Who is the manufacturer of Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)?

Suzhou Peaksonic Medical Technology Co., Ltd. filed the 510(k) submission for Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) (K201316).

What is the FDA product code for Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)?

IYO. It is classified under 21 CFR 892.1560 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)?

Bladder Scanner (Models: M2, M2-W, M1, M1-W) (K190769).

Who can help prepare an FDA 510(k) submission like Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

K201316 · Suzhou Peaksonic Medical Technology Co., Ltd. · IYO · Feb 26, 2021 · Radiology

Device Facts

Record ID	K201316
Device Name	Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)
Applicant	Suzhou Peaksonic Medical Technology Co., Ltd.
Product Code	IYO · Radiology
Decision Date	Feb 26, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1560
Device Class	Class 2

Intended 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.

Device Story

Handheld, battery-operated B-mode ultrasound device; consists of main unit, 3D (M4/M4-HD) or 2D (M3/M3-HD) probe, and app software on smartphone or tablet. Operator places probe on lower abdomen; device acquires multiple 2D ultrasound images; sophisticated image processing restores stereo image; algorithm calculates bladder volume. Results displayed on mobile device screen. Used by qualified medical professionals in clinical settings. Features include expert/easy/intelligence modes, wireless printing, and Wi-Fi/Bluetooth data transmission. Patient information is encrypted for privacy. Benefits include non-invasive, fast, and reliable bladder volume assessment to aid clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (ES60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output (NEMA UD 2), and wireless connectivity (FCC Part 15).

Technological Characteristics

Handheld B-mode ultrasound; mechanical probe (2.5MHz, 120° sector angle); PC material skin contact; battery-powered; Wi-Fi/Bluetooth connectivity; software-based image processing and volume calculation; complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and NEMA UD 2.

Indications for Use

Indicated for qualified medical professionals to perform non-invasive bladder volume calculation via B-mode pulsed-echo ultrasound imaging through the lower abdomen. Contraindicated for fetal use, pregnant patients, patients with ascites, patients with open or damaged skin, or wounds in the suprapubic region.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Bladder Scanner (Models: M2, M2-W, M1, M1-W) (K190769)

Related Devices

K190769 — Bladder Scanner (Models: M2, M2-W, M1, M1-W) · Suzhou Lischka Medtech Co., Ltd. · May 22, 2019
K153581 — Bladder Scanner · Caresono Technology Co., Ltd. · Apr 8, 2016
K171528 — Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) · Avantsonic Technology Co., Ltd. · Jan 24, 2018
K131227 — PADSCAN HD SERIES BLADDER SCANNER · Carenoso Technology Co., Ltd. · Jul 12, 2013
K250331 — Astrasono A3Pro Bladder Scanner (A3Pro) · Astrasono Technology Co., Ltd. · Sep 30, 2025

Submission Summary (Full Text)

{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}------------------------------------------------ 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 (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) - 2. 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. ### 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).