |
| Primary Product Code | IYN |
| Secondary Product Codes | IYO<br>ITX |
| Device Class | Class II |
| Classification Panel | Radiology |
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PHILIPS
### III. Predicate Device
K192226 - Philips Ultrasound - Lumify Diagnostic Ultrasound System
### IV. Device Description
Lumify Diagnostic Ultrasound System is a mobile, general, software-control medical device, which is intended to acquire high-resolution ultrasound data and to display the data in various modes of operation. It is intended to be used by trained professionals at various clinical settings including point-of-care.
The Lumify Diagnostic Ultrasound System provides various imaging features including guided scan protocol for comprehensive lung exam. The introduction of the subject B-lines Feature enables the automated detection and counting of B-lines during a lung exam; the subject feature also provides the users the capabilities of reviewing the detected B-lines and editing the number of B-lines for each scanned lung zone.
Clinically, B-line is a lung ultrasound artifact that can aid users in the assessment of patients with a variety of pulmonary conditions and diseases such as pneumonia, pulmonary edema, lung contusion, and acute respiratory distress syndrome (ARDS).
The Lumify Diagnostic Ultrasound System includes:
- A commercial off-the-shelf (COTS) mobile device l
- I Philips Ultrasound software running as an app on the COTS device
- I The C5-2 Curved array USB transducer
- I The L12-4 Linear array USB transducer
- I The S4-1 Sector array USB transducer
- I The Lumify Power Module (LPM) to convert the USB interface used on the family of Lumify transducers to Apple's iAP2 Lightning interface standard used on iPhones and iPads, and to provide battery power to the transducers when using an iOS mobile device.
#### V. Indications for Use
Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), and M modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung.
Lumify is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
Image /page/4/Picture/21 description: The image shows the Philips logo. The logo consists of a shield-like shape with a blue background. Inside the shield, there are three wavy lines stacked on top of each other, and two four-pointed stars, one on each side of the wavy lines. The logo is simple and recognizable.
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# PHILIPS
| | Lumify Diagnostic<br>Ultrasound System<br>K# Pending<br>(Subject Device) | Lumify Diagnostic<br>Ultrasound System<br>K192226<br>(Predicate Device) | Comparison |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Regulation<br>Number | 892.1550 | 892.1550 | Remains<br>unchanged |
| Device<br>Classification<br>Name | System, Imaging, Pulsed<br>Doppler, Ultrasonic | System, Imaging, Pulsed<br>Doppler, Ultrasonic | Remains<br>unchanged |
| Product Code | IYN | IYN | Remains<br>unchanged |
| Secondary<br>Product Code | IYO, ITX | IYO, ITX | Remains<br>unchanged |
| Indications<br>for Use | Philips Lumify Diagnostic<br>Ultrasound System is<br>intended for diagnostic<br>ultrasound imaging in B<br>(2D), Color Doppler,<br>Combined (B+Color), and<br>M modes. It is indicated for<br>diagnostic ultrasound<br>imaging and fluid flow<br>analysis in the following<br>applications:<br>Fetal/Obstetric, Abdominal,<br>Pediatric, Cephalic, Urology,<br>Gynecological, Cardiac Fetal<br>Echo, Small Organ,<br>Musculoskeletal, Peripheral<br>Vessel, Carotid, Cardiac,<br>Lung.<br>Lumify is a transportable<br>ultrasound system intended<br>for use in environments<br>where healthcare is provided<br>by healthcare professionals. | Philips Lumify Diagnostic<br>Ultrasound System is<br>intended for diagnostic<br>ultrasound imaging in B<br>(2D), Color Doppler,<br>Combined (B+Color), and<br>M modes. It is indicated for<br>diagnostic ultrasound<br>imaging and fluid flow<br>analysis in the following<br>applications:<br>Fetal/Obstetric, Abdominal,<br>Pediatric, Cephalic, Urology,<br>Gynecological, Cardiac Fetal<br>Echo, Small Organ,<br>Musculoskeletal, Peripheral<br>Vessel, Carotid, Cardiac.<br>Lumify is a transportable<br>ultrasound system intended<br>for use in environments<br>where healthcare is provided<br>by healthcare professionals. | Added "lung" to<br>indications for<br>use<br>statement |
| Reusable? | Yes | Yes | Remains<br>unchanged |
| | Lumify Diagnostic<br>Ultrasound System<br>K# Pending<br>(Subject Device) | Lumify Diagnostic<br>Ultrasound System<br>K192226<br>(Predicate Device) | Comparison |
| Duration of<br>Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Remains<br>unchanged |
| Imaging<br>Technology | Ultrasound Imaging | Ultrasound Imaging | Remains<br>unchanged |
| Principles of<br>Operation<br>(subject B-<br>lines Feature) | Automatic detection and<br>counting of B-lines from<br>lung ultrasound images | Manual counting of B-lines<br>from lung ultrasound images | B-lines Feature is<br>added to the<br>existing Lumify<br>app |
### VI. Comparison of Technological Characteristics between Proposed Subject Device and Predicate Device
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# HILIPS
### VII. Performance Data
The proposed introduction of the Lumify Diagnostic Ultrasound System was tested in accordance with Philips internal processes. Relevant non-clinical testing was conducted to address the change and performance test data is provided to support the introduction of the subject software algorithm for the B-lines Feature. The activities to assure the safe and effective performance of the software revision include but are not limited to the following:
- Requirements Review
- 트 Risk Analysis and Management
- 트 Product Specifications
- I Design Reviews
- 트 Product Performance testing
### VIII. Conclusion
For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed subject device meets its intended use. The relevant performance data and compatibility support a determination that the proposed subject device does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate device.
