(295 days)
Diagnostic ultrasound imaging of the human body as follows: Fetal, Abdominal, Cardiac Adult. Mode of Operation: B mode for Fetal and Abdominal, M mode for Cardiac Adult.
Model CTS-200 is a compact-type linear electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows abdominal organ and fetal images to be observed on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a full keyboard, 9inch video monitor and a special photographic unit.
The provided document K963068 is a Premarket Notification [510(k)] Summary for the SIUI CTS-200 Diagnostic Ultrasound System with EZU-PL21 Transducer. It focuses on demonstrating substantial equivalence to a predicate device, the Hitachi Medical Corporation EUB-240 (K862164), rather than providing detailed acceptance criteria and a study to prove the device meets those criteria in the way one might expect for a novel AI/software device.
Instead of traditional acceptance criteria and a study demonstrating performance against them, the document presents a "Comparison List" of the SIUI CTS-200 and the Hitachi EUB-240, highlighting that the SIUI device's technological characteristics are similar to those of the predicate device. The underlying assumption for 510(k) clearance is that if a new device is substantially equivalent to a legally marketed predicate device, it is as safe and effective as the predicate. The "acceptance criteria" here are essentially the specifications and functionalities of the predicate device.
Here's a breakdown based on the provided text, addressing your questions to the extent possible, and acknowledging what information is not present in a 510(k) summary focused on substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for the SIUI CTS-200 are implicitly the performance specifications and safety standards of the predicate device, the Hitachi EUB-240. The reported device performance for the SIUI CTS-200 is presented next to the predicate's specifications to demonstrate similarity.
| Acceptance Criteria (Predicate: Hitachi EUB-240 Specifications) | Reported Device Performance (SIUI CTS-200) |
|---|---|
| Scanning Mode: Electronic linear scanning (compatible 64 elements linear probe) | Electronic linear scanning (compatible 64 elements linear probe) |
| Display Mode: B, B/B, M, B/M mode simultaneously | B, B/B, M, B/M mode simultaneously |
| Measurement (B mode): Distance, area, circumference | Distance, area, circumference |
| Measurement (M mode): Time interval, velocity, heart rate | Time interval, velocity, heart rate |
| Calculation: Area, circumference, volume, heart rate, pregnant weeks | Area, circumference, volume, heart rate, pregnant weeks |
| Focusing Mode: 4-steps focusing with variable aperture and lens focusing | 4-steps focusing with variable aperture and lens focusing |
| Scanning Width (3.5MHz probe): 102mm | 102mm |
| Transmitting Voltage: Pulse height 120V | Pulse height 120V |
| Transmitting Pulse Width (3.5MHz): 190 us | 190 us |
| Detecting Depth (3.5MHz max): 200mm | 200mm |
| ZOOM Magnification: x1.0, x1.5, x2.0 selectable, depth shift | x1.0, x1.5, x2.0 selectable, depth shift |
| Frame Rate: Maximum 25 frame/second | Maximum 25 frame/second |
| Grey Scale: 16 | 16 |
| Memory: 256x512x4 bit | 256x512x4 bit |
| Video Output: PAL or NTSC system TV signal | PAL or NTSC system TV signal |
| Power Supply: 100V, 110V, 117V, 200V, 220V or 234V, ±10%, 50/60Hz, about 140W | 100V, 110V, 117V, 200V, 220V or 234V, ±10%, 50/60Hz, about 140W |
| Monitor: 9" black and white monitor | 9" black and white monitor |
| Cursor Shift: By 9 cursor shift keys | By 9 cursor shift keys |
| Electrical Safety Standard: Conform to IEC 601-1 Class I, B type apparatus | Conform to IEC 601-1 Class I, B type apparatus |
| Transducer: EZU-PL21: 64 elements 3.5MHz linear probe | EZU-PL21: 64 elements 3.5MHz linear probe |
| Operation Environment: Temperature 5-40° C, relative humidity 30-85% | Temperature 5-40° C, relative humidity 30-85% |
| Storage Environment: Temperature -10-60° C, relative humidity 30-95%, air pressure 700-1060 mB | Temperature -10-60° C, relative humidity 30-95%, air pressure 700-1060 mB |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For ultrasound systems demonstrating substantial equivalence rather than a new clinical claim, extensive clinical "test sets" in the way an AI/software device would have them are typically not required unless there are significant changes in technology or intended use that could affect safety or effectiveness. The comparison is primarily based on technical specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. This type of detail is usually part of a clinical validation study for devices requiring human interpretation, which is not the primary focus of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As above, this is relevant for clinical validation studies involving human interpretation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done, nor is it applicable here. This document is for a diagnostic ultrasound system, not an AI-assisted interpretation device. The purpose is to show the device is substantially equivalent to an existing ultrasound system, not to show improved human reader performance with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a diagnostic ultrasound system, not an AI algorithm for standalone performance. Its performance is inherent in its imaging capabilities and technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in the context of clinical studies (e.g., for AI devices) is not applicable to this 510(k) submission. The comparison is based on technical specifications and safety standards of the device itself relative to a predicate.
