(14 days)
K192226 Philips Lumify Diagnostic Ultrasound System, K182857 Philips EPIQ Diagnostic Ultrasound System, K182857 - Philips Affiniti Diagnostic Ultrasound System, K162329 Philips CX50 Diagnostic Ultrasound System, K162329 - Philips Sparq Diagnostic Ultrasound System, K191647 - QLAB Advanced Quantification Software
Not Found
No
The document describes standard ultrasound imaging and quantification software. There is no mention of AI or ML in the intended use, device description, or any other section.
No.
The device is described as a "diagnostic ultrasound imaging and fluid flow analysis" system, intended for diagnosis rather than treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems are "diagnostic ultrasound imaging and fluid flow analysis" devices and are used for "diagnosis of patients." The device description also refers to them as "Diagnostic Ultrasound Systems."
No
The device description explicitly states that the Philips Diagnostic Ultrasound Systems are "durable, reusable capital equipment medical devices" and 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." This indicates the device includes significant hardware components beyond just software. While QLAB is described as a software package, it is designed to view and quantify data from these hardware ultrasound systems and can be on-board the systems or a standalone product, not the primary device being described.
Based on the provided text, the described devices (Philips Affiniti, CX50, EPIQ, Lumify, and Sparq Diagnostic Ultrasound Systems, and QLAB Advanced Quantification Software) are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Description: The text clearly describes these devices as diagnostic ultrasound systems. Ultrasound imaging works by sending sound waves into the body and interpreting the echoes to create images of internal structures and fluid flow. This is an in vivo (within the living body) diagnostic method.
- Intended Use/Indications for Use: The intended uses listed are all related to imaging and fluid flow analysis within the human body for various anatomical sites and clinical applications. There is no mention of analyzing specimens taken from the body.
- Device Description: The description focuses on hardware components like consoles, transducers, and software for image processing and quantification of acquired image data, not analysis of biological samples.
Therefore, these devices fall under the category of medical imaging devices rather than In Vitro Diagnostic devices.
N/A
Intended Use / Indications for 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.
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)
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.
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.
QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.
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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, QIH
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 various clinical applications, and
- 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/phased 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 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 healthcare-associated infections.
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, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urology, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Ophthalmic, Intraoperative, Laparoscopic, Intracardiac echo, Carotid.
Indicated Patient Age Range
Adult, Pediatric, Fetal, Neonatal
Intended User / Care Setting
Trained professionals, healthcare professionals, Clinics, Hospitals, and clinical point-of-care.
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 performance data does not apply to this submission. Design control measures are described within submission support a decision of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K192226 Philips Lumify Diagnostic Ultrasound System, K182857 Philips EPIQ Diagnostic Ultrasound System, K182857 - Philips Affiniti Diagnostic Ultrasound System, K162329 Philips CX50 Diagnostic Ultrasound System, K162329 - Philips Sparq Diagnostic Ultrasound System, K191647 - QLAB Advanced Quantification Software
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
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
1
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 (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
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) | |
|---|---|
| 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
3
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 PRAStaff@fda.hhs.gov
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) | |
|---|---|
| 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
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)
| ☑ 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
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)
| Prescription Use (Part 21 CFR 201. Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201. Subpart C) |
| 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 PRAStaff@fda.hhs.gov
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) |
|---|
| ------------------------------------------------- |
| ☒ 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
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 | |
| and Address | Philips Ultrasound, Inc. |
| 22100 Bothell Everett Hwy | |
| Bothell, WA 98021-8431 | |
| Contact | |
| Information | Deep Pal |
| Head of Regulatory Affairs | |
| TEL: +1 (425) 219-3412 | |
| EMAIL: deep.pal@philips.com | |
| Secondary Contact | |
| Information | Benny Lam |
| Principal Regulatory Affairs Specialist | |
| TEL: +1 (425)-215-3496 | |
| EMAIL: benny.lam@philips.com | |
| II. Device | |
| Trade Name | Philips Lumify Diagnostic Ultrasound System |
| Philips EPIQ Diagnostic Ultrasound System Series | |
| Philips Affiniti Diagnostic Ultrasound System Series | |
| Philips CX50 Diagnostic Ultrasound System | |
| Philips Sparq Diagnostic Ultrasound System | |
| Philips QLAB Advanced Quantification Software | |
| Common Name | Diagnostic ultrasound system and transducers |
| Automated Radiological Image Processing Software | |
| Regulation Description | Ultrasonic pulsed doppler imaging system |
| Ultrasonic pulsed echo imaging system | |
| Diagnostic ultrasonic transducer | |
| Picture archiving and communications system | |
| Regulation Number | 892.1550 |
| 892.1560 | |
| 892.1570 | |
| 892.2050 | |
| Product Code | IYN |
| Secondary Product Codes | IYO |
9
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
-
- 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
10
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.
