(27 days)
The intended use of Philips EPIQ series diagnostic ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac). Musculoskeletal (Conventional). Musculoskeletal (Superficial). Other: Urology. Pediatric. Peripheral Vessel. Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.
The clinical environments where Philips EPIQ diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Philips EPIQ Diagnostic Ultrasound Systems are durable capital equipment / medical devices which are software-controlled and intended for high-resolution general imaging, interventional radiology, cardiology, vascular and OB/GYN applications and fluid flow analysis. They are intended to be used by trained professionals at various settings of patient care such as clinical admission, periodic evaluations, prior to hospitalization discharge, and/or academic research, via maneuverable caster wheels.
Software modes/applications, scanning protocols, and pre-installed settings or functionality to create dedicated settings for imaging of specific anatomy are available with the subject Philips EPIQ Diagnostic Ultrasound Systems and may vary among model configurations.
The systems are manufactured with hardware components which consist of:
- a primary console (e.g., workstation, tablet) with built-in software components, features, and various 1) clinical applications, and
-
- a range of compatible ultrasound transducers and ultrasound intravascular catheters.
A suite of reusable compatible transducer types are offered such as transesophageal echocardiography (TEE) transducers, non-imaging (pencil) probes, curved array and sector/phased array. Philips ultrasound transducers may be bagged into compatible transducer/probe cover sheaths, designed by other manufacturers, for each procedure to prevent cross-contamination and reduce the risk of healthcareassociated infections. Philips EPIQ Diagnostic Ultrasound Systems are also compatible with single-use diagnostic intravascular ultrasound catheters (i.e., Philips VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro Intracardiac Echocardiography (ICE) Catheter) that are intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart for image guidance during cardiac interventional procedures.
Some configurations may have additional previously-cleared accessories, components and software features which are manufactured by Philips Ultrasound, Inc. or other manufacturers.
The provided FDA 510(k) summary for the Philips EPIQ Series Diagnostic Ultrasound Systems with VeriSight ICE / Pro ICE Catheters does not contain the specific acceptance criteria or the study details that prove the device meets these criteria in the format requested.
The document states that "all pre-determined acceptance criteria were met" and that "Results of these tests show that the proposed subject Philips EPIQ Series Diagnostic Ultrasound Systems with VeriSight ICE / PRO ICE Catheters meet their intended use." However, it does not explicitly list these criteria or provide detailed results from studies designed to demonstrate compliance.
Instead, the document focuses on:
- Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This is primarily done through comparison of technological characteristics and safety standards.
- Compliance with Standards: It lists several IEC and ANSI standards that the device complies with, which are general safety and performance standards for medical electrical equipment and diagnostic ultrasound.
- Non-Clinical Verification Testing: It mentions that "Relevant non-clinical verification testing and compatibility information has been performed... to address system level requirements according to system and design specifications, and risk control measures." This implies internal testing was done, but details are not provided.
- Lack of Clinical Data: It explicitly states that "The proposed Philips EPIQ Diagnostic Ultrasound Systems did not require clinical data for determination of substantial equivalence." This means a human-in-the-loop (MRMC) study or standalone clinical performance study was not conducted or required for this 510(k) clearance.
Therefore, for the information requested in your bullet points, I can only extract general statements about compliance and the types of testing performed, not specific performance metrics against defined acceptance criteria.
Here's a breakdown of what can and cannot be derived from the provided text:
1. A table of acceptance criteria and the reported device performance
Cannot be provided from the text. The document states "all pre-determined acceptance criteria were met" and that the device meets its intended use, but it does not specify what those criteria are or report concrete performance metrics against them. The focus is on compliance with general safety and performance standards.
2. Sample size used for the test set and the data provenance
Cannot be provided from the text. The document does not describe a clinical test set or its provenance because it explicitly states that "The proposed Philips EPIQ Diagnostic Ultrasound Systems did not require clinical data for determination of substantial equivalence." The testing mentioned is "non-clinical verification testing and compatibility information." Details like sample size or data provenance for these internal non-clinical tests are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Cannot be provided from the text. Since no clinical test set was required or described, there were no experts used to establish ground truth in the context of clinical performance.
