(77 days)
K231190; Philips EPIQ Series Diagnostic Ultrasound System
Yes
The device description explicitly states that the Smart Doppler View ID feature uses an "artificial intelligence-based algorithm" and is referred to as an "Artificial Intelligence (Al) based tool".
No
Explanation: The intended use of the device is "diagnostic ultrasound imaging and fluid flow analysis of the human body," indicating it is used for diagnosis, not treatment, making it a diagnostic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "EPIQ Ultrasound Diagnostic System" and "Affiniti Series Diagnostic Ultrasound Systems" (which are the devices in question) are for "diagnostic ultrasound imaging and fluid flow analysis of the human body." It also mentions their use in "diagnosis of patients."
No
The device described is a software feature (Smart Doppler View ID) that is integrated into existing hardware medical devices (EPIQ and Affiniti Series Diagnostic Ultrasound Systems). While the feature itself is software, it is dependent on and operates within the context of the ultrasound hardware, which is not software-only.
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 describes a device that interacts directly with the patient to produce images and analyze physiological processes within the body.
- Mechanism of Action: The device uses ultrasound technology to generate images and analyze fluid flow. This is a non-invasive imaging modality, not a test performed on samples taken from the body.
- Smart Doppler View ID Feature: The new feature enhances the workflow for Doppler measurements by automating the navigation of the ultrasound system's interface. It processes the acquired Doppler spectrum (which is derived from the ultrasound signal interacting with blood flow in vivo) to suggest relevant measurement packages. It does not analyze biological samples.
- No Mention of Samples: The description does not mention the collection or analysis of any biological samples (blood, urine, tissue, etc.), which is a defining characteristic of IVDs.
- Clinical Environment: The clinical environments listed (clinics, hospitals, clinical point-of-care) are typical settings for diagnostic imaging, not exclusively for laboratory testing.
In summary, the device is a diagnostic ultrasound system that performs imaging and analysis in vivo (within the living body). IVDs, on the other hand, are used to examine specimens derived from the human body in vitro (outside the living body).
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
EPIQ:
The intended use of EPIQ Ultrasound Diagnostic System 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), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal, Lung.
The clinical environments where EPIQ Series 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 quidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Affiniti:
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, OBJ, QIH
Device Description
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Smart Doppler View ID software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems.
The purpose of the Smart Doppler View ID feature is to enhance the user's workflow through providing automation of the navigation of the touch screen groups on the Ultrasound System associated with Dopler Measurements. Without the Smart Doppler View ID feature, users must manually navigate to the desired Doppler Calculation Package Group on the Ultrasound System's various screens to perform a measurement. The Smart Doppler View ID feature automates this navigation and selects the associated calculation package group for the user based on the provided Doppler Spectrum acquired by the user using an artificial intelligence-based algorithm.
Smart Doppler View ID maps to six Doppler Calculations Package groups on the Ultrasound System screen:
- Aortic Valve
- Mitral Valve
- Tricuspid Valve
- Pulmonic Valve
- Venous Flow
- TDI Vel (Tissue Doppler Imaging Velocity) & Ratio
No hardware changes to the EPIQ or Affiniti systems are required when using the Smart Doppler View ID feature, and existing, commercialized Philips transducers are used for the Smart Doppler View ID feature.
The feature is supported by all EPIQ and Affiniti models running software version 11.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ 7, EPIQ 5, Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The Smart Doppler View ID feature is associated with the cardiac adult indication.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Mentions AI: "The Smart Doppler View ID feature automates this navigation and selects the associated calculation package group for the user based on the provided Doppler Spectrum acquired by the user using an artificial intelligence-based algorithm." "The Smart Doppler View ID algorithm is an Artificial Intelligence (Al) based tool that automates the navigation of the touch screen groups on the Ultrasound System associated with Doppler Measurements."
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Indicated Patient Age Range
Adult (Cardiac Adult), F18.4, 98.7 (range from study)
Intended User / Care Setting
Intended Users: appropriately trained healthcare professionals, interventionalist and surgeon (when integrated with Philips EchoNavigator), Board certified cardiologists and cardiac sonographers.
Care Setting: clinics, hospitals, and clinical point-of-care.
Description of the training set, sample size, data source, and annotation protocol
The clinical performance study [data] were completely distinct from that used during training of the algorithm, and there was no overlap between the two data sets.
