(28 days)
Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular and muscular-skeletal applications.
The SIUI CTS-900 is a digital diagnostic ultrasound system capable of the following operating modes: 2D (B mode) and B/M. The system is designed for use in linear and convex scanning modes and supports linear, and convex transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities. The system consists of probes, main unit, control panel and monitor.
This document, K081110, is a 510(k) Premarket Notification for the SIUI CTS-900 Digital Ultrasound Imaging System. It focuses on establishing substantial equivalence to previously cleared predicate devices (SIUI CTS-7700, K061083 and K070982) rather than conducting a de novo study with specific acceptance criteria and performance data for new clinical claims. Therefore, the information provided does not contain a study that proves the device meets specific performance acceptance criteria in the manner typically found in a clinical validation study for a new diagnostic claim or AI/CADe device.
Here's an analysis based on the provided text, addressing your points where possible, and noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for substantial equivalence of an ultrasound system, the "acceptance criteria" are implicitly met by demonstrating that the device has the same technological characteristics and intended uses as the predicate devices. The document does not specify quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy) like those for an AI or CADe device. Instead, the performance is assumed to be equivalent to the predicate devices for the listed clinical applications.
| Feature/Criterion | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (as listed in document) |
|---|---|---|
| Intended Use | Equivalent to predicate (K061083, K070982) for: Abdominal, Pediatric, Small organ, Cardiac, Peripheral vascular, Muscular-skeletal. | Confirmed for: Abdominal, Pediatric, Small Organ (thyroid, testes, breast), Cardiac, Peripheral Vascular, Muscular-Skeletal (Conventional, Superficial), Fetal, Uterus, Ovary, Prostate. |
| Operating Modes | Equivalent to predicate (B mode, M mode, combined B/M) | 2D (B mode), B/M mode |
| Transducers Supported | Equivalent to predicate | C3L60B (2.5-5.0 MHz 60R 128e convex), L7L38B (5.0-9.0 MHz 38mm 128e linear) |
| Focus Mode | Equivalent to predicate | Transmit focus (1-4 selectable, variable depth), Receive focus (dynamic) |
| Grey Scale | Equivalent to predicate | 256 |
| Pre-processing | Equivalent to predicate | 32-channel digital beam-former, Receive gain (70dB), Dynamic range (35-66dB), Edge enhancement (4 steps), Image persistence (7 steps), Line density (normal, high) |
| Post-processing | Equivalent to predicate | 10 types of gray maps (4 user-definable) |
| Image Manipulation | Equivalent to predicate | Real-time zoom (x4.0 max), Frozen image |
| B/M-mode speed | Equivalent to predicate | Time for full screen scroll: 1.2, 2.5, 5.0, 10.0 sec |
| Cine Capacity | Equivalent to predicate | Max. 256 frames |
| Image Store & Recall | Equivalent to predicate | 32 frames |
| Image Orientation | Equivalent to predicate | Left/right flip, Up/down flip, 90-degree rotation (0, 90, 180, 270 degrees) |
| Documentation & Storage | Equivalent to predicate | 60GB HDD (BMP), USB memory (BMP), B&W video printer |
| Measurements & Calculations | Equivalent to predicate | General 2D: Distance, Area, Circumference, Angle. General M-Mode: Distance, Time, Slope, Heart rate. Specific: Abdomen, Obstetrics, Gynecology, Cardiology, Small parts, Peripheral Vascular. |
The study that "proves" the device meets these criteria is the substantial equivalence comparison to the predicate devices, not a new clinical study with defined performance metrics. The core argument is summarized in the FDA's letter (K081110): "We have reviewed your Section 510(k) premarket notification... and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This submission relies on substantial equivalence. There is no mention of a dedicated "test set" of patient data for performance evaluation in the context of a new diagnostic claim. The "data" evaluated would have been the technical specifications and clinical indications of the device itself and the predicate devices.
- Data Provenance: Not applicable. The FDA reviewed technical specifications and claims against predicate devices. If any internal testing or demonstrations were performed, their details are not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no "ground truth" to establish for a test set in the context of this 510(k) submission. The FDA's determination is based on the comparison of the device's design, technology, and intended use to that of already cleared devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring expert adjudication is mentioned.
