(49 days)
Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular applications
The SIUI CTS-7700 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.
Here's an analysis of the provided text regarding the SIUI CTS-7700 Digital Ultrasound Imaging System, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary, which is a premarket notification to the FDA. This type of document primarily focuses on demonstrating substantial equivalence to a previously cleared device, not necessarily providing a detailed study report with specific acceptance criteria and performance metrics as one might find in a clinical trial. Therefore, much of the requested information about formal acceptance criteria, specific studies, sample sizes, and ground truth establishment will not be explicitly present in this type of regulatory submission. The goal of a 510(k) is to show the new device is as safe and effective as a predicate device, often by comparing technical characteristics and intended uses.
Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary, the "acceptance criteria" are implicitly tied to demonstrating that the new device (CTS-7700) is "substantially equivalent" to its predicate device (SIUI CTS-485, K012772) and meets the general controls and classifications for an ultrasonic pulsed echo imaging system (21 CFR 892.1560) and diagnostic ultrasonic transducer (21 CFR 892.1570).
The "performance" isn't reported in quantitative metrics against specific thresholds but rather as a list of features and capabilities that are comparable to or an evolution of the predicate device.
| Acceptance Criteria (Implied from 510(k) Goals) | Reported Device Performance (Characteristics) |
|---|---|
| Substantial Equivalence: Maintain or improve upon the safety and effectiveness of the predicate device. | The device is deemed substantially equivalent to the SIUI CTS-485 (K012772) predicate device. Functionally, it offers 2D (B mode) and B/M modes, supports convex and linear scanning, and includes features like cine review, image zoom, measurements and calculations, image storage, printing, and recording. |
| Clinical Applications: Cover the intended use cases safely and effectively. | System: Abdominal, Pediatric, Small Organ (thyroid, testes, breast), Cardiac (Pediatric), Peripheral Vascular, and "Others" (uterus, ovary, prostate) applications are indicated for B and B/M modes. |
| Transducer Compatibility & Functionality: Ensure transducers operate as intended for specific applications. | C3L60B (Convex Array, 2.5-5.0 MHz): Fetal, Abdominal, Pediatric Cardiac, and "Others" (Uterus, Ovary, Prostate) for B and B/M modes. L7L38B (Linear Array, 5.0-9.0 MHz): Pediatric, Small Organ (thyroid, testes, breast), Peripheral Vascular for B and B/M modes. |
| Technical Specifications: Meet established standards for ultrasound imaging systems. | Scanning Modes: Convex and linear. Display Modes: B-Mode (B, 2B), B/M-Mode. Supporting Transducers: C3L60B (2.5-5.0 MHz) and L7L38B (5.0-9.0 MHz). Focus Mode: Transmit (1-4 selectable, variable depth), Receive (dynamic focus). Grey Scale: 256. Pre-processing: 32-channel digital beam-former, 70dB receive gain, 35-66dB dynamic range, edge enhancement (4 steps), image persistence (7 steps), line density (normal, high). Post-processing: 10 types of grey maps (4 user-definable). Image Manipulation: Real-time zoom (x4.0 max), frozen image. B/M-mode speed: 1.2, 2.5, 5.0, 10.0 sec. Cine: Max. 256 frames. Image Store/Recall: 32 frames. Image Orientation: Left/right flip, up/down flip, 90-degree rotation. Documentation/Storage: 60GB HDD, USB, B&W video printer, Parallel port printer. Measurements/Calculations: General (Distance, Area, Circumference, Angle, Time, Slope, Heart rate) and Specific (Abdomen, Obstetrics, Gynecology, Cardiology, Small parts, Peripheral Vascular). |
Study Information (Based on 510(k) Summary's Limitations)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not provide information on a specific test set, its sample size, or data provenance. 510(k) submissions typically rely on technical comparisons and performance testing to standards rather than clinical study data from a "test set" in the context of AI/diagnostic accuracy.
