(295 days)
Diagnostic ultrasound imaging of the human body as follows: Fetal, Abdominal, Cardiac Adult (B mode, M mode)
Model CTS-285 is a compact-type linear/convex electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows adult heart, abdominal organ and fetal tomographic images to be observable 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, 9-inch video monitor and a special photographic unit.
This 510(k) premarket notification describes the CTS-285 Diagnostic Ultrasound System. The primary method for proving substantial equivalence to the predicate device, Hitachi Medical Corporation EUB-310 (K862867), is through a comparison of technological characteristics. There are no direct performance studies with acceptance criteria in the document that would be typical for AI/ML devices. Therefore, I will create a table to compare the reported specifications of the new device (SIUI CTS-285) against its predicate (Hitachi EUB-310A) to infer "acceptance criteria" based on the predicate's established performance, and then note the new device's "performance" based on its characteristics.
1. Table of Acceptance Criteria (Inferred from Predicate) and Reported Device Performance
| Feature/Parameter | Inferred Acceptance Criteria (Based on Hitachi EUB-310A) | Reported Device Performance (SIUI CTS-285) | Device Meets Criteria? |
|---|---|---|---|
| Scanning Modes | Electronic linear scanning (compatible 80 elements linear probe), Electronic convex sector (compatible convex probe of 80 elements) | Electronic linear scanning (compatible 64 elements linear probe), Electronic convex sector (compatible convex probe of 64 elements) | Partially (fewer elements) |
| Display Modes | B mode, B/B mode, M mode, B/M mode simultaneously | B mode, B/B mode, M mode, B/M mode simultaneously | Yes |
| Measurements (B-mode) | Distance, area, circumference | Distance, area, circumference | Yes |
| Measurements (M-mode) | Time interval, velocity, depth, heart rate | Time interval, velocity, depth, heart rate | Yes |
| Calculations | Area, circumference, volume, heart rate, pregnant weeks, heart function | Area, circumference, volume, heart rate, pregnant weeks, heart function | Yes |
| Focusing Mode | 4-steps dynamic focusing with variable aperture and lens focusing | 4-steps dynamic focusing with variable aperture and lens focusing | Yes |
| Scanning Width (3.5MHz linear) | 104mm | 102mm | Yes (within tolerance) |
| Scanning Width (Convex sector) | 60° | 60° | Yes |
| Transmitting Voltage | Pulse height 130V | Pulse height 130V | Yes |
| Transmitting Pulse Width (3.5MHz) | 140 μs | 160 μs | Yes (within acceptable range for diagnostic ultrasound) |
| Detecting Depth (3.5MHz) | Maximum 210mm | Maximum 210mm | Yes |
| Zoom (3.5MHz probe) | x1.0, x1.2, x1.5, x2.0 selectable, depth shift | x1.0, x1.2, x1.5, x2.0 selectable, depth shift | Yes |
| Frame Rate | Maximum 40 frame/second | Maximum 40 frame/second | Yes |
| Grey Scale | 16 | 16 | Yes |
| Memory | 512x512x4 bit | 512x512x4 bit | Yes |
| Video Output | PAL or NTSC system TV signal (confirmed in order) | PAL or NTSC system TV signal (confirmed in order) | Yes |
| Power Supply | 100-234V, ±10%, 50/60Hz, about 250W | 100-234V, ±10%, 50/60Hz, about 140W | Yes (lower power consumption is generally an advantage) |
| Monitor | 5.5" and 8" black and white monitor | 5.5" black and white monitor | Slightly lower (no 8" option) |
| Volume and Weight | Approx. 405(W)x710(L)x1310(H)mm, approx. 40kg | Approx. 280(W)x235(H)x415(L)mm, approx. 13kg | Yes (more compact and portable) |
| Electrical Safety Standard | Conform to requirement of I class B type apparatus of IEC 601-1; Isolate resistor testing: 1000V L-L, L-G>10MΩ; Leakage current: U-G<500 μA, P-G<100 μA; Voltage resistance testing: L-G, P-G 1500V 2mA, no sparking or arcing in 1 minute; Work normally when voltage changes ±10% | Conform to requirement of I class B type apparatus of IEC 601-1; Isolate resistor testing: 1000V L-L, L-G>10MΩ; Leakage current: U-G<500 μA, P-G<100 μA; Voltage resistance testing: L-G, P-G 1500V 2mA, no sparking or arcing in 1 minute; Work normally when voltage changes ±10% | Yes |
| Operation Environment | Temperature 5-40°C, relative humidity 30-85% (no water drop) | Temperature 5-40°C, relative humidity 30-50% (no water drop) | Yes (within range, but narrower humidity) |
| Storage Environment | Temperature -10-60°C, relative humidity 30-95% (no water drop), air pressure 700-1060mB | Temperature -10-60°C, relative humidity 30-95% (no water drop), air pressure 700-1060mB | Yes |
Summary of Device Performance Assessment:
The SIUI CTS-285 Diagnostic Ultrasound System demonstrates substantial equivalence to the Hitachi EUB-310A. Crucially, all core imaging and measurement capabilities (display modes, measurements, calculations, focusing, detecting depth, frame rate, grey scale, memory, video output, and electrical safety standards) meet or are comparable to the predicate device.
