Palm Bladder Scanner - PBSV5.1

{0}------------------------------------------------ Image /page/0/Picture/0 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 in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". Mianyang Meike Electronic Equipment Co., Ltd. % Ms. Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room 302, Building 3, Hangqian Mansion, Hangqian Street Lucheng District Wenzhou, Zhejiang 325000 CHINA June 5, 2019 Re: K191307 Trade/Device Name: Palm Bladder Scanner - PBSV5.1 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: April 1, 2019 Received: May 14, 2019 Dear Ms. Nan: 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 {1}------------------------------------------------ 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) 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 (OS) 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. #### 510(k) Number (if known) #### K191307 Device Name Palm Bladder Scanner - PBSV5.1 #### Indications for Use (Describe) Palm Bladder Scanner - PBSV5.1 is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease. Type of Use (Select one or both, as applicable) > 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 annonmally to 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." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "Meike" in blue, with Chinese characters above it. The Chinese characters are also in blue and appear to be a stylized font. To the right of the word "Meike" is a circled "R", indicating a registered trademark. # 007 510(k) Summarv K191307 (As required by 21 CFR 807.92(a)) ### 1.0 Submitter Information - · Company: Mianyang Meike Electronic Equipment Co., Ltd. - · Address: No.63, Yinping Road, Longmen Town, Fucheng District, Mianyang, Sichuan, 621000, CHINA - ・Phone: 086-13308119236 - · Contact: Wenjun Zhao, General Manager - · Date: Apr 1, 2019 # 2.0 Device Information - · Trade/Device Name: Palm Bladder Scanner PBSV5.1 - · Model: PBSV5.1 - · Common Name: Diagnostic Ultrasound System with Accessories - · Classification: Device: Ultrasonic Pulsed Echo Imaging System Diagnostic Ultrasonic Transducer Review Panel: Radiology Product Code: IYO, ITX Submission Type: Special 510(k) Regulation Number: CFR 892.1560, CFR 892.1570 Device Class: 2 # 3.0 Predicate Device Information Palm Bladder Scanner - PBSV4.1 [510K Number:K130229; submitted by Mianyang Meike Electronic Equipment Co., Ltd.] # 4.0 Device Description {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains a logo with Chinese characters and the word "Meike" in blue. The Chinese characters are stacked on top of the word "Meike". To the right of the word "Meike" is a circled "R", which is a symbol for a registered trademark. The logo appears to be for the brand "Meike". Palm Bladder Scanner - PBSV5.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The device consists of host and probe, it can speedily complete the detection of bladder area through scan of probe connected with the device, and transmit B ultrasound echo signal detected to embedded computer system after processing before computer identifies the edge of image and volume calculation, realizes the measurement of bladder volume, displays and prints out the relative information through LED/built-in printer. ### 5.0 Indications for Use Palm Bladder Scanner - PBSV5.1 is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease. # 6.0 Comparison of Technological Characteristics with the Predicate Device Palm Bladder Scanner - PBSV5.1 is substantially equivalent to the predicate device, Palm Bladder Scanner - PBSV4.1 cleared by the FDA in K130229. Palm Bladder Scanner - PBSV5.1 claims substantial equivalence because the proposed device has the same intended use, scope of application and operation compared with the predicate device. Meanwhile, PBSV5.1 also use the same ultrasound-based science technology and is the basic same in the technical characteristics, as well as the physical and operation. Both bladder scanner PBSV5.1 and PBSV4.1 use the piezoelectric ceramic wafers as the sensors to obtain B-type grayscale ultrasound images to achieve the intended use, and the material used in the product structure are {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "Meike" in blue font, with the trademark symbol to the right of it. Above the word "Meike" are two Chinese characters, also in blue. The font is a simple sans-serif font. also identical.Both bladder scanner PBSV5.1 and PBSV4.1 are portable devices, and can be used to measure the urine volume in the bladder. A brief summary of the similarities and differences between Palm Bladder Scanner - PBSV5.1 and Palm Bladder Scanner - PBSV4.1 (K130229) is included below: Similarities Both Palm Bladder Scanner - PBSV5.1 and Palm Bladder Scanner - PBSV4.1 have the same basic science & technology and all technical features. All technical features are as follows: 1)Both two devices use the piezoelectric ceramic wafers as transducers to obtain the ultrasound images of patient's bladder. 