(266 days)
No
The document describes a standard ultrasound system with various imaging modes and measurement tools, but there is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is described as a "Digital Ultrasonic Diagnostic Imaging System" intended for "ultrasound imaging, measurement, display and fluid flow analysis of the human body," indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" explicitly states "Digital Ultrasonic Diagnostic Imaging System (Model: F6) is a general use ultrasound device intended for use by appropriately qualified and trained healthcare professionals for ultrasound imaging, measurement, display and fluid flow analysis of the human body." Also, the "Device Description" mentions that the system "contains measurement of anatomical structures and analysis packages, which can offer diagnosticians detailed and useful information." Additionally, a predicate device, K102991, is named "SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD M5 DIAGNOSTIC ULTRASOUND SYSTEM," and clinical accuracy performance is mentioned in the safety testing.
No
The device description explicitly states it includes hardware components such as the ultrasound equipment, transducer, adapter, standard keyboards, touch panels, buttons, display screen, and different types of transducers. It is a physical ultrasound system, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The description clearly states that this device is a "Digital Ultrasonic Diagnostic Imaging System." Its function is to perform ultrasound imaging, measurement, display, and fluid flow analysis of the human body. This is done inside the body (in vivo) using sound waves.
- Intended Use: The intended use is for "ultrasound imaging, measurement, display and fluid flow analysis of the human body." This is a diagnostic imaging modality, not an in vitro test.
- Device Description: The description details components like transducers and the process of generating images of tissues, organs, and blood flow within the body.
The information provided consistently describes a diagnostic imaging device that operates on the human body directly, which is the opposite of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Digital Ultrasonic Diagnostic Imaging System (Model: F6) is a general use ultrasound device intended for use by appropriately qualified and trained healthcare professionals for ultrasound imaging, measurement, display and fluid flow analysis of the human body. Specific clinical applications and exam types include: Abdominal, Obstetrics, Gynaecology, Small Parts (breast, thyroid, etc.), Peripheral Vascular, Urology. Modes of operation include B mode, M mode, Color Doppler, Power Doppler, PWD and Combined (B+M; B+CD; B+PWD). This system is suitable for use in hospital and clinical settings.
Product codes
IYN, IYO, ITX
Device Description
The Digital Ultrasonic Diagnostic Imaging System is designed to be portable notebook ultrasound systems and mainly include the ultrasound equipment, transducer and adapter. The equipment to complete the ultrasonic imaging function, host completes the image display, measurement, patient information, image storage, and other applications Standard keyboards, touch panels, and buttons, as well as multifunctional editors, mainly control device operations. The display screen is used to display work interfaces, images, and parameters. Different interfaces are used to connect transducers, other devices, or power supplies. There are four different types of transducers, namely large convex, linear array, Micro convex, Intracavity, the frequency scope of different transducers is from 2.5MHz to 11MHz. The system provides a variety of modes for flexibly selecting, which include B-mode, M-mode, Color-mode, Power-mode, PW-mode, and combined modes (i.e., B/M- mode). Real time image and dynamic changes of tissues, orqans or vessels will be showed in the image under B-mode, while coloring blood flow can be seen under Color-mode, PW-mode or Power-mode. M-mode is defined as time motion display of the ultrasound wave along a chosen ultrasound line.
The system not only provides real-time tissues, organs or blood flow images, but also contains measurement of anatomical structures and analysis packages, which can offer diagnosticians detailed and useful information.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Obstetrics, Gynaecology, Small Parts (breast, thyroid, etc.), Peripheral Vascular, Urology
Indicated Patient Age Range
For use in all patients
Intended User / Care Setting
appropriately qualified and trained healthcare professionals; hospital and clinical settings.
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)
Summary of Non-Clinical Tests:
Digital Ultrasonic Diagnostic Imaging System has been evaluated the safety and performance by lab bench testing as following:
- A IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- A 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
- ♪ 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
- A IEC 62133-2 Edition1.0 2017-02 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
-
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
-
ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
- A "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, Guidance for Industry and Food and Drug Administration Staff", February 21, 2023: Acoustic Output Test per FDA Guidance for Track 3
-
"Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff", June 14, 2023
- A "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, Guidance for Industry and Food and Drug Administration Staff", February 21, 2023: Clinical accuracy performance
Summary of Clinical Performance Test:
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
March 22, 2024
Image /page/0/Picture/11 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
GuangDong Youkey Medical Co., Ltd. % Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3. Minjie Plaza, Shuixi Road Huangpu District. Guangzhou CHINA
Re: K231930
Trade/Device Name: Digital Ultrasonic Diagnostic Imaging System (Model: F6) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: February 27, 2024 Received: February 27, 2024
Dear Cassie Lee:
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 (the 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 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).
1
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 QS 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.