11
| Device | Indications for Use |
|---|---|
| Philips Lumify | |
| Diagnostic | |
| Ultrasound | |
| System | 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. | |
| Philips EPIQ | |
| Diagnostic | |
| Ultrasound | |
| System | The intended use of the EPIQ, EPIQ 5, EPIQ 7 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 (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 judgement and best clinical procedure. | |
| Philips Affiniti | |
| Diagnostic | |
| Ultrasound | |
| System | The intended use of the Affiniti 30, Affiniti 50 and 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 (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 Affiniti 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. | |
| Device | Indications for Use |
| Philips CX50 | |
| Diagnostic | |
| Ultrasound | |
| System | 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 | |
| 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 Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid) | |
| Philips Sparq | |
| Diagnostic | |
| Ultrasound | |
| System | 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 | |
| QLAB | |
| Advanced | |
| Quantification | |
| software | QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data |
| acquired on Philips ultrasound systems. |
12
13
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
K# Pending
(Subject Device) | Philips Lumify Diagnostic
Ultrasound System
K192226
(Predicate Device) | Comparison |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use | Philips Lumify Diagnostic Ultrasound
System is intended for diagnostic
ultrasound imaging in B (2D), Color
Doppler, Combined (B+Color), and M
modes. It is indicated for diagnostic
ultrasound imaging and fluid flow
analysis in the following applications:
Fetal/Obstetric, Abdominal, Pediatric,
Cephalic, Urology, Gynecological,
Cardiac Fetal Echo, Small Organ,
Musculoskeletal, Peripheral Vessel,
Carotid, Cardiac. Lumify is a
transportable ultrasound system
intended for use in environments where
healthcare is provided by healthcare
professionals. | Philips Lumify Diagnostic Ultrasound
System is intended for diagnostic
ultrasound imaging in B (2D), Color
Doppler, Combined (B+Color), and M
modes. It is indicated for diagnostic
ultrasound imaging and fluid flow
analysis in the following applications:
Fetal/Obstetric, Abdominal, Pediatric,
Cephalic, Urology, Gynecological,
Cardiac Fetal Echo, Small Organ,
Musculoskeletal, Peripheral Vessel,
Carotid, Cardiac. Lumify is a
transportable ultrasound system
intended for use in environments where
healthcare is provided by healthcare
professionals. | Identical |
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| Scientific
Technology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operating
principles | Compatible device generates electrical
current and sends to a connected,
compatible transducer to stimulate its
piezoelectric elements at the distal end. | Compatible device generates electrical
current and sends to a connected,
compatible transducer to stimulate its
piezoelectric elements at the distal end. | Identical |
| Standard Feature | Philips Lumify Ultrasound System
K# Pending
(Subject Device) | Philips Lumify Diagnostic
Ultrasound System
K192226
(Predicate Device) | Comparison |
| | 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. | 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. | |
| Type of Previously-
cleared
Transducers | Curved Array
Linear Array
Sector Array | Curved Array
Linear Array
Sector Array | Identical |
| Acoustic Outputs
Within Range? | Yes | Yes | Identical |
| Previously cleared
Imaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |
14
Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices
Page 7 of 19
15
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
System Series
K# Pending | Philips EPIQ Diagnostic Ultrasound
System Series
K182857 | Comparison |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | (Subject Device) | (Predicate Device) | |
| Indications for Use | The intended use of the EPIQ, EPIQ 5,
EPIQ 7 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
(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 | The intended use of the EPIQ, EPIQ 5,
EPIQ 7 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
(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 | Identical |
| Standard Feature | Philips EPIQ Diagnostic Ultrasound
System Series
K# Pending
(Subject Device) | Philips EPIQ Diagnostic Ultrasound
System Series
K182857
(Predicate Device) | Comparison |
| | 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. | 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. | |
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| Scientific
Technology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operating
principles | 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 | 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 | Identical |
| Standard Feature | Philips EPIQ Diagnostic Ultrasound
System Series
K# Pending
(Subject Device) | Philips EPIQ Diagnostic Ultrasound
System Series
K182857
(Predicate Device) | Comparison |
| | 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. | 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. | |
| Type of Previously-
cleared
Transducers | Curved Array
Linear Array
Sector Array | Curved Array
Linear Array
Sector Array | Identical |
| Acoustic Outputs
Within Range? | Yes | Yes | Identical |
| Previously cleared
Imaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |
| Standard Feature | Philips Affiniti Diagnostic
Ultrasound System Series
K# Pending
(Subject Device) | Philips Affiniti Diagnostic
Ultrasound System Series
K182857
(Predicate Device) | Comparison |
| Indications for Use | The intended use of the Affiniti 30,
Affiniti 50 and 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 (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
Affiniti 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 | The intended use of the Affiniti 30,
Affiniti 50 and 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 (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
Affiniti 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 | Identical |
| Standard Feature | Philips Affiniti Diagnostic
Ultrasound System Series
K# Pending
(Subject Device) | Philips Affiniti Diagnostic
Ultrasound System Series
K182857
(Predicate Device) | Comparison |
| | 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. | 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. | |
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| Scientific
