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

K190769 · Suzhou Lischka Medtech Co., Ltd. · IYO · May 22, 2019 · Radiology

Device Facts

• Record ID: K190769
• Device Name: Bladder Scanner (Models: M2, M2-W, M1, M1-W)
• Applicant: Suzhou Lischka Medtech Co., Ltd.
• Product Code: IYO · Radiology
• Decision Date: May 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended 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.

Device Story

Handheld, battery-operated B-mode ultrasound device; projects ultrasound energy through lower abdomen to image bladder; calculates bladder volume noninvasively. Operated by qualified medical professionals in clinical settings. Features 3D (M2, M2-W) or 2D (M1, M1-W) mechanical sector probes. Includes touch screen, voice input/play, and data storage. M2-W/M1-W models include Wi-Fi; all models support Bluetooth for printer connectivity. PC software enables image/parameter printing. Provides real-time pre-scan imaging. Benefits include fast, non-invasive, and accurate bladder volume assessment to aid clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output (NEMA UD 2), and biocompatibility (ISO 10993).

Technological Characteristics

Handheld B-mode pulsed-echo ultrasound; mechanical sector probe (1 element, 120° sector angle); 2.5MHz or 3.5MHz resonant frequency. PE patient-contact material. Battery-powered (7.4V Li-ion). Connectivity: USB, Wi-Fi (M2-W/M1-W), Bluetooth. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, ISO 10993. Software-based volume calculation.

Indications for Use

Indicated for noninvasive bladder volume calculation in patients via B-mode pulsed-echo ultrasound imaging of the lower abdomen. Contraindicated for fetal use, pregnant patients, patients with ascites, patients with open/damaged skin, or wounds in the suprapubic region. Intended for use by qualified medical professionals.

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

• PadScan HD series Bladder Scanner (K131227)

Submission Summary (Full Text)

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Image /page/0/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 & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Suzhou Lischka Medtech Co., Ltd. % Shi Jing R&D Manager NO.999 Quija Road, Qiandeng Town Kunshan, Jiangsu 215341 CHINA

Re: K190769

Trade/Device Name: Bladder Scanner (Models: M2, M2-W, M1, M1-W) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: March 26, 2019 Received: March 26, 2019

Dear Shi Jing:

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

May 22, 2019

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known)

#### K190769

Device Name Bladder Scanner (Models : M2, M2-W, M1, M1-W)

Indications for Use (Describe)

The Bladder Scanner (Models: M2, M1, M1-W) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M2, M2-W, M1, M1-W 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 M2, M2-W, M1, M1-W Bladder Scanner is intended to be used only by qualified medical professionals.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 10px;"> ☒ </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# Diagnostic Ultrasound Indications for Use Form

System: M2

Transducer: H3D-1

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|-----------------------|--------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Bladder) | N | | | | | | |
| Cardiac | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | | | | | | | |
| vascular | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

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### System: M1 Transducer: HD2-1

# Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|--------------------|-----------------|
| | | B | M | PW | CW | Color | Combined (Specify) | Other (Specify) |
| General | Specific | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal<br>Imaging<br>& Other | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Bladder) | N | | | | | | |
| Cardiac | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

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# 510(K) Summary

K190769

Prepared in accordance with the requirements of 21 CFR Part 807.92

### Prepared Date: 10 March 2019

# 1. Submitter's Information

The submitter of this pre-market notification is:

| Name: | Suzhou Lischka Medtech Co., Ltd. |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 2F,BuildingG4, Kunshan Hi-Tech Medical Device<br>Industrial Park, NO.999 Qujia Road, Qiandeng<br>Town, Kunshan City, Jiangsu Prov. 215341,China |
| Contact person: | Shi Jing |
| Title: | R&D manager |
| E-mail: | [e-mail] |
| Tel: | [phone]-831 |

# 2. Device Identification

| Trade/Device Name: | Bladder Scanner |
|--------------------|------------------------------------------------------------------------|
| Models: | M2, M2-W, M1, M1-W |
| Regulation Number: | 21 CFR 892.1560<br>21 CFR 892.1570 |
| Regulation Name: | Ultrasonic, Pulsed echo, Imaging<br>Transducer, Ultrasonic, Diagnostic |
| Regulation Class: | Class II |
| Product Code: | IYO, ITX |

