EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System

K201012 · Philips Ultrasound, Inc. · IYN · May 1, 2020 · Radiology

Device Facts

• Record ID: K201012
• Device Name: EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
• Applicant: Philips Ultrasound, Inc.
• Product Code: IYN · Radiology
• Decision Date: May 1, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Transesophageal (Cardiac), Transrectal, Transvaginal. The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, and clinical point-of-care for diagnosis of patients. When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

Device Story

Philips Diagnostic Ultrasound Systems (Lumify, EPIQ, Affiniti, CX50, Sparq) and QLAB software are reusable capital equipment for high-resolution imaging and fluid flow analysis. Systems use transducers with piezoelectric elements to generate and receive ultrasound waves; console processes echoes into images for display. Used in clinics, hospitals, and point-of-care by trained professionals. QLAB software views/quantifies image data on PCs or on-board systems. Devices assist interventionalists/surgeons via EchoNavigator for cardiovascular procedures using live X-ray and Echo guidance. Expanded labeling provides guidance for lung and cardiac ultrasound in COVID-19 patients. Benefits include diagnostic visualization and clinical decision support for cardiovascular and general imaging.

Clinical Evidence

No clinical data. Bench testing only; substantial equivalence supported by design control measures and comparison to predicate devices.

Technological Characteristics

Ultrasound imaging systems using piezoelectric transducers (curved, linear, sector, phased array, xMatrix). Biocompatibility per ISO 10993-1. Systems include primary console, software, and transducers. Connectivity via standard interfaces. Sterilization via compatible probe covers.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients across various clinical applications including abdominal, cardiac (adult/pediatric/fetal/transesophageal), vascular (cerebral/peripheral/intraoperative), obstetric/gynecological, musculoskeletal, urological, and small organ (breast/thyroid/testicle). Used in clinics, hospitals, and point-of-care settings by healthcare professionals.

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

• Philips Lumify Diagnostic Ultrasound System (K192226)
• Philips EPIQ Diagnostic Ultrasound System (K182857)
• Philips Affiniti Diagnostic Ultrasound System (K182857)
• Philips CX50 Diagnostic Ultrasound System (K162329)
• Philips Sparq Diagnostic Ultrasound System (K162329)
• QLAB Advanced Quantification Software (K191647)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Philips Ultrasound, Inc. % Deep Pal Director, Regulatory Affairs 22100 Bothell Everett Highway Bothell WA 98021

May 1, 2020

## Re: K201012

Trade/Device Name: Affiniti Diagnostic Ultrasound System Series Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH Dated: April 17, 2020 Received: April 20, 2020

Dear Deep Pal:

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/cfpmp/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); 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

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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) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] 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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510(k) Number (if known) K201012

### Device Name

Affiniti Diagnostic Ultrasound System Series

### Indications for Use (Describe)

The intended use of the Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Transesophageal (Cardiac), Transrectal, Transvaginal.

The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, and clinical point-of-care for diagnosis of patients.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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### *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 [e-mail]

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510(k) Number (if known) K201012

Device Name CX50 Diagnostic Ultrasound System

### Indications for Use (Describe)

Philips CX50 Diagnostic Ultrasound Systems is intended for diagnostic ultrasound imaging in B (or 2- D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes.

It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Intraoperative Laparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal Gynecological Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid)

X 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 [e-mail]

{4}------------------------------------------------

510(k) Number (if known) K201012

### Device Name

EPIQ Diagnostic Ultrasound System Series

### Indications for Use (Describe)

The intended use of the EPIQ, EPIQ 7 is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.