4. Adjudication method for the test set
Not applicable/Cannot be provided from the text. As no clinical test set or ground truth establishment by experts is described, no adjudication method would have been used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The document explicitly states: "The proposed Philips EPIQ Diagnostic Ultrasound Systems did not require clinical data for determination of substantial equivalence." This implies no MRMC comparative effectiveness study was conducted or needed. Furthermore, the device described is a general diagnostic ultrasound system, not explicitly an "AI" device with human-in-the-loop assistance in the context of improving reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The document states that "The proposed Philips EPIQ Diagnostic Ultrasound Systems did not require clinical data for determination of substantial equivalence." While "non-clinical verification testing" was performed, this refers to engineering and quality assurance testing against technical specifications and safety standards, not a standalone clinical performance study of an algorithm. The device is described as software-controlled, but not as an "algorithm only" device subject to standalone performance evaluation in a clinical sense.
7. The type of ground truth used
Not applicable/Cannot be provided from the text for clinical performance. For the non-clinical verification testing mentioned, the "ground truth" would likely be engineering specifications, established physical properties, and compliance with the listed safety standards (e.g., electrical safety, electromagnetic compatibility, acoustic output limits).
8. The sample size for the training set
Not applicable/Cannot be provided from the text. The document pertains to a diagnostic ultrasound system, not an AI model that undergoes a "training set" in the machine learning sense. The "software-controlled" aspect refers to the operational control of the ultrasound system itself, not necessarily an AI algorithm.
9. How the ground truth for the training set was established
Not applicable/Cannot be provided from the text. As above, this is not applicable for this type of device and submission.
In summary, the provided text from the FDA 510(k) summary demonstrates compliance by:
- Stating that "all pre-determined acceptance criteria were met" for internal non-clinical verification testing.
- Listing adherence to recognized safety and performance standards (ANSI/AAMI 60601-1, IEC 60601-1-2, IEC 60601-2-37).
- Asserting that no clinical data was required for substantial equivalence, implying that its performance is presumed to be equivalent to the predicate device based on technical and safety specifications.
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September 2, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Ultrasound, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114
Re: K202216
Trade/Device Name: EPIQ Series Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OBJ Dated: August 5, 2020 Received: August 6, 2020
Dear Prithul Bom:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202216
Device Name EPIQ Series Diagnostic Ultrasound Systems
Indications for Use (Describe)
The intended use of Philips EPIQ series diagnostic ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac). Musculoskeletal (Conventional). Musculoskeletal (Superficial). Other: Urology. Pediatric. Peripheral Vessel. Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.
The clinical environments where Philips EPIQ diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED |
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510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. Date Prepared: August 31, 2020
I. Submitter
| Manufacturer Nameand Address | Philips Ultrasound, Inc.22100 Bothell Everett HwyBothell, WA 98021-8431 |
|---|---|
| ContactInformation | Colin S. JacobSenior Regulatory Affairs SpecialistTEL: 425.908.1209EMAIL: colin.jacob@philips.com |
II. Device
| Trade Name | EPIQ Series Diagnostic Ultrasound Systems |
|---|---|
| Common Name | Diagnostic ultrasound system and transducers |
| Regulation Description | Ultrasonic pulsed doppler imaging systemUltrasonic pulsed echo imaging systemDiagnostic ultrasonic transducerDiagnostic intravascular catheter |
| Regulation Number | 892.1550892.1560892.1570870.1200 |
| Primary Product Code | IYN |
| Secondary Product Codes | IYOITXOBJ |
| Device Class | Class II |
| Classification Panel | Radiology |
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Predicate Device III.
- K200304 - Philips EPIQ Series Diagnostic Ultrasound Systems
IV. Device Description
Philips EPIQ Diagnostic Ultrasound Systems are durable capital equipment / medical devices which are software-controlled and intended for high-resolution general imaging, interventional radiology, cardiology, vascular and OB/GYN applications and fluid flow analysis. They are intended to be used by trained professionals at various settings of patient care such as clinical admission, periodic evaluations, prior to hospitalization discharge, and/or academic research, via maneuverable caster wheels.
Software modes/applications, scanning protocols, and pre-installed settings or functionality to create dedicated settings for imaging of specific anatomy are available with the subject Philips EPIQ Diagnostic Ultrasound Systems and may vary among model configurations.
The systems are manufactured with hardware components which consist of:
- a primary console (e.g., workstation, tablet) with built-in software components, features, and various 1) clinical applications, and
-
- a range of compatible ultrasound transducers and ultrasound intravascular catheters.
A suite of reusable compatible transducer types are offered such as transesophageal echocardiography (TEE) transducers, non-imaging (pencil) probes, curved array and sector/phased array. Philips ultrasound transducers may be bagged into compatible transducer/probe cover sheaths, designed by other manufacturers, for each procedure to prevent cross-contamination and reduce the risk of healthcareassociated infections. Philips EPIQ Diagnostic Ultrasound Systems are also compatible with single-use diagnostic intravascular ultrasound catheters (i.e., Philips VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro Intracardiac Echocardiography (ICE) Catheter) that are intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart for image guidance during cardiac interventional procedures.
