Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly mentions an "automated detection and counting of B-lines" feature, which is a strong indicator of an algorithm performing a task that would typically involve AI/ML in modern medical imaging analysis. While the terms "AI" or "ML" are not explicitly used, the functionality described aligns with AI/ML capabilities.

Therapeutic

No.

The device is described as a "Diagnostic Ultrasound System" intended for "diagnostic ultrasound imaging," which focuses on identifying medical conditions rather than treating them.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging." Additionally, the "Device Description" introduces it as "Lumify Diagnostic Ultrasound System."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Lumify Diagnostic Ultrasound System includes hardware components such as USB transducers and a power module, in addition to the software running on a COTS mobile device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The Philips Lumify Diagnostic Ultrasound System is an ultrasound imaging system. It uses sound waves to create images of internal body structures. It does not analyze specimens taken from the body.
Intended Use: The intended use clearly states "diagnostic ultrasound imaging" and "fluid flow analysis" within the body. It lists various anatomical sites for imaging.
No Mention of Specimen Analysis: The entire description focuses on imaging and image processing (specifically the B-lines feature, which is an image artifact analysis), not on analyzing biological samples.

Therefore, based on the provided information, the Philips Lumify Diagnostic Ultrasound System is a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

No
The input document does not contain any language indicating that a PCCP for this specific device has been reviewed, approved, or cleared by the FDA.

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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
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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound Imaging

Anatomical Site

Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained professionals at various clinical settings including point-of-care.
environments where healthcare is provided by healthcare professionals.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
Risk Analysis and Management
Product Specifications
Design Reviews
Product Performance testing
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K192226

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.

Not Found

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).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

Summary

0

February 23, 2021

Image /page/0/Picture/1 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" in blue, and "ADMINISTRATION" in a smaller font below.

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)

1

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

2

Image /page/2/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The color of the text is a medium blue. The background is white, providing a clear contrast that makes the text easily readable.

Page 6 of 53

| | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ 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." | | |
| FORM FDA 3881 (6/20) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | |
| | COMPANY CONFIDENTIAL
May Not Be Reproduced Without Written Permission | | |

3

Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The word is written in a bright blue color. The background is white, which makes the word stand out.

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
and Address | Philips Ultrasound, Inc.
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact
Information | Colin S. Jacob
Senior Regulatory Affairs Specialist
TEL: +1 (425)-908-1209
EMAIL: colin.jacob@philips.com |
| Secondary Contact
Information | Benny Lam
Principal Regulatory Affairs Specialist
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
Ultrasonic pulsed echo imaging system
Diagnostic ultrasonic transducer
Regulation Number	892.1550
892.1560
892.1570
Primary Product Code	IYN
Secondary Product Codes	IYO
ITX
Device Class	Class II
Classification Panel	Radiology

4

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.

5

PHILIPS

| | Lumify Diagnostic
Ultrasound System
K# Pending
(Subject Device) | Lumify Diagnostic
Ultrasound System
K192226
(Predicate Device) | Comparison |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Regulation
Number | 892.1550 | 892.1550 | Remains
unchanged |
| Device
Classification
Name | System, Imaging, Pulsed
Doppler, Ultrasonic | System, Imaging, Pulsed
Doppler, Ultrasonic | Remains
unchanged |
| Product Code | IYN | IYN | Remains
unchanged |
| Secondary
Product Code | IYO, ITX | IYO, ITX | Remains
unchanged |
| 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. | 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.
Lumify is a transportable
ultrasound system intended
for use in environments
where healthcare is provided
by healthcare professionals. | Added "lung" to
indications for
use
statement |
| Reusable? | Yes | Yes | Remains
unchanged |
| | Lumify Diagnostic
Ultrasound System
K# Pending
(Subject Device) | Lumify Diagnostic
Ultrasound System
K192226
(Predicate Device) | Comparison |
| Duration of
Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Remains
unchanged |
| Imaging
Technology | Ultrasound Imaging | Ultrasound Imaging | Remains
unchanged |
| Principles of
Operation
(subject B-
lines Feature) | Automatic detection and
counting of B-lines from
lung ultrasound images | Manual counting of B-lines
from lung ultrasound images | B-lines Feature is
added to the
existing Lumify
app |

VI. Comparison of Technological Characteristics between Proposed Subject Device and Predicate Device

6

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.