(100 days)
Not Found
No
The summary mentions "software algorithm" for image processing and volume calculation, but does not use terms like AI, ML, deep learning, or neural networks. The description focuses on traditional ultrasound and computer technology.
No
The device is used to image the bladder and calculate its volume, not to treat a condition.
Yes
The device is described as calculating bladder volume and obtaining an image of the bladder, which are diagnostic functions. The "Intended Use" section explicitly states its purpose is to "obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively," which directly supports diagnosis related to bladder conditions.
No
The device description explicitly states that the device is composed of a data processing host, a 3D ultrasonic probe, and application software, indicating it includes hardware components in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Palm Bladder Scanner - PBSV7.1 uses ultrasound energy applied externally to the lower abdomen to image the bladder and calculate its volume. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a non-invasive method of obtaining bladder information through external imaging.
Therefore, the device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Palm Bladder Scanner - PBSV7.1 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 (comma separated list FDA assigned to the subject device)
IYO, IYX
Device Description
Palm Bladder Scanner - PBSV7.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The PBSV7.1 is composed of data processing host, 3D ultrasonic probe and application software. The 3D ultrasonic probe will transmit the collected data to the host, which will process the received data into ultrasonic images and bladder volume data. Images and data will be transmitted to the running application software on the Android system PC tablet through the USB interface.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
lower abdomen, bladder
Indicated Patient Age Range
Not Found
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)
The function and performance of Palm Bladder Scanner - PBSV7.1 has been evaluated through non-clinical design verification and validation testing. All necessary testing was conducted on the proposed Palm Bladder Scanner - PBSV7.1 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 -PBSV7.1 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±5%(≥100mL)/ ±5mL(0~100mL)
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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.
Mianyang Meike Electronic Equipment Co., Ltd. Wenjun Zhao General Manger No.63, Yinping Road, Longmen Town, Fucheng District Mianyang, Sichuan, 621000 CHINA
Re: K210591
Trade/Device Name: Palm Bladder Scanner - PBSV7.1 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO,IYX
Dear Wenjun Zhao:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 9, 2021. Specifically, FDA is updating this SE Letter because of a clerical error in the 510(k) Summary as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jessica Lamb, Office of in vitro Diagnostics and Radiological Health, 301-796-6167, jessica.lamb@fda.hhs.gov.
Sincerely,
Michael D. O'Hara 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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The words "U.S. FOOD & DRUG" are on the first line, and "ADMINISTRATION" is on the second line.
Mianyang Meike Electronic Equipment Co., Ltd. Wenjun Zhao General Manger No.63, Yinping Road, Longmen Town, Fucheng District Mianyang, Sichuan, 621000 CHINA
Re: K210591
Trade/Device Name: Palm Bladder Scanner - PBSV7.1 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: April 20, 2021 Received: May 10, 2021
Dear Wenjun Zhao:
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 801 medical device reporting of medical device-related adverse events) (21 CFR 803) for devices
June 9, 2021
2
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,
Michael D. O'Hara
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
3
Indications for Use
510(k) Number (if known) K210591
Device Name Palm Bladder Scanner - PBSV7.1
Indications for Use (Describe)
Palm Bladder Scanner - PBSV7.1 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 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."
4
Image /page/4/Picture/0 description: The image shows a logo with two parts: Chinese characters at the top and the word "Meike" with a circled "R" symbol below. The Chinese characters are written in a traditional style, and the word "Meike" is in a bold, sans-serif font. The logo is in blue color. The logo likely represents a company or brand named "Meike".
007 510(k) Summary (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 |
| Title: | General Manager |
| Date: April. 26, 2021 |
2.0 Device Information
| Trade/Device Name: | Palm Bladder Scanner - PBSV7.1 |
|---|---|
| Model: | PBSV7.1 |
| Common Name: | Diagnostic Ultrasound System with Accessories |
| Regulation Description: | Ultrasonic pulsed echo imaging system; |
| Transducer, Ultrasonic, Diagnostic | |
| Device: | System, Imaging, Pulsed Echo, Ultrasonic; |
| 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: | Class II |
3.0 Predicate Device Information
| Trade/Device Name: | Palm Bladder Scanner - PBSV5.1 |
|---|---|
| 510k Number: | K191307 |
| Submitter: | Mianyang Meike Electronic Equipment Co., Ltd. |
4.0 Device Description
Palm Bladder Scanner - PBSV7.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The PBSV7.1 is composed of data processing host, 3D ultrasonic probe and application software. The 3D ultrasonic probe will transmit the collected data to the host, which will process the received data into ultrasonic images and bladder volume data. Images and data will be transmitted to the running application software on the Android system PC tablet through the USB interface.
