Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)

K171528 · Avantsonic Technology Co., Ltd. · IYO · Jan 24, 2018 · Radiology

Device Facts

• Record ID: K171528
• Device Name: Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)
• Applicant: Avantsonic Technology Co., Ltd.
• Product Code: IYO · Radiology
• Decision Date: Jan 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Bladder Scanner (model: PadScan Z3, PadScan Z3, PadScan Z5) 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 two operation modes (Expert/Easy), touch screen, and thermal printer. Provides real-time pre-scan imaging; outputs bladder volume and images. Data can be uploaded via USB or Bluetooth. Benefits include fast, non-invasive, and reliable bladder volume assessment, aiding clinical decision-making regarding urinary retention or catheterization.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output (NEMA UD 2), and biocompatibility (ISO 10993-1, 5, 10).

Technological Characteristics

Mechanical sector probe; 2.5 MHz resonant frequency; 120° sector angle; 12 scan planes. PE skin-contact material. Battery or AC/DC adapter powered. 7-8 inch TFT-LCD display. Connectivity via USB/Bluetooth. Class II equipment, Type B applied part. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2.

Indications for Use

Indicated for non-invasive bladder volume calculation in patients via B-mode pulsed-echo ultrasound. 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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January 24, 2018

Image /page/0/Picture/1 description: The image contains 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.

AvantSonic Technology Co., Ltd. % Mr. Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. 22A. Haijing Square. No. 18. Taizi Road Nanshan District, Shenzhen, 518067 CHINA

Re: K171528

Trade/Device Name: Bladder Scanner (model: PadScan ZS3. PadScan Z3. PadScan Z5) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: December 18, 2017 Received: December 18, 2017

Dear Mr. Wang:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K171528

### Device Name

Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)

Indications for Use (Describe)

The Bladder Scanner (model: PadScan Z3, PadScan Z3, PadScan Z5) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The 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 Bladder Scanner is intended to be used only by qualified medical professionals.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## Diagnostic Ultrasound Indications for Use Form

System: PadScan DS3

Transducer: MP2A

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 (Specify) | Other (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 | | | | | | |
| | Adult Cardiac | | | | | | | |
| 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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## System: PadScan Z3

## Transducer: MP2

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 | Other |
| | | | | | | | (Specify) | (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| Fetal | Neonatal Cephalic | | | | | | | |
| Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Bladder) | N | | | | | | |
| | Adult Cardiac | | | | | | | |
| 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: PadScan Z5

## Transducer: MP2

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 (Specify) | Other (Specify) |
| | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal / Obstetrics | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) | | | | | | | | |
| Fetal<br>Imaging<br>& Other | 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

Prepared in accordance with the requirements of 21 CFR Part 807.92

## Prepared Date: 2017/05/08

1. Submission sponsor

Name: AvantSonic Technology Co., Ltd. Address: No.394, Jingdongfang Avenue, Beibei District, Chongqing, P.R. China 400714 Contact person: Cuiling Wu Title: R&D manager E-mail: [e-mail] Tel: [phone]

#### Submission correspondent 2.

Name: Chonconn Medical Device Consulting Co., Ltd. Address: 22A, Haijing Square, No. 18, Taizi Road, Nanshan District, Shenzhen, P.R. China 518067 Contact person: Kevin Wang E-mail: [e-mail] Tel: [phone]

| Trade/Device Name | Bladder Scanner |
|-------------------|-----------------------------------------------------------------------------------------------------------------|
| Model | PadScan DS3, PadScan Z3, PadScan Z5 |
| Common Name | Diagnostic Ultrasound System with Accessories |
| Regulatory Class | Class II |
| Classification | 21CFR 892.1560/Ultrasonic Pulsed Echo Imaging System/IYO<br>21CFR 892.1570/Diagnostic Ultrasound Transducer/ITX |
| Submission type | Traditional 510(K) |

#### 3. Subject Device Information

#### Predicate Device 4.

| 510(K) number | K131227 |
|---------------|-----------------------------------|
| Device Name | PadScan HD series Bladder Scanner |
| Manufacturer | Caresono Technology Co., Ltd |
| Product Code | IYO, ITX |

### Device Description 5.

The PadScan Series manufactured by AvantSonic Technology Co., Ltd. provides non-invasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. The equipment consists of the main unit, 3D probe, battery and adapter.

It features:

Bladder Scanner– 510(k) submission

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- . 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
- . Urine volume setting and alarm setting
- . Multi-language selection
- . Combined power supply with AC adapter and a built-in battery

The difference between these models is the size of the LCD screen and enclosure structure. PadScan DS3 is provided 7-inch LCD screen. PadScan Z3 is provided 7-inch LCD screen and LCD screen stand. PadScan Z5 is provided 8-inch LCD screen and LCD screen which has a handle.

#### Intended use 6.

The Bladder Scanner (model: PadScan Z3, PadScan Z3, PadScan Z5) 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.

