Bladder Scanner Model: BVT02

K223448 · Xuzhou Kaixin Electronic Instrument Co., Ltd. · IYO · Jul 7, 2023 · Radiology

Device Facts

• Record ID: K223448
• Device Name: Bladder Scanner Model: BVT02
• Applicant: Xuzhou Kaixin Electronic Instrument Co., Ltd.
• Product Code: IYO · Radiology
• Decision Date: Jul 7, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The BVT02 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 BVT02 Bladder Scanner is intended to be used only by qualified medical professionals.

Device Story

Portable B-mode pulsed-echo ultrasound device; projects ultrasound energy through lower abdomen to obtain bladder images; calculates bladder volume noninvasively. Operated by qualified medical professionals in professional health care facilities. Features mechanical sector probe (2.5 MHz); acquires multiple 2D plane images in seconds; provides real-time imaging and volume measurement. Output displayed on 3.5" TFT-LCD; data upload via USB flash disk. Powered by battery or AC/DC adapter. Assists clinicians in assessing bladder volume; aids in clinical decision-making regarding urinary management. Benefits patient through noninvasive assessment, avoiding catheterization risks.

Clinical Evidence

Bench testing only. Evaluated for electrical/mechanical safety (ANSI/AAMI ES60601-1, IEC 60601-2-37), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-5, ISO 10993-10), acoustic output (IEC 62359), and volume accuracy. Results met pre-set acceptability criteria consistent with the predicate device.

Technological Characteristics

Portable B-mode ultrasound system; mechanical sector probe (2.5 MHz, 120-degree sector angle, 12 scan planes). Patient-contact material: Medical PP (ISO 10993 compliant). Power: Battery or AC/DC adapter. Display: 3.5" TFT-LCD. Connectivity: USB flash disk for data upload. Track 1 system; acoustic output not user-adjustable.

Indications for Use

Indicated for noninvasive bladder volume calculation in patients via B-mode pulsed-echo ultrasound. Intended for use by qualified medical professionals in professional health care facilities. Contraindicated for fetal use, pregnant patients, patients with ascites, patients with open/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

• PadScan HD series Bladder Scanner (K131227)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Xuzhou Kaixin Electronic Instrument Co., Ltd. % Long Yang, COO Shenzhen Hlongmed Biotech Co., Ltd. 1201, Haosheng Business Center, 4096 Dongbin Road, Nanshan Shenzhen, P.R.C. Shenzhen, Guangdong 518054 CHINA

July 7, 2023

Re: K223448

Trade/Device Name: Bladder Scanner Model: BVT02 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: June 7, 2023 Received: June 7, 2023

Dear Long Yang:

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

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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 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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Julie Sullivan -S

Julie Sullivan, Ph.D. Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K223448

Device Name Bladder Scanner, Model BVT02

Indications for Use (Describe)

The BVT02 Bladder Scanner is B-mode pulsed-echo ultrasound device. It is intended as a portable device. The BVT02 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 BVT02 Bladder Scanner is intended to be used only by qualified medical professionals. Intended use environment: Professional health care facilities.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| <span> <span style="font-size:16px">☒</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: BVT02 Bladder Scanner

Transducer: 2.5S120M2

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other(Bladder) | N | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

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

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# 510(k) Summary

# (as required by 807.92(c))

The assigned 510(K) number is: Date of Summary:

## 1. Submitter information

Manufacturer Name: Xuzhou Kaixin Electronic Instrument Co., Ltd.

Address: Kaixin Mansion, C-01, Economic Development Zone, Xuzhou, Jiangsu, China. Zip Code: 221004 Contact Person and Title: Chunmei Xu/ Technology Department Manager Tel: [phone]

Fax: [phone]

Email: [e-mail]

# 2. Contact person

## 2.1 Primary Contact Person

Long Yang (COO) Shenzhen Hlongmed Biotech Company 1201, Haosheng Business Center, 4096 Dongbin Road, Nanshan, Shenzhen, P.R.C Tel: [phone] Fax: [phone] E-mail: [e-mail]

### 2.2 Secondary Contact Person

Chunmei Xu (Technology Department Manager) Xuzhou Kaixin Electronic Instrument Co., Ltd. Kaixin Mansion, C-01, Economic Development Zone, Xuzhou, Jiangsu, China. Zip Code: 221004 Tel:[phone] E-mail: [e-mail]

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### 3. Device Information

| Trade/Device Name | Bladder Scanner |
|------------------------------|--------------------------------------------------------------------------------------|
| Model | BVT02 |
| Common Name | Diagnostic Ultrasound System with Accessories |
| Classification Name | Ultrasonic Pulsed Echo Imaging System(IYO)/<br>Diagnostic Ultrasound Transducer(ITX) |
| Regulatory Class | Class II |
| Classification regulation | 21CFR 892.1560 / 21CFR 892.1570 |
| Review Panel | Radiology |
| Regulation Medical Specialty | Radiology |
| Product Code | IYO/ITX |

### 4. Predicate Device

| 510(k) number | K131227 |
|---------------|-----------------------------------|
| Device name | PadScan HD series Bladder Scanner |
| Sponsor | Caresono Technology Co., Ltd |
| Product Code | IYO/ITX |

#### 5. Intended Use

The BVT02 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 BVT02 Bladder Scanner is intended to be used only by qualified medical professionals.