5.0 Indications for Use
Palm Bladder Scanner - PBSV7.1 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
5
Image /page/5/Picture/0 description: The image shows the word "Meike" in a stylized font, with the Chinese characters for "Meike" above it. The word "Meike" is in a dark blue color, and the Chinese characters are in a lighter blue. There is a circled "R" symbol to the right of the word "Meike", indicating that it is a registered trademark.
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
| Table 1 - Comparison table of the Subject device and Predicate device | ||
|---|---|---|
| Device Feature | Palm Bladder Scanner - | |
| PBSV7.1 | Palm Bladder Scanner - | |
| PBSV5.1 | ||
| 510k number | K210591 | K191370 |
| Classification | CFR 892.1560, CFR 892.1570 | |
| Product code | IYO, ITX | |
| Common name | Diagnostic Ultrasound System with Accessories | |
| Use | Prescription Use | |
| Indication for | ||
| use | Palm Bladder Scanner - | |
| PBSV7.1 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. | 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. | ||
| Display Mode | B | B |
| Frequency | 3.5MHz | 2.6MHZ |
| Scan Type | Convergent | Mechanical Sector Scan |
| Display Screen | Universal Tablet Computer | |
| (Non-medical Device) | 8.4"TFT Color LCD | |
| Power Supply | Internal Battery | |
| (four 18650 lithium | ||
| batteries) | Internal Battery | |
| (four 18650 lithium | ||
| batteries) | ||
| Battery Control | Capacity Instruction for | |
| Lower Power | Capacity Instruction and | |
| Alarm for Lower Power | ||
| Printer | Request Android system | Self-built printer for |
| printing micro characters, | ||
| graphic and image | ||
| Patient Case | ||
| Record | ≤10000 Pieces | 100 Pieces |
| Maximum | ||
| Measurement | 2000ml | 999ml |
| Accuracy | ±5%(≥100mL)/ ±5mL | |
| (0~100mL) | ±15%,±15 ml | |
| Dead Zone | ≤3mm | 8mm |
| Language of | ||
| Interface | English & Chinese | English |
Table 1 - Comparison table of the Subject device and Predicate device
6
Image /page/6/Picture/0 description: The image shows the logo for Meike. The logo consists of two Chinese characters in blue, stacked above the word "Meike" in blue, with a circled "R" symbol to the right of the word. The font of the word "Meike" is bolded.
A brief summary of the similarities and differences between Palm Bladder Scanner - PBSV7.1 and Palm Bladder Scanner - PBSV5.1 (K191307) is included below:
Similarities
Both Palm Bladder Scanner - PBSV7.1 and Palm Bladder Scanner -PBSV5.1 have the same basic science & technology and all technical features. All technical features are as follows:
- · Both two devices use the piezoelectric ceramic wafers as transducers to obtain the ultrasound images of patient's bladder.
- · Both two devices can obtain and process the B-type grayscale images of patient's bladder.
- Both two devices can obtain the boundaries of the patient's bladder image through the same software algorithm.
- Both two devices require the patient to be in a supine position.
- 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.
- Both two devices use the probe to scan and display the 12/24 B-mode ultrasound image of the patient's bladder
- 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.
- Both two devices use the same material of probe and host.
Differences
The summary of the differences between Palm Bladder Scanner -PBSV7.1 and Palm Bladder Scanner - PBSV5.1 are listed in the following:
-
Transducer Frequency
2.6 MHz for PBSV5.1 and 3.5 MHz for PBSV7.1. -
· Scan type
7
The scan type of the PBSV5.1 is mechanical sector scan and the PBSV7.1 uses convergent scan.
● Display screen
PBSV7.1 uses Android off-the-shelf tablet as the display screen, the PBSV5.1 uses built-in 8.4"TFT Color LCD screen.
● Printer
The PBSV5.1 has a printer as part of the device. The PBSV7.1 can print to a wireless printer available as an accessory through the off-the-shelf tablet.
● Performance
The performance of the PBSV7.1 has been greatly improved.
. Memory capacity of the patient case record has expanded from up to 100 pieces (PBSV5.1) to 10000 pieces (PBSV7.1).
· Maximum Measurement can reach to 2000ml (PBSV7.1) instead of the 999ml (PBSV5.1).
·Accuracy are improved. In PBSV5.1, there's a 15%/15ml margin of error, the PBSV7.1 managed to reduce the error to 5%/5m1. The area of dead zone reduces from 8mm to less than 3mm.
· There are more language options in the PBSV7.1- Chinese and English while the PBSV5.1 can only be operated in English.
· Software
Under the premise of not changing the user operation, we have optimized the interface UI. At the same time, PBSV7.1 have been removed the bar code scanning function and the gender switch function. The added functions are · Hospital information setting function · Batch data operation function .Data uploading .Exporting, backup and restoring function .User automatic logout function. The design and development of software meets the requirement of IEC62304.
The differences noted between Palm Bladder Scanner - PBSV7.1 and the predicate device, Palm Bladder Scanner - PBSV5.1 (K191307), do not present any new or different questions related to safety and effectiveness.
7.0 Compatibility Specifications for Universal PC Tablet
7.1 Universal PC Tablet Compatibility
Table 2 - List of Compatibility Specifications
| Specification | Requirement |
|---|---|
| CPU: | Above 1.5GHz |
| RAM: | Above 3GB |
| Storage Memory: | Above 32GB |
| Screen: | Above 1920×1080 of Resolution |
8
Image /page/8/Picture/0 description: The image shows a logo with the Chinese characters "美科" in blue at the top. Below the Chinese characters, the word "Meike" is written in blue, followed by the registered trademark symbol. The logo appears to be for the brand "Meike."
Mianyang Meike Electronic Equipment Co., Ltd.
| Network: | Wi-Fi, Bluetooth |
|---|---|
| USB Interface: | Type-C |
| OS Version: | On Android 8.0 and above |
| Print: | Support Wi-Fi Print |
| EMC and Electrical Safety: | Meet the standard of IEC60601-1 or |
| IEC62368-1 | |
| Mobile Phone Capability: | Must approved by FCC |
7.2 Warnings
Risks and safety accidents may be caused by irregular use or use of any tablet PC tablet that does not meet the specific requirements listed in the Compatibility Specifications Table for that may lead to abnormal operations of the application software or other issues.
The user must assume responsibility for assuring the performance of any tablet PC with the system other than listed in the Compatibility Specifications Table and using the tablet PC regularly.
8.0 Discussion of Tests Performed
8.1 Clinical Tests
Clinical testing was not performed for the subject device as part of the submission.
8.2 Non-Clinical Tests
The function and performance of Palm Bladder Scanner - PBSV7.1 has been evaluated through non-clinical design verification and validation testing. All necessary testing was conducted on the proposed Palm Bladder Scanner - PBSV7.1 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 -PBSV7.1 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:
| Standard | Title |
|---|---|
| IEC 60601-1: | |
| 2005+A1:2012 | Medical Electrical Equipment - Part 1: General |
| Requirements For Basic Safety And Essential | |
| Performance (IEC 60601-1:2005, MOD). |
Table 3 - Performance testing
9
Image /page/9/Picture/0 description: The image shows a logo with Chinese characters at the top and the word "Meike" in English below. The Chinese characters are written in a traditional style, and the English word "Meike" is in a bold, sans-serif font. There is a circled "R" symbol to the right of the word "Meike", indicating that it is a registered trademark. The logo is in blue color.
Mianyang Meike Electronic Equipment Co., Ltd.
| IEC 60601-2-37:
2007+ AMD1 2015 | Medical Electrical Equipment - Part 2-37:
Particular Requirements For The Basic Safety And
Essential Performance Of Ultrasonic Medical
Diagnostic And Monitoring Equipment. |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2:
2007+ AMD1 2015 | Medical Electrical Equipment -- Part 1-2: General
Requirements For Basic Safety And Essential
Performance -- Collateral Standard:
Electromagnetic Disturbances -- Requirements
And Tests. |
| IEC 62133:2012 | 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 [Including:
Corrigendum 1 (2013)]. |
| IEC 62359: 2017 | Ultrasonics - Field characterization - Test methods
for the determination of thermal and mechanical
indices related to medical diagnostic ultrasonic
fields. |
| ISO 10993-5:2009 | Biological Evaluation Of Medical Devices -- Part
5: Tests For In Vitro Cytotoxicity. |
| ISO 10993-10:2010 | Biological Evaluation Of Medical Devices - Part
10: Tests For Irritation And Skin Sensitization |
The conclusion from the testing is the device is safe and effective for it's intended use, and performs as well or better than the predicate devices.
9.0 Software
The software and firmware in the Palm Bladder Scanner - PBSV7.1 has been developed and verified according to IEC 62304:2006. The verification report, traceability, and risk analysis demonstrate the PBSV7.1 operates as intended and risks mitigated in firmware have been verified.
10.0 Conclusion
First, the subject device - Palm Bladder Scanner - PBSV7.1 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 - PBSV7.1 have been evaluated according to appropriate standards, which ensures that the new device will not bring new safety and effectiveness concerns, that the
10
Image /page/10/Picture/0 description: The image shows a logo with Chinese characters at the top and the word "Meike" in English below. The Chinese characters are stylized and appear to be a brand name. The word "Meike" is in a simple, bold font, and there is a circled "R" symbol next to it, indicating that it is a registered trademark.
subject device is substantial equivalent to the predicate device.
In a word, it is reasonable for us to conclude that the subject device - Palm Bladder Scanner - PBSV7.1 is substantially equivalent to the predicate device - Palm Bladder Scanner - PBSV5.1 (K191307).