DIGITAL ULTRASOUND SCANNER

{0}------------------------------------------------ KLOOO79 # Section 3 510(k) Summary As required by 807.97 " . . . .. MAR - 1 2010 The assigned 510(k) Number is ________________________________________________________________________________________________________________________________________________ | Sponsor | Shenzhen Well.D Medical Electronics Co., Ltd.<br>13/F & 12/F North, New Energy Bldg, Nanhai Ave,<br>Nanshan District, Shenzhen 518054, China | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Mr. Ning Bai, General Manager | | | Tel:+86-755-26073352 | | | Fax: +86-755-26073356 | | | Email: Weld-2000@163.com | | Submission<br>Correspondent | Mr. Tarzan Wang / Ms. Diana Hong<br>Shanghai Mid-Link Business Consulting Co., Ltd<br>Sute 5D, No. 19, Lane 999, Zhongshan No.2 Road(S)<br>Shanghai, 200030, China<br>Tel: +86-21-64264467<br>Fax: +86-21-64264467 ext. 809<br>Email: tarzan.wang@mid-link.net | | Preparing Date: | Sept. 28, 2009 | | Proposed Product | | | Trade Name | Digital Ultrasound Scanner | | Model | WED-3100 | | Product Code: | IYO & ITX | | Regulation Number: | 21 CFR 892.1560 & 21 CFR 892.1570 | | Device Class: | Class II | | Submission Purpose: | New Device | | Predicate Device: | EMP-2100 Full Digital Ultrasound Diagnostic Device<br>K081873<br>Manufactured by: Shenzhen Emperor Electronic Technology<br>Co., Ltd. | | Device Description | This equipment is high resolution linear/convex ultrasound<br>scanning diagnostic equipment. It adopts micro-computer<br>control and digital scan converter (DSC), digital | | | beam-forming (DBF), real time dynamic aperture (RDA),<br>real time dynamic receiving apodization, real time dynamic<br>receiving focusing (DRF), Digital frequency scan (DFS),<br>frame correlation technologies to endue its image with<br>clarity, stability and high resolution. | | Test Conclusion | Laboratory testing was conducted to validate and verify that<br>the proposed devices met all design specifications, including<br>electrical safety, EMC, specifications. | | Intended<br>Use/Indication for Use | WED-3100 Digital Ultrasound Scanner is intended for diagnostic<br>ultrasound imaging analysis for abdomen, gynecology, obstetric,<br>urology, small-parts.<br>The system is intended to use for the following type of studies: fetal,<br>abdominal, pediatric, small organs, peripheral vascular, and<br>musculo-skeletal (both conventional and superficial). The device is<br>intended to adult, pregnant woman, pediatric and neonate.<br>The system is a prescription device intended to be used by or on the<br>order of a physician or similar qualified health care professional. This<br>device is not intended for home use. | {1}------------------------------------------------ # Technology Characteristics . .............................................................................................................................................................................. . . | Model | WED-3100 | |-------------------|-----------------------------------------------| | Monitor size | 5 inch | | Display mode | B, B+B, B+M, M, 4B | | Image gray scale | 256 | | Image storage | 128 | | Cine loop | ≥400 frame | | Scan depth | 80 mm~220 mm | | Image flip | Up/down, left/right | | Focus position | Adjustable | | posture mark | 40 | | Image Process | Histogram, Color encode, GAMA, Image Smoothen | | Frame correlation | Adjustable | ## Table 3-1 WED-3100 basic technical specifications 3-2 ・ {2}------------------------------------------------ · · ···· · | Measurement | Distance, circumference, area, volume, heart rate. GA,FW,EDD | |-------------------------|------------------------------------------------------------------| | Notation | Date, time, name, sex, age, hospital name、Full screen words edit | | output report | Measurement, Obstetric | | Battery Continuous work | ≥3Hours | | Size | L(230mm)*W(120mm)*H(38mm) | | Net weight | 700g | | Accuracy | Error ≤ ±10% | | Measurement Range | Horizontal ≥ 1mm & Vertical ≥ 1mm | - Tabel 3-2 Probe Technical Specification | Probe Mode | C1-11/50R/3.5MHz | L1-5/7.5MHz | |---------------------------------------------------|--------------------------|------------------------------------| | Nominal Frequency | convex array probe | high-frequency linear array probe | | Type | | | | Scan angle/width | 70.4° | 40mm | | Number of Element | 80 | 80 | | Size of Element | 0.765mm x 16.3mm | 0.5mm x 11 mm | | Spacing of Element | 0.765mm | 0.5mm | | Size | 62.4mm×16.30mm | 47.00mm×11.00mm | | Maximum number of active elements of single pulse | 16 | 16 | | Scan Depth | 80mm~220mm | 40mm~90mm | | Array