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)
- No information is provided regarding experts or ground truth establishment for a test set, as no dedicated clinical study with such a methodology is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No information is provided on an adjudication method, as no formal "test set" requiring expert adjudication is discussed in this summary.
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
- No, an MRMC comparative effectiveness study was not done or reported. This device is an analog/digital ultrasound imaging system, not an AI-powered diagnostic tool. The concept of human readers improving with AI assistance is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware imaging system, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For an ultrasound imaging system, the "ground truth" for demonstrating performance would typically involve phantom studies (to assess image quality metrics like resolution, penetration, contrast, etc.), biocompatibility testing, electrical safety testing, and comparison of technical specifications to a predicate device, confirming that the images produced are diagnostically acceptable and comparable. Clinical efficacy (diagnostic accuracy) is often implied by demonstrating similar technical performance to a legally marketed equivalent device, rather than a de novo clinical trial with pathology or outcomes-based ground truth. The document does not explicitly describe these ground truth methods.
8. The sample size for the training set
- This device is an ultrasound imaging system, not a machine learning model. Therefore, the concept of a "training set" in the AI sense is not applicable.
9. How the ground truth for the training set was established
- As explained above, the concept of a "training set" (for an AI model) is not applicable to this device.
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SIUI CTS-7700 Digital Ultrasound Imaging System
Tab 9
K061083
Page 1 of 2
PREMARKET NOTIFICATION [510(k)| Summary
| Trade Name: | CTS-7700 with C3L60B and L7L38B Transducers | JUN - 6 200 |
|---|---|---|
| Common Name: | Digital Ultrasound Imaging System | |
| Classification Name: | Ultrasonic Pulsed Echo Imaging System, 90 IYO(per 21 CFR section 892.1560) | |
| Manufacturer's Name: | Shantou Institute of Ultrasonic Instruments | |
| Address: | #77, Jinsha Road,Shantou SEZ, 515041, China | |
| Corresponding Official: | Li Delai | |
| Title: | President | |
| Telephone: | (86) 754-8250150 | Fax: (86) 754-8251499 |
| US Agent: | Bob Leiker/ Consultant /QRS7263 Cronin Circle, Dublin, CA 94568 | |
| Telephone: 1-925-556-1302 | Fax: 1-866-718-3819 |
SIUI CTS-485, K012772 Predicate Device:
Device Description:
The SIUI CTS-7700 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 applications
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Technological Characteristics:
-
- Scanning modes: convex and linear scanning
-
- Display modes:
- B-Mode (B, 2B) a)
- B/M-Mode b)
-
- Supporting transducers:
- C3L60B: 2.5-5.0 MHz 60R 128e convex transducer a)
- L7L38B: 5.0-9.0 MHz 38mm 128e linear transducer b)
-
- Focus mode:
- Transmit focus mode: 1-4 selectable, focus depth: variable a)
- Receive focus mode: dynamic focus b)
- Grey scale: 256 5)
- Pre-processing: 6)
- 32-channel digital beam-former; a)
- Receive gain (include TGC): 70dB b)
- c) Dynamic range: 35-66dB
- 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: 8)
- Real-time zoom in x4.0 max. a)
- Frozen image b)
-
- B/M-mode speed:
Time for full screen scroll: 1.2, 2.5, 5.0, 10.0 sec
-
- Cine: Max. 256 frames
-
- Image store and recall: 32 frames
-
- Image orientation:
- a) Left/right flip
- b) Up/down flip
- 90-degree rotation (selectable steps: 0, 90, 180, 270 degrees) c)
-
- Documentation and storage:
- 60GB HDD, images stored in BMP file format; a)
- b) USB interface memory, images stored in BMP file format
- Documentation devices: c)
- B&W video printer d)
- Parallel port printer (Inkjet or LaserJet) e)
-
- Measurements and calculations
- General measurements and calculations a) 2D: Distance, Area, Circumference, and Angle M-Mode: Distance, Time, Slope, Heart rate
- Specific measurements and calculations b)
Abdomen, Obstetrics, Gynecology, Cardiology, Small parts, Peripheral Vascular
K061083
page 2 of 2
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Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle emblem, with three curved lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD-20850
JUN - 6 2006
Shantou Institute of Ultrasonic Instruments % Mr. Bob Leiker Consultant/QRS 7263 Cronin Circle DUBLIN CA 94568
Re: K061083
Trade Name: CTS-7700 Digital Ultrasound Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO and ITX Dated: April 3, 2006 Received: April 18, 2006
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.