8. The sample size for the training set
This information is not provided and is not applicable to a traditional medical device 510(k) submission for an ultrasound system, which does not involve machine learning "training sets."
9. How the ground truth for the training set was established
This information is not provided and is not applicable to this type of device submission.
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Image /page/0/Picture/1 description: The image shows the word "SIUI" in a bold, textured font. The letters are large and take up most of the frame. The texture of the letters gives them a slightly rough or distressed appearance.
汕頭頂 南昌 南昌 南昌 南昌 南昌 南昌 南昌 南昌
MAY 2 9 1997
Premarket Notification [510(k)] Summarv
July 30, 1996 (revised 5/6/97)
Trade Name: CTS-200 with EZU-PL21 Transducer
Common Name: Diagnostic Ultrasound System
SHANTOU INSTITUTE C
Ultrasonic Pulsed Echo Imaging System, 90 IYO Classification Name: (per 21 CFR section 892.1560)
Shantou Institute of Ultrasonic Instruments Manufacturer's Name: #2. Jinsha Road. M., Address: Shantou Sez, 515041, China
Corresponding Official: Mr. Jinzhong Yao Title: President
Fax: (86) 754-8251499 Telephone: (86) 754-8250150
Hitachi Medical Corporation EUB-240, K862164 Predicate:
Device Description: Model CTS-200 is a compact-type linear electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows abdominal organ and fetal images to be observed on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a full keyboard, 9inch video monitor and a special photographic unit.
Intended Use: Ultrasonic pulsed echo imaging and measurement for fetal and abdominal imaging and adult cardiac M-mode.
Technological Characteristics: See the attached "Comparison List" of the SIUI CTS-200 and the Hitachi EUB-240.
御蔵 家居TEL: (0754) 8250150 感 誕生4K (0754) 3581498
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COMPARISON LIST OF SIUI PRODUCT AND HITACHI PRODUCT
1 2 3 3 1 3
| Performance | CIS-200 (portable) (SIUI) | EUB-240 (HITACHI) | |||||
|---|---|---|---|---|---|---|---|
| mainuni t | scanning mode | electronic linear scanning (compa-tible 64 elements linear probe) | electronic linear scanning (compa-tible 64 elements linear probe) | ||||
| display mode | B mode, B/B mode, M mode, B/M modesimutaneous ly | B mode, B/B mode, M mode, B/M modesimutaneouslyin B mode display: distance, areaand circumferencein M mode display: time interval,velocity and heart ratearea, circumference, volume, heartrate and pregnant weeks4-steps focusing with variableaperture and lens focusing | |||||
| measurement | in B mode display: distance, areaand circumferencein M mode display: time interval,velocity and heart rate. | ||||||
| caculation | area, circumference, volume, heartrate and pregnant weeks | ||||||
| focusing mode | 4-steps focusing with variableaperture and lens focusing | ||||||
| scanning width | 3. 5MHz probe: 102mm | 3.5MHz probe: 102mm5 MHz probe: 56mm | |||||
| transmittingvoltage | pulse height 120V | pulse height 120V | |||||
| transmittingpulse width | 3.5MHz pulse width 190 us | 3.5MHz pulse width 190 us5MHz pulse width 144 u s | |||||
| detectingdepth | 3.5MHz maximum depth: 200mm | 3. 5MHz maximum depth: 200mm5MHz maximum depth: 180mm | |||||
| ZOODmagnification | 11.0, x1.5, x2.0 selectable aswell as depth shift | x1.0, x1.5, x2.0 selectable aswell as depth shift | |||||
| frame rate | the maximum is 25 frame/second | the maximum is 25 frame/second | |||||
| grey scale | 16 | 16 | |||||
| memory | 256x512x4 bit | 256x512x4 bit | |||||
| video output | PAL or NTSC system TV signal(confirmed in order) | PAL or NTSC system TV signal(comfirmed in order) | |||||
| power supply | 100V, 110V, 117V, 200V, 220V or234V, ±10%, 50/60Hz, about 140W | 110V, 117V, 200V, 220V or100V.±10%, 50/60Hz, about 140W234V, | |||||
