(86 days)
This ARIETTA 50 is intended for use by trained personnel (doctor, sonographer, etc.) while in a healthcare facility for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), A Small Organ (Spec.), Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Other (Wound), Cardiac Adult, Cardiac Pediatric, Transesophageal (card.), Peripheral vessel, Other (Gynecological), clinical applications.
The Modes of Operation are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging).
The ARIETTA 50 is a multi-functional ultrasound diagnostic scanner in which Doppler, Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex, radial and phased array scan type probes for usage with a variety of clinical applications.
The ARIETTA 50 can be used for individual or combined display in the image display model listed below.
- . B mode is a display mode in which the tomographic image is formed with plural ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image.
- M mode is a display mode of ultrasound beams received sequentially and repeatedly on . the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale.
- There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. . PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method.
- Color Doppler mode receives ultrasound from the same direction and detects any . changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode, Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need.
The 4 methods of electronic scanning are as follows.
-
. Linear Scanning Method:
By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject. -
Convex Scanning Method:
By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject. -
. Sector Scanning Method:
By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject. -
Trapezoidal Scanning Method: ●
By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.
This document describes the Fujifilm ARIETTA 50 ultrasound system and its substantial equivalence to a predicate device. Below is a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a table of specific acceptance criteria (e.g., specific quantitative metrics for performance) or a direct comparison of the reported device performance against such criteria. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ARIETTA 50, K190248) through a comparison of physical, performance, and technological characteristics.
The "Performance Comparison" section states: "No new hazards were identified with the ARIETTA 50. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards."
The implicit acceptance criteria are the safety and effectiveness standards met by the predicate device and the applicable medical device safety standards mentioned. The reported device performance is that the ARIETTA 50 "conforms to applicable medical device safety standards" and its "performance characteristics... are comparable to the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Performance Testing - Clinical: None required." This indicates that no clinical test set of patient data (retrospective or prospective) was used for evaluating the device's performance in a clinical setting against specific acceptance criteria for diagnostic accuracy or efficacy. The evaluation appears to be based on an engineering and regulatory comparison to a predicate device.
Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable as no such clinical study was conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical test set was used for performance testing (as clinical testing was not required), there is no information about experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
As no clinical test set was used, there is no adjudication method to report.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
No MRMC comparative effectiveness study was mentioned or implied. The device is an ultrasound diagnostic scanner, and the evaluation focused on physical and technical equivalence to a predicate, not on human-in-the-loop performance or AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
The document does not describe any standalone algorithm performance study. The ARIETTA 50 is an ultrasound system with various imaging modes, not an AI-driven algorithm designed to perform diagnostic tasks without human interaction. Its evaluation focuses on the overall system's safety and performance characteristics compared to a predicate ultrasound system.
7. The Type of Ground Truth Used
Given that clinical testing was not required and the submission relies on substantial equivalence to a predicate device, there is no mention of ground truth established through expert consensus, pathology, or outcomes data for the ARIETTA 50 itself. The basis for safety and effectiveness is compliance with standards and comparability to the predicate.
8. The Sample Size for the Training Set
No training set is mentioned as neither an AI/ML component requiring a training set nor a clinical study with a training phase was conducted.
9. How the Ground Truth for the Training Set Was Established
Since no training set was used, this information is not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 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 agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
FUJIFILM Healthcare Corporation % Dennis Domoracki Senior Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 LEXINGTON MA 02421
Re: K220295
April 29, 2022
Trade/Device Name: ARIETTA 50 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 27, 2022 Received: February 2, 2022
Dear Dennis Domoracki:
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
{1}------------------------------------------------
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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb, Ph.D. Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name ARIETTA 50
Indications for Use (Describe)
This ARIETTA 50 is intended for use by trained personnel (doctor, sonographer, etc.) while in a healthcare facility for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), A Small Organ (Spec.), Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Other (Wound), Cardiac Pediatric, Transesophageal (card.), Peripheral vessel, Other (Gynecological), clinical applications.
The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler , Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging).
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the Fujifilm logo in black with a red accent. The logo is a stylized version of the company's name, with the letters "FUJIFILM" in a bold, sans-serif font. Below the logo is the tagline "Value from Innovation" in a smaller font. The logo is simple and modern, and the red accent adds a touch of color and visual interest.
