(26 days)
Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular applications. Muscular-Skeletal Conventional and Superficial applications. Small organs include: thyroid, testes, breast. Other uses include: Uterus, Ovary, and Prostate.
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.
The SIUI CTS-7700 Digital Ultrasound System is an ultrasonic pulsed echo imaging system intended for diagnostic use. The relevant submission K070982 specifically adds Muscular-Skeletal Conventional and Superficial applications to the system.
1. Acceptance Criteria and Reported Device Performance:
The provided documents do not detail specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) for the addition of Muscular-Skeletal Conventional and Superficial applications. Instead, the "acceptance criteria" appear to be based on demonstrating substantial equivalence to a predicate device (SonoAce 6000, K981510) for these expanded indications.
The device's performance is not presented in quantitative metrics but rather by the FDA's determination of substantial equivalence, which implies that its technological characteristics and intended use for the new applications are comparable to those of the predicate device and meet safety and effectiveness standards.
| Acceptance Criteria (Implied by Substantial Equivalence Review) | Reported Device Performance (as determined by FDA) |
|---|---|
| Device functions as an Ultrasonic Pulsed Echo Imaging System. | The SIUI CTS-7700 is a digital diagnostic ultrasound system capable of 2D (B mode) and B/M modes, supporting linear and convex transducers. |
| System capable of Muscular-Skeletal Conventional imaging. | "N" (New Indication) marked for Muscular-Skeletal Conventional for the system and the L7L38B linear array transducer, indicating the FDA cleared this new application. |
| System capable of Muscular-Skeletal Superficial imaging. | "N" (New Indication) marked for Muscular-Skeletal Superficial for the system and the L7L38B linear array transducer, indicating the FDA cleared this new application. |
| Technological characteristics are largely similar to previously cleared devices. | The technological characteristics (scanning modes, display modes, supporting transducers, focus mode, grey scale, pre-processing, post-processing, image manipulation, cine, image store/recall, image orientation, documentation/storage, measurements/calculations) are described and are consistent with general ultrasound systems. No changes were made that impact the previously cleared applications. |
| Device is safe and effective for the stated indications. | FDA granted substantial equivalence, allowing the device to be marketed for the expanded indications. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided documents do not describe any specific test set, clinical study, or patient data used to demonstrate the performance of the device for the new Muscular-Skeletal Conventional and Superficial applications. The submission primarily focuses on technological characteristics and comparison to a predicate device to establish substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Since no specific test set or clinical study is described, there is no information available regarding experts used for establishing ground truth.
4. Adjudication Method for the Test Set:
As no specific test set or clinical study is described, there is no information available regarding any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC comparative effectiveness study is mentioned or appears to have been conducted as part of this submission. The submission relies on substantial equivalence to a predicate device rather than a direct comparison of human reader performance with and without AI assistance (which is not applicable here as it's an ultrasound system, not an AI-assisted diagnostic tool).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is a digital ultrasound system, not an AI algorithm. Therefore, a "standalone" performance study in the context of an algorithm would not be applicable and is not mentioned. Its performance is inherent to its imaging capabilities, which are assessed for safety and effectiveness in comparison to predicate devices.
7. The Type of Ground Truth Used:
Given the nature of the submission (510(k) for an ultrasound system expansion based on substantial equivalence), the "ground truth" implicitly relies on:
- Engineering and technical specifications: Ensuring the system's output (image quality, measurements, modes) meets industry standards and is comparable to the predicate device.
- Clinical experience and predicate device history: The understanding that similar ultrasound systems with comparable specifications are safe and effective for the stated indications through prior regulatory clearances and medical practice.
There is no mention of specific pathology, expert consensus on case reads, or outcomes data being used to establish a "ground truth" for the clearance of these new indications.
8. The Sample Size for the Training Set:
This device is a hardware/software system, not a machine learning model. Therefore, the concept of a "training set" in the context of AI is not applicable and no training set size is mentioned.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for an AI model, this question is not applicable. The "ground truth" for the system's design and engineering would be based on established ultrasound physics, medical imaging principles, and technical performance standards.
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SIUI CTS-7700 Digital Ultrasound System - Muscular-Skeletal Conventional and Superficial
MAY - 2 2007
Tab 9 PREMARKET NOTIFICATION [510(k)] Summary
The CTS-7700 can be used for with Muscular-Skeletal Conventional and Superficial Superficial applications without any system or transducer modifications.
Nothing described in our previous submission, K061083 has been changed or modified for this submission.
