MD-320W Ultrasound Biomicroscope

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font. The logo is simple and professional, conveying the organization's role in regulating food and drugs. MEDA Co., LTD % Linda Zhang RA, R & D Department F2C,F3D,F4C,F5, F6C, Building C2, Xinmao Science Skill Park, Huayuan Industry Development Area Tianjin, 300384 P.R. CHINA Re: K213070 Trade/Device Name: MD-320W Ultrasound Biomicroscope Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: September 15, 2021 Received: September 23, 2021 November 18, 2021 # Dear Linda Zhang: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213070 Device Name MD-320W Ultrasound Biomicroscope ### Indications for Use (Describe) MD-320W Ultrasound Biomicroscope is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes. The device is intended to be used in hospitalmology clinics. The operators should be trained professionals and have basic capabilities for PC operation. It is not allowed to use UBM on patients with eye trauma, inflammation or infection. Type of Use (Select one or both, as applicable) | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------| | <span></span> 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K213070 # 510(k) SUMMARY ## 1. Submitter Information | 510(k) owner's name: | MEDA Co., Ltd.<br>Add: F2C, F3D, F4C, F5, F6C, Building C2, Xinmao Science Ski Park, Huayuan Industry Development Area, Tianjin 300384, P. R. China<br>Tel: +86-22-83713808<br>Fax: +86-22-83713880 | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Linda Zhang<br>Add: C2-2-C, Xinmao Science Skill Park, Huayuan Industry Development Area, 300384 Tianjin, P. R. China<br>Tel: +86-22-8371 3808 ext. 812<br>Fax: +86-22-8371 3880<br>E-mail: linda.zhang@meda.com.cn | | Alternative Contact Person: | Kai Chen<br>Medtech International, Inc. and<br>United States Designated Agent of MEDA Co., Ltd.<br>Add: 13505 Broadfield Drive, Potomac, MD 20854<br>Tel: 240 888 4001<br>Fax: 301 251 2881<br>Email: Drkaichen@gmail.com | | Date Prepared: | September 15, 2021 | #### 2. Device Information Trade Name/Common Name: MD-320W Ultrasound Biomicroscope | | Classification Name: Ultrasonic Pulsed Echo Imaging System (IYO)<br>Diagnostic Ultrasound Transducer (ITX) | |--------------------|---------------------------------------------------------------------------------------------------------------| | Regulatory Class: | Class II | | Regulation Number: | 892.1560; 892.1570 | | Product Code: | IYO; ITX | #### Predicate Devices 3. Device Name: VuPad Ophthalmic Ultrasound System 510(k) Number: K140199 Manufacturer: Sonomed Inc. #### 4. Device Description MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It consists of AC-DC power adapter, main unit, 50MHz sector scan probe, footswitch, USB cable {4}------------------------------------------------ and two user-selectable APPs: MD3XUBM.AP1-C V1.0 APP (included in MD3XUBM-C V1.0) runs on the windows operating system of the PC and allows the user to control probe scanning, image acquisition and display via the PC user interface. MD3XUBM.AP1-S V1.0 APP (included in MD3XUBM-S V1.0) runs on the operating system of the legally marketed MD-2300S Ultrasonic A/B Scanner for Ophthalmology (K152318) and allows the user to control probe scanning, image acquisition and display via the MD-2300S user interface. Under the excitation of electric pulse, the 50MHz ultrasound transducer emits ultrasonic pulse into eye and receives reflective echo from the surfaces of different tissue, thus forming real-time two-dimensional image of eye tissue. Indications for Use 5. > MD-320W Ultrasound Biomicroscope is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes. > It is intended to be used in hospitals and ophthalmology clinics. The operators should be trained professionals and have basic capabilities for PC operation. It is not allowed to use UBM on patients with eye trauma, inflammation or infection. #### Comparison of Technological Characteristics 6. The VuPad diagnostic ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurements of axial length