Some configurations may have additional previously-cleared accessories, components and software features which are manufactured by Philips Ultrasound, Inc. or other manufacturers.
Image /page/4/Picture/14 description: The image shows the Philips logo. The logo is a blue shield with the word "PHILIPS" at the top. Inside the shield, there are wavy lines and four stars. The logo is simple and recognizable.
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V. Indications for Use
| Device | Indications for Use |
|---|---|
| Philips EPIQDiagnosticUltrasoundSystem | The intended use of Philips EPIQ series diagnostic ultrasound systems is diagnostic ultrasound imaging and fluid flowanalysis of the human body, with the following indications for use:Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic(Neonatal), Fetal/Obstetric, Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular),Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric,Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.The clinical environments where Philips EPIQ diagnostic ultrasound systems can be used include clinics, hospitals,and clinical point-of-care for diagnosis of patients.When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with imageguidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echoguidance.The systems are intended to be installed, used, and operated only in accordance with the safety procedures andoperating 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 bestclinical procedure. |
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Comparison of Technological Characteristics between Proposed Subject Device and Predicate Device VI.
| Standard Feature | Philips EPIQ Series DiagnosticUltrasound SystemsK202216(Subject Device) | Philips EPIQ Series DiagnosticUltrasound SystemsK200304(Predicate Device) | Comparison |
|---|---|---|---|
| RegulationNumber | 892.1550 | 892.1550 | Same |
| DeviceClassificationName | System, Imaging, Pulsed Doppler,Ultrasonic | System, Imaging, Pulsed Doppler,Ultrasonic | Same |
| Product Code | IYN | IYN | Same |
| Secondary ProductCode | IYO, ITX, OBJ | IYO, ITX | Subject of submission |
| Indications for Use | The intended use of Philips EPIQ seriesdiagnostic ultrasound systems isdiagnostic ultrasound imaging and fluidflow analysis of the human body, withthe following indications for use:Abdominal, Cardiac Adult, Cardiac other(Fetal), Cardiac Pediatric, CerebralVascular, Cephalic (Adult), Cephalic(Neonatal), Fetal/Obstetric,Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular),Intraoperative (Cardiac), Musculoskeletal(Conventional), Musculoskeletal(Superficial), Other: Urology, Pediatric, | The intended use of Philips EPIQ seriesdiagnostic ultrasound systems isdiagnostic ultrasound imaging and fluidflow analysis of the human body, withthe following indications for use:Abdominal, Cardiac Adult, Cardiac other(Fetal Echo), Cardiac Pediatric, CerebralVascular, Cephalic (Adult), Cephalic(Neonatal), Fetal/Obstetric,Gynecological, Intraoperative (Vascular),Intraoperative (Cardiac), Musculoskeletal(Conventional), Musculoskeletal(Superficial), Other: Urology, Pediatric, | Subject of submissionIndications for use ofEPIQ is being updated toinclude "Intra-cardiacecho, Intra-luminial" toreflect compatibility withultrasound intravascularcatheters (K200812) |
| Standard Feature | Philips EPIQ Series DiagnosticUltrasound SystemsK202216(Subject Device) | Philips EPIQ Series DiagnosticUltrasound SystemsK200304(Predicate Device) | Comparison |
| Thyroid, Testicle), Transesophageal | Thyroid, Testicle), Transesophageal | ||
| (Cardiac), Transrectal, Transvaginal. | (Cardiac), Transrectal, Transvaginal. | ||
| The clinical environments where PhilipsEPIQ diagnostic ultrasound systems canbe used include clinics, hospitals, andclinical point-of-care for diagnosis ofpatients. | The clinical environments where PhilipsEPIQ diagnostic ultrasound systems canbe used include clinics, hospitals, andclinical point-of-care for diagnosis ofpatients. | ||
| When integrated with PhilipsEchoNavigator, the systems can assistthe interventionalist and surgeon withimage guidance during treatment ofcardiovascular disease in which theprocedure uses both live X-ray and liveecho guidance. | When integrated with PhilipsEchoNavigator, the systems can assistthe interventionalist and surgeon withimage guidance during treatment ofcardiovascular disease in which theprocedure uses both live X-ray and liveecho guidance. | ||
| The systems are intended to be installed,used, and operated only in accordancewith the safety procedures and operatinginstructions given in the product userinformation, and only for the purposes | The systems are intended to be installed,used, and operated only in accordancewith the safety procedures and operatinginstructions given in the product userinformation, and only for the purposes | ||