Minor differences exist:
- The SIUI device has fewer elements in its linear and convex probes (64 vs 80), which might slightly impact image resolution or field of view, but this is not considered a critical difference for substantial equivalence in this context, especially given the intended uses.
- The SIUI device is more compact and lighter, representing an improvement in portability.
- Its power consumption is lower.
- It offers only a 5.5" monitor compared to the predicate's 5.5" and 8" options.
- Its operational humidity range is narrower, but still within acceptable clinical conditions.
The document argues that these differences do not raise new questions of safety or effectiveness, therefore establishing substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This is a medical device premarket notification (510(k)) based on substantial equivalence, not an AI/ML device study. Therefore, there is no "test set" in the sense of a dataset for algorithmic performance evaluation. The "test" for substantial equivalence is primarily a comparison of the device's technological characteristics, intended use, and safety/effectiveness profile against a legally marketed predicate device.
The data provenance for the comparison is the specifications provided by the manufacturer of the SIUI CTS-285 and the publicly available specifications of the Hitachi EUB-310A (predicate device). This is considered retrospective in the sense that existing device specifications are being compared. The country of origin of the new device is China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As there is no "test set" or algorithmic performance evaluation in this 510(k) submission, no experts were used to establish ground truth for a test set. The "ground truth" for substantial equivalence is the established performance and safety of the predicate device.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of an algorithm's performance evaluation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for the substantial equivalence of a diagnostic ultrasound system based on its physical and functional specifications, not a study evaluating human reader performance with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a traditional ultrasound imaging system; it does not feature an AI algorithm.
7. The type of ground truth used
The "ground truth" for this 510(k) submission is the established safety and effectiveness profile, and technical specifications, of the legally marketed predicate device (Hitachi Medical Corporation EUB-310, K862867). The new device is deemed substantially equivalent if its differences do not raise new questions of safety or effectiveness.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device. There is no "training set."
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device. There is no "training set" or ground truth for such a set.
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K46 3065
11 10 10 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11
CHAMOT INSTITUTE OF ULTRASTRUCTURE
無障礙 強 印度 無因 三十
MAY 2 9 1997
Premarket Notification [510(k)] Summary
July 30, 1996 (Revised 5/6/97)
Trade Name: CTS-285 with EZU-PL21 and EZU-PC3B Transducers
Common Name: Diagnostic Ultrasound System
Classification Name: Ultrasonic Pulsed Echo Imaging System, 90 IYO (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
Telephone: (86) 754-8250150 Fax: (86) 754-8251499
Hitachi Medical Corporation EUB-310, K862867 Predicate:
Device Description: Model CTS-285 is a compact-type linear/convex electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows adult heart, abdominal organ and fetal tomographic images to be observable 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, 9-inch video monitor and a special photographic unit.
Intended Use: Ultrasonic pulsed echo imaging and measurement for fetal, abdominal, and adult cardiac imaging as well as adult cardiac M-mode.
Technological Characteristics: See the attached "Comparison List" of the SIUI CTS-285 and the Hitachi EUB-310.
関連アレア アスト 205 1459
했다.2087000만 51504 : idd: Jinsha Road i Frantiou China 路唯一中国有限市 在世界活 Program Collectors
・ベース か コウニミ:スク
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COMPARIS ON LIST OF SIUI PRODUCT AND HITACHI PRODUCT
الموالي
| Performance | CTS-285 (portable) (SIUI) | EUB-310A (HITACHI) | |
|---|---|---|---|
| mainunit | scanning mode | electronic linear scanning (compa-tible 64 elements linear probe)electronic convex sector (compatibleconvex probe of 64 elements) | electronic linear scanning (compa-tible 80 elements linear probe)electronic convex sector (compatibleconvex probe of 80 elements |
| display mode | B mode. B/B mode. M mode. B/M modesimultaneously | B mode. B/B mode. M mode. B/M modesimultaneously | |
| measurement | in B mode display: distance, areaand circumferencein M mode display: time interval,velocity, depth and heart rate | in B mode display: distance, areaand circumferencein M mode display: time interval,velocity, depth and heart rate | |
| calculation | area, circumference, volume, heartrate, pregnant weeks and heartfunction | area, circumference, volume, heartrate, pregnant weeks and heartfunction | |
| focusing mode | 4-steps dynamic focusing withvariable aperture and lens focusing | 4-steps dynamic focusing withvariable aperture and lens focusing | |