All of the sections in this Tab 9 Premarket Notification [510(k)] Summary remain unchanged in this submission.
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Tab 9 PREMARKET NOTIFICATION [510(k)] Summary
| Trade Name: | CTS-7700 with C3L60B and L7L38B Transducers | |
|---|---|---|
| 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 |
SonoAce 6000, K981510 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:
- a) B-Mode (B, 2B)
- b) B/M-Mode
-
- Supporting transducers:
- C3L60B: 2.5-5.0 MHz 60R 128e convex transducer a)
- b) L7L38B: 5.0-9.0 MHz 38mm 128e linear transducer
-
- Focus mode:
- a) Transmit focus mode: 1-4 selectable, focus depth: variable
- Receive focus mode: dynamic focus ﻘ
-
- Grey scale: 256
-
- Pre-processing:
- a) 32-channel digital beam-former;
- 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 ਿ
-
- 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
-
- 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:
- a) 60GB HDD, images stored in BMP file format:
- USB interface memory, images stored in BMP file format b)
- Documentation devices: C)
- B&W video printer ರ)
- e) Parallel port printer (Inkjet or LaserJet)
-
- 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
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shantou Institute of Ultrasonic Instruments % Mr. Bob Leiker Consultant QRS 7263 Cronin Circle DUBLIN CA 94568
MAY - 2 2007
Re: K070982
Trade Name: CTS-7700 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 4, 2007 Received: April 6, 2007
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, 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
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Page 2 - Mr. Leiker
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 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, (enclosed) 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 Act from 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 Ewa Czerska at (240) 276-3666.
Sincerely vours.
Nancy L. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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SIUI CTS-7700 Digital Ultrasound System - Muscular-Skeletal, Conventional and Superficial Imaging
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 | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Opthalmic | ||||||||||
| Fetal | P | P | ||||||||
| Abdominal | P | P | ||||||||
| IntraOperative(Cardiac) | ||||||||||
| IntraOperativeNeurological | ||||||||||
| Pediatric | P | P | ||||||||
| Small Organ(Specify) | P | P | ||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Adult) | ||||||||||
| Cardiac (Pediatric) | P | P | ||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral Vascular | P | P | ||||||||
| Laparascopic | ||||||||||
| Muscular-SkeletalConventional | N | N | ||||||||
| Muscular-SkeletalSuperficial | N | N | ||||||||
| Others (Specify) | P | P |
Moda of Oneration
N = new indication P = previously cleared by FDA (K061083) E = added under Appendix E 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 Evaluation (ODE)
Nancye Brogdon
Division Sign-Off
Division of Reproductive and Radiological Device 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Indications For Use
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SIUI CTS-7700 Digital Ultrasound System - Muscular-Skeletal, Conventional and Superficial Imaging
Diagnostic Ultrasound Indications for Use Form
3.2 Transducer Indications for Use Form
Device Name: Convex Array C3L60B
| Device Name/Center | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Operation | ||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Opthalmic | ||||||||||
| Fetal | P | P | ||||||||
| Abdominal | P | P | ||||||||
| IntraOperative(Cardiac) | ||||||||||
| IntraOperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Adult) | ||||||||||
| Cardiac (Pediatric) | P | P | ||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparascopic | ||||||||||
| Muscular-SkeletalConventional | ||||||||||
| Muscular-SkeletalSuperficial | ||||||||||
| Others (Specify) | P | P |
P = previously cleared by FDA (K061083) 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)
uation (ODE)
Nancy Brogdon
(Division Sign-Off)
Division of Reprod and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Indications For Use
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SIUI CTS-7700 Digital Ultrasound System - Muscular-Skeletal, Conventional and Superficial Imaging Diagnostic Ultrasound Indications for Use Form
3.3 Transducer Indications for Use Form
Device Name: Linear Array L7L38B
Mode of Operation
| 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 | P | P | ||||||||
| Small Organ(Specify) | P | P | ||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Adult) | ||||||||||
| Cardiac (Pediatric) | ||||||||||
| Transesophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Vascular | ||||||||||
| Peripheral Vascular | P | P | ||||||||
| Laparascopic | ||||||||||
| Muscular-SkeletalConventional | N | N | ||||||||
| Muscular-SkeletalSuperficial | N | N | ||||||||
| Others (Specify) |
P = previously cleared by FDA (K061083) 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 C Brogdon
(Division Sig Division of Reproductive, Ab and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
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.