| for which it was designed. However, | for which it was designed. However, | ||
| nothing stated in the user information | nothing stated in the user information | ||
| reduces your responsibility for sound | reduces your responsibility for sound | ||
| Standard Feature | Philips EPIQ Series DiagnosticUltrasound SystemsK202216(Subject Device) | Philips EPIQ Series DiagnosticUltrasound SystemsK200304(Predicate Device) | Comparison |
| clinical judgement and best clinicalprocedure. | clinical judgement and best clinicalprocedure. | ||
| Reusable? | Yes | Yes | Same |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Same |
| ScientificTechnology | Ultrasound Imaging | Ultrasound Imaging | Same |
| Principles ofOperation | System console generates electricalcurrent and sends to a connected,compatible transducer to stimulate itspiezoelectric elements at the distal end.Stimulation causes the elements toexpand and contract which creates ahigh-pressured wave (i.e., soundwave). Aseries of soundwaves then propagatetoward tissue medium (e.g., mucusmembrane, bone). The transducer thenreceives echoed soundwaves that arereflected from the tissue medium andtransmits it to the system. The systemprocesses the echoed soundwaves intoan image which is displayed on thedisplay monitor screen of the system foruser interpretation. | System console generates electricalcurrent and sends to a connected,compatible transducer to stimulate itspiezoelectric elements at the distal end.Stimulation causes the elements toexpand and contract which creates ahigh-pressured wave (i.e., soundwave). Aseries of soundwaves then propagatetoward tissue medium (e.g., mucusmembrane, bone). The transducer thenreceives echoed soundwaves that arereflected from the tissue medium andtransmits it to the system. The systemprocesses the echoed soundwaves intoan image which is displayed on thedisplay monitor screen of the system foruser interpretation. | Same |
| Type ofCompatibleComponents | TEE ProbesNon-imaging (pencil) probesCurved Array Transducers | TEE ProbesNon-imaging (pencil) probesCurved Array Transducers | Subject of submission |
| Standard Feature | Philips EPIQ Series DiagnosticUltrasound SystemsK202216(Subject Device) | Philips EPIQ Series DiagnosticUltrasound SystemsK200304(Predicate Device) | Comparison |
| Linear Array TransducersSector Array TransducersUltrasound Intravascular Catheters* | Linear Array TransducersSector Array Transducers | ||
| Acoustic OutputsWithin Range? | Yes | Yes | Same |
| Previously clearedImaging Modes? | Yes | Yes | Same |
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w / VeriSight ICE / Pro ICE Catheters
Page 5 of 8
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w/ VeriSight ICE / Pro ICE Catheters
Page 6 of 8
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Image /page/9/Picture/0 description: The image shows the Philips logo on the left side of the image. To the right of the logo is the text "TRADITIONAL 510(k) EPIQ Series Diagnostic Ultrasound Systems w/ VeriSight ICE / Pro ICE Catheters". On the right side of the image is the text "Page 7 of 8".
*Compatible ultrasound intravascular catheter in K200812.
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VII. Performance Data
Relevant non-clinical verification testing and compatibility information has been performed and included in this submission to address system level requirements according to system and design specifications, and risk control measures. The proposed Philips EPIQ Diagnostic Ultrasound Systems did not require clinical data for determination of substantial equivalence.
The proposed Philips EPIQ Series Diagnostic Ultrasound Systems with the VeriSight ICE / PRO ICE Catheters is an electronic product as defined by 21 CFR Subject Chapter J regulations, and is Track 3 Device and complies with the referenced standard as the FDA ultrasound guidance document, Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued on June 27, 2019.
Philips Ultrasound, Inc. performed the following testing to ensure the safety and effectiveness of the proposed Philips EPIQ Series Diagnostic Ultrasound Systems with the VeriSight ICE / PRO ICE catheters:
- 트 ANSI/AAMI 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012,
- I IEC 60601-1-2 Medical Electrical Equipment - Part 1-2, General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic Compatibility, 2014,
- IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2015.
VIII. Conclusion
For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed subject Philips EPIQ Series Diagnostic Ultrasound Systems with VeriSight ICE / PRO ICE Catheters meet their intended use. The results of the relevant performance data and compatibility support a determination that the proposed subject device does not rasse new questions of safety or effectiveness and is substantially equivalent to the predicate device.
§ 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.