| scanning width | linear scanning: 3.5MHz probe 102mm.convex sector scanning probe: sectorangle 60° | linear scanning: 3.5MHz probe 104mm5MHz probe 61mmconvex sector scanning probe: sectorangle 60° | |
| transmittingvoltage | pulse height 130V | pulse height 130V | |
| transmittingpulse width | 3.5MHz pulse width 160 μs | 3.5MHz pulse width 140 μs5MHz pulse width 100 μs | |
| detectingdepth | 3.5MHz probe maximum depth: 210mm | 3.5MHz probe maximum depth: 210mm5MHz probe maximum depth: 140mm | |
| zoom | 3.5MHz probe: x1.0, x1.2, x1.5, x2.0selectable as well as depth shift | 3.5MHz probe: x1.0, x1.2, x1.5, x2.0selectable as well as depth shift5MHz probe: x1.0, x1.5, x2.0selectable as well as depth shift | |
| frame rate | the maximum is 40 frame/second | the maximum is 40 frame/second | |
| grey scale | 16 | 16 | |
| memory | 512x512x4 bit | 512x512x4 bit | |
| coordinatetransformationfunction | monitor can display electroniclinear scanning image or convexsector scanning image | monitor can display electroniclinear scanning image or convexsector scanning image | |
| Performance | CTS-285 (portable) (SIUI) | EUB-310A (HITACHI) | |
| mainunit | video output | PAL or NTSC system TV signal(confirmed in order) | PAL or NTSC system TV signal(confirmed in order) |
| power supply | 100V, 110V, 117V, 200V, 220V or234V, ±10%, 50/60Hz, about 140W | 100V, 110V, 117V, 200V, 220V or234V, ±10%, 50/60Hz, about 250W | |
| monitor | 5.5" black and white monitor | 5.5" and 8" black and white monitor | |
| volume andweight | 280(W)x235(H)x415(L)mmapprox. 13kg | 405(W)x710(1)x1310(H)mmapprox. 40kg | |
| cursor shift | by trackball on keyboard | by joystick on keyboard | |
| electricapparatussaftystandard | conform ot 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 ultrasoundtransmittingfrequency | linear probe:EZU-PL21 64 elements, 3.5MHz,scanning width 102mmConvex sector probe:EZU-PC3B 64 elements, 40R, 3.5MHz,scanning width 60° | linear probe:EZU-PL11 80 elements, 3.5MHzscanning width 104mmEZU-PL12 80 elements, 5MHzscanning width 61mmEUU-L11S 80 elements, 3.5MHzscanning width 84mmconvex sector probe:EZU-PC3A 80 elements, 40R, 3.5MHz,scanning angle 60°EZU-PC2A 80 elements, 40R, 5MHz,scanning angle 60°EUP-V12A 40 elements, 40R, 5MHz,scanning angle 40° (transverginalprobe) | |
| operationenvironment | temperature 5-40° C, relativehumidity 30-50% (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 700-1060mB | temperature -10-60° C, relativehumidity 30-95% (no water drop)air pressure 700-1060mB | |
| note |
31
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COMPARIS ON LIST OF SIUI PRODUCT AND HITACHI PRODUCT
transformation
:
. * U means main unit.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, representing care and protection.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shantou Institute of Ultrasonic Instruments c/o Robert J. Morton, President Quality and Regulatory Services 1106 Chiltern Drive Walnut Creek, CA 94596
MAY 2 9 1997
Re: K963065
CTS-285 Diagnostic Ultrasound System with Model EZU-PL 21 --and EZU-PC3B Transducers Dated: April 4, 1997 Received: April 7, 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-285 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
EZU-PL21 (3.5MHz) EZU-PC3B (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 (TDA) may publish further announcements concerning your device in the Federal 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 - Robert J. 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 "dsmo@fdadr.cdrh.fda.gov".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Ytanist A. Segram
Lillian Yin, Ph.D.
for
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) : __________________________________________________________________________________________________________________________________________________
Fill out one form for each ultrasound system or transducer.
Diagnostic ultrasound imaging XXXXOQQQWGXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX Indications For Use: (Specify) of the human body as follows:
Mode of Operation
| Clinical Application | Mode of Operation |
|---|---|
| ---------------------- | ------------------- |
| A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | X | |||||||||
| Abdominal | X | |||||||||
| Intra-operative (Specify) | ||||||||||
| Intra-operative Neurological | ||||||||||
| 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 |
Other Indications or Modes:(PLEASE DO NOT HRITE BELOW THIS LINE-CONTINUE ON ANSOTHER PAGE IF NEEDED! Coucurrence of CDRB. Office
Elmer A. DeYoung
(Division Sign-Off) Division of Reproductive, Abdominal. El and Radiological D
510(k) Number
Prescription Use (Per 21 CFR 801.109)
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510(k) Number (if known): K963065 510(k) Number (if known) : 1505005
Device Name :Transducer Model 3.5MHz EZU-PC3B for CTS-285
Fill out one form for each ultrasound system or transducer.
Diagnostic ultrasound imaging 예뻐서 예뻐서 있었고 있었 Indications For Use: (Specify) of the human body as follows:
Mode of Operation
| ClinicalApplication | A | B | M | PMD | CWD | CelarDoppler | 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 | X | ||||||||
| Cardiac Pediatric | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic |
(PLEASE DO NOT FRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE TP NEEDED Concurrence of CDRB. Office
David A. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
Prescription Use (Per 21 CFR 801.109)
§ 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.