#### 7. Indication for use

The Bladder Scanner (model: PadScan Z3, PadScan Z3, PadScan Z5) is B-mode pulsed-echo ultrasound device. It intended as a handheld batterv-operated device. The 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 Bladder Scanner is intended to be used only by qualified medical professionals.

#### 8. 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

#### 9. 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 | PadScan DS3, PadScan Z3,<br>PadScan Z5 | PadScan HD series Bladder<br>Scanner | Note |
|-----------------|----------------------------------------|--------------------------------------|------|
| Manufacturer/K# | AvantSonic/Present<br>application | Caresono/K131227 | -- |

Tahle 1

Bladder Scanner- 510(k) submission

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# AvantSonic

| Intended Use | The PadScan series Bladder<br>Scanner projects ultrasound<br>energy through the lower<br>abdomen of the patient to<br>obtain images of the<br>bladder which is used to<br>calculate bladder volume<br>noninvasively. The<br>PadScan HD series Bladder<br>Scanner is intended to be | The PadScan HD series<br>Bladder Scanner projects<br>ultrasound energy through<br>the lower abdomen of the<br>patient to obtain images of<br>the bladder which is used to<br>calculate bladder volume<br>noninvasively. The PadScan<br>HD series Bladder Scanner<br>is intended to be used only | Same |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | used only by qualified<br>medical professionals. | by qualified medical<br>professionals. | |
| Contraindications | Do not use the Bladder<br>Scanner on following cases:<br>a) Fetal use or pregnant<br>patients<br>b) Patients with ascites<br>c) Patients with open or<br>damaged<br>skin.<br>d) Wounds in the<br>suprapubic region | Do not use the PadScan<br>HD2 Bladder<br>Scanner on following cases:<br>a) Fetal use or pregnant<br>patients<br>b) Patients with ascites<br>c) Patients with open or<br>damaged<br>skin.<br>d) Wounds in the suprapubic<br>region | Same |
| Modes of operation | B mode | B mode | Same |
| System<br>Characteristics | a) Portable<br>b) LCD Display<br>c) Thermal Printer<br>d) Power source: Battery or<br>AD-DC adapter | a) Portable<br>b) LCD Display<br>c) Thermal Printer<br>d) Power source: Battery or<br>AD-DC adapter | Same |
| Display | PadScan DS3: 7" TFT-LCD<br>PadScan Z3: 7" TFT-LCD<br>PadScan Z5: 8" TFT-LCD | PadScan HD3: 7" TFT-LCD<br>PadScan HD5: 8" TFT-LCD | Same |
| Controls for Change<br>of acoustic output<br>during scan | No | No | Same |
| Transducer Type | Mechanical Sector Probe | Mechanical Sector Probe | Same |
| Measurement place | Abdomen | Abdomen | Same |
| Transducer Resonant<br>Frequency | 2.5Mhz | 2.5Mhz | Same |
| Number of elements | 1 | 1 | Same |
| Sector Angle | 120° | 120° | Same |
| Number of Scan<br>Planes | 12 | 12 | Same |
| Patient Contacting<br>Material | PE (skin contact) | PE (skin contact) | Same |
| Volume measurement<br>range | 0ml-999ml | 0ml-999ml | Same |
| Volume measurement<br>accuracy | ±10%, ±10ml | ±15%, ±15ml | Different |
| 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 scanning | Yes (Pre-scan) | Yes (Pre-scan) | Same |
| PC Data Upload | USB, Bluetooth | SD card | Different |
| Power | AC/DC Adapter:<br>Input: AC 100V-240V,<br>50/60Hz,<br>Output: DC13.5V±0.5V<br>Battery: Li-ion<br>rechargeable | AC/DC Adapter:<br>Input: AC100-240V,<br>50/60Hz,<br>Output: DC14V±0.5V<br>Battery: Li-ion rechargeable | Different |
| Standards compliance | IEC 60601-<br>1:2005+A1:2012 | IEC 60601-1:2005<br>+CORR.1(2006)<br>+CORR.2(2007) | Different |
| | IEC 60601-1-2:2014 | IEC 60601-1-2:2007 | |
| | IEC 60601-2-37:2015 | IEC 60601-2-37:2007 | Different |
| FDA limit | Track 1 | Track 1 | Same |

Bladder Scanner– 510(k) submission

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## AvantSonic

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.

## 10. Performance Data

## Clinical test:

Clinical testing is not required.

## Non-clinical data

The PadScan DS3, PadScan Z3 and PadScan Z5 Bladder Scanner comply with:

(1) IEC 60601-1 Electrical Safety

(2) IEC 60601-1-2 Electromagnetic Compatibility

(3) IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

Bladder Scanner– 510(k) submission

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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.

The following biocompatibility standards are conducted on the subject device: (1) ISO 10993-1, ISO 10993-5 and ISO 10993-10

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

## 11. Conclusion

Based on the safety and performance testing and compliance with acceptable voluntary standards, we believe that the PadScan DS3, PadScan Z3 and PadScan Z5 Bladder Scanner are substantially equivalent to their predicate device in K131227 and does not raise any new safety and/or effectiveness issues.