# 3. Predicate Device

| 510(K) number: | K131227 |
|--------------------|------------------------------------------------------------------------|
| Device Name: | PadScan HD series Bladder Scanner |
| Manufacturer: | Caresono Technology Co., Ltd |
| Regulation Number: | 21 CFR 892.1560<br>21 CFR 892.1570 |
| Regulation Name: | Ultrasonic, Pulsed echo, Imaging<br>Transducer, Ultrasonic, Diagnostic |
| Regulation Class: | Class II |
| Product Code: | IYO, ITX |

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# 4. Device Description

The M Series Bladder Scanner manufactured by Suzhou Lischka Medtech Co., Ltd. provides noninvasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. The equipment consists of the main unit, 3D probe (M2, M2-W)/2D probe (M1, M1-W), battery and Charger. It features:

- Two Operation Modes: Expert Mode and Easy Mode .
- Non-invasive, comfortable, correct, reliable, fast and simple operation .
- Printouts with ultrasound images and various parameters through PC software .
- . Touch screen keyboard operation
- . Voice input and play functions
- Multi-language selection .
- Information storage •
- . Information printing
- . built-in battery

The difference between these models is that the model of the probe is different. M2, M2-W is 3D probe .M1,M1-W is 2D probe. M2-W, M1-W have WIFI connection function, M2, M1 do not have WIFI connection function.

# 5. Intended 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.

# 6. Indication for use

The Bladder Scanner (Models: M2, M1, M1-W) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M2, M2-W, M1, M1-W 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 M2, M2-W, M1, M1-W Bladder Scanner is intended to be used only by qualified medical professionals.

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.

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# 7. 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