### 6. Indications for Use

The BVT02 Bladder Scanner is B-mode pulsed-echo ultrasound device. It is intended as a portable device. The BVT02 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 BVT02 Bladder Scanner is intended to be used only by qualified medical professionals. Intended use environment: Professional health care

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#### facilities.

#### 7. Device Description

The BVT02 Bladder Scanner manufactured by Xuzhou Kaixin Electronic Instrument Co., Ltd. provides real - time ultrasound imaging and measuring, and also provides non invasive volume measurement of the bladder. During image scanning, multiple 2D plane ultrasonic images are acquired in several seconds.

It features:

- Expert operating mode and Lite operating mode.
- Portable.
- Combined power supply with AC adapter and a battery.

## 8. Contraindications

Do not use the BVT02 Bladder Scanner on following case:

- 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

Xuzhou Kaixin Electronic Instrument Co., Ltd. believes the BVT02 Bladder Scanner described in this submission is substantially equivalent to the predicate devices as follows:

PadScan HD series Bladder Scanner (K131227)

The ultrasound power transmitted from the device is not user adjustable, and BVT02 Bladder Scanner is Track 1 System and meets the FDA's pre-amendment acoustic output limits, so as the predicate devices(PadScan HD 5, PadScan HD 3) are. Although there are some differences such as System Characteristics, Display, Patient Contacting Material, Range and Power, there is no significant differences in technological characteristics that affecting the safety and efficiently. These are evaluated by safety test and acoustic output test.