The clinical environments where the EPIQ Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

### 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 [e-mail]

{5}------------------------------------------------

510(k) Number (if known) K201012

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. 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)

| <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|

### 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 [e-mail]

{6}------------------------------------------------

510(k) Number (if known) K201012

Device Name

QLAB Advanced Quantification Software

Indications for Use (Describe)

QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 201. Subpart D) </span> |
|---------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 201. Subpart C) </span> |

| X 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 [e-mail]

{7}------------------------------------------------

510(k) Number (if known) K201012

Device Name Sparq Diagnostic Ultrasound System

### Indications for Use (Describe)

Philips Sparq Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2- D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Fetal Abdominal Pediatric Small Organ Adult Cephalic Trans-vaginal Trans-rectal Musculo-skeletal Gynecological Cardiac Adult Trans-Esoph. (Cardiac) Peripheral Vessel.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:16px">☐</span> 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 [e-mail]

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.

I

# 510(k) Summary

This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. Date Prepared: April 30, 2020

| I. Submitter | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer Name<br>and Address | Philips Ultrasound, Inc.<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 |
| Contact<br>Information | Deep Pal<br>Head of Regulatory Affairs<br>TEL: [phone]<br>EMAIL: [e-mail] |
| Secondary Contact<br>Information | Benny Lam<br>Principal Regulatory Affairs Specialist<br>TEL: [phone]<br>EMAIL: [e-mail] |
| II. Device | |
| Trade Name | Philips Lumify Diagnostic Ultrasound System<br>Philips EPIQ Diagnostic Ultrasound System Series<br>Philips Affiniti Diagnostic Ultrasound System Series<br>Philips CX50 Diagnostic Ultrasound System<br>Philips Sparq Diagnostic Ultrasound System<br>Philips QLAB Advanced Quantification Software |
| Common Name | Diagnostic ultrasound system and transducers<br>Automated Radiological Image Processing Software |
| Regulation Description | Ultrasonic pulsed doppler imaging system<br>Ultrasonic pulsed echo imaging system<br>Diagnostic ultrasonic transducer<br>Picture archiving and communications system |
| Regulation Number | 892.1550<br>892.1560<br>892.1570<br>892.2050 |
| Product Code | IYN |
| Secondary Product Codes | IYO |

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## ITX OIH

| Device Class | Class II |
|----------------------|-----------|
| Classification Panel | Radiology |

#### III. Predicate Device

- K192226 Philips Lumify Diagnostic Ultrasound System ■
- K182857 Philips EPIQ Diagnostic Ultrasound System ■
- l K182857 - Philips Affiniti Diagnostic Ultrasound System
- K162329 Philips CX50 Diagnostic Ultrasound System ■
- I K162329 - Philips Sparq Diagnostic Ultrasound System
- K191647 - QLAB Advanced Quantification Software

#### IV. Device Description

Philip Diagnostic Ultrasound Systems are durable, reusable capital equipment medical devices which are intended for high-resolution general imaging, interventional radiology, cardiology, vascular and OB/GYN applications and fluid flow analysis. They are intended to be used by trained professionals at various settings of patient care such as clinical admission, periodic evaluations, prior to hospitalization discharge, and/or academic research, via maneuverable caster wheels or mobile handheld components.

Philips QLAB Advanced Quantification software (QLAB) is designed to view and quantify image data acquired on Philips ultrasound systems. QLAB is available either as a stand-alone product that can function on a standard PC, a dedicated workstation, and on-board Philips' Diagnostic Ultrasound Systems.

Software modes/applications, scanning protocols, and pre-installed settings or functionality to create dedicated settings for imaging of specific anatomy are available with the subject Philips Diagnostic Ultrasound Systems and QLAB software and may vary among model configurations.

The diagnostic ultrasound systems are manufactured with hardware components which consist of:

- a primary console (e.g., workstation, tablet) with built-in software components, features, and 1) various clinical applications, and
- 2) a range of compatible ultrasound transducers.

