CTS-7700

{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<br>(per 21 CFR section 892.1560) | | | Manufacturer's Name: | Shantou Institute of Ultrasonic Instruments | | | Address: | #77, Jinsha Road,<br>Shantou SEZ, 515041, China | | | Corresponding Official: | Li Delai | | | Title: | President | | | Telephone: | (86) 754-8250150 | Fax: (86) 754-8251499 | | US Agent: | Bob Leiker/ Consultant /QRS<br>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: - 1) Scanning modes: convex and linear scanning - 2) Display modes: - B-Mode (B, 2B) a) - B/M-Mode b) - 3) Supporting transducers: - C3L60B: 2.5-5.0 MHz 60R 128e convex transducer a) - L7L38B: 5.0-9.0 MHz 38mm 128e linear transducer b) - 4) 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) - 7) 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) - 9) 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: - a) Left/right flip - b) Up/down flip - 90-degree rotation (selectable steps: 0, 90, 180, 270 degrees) c) - 13) 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) - 14) 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<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | Opthalmic | | | | | | | | | | | | Fetal | | N | | | | | | | N | | | Abdominal | | N | | | | | | | N | | | IntraOperative<br>(Cardiac) | | | | | | | | | | | | IntraOperative<br>Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ<br>(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<br>Conventional | | | | | | | | | | | | Muscular-Skeletal<br>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<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | Opthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | IntraOperative<br>(Cardiac) | | | | | | | | | | | | IntraOperative<br>Neurological | | | | | | | | | | | | Pediatric | | N | | | | | | | N | | | Small Organ<br>(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<br>Conventional | | | | | | | | | | | | Muscular-Skeletal<br>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)