for determination of IOL Power. lt has 10MHz A-scan probe and 12.5 MHz, 20 MHz, 35 MHz and 50MHz B-scan probes. The function of the 35MHz and 50MHz probes is also called Ultrasound Biomicroscopy (UBM), which is used to collect live B-scan images of the anterior segment of the eye. MD-320W Ultrasound Biomicroscope is fundamentally identical to the Ultrasound Biomicroscopy (UBM) capabilities of the VuPad System. The intended usage and method of application for these transducers are the same for both systems. The subject and the predicate devices (UBM part) are based on the following same technological elements: | Item | Model<br>Subject Device | Predicate Device | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | 510(K) number | MD-320W Ultrasound Biomicroscope | K140199 | | | Intended Use | It is intended to be used in clinical<br>ophthalmology for ultrasonic<br>diagnosis on the anterior segment of<br>eyes. | The VuPad ultrasound system is<br>a multi-purpose computer-based<br>ultrasonic diagnostic system for<br>ophthalmic application, intended<br>to both visualize the interior of | | | the eye by means of ultrasound<br>and to make measurements<br>inside the eye, including the<br>measurement of axial length for<br>determination of IOL Power.<br>*The UBM part is used to collect<br>live B-scan images of the<br>anterior segment of the eye.<br>Note: See §8 of 510(K)<br>Summary of K140199. | Modes of Operation | B-Mode | B -Mode | | | Selectable A-Scan<br>Vector while in<br>B-Scan mode | Yes | Yes | | | Technology | Visualization by Ultrasound | Visualization by Ultrasound | | | General Method of<br>Operation | Echoes converted to images on a<br>screen. Measurement made by time<br>delays | Echoes converted to images on<br>a screen. Measurement made<br>by time delays | | | Digital System | Echoes converted into digital pulses,<br>all operation carried out digitally | Echoes converted into digital<br>pulses, all operation carried out<br>digitally | | | Probe /Transducer<br>type | probe with sector scanning (Open<br>Pivoting Single-Element) | Open Pivoting Single-Element | | | Transducer<br>Frequency Range<br>(MHz) | 50 | 35 and 50 for UBM | | | Internal Storage | ≥512GB (Stored in PC) | ≥512GB (Stored in tablet PC) | | | Control Interface | Operator uses PC with keyboard,<br>mouse and footswitch, or<br>MD-2300S with LCD touch screen<br>and footswitch, to collect exam data. | Operator uses tablet PC with<br>LCD touch screen and foot<br>pedal switch to collect exam<br>data, | | | Data<br>Storage<br>Location | Storage within software database<br>with ability to recall patient exam<br>records | Storage within software<br>database with ability to recall<br>patient exam records | | | Printer | Any Windows-compatible printer<br>(separate) | Any Windows-compatible printer<br>(separate) | | | Acoustic output<br>MI < 0.23<br>ISPTA.3 < 17 mW/cm²<br>ISPPA.3 < 28 W/cm² | Track 1 | Track 1 | | | Compliance<br>standards | IEC 60601-1: 2005, AMD1: 2012;<br>ANSI/AAMI ES 60601-1:<br>2005(R)2012 and A1: 2012,<br>C1:2009(R)2012 and | IEC 60601 -1, | {5}------------------------------------------------ {6}------------------------------------------------ | A2:2010/(R)2012;<br>IEC 60601-2-37 (ed.2), am1;<br>IEC 60601-1-2: 2014 | IEC 60601-2-37,<br>EN/IEC 60601-1-2 (2001) | |------------------------------------------------------------------------|--------------------------------------------| |------------------------------------------------------------------------|--------------------------------------------| The differences of MD-320W Ultrasound Biomicroscope and its predicate device: | Model | MD-320W Ultrasound<br>Biomicroscope | VuPad | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(K) number | | K140199 | | Intended Use | It is intended to be used in<br>clinical ophthalmology for<br>ultrasonic diagnosis on the<br>anterior segment of eyes. | The VuPad ultrasound system is<br>a multi-purpose computer-based<br>ultrasonic diagnostic system for<br>ophthalmic application, intended<br>to both visualize the interior of<br>the eye by means