CMS600P2 B-Ultrasound Diagnostic System

{0}------------------------------------------------ November 17, 2017 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Contec Medical System Co., Ltd. % Mr. Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206. Build 332. DaFangJu. No.25 BanBiDian Road LiYuan Town, TongZhou District, Beijing, 101121 CHINA Re: K170856 Trade/Device Name: CMS600P2 B-Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: October 18, 2017 Received: October 23, 2017 Dear Mr. Wang: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ ## Page 2 - Mr. Ray Wang and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K170856 #### Device Name CMS600P2 B-Ultrasound Diagnostic System CMS600P2 B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen,gynecology, obstetric, urology,and small-parts application. The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, transvaginal, 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. Please refer to the acoustic output declaration for each transducer as following pages. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 EF PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ System: CMS600P2 B-Ultrasound Diagnostic System Transducer: Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |------------------------------|------------------------------------|-------------------|---|-----|-----|----------------------|----------------------------------|-------------------------| | General<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Dopple<br>r | Combine<br>d<br>(Specify)<br>B/M | Other*<br>(Specify<br>) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal | N | N | | | | N | | | | Abdominal | N | N | | | | N | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | Fetal<br>Imaging<br>& Other | Laparoscopic | | | | | | | | | | Pediatric | N | N | | | | N | | | | Small Organ (Specify) | N | N | | | | N | Note 2,3 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | N | N | | | | N | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal(Conve<br>ntional) | N | N | | | | N | | | | Musculo-skeletal<br>(Superficial) | N | N | | | | N | | | | Intravascular | | | | | | | | | | Other (Specify) | N | N | | | | N | Note 1 | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | N | N | | | | N | | | | Other (Specify) | | | | | | | | | Clinical Application | | Mode of Operation | | | | | | | | General<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combine<br>d<br>(Specify)<br>B/M | Other*<br>(Specify<br>) | | Ophthalm<br>ic | Ophthalmic | | | | | | | | | | Fetal | N | N | | | | N | | | | Abdominal | N | N | | | | N | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | Fetal<br>Imaging<br>& Other | Laparoscopic | | | | | | | | | | Pediatric | N | N | | | | N | | | | Small Organ (Specify) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal(Conve<br>ntional) | N | N | | | | N | | | | Musculo-skeletal<br>(Superficial) | N | N | | | | N | | | | Intravascular | | | | | | | | | | Other (Specify) | N | N | | | | N | Note 1 | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | Other (Specify) | | | | | | | | | Clinical Application | | Mode of Operation | | | | | | | | General<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combine<br>d<br>(Specify) | Other*<br>(Specify) | | Ophthalm<br>ic | Ophthalmic | | | | | | | | | Fetal<br>Imaging<br>& Other | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | N | N | | | | N | | | | 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 | | | | | | | | | | Other (Specify) | | | | | | | | | Clinical Application | | Mode of Operation | | | | | | Other*<br>(Specify) | | General<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Dopple<br>r | Combine<br>d<br>(Specify) | | | Ophthalm<br>ic | Ophthalmic | | | | | | | | | | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | Fetal<br>Imaging<br>& Other | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (Specify) | N | N | | | | N | Note 2,3 | | | 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 | | | | Other (Specify) | | | | | | | | Additional comment:Combined mode : B/M Note 1:urology: prostate and vesica urinaria; Note 2: Thyroid Gland; Note 3: Hip Joint N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging {4}------------------------------------------------ ### System: CMS600P2 B-Ultrasound Diagnostic System Transducer: Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Additional comment:Combined mode : B/M Note 1:urology: prostate and vesica urinaria N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging {5}------------------------------------------------ #### System: CMS600P2 B-Ultrasound Diagnostic System E6.5-80R13-A16A Transducer: Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Additional comment:Combined mode : B/M N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging {6}------------------------------------------------ ### System: CMS600P2 