A suite of compatible transducer types are offered such as transesophageal echocardiography (TEE) transducers, non-imaging (pencil) probes, curved array, linear array and sector/ohased array transducer models which have a prefix "C" are designed to provide larger fields of view and penetration for e.g., consolidation between bone spaces while linear array transducer models, which can be identified with a "L" prefix model name are designed to provide shallow visualization which are optimal for tissue layer interfaces. Sector/phased array transducer models which usually have a "S" prefix model names are designed to be applied for difficult anatomical sites (e.g., cardiac intercostal space (ICS)). Other Philips ultrasound transducers may also start with the prefix "X" which is referring to the xMatrix technology for two full-resolution planes of imaging. Volumetric three-dimensional (3D) imaging functionality is also available when specific transducer models are connected to the primary console. Philips ultrasound

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Image /page/10/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The color of the text is a bright blue. The letters are evenly spaced and the word is centered in the image.

### SPECIAL 510(k) Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices

transducers may be bagged into compatible transducer/probe cover sheaths, designed by other manufacturers, for each procedure to prevent cross-contamination and reduce the risk of healthcareassociated infections.

Some configurations may have additional previously-cleared accessories, components and software features which are manufactured by Philips Ultrasound, Inc. or other manufacturers.

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| Device | Indications for Use |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Philips Lumify<br>Diagnostic<br>Ultrasound<br>System | Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined<br>(B+Color), and M modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:<br>Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal,<br>Peripheral Vessel, Carotid, Cardiac. Lumify is a transportable ultrasound system intended for use in environments where<br>healthcare is provided by healthcare professionals. |
| Philips EPIQ<br>Diagnostic<br>Ultrasound<br>System | The intended use of the EPIQ, EPIQ 5, EPIQ 7 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow<br>analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac<br>Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular),<br>Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral<br>Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.<br>The clinical environments where the EPIQ Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical<br>point-of-care for diagnosis of patients.<br>When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during<br>treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.<br>The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating<br>instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated<br>in the user information reduces your responsibility for sound clinical judgement and best clinical procedure. |
| Philips Affiniti<br>Diagnostic<br>Ultrasound<br>System | The intended use of the Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging<br>and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other<br>(Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic<br>(Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional),<br>Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle),<br>Transesophageal (Cardiac), Transrectal, Transvaginal.<br>The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical<br>point-of-care for diagnosis of patients.<br>When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during<br>treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance. |
| Device | Indications for Use |
| Philips CX50<br>Diagnostic<br>Ultrasound<br>System | The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating<br>instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated<br>in the user information reduces your responsibility for sound clinical judgement and best clinical procedure |
| | Philips CX50 Diagnostic Ultrasound Systems is intended for diagnostic ultrasound imaging in B (or 2- D), M-mode (including<br>Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics<br>(Tissue and Contrast) modes.<br>It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Intraoperative<br>Laparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal<br>Gynecological Cardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid) |
| Philips Sparq<br>Diagnostic<br>Ultrasound<br>System | Philips Sparq Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2- D), M-mode (including<br>Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics<br>(Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:<br>Ophthalmic Fetal Abdominal Pediatric Small Organ Adult Cephalic Trans-vaginal Trans-rectal Musculo-skeletal Gynecological<br>Cardiac Adult Trans-Esoph. (Cardiac) Peripheral Vessel |
| QLAB<br>Advanced<br>Quantification<br>software | QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data<br>acquired on Philips ultrasound systems. |

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Page 6 of 19

#### VI. Comparison of Technological Characteristics with the Predicate Device

Table 1: Technological Comparison of Subject Device (i.e., Philips Lumify Diagnostic Ultrasound System) & Predicate Device

