EPIQ Series Diagnostic Ultrasound System
Device Facts
| Record ID | K231190 |
|---|---|
| Device Name | EPIQ Series Diagnostic Ultrasound System |
| Applicant | Philips Ultrasound, LLC |
| Product Code | IYN · Radiology |
| Decision Date | May 12, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
The intended use of EPIQ Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: · Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), 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. · However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.
Device Story
EPIQ Series Diagnostic Ultrasound System is a diagnostic imaging platform; utilizes ultrasound transducers (including new mL26-8 linear array) to capture acoustic signals from human tissue; transforms signals into diagnostic images and flow analysis; operated by trained healthcare professionals in clinics, hospitals, and point-of-care settings. When integrated with Philips EchoNavigator, provides live image guidance for cardiovascular procedures using combined X-ray and echo data. Output displayed for clinician interpretation to support diagnosis and clinical decision-making. Benefits include high-resolution imaging for superficial structures and enhanced guidance for interventional procedures.
Clinical Evidence
No clinical data required. Substantial equivalence demonstrated via design features, indications for use, fundamental scientific technology, and non-clinical performance testing (bench testing).
Technological Characteristics
Ultrasonic pulsed doppler/echo imaging system. mL26-8 linear array transducer (6-13.33 MHz). Complies with ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62359, and ISO 10993-1. Track 3 device.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients requiring abdominal, cardiac (adult/pediatric/fetal), vascular (cerebral/peripheral), cephalic, obstetric, gynecological, musculoskeletal, ophthalmic, urological, pediatric, small organ, transesophageal, transrectal, transvaginal, or lung examinations. Used by trained healthcare professionals in clinics, hospitals, and point-of-care settings.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Philips EPIQ Series Diagnostic Ultrasound System (K212704)
Reference Devices
Submission Summary (Full Text)
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May 12, 2023
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Philips Ultrasound LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114
Re: K231190
Trade/Device Name: EPIQ 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: April 26, 2023 Received: April 26, 2023
Dear Prithul Bom:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
Enclosure
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## Indications for Use
Submission Number (if known)
K231190
Device Name
EPIQ Series Diagnostic Ultrasound System
Indications for Use (Describe)
The intended use of EPIQ Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
· Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), 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.
· 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)
ver-The-Counter Use (21 CFR 801 Subpart C)
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### 510(k) Summary
### #K231190
This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. Date Prepared: March 24, 2023
### l. Submitter
| Manufacturer Name and<br>Address | Philips Ultrasound LLC<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 USA |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Information | Courtney Nix<br>Senior Regulatory Affairs Specialist<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 USA |
| Secondary Contact | Tamara Daniels<br>Senior Regulatory Affairs Manager<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 USA |
#### II. Device
| Proprietary Name | EPIQ Series Diagnostic Ultrasound System |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Diagnostic Ultrasound System and Transducers |
| Product Code;<br>Regulation Description;<br>Regulation Number | IYN; Ultrasonic Pulsed Doppler Imaging System; 21 CFR<br>892.1550 (Primary)<br>IYO; Ultrasonic Pulsed Echo Imaging System; 21 CFR<br>892.1560<br>ITX; Diagnostic Ultrasonic Transducer; 21 CFR 892.1570<br>OBJ; Diagnostic Intravascular Catheter; 21 CFR 870.1200<br>QIH; Medical Image Management and Processing System;<br>21 CFR 892.2050 |
| Device Class | Class II |
| Review Panel | Radiology |
| Predicate Device | K212704; Philips EPIQ Series Diagnostic Ultrasound System |
| Reference Device | K162329; CX50 Diagnostic Ultrasound System, Sparq<br>Diagnostic Ultrasound System |
#### III. Device Description
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the mL26-8 transducer:
The mL26-8 is a linear array transducer designed primarily for superficial high-resolution imaging in Musculoskeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, and Small Organ (Breast, Thyroid, Testicle). The mL26-8 has a frequency of 6-13.33 MHz.
#### IV. 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:
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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. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
#### V. Comparison of Technological Characteristics with the Predicate
The purpose of the submission is to introduce the mL26-8 transducer to the EPIQ Series Diagnostic Ultrasound Systems.
The intended users, use environment, intended use, accessories and offered features are unchanged as compared to the predicate. The expansion of the indications for use to include Ophthalmic is supported by the reference device. All other indications are unchanged from the predicate device.
#### Safety Considerations VI.
The proposed EPIQ Series Diagnostic Ultrasound System, including mL26-8, are all Track 3 Devices and comply with the referenced standards as well as the FDA ultrasound guidance document, Guidance for Industry and FDA Staff – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued in February 2023.
#### VII. Nonclinical Performance Data
Philips Ultrasound performed the following testing to ensure the safety and effectiveness of the proposed EPIQ Series Diagnostic Ultrasound System:
- . ANSI/AAMI ES 60601-1: Medical electrical equipment. Part 1: General requirements for basic safety and essential performance, 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (consolidated text)
- . IEC 60601-1-2 Medical Electrical Equipment – Part 1-2, General Requirements for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility, 2014
- . IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General Requirements for Basic Safety and Essential Performance- Collateral standard: Usability, 2013
- IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. 2015
- IEC 62304: Medical Device Software - Software life cycle process, 2015
- IEC 62359, Ultrasonics Field characterization Test methods for the determination of thermal . and mechanical indices related to medical diagnostic ultrasonic fields, 2017-09
- . ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process; 2018
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# DHILIPS
Non-Clinical performance testing has been conducted addressing system level requirements according to system and design specifications, and risk control measures. Design Control activities to assure the safety and effectiveness of EPIQ Series Diagnostic Ultrasound System include but are not limited to the following:
- Requirements Review .
- . Risk Analysis and Management
- Product Specifications ●
- Design Reviews .
#### VIII. Clinical Data
The proposed EPIQ Series Diagnostic Ultrasound System did not require clinical data for determination of substantial equivalence since substantial equivalence was demonstrated based on the following attributes:
- Design features ●
- Indications for use
- Fundamental scientific technology ●
- . Non-clinical performance testing
- Safety and effectiveness
#### IX. Conclusion
For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed EPIQ Series Diagnostic Ultrasound System, including mL26-8, met the intended use.
While the predicate, Philips EPIQ Diagnostic Ultrasound System (K212704), does not have the 'Ophthalmic' indication, the L12-4 transducer, currently compatible with and cleared on the reference device, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System (K162329), is currently indicated for 'Ophthalmic'. Furthermore, the proposed mL26-8 has a higher frequency when compared to the existing compatible transducer on the Philips EPIQ Diagnostic Ultrasound System, however, the proposed mL26-8 transducer's frequency is within the limits of the Guidance for Industry and FDA Staff - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued in February 2023. The additional indication and higher frequency enhances the predicate device, the Philips EPIQ Diagnostic Ultrasound System (K212704), these design changes do not significantly affect the use of the device, nor do they introduce any new or significantly modified risks. The differences between the proposed device and the predicate and reference devices do not raise new questions of safety and/or effectiveness. Therefore, the proposed EPIQ Series Diagnostic Ultrasound System is similar to the predicate, Philips EPIQ Diagnostic Ultrasound System, in terms of indications for use, design, technological characteristics, modes of operations, safety and effectiveness.