Description of the test set, sample size, data source, and annotation protocol
A study was conducted to evaluate the performance of the new algorithm, where 1100 previously collected TTE (transthoracic echo) cardiac clips acquired with doppler mode from 400 subject videos were processed through the Smart Doppler View ID algorithm and its output (touch screens) compared to Standard of Care obtained group of measurements (touch screens). The Standard of Care measurements are those measurements recommended by the American Society of Echocardiography (ASE) guidelines for routine TTE cardiac exams.
The primary endpoint was accuracy between Smart Doppler View ID and ground truth. The Ground truth for the study was based on a group of measurements performed by intended users (i.e., Board certified cardiologists and cardiac sonographers) of the Ultrasound Systems as part of Standard of Care TTE exam per ASE guidelines at a large US-based hospital. The Ground truth (touch screen) was determined on a set of measurements performed on acquired Doppler waveforms and mapped to touch screens (i.e., a Power Doppler Waveform acquired to measure the mitral valve inflow is mapped to the Mitral Valve Touch Screen group). All of the Doppler TTE clips included in the ground truthing were acquired by the 16 cardiac sonographers with a high level of expertise, and all these studies have been vetted and interpreted by Board certified cardiologists that have successfully passed the National Board of Echocardiography Examination. Accuracy was evaluated by comparing the ground truth touch screens and Smart Doppler View ID auto-detected touch screen for the same TTE clips as outputted by the algorithm.
Subjects from whom the study data were sampled had presented to a USA-based hospital and underwent routine TTE adult cardiac exam. Overall. 400 subjects contributed 1100 clips evaluated in this study. The touchscreen distribution in the study closely resembled the anticipated clinical distribution based on typical measurements performed as part of standard of care TTE cardiac assessment exams as recommended by the American Society of Echocardiography (ASE) guidelines. Moreover, subjects whose clips contributed to the study represented a broad range of demographics and body habitus, representative of the intended population.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Performance evaluation of the Smart Doppler View ID algorithm, which is an Artificial Intelligence (AI) based tool.
Sample Size: 1100 previously collected TTE cardiac clips from 400 subjects.
Standalone Performance: Not explicitly stated, but the algorithm's accuracy was evaluated against ground truth.
Key Results: The results of the primary endpoint analysis demonstrated algorithm accuracy of 97.5% (95%CI 96.3%, 98.3%), p-value
§ 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
February 13, 2024
Image /page/0/Picture/1 description: The image shows the logo for 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 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 LLC Michael Chambers Sr. Regulatory Affairs Specialist 22100 Bothell Everett Hwy BOTHELL WA 98021
Re: K233788
Trade/Device Name: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, OBJ, QIH Dated: November 17, 2023 Received: November 28, 2023
Dear Michael Chambers:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Indications for Use (Describe)
EPIQ:
The intended use of EPIQ Ultrasound Diagnostic System 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), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal, Lung.
The clinical environments where EPIQ Series 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 quidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Affiniti:
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be
3
operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
PHIL
l. 510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.
510(k) Number: K233788
Date Prepared: February 13, 2024
II. Submitter
| Manufacturer Name and
Address | Philips Ultrasound LLC
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 USA |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information | Mike Chambers
Senior Regulatory Affairs Specialist
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 USA
+1 (315) 262-7702 |
| Secondary Contact | Tamara Daniels
Senior Regulatory Affairs Manager
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 USA
+1 (203) 213-6862 |
lll. Device
| Proprietary Name | EPIQ Series Diagnostic Ultrasound System
Affiniti Series Diagnostic Ultrasound System | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|--------------|
| Common Name | Diagnostic Ultrasound System and Transducers | | |
| Regulation Description | Classification Description | 21 CFR § | Product Code |
| | Primary | | |
| | System, imaging, pulsed doppler,
ultrasonic | 892.1550 | IYN |
| | Secondary | | |
| | System, imaging, pulsed echo,
ultrasonic | 892.1560 | IYO |
| | Transducer, ultrasonic, diagnostic | 892.1570 | ITX |
| | Automated Radiological Image
Processing Software | 892.2050 | QIH |
| | Diagnostic Intravascular Catheter | 870.1200 | OBJ* |
| | *Applicable only to Philips EPIQ Series Diagnostic Ultrasound System, per clearance
under K202216; Not applicable for Philips Affiniti Series Diagnostic Ultrasound System | | |
| Device Class | Class II | | |
| Review Panel | Radiology | | |
| Predicate Device | K211597; Philips EPIQ Series Diagnostic Ultrasound System
K211597; Philips Affiniti Series Diagnostic Ultrasound System | | |
| Reference Device | K231190; Philips EPIQ Series Diagnostic Ultrasound System | | |
5
IV. Device Description
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Smart Doppler View ID software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems.