2)Both two devices can obtain and process the B-type grayscale images of patient's bladder. 3)Both two devices can obtain the boundaries of the patient's bladder image through the same software algorithm. 4)Both two devices require the patient to be in a supine position. 5)Both two devices require an ultrasonic coupling agent to be placed between the probe sound-permeable window and the patient's skin surface for use as an ultrasound conductive medium. 6)Both two devices use the probe to scan and display the 12/24 B-mode ultrasound image of the patient's bladder 7)Both two devices use the same technology to achieve 3D image reconstruction, and use the same algorithm to calculate the volume of the reconstructed 3D image. # Differences Compared with the predicate device, Palm Bladder Scanner - PBSV5.1 uses the new housing, replace the original ultrasonic transceiver part with an {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains a logo with Chinese characters and the word "Meike" in blue. The Chinese characters are positioned above the word "Meike", which is followed by a circled "R" symbol, indicating a registered trademark. The overall design is simple and clean, with a focus on the brand name. analog circuit into a digital circuit, optimizes the software UI interface and change the battery. The summary of the differences between Palm Bladder Scanner - PBSV5.1 and Palm Bladder Scanner - PBSV4.1 are listed in the following table. | Modification | Discussion | Modification | Test Performed | Type of Testing | |-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | Housing | PBSV5.1 uses the same material as PBSV4.1, and<br>the housing of PBSV5.1 was industrially designed<br>for a better ergonomic interaction experience. The<br>updated housing meets the mechanical strength<br>requirements of 15.3 of IEC 60601-1. | Housing | This device have<br>been tested all<br>electrical safety and<br>basic performance by | AAMI / ANSI<br>ES60601-1:2005/(R)2012 And<br>A1:2012, C1:2009/(R)2012 And<br>A2:2010/(R)2012 (Consolidated) | | Digital Circuit | In the circuit board, the ultrasonic transmitting and<br>receiving part is replaced by an analog circuit to a<br>digital circuit, which improves the signal-to-noise<br>ratio of the ultrasonic signal and the image quality.<br>The barcode scanning module has been added to<br>input the patient information for the operator. The<br>new circuit board meets the relevant requirements of<br>IEC60601-1 and IEC60601-1-2. | | | | | Software | Under the premise of not changing the user<br>operation, we have optimized the interface UI. At the<br>same time,this device have been added the barcode<br>scanning function and the operation mode of expert<br>and simple. The design and development of software<br>meets the requirement of IEC62304 | | | | | Battery | The customized 7.4V lithium battery pack is changed<br>to 4 standard 18650 lithium battery pack synthesis<br>7.4V to provide the power for the equipment. | | | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Meike. The logo consists of two parts: the Chinese characters "美科" in blue, and the word "Meike" in blue with the registered trademark symbol. The Chinese characters are stacked on top of the word "Meike". The differences noted between Palm Bladder Scanner - PBSV5.1 and the predicate device, Palm Bladder Scanner - PBSV4.1 (K130229), do not present any new or different questions related to safety and effectiveness. ### 7.0 Discussion of Tests Performed # 7.1 Clinical Tests Clinical testing was not performed for the subject device as part of the submission. #### 7.2 Non-Clinical Tests The function and performance of Palm Bladder Scanner - PBSV5.1 has been evaluated through non-clinical design verification and validation testing. All necessary testing was conducted on the proposed Palm Bladder Scanner - PBSV5.1 to support a determination of substantial equivalence to the unmodified predicate device. Specifically, the impacts of the design changes presented with the subject device were evaluated through Design Control, and a number of required testing accordingly determined and subsequently performed. All necessary validation testing, including comprehensive software verification and validation, was performed, the results of which demonstrate that Palm Bladder Scanner - PBSV5.1 successfully meets design specification. These testings confirm that the design changes presented with the subject device do not raise new questions of safety and effectiveness, the subject