(49 days)
Not Found
No
The summary describes a standard digital diagnostic ultrasound system with typical features like 2D/B mode, cine review, measurements, and image storage. There is no mention of AI, ML, or any related terms, nor are there descriptions of training or test sets which would be expected for an AI/ML device.
No
The device is described as a "digital diagnostic ultrasound system" for "imaging and measurement," indicating its purpose is for diagnosis rather than treatment.
Yes
The device is described as a "digital diagnostic ultrasound system" in the Device Description, and its "Intended Use / Indications for Use" specifies "imaging and measurement" for various medical applications, which are inherently diagnostic in nature.
No
The device description explicitly states that the system consists of "probes, main unit, control panel and monitor," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an "Ultrasonic pulsed echo imaging and measurement" system for various anatomical sites. This is a description of an in vivo imaging device, meaning it is used to image structures within the living body.
- Device Description: The description confirms it's a "digital diagnostic ultrasound system" with probes, a main unit, control panel, and monitor. This is consistent with an ultrasound machine used for imaging the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. There is no mention of analyzing biological samples or performing tests on specimens in the provided text.
Therefore, the SIUI CTS-7700 is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- System Indications for Use: "Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular applications".
- New (N) indications for the system: Fetal, Abdominal, Pediatric, Small Organ, Cardiac (Pediatric), Peripheral Vascular, Others (Uterus, Ovary, and Prostate).
- Transducer Model: Convex Array C3L60B: New (N) indications: Fetal, Abdominal, Cardiac (Pediatric), Others (Uterus, Ovary, and Prostate).
- Transducer Model: Linear Array L7L38B: New (N) indications: Pediatric, Small Organ (Thyroid, Testes, Breast), Peripheral Vascular.
- Combined mode of operation: B/M Mode.
Product codes
IYO, ITX
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.
Technological Characteristics:
- Scanning modes: convex and linear scanning
- Display modes: B-Mode (B, 2B), B/M-Mode
- Supporting transducers: C3L60B (2.5-5.0 MHz 60R 128e convex transducer), L7L38B (5.0-9.0 MHz 38mm 128e linear transducer)
- Focus mode: Transmit focus mode (1-4 selectable, focus depth: variable), Receive focus mode (dynamic focus)
- Grey scale: 256
- Pre-processing: 32-channel digital beam-former; Receive gain (include TGC): 70dB; Dynamic range: 35-66dB; Edge enhancement: 4 steps; Image persistence: 7 steps; Line density: normal, high
- Post-processing: 10 types of gray maps, among which 4 types are user-definable
- Image manipulation: Real-time zoom in x4.0 max., Frozen image
- 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: Left/right flip, Up/down flip, 90-degree rotation (selectable steps: 0, 90, 180, 270 degrees)
- Documentation and storage: 60GB HDD, images stored in BMP file format; USB interface memory, images stored in BMP file format; Documentation devices: B&W video printer, Parallel port printer (Inkjet or LaserJet)
- Measurements and calculations: General measurements and calculations (2D: Distance, Area, Circumference, and Angle M-Mode: Distance, Time, Slope, Heart rate), Specific measurements and calculations (Abdomen, Obstetrics, Gynecology, Cardiology, Small parts, Peripheral Vascular)
Mentions image processing
Yes, the device capabilities include "image zoom", "Image manipulation: Real-time zoom in x4.0 max., Frozen image", "Image orientation: Left/right flip, Up/down flip, 90-degree rotation (selectable steps: 0, 90, 180, 270 degrees)", "Pre-processing: Edge enhancement: 4 steps; Image persistence: 7 steps; Line density: normal, high", and "Post-processing: 10 types of gray maps, among which 4 types are user-definable."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, pediatric, small organ (thyroid, testes, breast), cardiac, peripheral vascular, fetal, uterus, ovary, prostate.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 /QRS | |
| 7263 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
1
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
2
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
3
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)
4
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
5
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 | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | N | N | ||||||||
| Abdominal | N | N | ||||||||
| IntraOperative | ||||||||||
| (Cardiac) | ||||||||||
| IntraOperative | ||||||||||
| Neurological | ||||||||||
| 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-Skeletal | ||||||||||
| Conventional | ||||||||||
| Muscular-Skeletal | ||||||||||
| Superficial | ||||||||||
| 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)
6
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 | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| IntraOperative | ||||||||||
| (Cardiac) | ||||||||||
| IntraOperative | ||||||||||
| Neurological | ||||||||||
| 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-Skeletal | ||||||||||
| Conventional | ||||||||||
| Muscular-Skeletal | ||||||||||
| Superficial | ||||||||||
| 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)