EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

K211597 · Philips Medical Systems · IYN · Sep 8, 2021 · Radiology

Device Facts

• Record ID: K211597
• Device Name: EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
• Applicant: Philips Medical Systems
• Product Code: IYN · Radiology
• Decision Date: Sep 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

Intended Use

The intended use of Philips EPIQ series 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 (Adult), Cephalic (Neonatal). Fetal/Obstetric. Gynecological. Intra-cardiac Echo. Intra-luminal, Intraoperative (Vascular). Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Transesophageal (Cardiac), Transrectal, Transvaginal, Lung, The clinical environments where Philips 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. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure. The intended use of the Affiniti Series 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 (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, and clinical point-of-care for diagnosis of patients. 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. Systems are to be operated only by appropriately trained healtheare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

Device Story

Philips EPIQ and Affiniti Series are diagnostic ultrasound systems for high-resolution imaging and fluid flow analysis. The Auto Measure feature is a software-only addition using an AI/ML-enabled algorithm to provide semi-automated 2D and Doppler measurements during adult transthoracic echocardiography (TTE) with simultaneous ECG. The system takes ultrasound image data and ECG signals as input; the algorithm processes these to generate semi-automated measurements. The clinician reviews, edits, accepts, or rejects these measurements. Used in hospitals and clinics by trained professionals, the device assists in clinical decision-making by streamlining measurement workflows. Benefits include increased efficiency and consistency in echocardiographic quantification compared to manual methods.

Clinical Evidence

No clinical data. Performance validation was conducted via non-clinical bench testing, including software verification and validation, to confirm the Auto Measure feature meets defined requirements and performance claims.

Technological Characteristics

Capital equipment ultrasound system; 2D and Doppler imaging; AI/ML-enabled software algorithm for semi-automated measurements; integrates with ECG input; mobile form factor with caster wheels; software version 9.0.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients requiring abdominal, cardiac (adult/pediatric/fetal), vascular (cerebral/peripheral), cephalic, obstetric, gynecological, musculoskeletal, urological, small organ, and lung examinations. Used in clinics, hospitals, and point-of-care settings by trained 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

• EPIQ Series Diagnostic Ultrasound System (K202216)
• Affiniti Series Diagnostic Ultrasound System (K201012)

Reference Devices

• QLAB Advanced Quantification System (K200974)

Submission Summary (Full Text)

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September 8, 2021

Image /page/0/Picture/1 description: The image shows 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Philips Medical Systems Tamara Daniels Senior Regulatory Affairs Manager 22100 Bothell Everett Hwy BOTHELL WA 98021

# Re: K211597

Trade/Device Name: EPIO Series Diagnostic Ultrasound System, Affiniti Series 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, OBJ, QIH Dated: August 10, 2021 Received: August 12, 2021

Dear Tamara Daniels:

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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) 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 ([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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

## K211597

### Device Name

EPIO Series Diagnostic Ultrasound System

### Indications for Use (Describe)

The intended use of Philips EPIQ series 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 (Adult), Cephalic (Neonatal). Fetal/Obstetric. Gynecological. Intra-cardiac Echo. Intra-luminal, Intraoperative (Vascular). Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Transesophageal (Cardiac), Transrectal, Transvaginal, Lung,

The clinical environments where Philips 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. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.

However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

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)

## 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."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

# K211597

Device Name

Affiniti Series Diagnostic Ultrasound System

### Indications for Use (Describe)

The intended use of the Affiniti Series 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 (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

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

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. Systems are to be operated only by appropriately trained healtheare professionals for the purposes for which they were 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)

> 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."

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## TRADITIONAL 510(k) Philips EPIQ and Affiniti Ultrasound Systems with Auto Measure

510(k) number: K211597

# 510(k) Summary

This summary of safety and effectiveness information is submitted in accordance with 21 CFR \$807.92

| I. | Submitter | |
|-----|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Manufacturer Name and Address | Philips Ultrasound, Inc.<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 |
| | Contact Information | Tamara Daniels<br>Senior Manager, Regulatory Affairs<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431<br>Phone: [phone]<br>Fax: [phone] |
| | Secondary Contact Information | Anne Rossi<br>Director, Regulatory Affairs<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431<br>Phone: [phone]<br>Fax: [phone] |
| | Date Prepared | August 10, 2021 |
| II. | Device | |
| | Proprietary Name | Philips EPIQ Series Diagnostic Ultrasound System<br>Philips Affiniti Series Diagnostic Ultrasound System |
| | Common Name | Auto Measure<br>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 ultrasound transducer<br>Picture archiving and communications system |
| | Primary Regulation Number<br>and Product Code | 892.1550, IYN |
| | Secondary Regulation Number<br>and Product Codes | 892.1560, IYO<br>892.1570, ITX<br>870.1200, OBJ*<br>892.2050, OIH |

*Applicable only to Philips EPIQ Series Diagnostic Ultrasound System, per clearance under K202216; Not applicable for Philips Affiniti Series Diagnostic Ultrasound System

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## TRADITIONAL 510(k) Philips EPIQ and Affiniti Ultrasound Systems with Auto Measure

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

#### III. Predicate & Reference Devices

Primary Predicate Devices:

- K202216 EPIQ Series Diagnostic Ultrasound System
- K201012 Affiniti Series Diagnostic Ultrasound System ●

Reference Predicate Device:

- K200974 QLAB Advanced Quantification System
#### IV. Device Description

Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems are durable, reusable capital equipment medical devices intended for high-resolution general imaging; interventional radiology, cardiology, vascular, obstetrics, and gynecology 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.