| monitor | 9" black and white monitor | 9" black and white monitor | |||||
| volume andweight | 280 (w) x235 (1) x415 (h) mmapprox.13kg | 400 (w) x720 (1) x1290 (h) mmapprox. 65kg | |||||
| cursor shift | by 9 cursor shift keys t , 1 . - .-. / . . / . \ and FAST | by 9 cursor shift keys t , 1 , - ,+, / , , / , \ and FAST |
:
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| Performance | CTS-200 (portable) (SIUI) | EUB-240 (HITACHI) |
|---|---|---|
| main electricunit apparatussaftystandard | conform to requirement of I classB type apparatus of IEC 601-1isolate resistor testing: testingvoltage 1000V L-L, L-G>10MΩleakage current: U-G<500 μAP-G<100 μAvoltage resistance testing: L-G,P-G, 1500V 2mA, no sparking orarcing in 1 minutework normally when voltage changes±10% | conform to requirement of I classB type apparatus of IEC 601-1isolate resistor testing: testingvoltage 1000V L-L, L-G>10MΩleakage current: U-G<500 μAP-G <100 μAvoltage resistance testing: L-G,P-G, 1500V 2mA, no sparking orarcing in 1 minutework normally when voltage changes±10% |
| probe (compatible) | EZU-PL21: 64 elements 3.5MHz linearprobe | EZU-PL21: 64 elements 3.5MHz linearprobeEZU-PL22: 64 elements 3.5MHz linearprobe |
| operationenvironment | temperature 5-40° C, relativehumidity 30-85% (no water drop) | temperature 5-40° C, relativehumidity 30-85% (no water drop) |
| storageenvironment | temperature -10-60° C, relativehumidity 30-95% (no water drop)air pressure 700-1060 mB | temperature -10-60° C, relativehumidity 30-95% (no water drop)air pressure 700-1060mB |
COMPARIS ON LIST OF SIUI PRODUCT AND HITACHI PRODUCT
a ma
10000 .
· U means main unit.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head, representing the department's commitment to health, services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
9200 Corporate Boulevard Rockville MD 20850
Food and Drug Administration
MAY 2 9 1997
Shantou Institute of Ultrasonic Instruments c/o Robert J. Morton, President Quality and Regulatory Services 1106 Chiltern Drive Walnut Creek, CA 94596
Re: K963068
CTS-200 Diagnostic Ultrasound System with Model EZU-PL21 Dated: May 9, 1997 Received: May 12, 1997 Regulatory Class: II 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX
Dear Mr. Morton:
We have reviewed your section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the CTS-200 Diagnostic Ultrasound System as described in your premarket notification:
Transducer Model Number
EZU-PL21 (3.5MHz)
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Foderal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
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Page 2 - Mr. Robert Morton
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours.
David h. Tyson
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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510(k) Number (if known): K963068 5.0(x) Name:Transducer Model 3.5MHz EZU-PL21 for CTS-200
Pill out one form for each ultrasound system or transducer.
Indications For Use:
Diagnostic ultrasound imaging MXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX (Specify) of the human body as follows: Mode of Operation
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined.(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | X | |||||||||
| Abdominal | X | |||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | X | |||||||||
| Cardiac Pediatric | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic |
DO NOT WRITE BELOM THIS LINE-CONTINUE ON ANOTHER PAGE IP NEED Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per /21 CFR 80
Uhmil a. Seyyom
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K963068
L-1
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.