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 (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,
Marjan Nabili -S
for
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
2
Indications for Use
510(k) Number (if known) K231930
Device Name
Digital Ultrasonic Diagnostic Imaging System
Indications for Use (Describe)
Digital Ultrasonic Diagnostic Imaging System (Model: F6) is a general use ultrasound device intended for use by appropriately qualified and trained healthcare professionals for ultrasound imaging, measurement, display and fluid flow analysis of the human body. Specific clinical applications and exam types include: Abdominal, Obstetrics, Gynaecology, Small Parts (breast, thyroid, etc.), Peripheral Vascular, Urology. Modes of operation include B mode, M mode, Color Doppler, Power Doppler, PWD and Combined (B+M; B+CD; B+PWD). This system is suitable for use in hospital and clinical settings.
| 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
510(k) Summary for K231930
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: GuangDong Youkey Medical Co., Ltd. Establishment Registration Number: 3025429169 Address: Unit 601, 6/F, Block B, Building 1, B1 District, Hantian Technology City, Dongping Road, Pingxi Shanghai Village, Guicheng Street, Nanhai District, Foshan City, Guangdong Province, China Tel: +(86)18971511819 Contact Person: Hu Zeyi E-mail: 2605171549@qq.com
Application Correspondent:
Contact Person: Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446
Date of the summary prepared: 3/22/2024
2. Subject Device Information
E-mail: 382198657@gq.com
Type of 510(k): Traditional
Trade Name: Digital Ultrasonic Diagnostic Imaging System
Model: F6
Common Name: Diagnostic Ultrasound System and Transducer
4
Classification name: Ultrasonic Pulsed Doppler Imaging System Review Panel: Radiology Product Code: IYN, IYO, ITX Regulation Class: II Regulation Number: 21 CFR 892.1550
3. Predicate Device Information
Primary Predicate Device:
Sponsor: GuangDong Youkey Medical Co., Ltd. Trade Name: Pocket Ultrasound System Common Name: Diagnostic Ultrasound System and Transducer Classification name: Ultrasonic Pulsed Doppler Imaging System 510(K) Number: K211746 Review Panel: Radiology Product Code: IYN, IYO, ITX Regulation Class: II Regulation Number: 21 CFR 892.1550 Reference Device 1: Sponsor: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Trade Name: M5 DIAGNOSTIC ULTRASOUND SYSTEM Common Name: Diagnostic Ultrasound System and Transducer Classification name: Ultrasonic Pulsed Doppler Imaging System 510(K) Number: K102991 Review Panel: Radiology Product Code: IYN, IYO, ITX Regulation Class: II Regulation Number: 21 CFR 892.1550 Reference Device 2: Sponsor: Healcerion Co., Ltd.
Trade Name: SONON Ultrasound Imaging System (Model: SONON 300C)
2 / 13
5
Common Name: Diagnostic Ultrasound System and Transducer Classification name: Ultrasonic Pulsed Doppler Imaging System 510(K) Number: K151339 Review Panel: Radiology Product Code: IYO, ITX Regulation Class: II Regulation Number: 21 CFR 892.1560 Reference Device 3 Sponsor: Healcerion Co., Ltd Trade Name: SONON Ultrasound Imaging System (Model: 300L) Common Name: Diagnostic Ultrasound System and Transducer Classification name: Ultrasonic Pulsed Doppler Imaging System 510(K) Number: K170085 Review Panel: Radiology Product Code: IYN, IYO, ITX Regulation Class: II Regulation Number: 21 CFR 892.1550
4. Device Description
The Digital Ultrasonic Diagnostic Imaging System is designed to be portable notebook ultrasound systems and mainly include the ultrasound equipment, transducer and adapter. The equipment to complete the ultrasonic imaging function, host completes the image display, measurement, patient information, image storage, and other applications Standard keyboards, touch panels, and buttons, as well as multifunctional editors, mainly control device operations. The display screen is used to display work interfaces, images, and parameters. Different interfaces are used to connect transducers, other devices, or power supplies. There are four different types of transducers, namely large convex, linear array, Micro convex, Intracavity, the frequency scope of different transducers is from 2.5MHz to 11MHz. The system provides a variety of modes for flexibly selecting, which include B-mode, M-mode, Color-mode, Power-mode, PW-mode, and combined modes (i.e., B/M- mode). Real time
6
image and dynamic changes of tissues, orqans or vessels will be showed in the image under B-mode, while coloring blood flow can be seen under Color-mode, PW-mode or Power-mode. M-mode is defined as time motion display of the ultrasound wave along a chosen ultrasound line.
The system not only provides real-time tissues, organs or blood flow images, but also contains measurement of anatomical structures and analysis packages, which can offer diagnosticians detailed and useful information.
5. Intended Use / Indications for Use
Digital Ultrasonic Diagnostic Imaging System (Model: F6) is a qeneral use ultrasound device intended for use by appropriately qualified and trained healthcare professionals for ultrasound imaging, measurement, display and fluid flow analysis of the human body. Specific clinical applications and exam types include: Abdominal, Obstetrics, Gynaecology, Small Parts (breast, thyroid, etc.), Peripheral Vascular, Urology. Modes of operation include B mode, M mode, Color Doppler, Power Doppler, PWD and Combined (B+M; B+CD; B+PWD). This system is suitable for use in hospital and clinical settings.