Technology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operating
principles | 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 | 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 | Identical |
| Standard Feature | Philips Affiniti Diagnostic
Ultrasound System Series
K# Pending
(Subject Device) | Philips Affiniti Diagnostic
Ultrasound System Series
K182857
(Predicate Device) | Comparison |
| | 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. | 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. | |
| Type of Previously-
cleared
Transducers | Curved Array
Linear Array
Sector Array | Curved Array
Linear Array
Sector Array | Identical |
| Acoustic Outputs
Within Range? | Yes | Yes | Identical |
| Previously cleared
Imaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |
| Standard Feature | Philips CX50 Diagnostic Ultrasound
System
K# Pending | Philips CX50 Diagnostic Ultrasound
System
K162329 | Comparison |
| | (Subject Device) | (Predicate Device) | |
| Indications for Use | 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 Adult Cardiac Pediatric Trans-
Esoph. (Cardiac) Intracardiac echo
Peripheral Vessel Other (Carotid) | 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 Adult Cardiac Pediatric Trans-
Esoph. (Cardiac) Intracardiac echo
Peripheral Vessel Other (Carotid) | Identical |
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| Scientific
Technology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operating
principles | System console generates electrical
current and sends to a connected,
compatible transducer to stimulate its | System console generates electrical
current and sends to a connected,
compatible transducer to stimulate its | Identical |
| Standard Feature | Philips CX50 Diagnostic Ultrasound
System
K# Pending
(Subject Device) | Philips CX50 Diagnostic Ultrasound
System
K162329
(Predicate Device) | Comparison |
| | 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. | 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. | |
| Type of Previously-
cleared
Transducers | Curved Array
Linear Array
Sector Array | Curved Array
Linear Array
Sector Array | Identical |
| Acoustic Outputs
Within Range? | Yes | Yes | Identical |
| Previously cleared
Imaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |
| Standard Feature | Philips Sparq Diagnostic Ultrasound
System
K# Pending
(Subject Device) | Philips Sparq Diagnostic Ultrasound
System
K162329
(Predicate Device) | Comparison |
| Indications for Use | 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 | 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 | Identical |
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| Scientific
Technology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operating
principles | 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 | 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 | Identical |
| Standard Feature | Philips Sparq Diagnostic Ultrasound
System
K# Pending
(Subject Device) | Philips Sparq Diagnostic Ultrasound
System
K162329
(Predicate Device) | Comparison |
| | 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. | 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. | |
| Type of Previously-
cleared
Transducers | Curved Array
Linear Array
Sector Array | Curved Array
Linear Array
Sector Array | Identical |
| Acoustic Outputs
Within Range? | Yes | Yes | Identical |
| Previously cleared
Imaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |
16
Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices
Page 9 of 19
17
Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices
Page 10 of 19
18
Page 11 of 19
Table 3: Technological Comparison of Subject Device (i.e., Philips Affiniti Diagnostic Ultrasound System Series) & Predicate Device
19
Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices
Page 12 of 19
20
Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices
Page 13 of 19
21
Table 4: Technological Comparison of Subject Device (i.e., Philips CX50 Diagnostic Ultrasound System) & Predicate Device
22
Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices
Page 15 of 19
23
Table 5: Technological Comparison of Subject Device (i.e., Philips Sparq Diagnostic Ultrasound System) & Predicate Device
24
Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices
Page 17 of 19
25
| PHILIPS | SPECIAL 510(K)
Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB
Devices | Page 18 of 19 | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Table 6: Technological Comparison of Subject Device (i.e., QLAB Advanced Quantification Software) & Predicate Device | | |
| Standard Feature | QLAB Advanced Quantification
Software
K# Pending
(Subject Device) | QLAB Advanced Quantification
Software
K191647
(Predicate Device) | Comparison |
| Indications for Use | QLAB Advanced Quantification
Software is a software application
package. It is designed to view and
quantify image data acquired on Philips
ultrasound systems. | QLAB Advanced Quantification
Software is a software application
package. It is designed to view and
quantify image data acquired on Philips
ultrasound systems. | Identical |
| Application
Descriptions | Semiautomatic border detection,
chamber identification, contour
generation, measurement parameters | Semiautomatic border detection,
chamber identification, contour
generation, measurement parameters | Identical |
26
Image /page/26/Picture/0 description: The image contains the word "PHILIPS" in a bold, sans-serif font. The word is written in a bright blue color. The letters are evenly spaced and the overall appearance is clean and professional.
VII. Performance Data
Relevant performance data does not apply to this submission. Design control measures are described within submission support a decision of substantial equivalence.
VIII. Conclusion
There are no changes in software, hardware, and intended uses of the subject devices comparing to the predicates. User labeling for the subject devices has been expanded to include information about lung and cardiac ultrasound imaging, based on established methods or the latest society guidelines, for patients with coronavirus disease 2019 (COVID-19). The results of the design controls activity support a determination that the subject devices do not raise new questions of safety or effectiveness and are substantially equivalent to the predicate devices.
Image /page/26/Picture/7 description: The image shows the Philips logo. The logo consists of a blue circle with a white wave pattern inside. There are also four white stars inside the circle. The Philips logo is a well-known symbol associated with the company's brand.