| SE Comparisons | Bladder Scanner<br>(Models: M2, M2-W,<br>M1, M1-W) | PadScan HD series<br>Bladder Scanner | Note |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/K# | Suzhou Lischka<br>/Present<br>application | Caresono/K131227 | -- |
| Trade name and<br>model | Bladder Scanner<br>(Models: M2, M2-W,<br>M1, M1-W) | PadScan HD series<br>Bladder Scanner<br>(Models: HD5, HD3) | |
| Classifications<br>name and<br>Regulation Name | Regulation Number:<br>21 CFR 892.1560<br>21 CFR 892.1570<br>Regulation Name:<br>Ultrasonic, Pulsed<br>echo, Imaging<br>Transducer,<br>Ultrasonic, Diagnostic<br>Product Code: IYO,<br>ITX | Regulation Number:<br>21 CFR 892.1560<br>21 CFR 892.1570<br>Regulation Name:<br>Ultrasonic, Pulsed<br>echo, Imaging<br>Transducer, Ultrasonic,<br>Diagnostic<br>Product Code: IYO, ITX | Same |
| Intended Use | The Bladder Scanner<br>(Models: M2, M2-W,<br>M1, M1-W) projects<br>ultrasound energy<br>through the lower<br>abdomen of the<br>patient to obtain<br>images of the bladder<br>which is used to<br>calculate bladder<br>volume noninvasively.<br>The Bladder Scanner<br>is intended to be used<br>only by qualified<br>medical professionals. | The PadScan HD<br>series Bladder Scanner<br>projects ultrasound<br>energy through the<br>lower abdomen of the<br>patient to obtain images<br>of the bladder which is<br>used to calculate<br>bladder volume<br>noninvasively. The<br>PadScan HD series<br>Bladder Scanner is<br>intended to be used<br>only by qualified<br>medical professionals. | Same |
| Contraindications | Do not use the<br>Bladder Scanner on<br>following cases: | Do not use the<br>PadScan<br>HD Bladder Scanner on<br>following cases: | Same |
| | a) Fetal use or<br>pregnant patients<br>b) Patients with<br>ascites<br>c) Patients with open<br>or<br>damaged skin.<br>d) Wounds in the<br>suprapubic region | a) Fetal use or pregnant<br>patients<br>b) Patients with ascites<br>c) Patients with open or<br>damaged skin.<br>d) Wounds in the<br>suprapubic region | |
| Modes of<br>operation | B mode | B mode | Same |
| System<br>Characteristics | Portable<br>LCD Display<br>Thermal Printer<br>Power source: Battery | Portable<br>LCD Display<br>Thermal Printer<br>Power source: Battery<br>or<br>AC-DC adapter | Different, but both our<br>device and predicate device<br>met the requirements of IEC<br>60601-1. The difference<br>does not affect the safety<br>and performance. |
| Display | M2: 2.4" TFT-LCD<br>M1: 2.4" TFT-LCD | PadScan HD2: 2.5"<br>TFT-LCD<br>PadScan HD5: 8" TFT-<br>LCD | Different,<br>The size of the display is<br>different and does not affect<br>product safety and<br>performance. |
| Controls for<br>Change of<br>acoustic output<br>during scan | No | No | Same |
| Transducer Type | Mechanical Sector<br>Probe | Mechanical Sector<br>Probe | Same |
| Measurement<br>place | Abdomen | Abdomen | Same |
| Transducer<br>Resonant<br>Frequency | 3.5Mhz or 2.5Mhz | 2.5Mhz | Basically the same |
| Number of<br>elements | 1 | 1 | Same |
| Sector Angle | 120° | 120° | Same |
| Number of Scan<br>Planes | M2, M2-W-12 ,<br>M1, M1-W-1 | PadScan HD5-12,<br>PadScan HD2-1 | Same |
| Patient<br>Contacting<br>Material | PE (skin contact) | PE (skin contact) | Same |
| Volume<br>measurement<br>range | 0ml-999ml | 0ml-999ml | Same |
| Volume<br>measurement<br>accuracy | M2/M2-W: ±7%,<br>±7ml<br>M1/M1-W: ±14%,<br>±14ml | ±15%, ±15ml | Different, Our products are<br>more accurate than the<br>predicate device, and<br>performed the accurate test,<br>the performance is better<br>than the predicate device<br>without additional risks. |
| Classification of<br>protection against<br>electric shock | Class II equipment | Class II equipment | Same |
| Applied part type | B type | B type | Same |
| Real-time<br>scanning | Yes (Pre-scan) | Yes (Pre-scan) | Same |
| PC Data Upload | USB connection | Using USB flash disk | Different , Compared to the<br>predicate devices, the way<br>of PC Data Upload is<br>changed from SD card to<br>USB connection<br>Transmission. The<br>difference does not affect<br>the Intended Use, it will not<br>raise safety and<br>effectiveness issue. |
| Power | Lithium battery:<br>URR18650ZY-2600<br>mAh(SNLB-435 )<br>7.4Vd.c. 2600mAh<br>Charger: HXY-<br>084V1500A-UL<br>AC100-240Va | AC/DC Adapter:<br>Input: AC100-240V,<br>50/60Hz,<br>Output: DC14V±0.5V<br>Battery: Li-ion<br>rechargeable | Different, all the electrical<br>safety testing has been<br>conducted according to IEC<br>60601-1: 2012, and results<br>showed pass, therefore,<br>difference between input<br>power will not reduce the<br>subject's safety and<br>effectiveness. Please refer<br>to 015 IEC60601-1 test<br>report of M2,M2-W,M1,M1-<br>W. |
| WIFI | M1, M2 does not<br>contain WIFI<br>connection<br>M1-W, M2-W contain<br>WIFI connection | Do not contain WIFI<br>connection. | Different, Compared with<br>equivalent equipment, our<br>products have added WIFI<br>and bluetooth connection<br>functions. We have tested<br>according to FCC<br>requirements (CFR 47<br>PART 15), which proves that<br>our products meet the<br>requirements for wireless<br>signal function safety, and<br>there is no unacceptable<br>safety and performance. |
| Bluetooth | Connect to the printer<br>using Bluetooth to<br>print a test image | Do not contain<br>Bluetooth connection. | requirements (CFR 47<br>PART 15), which proves that<br>our products meet the<br>requirements for wireless<br>signal function safety, and<br>there is no unacceptable<br>safety and performance. |
| Standards<br>compliance | IEC 60601-<br>1:2005+A1:2012<br>IEC 60601-1-2:2014<br>IEC 60601-2-37:2015 | IEC 60601-1:2005<br>+CORR.1(2006)<br>+CORR.2(2007)<br>IEC 60601-1-2:2007<br>IEC 60601-2-37:2007 | Different, We verified the<br>product with a newer<br>version of the standard.<br>Compliance with new<br>standards does not reduce<br>the subject's safety and<br>effectiveness. |
| FDA limit | Track 1 | Track 1 | Same |

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Suzhou Lischka

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Suzhou Lischka

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Suzhou Lischka

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.

# 8. Performance Data

# Clinical test:

Clinical testing is not required.

# Non-clinical data

The M2, M2-W, M1, M1-W 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

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- 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 guideline "Information for Manufacturers Seeking Marketing

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

Biocompatibility:

- 6. ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- 7. ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- 8. ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

WIFI and Bluetooth connection:

- 9. 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.

### 9. Conclusion

The M series Bladder Scanner was evaluated with safety, EMC, Biocompatibility and Acoustic Output.

The conclusions drawn from testing of the M series Bladder Scanner demonstrate that the device is as safe and effective as the legally marketed predicate devices.