dimensions | 62.4mm x 16.3mm | 47.0mm x 11.0mm | | Dead Zone (mm) | ≤3 | ≤6 | | Detect Depth(mm) | ≥80 | ≥140 | | Resolution (mm) | Lateral<br>≤1 (Depth≤60) | ≤3 (depth≤80)<br>≤5 (80<depth≤130) | | | Axial<br>≤1 (Depth≤80) | ≤1 (depth≤80) | | Geometric position precision | Horizontal<br>≤5 | ≤7.5 | | | Vertical<br>≤5 | ≤5 | 3-3 {3}------------------------------------------------ | Transducer Model | Type | Frequency | Track | |------------------|--------------|-----------|-------| | C1-11 | Convex Array | 3.5MHz | 1 | | L1-5 | Linear | 7.5MHz | 1 | #### Table 3-3 Transducer List #### Effectiveness and Safety Considerations #### Effectiveness: Clinical Measurement Effectiveness Test was conducted on the subject device to evaluate its measurement accuracy. #### Safety: The subject device meet the following Electrical Safety Standards and Biocompatibility Standards. IEC 60601-1: 1988 Amendment 1, 1991-11 Amendment 2 1995, Medical Electrical Equipment ~ Part 1 : General Requirements for safety. IEC 60601-1-2: 2001, Medical Electrical Equipment -- Part 1-2: General Requirements for safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests IEC 60601-2-37:2004, Medical Electrical Equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. NEMA UD 2: 2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. ISO 10993 -5: 1999, Biological Evaluation of Medical Devices - Part 5: Test for in vitro cytotoxicity ISO 10993-10: 2002, Biological Evaluation of Medical Devices -- Part 10: Tests for irritation and delayed-type hypersensitivity ISO 10993-12. 1999, Biological Evaluation of Medical Devices - Part 12: Sample preparation and reference materials. {4}------------------------------------------------ #### SE Analysis The subject device has same classification information, same intended use, same indication for use, similar product design, similar specification, same safety elements, similar label and labeling, same software specification as predicate device, The differences are included as followings: The device and predicate device have difference in performance specification, such as scan/angle/width, maximum number of elements for a single pulse, frequency, number of element, size of element, spacing of element, array dimensions, detect depth and resolution. But the propose device have tested for clinical measurement accuracy, so these difference can prove the effectiveness of propose device. The device and predicate device have difference in label and labeling, but all of the label and labeling meet the requirements of FDA. The proposed device has tested according with the safety standard IEC 60601-1, IEC60601-1-2 for the safety. The proposed device has tested according with the clinical measurement accuracy report, UD2 Acoustic Output report for the effectiveness. The proposed device has tested according with the ISO 10993 series standard for the Biocompatibility performance. Therefore, the differences above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety. No new technology is applied in the subject device. Most of the main aspects on effectiveness and safety between the subject device and predicate device are same. The differences are slight so that no substantial influence on the effectiveness and safety. #### SE Determination The proposed device, Digital Ultrasonic Diagnostic Scanner/WED 3100, is substantially equivalent (SE) to the predicate device EMP-2100 Full Digital Ultrasound Diagnostic Device (K081873). {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's commitment to health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 MAR - 1 2010 Shenzhen Well.D Medical Electronics Co., Ltd. % Mr. Marc M. Mouser Program Manager & FDA Office Coordinator Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542 Re: K100079 Trade/Device Name: Digital Ultrasound Diagnostic Scanner, WED-3100 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: February 5, 2010 Received: February 16, 2010 Dear Mr. Mouser: 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 Digital Ultrasound Diagnostic Scanner, WED-3100, as described in your premarket notification: #### Transducer Model Number LI-5 C1-11 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 {6}------------------------------------------------ can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242. Sincerely yours, J. D. K. Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure(s) {7}------------------------------------------------ # Indication for Use 510(k) Number (if known): Device Name: WED-3100 Digital Ultrasound Scanner Indications for Use: WED-3100 Digital Ultrasound Scanner is intended for diagnostic ultrasound imaging analysis for abdomen, gynecology, obstetric, urology and small-parts. The system is intended to use for the following type of studies: fetal, abdominal, pediatric, small organs, peripheral vascular and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate. The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use. Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation:  (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Page _ 1 of 510(k) Number K100079 {8}------------------------------------------------ #### System: WED-3100 Digital Ultrasound Scanner ﺮ ﺍﻟ | Clinical Application | | Mode of Operation | | | | | | | |-----------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|------------------|------------------| | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(BM) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging &<br>Other | Fetal | N | N | | | | N | Note 1 | | Other | Abdominal | N | | | | | | Note 1 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | N | | | | | | Note 1 | | | Small Organ (Specify) | N | | | | | | Note 1 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal<br>(Conventional) | N | | | | | | Note 1 | | Musculo-skeletal<br>(Superficial) | N | | | | | | Note 1 | | | Intravascular | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | N | N | | | | N | Note 1 | | Vessel | Other (Specify) | | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Note 1: B+B mode, 4B mode N = new indication; P = previously cleared by FDA; E = added under this appendix Page 2 of 4 J. Afl (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number K100079 {9}------------------------------------------------ System: WED-3100 Digital Ultrasound Scanner Transducer: C1-11- | Clinical Application | | | | Mode of Operation | | | | | | |---------------------------|------------------------------------|---|---|-------------------|-----|------------------|------------------|---------------------|--| | General<br>(Track I Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(BM) | Other*<br>(Specify) | | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal Imaging &<br>Other | Fetal | N | N | | | | N | Note 1 | | | | Abdominal | N | | | | | | Note 1 | | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | N | | | | | | Note 1 | | | | Small Organ (Specify) | N | | | | | | Note 1 | | | | Neonatal Cephalic. | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skeletal<br>(Conventional) | N | | | | | | Note 1 | | | | Musculo-skeletal<br>(Superficial) | N | | | | | | Note 1 | | | | Intravascular | | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Other (Specify) | | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | | Other (Specify) | | | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Note 1: B+B mode, 4B mode N = new indication; P = previously cleared by FDA; E = added under this appendix Page _3_of র্ব D (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number K160079 {10}------------------------------------------------ ### System: WED-3100 Digital Ultrasound Scanner Transducer: Ll-5 | Clinical Application | | Mode of Operation | | | | | | |---------------------------|------------------------------------|-------------------|---|---------|------------------|------------------|---------------------| | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD CWD | Color<br>Doppler | Combined<br>(BM) | Other*<br>(Specify) | | Ophthalmic | Ophthalmic | | | | | | | | Fetal Imaging &<br>Other | Fetal | | | | | | | | | Abdominal | | | | | | | | | Intra-operative (Specify) | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | Laparoscopic | | | | | | | | | Pediatric | | | | | | | | | Small Organ (Specify) | | | | | | | | | Neonatal Cephalic | | | | | | | | | Adult Cephalic | | | | | | | | | Trans-rectal | | | | | | | | | Trans-vaginal | | | | | | | | | Trans-urethral | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | Musculo-skeletal<br>(Conventional) | | | | | | | | | Musculo-skeletal<br>(Superficial) | | | | | | | | | Intravascular | | | | | | | | | Other (Specify) | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | Cardiac Pediatric | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | Intra-cardiac | | | | | | | | | Other (Specify) | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | N | N | | | N | Note 1 | | Vessel | Other (Specify) | | | | | | | . . . : Page 4 of 4 : Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Note 1: B+B mode, 4B mode N = new indication; P = previously cleared by FDA; E = added under this appendix signature .. (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number K100079