#### Table 6 Comparison to the predicate

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| Item | Element Of<br>Comparison | Proposed Device | Predicate Device-K131227 |
|------|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Trade Name | Bladder Scanner | PadScan HD series Bladder<br>Scanner |
| 2 | Model | BVT02 | PadScan HD 5, PadScan HD 3 |
| 3 | 510k submitter | Xuzhou Kaixin Electronic<br>Instrument Co., Ltd. | Caresono Technology Co., Ltd. |
| 4 | 510(K) Number | K223448 | K131227 |
| 5 | Classifications<br>Name &<br>Citations | 21 CFR 892.1560 Ultrasonic<br>Pulsed Echo Imaging System<br>(Product code: IYO)<br>21 CFR 892.1570 Diagnostic<br>Ultrasonic Transducer<br>(Product code: ITX) | 21 CFR 892.1560 Ultrasonic<br>Pulsed Echo Imaging System<br>(Product code: IYO)<br>21 CFR 892.1570 Diagnostic<br>Ultrasonic Transducer<br>(Product code: ITX) |
| 6 | Intended Use | The BVT02 Bladder Scanner<br>projects ultrasound energy<br>through the lower abdomen of the<br>patient to obtain images of the<br>bladder which is used to calculate<br>bladder volume non-invasively.<br>The BVT02 Bladder Scanner is<br>intended to be used only by<br>qualified medical professionals. | The PadScan HD series Bladder<br>Scanner projects ultrasound<br>energy through the lower<br>abdomen of the patient to obtain<br>images of the bladder which is<br>used to calculate bladder volume<br>noninvasively. The PadScan HD<br>series Bladder Scanner is<br>intended to be used only by<br>qualified medical professionals. |
| 7 | Indications for<br>Use | The BVT02 Bladder Scanner is<br>B-mode pulsed-echo ultrasound<br>device. It is intended as a portable<br>device. The BVT02 Bladder<br>Scanner projects ultrasound<br>energy through the lower<br>abdomen of the patient to obtain | The PadScan HD series Bladder<br>Scanner is B-mode pulsed-echo<br>ultrasound device. It intended as<br>a portable battery-operated<br>device. The PadScan HD series<br>Bladder Scanner projects<br>ultrasound energy through the |
| Item | Element Of<br>Comparison | Proposed Device | Predicate Device-K131227 |
| | | images of the bladder which is<br>used to calculate<br>bladder volume non-invasively.<br>The BVT02 Bladder Scanner is<br>intended to be used only by<br>qualified medical professionals.<br>Intended use environment:<br>Professional health care facilities. | lower abdomen of the patient to<br>obtain images of the bladder<br>which is used to calculate<br>bladder volume noninvasively.<br>The PadScan HD series Bladder<br>Scanner is intended to be used<br>only by qualified medical<br>professionals. |
| 8 | Contraindicatio<br>ns | Do not use the BVT02 Bladder<br>Scanner on following cases:<br>a) Fetal use or pregnant patients.<br>b) Patients with ascites.<br>c) Patients with open or damaged<br>skin.<br>d) Wounds in the suprapubic<br>region. | Do not use the PadScan HD<br>series Bladder Scanner on<br>following cases:<br>a) Fetal use or pregnant patients<br>b) Patients with ascites<br>c)Patients with open or damaged<br>skin<br>d) Wounds in the suprapubic<br>region |
| 9 | Modes of<br>operation | B mode | B mode |
| 10 | System<br>Characteristics | a)Portable<br>b)LCD Display<br>c)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 |
| 11 | Display | 3.5" TFT-LCD | PadScan HD5: 8" TFT-LCD<br>PadScan HD3: 7" TFT-LCD |
| 12 | Controls for<br>Change of<br>acoustic output | No | No |
| Item | Element Of<br>Comparison | Proposed Device | Predicate Device-K131227 |
| | during scan | | |
| 13 | Transducer | Mechanical Sector Probe | Mechanical Sector Probe |
| | Type | | |
| 14 | Measurement | Abdomen | Abdomen |
| | localization | | |
| 15 | Transducer | 2.5 MHz | 2.5 MHz |
| | Resonant | | |
| | Frequency | | |
| 16 | Number of | 1 | 1 |
| | elements | | |
| 17 | Sector Angle | 120 degrees | 120 degrees |
| 18 | No. of Scan | 12 | 12 |
| | Planes | | |
| 19 | FDA Limits | Track 1 | Track 1 |
| 20 | Product Safety | AAMI / ANSI | IEC 60601-1:2005 |
| | Certification | ES60601-1:2005/(R)2012 And | +CORR.1(2006) |
| | | A1:2012, C1:2009/(R)2012 And | +CORR.2(2007) |
| | | A2:2010/(R)2012 | |
| | | IEC 60601-2-37:2015 | IEC 60601-2-37:2007 |
| 21 | EMC | IEC 60601-1-2:2014 | IEC 60601-1-2:2007 |
| | Compliance | | |
| 22 | Patient | Plastic, Medical PP (Skin | Plastic, PE (Skin Contact) |
| | Contacting | Contact) | Complies with ISO 10993 |
| | Material | Complies with ISO 10993 | Complies with ISO 10993 |
| 23 | Range | Bladder volume range: 20-999ml | Bladder volume range: 0-999ml |
| | | Accuracy: ±15%, ±15ml | Accuracy: ±15%, ±15ml |
| 24 | Classification of | Class II equipment | Class II equipment |
| | protection | Type B equipment | Type B equipment |
| | against | | |
| Item | Element Of<br>Comparison | Proposed Device | Predicate Device-K131227 |
| | electric shock | | |
| 26 | Real-time<br>scanning | Yes (Pre-scan) | Yes (Pre-scan) |
| 27 | Scan time | < 5 seconds | < 5 seconds |
| 27 | PC Data Upload | Using USB flash disk | Using USB flash disk |
| 28 | Power | AC/DC Adapter:<br>Input:AC100-240V, 50-60Hz<br>Output: DC12.8V 3.0A<br>Battery: Li-ion rechargeable | AC/DC Adapter:<br>Input: AC100-240V, 50/60Hz,<br>Output: DC14V±0.5V<br>Battery: Li-ion rechargeable |

# (PadScan HD 5, PadScan HD 3)

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Xuzhou Kaixin Electronic Instrument Co., Ltd. believes that the BVT02 Bladder Scanner is substantially equivalent to the PadScan HD series Bladder Scanner of Caresono Technology Co., Ltd.

#### 10. Non-clinical Testing Summary

#### 10.1 Safety

Electrical, mechanical, environmental safety and performance data demonstrates that the device is in compliance with ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 and IEC 60601-2-37:2007+AMD1:2015 CSV.

#### 10.2 EMC

Electromagnetic Compatibility data demonstrates that the device is in compliance with IEC 60601-1-2:2014.

#### 10.3 Performance-Bench Testing

1) The BVT02 Bladder Scanner had been tested as Track 1 device per the FDA Guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in June 27, 2019. The acoustic output is measured and calculated per IEC 62359:2010+AMD1:2017 CSV.

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2) The BVT02 Bladder Scanner had been tested volume accuracy per the FDA Guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in June 27, 2019. All the test results comply with the pre-set acceptability criterion, which is the same as predicate device.

#### 10.4 Biocompatibility

The biocompatibility testing conducted in according with standard Biocompatibility ISO 10993-5:2009 and ISO 10993-10:2010.

#### 11. Substantial Equivalence Conclusion

The BVT02 Bladder Scanner was evaluated with safety (AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 and IEC 60601-2-37:2007+AMD1:2015 CSV), EMC (IEC (IEC 60601-1-2:2014), Biocompatibility (ISO 10993-5:2009, ISO10993-10:2010), Acoustic Output (IEC 62359:2010+AMD1:2017 CSV) and volume accuracy. The conclusions drawn from testing of the BVT02 Bladder Scanner demonstrate that the device is as safe and effective as the legally marketed predicate device.