The purpose of the Smart Doppler View ID feature is to enhance the user's workflow through providing automation of the navigation of the touch screen groups on the Ultrasound System associated with Dopler Measurements. Without the Smart Doppler View ID feature, users must manually navigate to the desired Doppler Calculation Package Group on the Ultrasound System's various screens to perform a measurement. The Smart Doppler View ID feature automates this navigation and selects the associated calculation package group for the user based on the provided Doppler Spectrum acquired by the user using an artificial intelligence-based algorithm.
Smart Doppler View ID maps to six Doppler Calculations Package groups on the Ultrasound System screen:
- Aortic Valve
- Mitral Valve
- Tricuspid Valve
- . Pulmonic Valve
- Venous Flow
- · TDI Vel (Tissue Doppler Imaging Velocity) & Ratio
No hardware changes to the EPIQ or Affiniti systems are required when using the Smart Doppler View ID feature, and existing, commercialized Philips transducers are used for the Smart Doppler View ID feature.
The feature is supported by all EPIQ and Affiniti models running software version 11.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ 7, EPIQ 5, Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The Smart Doppler View ID feature is associated with the cardiac adult indication.
V. Intended Use and Indications for Use
EPIQ Intended Use
The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body.
EPIQ Indications for Use:
The intended use of EPIQ Ultrasound Diagnostic System 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), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
The clinical environments where EPIQ Series Diagnostic ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.
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Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in blue, block letters against a white background. The font is bold and sans-serif, giving the logo a clean and modern appearance. The letters are evenly spaced and aligned, creating a visually balanced and recognizable brand mark.
However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Note: There are no changes to the EPIQ Ultrasound System Indications for Use due to the introduction of the Smart Doppler View ID feature. The Smart Doppler View ID is associated with the Cardiac Adult indication.
Affiniti Intended Use:
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body.
Affiniti Indications for Use:
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Note: There are no changes to the Affiniti Ultrasound System Indications for Use due to the introduction of the Smart Doppler View ID feature. The Smart Doppler View ID is associated with the Cardiac Adult indication.
VI. Comparison of Technological Characteristics with the Predicate
The purpose of the submission is to introduce the Smart Doppler View ID feature to the EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System. The subject devices are substantially equivalent to the predicate devices (K211597) and reference device (K231190).
| Feature | EPIQ Series Diagnostic
Ultrasound System
Affiniti Series Diagnostic
Ultrasound System
Proposed Devices | Philips EPIQ Series
Diagnostic Ultrasound
System
Affiniti Diagnostic
Ultrasound System
(K211597)
Predicate Devices | Philips EPIQ Series
Diagnostic Ultrasound
System
(K231190)
Reference Device | Comparison |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| USA FDA
Classification | Class II | Class II | Class II | Identical |
| Primary Product
Code | IYN | IYN | IYN | Identical |
| Primary
Regulation
Number | 21 CFR 892.1550 | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical |
| Marketing Name of
Application | Smart Doppler View ID | Not applicable since the
application is new | Not applicable since the
application is new | Subject of this submission |
| | EPIQ Series Diagnostic
Ultrasound System | Philips EPIQ Series
Diagnostic Ultrasound
System | Philips EPIQ Series
Diagnostic Ultrasound
System | |
| Feature | Affiniti Series Diagnostic
Ultrasound System | Affiniti Diagnostic
Ultrasound System | | Comparison |
| | Proposed Devices | (K211597)
Predicate Devices | (K231190)
Reference Device | |
| Application
Description | The proposed Smart
Doppler View ID feature is
intended to be used Adult
Cardiology Transthoracic
examinations to automate
the navigation of the
Calculations Package
group associated with
Doppler Measurements.
Without the Smart Doppler
View ID feature, users
must manually navigate to
the desired Doppler
Calculations Package
Group on the Ultrasound
System to perform a
measurement. The Smart
Doppler View ID feature
automates this navigation
and selects the associated
Calculations Package
group for the user based
on the provided Doppler
Spectrum acquired by the
user.