of ultrasound<br>and to make measurements<br>inside the eye, including the<br>measurement of axial length for<br>determination of IOL Power. | | Modes of Operation | B-Mode (anterior segment of<br>eyes) | Ophthalmic A and B Scans | | B-Scan Lines per Scan | 768 | 256 | | B-Scan Scan Display<br>Controls | TGC, Adjustable Gain: 1-99dB | Fully adjustable time-varied gain<br>(TVG), baseline, log gain, and<br>exponential gain | | Probe /Transducer type | Mechanical Sector Scan Probe<br>(open pivoting single-element) | Sealed Pivoting Single-Element,<br>and Open Pivoting<br>Single-Element for UBM | | B-Scan Transducer<br>Frequency. | 50 MHz | 10, 12.5, 20 MHz;<br>35, 50 MHz for UBM. | | B-Scan Axial Accuracy<br>(Theoretical) | 50 MHz: 0.0153mm | 50 MHz: 0.0146mm | | Hardware Configuration<br>and Components | System consists of AC-DC<br>power adapter, main unit,<br>50MHz sector scan probe, USB<br>cable and two user-selectable<br>APPs. | System consists of unit with<br>integrated LCD touch screen, A-<br>probe, sealed B-probe, open<br>transducer water path B-probe,<br>calibration cylinder, probe<br>holder, and foot pedal | | B-Scan Video Clips | Capture and store 100- frame<br>video clips | Capture and store 50- frame<br>video clips | | Display Screen | LCD Panel<br>(10.1" diagonal wide-screen,<br>1020 x 768 pixel resolution, or | Integrated LCD Panel<br>(10.1" diagonal wide-screen,<br>1920x1080 pixel resolution) | | Model | MD-320W Ultrasound<br>Biomicroscope | VuPad | | | 14" diagonal wide-screen,<br>1366 x 768 pixel resolution) | | | Dimensions (inches) | 1.6x 8.3x9.6 | 2 x 8x13.3 | {7}------------------------------------------------ The VuPad system is a multi-purpose ophthalmic ultrasonic diagnostic system with three relatively independent functions: biometric A-scan (10MHz), B-scan posterior segment imaging (12.5, 20MHz) and B-scan anterior segment imaging - UBM (35, 50MHz). MD-320W Ultrasound Biomicroscope (UBM) is only used for imaging of the anterior segment of the eye, so it is compared with the UBM part of VuPad. As can be seen from the above tables, MD-320W's intended use, working principle, structural composition, mode of operation, Probe/Transducer type and compliance standard are substantially equivalent as the UBM part of the predicate device. The intended use and hardware configuration and components that differ from the predicate device are those outside the UBM function, such as the A-scan for biometrics, and the 12.5MHz, 20MHz Sealed Pivoting Single-Element probe for imaging of the posterior segment of the eye. The differences in parameters such as Display Screen, Dimensions, B-Scan Video Clips and B-Scan Lines per Scan have no substantial impact on the intended use, safety and effectiveness of the device. #### 7. Brief Discussion of Non-clinical Tests The safety and EMC testing were conducted on the MD-320W and the testing results comply with the requirements of IEC 60601-1 and IEC 60601-2-37 for safety and the IEC 60601-1-2 for EMC. The acoustic output parameters comply with the requirements of IEC 60601-2-37 and FDA Guidance on diagnostic ultrasound systems and transducers. It is recommended to use FDA-cleared disposable sterile water sac which meets the relevant requirements of ISO10993 to contact patients, such as ClearScan Transducer Cover (K080119). The biocompatibility evaluation has been conducted by the manufacturer according to ISO 10993. The software and essential performance have passed verification and validation, and the results comply with the related requirements as per the FDA Guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in June 27, 2019. ## 8. Conclusions The results of non-clinical tests as well as the software and essential performance verification and validation demonstrate that the MD-320W Ultrasound Biomicroscope is substantially equivalent in safety, effectiveness and performance to the legally marketed predicate device. While there are some differences between the MD-320W Ultrasound Biomicroscope and its predicate device, they do not affect the safety or effectiveness.