Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes "sophisticated image processing techniques" and a "sophisticated algorithm" for volume measurement, but does not explicitly mention or provide details about the use of AI or ML.

Therapeutic

No
The device is used for non-invasive bladder volume measurement and imaging for diagnostic purposes, not for treating a condition or disease.

Diagnostic

Yes

The device is intended to obtain images of the bladder to calculate bladder volume noninvasively and is used by qualified medical professionals for this purpose. This falls under the definition of a diagnostic device, as it provides information about a patient's condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a main unit, 3D/2D probe, data processing and storage modules, APP software, battery, and charger, indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Bladder Scanner uses ultrasound energy to non-invasively image the bladder and calculate its volume. It does not analyze samples taken from the body.
Intended Use: The intended use clearly states it's a B-mode pulsed-echo ultrasound device for obtaining images and calculating bladder volume noninvasively.

Therefore, the Bladder Scanner falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

IYO, ITX

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.

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.

Mentions image processing

Yes, "The equipment adopts sophisticated image processing techniques to restore the stereo image".

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

B-mode pulsed-echo ultrasound

Anatomical Site

lower abdomen of the patient / Abdomen

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified medical professionals

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

Clinical test:
Clinical testing is not required.

Non-clinical data:
The M3,M3-HD,M4,M4-HD Bladder Scanner comply with:

Safety:

ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
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:
3. IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
4. NEMA UD 2 Standard for real-time display of thermal and mechanical acoustic output indies on diagnostic ultrasound equipment.
5. 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:
6. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Volume measurement accuracy:
M4/M4-HD: under 100 mL: ± 7mL; 100 to 999 mL: ± 7%
M3/M3-HD: under 100 mL: ± 14mL; 100 to 999 mL: ± 14%

Predicate Device(s)

K190769

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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)

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.

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, Kunshan
Hi-Tech Medical Device Industrial Park ,
Qiandeng Town, Kunshan
Suzhou, 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 892.1560
21 CFR 892.1570
Common Name:	Ultrasonic, Pulsed echo, Imaging
Transducer, 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 892.1560
21 CFR 892.1570
Common Name:	Ultrasonic, Pulsed echo, Imaging
Transducer, Ultrasonic, Diagnostic
Regulation Class:	Class II
Product Code:	IYO, ITX

4

4. 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.

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 Lischka
Medtech Co., Ltd./
K190769	SUZHOU PEAKSONIC
MEDICAL
TECHNOLOGY CO.,
LTD.	/
Trade name and
model	Bladder Scanner
(Models: M2, M2-W,
M1, M1-W)	Bladder Scanner
(Models: M3, M3-HD,
M4, M4-HD)	/
Classifications
name
and
Regulation Name	Regulation Number:
21 CFR 892.1560
21 CFR 892.1570
Regulation Name:
Ultrasonic, Pulsed
echo, Imaging
Transducer,
Ultrasonic, Diagnostic
Product Code: IYO,
ITX	Regulation Number:
21 CFR 892.1560
21 CFR 892.1570
Regulation Name:
Ultrasonic, Pulsed
echo, Imaging
Transducer, Ultrasonic,
Diagnostic
Product Code: IYO, ITX	Same
Indication for use	The Bladder Scanner
(Models: M2, M2-W, M1, M1-W) 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 Bladder Scanner
is intended to be used
only by qualified
medical professionals.	The Bladder Scanner
(Models: M3, M3-HD,
M4, M4-HD) 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 Bladder Scanner is
intended to be used only
by qualified medical
professionals.	Same
Contraindications	Do not use the Bladder
Scanner on following
cases:
a) Fetal use or
pregnant patients
b) Patients with
ascites
c) Patients with open
or damaged skin.
d) Wounds in the
suprapubic region	Do not use the Bladder
Scanner on following
cases:
a) Fetal use or pregnant
patients
b) Patients with ascites
c) Patients with open or
damaged skin.
d) Wounds in the
suprapubic region	Same
Modes
of
operation	B mode	B mode	Same
System
Characteristics
and structure	Portable,
LCD Display,
Thermal Printer,
Power source: Battery	Portable,
Smartphone or tablet
computer display,
Thermal Printer,
Power source: Battery	Different,
The design of
predicate device is built-in
software and ultrasound
image and data is displayed
on the device's display.
Subject device has no
display itself and ultrasound
image and data is displayed
on the smartphone and
tablet computer through APP
software. The principles,
algorithms, and probes of
both devices are the same.
The subject device has
performed
software
verification according to the
FDA guidance and IEC
62304, the difference does
not affect the safety and
performance.
Display	M2: 2.4" TFT-LCD
M1: 2.4" TFT-LCD	M3-HD, M4-HD will be
provided customer with
a Samsung SM-T590
10.5 inch.
The display of M3, M4
will be according to the
customer's smart
mobile
phone
specifications	Different,
The size and specification of
the display is different and
does not affect product
safety and performance.
Controls
for
Change
of
acoustic output
during scan	No	No	Same
Transducer Type	Mechanical
Probe	Mechanical
Probe	Same
Measurement
place	Abdomen	Abdomen	Same
Transducer
Resonant
Frequency	2.5Mhz	2.5Mhz	Same
Number
of
elements	1	1	Same
Sector Angle	120°	120°	Same
Number of Scan
Planes	M2, M2-W:12 ,
M1, M1-W:1	M4, M4-HD:12 ,
M3, M3-HD:1	Same

Patient
Contacting
Material	PC (skin contact)	PC (skin contact)	Same
Volume
measurement
range	0ml-999ml	0ml-999ml	Same
Volume
measurement
accuracy	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
Classification
of
protection against
electric shock	Class II equipment	Class II equipment	Same
Applied part type	B type	B type	Same
Real-time
scanning	Yes (Pre-scan)	Yes (Pre-scan)	Same
PC Data Upload	USB connection	USB connection	Same
Power	Lithium
battery:
URR18650ZY-2600
mAh(SNLB-435
7.4Vd.c. 2600mAh
Charger:
HXY-
084V1500A-UL
AC100-240Va	Lithium
battery:
NCA653864SA-2400
mAh
(PC015-2S1P)
7.4Vd.c. 2400mAh
Charger: HXY-
084V1500A-UL
AC100-240Va	Different, The lithium battery
used in the predicate device
and subject device is
different.
The lithium battery has been
performed
safety
test
according to the IEC62133,
and the subject device has
been performed safety test
according to the IEC 60601-
1, so the difference in lithium
battery specifications will not
raise
new
safety
and
performance risks.
WIFI	M1, M2 does not
contain WIFI
connection.
M1-W, M2-W contain
WIFI connection	WIFI connection.	Same
Bluetooth	Connect to the printer
using Bluetooth to
print a test image.	Connect to the printer
using Bluetooth to print
a test image.	Same
Safety and EMC
Standards
compliance	ES60601-
1:2005+A1:2012
IEC 60601-1-2:2014
IEC 60601-2-37:2015	ES60601-
1:2005+A1:2012
IEC 60601-1-2:2014
IEC 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).