| Standard Feature | Philips Lumify Ultrasound System<br>K# Pending<br>(Subject Device) | Philips Lumify Diagnostic<br>Ultrasound System<br>K192226<br>(Predicate Device) | Comparison |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use | Philips Lumify Diagnostic Ultrasound<br>System is intended for diagnostic<br>ultrasound imaging in B (2D), Color<br>Doppler, Combined (B+Color), and M<br>modes. It is indicated for diagnostic<br>ultrasound imaging and fluid flow<br>analysis in the following applications:<br>Fetal/Obstetric, Abdominal, Pediatric,<br>Cephalic, Urology, Gynecological,<br>Cardiac Fetal Echo, Small Organ,<br>Musculoskeletal, Peripheral Vessel,<br>Carotid, Cardiac. Lumify is a<br>transportable ultrasound system<br>intended for use in environments where<br>healthcare is provided by healthcare<br>professionals. | Philips Lumify Diagnostic Ultrasound<br>System is intended for diagnostic<br>ultrasound imaging in B (2D), Color<br>Doppler, Combined (B+Color), and M<br>modes. It is indicated for diagnostic<br>ultrasound imaging and fluid flow<br>analysis in the following applications:<br>Fetal/Obstetric, Abdominal, Pediatric,<br>Cephalic, Urology, Gynecological,<br>Cardiac Fetal Echo, Small Organ,<br>Musculoskeletal, Peripheral Vessel,<br>Carotid, Cardiac. Lumify is a<br>transportable ultrasound system<br>intended for use in environments where<br>healthcare is provided by healthcare<br>professionals. | Identical |
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| Scientific<br>Technology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operating<br>principles | Compatible device generates electrical<br>current and sends to a connected,<br>compatible transducer to stimulate its<br>piezoelectric elements at the distal end. | Compatible device generates electrical<br>current and sends to a connected,<br>compatible transducer to stimulate its<br>piezoelectric elements at the distal end. | Identical |
| Standard Feature | Philips Lumify Ultrasound System<br>K# Pending<br>(Subject Device) | Philips Lumify Diagnostic<br>Ultrasound System<br>K192226<br>(Predicate Device) | Comparison |
| | Stimulation causes the elements to<br>expand and contract which creates a<br>high-pressured wave (i.e., soundwave). A<br>series of soundwaves then propagate<br>toward tissue medium (e.g., mucus<br>membrane, bone). The transducer then<br>receives echoed soundwaves that are<br>reflected from the tissue medium and<br>transmits it to the system. The system<br>processes the echoed soundwaves into<br>an image which is displayed on the<br>display monitor screen of the system for<br>user interpretation. | Stimulation causes the elements to<br>expand and contract which creates a<br>high-pressured wave (i.e., soundwave). A<br>series of soundwaves then propagate<br>toward tissue medium (e.g., mucus<br>membrane, bone). The transducer then<br>receives echoed soundwaves that are<br>reflected from the tissue medium and<br>transmits it to the system. The system<br>processes the echoed soundwaves into<br>an image which is displayed on the<br>display monitor screen of the system for<br>user interpretation. | |
| Type of Previously-<br>cleared<br>Transducers | Curved Array<br>Linear Array<br>Sector Array | Curved Array<br>Linear Array<br>Sector Array | Identical |
| Acoustic Outputs<br>Within Range? | Yes | Yes | Identical |
| Previously cleared<br>Imaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |

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# Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices

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Page 8 of 19

Table 2: Technological Comparison of Subject Device (i.e., Philips EPIQ Diagnostic Ultrasound System Series) & Predicate Device

