(280 days)
Not Found
No
The summary does not mention AI, ML, or related terms like deep learning or neural networks. The description focuses on standard ultrasound technology and signal processing.
No
The device is described as an "Ultrasound Diagnostic System" intended for "ultrasound imaging, measurement, display and analysis," indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states "The ULTIMUS Series Ultrasound Diagnostic System is a general-purpose ultrasound system." and "This device is indicated for... diagnostic Ultrasound applications." The "Device Description" also mentions "The ULTIMUS series is a Track 3 diagnostic ultrasound system."
No
The device description explicitly states it consists of a mobile console with hardware components like a control panel, LCD touch panel, LCD display monitor, and electronic array transducers. It also mentions hardware for image storage.
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 (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: The ULTIMUS Series Ultrasound Diagnostic System is described as a general-purpose ultrasound system that uses ultrasound waves to create images of the inside of the human body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "ultrasound imaging, measurement, display and analysis of the human body and fluid." This is in vivo (within the living body) imaging, not in vitro (in glass/outside the body) analysis.
Therefore, the ULTIMUS Series Ultrasound Diagnostic System is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The ULTIMUS Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospitals or clinics environment.
The systems support the following clinical applications:
This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology; Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Adult Cephalic diagnostic Ultrasound applications.
Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The ULTIMUS Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, endocavity, and real time 3D transducer.
The ULTIMUS series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal; Fetal/Obstetrics; Gynecology; Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Adult Cephalic.
Indicated Patient Age Range
Adult, Child, Neonatal.
Intended User / Care Setting
Qualified and trained physician in hospitals or clinics environment.
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)
The subject of this premarket submission, did not require clinical studies to support substantial equivalence.
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 & 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 in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
December 16, 2024
Vinno Technology (Suzhou) Co.,Ltd Jeff Zhou Regulatory Registered Engineer 5F Building A.4F Building C No. 27 Xinfa Rd. Suzhou Industrial Park Suzhou, Jiangsu 215123 CHINA
Re: K240676
Trade/Device Name: ULTIMUS Series Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, Dated: June 3, 2024 Received: June 3, 2024
Dear Jeff Zhou:
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 (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 available 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
(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
3
Indications for Use
Mansanto
Submission Number (if known)
Device Name
ULTIMUS Series Ultrasound Diagnostic System
Indications for Use (Describe)
The ULTIMUS Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospitals or clinics environment.
The systems support the following clinical applications:
This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology; Transvaginal;
Urology(including prostate); Transrectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial);
Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Adult Cephalic diagnostic Ultrasound applications.
Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
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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Image /page/4/Picture/0 description: The image shows the logo for VINNO, a company that focuses on vision in innovation. The word "VINNO" is written in large, bold letters at the top of the logo. Below the company name, the words "VISION IN INNOVATION" are written in a smaller font. The logo is simple and modern, and it conveys the company's focus on innovation.
K240676 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date Prepared:
Manufacturer: | Feb 28, 2024
VINNO Technology (Suzhou) Co., Ltd
5F Building A, 4F Building C No. 27 XinFa Rd.
Suzhou Industrial Park, SuZhou 215123
Jiangsu China |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jeff Zhou
Regulatory Registered Engineer
VINNO Technology (Suzhou) Co., Ltd
Tel: +86 512 6287380
Fax: +86 512 62873801 |
email: Jeff.zhou@vinno.com
ldentification of the Device:
| Trade Name: | ULTIMUS Series Ultrasound Diagnostic System |
|---|---|
| Model Name: | ULTIMUS 9E、ULTIMUS 9P、ULTIMUS 9、ULTIMUS 8E、ULTIMUS 8P、ULTIMUS 8、ULTIMUS 7E、ULTIMUS 7P、ULTIMUS 7、ULTIMUS 6E、ULTIMUS 6P、ULTIMUS 6、ULTIMUS 5E、ULTIMUS 5P、ULTIMUS 5 |
| Classification Name: | Ultrasound Diagnostic System |
| Regulation Name: | Ultrasonic Pulsed Doppler Imaging System |
| Regulatory Number: | 21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 892.1570 |
| Product Code: | IYN, IYO, ITX |
| Device Class: | Class II |
| Review Panel: | Radiology |
Primary Predicate Device:
| Proprietary/Trade Name: | LOGIQ E10 |
|---|---|
| Classification Name: | Ultrasound Diagnostic System |
| Regulation Name: | Ultrasonic Pulsed Doppler Imaging System |
| Regulatory Number: | 21 CFR 892.1550, 21 CFR 892.1560, 21 CFR |
| 892.1570 | |
| Product Code: | IYN, IYO, ITX |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Submitter/510(k) Holder: | GE Medical Systems Ultrasound and Primary |
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Image /page/5/Picture/1 description: The image shows the logo for VINNO, a company that specializes in vision and innovation. The logo is composed of the company name in bold, sans-serif font, with the tagline "VISION in innovation" written in a smaller font size underneath. The logo is simple and modern, and it conveys the company's focus on innovation and technology.
