(21 days)
Not Found
No
The summary describes a standard ultrasound imaging system with various modes and measurement capabilities. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image analysis, interpretation, or other functions. The performance studies focus on software verification, electrical safety, EMC, risk management, and human factors, not on the performance of an AI/ML algorithm.
No
The device is used to observe and store real-time ultrasound images for diagnostic purposes, not to provide therapy. Devices that use ultrasound for imaging are typically diagnostic, while therapeutic ultrasound devices deliver energy to tissue for treatment.
Yes
The device is intended to observe and store real-time ultrasound images to observe organs and provides measurements and calculations, which are actions typically performed to aid in diagnosis.
No
The device description explicitly states it is a "system" that is "combined with Ultrasound videoscopes or Ultrasound probes" and mentions electrical safety and EMC testing, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is an ultrasound center used with endoscopes and probes to generate real-time ultrasound images within the body. It's an imaging device, not a device that analyzes samples taken from the body.
- Intended Use: The intended use clearly states it's for observing and storing real-time ultrasound images within specific anatomical sites (GI tract, biliary and pancreatic ducts, etc.). This is consistent with in-vivo imaging, not in-vitro diagnostics.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
This ultrasound center is intended to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images and indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, and tracheobronchial tree, and urinary tract.
B, PWD (Pulsed Wave Doppler), Color Doppler (including Power Doppler), Combination of each operating mode) and other (3-D Imaging and Harmonic Imaging*). *Only for the EU-ME2 PREMIER PLUS.
Appropriately-trained healthcare professional.
Hospital.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, ODG
Device Description
The subject system (OLYMPUS EU-ME2) combined with Ultrasound videoscopes or Ultrasound probes to make an endoscopic ultrasound imaging system that can acquire and display high-resolution and high-penetration, real-time ultrasound images of the target organs.
The subject system has modes of B, PWD, Color Doppler, Combined (combination of each operating mode) and other (3-D Imaging).The subject system has no Harmonic Imaging function compared to the predicate device.
The subject system provides measurements and calculations of distance, area, circumference, volume, time, and blood velocity. It also allows for the storage and retrieval of images for reviewing and printing.
The subject system enables the user to print and record images to an external recording device.
The subject system can identify and recognize the compatible Olympus transducers and display endoscopic and ultrasound images.
The basic design, system configuration, general operation and user interface of this subject system is substantially equivalent to the predicate devices.
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS
The subject system (OLYMPUS EU-ME2 PREMIER PLUS) combined with Ultrasound videoscopes or Ultrasound probes to make an endoscopic ultrasound imaging system that can acquire and display high-resolution and high-penetration, real-time ultrasound images of the target organs.
The subject system has modes of B, PWD, Color Doppler, Combined (combination of each operating mode), other (3-D Imaging and Harmonic Imaging) and Elastography function which visualizes the amount of strain in tissue (hardness of tissue) during compression and retraction.
The subject system provides measurements and calculations of distance, area, circumference, volume, time and blood velocity. It also allows for the storage and retrieval of images for reviewing and printing.
The subject system enables the user to print and record images to an external recording device. Additionally, the subject system enables the user to record movies to internal memory.
The subject system can identify and recognize compatible Olympus transducers and display endoscopic and ultrasound images.
The basic design, system configuration, general operation, and user interface of this subject system is substantially equivalent to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, and tracheobronchial tree, and urinary tract.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Appropriately-trained healthcare professional.
Hospital.
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)
Software verification and validation testing was conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
Electrical safety and EMC testing was conducted in accordance with the ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, and IEC 60601-2-18:2009 standards for safety, and IEC 60601-1-2:2014 standards for EMC and IEC 60601-2-37:2015.
No animal study was performed to demonstrate substantial equivalence.
No clinical study was performed to demonstrate substantial equivalence.
Risk management was performed in accordance with ISO 14971:2007, and a human factors validation was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices". The design verification tests and their acceptance criteria were identified and performed as a result of this risk management.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Olympus Medical Systems Corp. % Lisa Boyle RA Program Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610 November 9, 2020
Re: K203128
Trade/Device Name: EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/ EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, ODG Dated: September 30, 2020 Received: October 19, 2020
Dear Lisa Boyle:
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.