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
- Not applicable. This is not an AI/CADe device, and no MRMC study was conducted or referenced in this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is an ultrasound imaging system, not an algorithm, and no standalone performance study in this context was performed.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the sense of a clinical validation study. The "ground truth" for the FDA's decision is the established safety and effectiveness of the legally marketed predicate devices to which the SIUI CTS-900 is compared.
8. The sample size for the training set
- Not applicable. This device is an imaging system and does not involve AI or machine learning that would require a "training set" of data in the manner you're describing.
9. How the ground truth for the training set was established
- Not applicable, for the same reasons as point 8.
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SIUI CTS-900 Digital Ultrasound Imaging System
MAY 1 6 2008
Section 7 510(k) Summary of Safety and Effectiveness
| Trade Name: | CTS-900 with C3L60B and L7L38B Transducers |
|---|---|
| Common Name: | Digital Ultrasound Imaging System |
| Classification Name: | Ultrasonic Pulsed Echo Imaging System, IYO(Per 21 CFR section 892.1560)Diagnostic Ultrasonic Transducer, ITX(Per 21 CFR section 892.1570) |
| Manufacturer's Name: | Shantou Institute of Ultrasonic Instruments |
| Address: | #77, Jinsha Road,Shantou, Guangdong 515041, China |
| Corresponding Official: | Flower Cai |
| Title: | Overseas Cooperation Supervisor |
| Telephone: | (86) 754- 8250150 Fax: (86) 754-8251499 |
| US Agent: | Bob Leiker/ Consultant /QRSDublin, CA 94568Telephone: 1-925-556-1302 Fax: 1-866-718-3819 |
| Predicate Device: | SIUI CTS-7700 , K061083 and K070982 |
Device Description: The SIUI CTS-900 is a digital diagnostic ultrasound system capable of the following operating modes: 2D (B mode) and B/M. The system is designed for use in linear and convex scanning modes and supports linear, and convex transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities. The system consists of probes, main unit, control panel and monitor.
Intended Use: Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular and muscular-skeletal applications.
Technological Characteristics:
-
- Scanning modes: convex and linear scanning
-
- Display modes:
- a) B-Mode (B, 2B)
- b) B/M-Mode
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-
- Supporting transducers:
- a) C3L60B: 2.5-5.0 MHz 60R 128e convex transducer
- b) L7L38B: 5.0-9.0 MHz 38mm 128e linear transducer
-
- Focus mode:
- a) Transmit focus mode:
- 1-4 selectable, focus depth: variable
- b) Receive focus mode: dynamic focus
-
- Grey scale: 256
-
- Pre-processing:
- 32-channel digital beam-former: a)
- Receive gain (include TGC): 70dB b)
- Dynamic range: 35-66dB c)
- Edge enhancement: 4 steps d)
- Image persistence: 7 steps e)
- Line density: normal, high f)
-
- Post-processing
10 types of gray maps, among which 4 types are user-definable
-
- Image manipulation:
- a) Real-time zoom in x4.0 max.
- b) Frozen image
-
- B/M-mode speed:
Time for full screen scroll: 1.2, 2.5, 5.0, 10.0 sec
- 10)Cine: Max. 256 frames
- 11)Image store and recall: 32 frames
- 12)Image orientation:
- c) Left/right flip
- d) Up/down flip
- e) 90-degree rotation (selectable steps: 0, 90, 180. 270 degrees)
13)Documentation and storage:
- a) 60GB HDD, images stored in BMP file format;
- b) USB interface memory, images stored in BMP file format
- c) Documentation devices:
- d) B&W video printer
14)Measurements and calculations
-
a) General measurements and calculations 2D: Distance, Area, Circumference, and Angle M-Mode: Distance, Time, Slope, Heart rate
-
b) Specific measurements and calculations Abdomen, Obstetrics, Gynecology, Cardiology, Small parts, Peripheral Vascular.
-
510(k) Summary of Safety and Effectiveness
Page 2 of 2
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shantou Institute of Ultrasonic Instruments (SIUI) % Mr. Bob Leiker Consultant Quality & Regulatory Services 7263 Cronin Circle DUBLIN CA 94568
Re: K081110
Trade/Device Name: SIUI CTS-900 Digital Ultrasound Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: April 15, 2008 Received: April 18, 2008
Dear Mr. Leiker:
We have reviewed your Section 510(k) premarket 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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
MAY 1 6 2008
This determination of substantial equivalence applies to the following transducers intended for use with the SISU CTS-900 Digital Ultrasound Imaging System as described in your premarket notification:
Transducer Model Number
Convex Array C3L60B Linear Array L7L38B
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (cnclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Sundar Rajan at (240) 276-3666.