| Standard Feature | Philips EPIQ Diagnostic Ultrasound<br>System Series<br>K# Pending | Philips EPIQ Diagnostic Ultrasound<br>System Series<br>K182857 | Comparison |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | (Subject Device) | (Predicate Device) | |
| Indications for Use | The intended use of the EPIQ, EPIQ 5,<br>EPIQ 7 Diagnostic Ultrasound Systems<br>is diagnostic ultrasound imaging and<br>fluid flow analysis of the human body<br>with the following Indications for Use:<br>Abdominal, Cardiac Adult, Cardiac other<br>(Fetal), Cardiac Pediatric, Cerebral<br>Vascular, Cephalic (Adult), Cephalic<br>(Neonatal), Fetal/Obstetric,<br>Gynecological, Intraoperative (Vascular),<br>Intraoperative (Cardiac), Musculoskeletal<br>(Conventional), Musculoskeletal<br>(Superficial), Other: Urology, Pediatric,<br>Peripheral Vessel, Small Organ (Breast,<br>Thyroid, Testicle), Transesophageal<br>(Cardiac), Transrectal, Transvaginal.<br>The clinical environments where the<br>EPIQ Diagnostic Ultrasound Systems<br>can be used include Clinics, Hospitals,<br>and clinical point-of-care for diagnosis of<br>patients.<br>When integrated with Philips<br>EchoNavigator, the systems can assist<br>the interventionalist and surgeon with<br>image guidance during treatment of | The intended use of the EPIQ, EPIQ 5,<br>EPIQ 7 Diagnostic Ultrasound Systems<br>is diagnostic ultrasound imaging and<br>fluid flow analysis of the human body<br>with the following Indications for Use:<br>Abdominal, Cardiac Adult, Cardiac other<br>(Fetal), Cardiac Pediatric, Cerebral<br>Vascular, Cephalic (Adult), Cephalic<br>(Neonatal), Fetal/Obstetric,<br>Gynecological, Intraoperative (Vascular),<br>Intraoperative (Cardiac), Musculoskeletal<br>(Conventional), Musculoskeletal<br>(Superficial), Other: Urology, Pediatric,<br>Peripheral Vessel, Small Organ (Breast,<br>Thyroid, Testicle), Transesophageal<br>(Cardiac), Transrectal, Transvaginal.<br>The clinical environments where the<br>EPIQ Diagnostic Ultrasound Systems<br>can be used include Clinics, Hospitals,<br>and clinical point-of-care for diagnosis of<br>patients.<br>When integrated with Philips<br>EchoNavigator, the systems can assist<br>the interventionalist and surgeon with<br>image guidance during treatment of | Identical |
| Standard Feature | Philips EPIQ Diagnostic Ultrasound<br>System Series<br>K# Pending<br>(Subject Device) | Philips EPIQ Diagnostic Ultrasound<br>System Series<br>K182857<br>(Predicate Device) | Comparison |
| | cardiovascular disease in which the<br>procedure uses both live X-ray and live<br>Echo Guidance.<br>The systems are intended to be installed,<br>used, and operated only in accordance<br>with the safety procedures and operating<br>instructions given in the product user<br>information, and only for the purposes<br>for which it was designed. However,<br>nothing stated in the user information<br>reduces your responsibility for sound<br>clinical judgement and best clinical<br>procedure. | cardiovascular disease in which the<br>procedure uses both live X-ray and live<br>Echo Guidance.<br>The systems are intended to be installed,<br>used, and operated only in accordance<br>with the safety procedures and operating<br>instructions given in the product user<br>information, and only for the purposes<br>for which it was designed. However,<br>nothing stated in the user information<br>reduces your responsibility for sound<br>clinical judgement and best clinical<br>procedure. | |
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| Scientific<br>Technology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operating<br>principles | System console generates electrical<br>current and sends to a connected,<br>compatible transducer to stimulate its<br>piezoelectric elements at the distal end.<br>Stimulation causes the elements to<br>expand and contract which creates a<br>high-pressured wave (i.e., soundwave). A<br>series of soundwaves then propagate<br>toward tissue medium (e.g., mucus<br>membrane, bone). The transducer then<br>receives echoed soundwaves that are | System console generates electrical<br>current and sends to a connected,<br>compatible transducer to stimulate its<br>piezoelectric elements at the distal end.<br>Stimulation causes the elements to<br>expand and contract which creates a<br>high-pressured wave (i.e., soundwave). A<br>series of soundwaves then propagate<br>toward tissue medium (e.g., mucus<br>membrane, bone). The transducer then<br>receives echoed soundwaves that are | Identical |
| Standard Feature | Philips EPIQ Diagnostic Ultrasound<br>System Series<br>K# Pending<br>(Subject Device) | Philips EPIQ Diagnostic Ultrasound<br>System Series<br>K182857<br>(Predicate Device)…