(27 days)
No
The document does not mention AI, ML, or any related terms in the description of the device's functionality or features. The focus is on standard ultrasound imaging and processing.
No
The intended use statement explicitly states the device is for "diagnostic ultrasound imaging and fluid flow analysis." While it can assist in image guidance during treatment, its primary function is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states "The intended use of Philips EPIQ series diagnostic ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body". The "Device Description" also refers to them as "Philips EPIQ Diagnostic Ultrasound Systems".
No
The device description explicitly states that the system is manufactured with hardware components, including a primary console and compatible ultrasound transducers and catheters. While it is software-controlled, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid flow analysis of the human body." This involves imaging the internal structures of the body using ultrasound waves.
- Device Description: The description details a system with a console, software, and ultrasound transducers/catheters. These are components used for generating and receiving ultrasound waves and processing them into images.
- Mechanism of Action: The system processes "echoed soundwaves into an image." This is the fundamental principle of ultrasound imaging, which is a non-invasive imaging modality.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on biological specimens.
The device is a diagnostic imaging system that uses ultrasound to visualize internal anatomy and fluid flow in vivo (within the body). This falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for 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-luminal, 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 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, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, OBJ
Device Description
Philips EPIQ Diagnostic Ultrasound Systems are durable capital equipment / medical devices which are software-controlled and 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.
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 EPIQ Diagnostic Ultrasound Systems and may vary among model configurations.
The systems are manufactured with hardware components which consist of:
- a primary console (e.g., workstation, tablet) with built-in software components, features, and various 1) clinical applications, and
-
- a range of compatible ultrasound transducers and ultrasound intravascular catheters.
A suite of reusable compatible transducer types are offered such as transesophageal echocardiography (TEE) transducers, non-imaging (pencil) probes, curved array and sector/phased array. Philips ultrasound 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. Philips EPIQ Diagnostic Ultrasound Systems are also compatible with single-use diagnostic intravascular ultrasound catheters (i.e., Philips VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro Intracardiac Echocardiography (ICE) Catheter) that are intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart for image guidance during cardiac interventional procedures.
Some configurations may have additional previously-cleared accessories, components and software features which are manufactured by Philips Ultrasound, Inc. or other manufacturers.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound Imaging
Anatomical Site
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), Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals at various settings of patient care such as clinical admission, periodic evaluations, prior to hospitalization discharge, and/or academic research. Clinical environments include clinics, hospitals, and clinical point-of-care for diagnosis of patients. Interventionalist and surgeon for image guidance during treatment of cardiovascular disease.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Relevant non-clinical verification testing and compatibility information has been performed and included in this submission to address system level requirements according to system and design specifications, and risk control measures. The proposed Philips EPIQ Diagnostic Ultrasound Systems did not require clinical data for determination of substantial equivalence.
Philips Ultrasound, Inc. performed the following testing to ensure the safety and effectiveness of the proposed Philips EPIQ Series Diagnostic Ultrasound Systems with the VeriSight ICE / PRO ICE catheters:
- ANSI/AAMI 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012,
- IEC 60601-1-2 Medical Electrical Equipment - Part 1-2, General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic Compatibility, 2014,
- IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2015.
For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed subject Philips EPIQ Series Diagnostic Ultrasound Systems with VeriSight ICE / PRO ICE Catheters meet their intended use. The results of the relevant performance data and compatibility support a determination that the proposed subject device does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
September 2, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Ultrasound, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114
Re: K202216
Trade/Device Name: EPIQ Series Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OBJ Dated: August 5, 2020 Received: August 6, 2020
Dear Prithul Bom:
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
1
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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202216
Device Name EPIQ Series Diagnostic Ultrasound Systems
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-luminal, 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 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, and only for the purposes for which it was 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."
3
510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. Date Prepared: August 31, 2020
I. Submitter
| Manufacturer Name
and Address | Philips Ultrasound, Inc.
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact
Information | Colin S. Jacob
Senior Regulatory Affairs Specialist
TEL: 425.908.1209
EMAIL: colin.jacob@philips.com |
II. Device
| Trade Name | EPIQ Series Diagnostic Ultrasound Systems |
|---|---|
| Common Name | Diagnostic ultrasound system and transducers |
| Regulation Description | Ultrasonic pulsed doppler imaging system |
| Ultrasonic pulsed echo imaging system | |
| Diagnostic ultrasonic transducer | |
| Diagnostic intravascular catheter | |
| Regulation Number | 892.1550 |
| 892.1560 | |
| 892.1570 | |
| 870.1200 | |
| Primary Product Code | IYN |
| Secondary Product Codes | IYO |
| ITX | |
| OBJ | |
| Device Class | Class II |
| Classification Panel | Radiology |
4
Predicate Device III.
- K200304 - Philips EPIQ Series Diagnostic Ultrasound Systems
IV. Device Description
Philips EPIQ Diagnostic Ultrasound Systems are durable capital equipment / medical devices which are software-controlled and 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.
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 EPIQ Diagnostic Ultrasound Systems and may vary among model configurations.
The systems are manufactured with hardware components which consist of:
- a primary console (e.g., workstation, tablet) with built-in software components, features, and various 1) clinical applications, and
-
- a range of compatible ultrasound transducers and ultrasound intravascular catheters.
A suite of reusable compatible transducer types are offered such as transesophageal echocardiography (TEE) transducers, non-imaging (pencil) probes, curved array and sector/phased array. Philips ultrasound 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. Philips EPIQ Diagnostic Ultrasound Systems are also compatible with single-use diagnostic intravascular ultrasound catheters (i.e., Philips VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro Intracardiac Echocardiography (ICE) Catheter) that are intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart for image guidance during cardiac interventional procedures.
Some configurations may have additional previously-cleared accessories, components and software features which are manufactured by Philips Ultrasound, Inc. or other manufacturers.
Image /page/4/Picture/14 description: The image shows the Philips logo. The logo is a blue shield with the word "PHILIPS" at the top. Inside the shield, there are wavy lines and four stars. The logo is simple and recognizable.
5
V. Indications for Use
| Device | Indications for Use |
|---|---|
| Philips EPIQ | |
| Diagnostic | |
| Ultrasound | |
| System | 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, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.
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, and only for the purposes for which it was designed.
However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best
clinical procedure. |
6
Comparison of Technological Characteristics between Proposed Subject Device and Predicate Device VI.
| Standard Feature | Philips EPIQ Series Diagnostic
Ultrasound Systems
K202216
(Subject Device) | Philips EPIQ Series Diagnostic
Ultrasound Systems
K200304
(Predicate Device) | Comparison |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | 892.1550 | 892.1550 | Same |
| Device
Classification
Name | System, Imaging, Pulsed Doppler,
Ultrasonic | System, Imaging, Pulsed Doppler,
Ultrasonic | Same |
| Product Code | IYN | IYN | Same |
| Secondary Product
Code | IYO, ITX, OBJ | IYO, ITX | Subject of submission |
| Indications for 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, | 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 Echo), Cardiac Pediatric, Cerebral
Vascular, Cephalic (Adult), Cephalic
(Neonatal), Fetal/Obstetric,
Gynecological, Intraoperative (Vascular),
Intraoperative (Cardiac), Musculoskeletal
(Conventional), Musculoskeletal
(Superficial), Other: Urology, Pediatric, | Subject of submission
Indications for use of
EPIQ is being updated to
include "Intra-cardiac
echo, Intra-luminial" to
reflect compatibility with
ultrasound intravascular
catheters (K200812) |
| Standard Feature | Philips EPIQ Series Diagnostic
Ultrasound Systems
K202216
(Subject Device) | Philips EPIQ Series Diagnostic
Ultrasound Systems
K200304
(Predicate Device) | Comparison |
| | Thyroid, Testicle), Transesophageal | Thyroid, Testicle), Transesophageal | |
| | (Cardiac), Transrectal, Transvaginal. | (Cardiac), Transrectal, Transvaginal. | |
| | The clinical environments where Philips
EPIQ diagnostic ultrasound systems can
be used include clinics, hospitals, and
clinical point-of-care for diagnosis of
patients. | 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. | 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 | 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, | for which it was designed. However, | |
| | nothing stated in the user information | nothing stated in the user information | |
| | reduces your responsibility for sound | reduces your responsibility for sound | |
| Standard Feature | Philips EPIQ Series Diagnostic
Ultrasound Systems
K202216
(Subject Device) | Philips EPIQ Series Diagnostic
Ultrasound Systems
K200304
(Predicate Device) | Comparison |
| | clinical judgement and best clinical
procedure. | clinical judgement and best clinical
procedure. | |
| Reusable? | Yes | Yes | Same |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Same |
| Scientific
Technology | Ultrasound Imaging | Ultrasound Imaging | Same |
| Principles of
Operation | System console generates electrical
current and sends to a connected,
compatible transducer to stimulate its
piezoelectric elements at the distal end.