1
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 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 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.
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
2
Indications for Use
510(k) Number (if known) K203128
Device Name
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/ EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS
Indications for Use (Describe)
This ultrasound center is intended to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images and indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, and tracheobronchial tree, and urinary tract.
B, PWD (Pulsed Wave Doppler), Color Doppler (including Power Doppler), Combination of each operating mode) and other (3-D Imaging and Harmonic Imaging*). *Only for the EU-ME2 PREMIER PLUS.
Appropriately-trained healthcare professional.
Hospital.
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)
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3
Date Prepared: September 30, 2020
510(k) Summary
K203128
1. GENERAL INFORMATION
| ■ 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-machi, Hachioji-shi, Tokyo 192-8507 Japan |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Contact Person: | Lisa M. Boyle
Olympus Corporation of the Americas
3500 Corporate Parkway PO Box 610
Center Valley, PA 18034-0610, USA
Phone: 484-896-3676
Fax: 484-896-7128
Email: lisa.boyle@olympus.com |
| ■ Manufacturing site: | Shirakawa Olympus Co., Ltd.
3-1 Okamiyama, Odakura, Nishigo-mura,
Nishishirakawa-gun, Fukushima 961-8061, Japan |
2. DEVICE IDENTIFICATION
| Device Name: | Model Name: |
|---|---|
| EVIS EUS ENDOSCOPIC | |
| ULTRASOUND CENTER | OLYMPUS EU-ME2 |
| EVIS EUS ENDOSCOPIC | |
| ULTRASOUND CENTER | OLYMPUS EU-ME2 PREMIER PLUS |
| ■ Accessories included in the | |
| subject device | Keyboard MAJ-1995 |
| ULTRASOUND CABLE MAJ-2056 | |
| ■ Common Name: | Diagnostic Ultrasound System |
| ■ Regulation Number: | 892.1550 Ultrasonic pulsed doppler imaging system |
| 892.1560 Ultrasonic pulsed echo imaging system | |
| 892.1570 Diagnostic ultrasonic transducer | |
| 876.1500 Endoscope and Accessories |
4
| Regulatory Class: | II |
|---|---|
| Product Code: | IYN: System, Imaging, Pulsed Doppler, Ultrasonic |
| IYO: System, Imaging, Pulsed Echo, Ultrasonic | |
| ITX: Transducer, Ultrasonic, Diagnostic | |
| ODG: Endoscopic ultrasound system, | |
| Gastroenterology-urology | |
| Classification Panel: | Radiology |
3. PREDICATE DEVICE
■ Predicate device
| Subject device name | Predicate device
name | 510(k) Submitter | 510(k) No. |
|----------------------------------------------------------------------------|---------------------------------------------|-------------------------------------|------------|
| EVIS EUS ENDOSCOPIC
ULTRASOUND CENTER
OLYMPUS EU-ME2 | ENDOSCOPIC
ULTRASOUND
CENTER EU-Y0006 | OLYMPUS
MEDICAL
SYSTEMS CORP. | K121564 |
| EVIS EUS ENDOSCOPIC
ULTRASOUND CENTER
OLYMPUS EU-ME2
PREMIER PLUS | ENDOSCOPIC
ULTRASOUND
CENTER EU-Y0008 | OLYMPUS
MEDICAL
SYSTEMS CORP. | K130058 |
| MAJ-1995
Keyboard | MAJ-Y0140
Keyboard | OLYMPUS
MEDICAL
SYSTEMS CORP. | K121564 |
| MAJ-2056
ULTRASOUND CABLE | XMAJ-1597
ULTRASONIC
CABLE | OLYMPUS
MEDICAL
SYSTEMS CORP. | K070983 |
4. DEVICE DESCRIPTION
General Description of the subject device . EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2
The subject system (OLYMPUS EU-ME2) combined with Ultrasound videoscopes or Ultrasound probes to make an endoscopic ultrasound imaging system that can acquire and display high-resolution and high-penetration, real-time ultrasound images of the target organs.