Automated selection of
Calculation Package
Groups by Smart Doppler | Manual selection by the
user of Calculations
Package group on the
ultrasound system
associated with
measurement groups on
the ultrasound system.
Manual selection of
Calculation Package
Groups by the user: | Manual selection by the
user of Calculations
Package group on the
ultrasound system
associated with
measurement groups on
the ultrasound system.
Manual selection of
Calculation Package
Groups by the user: | Subject of this submission.
The Smart Doppler View ID
automates the selection of
Calculations Package group
on the ultrasound system
during Adult Cardiology
Transthoracic examinations,
where the predicate and
reference devices require
users to manually navigate to
their desired Calculations
Package group to perform
subsequent measurements.
The Smart Doppler View ID
feature does not perform any
measurements itself and is
only intended to automate the
selection of the Calculations
Package group associated
with an acquired doppler
spectrum.
There is no change to the
Calculation Package Groups
available to the user. |
| | View ID:
• Aortic Valve
• Mitral Valve
• Tricuspid Valve
• Pulmonic Valve
• Venous Flow
• TDI Vel & Ratio | • Aortic Valve
• Mitral Valve
• Tricuspid Valve
• Pulmonic Valve
• Venous Flow
• TDI Vel & Ratio | • Aortic Valve
• Mitral Valve
• Tricuspid Valve
• Pulmonic Valve
• Venous Flow
• TDI Vel & Ratio | |
| User Interface
Presentation | After a user acquires a
doppler spectrum, a
Calculations Package
group is automatically
highlighted on the
ultrasound system display
for the user by Smart
Doppler View ID. From the
highlighted Calculations
Package group, the user
may select a desired
measurement to perform
on the image. If the user
disagrees with the
highlighted Calculations
Package group, they can
manually navigate to their
desired Calculations
Package group. | After a user acquires a
doppler spectrum, the user
must manually navigate to
the desired Calculations
Package group. From the
manually selected
Calculations Package
group, the user may select
a desired measurement to
perform on the image. | After a user acquires a
doppler spectrum, the user
must manually navigate to
the desired Calculations
Package group. From the
manually selected
Calculations Package
group, the user may select
a desired measurement to
perform on the image. | The only difference with Smart
Doppler View ID is that the
Measurement Calculations
Package group is
automatically highlighted for
the user after a doppler
spectrum is acquired. Without
Smart Doppler View ID, users
must manually navigate to
their desired Calculations
Package group.
There is no change to the
user's functionality once the
Calculations Package group is
selected for them compared to
their workflow without Doppler
View ID. |
| | EPIQ Series Diagnostic
Ultrasound System
Affiniti Series Diagnostic
Ultrasound System
Proposed Devices | Philips EPIQ Series
Diagnostic Ultrasound
System
Affiniti Diagnostic
Ultrasound System
(K211597)
Predicate Devices | Philips EPIQ Series
Diagnostic Ultrasound
System
(K231190)
Reference Device | Comparison |
| Feature | | | | |
| Compatible
transducers | EPIQ:
X5-1, X5-1c, and S5-1 are
already commercially
available and compatible
with the EPIQ Ultrasound
System.
Affiniti:
S5-1, X5-1, and S4-2 are
already commercially
available and compatible
with the Affiniti Ultrasound
System.
No new transducers.
Transducer modes for
Smart Doppler View ID:
2D, PWD, CWD, TDI. No
new transducer modes. | No new transducers and no
new modes | The K231190 submission
introduced the mL26-8
transducer. This transducer
is not compatible with the
proposed Smart Doppler
View ID feature. | No new transducers or modes
are being introduced in this
submission. All transducers
are already available with the
EPIQ and Affiniti Ultrasound
Systems. |
| Measurements
Performed | No measurements are
performed by the Smart
Doppler View ID feature.
Any cardiac adult TTE
measurements resulting
from the view selection are
performed either manually
by the user or by the
commercially available
AutoMeasure function
(K211597). | Any cardiac adult TTE
measurements resulting
from the view selection are
performed either manually
by the user or by the
commercially available
AutoMeasure function
(K211597). | Any cardiac adult TTE
measurements resulting
from the view selection are
performed either manually
by the user or by the
commercially available
AutoMeasure function
(K211597) | No new measurements are
being introduced in this
submission. The subject of this
submission is to provide
workflow enhancements using
an artificial intelligence -
application. |
| Application
performance | Algorithm accuracy of
97.5% (95%CI 96.3%,
98.3%), p-value