device meets design specifications, and that the subject and predicate devices are substantially equivalent: {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "Meike" in blue, with Chinese characters above it. The word "Meike" is written in a bold, sans-serif font. To the right of the word "Meike" is a circled "R", which is a symbol for a registered trademark. The background of the image is white. | China Testing and<br>Testing Group Co.,<br>Ltd. | Text) Medical Electrical<br>Equipment - Part 1: General<br>Requirements For Basic Safety<br>And Essential Performance (Iec<br>60601-1:2005, Mod). (General II<br>(ES/EMC)) | | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Digital Circuit | This device have<br>been tested all<br>electrical safety,<br>basic performance<br>and Ultrasonic sound<br>output by China<br>Testing and Testing<br>Group Co., Ltd. | AAMI / ANSI<br>ES60601-1:2005/(R)2012 And<br>A1:2012, C1:2009/(R)2012 And<br>A2:2010/(R)2012 (Consolidated<br>Text) Medical Electrical<br>Equipment - Part 1: General<br>Requirements For Basic Safety<br>And Essential Performance (Iec<br>60601-1:2005, Mod). (General II<br>(ES/EMC));<br><br>AAMI / ANSI / IEC<br>60601-1-2:2014, Medical<br>Electrical Equipment -- Part 1-2:<br>General Requirements For Basic<br>Safety And Essential Performance<br>-- Collateral Standard:<br>Electromagnetic Disturbances --<br>Requirements And Tests. (General<br>II (ES/EMC));<br><br>IEC 60601-2-37 Edition 2.1 2015,<br>Medical Electrical Equipment - | | | | Part 2-37: Particular Requirements<br>For The Basic Safety And<br>Essential Performance Of<br>Ultrasonic Medical Diagnostic<br>And Monitoring<br>Equipment. (Radiology); | | | | NEMA UD 2-2004 (R2009),<br>Acoustic Output Measurement<br>Standard For Diagnostic<br>Ultrasound Equipment Revision<br>3. (Radiology); | | | | NEMA UD 3:2004 Standard for<br>real-time display of thermal and<br>mechanical acoustic output indices<br>on diagnostic ultrasound<br>equipment; | | | | Acoustic output testing as per the<br>guideline “Information for<br>Manufacturers Seeking Marketing<br>Clearance of Diagnostic<br>Ultrasound Systems and<br>Transducers” dated September 9,<br>2008 | | Software | The development of<br>software have been<br>controlled according | ISO13485 Third edition<br>2016-03-01 Medical devices -<br>Quality management systems - | | Battery | to the requirements<br>of the software<br>control procedures,<br>and the software<br>have been verified<br>and validated. | Requirements for regulatory<br>purposes:7.3 Design and<br>Development;<br><br>IEC62304 Medical Device<br>Software - Software Life Cycle<br>Processes | | | According to the<br>requirements of<br>IEC62133, the<br>battery have been<br>tested all items by<br>China Testing and<br>Testing Group Co.,<br>Ltd. | IEC 62133 Edition 2.0 2012-12,<br>Secondary Cells And Batteries<br>Containing Alkaline Or Other<br>Non-Acid Electrolytes - Safety<br>Requirements For Portable Sealed<br>Secondary Cells, And For<br>Batteries Made From Them, For<br>Use In Portable Applications | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows a logo with Chinese characters and the word "Meike" in blue. The Chinese characters are positioned above the word "Meike". A registered trademark symbol is located to the right of the word "Meike". {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "Meike" in blue, with the trademark symbol next to it. Above the word "Meike" are two Chinese characters, also in blue. The font is a simple sans-serif font. #### 8.0 Conclusion: First, the subject device - Palm Bladder Scanner - PBSV5.1 enjoys the same intended use with the predicate device, which forms the foundation of their substantial equivalence. Secondly, they share almost the same technological characteristics and the differences will not affect the core usage of the subject device, which further support their substantial equivalence. Moreover, the safety and effectiveness of Palm Bladder Scanner - PBSV5.1 have been evaluated according to appropriate standards, which ensures that the new device will not bring new safety and effectiveness concerns, that the subject device is substantial equivalent to the predicate device. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image contains the word "Meike" in blue font, with Chinese characters above it, also in blue. To the right of the word "Meike" is the registered trademark symbol, which is an R inside of a circle. The Chinese characters appear to be a stylized logo or brand name. The overall impression is that this is a company logo or brand mark. In a word, it is reasonable for us to conclude that the subject device - Palm Bladder Scanner - PBSV5.1 is substantially equivalent to the predicate device - Palm Bladder Scanner - PBSV4.1 (K130229).