The subject system has modes of B, PWD, Color Doppler, Combined (combination of each operating mode) and other (3-D Imaging).The subject system has no Harmonic Imaging function compared to the predicate device.
5
The subject system provides measurements and calculations of distance, area, circumference, volume, time, and blood velocity. It also allows for the storage and retrieval of images for reviewing and printing.
The subject system enables the user to print and record images to an external recording device.
The subject system can identify and recognize the compatible Olympus transducers and display endoscopic and ultrasound images.
The basic design, system configuration, general operation and user interface of this subject system is substantially equivalent to the predicate devices.
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS
The subject system (OLYMPUS EU-ME2 PREMIER PLUS) combined with Ultrasound videoscopes or Ultrasound probes to make an endoscopic ultrasound imaging system that can acquire and display high-resolution and high-penetration, real-time ultrasound images of the target organs.
The subject system has modes of B, PWD, Color Doppler, Combined (combination of each operating mode), other (3-D Imaging and Harmonic Imaging) and Elastography function which visualizes the amount of strain in tissue (hardness of tissue) during compression and retraction.
The subject system provides measurements and calculations of distance, area, circumference, volume, time and blood velocity. It also allows for the storage and retrieval of images for reviewing and printing.
The subject system enables the user to print and record images to an external recording device. Additionally, the subject system enables the user to record movies to internal memory.
The subject system can identify and recognize compatible Olympus transducers and display endoscopic and ultrasound images.
The basic design, system configuration, general operation, and user interface of this subject system is substantially equivalent to the predicate devices.
6
5. INDICATIONS FOR USE
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/ EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS
This ultrasound center is intended to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images and indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree, and urinary tract.
B, PWD (Pulsed Wave Doppler), Color Doppler (including Power Doppler), Combined (combination of each operating mode) and other (3-D Imaging and Harmonic Imaging*). *Only for the EU-ME2 PREMIER PLUS.
Appropriately-trained healthcare professional.
Hospital.
6. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2
The subject device has the same fundamental scientific technology, principle of operation and energy source as the legally marketed ENDOSCOPIC ULTRASOUND CENTER (EU-Y0006) in K121564, with the following modifications. A side by side comparison of the subject device and the predicate device is provided in the table below.
| Item | Subject Device
OLYMPUS EU-ME2 | Predicate Device
EU-Y0006
(K121564) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | This ultrasound center is
intended to be used with
Olympus ultrasound
endoscopes, Olympus | This ultrasound center is
intended to be used with
Olympus ultrasound
endoscopes, Olympus |
| Item | Subject Device
OLYMPUS EU-ME2 | Predicate Device
EU-Y0006
(K121564) |
| | ultrasound probes or
Olympus esophageal
ultrasound probes to observe
and to store real-time
ultrasound images and
indicated for use within the
gastrointestinal (GI) tract,
biliary and pancreatic ducts
and surrounding organs,
airways and tracheobronchial
tree, and urinary tract
B, PWD (Pulsed Wave
Doppler), Color Doppler
(including Power Doppler),
Combined (combination of
each operating mode) and
other (3-D Imaging and
Harmonic Imaging*).
*Only for the EU-ME2
PREMIER PLUS.
Appropriately-trained
healthcare professional.