This determination of substantial equivalence applies to the following transducers intended for use with the CTS-7700 Digital Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
Convex Array C3L60B (2.5-5.0 MHz 60mm 128e convex transducer) Linear Array L7L38B (5.0-9.0 MHz 38mm 128e linear transducer)
Protecting and Promoting Public Health
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Page 2 - Mr. Leiker
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 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 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 Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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 Sophie Paquerault at (301) 594-1212.
Sincerely yours,
David A. Ingram
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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Diagnostic Ultrasound Indications for Use Form
3.1 System Indications for Use Form
Device Name: CTS-7700
Mode of Operation
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Opthalmic | ||||||||||
| Fetal | N | N | ||||||||
| Abdominal | N | N | ||||||||
| IntraOperative (Cardiac) | ||||||||||
| IntraOperative Neurological | ||||||||||
| Pediatric | N | N | ||||||||
| Small Organ (Specify) | N | N | ||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Adult) | ||||||||||
| Cardiac (Pediatric) | N | N | ||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral Vascular | N | N | ||||||||
| Laparascopic | ||||||||||
| Muscular-Skeletal Conventional | ||||||||||
| Muscular-Skeletal Superficial | ||||||||||
| Others (Specify) | N | N |
N = new indication P = previously cleared by FDA E = added under Appendix E
N = new indication Additional Comments: Small organs include: thyroid, testes, breast Combined: B/M Mode Other uses include: Uterus, Ovary, and Prostate
Concurrence of CDRH, Office of Device Evalue
David H. Pryor
(Division Sign-Org
Division of Reproductive, Abdominal,
and Radiological Devices K001083
510(k) Number
Prescription Use (Per 21 CFR 801.109)
Indications For Use
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Diagnostic Ultrasound Indications for Use Form
3.2 Transducer Indications for Use Form
Device Name: Convex Array C3L60B
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Opthalmic | ||||||||||
| Fetal | N | N | ||||||||
| Abdominal | N | N | ||||||||
| IntraOperative(Cardiac) | ||||||||||
| IntraOperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Adult) | ||||||||||
| Cardiac (Pediatric) | N | N | ||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | . * | |||||||||
| Peripheral Vascular | ||||||||||
| Laparascopic | ||||||||||
| Muscular-SkeletalConventional | ||||||||||
| Muscular-SkeletalSuperficial | ||||||||||
| Others (Specify) | N | N |
Mode of Oneration
P = previously cleared by FDA E = added under Appendix E N = new indication Additional Comments: Uterus, Ovary, and Prostate, Combined: B/M Mode
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K061083 |
- State of the Court of the Course
Prescription Use (Per 21 CFR 801.109)
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SIUI CTS-7700 Digital Ultrasound Imaging System
Diagnostic Ultrasound Indications for Use Form
3.3 Transducer Indications for Use Form
Device Name: Linear Array L7L38B
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| IntraOperative(Cardiac) | ||||||||||
| IntraOperativeNeurological | ||||||||||
| Pediatric | N | N | ||||||||
| Small Organ(Specify) | N | N | ||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Adult) | ||||||||||
| Cardiac (Pediatric) | ||||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral Vascular | N | N | ||||||||
| Laparascopic | ||||||||||
| Muscular-SkeletalConventional | ||||||||||
| Muscular-SkeletalSuperficial | ||||||||||
| Others (Specify) |
P = previously cleared by FDA E = added under Appendix E N = new indication Additional Comments: Small organs include: thyroid, testes, breast Combined: B/M Mode
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign
Division of
and Radiologira Desa
510(k) Number K061083
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.