(28 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound technology and signal processing.
No
The device is described as a "Diagnostic ultrasound imaging" system, and its function is to "acquire ultrasound data and to display the data" for diagnosis. There is no mention of treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body" and "The clinical environments where the EPIQ Diagnostic Ultrasound System can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients." Additionally, the "Device Description" mentions that the system "offers analysis packages that provide information used by competent healthcare professionals to make a diagnosis."
No
The device description explicitly states it consists of a system console and transducers, which are hardware components. It also mentions physical knobs, buttons, a touch screen, and a QWERTY keyboard as part of the user interface, further indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the EPIQ Diagnostic Ultrasound System is a "diagnostic ultrasound system." Its function is to acquire ultrasound data and display it for imaging and fluid flow analysis of the human body. It uses ultrasonic pressure waves transmitted through body tissues and processes echoes from within the body.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. It interacts directly with the body using ultrasound waves.
Therefore, the EPIQ Diagnostic Ultrasound System falls under the category of in vivo diagnostic imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Fetal/Obstetric, Gynecological, Intra-operative (Vascular, Cardiac), Abdominal, Pediatric, Small Organ (Breast, Thyroid, Testicle), Cephalic (Adult, Neonatal), Trans-rectal, Trans-vaginal, Musculoskeletal (Conventional and Superficial), Urology, Cardiac (Adult, Pediatric, Fetal, Trans-esophageal), Fetal Echo, Peripheral Vessel, Vascular (Cerebral).
The clinical environments where the EPIQ Diagnostic Ultrasound System can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The EPIQ Diagnostic Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation.
The device consists of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). In addition to the physical knobs and buttons of the main control panel, the user interface consists of a touch screen with soft key controls, and a QWERTY keyboard.
The removable transducers are connected to the system using a standard technology, multi-pin connectors. The EPIQ system uses standard transducer technology, and supports phased, linear, curved linear array, TEE, motorized 3D curved linear arrays as well as non-imaging (pencil) probes.
Clinical data storage consists of a local repository as well as off-line image storage via the network, DVR, DVD, and USB storage devices. The images are stored in industry-standard formats (Ex: JPEG, AVI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA.
The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of the system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow.
The EPIQ system gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used by competent healthcare professionals to make a diagnosis. The EPIQ system enables image guided navigation and image fusion via the optional PercuNav feature.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound system
Anatomical Site
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetabl/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Competent healthcare professionals. Clinical environments include 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)
A clinical trial was not required to demonstrate safety and effectiveness of the EPIQ Diagnostic Ultrasound System. Clinical validation is unnecessary as EPIQ introduces no new indications for use, no new modes or features that have not been previously cleared on the identified predicates. The clinical safety and effectiveness of ultrasound systems with these characteristics are historically accepted for both predicate and subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K130499, K121498, K093563, K042540, K030455
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary of Safety and Effectiveness EPIQ Diagnostic Ultrasound System
This summary of safety and effectiveness information is submitted in accordance with 21CFR §807.92
-
- Submitter's name, address, telephone number, contact person. Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021-8431
AUG
21 2013
- Submitter's name, address, telephone number, contact person. Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021-8431
Jessica Stenberg, Regulatory Affairs Specialist Contact person: Email: Jessica. Stenberg@philips.com Tel: (425) 487-7371 Fax: (425) 487-8666
Date prepared: June 27th, 2013
-
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/usual name: Diagnostic ultrasound system and transducers Proprietary name: EPIQ Ultrasound System
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
These devices are classified as follows:
| Classification Name | 21 CFR Section | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX |
As stated in 21 CFR, parts 892.1550, 892.1560, 892.1570, and 892.1750 each of these generic types of devices have been classified as Class II.
3. Substantially Equivalent Devices
Philips Ultrasound believes the EPIQ Ultrasound System is substantially equivalent to the following currently marketed devices:
| Product | 510(k) |
|---|---|
| Philips iU22 Diagnostic Ultrasound System | K130499, K121498, K093563, K042540, |
| K030455 |
1
4. Device Description
The EPIQ Diagnostic Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation.
The device consists of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). In addition to the physical knobs and buttons of the main control panel, the user interface consists of a touch screen with soft key controls, and a QWERTY keyboard.
The removable transducers are connected to the system using a standard technology, multi-pin connectors. The EPIQ system uses standard transducer technology, and supports phased, linear, curved linear array, TEE, motorized 3D curved linear arrays as well as non-imaging (pencil) probes.
Clinical data storage consists of a local repository as well as off-line image storage via the network, DVR, DVD, and USB storage devices. The images are stored in industrystandard formats (Ex: JPEG, AVI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA.
The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of the system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow.
The EPIQ system gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used by competent healthcare professionals to make a diagnosis. The EPIQ system enables image guided navigation and image fusion via the optional PercuNav feature
5. Technological Comparison to Predicate Devices
The EPIQ system is based on the latest technology in circuitry, memory, and essential hardware. While this hardware is new, the intended use and indications for use of the device remain unchanged from the Predicate iU22 system (K130499, K121498, K093563, K042540, K030455).
2
Both the EPIQ system and the predicate iU22 use both hard and soft keys for operating controls. On the EPIQ system hard keys (knobs, buttons) have been changed to soft keys.
The EPIQ system offers a suite of transducers which have essentialy the same hardware save the connector. The EPIQ system has a new multipin connector which is compact as in comparison to the iU22 transducer connectors. The transducers represent the only patient contact materials of the Ultrasound System. The EPIQ system introduces no new patient contact materials that have not been previously cleared on the predicate iU22 system.
The EPIQ system is a Track 3 system that employs the same fundamental scientific technology as the predicate iU22 system.
6. Indications for Use
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetabl/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 System can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.
7. Safety Considerations
As a track 3 ultrasound device the EPIQ Ultrasound System is designed to comply with the acoustic output display requirements of IEC 60601-2-37 Ed 2.0 (Particular requirements for the basic safety and essential performance of ultrasonic medical and monitoring equipment) and IEC 62359, Ed 2.0 (Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields).
The EPIQ Ultrasound System complies with the referenced standard as well as the FDA ultrasound specific guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008).
The system acoustic output limits are:
- Ispta.3 ≤ 720 MW/cm² .
- . MI