Hospital. | ultrasound probes or
Olympus esophageal
ultrasound probes to observe
and to store real-time
ultrasound images and
indicated for use within the
gastrointestinal (GI) tract,
biliary and pancreatic ducts
and surrounding organs,
airways and tracheobronchial
tree, and urinary tract. |
| Mode | B | B |
| | PW Doppler(PWD) | PW Doppler(PWD) |
| | Color flow
(Color Doppler) | Color flow
(Color Doppler) |
| | Power flow
(Power Doppler) | Power flow
(Power Doppler) |
| | Not applicable | Tissue harmonic echo
(Harmonic Imaging) |
| | Combined | Combined |
| | 3-D Imaging | 3-D Imaging |
| Item | Subject Device
OLYMPUS EU-ME2 | Predicate Device
EU-Y0006
(K121564) |
| Patient Contact
Material | None | None |
| 510(k) track | Track 3 | Track 3 |
| Outer Dimensions
(mm) | Main Unit :
445(w) X 495(d) X 184(h)
Keyboard :
392(w) X 207(d) X 39(h) | Main Unit :
445(w) X 500(d) X 183 (h)
Keyboard :
392(w) X 207(d) X 42(h) |
| Weight (kg) | 22.5 | 22 |
Table 1: Comparison of the Subject and Predicate Device
7
8
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS
The subject device has the same fundamental scientific technology, principle of operation and energy source as the legally marketed ENDOSCOPIC ULTRASOUND CENTER (EU-Y0008) in K130058, with the following modifications. A side by side comparison of the subject device and the predicate device is provided table below.
| Item | Subject Device
OLYMPUS EU-ME2
PREMIER PLUS | Predicate Device
EU-Y0008
(K130058) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | This ultrasound center is
intended to be used with
Olympus ultrasound
endoscopes, Olympus
ultrasound probes or
Olympus esophageal
ultrasound probes to observe
and to store real-time
ultrasound images and
indicated for use within the
gastrointestinal (GI) tract,
biliary and pancreatic ducts
and surrounding organs,
airways and tracheobronchial
tree, and urinary tract.
B, PWD (Pulsed Wave
Doppler), Color Doppler
(including Power Doppler), | This ultrasound center is
intended to be used with
Olympus ultrasound
endoscopes, Olympus
ultrasound probes or
Olympus esophageal
ultrasound probes to observe
and to store real-time
ultrasound images and
indicated for use within the
gastrointestinal (GI) tract,
biliary and pancreatic ducts
and surrounding organs,
airways and tracheobronchial
tree, and urinary tract. |
| Item | Subject Device | Predicate Device |
| | OLYMPUS EU-ME2
PREMIER PLUS | EU-Y0008
(K130058) |
| | Combined (combination of
each operating mode) and | |
| | other (3-D Imaging and | |
| | Harmonic Imaging*). | |
| | *Only for the EU-ME2
PREMIER PLUS. | |
| |
Appropriately-trained
healthcare professional. | |
| | | |
| |
Hospital. | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| Mode | B | B |
| | PW Doppler(PWD) | PW Doppler(PWD) |
| | Color flow
(Color Doppler) | Color flow
(Color Doppler) |
| | Power flow
(Power Doppler) | Power flow
(Power Doppler) |
| | Tissue harmonic echo
(Harmonic Imaging) | Tissue harmonic echo
(Harmonic Imaging) |
| | Combined | Combined |
| | 3-D Imaging | 3-D Imaging |
| Image function | Elastography | Elastography |
| Patient Contact | None | None |
| Material | None | None |
| 510(k) track | Track 3 | Track 3 |
| Outer Dimensions
(mm) | Main Unit :
445(w) X 495(d) X 184(h)
Keyboard :
392(w) X 207(d) X 39(h) | Main Unit :
445(w) X 500(d) X 183 (h)
Keyboard :
392(w) X 207(d) X 42(h) |
| Weight (kg) | 22.5 | 22 |
Table 2: Comparison of the Subject and Predicate Device
9
7. PERFORMANCE DATA
The following performance testing was conducted in support of the substantial equivalence determination.
10
7.1 Software verification and validation testing
Software verification and validation testing was conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
7.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing was conducted in accordance with the ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, and IEC 60601-2-18:2009 standards for safety, and IEC 60601-1-2:2014 standards for EMC and IEC 60601-2-37:2015.
7.3 Performance testing - Animal
No animal study was performed to demonstrate substantial equivalence.
7.4 Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
7.5 Risk management
Risk management was performed in accordance with ISO 14971:2007, and a human factors validation was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices". The design verification tests and their acceptance criteria were identified and performed as a result of this risk management.
8. CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, the subject device raises no new issue of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, effectiveness and performance.