Value from Innovation
Section 5 510(k) Summary
Submitter Information
| Submitter: | FUJIFILM Healthcare Corporation2-1, Shintoyofuta,Kashiwa-Shi, Chiba, JP 277-0804 |
|---|---|
| Contact: | Dennis Domoracki, Senior Regulatory Affairs Specialist |
| Telephone number: | (330)-425-1313 Ext:2792 |
| E-mail: | dennis.domoracki@fujifilm.com |
| Date: | January 27, 2022 |
Contact Information (USA)
| Address: | FUJIFILM Healthcare Americas Corporation81 Hartwell Avenue, Suite 300Lexington, MA 02421 USA |
|---|---|
| ---------- | ------------------------------------------------------------------------------------------------------ |
Subject Device Name
| Trade/Proprietary Name: | ARIETTA 50 |
|---|---|
| Regulation Number: | 21 CFR 892.1550 |
| Regulation Name: | Diagnostic Ultrasound System and Accessories |
| Product Code | 90-IYN, 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System90-IYO, 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System90-ITX, 21 CFR 892.1570 Diagnostic Ultrasonic Transducer |
| Class | II |
| Panel | Radiology |
Predicate Device Name
| Predicate Device(s): | ARIETTA 50 (K190248) |
|---|---|
| Regulation Number: | 21 CFR 892.1550 |
| Regulation Name: | Diagnostic Ultrasound System and Accessories |
| Product Code | 90-IYN, 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System90-IYO, 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System90-ITX, 21 CFR 892.1570 Diagnostic Ultrasonic Transducer |
| Class | II |
| Panel | Radiology |
Indications for Use
This ARIETTA 50 is intended for use by trained personnel (doctor, sonographer, etc.) while in a healthcare facility for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), A Small Organ (Spec.), Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Other (Wound), Cardiac Adult, Cardiac Pediatric, Transesophageal (card.), Peripheral vessel, Other (Gynecological), clinical applications.
The Modes of Operation are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging).
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the Fujifilm logo. The logo is in black and red. Below the logo is the text "Value from Innovation."
Device Description
Function
The ARIETTA 50 is a multi-functional ultrasound diagnostic scanner in which Doppler, Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex, radial and phased array scan type probes for usage with a variety of clinical applications.
The ARIETTA 50 can be used for individual or combined display in the image display model listed below.
- . B mode is a display mode in which the tomographic image is formed with plural ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image.
- M mode is a display mode of ultrasound beams received sequentially and repeatedly on . the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale.
- There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. . PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method.
- Color Doppler mode receives ultrasound from the same direction and detects any . changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode, Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need.
The 4 methods of electronic scanning are as follows.
-
. Linear Scanning Method:
By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject. -
Convex Scanning Method:
By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject. -
. Sector Scanning Method:
By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject. -
Trapezoidal Scanning Method: ●
By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the Fujifilm logo. The logo is black with a red accent on the "i". The logo is simple and modern. The text is bold and easy to read.
Value from Innovation
Scientific Concepts
The principle of operation of ultrasound imaging involves generation of an ultrasound wave pulses with an electric signal applied to a transducer, direction of the resulting ultrasound wave into the tissue of the body, and reception and analysis of the echoes reflected back to the same or an adjacent transducer from the various tissues along the path of the ultrasound wave. The ultrasound waves comprising a beam travel in as straight line in homogeneous media. When an ultrasound wave reaches an interface between two media of different impedances, a portion of the beam energy may pass through the boundary (transmission), and a portion may be reflected. The direction of propagation of the transmitted beam is determined by the angle of incidence of the incident beam upon the boundary, and differences (if any) in the speed of sound in the two media. The direction of reflection is determined solely by the angle of incidence upon the boundary. The relative strength of the reflected wave depends upon the differences in the impedances between the two media. Reflection at a boundary between soft tissue and bone, as an example, involves a large impedance difference, and results in a relatively strong reflected echo. Reflection at a boundary between two soft tissue-types with a relatively small impedance difference, on the other hand, results in a relatively weak reflected echo.
Physical and Performance Characteristics
Analysis confirms the performance characteristics of the ARIETTA 50 are comparable to the predicate device and support our conclusion that the subject system is substantially equivalent.
Performance Comparison
No new hazards were identified with the ARIETTA 50. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.
| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing - Bench | FUJIFILM Healthcare Corporation judged that ARIETTA 50 is substantially equivalent tothe predicate. |
| Performance Testing - Clinical | None required |
The analysis confirms the performance characteristics of the ARIETTA 50 are comparable to the predicate device and support our conclusion that the subject device is substantially equivalent.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a small red square above the letter "I". Below the logo is the text "Value from Innovation".
Device Technological Characteristics
The technological characteristics differences between the ARIETTA 50 and the predicate device ARIETTA 50 (K190248) are:
| ● | Physical characteristics of the system | There are no significant differences in appearance, weight, size, hardware, transmit/receive parameters, modes of operation, and features from the predicate device. | |
|---|---|---|---|
| ARIETTA 50 Subject Device | ARIETTA 50 Predicate Device (K190248) | ||
| ● | Probes | Probe | Previous Clearance |
| C22K | ARIETTA 65 (K202422) | ||
| C22P | ARIETTA 65 (K202422) | ||
| C251 | ARIETTA 65 (K202422) | ||
| C35 | ARIETTA 65 (K202422) | ||
| C41B | ARIETTA 65 (K202422) | ||
| C41L47RP | ARIETTA 65 (K202422) | ||
| C41RP | ARIETTA 65 (K202422) | ||
| C41V | ARIETTA 65 (K202422) | ||
| C42K | ARIETTA 65 (K202422) | ||
| CC41R | ARIETTA 65 (K202422) | ||
| L64 | ARIETTA 65 (K202422) | ||
| S31 | ARIETTA 65 (K202422) | ||
| VC35 | ARIETTA 65 (K202422) | ||
| VC41V | ARIETTA 65 (K202422) | ||
| ● | New Features | Real-time 3D4Dshading |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a small red square above the letter 'I'. Below the logo is the text 'Value from Innovation'.
Value from Innovation
Substantial Equivalence
A summary decision was based on a thorough analysis and comparison of the functions. scientific concepts, physical and performance characteristics, performance comparison and technological characteristics.
Probes
The 13 additional probes for the system meet user requirements in regards to indications for use and have no effect on the safety and effectiveness of the device. These probes have been cleared by previous 510(k) submissions of art below.
Features
The ARIETTA 50 has 2 additional features (Real-time 3D, 4Dshading). However, these features where cleared in previous 510(k) submissions (ARIETTA 65, K202422). Therefore, FUJIFILM judges that the ARIETTA 50 has no additional issues with safety and effectiveness.
Based on analysis of the above-mentioned comparison. FUJIFILM Healthcare Corporation has judged the subject device to have the equivalent safety and effectiveness of the predicate device.
Summary of Non-Clinical Testing
The ARIETTA 50 V3.0 system is in conformance with the applicable parts of the following standards:
-
AAMI ANSI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and ● A2:2010/(R)2012
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) -
IEC 60601-2-37 Edition 2.1 2015 .
Medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. (Radiology) -
IEC 60601-1-2 Edition 4.0 2014-02 . Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests. (General II (ES/EMC))
-
AAMI I ANSI I ISO 10993-1:2009/(R)2013 ● Biological evaluation of medical devices - part I: evaluation and testing within a risk management process. (Biocompatibility)
-
AAMI I ANSI I ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - part 5: tests for in vitro cytotoxicity. (Biocompatibility)
-
AAMI I ANSI I ISO I 0993-10: 2002 + am1 2006 ● Biological evaluation of medical devices - part I 0: tests for irritation and skin sensitization. (Biocompatibility)
Summary of Clinical Testing
Clinical testing was not required.
Conclusions
It is the opinion of FUJIFILM Healthcare Corporation, that the ARIETTA 50 Ultrasound Diagnostic scanner and transducers is substantially equivalent to the predicate devices. The subject device software features, intended use, materials, and diagnostic capabilities have been taken from the predicate devices. In addition, we have concluded that the subject device and predicate devices are substantially equivalent with respect to safety, effectiveness, and functionality.
§ 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.