6. Test Summary
6.1 Summary of Non-Clinical Tests
Digital Ultrasonic Diagnostic Imaging System has been evaluated the safety and performance by lab bench testing as following:
- A IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
A 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
- ♪ IEC 60601-2-37 Edition 2.1 2015
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and
7
essential performance of ultrasonic medical diagnostic and monitoring equipment
-
A IEC 62133-2 Edition1.0 2017-02
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 -
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
-
ISO 10993-23 First edition 2021-01
Biological evaluation of medical devices - Part 23: Tests for irritation
- A "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, Guidance for Industry and Food and Drug Administration Staff", February 21, 2023: Acoustic Output Test per FDA Guidance for Track 3
-
"Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff", June 14, 2023
- A "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, Guidance for Industry and Food and Drug Administration Staff", February 21, 2023: Clinical accuracy performance
- 6.2 Summary of Clinical Performance Test
No clinical study is included in this submission.
7. Comparison to predicate device
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Digital Ultrasonic Diagnostic Imaging System is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
8
| Elements of
Comparison | Subject Device | Primary Predicate
Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Verdict |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Manufacturer | GuangDong Youkey
Medical Co., Ltd. | GuangDong Youkey
Medical Co., Ltd. | SHENZHEN
MINDRAY
BIO-MEDICAL
ELECTRONICS CO.,
LTD | Healcerion Co., Ltd. | Healcerion Co., Ltd. | -- |
| Trade Name
and model | Digital Ultrasonic
Diagnostic Imaging System
(model: F6) | Pocket Ultrasound
System (model:
P50,P51,P52,P53,P54,P
55,P56) | M5 DIAGNOSTIC
ULTRASOUND
SYSTEM | SONON Ultrasound
Imaging System
(model: 300C) | SONON Ultrasound
Imaging System
(model: 300L) | -- |
| 510(k) Number | K231930 | K211746 | K102991 | K151339 | K170085 | -- |
| Classification, Indications for Use and Intended Use | | | | | | |
| Classification
Product
Code | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | IYO, ITX | IYN, IYO, ITX | Same |
| Indications for | Digital Ultrasonic | Pocket Ultrasound | The M5 Diagnostic | The SONON | The SONON | Same |
| Elements of
Comparison | Subject Device | Primary Predicate
Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Verdict |
| Use | Diagnostic Imaging System
(Model: F6) is a general
use ultrasound device
intended for use by
appropriately qualified and
trained healthcare
professionals for ultrasound
imaging, measurement,
display and fluid flow
analysis of the human
body. Specific clinical
applications and exam
types include: Abdominal,
Obstetrics, Gynaecology,
Small Parts (breast, | System
(Model:P50,P51,P52,P5
3,P54,P55,P56) is
intended for use by an
appropriately trained,
qualified physician for
ultrasound evaluation.
Specific clinical
applications and exam
types include:
Abdominal, Obstetrics,
Gynaecology, Small
Parts (breast, thyroid,
etc), Peripheral
Vascular, Urology. This | Ultrasound System is
applicable for adults,
pregnant women,
pediatric patients and
neonates. It is
intended for- use in
abdomen,
gynecology,
obstetrics, small
parts (breast, testes,
thyroid, etc.),
pediatrics,
transcranial, cardiac,
peripheral
vascular, urology, | Ultrasound Imaging
System (Model:
SONON 300C) is
intended for diagnostic
ultrasound echo
imaging,
measurement, and
analysis of the human
body for general
clinical applications
including obstetrics
(OB), gynecology (GY)
and general
(abdominal) imaging. | Ultrasound Imaging
System (Model: 300L)
is intended for
diagnostic ultrasound
echo imaging,
measurement, and
analysis of the human
body for general
clinical applications
including
musculoskeletal
(MSK), vascular, small
parts (breast, thyroid),
and thoracic/pleural
motion and fluid | |
| Elements of
Comparison | Subject Device | Primary Predicate
Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Verdict |
| | thyroid, etc.), Peripheral
Vascular, Urology. Modes
of operation include B
mode, M mode, Color
Doppler, Power Doppler,
PWD and Combined (B+M;
B+CD; B+PD; B+PWD).
This system is suitable for
use in hospital and clinical
settings. | system is suitable for
use in hospital and
clinical settings. | orthopedics,
intracoperative and
musculoskeletal
(general and
superficial) exams. | | detection imaging. | |
| Technological Characteristics | | | | | | |
| Portability | Portable ultrasound system | Portable ultrasound
system | Portable ultrasound
system | Portable ultrasound
system | Portable ultrasound
system | Same |
| Duration of Use | Limited (