The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto Measure software-only feature for use on the Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The Philips Auto Measure feature provides the end user with semiautomated functionality for a subset of 2D and Doppler measurements currently available on the Philips EPIQ and Affiniti systems when performing or reviewing an adult transthoracic echocardiography (TTE) with simultaneously acquired electrocardiogram (ECG). The AI/MLenabled algorithm is designed to produce semi-automated and editable measures.

The Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems were selected as the primarypredicate for the subject device. This application provides a semi-automated means to perform 2D and Doppler measurements during an echocardiography test. The end user can edit, accept, or reject the measurement(s). On the predicate devices, the end user would perform these measurements manually.

This technology is similar to the cleared QLAB feature (3D Auto MV). The Philips QLAB Advanced Quantification Software System (QLAB) is designed to view and quantify image data acquired on Philips EPIQ and Affiniti Ultrasound Systems. The 3D Auto MV feature is a cardiac quantification application with a machine learning algorithm.

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## TRADITIONAL 510(k) Philips EPIQ and Affiniti Ultrasound Systems with Auto Measure

### V. Indications for Use

| Device | <b>Indications for Use</b> |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Philips EPIQ Series<br>Diagnostic Ultrasound<br>System | The intended use of Philips EPIQ series diagnostic ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of<br>the human body, with the following indications for use: |
| | Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal),<br>Fetal/Obstetric, Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac),<br>Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ<br>(Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. |
| | The clinical environments where Philips EPIQ diagnostic ultrasound systems can be used include clinics, hospitals, and clinical<br>point-of-care for diagnosis of patients. |
| | 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. |
| | 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. Systems are to be operated only by appropriately trained healthcare<br>professionalsfor the purposes for which they were designed. However, nothing stated in the user information reduces your<br>responsibility for sound clinical judgement and best clinical procedure. |
| Philips Affiniti Series<br>Diagnostic Ultrasound<br>System | The intended use of the Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of<br>the human body with the following Indications for Use: |
| | Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal),<br>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, Lung. |
| | 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. |
| | 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. Systems are to be operated only by appropriately trained healthcare<br>professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your<br>responsibility for sound clinical judgment and best clinical procedure. |

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## TRADITIONAL 510(k) Philips EPIQ and Affiniti Ultrasound Systems with Auto Measure

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

The selection of the predicate devices (K202216, K201012) is based on the similarity in indications for use, clinical use scenarios, and principles of operation among devices. The introduction of the Auto Measure feature does not modify the Philips EPIQ and Affiniti Ultrasound System indications.

The Auto Measure feature functionality does not introduce any new transthoracic echo measurements. With a machine learning algorithm, this feature allows the end user the enable semi-automated, editable measurements when performing an adult transthoracic echocardiogram in 2D and Doppler modes. The end user can also disable Auto Measure functionality on the 2D and Doppler measurements. The Auto Measure feature provides the same measurements as the predicate devices.

The selection of the reference device (K200974) is based on the similarity of the functionality and product code QIH (automated radiological image processing software), specifically the most recently cleared feature, 3D Auto MV. Similar to Auto Measure, 3D Auto MV uses machine learning to develop an algorithm that provides the user with semi-automated functionality for various measurements.

#### VII. Performance Data

The proposed introduction of the subject Philips Auto Measure feature was tested in accordance with Philips internal processes. Design Control activities to assure the safe and effective performance of the Auto Measure feature include but are not limited to the following:

- Requirements Review ●
- Risk Analysis and Management ●
- Product Specifications ●
- Design Reviews
- Software Verification and Validation ●

Non-clinical testing also included the Performance Validation Study for the proposed Auto Measure software application.

Software Verification and Validation testing were used to support substantial equivalence of the new Auto Measure feature (as part of the EPIQ / Affiniti System software release version 9.0) to the currently marketed manual measuring options. The software documentation is presented in accordance with the FDA's Guidance for Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005.

#### VIII. Conclusion

Based on adherence to the aforementioned Philips internal processes and the successful verification and validation testing, the proposed Auto Measure software feature is substantially equivalent to the predicate device Philips EPIQ and Affiniti Series Ultrasound Systems. Testing performed demonstrated that the proposed Auto Measure feature meets the defined requirements and performance claims.