Clearance:
Care Diagnostics, LLC K231966 (cleared Nov 07, 2022)
Device Description:
The ULTIMUS Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, endocavity, and real time 3D transducer.
The ULTIMUS series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage.
Indications for Use:
The ULTIMUS Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospitals or clinics environment.
The systems support the following clinical applications:
This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology; Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculoskeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Adult Cephalic diagnostic Ultrasound applications.
Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
Comparison with Predicate Device:
The ULTIMUS Series and its predicate device, the GE LOGIQ E10 Ultrasound Diagnostic System (K231966), have the equivalent intended use, and similar physical characteristics.
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Image /page/6/Picture/0 description: The image shows the logo for VINNO, a company that focuses on vision in innovation. The logo is in black and white, with the word "VINNO" in large, bold letters. Below the company name is the phrase "vision in innovation" in a smaller font. The logo is simple and modern, and it conveys the company's focus on innovation.
| Description | Subject Device | Predicate Device |
|---|---|---|
| ULTIMUS Ultrasound Diagnostic | ||
| System | GE LOGIQ E10 Ultrasound Diagnostic | |
| System (K231966) | ||
| Model | ULTIMUS 9E, ULTIMUS 9P, ULTIMUS | |
| 9, ULTIMUS 8E, ULTIMUS 8P, | ||
| ULTIMUS 8, ULTIMUS 7E, ULTIMUS | ||
| 7P, ULTIMUS 7, ULTIMUS 6E, | ||
| ULTIMUS 6P, ULTIMUS 6, ULTIMUS | ||
| 5E, ULTIMUS 5P, ULTIMUS 5 | LOGIQ E10 | |
| Indications | ||
| for use | The ULTIMUS Series Ultrasound | |
| Diagnostic System is a general- | ||
| purpose ultrasound system. It is | ||
| intended for use by, or under the | ||
| direction of a qualified and trained | ||
| physician for ultrasound imaging, | ||
| measurement, display and analysis of | ||
| the human body and fluid. The device | ||
| is intended for use in a hospitals or | ||
| clinics environment. | ||
| The systems support the following | ||
| clinical applications: | ||
| This device is indicated for Abdominal; | ||
| Fetal/Obstetrics; Gynecology; | ||
| Transvaginal; Urology(including | ||
| prostate); Transrectal; Cardiac(adult | ||
| and child); Peripheral Vascular; Small | ||
| Organs/Parts(thyroid, breast, testicle, | ||
| Musculo-skeletal Conventional and | ||
| Superficial); Pediatrics(including | ||
| neonatal cephalic); | ||
| interventional(nerve block and | ||
| vascular access); Adult Cephalic | ||
| diagnostic Ultrasound applications. | LOGIQ E10 is intended for use by a | |
| qualified physician for ultrasound | ||
| evaluation of Fetal / Obstetrics; | ||
| Abdominal (including Renal, | ||
| Gynecology/Pelvic); Pediatric; Small | ||
| Organ (Breast, Testes, Thyroid); | ||
| Neonatal Cephalic; Adult Cephalic; | ||
| Cardiac (Adult and Pediatric); | ||
| Peripheral V ascular; Musculo-skeletal | ||
| Conventional and Superficial; Urology | ||
| (including Prostate); Transrectal; | ||
| Transvaginal; Transesophageal and | ||
| Intraoperative (Abdominal and | ||
| Vascular). | ||
| The LOGIQ E10 is intended to be used | ||
| in a hospital or medical clinic. | ||
| User | ||
| qualification | Qualified healthcare professionals | Qualified physicians or sonographers |
| Environme | ||
| nt | hospitals or clinics environment | hospitals or clinics environment |
| Description | Subject Device | |
| ULTIMUS | ||
| Ultrasound | ||
| Diagnostic | ||
| System | Predicate Device | |
| GE LOGIQ E10 Ultrasound Diagnostic | ||
| System (K231966) | ||
| Design | This device is designed for the safety | |
| of the patient and operator. | ||
| This product is designed to fully comply | ||
| with the EN60601-1-2 (IEC60601-1-2), | ||
| Class A, in medical electric equipment | ||
| EMC regulations. | ||
| And compliance with IEC60601-1, | ||
| 60601-2-37 | This device is designed for the safety | |
| of the patient and opeartor. | ||
| This product is designed to fully | ||
| comply with the EN60601-1-2 | ||
| (IEC60601-1-2), | ||
| Class A, in medical electric equipment | ||
| EMC regulations. | ||
| And compliance with IEC60601-1, | ||
| 60601-2-37 | ||
| Patient | ||
| contact | ||
| materials | Material meet ISO 10993-1 and FDA | |
| guidance | Material meet ISO 10993-1 and FDA | |
| guidance | ||
| Operating | ||
| modes | • B mode | |
| • HAR mode | ||
| • M mode | ||
| • CF mode | ||
| • Multi-Angle M mode | ||
| • Color M(CM) mode | ||
| • PDI mode | ||
| • Tissue Doppler (TD) mode | ||
| • PW mode | ||
| • CW mode | ||
| • Tissue Velocity Imaging (TVI) mode | ||
| • Tissue Power Imaging (TPI) mode | ||
| • Tissue Velocity M (TVM) mode | ||
| • 3D/Free 3D mode | ||
| • 4D/ STIC mode | ||
| • Contrast Bubble Imaging(CBI)mode | ||
| • Elastography Imaging (EI) mode | ||
| • Pulse wave velocity imaging (PWV) | ||
| mode | ||
| • Strain and strain rate imaging mode | ||
| • Shear Wave Elastography (SWE) | ||
| mode (VShear) | • B-Mode (B) | |
| • Harmonics (HAR) | ||
| • M-Mode (M) | ||
| • Color Flow Mode (CF) | ||
| • M-Mode | ||
| • Color M mode | ||
| • Power Doppler Imaging (PDI) | ||
| • Tissue Doppler Imaging (TD) | ||
| • Pulse Wave Mode (PW) | ||
| • Continuous Wave Mode (CW) | ||
| • Tissue Velocity Imaging (TVI) | ||
| • Tissue Power | ||
| • Tissue Velocity Doppler (TVD) | ||
| • 3D/Easy 3D/Advance 3D/Tur 3D | ||
| • 4D mode | ||
| • Contrast Enhanced Ultrasound | ||
| (CEUS) | ||
| • Elastography (ELASTO) | ||
| • PW Doppler with High PRF (PW) | ||
| • Strain and strain rate imaging mode | ||
| • Shear Wave Elastography (SWE) | ||
| mode | ||
| Description | Subject Device | Predicate Device |
| ULTIMUS | ||
| Ultrasound | ||
| Diagnostic | GE LOGIQ E10 Ultrasound Diagnostic | |
| System | System (K231966) | |
| Functions | • Har mode | • Coded Harmonic Imaging, |
| • Steer | • Steering, | |
| • Vfusion | • CrossXBeam | |
| • Vspeckle | • SRI | |
| • Vsharpen | • Edge Enhance, | |
| • Persistence | • Frame Averaging, | |
| • GrayFilter | • Rejection, | |
| • Smooth | • B Softener, | |
| • Vtissue | • Suppression | |
| • 2D Automatic Optimization | • Auto Tissue Optimization: ATO, | |
| • PW automatic optimization | • Auto Spectrum Optimization: ASO, | |
| • Auto spectrum trace | • Doppler auto trace | |
| • Auto trace | • Auto trace | |
| • Tview | • Virtual Convex, | |
| • Pview | • LOGIQView, | |
| • Dual & Quad view | • Independent Dual B/PW Display, | |
| Quad Screen Display | ||
| • Image rotation, invert and zoom | • Zoom: Write/Read/Pan, Image | |
| Rotation | ||
| • Duplex and Triplex | • Duplex, Real-time Triplex Mode at | |
| any Depth and PRF, | ||
| • Stress echo | • Stress echo, | |
| • 4D rendering | • Render, Texture | |
| • Mcut | • Tomographic Ultrasound Imaging | |
| (TUI), | ||
| • Color 3D | • HDlive Flow | |
| • Light Lab | • HDlive Studio | |
| • VLuminous flowing | • Radiantflow™ | |
| • MCP(Micro Contrast Perfusion) | • MVI(CEUS) | |
| • SMF (Super Micro Flow) | • Micro Vascular Imaging | |
| Description | Subject Device | Predicate Device |
| ULTIMUS Ultrasound Diagnostic | ||
| System | GE LOGIQ E10 Ultrasound Diagnostic | |
| System (K231966) | ||
| Measureme | ||
| nt | Measurements: | |
| • Abdominal measurements | ||
| • Obstetrics Measurements | ||
| • Gynecology Measurements | ||
| • Cardiac Measurements | ||
| • Vessel measurements | ||
| • Urology Measurements | ||
| • Small organ measurements | ||
| • Pediatric Measurements | Categories include the following: | |
| • Abdomen | ||
| • Obstetrics | ||
| • Gynecology | ||
| • Cardiology | ||
| • Vascular | ||
| • Urology | ||
| • Small Parts | ||
| • Pediatrics | ||
| Probe types | Phased array S1-6P | |
| Convex array X2-6C | ||
| Micro convex (Endocavity) X4-9E | ||
| Linear array X6-16L | ||
| Volume convex array D2-6C | Sector Phased Array | |
| Convex Array | ||
| Micro convex Array | ||
| Linear Array | ||
| Volume Probes (4D) | ||
| Acoustic | ||
| output | Track 3; | |
| $Ispta.3 \le 720$ | ||
| mW/cm2 | ||
| $MI \le 1.9$ | ||
| $TI \le 6.0$ | Track 3; | |
| $Ispta.3 \le 720$ | ||
| mW/cm2 | ||
| $MI \le 1.9$ | ||
| $TI \le 6.0$ | ||
| Labeling | Conforms to 21 CFR Part 801 | Conforms to 21 CFR Part 801 |
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Image /page/7/Picture/0 description: The image shows the logo for VINNO, a company whose slogan is "Vision in Innovation". The logo is in black and white, with the word "VINNO" in large, bold letters. Below the company name is the slogan, which is written in a smaller font. The logo is simple and modern, and it conveys the company's focus on innovation.