B-Ultrasound Diagnostic System Transducer: Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Additional comment:Combined mode : B/M Note 2: Thyroid Gland Note 3: Hip Joint N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging {7}------------------------------------------------ # Tab #4 510(k) Summary This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: K170856 - 1. Date of Preparation: 11/18/2017 - 2. Sponsor Identification Contec Medical System Co., Ltd. No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei, 066004, China. Establishment Registration Number: 3006979678 Contact Person: Xueyong Li Position: Quality Manager Tel: 86-355-8015490 Fax: 86-355-8015490 Email:_lxy1011@163.com - 3. Designated Submission Correspondent Mr. Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China Tel: +86-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com {8}------------------------------------------------ #### 4. Identification of Proposed Device Trade Name: CMS600P2 B-Ultrasound Diagnostic System Common Name: Diagnostic Ultrasound System with Accessories Model(s): CMS600P2 Regulatory Information Classification Name: System, Imaging, Pulsed Echo, Ultrasonic ; Transducer, Ultrasonic, Diagnostic Classification:II Product Code:IYO & ITX Regulation Number:21 CFR 892.1560 & 21 CFR 892.1570 Review Panel:Radiology: Intended Use Statement: CMS600P2 B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen,gynecology, obstetric, urology,and small-parts application. The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, transvaginal, 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. Please refer to the acoustic output declaration for each transducer as following pages. #### Device Description ● The apparatus is high resolution ultrasound diagnostic system, which adopts digital beam forming(DBF), real-time dynamic aperture(RDA), real-time dynamic beam apodization (DRA), real-time dynamic receive focusing (DRF), digital-control dynamic frequency scanning (DFS), frame correlation etc. technologies. The image is clear, stable, and high resolution. ● It adopts embedded operating system, which greatly improve the product security and compatibility, and enhance the data processing ability. ● The apparatus is taken more conveniently for its humane operation interface and management system, flexible expansibility and compatibility, pop-up menu and keyboard design. ● Users can chose different kinds of display modes,such as:B, 2B, 4B, BM, M. Image real-time, freeze, memory, calling up and large capability cine loop can be realized; the device possesses multilevel scanning depth, dynamic range, sound output power and focus number, focus space, focus position adjusting etc. functions. ● With controllable frame correlation, gamma correction, image reversing, histogram, depth advance, zoom magnification, no distortion real-time part magnification etc. image processing functions. It is convenient for choice of optimal diagnostic image with image pigeonhole, browse, management functions. Measure, calculation, and report features are provided to facilitate image measurement. {9}------------------------------------------------ - The device supports linear probe and convex probe. The frequency of the device is 2.0 MHz-10.0 MHz. It has extensive application that is suitable for clinic diagnosis, such as abdomen, obstetrics, gynecology, small organs, cardiology and urology etc. . - The device is consist of three parts: mainframe, transducer(probe), adapter. - The transducers provided are listed below in table 7-1, the specification of the system and transducers please refer to Tab 9 section 7 Technical Specifications. The picture and design drawing of the subject device and its transducer is presented in Tab 9 section 2 Device Illustration. | Transducer Model | Type | Frequency | Application | |------------------|--------------------|-----------|------------------------------| | C3.5-80R60-A16A | convex probe | 3.5 MHz | Abdomen, obstetrics, urology | | L7.5-80L40-A16A | linear probe | 7.5 MHz | small organs | | E6.5-80R13-A16A | endo-vaginal probe | 6.5 MHz | Gynecology and transvaginal | Image /page/9/Figure/6 description: The image shows the title of a table. The title is "Table 7-1 Transducer List". The title is written in a clear, sans-serif font and is centered on the page. Image /page/9/Figure/7 description: The image shows the text "Fig 7-1 Working Frame of CMS600P2". The text appears to be a figure label or title, possibly from a technical document or manual. The text indicates that the figure is related to the working frame of a device or system named CMS600P2. The figure is labeled as "Fig 7-1", suggesting it is the first figure in chapter 7. Image /page/9/Figure/8 description: The image shows a block diagram of a system. The system includes components such as a probe, beamforming, A/D converter, TGC control, multi-route pulse control, FPGA, image processing, arithmetic software package, ARM, LCD display, image and video memory, and keypad input. The components are connected by arrows, indicating the flow of data or control signals within the system. - ર . Identification of Predicate Device(s) Predicate Device : 510(k) Number: K081873 Product Name: Full Digital Ultrasound Diagnostic Device Model Name: EMP-2100 Manufacturer: Shenzhen Emperor Electronic Technology Co., Ltd. {10}------------------------------------------------ - 6. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - a. IEC 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance - b. IEC 60601-1-2:2007, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests - IEC 60601-2-37:2007 Medical electrical equipment Part 2-37: Particular requirements for the C. basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment - IEC61157:1992 Requirements for the Declaration of the Acoustic Output of Medical Ultrasound d. Diagnostic Apparatus - ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity. e. - f. ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity - Clinical Test Conclusion 7. No clinical study is included in this submission. {11}------------------------------------------------ # 8. Substantially Equivalent (SE) Comparison | Item | Proposed Device(s) | Predicate Device(s) | Remark | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Device name | CMS600P2 B-Ultrasound Diagnostic System | EMP-2100 Full Digital<br>Ultrasound Diagnostic Device | / | | Classification Name | System, Imaging, Pulsed echo,<br>Ultrasonic<br>Transducer, Ultrasonic, Diagnostic | System, Imaging, Pulsed echo,<br>Ultrasonic<br>Transducer, Ultrasonic, Diagnostic | SE | | Product Code | IYO<br>ITX | IYO<br>ITX | SE | | Regulation Number | 892.1560<br>892.1570 | 892.1560<br>892.1570 | SE | | Comparison<br>Statement | The proposed device has same classification information as the predicate device. | | | | Intended Use | CMS600P2 B-Ultrasound Diagnostic System in a<br>general-purpose, digital ultrasound diagnostic system for<br>abdomen,gynecology, obstetric, urology,small-parts, and<br>cardiology application.<br>The system is intended to use for the following type of studies:<br>fetal organ, abdominal, pediatric, small organs, neonatal<br>cephalic, cardiac, transvaginal, peripheral vascular,and<br>musculo-skeletal (both conventional and superficial). The<br>device is intended to adult, pregnant woman, pediatric and<br>neonate.<br>The system is a prescription device intended to be used by or on | EMP-2100 Full Digital Ultrasound Diagnostic Device in a<br>general-purpose, digital ultrasound diagnostic system for<br>abdomen, gynecology,obstetric, urology,small-parts,and<br>cardiology application.<br>The system is intended to use for the following type of<br>studies:fetal organ, abdominal, pediatric, small organs,<br>Neonatal cephalic, cardiac, transvaginal, peripheral<br>vascular,and musculo-skeletal (both conventional and<br>superficial). The device is intended to adult, pregnant<br>woman, pediatric and neonate.<br>The system is a prescription device intended to be used by or | SE | # Table 7-1 Comparison of Technology Characteristics {12}------------------------------------------------ | the order of a physician or similar qualified health care | | | on the order of a physician or similar qualified health care | | | | | | | |-----------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------------------|---------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------|------------------|-----------| | professional. | | | professional. | | | | | | | | This device is not intended for home use. | | | This device is not intended for home use. | | | | | | | | Comparison | The proposed device has similar intended use as the predicate device. | | | | | | | | | | | Main Unit Technical Specifications | | | | | | | | | | Probe mode | C3.5-80R60<br>-A16A<br>Convex probe | L7.5-80L40-<br>A16A<br>linear | E6.5-80R13-<br>A16A<br>endo-vaginal | C128-50<br>Convex | L096-42C<br>Linear | C080-13G<br>Micro Convex | C096-20A<br>Micro Convex | / | | | | Scan angle/width | 110° | 6.3mm | 114.6° | 128° | 40mm | 120° | 88° | Analyse1 | | | Maximum number of<br>Active elements for a<br>single pulse | 5 | 5 | 5 | 32 | 32 | 32 | 32 | Analyse 1 | | Frequency | 3.5MHz | 7.5MHz | 6.5MHz | 3.5MHz | 6.5MHz | 6.5MHz | 3.5MHz | Analysel | | | Number of Element | 80 | 80 | 80 | 128 | 96 | 80 | 96 | Analyse1 | | | Size of Element(mm) | 0.48x7.5 | 0.5x6.3 | 0.33x7.3 | 0.41x13.4 | 0.34 x8.2 | 0.26 x8.2 | 0.24 x11.4 | Analyse 1 | | | Spacing of<br>element(mm) | 0.48 | 0.5 | 0.33 | 0.49 | 0.42 | 0.34 | 0.32 | Analysel | | | Array<br>dimensions(mm) | 38.4x7.5 | 40x6.3 | 26.4x7.3 | 62.8x13.4 | 40.3 x8.2 | 27.2 x8.2 | 30.7 x11.4 | Analyse 1 | | | Detect Depth(mm) | ≥160 | ≥50 | ≥40 | ≥200 | ≥90 | ≥90 | ≥90 | Analysel | | | Resolution<br>(mm) | Lateral | ≤3(Depth≤80)<br>≤4(80≤130) | ≤2(Depth≤<br>40) | ≤2(Depth<br>≤30) | ≤3(depth≤8<br>0)≤4(80 <<br>depth≤130) | ≤2(depth<br>≤60) | ≤2(depth<br>≤60) | ≤2(depth<br>≤40) | Analyse 1 | | | Axial | ≤2(Depth≤80)<br>≤3(80 ≤1(Depth<br>≤50) ≤1(Depth<br>≤40) ≤1(80<<br>depth≤130) ≤0.5<br>(depth≤80) ≤0.5<br>(depth ≤60) ≤0.5<br>(depth≤40) Analyse 1 | | | | | | | | | | | ≤130) | ≤5 | ≤3 | ≤4 | ≤3 | ≤3 | ≤3 | Analyse1 | | Blind Zone(mm) | | | ≤5 | ≤3 | ≤4 | ≤3 | ≤3 | ≤3 | Analyse1 | | Focus Position | | 4 focus, adjustable position | | 4 focus, position is not adjustable | | 4-steps dynamic focusing | | | Analyse1 | | Monitor Size | | 10.1 inch | | | | 10 inch | | | SE | | Display Mode | | B, 2B, BM, M, 4B | | | | B, B+B, B+M, M, 4B | | | SE | | Image gray scale | | 256 level | | | | 256 | | | SE | | Image Storage | | 2048 frame | | | | 16 | | | Analyse1 | | Cine Loop | | 600 frame | | | | 256 frame | | | Analyse1 | | Image Flip | | Up/down, left/right, black/white | | | | Up/down, left/right | | | Analyse1 | | Image Process | | Gamma (gray scale) correction, tissue harmonic imaging,<br>histogram, local magnification | | | | Dynamic range, edge enhancement, frame correlation, smooth,<br>IP, gray map,r-correction, rejection | | | Analyse1 | | Measurement | | Distance, circumference, area, volume, heart, pregnant age,<br>fetal weight, expected date | | | | Distance, circumference, area,volume, histogram, profile, time<br>velocity heart rate | | | Analyse1 | | Notation | | Date, time, name, No., sex, age, doctor, hospital name, probe<br>frequency, etc. | | | | Date, Time, Name, Sex, Age, Doctor, Hospital name, probe<br>frequency, etc. | | | SE | | Net weight | | 2.3 kg (include probe) | | | | 10kg | | | SE | | Power supply | | DC15V; Adapter:100 V~240 V, 50 Hz/60 Hz | | | | AC 100-240V, 47-60Hlz | | | Analyse2 | | Dimensions(mm) | | 292 mm(L) × 232 mm(W) × 45 mm(H) | | | | 365 (height) X292 (width) X380 (depth) | | | SE | | Configuration | | mainframe, transducer(probe) | | | | mainframe, transducer(probe) | | | SE | | Acoustic | Ispta. 3 | | | | | | | | | | Output<br>Isppa. 3 | | Meet the requirements of Track 3 | | | | Meet the requirements of Track 1 | | | Analyse1 | | Parameter | MI | | | | | | | | | | Skin<br>Contacted | | Probe Cover (ABS) | | | | Probe Cover (ABS) | | | SE | | Material | | Acoustic Lens (Silicone elastomer) | | | | Acoustic Lens (Silicone elastomer) | | | SE | {13}------------------------------------------------ # 510(k) Summary {14}------------------------------------------------ | Operation<br>Environment | Temperature: +10°C~ +40°C<br>Relative humidity: 30%~ 75%<br>Atmosphere pressure: 700 hPa ~ 1060 hPa | Temperature 5°C -40°C ,<br>relative humidity up to 90%RH<br>air pressure 70-106Kpa | SE | |--------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------| | Storage environment | Temperature: -10°C~+55°C,<br>Relative Humidity: ≤93%, no condensation.<br>Atmosphere pressure: 700 hPa ~ 1060 hPa, | Temperature -5-40°C ,<br>relative humidity up to 90%RH (no water I drop)<br>air pressure 70-106Kpa | SE | | Sterile | No | No | SE | | Single Use | No | No | SE | | Comparison<br>Statement: | The proposed device has the similar main unit specifications with the predicate device. | | | | Applied Standards: | | | | | Biocompatibility | ISO10993-5&ISO10993-10 | ISO10993-5&ISO10993-10 | SE | | Electrical Safety | IEC60601-1 | IEC60601-1 | SE | | EMC | IEC60601-1-2 | IEC60601-1-2 | SE | | Performance | IEC 60601-2-37;IEC61157 | UD2 | Analyse1 | | Comparison<br>Statement | The proposed probe has similar applied Standards with the predicate device. | | | {15}------------------------------------------------ 9. Substantially Equivalent (SE) Conclusion 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 applied Standards as predicate device. The differences are included as followings: Analyse 1: 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 measurement accuracy by accuracy testing and software validation, so these difference can prove the effectiveness of propose device. 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 accuracy report, IEC60601-2-37 report, IEC61157 Acoustic Output report for the effectiveness. The proposed device has tested according with the ISO 10993 series standard for the Biocompatibility . Therefore, the differences above between the proposed 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 proposed device and predicate device are same. The differences are slight so that no substantial influence on the effectiveness and safety. Analyse 2 : Although the Power supply specifications of CMS600P2 is different from the predicate device,but both the predicate device and the proposed device has passed the IEC60601-1 safety test, we believe these differences will not affect the effectiveness and safety compared with the predicate device. Conclusion: The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness.