The Bladder Scanner (Models: M3, M4, M4-HD) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M3, M3-HD, M4, M4-HD Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively. The M3, M3-HD, M4, M4-HD Bladder Scanner is intended to be used only by qualified medical professionals.

Device Description

The M Series Bladder Scanner is a handheld battery-operated device, which is developed by SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD., and manufactured by Suzhou Lischka Medtech Co., Ltd., it provides non-invasive bladder volume measurement utilizing real-time ultrasound imaging. The device consists of the main unit, 3D probe (M4, M4-HD)/2D probe (M3, M3-HD), Data processing and storage modules, APP software, battery and Charger.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in an "acceptance criteria" section. However, it does list the "Volume measurement accuracy" and implicitly sets the predicate device's performance as the benchmark for substantial equivalence.

Metric / Parameter	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Subject Device)
Bladder Volume Measurement Accuracy (M4/M4-HD)	Under 100 mL: ± 7 mL100 to 999 mL: ± 7%	Under 100 mL: ± 7 mL 100 to 999 mL: ± 7%
Bladder Volume Measurement Accuracy (M3/M3-HD)	Under 100 mL: ± 14 mL100 to 999 mL: ± 14%	Under 100 mL: ± 14 mL 100 to 999 mL: ± 14%

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Clinical testing is not required." This implies that no clinical test set with human patients was used to prove the device meets these specific performance metrics. The performance metrics are likely derived from non-clinical phantom studies or internal validation processes that are not detailed in this summary. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective) for a clinical test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since clinical testing was not required, there is no mention of experts being used to establish ground truth for a test set in the context of human patient data.

4. Adjudication Method

Not applicable, as no clinical test set with human data was used requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document clearly states that clinical testing was not required. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. Standalone (Algorithm Only) Performance Study

The document focuses on the device performance and states that "The M3,M3-HD,M4,M4-HD Bladder Scanner was evaluated with safety, EMC and Acoustic Output." It provides performance accuracy figures for volume measurement. This suggests that the algorithm's performance, as integrated into the device, was evaluated to achieve these accuracy figures. While the term "standalone study" in the context of an algorithm might imply a specific type of evaluation (e.g., using a separate dataset to test the algorithm's output without the full device), the volume measurement accuracy directly reflects the algorithm's capability.

7. Type of Ground Truth Used

Based on the lack of clinical testing, the ground truth for the stated performance accuracy (bladder volume measurement) was likely established through:

Phantom studies: Using calibrated phantoms with known volumes. This is a common method for validating ultrasound device accuracy.
Engineering measurements: Direct measurements of physical models.

The document does not specify the exact method for establishing ground truth for the performance metrics, but it is implied to be non-clinical.

8. Sample Size for the Training Set

The document does not provide any information regarding the training set size for the device's algorithms.

9. How the Ground Truth for the Training Set Was Established

The document does not provide any information regarding how the ground truth for the training set (if any, as it could be rule-based or trained on phantom data) was established.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Suzhou Peaksonic Medical Technology Co., Ltd. % Calvin Ma General Manager 2A, West Side of Building G4 Kunshan Hi-Tech Medical Device Industrial Park Qiandeng, Kunshan, Suzhou, Jiangsu 215341 CHINA

February 26, 2021

Re: K201316

Trade/Device Name: Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: January 1, 2021 Received: January 25, 2021

Dear Calvin Ma:

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}------------------------------------------------

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 medical devices and radiation-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)

K201316

Device Name Bladder Scanner (Model:M3, M3-HD, M4, M4-HD)

Indications for Use (Describe)

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."

{3}------------------------------------------------

510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: January 1, 2021

K201316

1. Submitter's Information

The submitter of this pre-market notification is:

Name:	SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD
Address:	2A, West Side of Building G4, KunshanHi-Tech Medical Device Industrial Park ,Qiandeng Town, KunshanSuzhou, JIANGSU, 215341, CHINA
Contact person:	Calvin Ma
Title:	General manager
E-mail:	service@peaksonic.com.cn
Tel:	+86- 512-36693388

2. Device Identification

Trade/Device Name:	Bladder Scanner
Models:	M3, M3-HD, M4, M4-HD
Regulation Number:	21 CFR 892.156021 CFR 892.1570
Common Name:	Ultrasonic, Pulsed echo, ImagingTransducer, Ultrasonic, Diagnostic
Regulation Class:	Class II
Product Code:	IYO, ITX

3. Predicate Device

510(K) number:	K190769
Device Name:	Bladder Scanner (Models:M2, M2-W, M1, M1-W)
Manufacturer:	Suzhou Lischka Medtech Co., Ltd.
Regulation Number:	21 CFR 892.156021 CFR 892.1570
Common Name:	Ultrasonic, Pulsed echo, ImagingTransducer, Ultrasonic, Diagnostic
Regulation Class:	Class II
Product Code:	IYO, ITX

{4}------------------------------------------------

4. Device Description

It features:
. M3 and M3-HD has two Operation Modes: Expert Mode and Easy Mode, M4 and M4-HD has three Operation Modes: Expert Mode, Easy Mode and intelligence mode
. Non-invasive, comfortable, correct, reliable, fast and simple operation. When the operator releases the button on the probe, multiple 2D plane ultrasound images are acquired in a few seconds. The equipment adopts sophisticated image processing techniques to restore the stereo image, and adopts a sophisticated algorithm to measure bladder volume and displays the measurement results on the screen.
Use touch screen keyboard operation on tablet computer (or mobile phone)
. Multilinqual choice
Bluetooth Wireless Printing Report
. Volume preset reminder
. Information management, storage and printing
Wifi wireless bidirectional transmission
Leak-proof management of patient information: information is stored and transmitted after encryption, and the patient information can be viewed and uploaded only after password landing.
. The instrument consists of a handheld wireless scanner and a tablet computer (or mobile phone)
Built-in battery power supply .

The difference between these models is that the model of the probe is different. M4. M4-HD is 3D probe .M3, M3-HD is 2D probe. M3-HD, M4-HD will be operated by tablet computer, M3, M4 will be operated by smart mobile phone.

5. Indication for use

The Bladder Scanner (Models: M3, M3-HD, M4, M4-HD) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M3, M3-HD, M4, M4-HD Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively. The M3, M3-HD, M4, M4-HD Bladder Scanner is intended to be used only by qualified medical professionals.

6. Comparison to Predicate Device

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table:

{5}------------------------------------------------

SE Comparisons	Predicate device	Subject device	Comments
Manufacturer/K#	Suzhou LischkaMedtech Co., Ltd./K190769	SUZHOU PEAKSONICMEDICALTECHNOLOGY CO.,LTD.	/
Trade name andmodel	Bladder Scanner(Models: M2, M2-W,M1, M1-W)	Bladder Scanner(Models: M3, M3-HD,M4, M4-HD)	/
ClassificationsnameandRegulation Name	Regulation Number:21 CFR 892.156021 CFR 892.1570Regulation Name:Ultrasonic, Pulsedecho, ImagingTransducer,Ultrasonic, DiagnosticProduct Code: IYO,ITX	Regulation Number:21 CFR 892.156021 CFR 892.1570Regulation Name:Ultrasonic, Pulsedecho, ImagingTransducer, Ultrasonic,DiagnosticProduct Code: IYO, ITX	Same
Indication for use	The Bladder Scanner(Models: M2, M2-W, M1, M1-W) projectsultrasound energythrough the lowerabdomen of thepatient to obtainimages of the bladderwhich is used tocalculate bladdervolume noninvasively.The Bladder Scanneris intended to be usedonly by qualifiedmedical professionals.	The Bladder Scanner(Models: M3, M3-HD,M4, M4-HD) projectsultrasound energythrough the lowerabdomen of the patientto obtain images of thebladder which is used tocalculate bladdervolume noninvasively.The Bladder Scanner isintended to be used onlyby qualified medicalprofessionals.	Same
Contraindications	Do not use the BladderScanner on followingcases:a) Fetal use orpregnant patientsb) Patients withascitesc) Patients with openor damaged skin.d) Wounds in thesuprapubic region	Do not use the BladderScanner on followingcases:a) Fetal use or pregnantpatientsb) Patients with ascitesc) Patients with open ordamaged skin.d) Wounds in thesuprapubic region	Same
Modesofoperation	B mode	B mode	Same
SystemCharacteristicsand structure	Portable,LCD Display,Thermal Printer,Power source: Battery	Portable,Smartphone or tabletcomputer display,Thermal Printer,Power source: Battery	Different,The design ofpredicate device is built-insoftware and ultrasoundimage and data is displayedon the device's display.Subject device has nodisplay itself and ultrasoundimage and data is displayedon the smartphone andtablet computer through APPsoftware. The principles,algorithms, and probes ofboth devices are the same.The subject device hasperformedsoftwareverification according to theFDA guidance and IEC62304, the difference doesnot affect the safety andperformance.
Display	M2: 2.4" TFT-LCDM1: 2.4" TFT-LCD	M3-HD, M4-HD will beprovided customer witha Samsung SM-T59010.5 inch.The display of M3, M4will be according to thecustomer's smartmobilephonespecifications	Different,The size and specification ofthe display is different anddoes not affect productsafety and performance.
ControlsforChangeofacoustic outputduring scan	No	No	Same
Transducer Type	MechanicalProbe	MechanicalProbe	Same
Measurementplace	Abdomen	Abdomen	Same
TransducerResonantFrequency	2.5Mhz	2.5Mhz	Same
Numberofelements	1	1	Same
Sector Angle	120°	120°	Same
Number of ScanPlanes	M2, M2-W:12 ,M1, M1-W:1	M4, M4-HD:12 ,M3, M3-HD:1	Same

PatientContactingMaterial	PC (skin contact)	PC (skin contact)	Same
Volumemeasurementrange	0ml-999ml	0ml-999ml	Same
Volumemeasurementaccuracy	M2/M2-W: $\pm$ 7%,$\pm$ 7ml;M1/M1-W: $\pm$ 14%,$\pm$ 14ml	M4/M4-HD:under 100 mL: $\pm$ 7mL;100 to 999 mL: $\pm$ 7%,M3/M3-HD:under 100 mL: $\pm$ 14mL;100 to 999 mL: $\pm$ 14%	Same
Classificationofprotection againstelectric shock	Class II equipment	Class II equipment	Same
Applied part type	B type	B type	Same
Real-timescanning	Yes (Pre-scan)	Yes (Pre-scan)	Same
PC Data Upload	USB connection	USB connection	Same
Power	Lithiumbattery:URR18650ZY-2600mAh(SNLB-4357.4Vd.c. 2600mAhCharger:HXY-084V1500A-ULAC100-240Va	Lithiumbattery:NCA653864SA-2400mAh(PC015-2S1P)7.4Vd.c. 2400mAhCharger: HXY-084V1500A-ULAC100-240Va	Different, The lithium batteryused in the predicate deviceand subject device isdifferent.The lithium battery has beenperformedsafetytestaccording to the IEC62133,and the subject device hasbeen performed safety testaccording to the IEC 60601-1, so the difference in lithiumbattery specifications will notraisenewsafetyandperformance risks.
WIFI	M1, M2 does notcontain WIFIconnection.M1-W, M2-W containWIFI connection	WIFI connection.	Same
Bluetooth	Connect to the printerusing Bluetooth toprint a test image.	Connect to the printerusing Bluetooth to printa test image.	Same
Safety and EMCStandardscompliance	ES60601-1:2005+A1:2012IEC 60601-1-2:2014IEC 60601-2-37:2015	ES60601-1:2005+A1:2012IEC 60601-1-2:2014IEC 60601-2-37:2015	Same
FDA limit	Track 1	Track 1	Same

{6}------------------------------------------------

007_510(k) Summary

{7}------------------------------------------------

007_510(k) Summary

{8}------------------------------------------------

007 510(k) Summary

All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion.

7. Performance Data

Clinical test:

Clinical testing is not required.

Non-clinical data

The M3,M3-HD,M4,M4-HD Bladder Scanner comply with:

Safety:

1. ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
1. IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests

Performance:

1. IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
1. NEMA UD 2 Standard for real-time display of thermal and mechanical acoustic output indies on diagnostic ultrasound equipment.
1. Acoustic output testing as per the quideline "Information for Manufacturers Seeking Marketing

Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.

WIFI and Bluetooth connection:

FCC CFR TITLE 47 PART 15 SUBPART C SECTION 15.247

The tests were selected to show substantial equivalence between the subject device and the predicate.

8. Conclusion

The M3,M3-HD,M4,M4-HD Bladder Scanner was evaluated with safety, EMC and Acoustic Output. The conclusions drawn from testing of the M3,M3-HD,M4,M4-HD Bladder Scanner demonstrate that the device is as safe and effective as the legally marketed predicate devices(K190769).

Regulation Number and Section

§ 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.