Sincerely yours.
Vorui M. Whag
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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SIUI CTS-900 Digital Ultrasound Imaging System Diagnostic Ultrasound Indications for Use Form
1. System Indications for Use Form
Device Name: CTS-900
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | Power | Color | Combined | Other |
| Doppler | (Amplitude) | Velocity | (Specify) | (Specify) | ||||||
| Doppler | Imaging | |||||||||
| Opthalmic | ||||||||||
| Fetal | P1 | P1 | ||||||||
| Abdominal | P1 | P1 | ||||||||
| IntraOperative | ||||||||||
| (Cardiac) | ||||||||||
| IntraOperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P1 | P1 | ||||||||
| Small Organ | P1 | P1 | ||||||||
| (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P1 | P1 | ||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral Vascular | P1 | P1 | ||||||||
| Laparascopic | ||||||||||
| Muscular-Skeletal | P2 | P2 | ||||||||
| Conventional | ||||||||||
| Muscular-Skeletal | P2 | P2 | ||||||||
| Superficial | ||||||||||
| Others (Specify) | P1 | P1 |
N=new indication
:
E=added under Appendix E
P1=previously cleared by FDA (K061083)
E=added under Appendix E
P2=previously cleared by FDA (K070982)
Additional Comments: Small organs include: thyroid, testes, breast Combined: B/M Mode
Other uses include: Uterus, Ovary, and Prostate
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, office of Device Evaluation(((Division Sign-Off)
y
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _______________________________________________________________________________________________________________________________________________________________ KO81110
:ription Use (Per 21 CFR 801.109)
ગા 8
Indications For Use
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SIUI CTS-900 Digital Ultrasound Imaging System
Diagnostic Ultrasound Indications for Use Form
2. Transducer Indications for Use Form
Device Name: Convex Array C3L60B
Mode of Operation
| Clinical Application | A | B | M | PWD | CWD | Color | Power | Color | Combined | Other |
|---|---|---|---|---|---|---|---|---|---|---|
| Doppler | (Amplitude) | Velocity | (Specify) | (Specify) | ||||||
| Doppler | Imaging | |||||||||
| Opthalmic | ||||||||||
| Fetal | P1 | P1 | ||||||||
| Abdominal | P1 | P1 | ||||||||
| IntraOperative | ||||||||||
| (Cardiac) | ||||||||||
| IntraOperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P1 | P1 | ||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethrai | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparascopic | ||||||||||
| Muscular-Skeletal | ||||||||||
| Conventional | ||||||||||
| Muscular-Skeletal | ||||||||||
| Superficial | ||||||||||
| Others (Specify) | P1 | P1 |
N=new indication
E=added under Appendix E
P1=previously cleared by FDA (K061083) P2=previously cleared by FDA (K070982)
Additional Comments: other uses include: Uterus, Ovary and Prostate Combined: BIM Mode
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, office of Device Evaluation (ODE)
Jorge M. Ortiz
Division of Reproductive, Abdominal and Radiological Devices Kog 1110 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109) Section 8
Indications For Use
Page 3 of 4
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SIUI CTS-900 Digital Ultrasound Imaging System
Diagnostic Ultrasound Indications for Use Form
3. Transducer Indications for Use Form
Device Name: Linear Array L7L38B
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| IntraOperative(Cardiac) | ||||||||||
| IntraOperativeNeurological | ||||||||||
| Pediatric | P1 | P1 | ||||||||
| Small Organ(Specify) | P1 | P1 | ||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral Vascular | P1 | P1 | ||||||||
| Laparascopic | ||||||||||
| Muscular-SkeletalConventional | P2 | P2 | ||||||||
| Muscular-SkeletalSuperficial | P2 | P2 | ||||||||
| Others (Specify) |
Mode of Operation
N=new indication
E=added under Appendix E
P1=previously cleared by FDA (K061083) P2=previously cleared by FDA (K070982) Additional Comments: Small organs include: thyroid, testes, breast Combined: B/M Mode
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, office of Device Evaluation (ODE)
Ibrú Mthz
(Division Sian-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number Page 4 of 4
Prescription Use (Per 21 CFR 801.109) Section 8
Indications For Use
§ 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.