8
Image /page/8/Picture/0 description: The image contains the logo for VINNO, a company whose slogan is "Vision in Innovation". The logo is in black and the text is in all capital letters. The word VINNO is in a larger, bolder font than the slogan below it.
9
Image /page/9/Picture/0 description: The image shows the logo for VINNO, a company focused on vision and innovation. The logo features the company name in bold, sans-serif font, with the tagline "VISION in innovation" written in a smaller font size underneath. The overall design is simple and modern, conveying a sense of technological advancement and forward-thinking.
Technology:
The ULTIMUS Series employs the same fundamental scientific technology as its predicated device.
Determination of substantial equivalence:
The Proposed ULTIMUS Series system are substantially equivalent to the predicate GE LOGIQ E10 Ultrasound Diagnostic System (K231966) with regards to intended use, indication for use, image capabilities, technological characteristics, image mode, and safety effectiveness.
The following is an overview of the differences between the proposed ULTIMUS Series and its predicate device.
Comparison Analysis
Note 1: Indications for use
Both the subject and predicate devices are used for the diagnostic ultrasonic imaging. The indications for use of the subject devices - ULTIMUS 9E, ULTIMUS 9P,ULTIMUS 9, ULTIMUS 8E, ULTIMUS 8P, ULTIMUS 8, ULTIMUS 7E, ULTIMUS 7P,
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Image /page/10/Picture/0 description: The image shows the logo for VINNO, a company that specializes in vision and innovation. The word "VINNO" is written in large, bold letters, with the words "VISION IN INNOVATION" written in smaller letters below it. The logo is simple and modern, and it conveys the company's focus on technology and innovation. The logo is black and white.
ULTIMUS 7, ULTIMUS 6E. ULTIMUS 6P. ULTIMUS 6, ULTIMUS 5E, ULTIMUS 5P. ULTIMUS 5 are covered by the indications for use of the predicate device. Transesophaqeal and Intraoperative are not intended to be used with the subject device. The less indication for use of the subject device does not impact safety and effectiveness.
Note2: Patient Contact Materials.
The Patient Contact Materials of probes is equivalent to the predicated device, both the subject and predicated device probe material meet ISO 10993-1 and FDA guidance requirement. They can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
The subjected device and the predicted device are identical in the indications for use, patient population, use environment, biocompatibility and electrical safety. They are similar in technical specification. The differences between the proposed device and the predicate device will not raise any new issues of safety or effectiveness.
Summary of Non-clinical test:
The ULTIMUS Series were evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standard. The ULTIMUS Series complies with voluntary standards:
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- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
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- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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- IEC/TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
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- 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
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- IEC62359, Ultrasonics-Field characterization- Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017.
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Image /page/11/Picture/0 description: The image shows the logo for VINNO, a company whose slogan is "Vision in Innovation". The logo is in black and white, with the company name in large, bold letters. The slogan is in smaller letters below the company name. The logo is simple and modern, and it conveys the company's focus on innovation.
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- ISO10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
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- ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
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- ISO10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
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- ISO14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
- 11.NEMAPS 3.1 3.20 2022d Digital I Imaging and Communications I in Medicine (DICOM) Set.
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- IEC60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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- IEC62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION 1 Medical devices - Part 1: Application of usability engineering to medical devices
- 14.IEC62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
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- ISTA 3E 2017 Similar Packaged-Products in Unitized Loads for Truckload Shipment
- 16.IEC 62133-2:2017+AMD1:2021 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
Summary of Clinical Tests:
The subject of this premarket submission, did not require clinical studies to support substantial equivalence.
Conclusion:
VINNO Technology (Suzhou) Co., Ltd Considers the ULTIMUS Series Ultrasound Diagnostic System to be as safe, as effective, and performance is substantially equivalent to the predicate device.