(22 days)
Not Found
No
The description mentions "computer identifies the edge of image and volume calculation" which is standard image processing, not necessarily AI/ML. There is no mention of AI, ML, deep learning, or any related terms.
No
The device is described as a scanner that uses ultrasound to image the bladder and calculate its volume non-invasively; it is used for diagnostic purposes and does not provide therapy.
Yes
The device obtains an image of the bladder and calculates the bladder volume non-invasively, which is a diagnostic function.
No
The device description explicitly states that the device "consists of host and probe," indicating the presence of hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves things like blood, urine, tissue, etc., to provide information about a physiological state, health, or disease.
- The Palm Bladder Scanner - PBSV5.1 uses ultrasound energy to image the bladder within the patient's body. It does not analyze a sample taken from the patient.
The device is a non-invasive medical device that uses imaging to measure bladder volume. This falls under the category of diagnostic imaging devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
IYO, ITX
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
lower abdomen, bladder
Indicated Patient Age Range
nonpregnant patient (no further specification)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Housing: This device have been tested all electrical safety and basic performance by AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated)
- Digital Circuit: This device have been tested all electrical safety, basic performance and Ultrasonic sound output by China Testing and Testing Group Co., Ltd.
- Applicable standards: AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (Iec 60601-1:2005, Mod). (General II (ES/EMC)); AAMI / ANSI / IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests. (General II (ES/EMC)); IEC 60601-2-37 Edition 2.1 2015, Medical Electrical Equipment - Part 2-37: Particular Requirements For The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment. (Radiology); NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3. (Radiology); NEMA UD 3:2004 Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment; Acoustic output testing as per the guideline “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers” dated September 9, 2008
- Software: The development of software have been controlled according to the requirements of the software control procedures, and the software have been verified and validated.
- Applicable standards: ISO13485 Third edition 2016-03-01 Medical devices - Quality management systems - Requirements for regulatory purposes:7.3 Design and Development; IEC62304 Medical Device Software - Software Life Cycle Processes
- Battery: According to the requirements of IEC62133, the battery have been tested all items by China Testing and Testing Group Co., Ltd.
- Applicable standard: IEC 62133 Edition 2.0 2012-12, Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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
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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
(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
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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
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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
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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 | |||
| the housing of PBSV5.1 was industrially designed | ||||
| for a better ergonomic interaction experience. The | ||||
| updated housing meets the mechanical strength | ||||
| requirements of 15.3 of IEC 60601-1. | Housing | This device have | ||
| been tested all | ||||
| electrical safety and | ||||
| basic performance by | AAMI / ANSI | |||
| ES60601-1:2005/(R)2012 And | ||||
| A1:2012, C1:2009/(R)2012 And | ||||
| A2:2010/(R)2012 (Consolidated) | ||||
| Digital Circuit | In the circuit board, the ultrasonic transmitting and | |||
| receiving part is replaced by an analog circuit to a | ||||
| digital circuit, which improves the signal-to-noise | ||||
| ratio of the ultrasonic signal and the image quality. | ||||
| The barcode scanning module has been added to | ||||
| input the patient information for the operator. The | ||||
| new circuit board meets the relevant requirements of | ||||
| IEC60601-1 and IEC60601-1-2. | ||||
| Software | Under the premise of not changing the user | |||
| operation, we have optimized the interface UI. At the | ||||
| same time,this device have been added the barcode | ||||
| scanning function and the operation mode of expert | ||||
| and simple. The design and development of software | ||||
| meets the requirement of IEC62304 | ||||
| Battery | The customized 7.4V lithium battery pack is changed | |||
| to 4 standard 18650 lithium battery pack synthesis | ||||
| 7.4V to provide the power for the equipment. |
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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:
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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
Testing Group Co.,
Ltd. | Text) Medical Electrical
Equipment - Part 1: General
Requirements For Basic Safety
And Essential Performance (Iec
60601-1:2005, Mod). (General II
(ES/EMC)) | |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Digital Circuit | This device have
been tested all
electrical safety,
basic performance
and Ultrasonic sound
output by China
Testing and Testing
Group Co., Ltd. | AAMI / ANSI
ES60601-1:2005/(R)2012 And
A1:2012, C1:2009/(R)2012 And
A2:2010/(R)2012 (Consolidated
Text) Medical Electrical
Equipment - Part 1: General
Requirements For Basic Safety
And Essential Performance (Iec
60601-1:2005, Mod). (General II
(ES/EMC));
AAMI / ANSI / IEC
60601-1-2:2014, Medical
Electrical Equipment -- Part 1-2:
General Requirements For Basic
Safety And Essential Performance
-- Collateral Standard:
Electromagnetic Disturbances --
Requirements And Tests. (General
II (ES/EMC));
IEC 60601-2-37 Edition 2.1 2015,
Medical Electrical Equipment - |
| | | Part 2-37: Particular Requirements
For The Basic Safety And
Essential Performance Of
Ultrasonic Medical Diagnostic
And Monitoring
Equipment. (Radiology); |
| | | NEMA UD 2-2004 (R2009),
Acoustic Output Measurement
Standard For Diagnostic
Ultrasound Equipment Revision
3. (Radiology); |
| | | NEMA UD 3:2004 Standard for
real-time display of thermal and
mechanical acoustic output indices
on diagnostic ultrasound
equipment; |
| | | Acoustic output testing as per the
guideline “Information for
Manufacturers Seeking Marketing
Clearance of Diagnostic
Ultrasound Systems and
Transducers” dated September 9,
2008 |
| Software | The development of
software have been
controlled according | ISO13485 Third edition
2016-03-01 Medical devices -
Quality management systems - |
| Battery | to the requirements
of the software
control procedures,
and the software
have been verified
and validated. | Requirements for regulatory
purposes:7.3 Design and
Development;
IEC62304 Medical Device
Software - Software Life Cycle
Processes |
| | According to the
requirements of
IEC62133, the
battery have been
tested all items by
China Testing and
Testing Group Co.,
Ltd. | IEC 62133 Edition 2.0 2012-12,
Secondary Cells And Batteries
Containing Alkaline Or Other
Non-Acid Electrolytes - Safety
Requirements For Portable Sealed
Secondary Cells, And For
Batteries Made From Them, For
Use In Portable Applications |
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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.
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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).