Stimulation causes the elements to
expand and contract which creates a
high-pressured wave (i.e., soundwave). A
series of soundwaves then propagate
toward tissue medium (e.g., mucus
membrane, bone). The transducer then
receives echoed soundwaves that are
reflected from the tissue medium and
transmits it to the system. The system
processes the echoed soundwaves into
an image which is displayed on the
display monitor screen of the system for
user interpretation. | System console generates electrical
current and sends to a connected,
compatible transducer to stimulate its
piezoelectric elements at the distal end.
Stimulation causes the elements to
expand and contract which creates a
high-pressured wave (i.e., soundwave). A
series of soundwaves then propagate
toward tissue medium (e.g., mucus
membrane, bone). The transducer then
receives echoed soundwaves that are
reflected from the tissue medium and
transmits it to the system. The system
processes the echoed soundwaves into
an image which is displayed on the
display monitor screen of the system for
user interpretation. | Same |
| Type of
Compatible
Components | TEE Probes
Non-imaging (pencil) probes
Curved Array Transducers | TEE Probes
Non-imaging (pencil) probes
Curved Array Transducers | Subject of submission |
| Standard Feature | Philips EPIQ Series Diagnostic
Ultrasound Systems
K202216
(Subject Device) | Philips EPIQ Series Diagnostic
Ultrasound Systems
K200304
(Predicate Device) | Comparison |
| | Linear Array Transducers
Sector Array Transducers
Ultrasound Intravascular Catheters* | Linear Array Transducers
Sector Array Transducers | |
| Acoustic Outputs
Within Range? | Yes | Yes | Same |
| Previously cleared
Imaging Modes? | Yes | Yes | Same |
7
w / VeriSight ICE / Pro ICE Catheters
Page 5 of 8
8
w/ VeriSight ICE / Pro ICE Catheters
Page 6 of 8
9
Image /page/9/Picture/0 description: The image shows the Philips logo on the left side of the image. To the right of the logo is the text "TRADITIONAL 510(k) EPIQ Series Diagnostic Ultrasound Systems w/ VeriSight ICE / Pro ICE Catheters". On the right side of the image is the text "Page 7 of 8".
*Compatible ultrasound intravascular catheter in K200812.
10
VII. Performance Data
Relevant non-clinical verification testing and compatibility information has been performed and included in this submission to address system level requirements according to system and design specifications, and risk control measures. The proposed Philips EPIQ Diagnostic Ultrasound Systems did not require clinical data for determination of substantial equivalence.
The proposed Philips EPIQ Series Diagnostic Ultrasound Systems with the VeriSight ICE / PRO ICE Catheters is an electronic product as defined by 21 CFR Subject Chapter J regulations, and is Track 3 Device and complies with the referenced standard as the FDA ultrasound guidance document, Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued on June 27, 2019.
Philips Ultrasound, Inc. performed the following testing to ensure the safety and effectiveness of the proposed Philips EPIQ Series Diagnostic Ultrasound Systems with the VeriSight ICE / PRO ICE catheters:
- 트 ANSI/AAMI 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012,
- I IEC 60601-1-2 Medical Electrical Equipment - Part 1-2, General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic Compatibility, 2014,
- IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2015.
VIII. Conclusion
For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed subject Philips EPIQ Series Diagnostic Ultrasound Systems with VeriSight ICE / PRO ICE Catheters meet their intended use. The results of the relevant performance data and compatibility support a determination that the proposed subject device does not rasse new questions of safety or effectiveness and is substantially equivalent to the predicate device.