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 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.

AI/ML Overview

The provided text describes the Philips Lumify Diagnostic Ultrasound System and its new B-lines Feature. However, it does not contain specific acceptance criteria, detailed study results, or information about sample sizes, ground truth establishment, or expert qualifications for the B-lines Feature.

Instead, the document primarily focuses on regulatory approval (510(k) submission) and states generally that "all pre-determined acceptance criteria were met" and "performance test data is provided to support the introduction of the subject software algorithm."

Therefore, I cannot fulfill your request for a detailed table of acceptance criteria, reported performance, sample sizes, ground truth details, expert qualifications, or MRMC study information based solely on the provided text.

Here's what can be extracted and what is missing:

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

Acceptance Criteria	Reported Device Performance
Not specified	"all pre-determined acceptance criteria were met"

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

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

Not specified.

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:

An MRMC study is not explicitly mentioned. The document states the B-lines Feature provides "automated detection and counting of B-lines," while the predicate had "manual counting," implying a standalone algorithm. However, no comparative effectiveness study with human readers and AI assistance is described, nor an effect size.

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

The description of the B-lines Feature ("Automated detection and counting of B-lines from lung ultrasound images") suggests a standalone algorithm component. However, specific standalone performance metrics are not provided. The phrasing "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" indicates a human-in-the-loop interaction, where the user can review and edit the device's output.

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

Not specified.

8. The sample size for the training set:

Not specified.

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

Not specified.

Summary of what is present in the document:

The device is called the "Lumify Diagnostic Ultrasound System" with a new "B-lines Feature."
The B-lines Feature provides "automatic detection and counting of B-lines during a lung exam."
Users can review and edit the detected B-lines.
Clinically, B-lines are lung ultrasound artifacts that aid in assessing pulmonary conditions.
The study conducted was "non-clinical testing" addressing the change and performance, following Philips' internal processes (Requirements Review, Risk Analysis and Management, Product Specifications, Design Reviews, Product Performance testing).
The conclusion states that "all pre-determined acceptance criteria were met" and the device "does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate device."
The predicate device involved "manual counting of B-lines from lung ultrasound images."

Summary

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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)

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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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Page 6 of 53

	DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2023See 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 ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@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 CONFIDENTIALMay 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 Nameand Address	Philips Ultrasound, Inc.22100 Bothell Everett HwyBothell, WA 98021-8431
ContactInformation	Colin S. JacobSenior Regulatory Affairs SpecialistTEL: +1 (425)-908-1209EMAIL: colin.jacob@philips.com
Secondary ContactInformation	Benny LamPrincipal Regulatory Affairs SpecialistTEL: +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 systemUltrasonic pulsed echo imaging systemDiagnostic ultrasonic transducer
Regulation Number	892.1550892.1560892.1570
Primary Product Code	IYN
Secondary Product Codes	IYOITX
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

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

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 DiagnosticUltrasound SystemK# Pending(Subject Device)	Lumify DiagnosticUltrasound SystemK192226(Predicate Device)	Comparison
RegulationNumber	892.1550	892.1550	Remainsunchanged
DeviceClassificationName	System, Imaging, PulsedDoppler, Ultrasonic	System, Imaging, PulsedDoppler, Ultrasonic	Remainsunchanged
Product Code	IYN	IYN	Remainsunchanged
SecondaryProduct Code	IYO, ITX	IYO, ITX	Remainsunchanged
Indicationsfor Use	Philips Lumify DiagnosticUltrasound System isintended for diagnosticultrasound imaging in B(2D), Color Doppler,Combined (B+Color), andM modes. It is indicated fordiagnostic ultrasoundimaging and fluid flowanalysis in the followingapplications:Fetal/Obstetric, Abdominal,Pediatric, Cephalic, Urology,Gynecological, Cardiac FetalEcho, Small Organ,Musculoskeletal, PeripheralVessel, Carotid, Cardiac,Lung.Lumify is a transportableultrasound system intendedfor use in environmentswhere healthcare is providedby healthcare professionals.	Philips Lumify DiagnosticUltrasound System isintended for diagnosticultrasound imaging in B(2D), Color Doppler,Combined (B+Color), andM modes. It is indicated fordiagnostic ultrasoundimaging and fluid flowanalysis in the followingapplications:Fetal/Obstetric, Abdominal,Pediatric, Cephalic, Urology,Gynecological, Cardiac FetalEcho, Small Organ,Musculoskeletal, PeripheralVessel, Carotid, Cardiac.Lumify is a transportableultrasound system intendedfor use in environmentswhere healthcare is providedby healthcare professionals.	Added "lung" toindications forusestatement
Reusable?	Yes	Yes	Remainsunchanged
	Lumify DiagnosticUltrasound SystemK# Pending(Subject Device)	Lumify DiagnosticUltrasound SystemK192226(Predicate Device)	Comparison
Duration ofUse	Limited (≤ 24 hours)	Limited (≤ 24 hours)	Remainsunchanged
ImagingTechnology	Ultrasound Imaging	Ultrasound Imaging	Remainsunchanged
Principles ofOperation(subject B-lines Feature)	Automatic detection andcounting of B-lines fromlung ultrasound images	Manual counting of B-linesfrom lung ultrasound images	B-lines Feature isadded to theexisting Lumifyapp

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.

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.