The Bladder Scanner is B-mode pulsed-echo ultrasound device adopts a 3D mechanical fan scanning probe for the ultrasonic scanning for bladder and measures the bladder volume from the abdominal surface of ultrasonic imaging. The Bladder Scanner is intended to be used only in hospital and by qualified medical professionals.

Device Description

The Bladder Scanner (Model: AS-2) is a hand-held battery-operated device, it provides non-invasive bladder volume measurement utilizing real-time ultrasound imaging. The proposed device consists of the main unit (include 3D probe), battery power adapter and USB charging cable.

AI/ML Overview

This FDA 510(k) summary provides information for a device called "Bladder Scanner" (Model: AS-2) by Avantsonic Technology Co., Ltd. The document primarily focuses on establishing substantial equivalence to a predicate device (K201316 Bladder Scanner by Suzhou Peaksonic Medical Technology Co., Ltd.) rather than detailing an independent study against acceptance criteria. However, it does state the acceptance criteria for volume measurement accuracy and reports whether the device met these criteria through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Bladder Volume Measurement Accuracy)	Reported Device Performance
≤ ±10 ml (measured volume < 100ml)	Met the requirements
≤ ±7.5% (measured volume ≥ 100ml)	Met the requirements

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: The document states that the "Bladder Scanner volume measurement accuracy test" was conducted for the measurement range of 0 ml ~ 999 ml, implying a range of volumes were tested to verify accuracy across this spectrum. However, a specific number of samples (e.g., number of measurements, number of phantoms/models used) is not provided.
Data Provenance: The document does not specify the country of origin for the data or whether the tests were retrospective or prospective. Given that it's a non-clinical test, it likely refers to laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided. The document mentions non-clinical tests were conducted, which typically involve measuring known volumes using standard metrology rather than expert judgment on images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided. As it refers to non-clinical testing of volume measurement accuracy, an adjudication method in the context of expert review is not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission." The device's primary function is to measure bladder volume using ultrasound, not to assist human readers in interpreting complex images or diagnoses.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, in essence, a standalone evaluation was performed in terms of the device's ability to measure volume. The "Bladder Scanner volume measurement accuracy test" assesses the device's algorithmic and hardware performance in calculating volume against known standards, independent of human interpretation or assistance during the measurement process itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth for the "Bladder Scanner volume measurement accuracy test" would have been known, precisely measured volumes. These are typically established using phantoms or controlled liquid volumes where the true volume is known and verifiable through other metrological means.

8. The sample size for the training set:

This information is not provided. The document describes a "Bladder Scanner" which is a hardware device that utilizes ultrasound principles. While it inherently relies on algorithms for volume calculation, the document does not detail any specific "training set" in the context of machine learning or AI. It's more likely based on established physics and signal processing principles rather than a trained AI model in the modern sense.

9. How the ground truth for the training set was established:

This information is not provided and is likely not applicable in the context of the information given. As mentioned above, the device's mechanism is described in terms of "B-mode pulsed-echo ultrasound" and "3D mechanical fan scanning probe," suggesting a more traditional ultrasound technology rooted in physics rather than a deep learning model requiring a distinct training set with established ground truth labels.

Summary

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Avantsonic Technology Co., Ltd. Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd 2F, Building 4A, No. 21Changkang Road Yuzui Tow Liangjiang New Area Chongquing 401133 China

December 29, 2023

Re: K230986

Trade/Device Name: Bladder Scanner Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, ITX Dated: November 23, 2023 Received: November 24, 2023

Dear Ray 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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Indications for Use

510(k) Number (if known) K230986

Device Name Bladder Scanner

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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The assigned 510(k) Number: K230986

510(k) Summary

This 510(k) Summary of 510(k) substantial equivalence information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

1. Date of Preparation: 2023/12/27
1. Sponsor Identification

Avantsonic Technology Co., Ltd.

2F, Building 4A, No. 21, Changkang Road, Yuzui Town, Liangjiang New Area, Chongqing, China. 401133.

Contact Person: Winnie Wang Position: General Manager Tel: +86-13993103280 Fax: +86-023-60307657 Email: wangfang@avantsonic.com

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China

Tel: +86-18910677558 Fax: +86-10-56335780 Email: information(@believe-med.com

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4. Identification of Proposed Device

Trade Name: Bladder Scanner Common Name: Diagnostic Ultrasound System with Accessories

Regulatory Information Classification Name: Ultrasonic Pulsed Echo Imaging System(IYO) , Diagnostic Ultrasound Transducer (ITX) Classification: II Product Code: IYO, ITX Regulation Number: 21 CFR 892.1560, 21 CFR 892.1570 Review Panel: Radiology

Indication for use Statement:

The Bladder Scanner is B-mode pulsed-echo ultrasound device adopts a 3D mechanical fan scanning probe for the ultrasonic scanning for bladder and measures the bladder volume from the abdominal surface utilizing the principles of ultrasonic imaging. The Bladder Scanner is intended to be used only in hospital and by qualified medical professionals.

Device Description:

The device features:

· The measurement of bladder capacity includes two operation modes: Pre-scanning and Scanning:
· There are two ways to enter the scanning stage in the pre-scanning stage: first, when the probe is in the center of bladder for about 5 seconds, the device automatically enters the scanning mode; Second, during the pre-scanning process, the user can click the scanning button again to force the device to enter the scanning mode.
· Non-invasive operation.
Volume setting
Built-in battery power supply
· The ultrasonic signal is continuously transmitted at a frequency of 2.5 MHz.

5. Identification of Predicate Device(s)

Predicate Device: 510(k) Number: K201316 Product Name: Bladder Scanner Manufacturer: Suzhou Peaksonic Medical Technology Co., Ltd.

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6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment;
IEC 62359 Edition 2.1 2017-09 Ultrasonics Field characterization Test methods for the A determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

The Bladder Scanner volume measurement range is: 0 ml〜999 ml;

The Bladder Scanner volume measurement accuracy is:

≤±10 ml (measured volume<100ml), ≤±7.5% (measured volume≥100ml).

Conducted the Bladder Scanner volume measurement accuracy test for the measurement range 0 ml ~999 ml, the measurement accuracy met the requirements.

1. Clinical Test Conclusion
  No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 8.

Item	Proposed Device	Predicate DeviceK201316	Remark
Device name	Bladder Scanner	Bladder Scanner	/
Model	AS-2	M3-HD, M4-HD	/
Classification	21 CFR 892.1560	21 CFR 892.1560	SAME
Regulation	21 CFR 892.1570	21 CFR 892.1570	SAME
Classification	II	II	SAME
Product Code	IYO, ITX	IYO, ITX	SAME
Regulation Name	Ultrasonic Pulsed Echo ImagingSystem(IYO)Diagnostic Ultrasound Transducer (ITX)	Ultrasonic Pulsed Echo ImagingSystem(IYO)Diagnostic Ultrasound Transducer (ITX)	SAME
Indicationsfor use	The Bladder Scanner is B-modepulsed-echo ultrasound device adopts a3D mechanical fan scanning probe for theultrasonic scanning for bladder andmeasures the bladder volume from theabdominal surface utilizing the principlesof ultrasonic imaging. The BladderScanner is intended to be used only byqualified medical professionals.	The Bladder Scanner (Models: M3,M3-HD, M4, M4-HD) is B-modepulsed-echo ultrasound device. Itintended as a handheld battery-operateddevice. The M3, M3-HD, M4, M4-HDBladder Scanner projects ultrasoundenergy through the lower abdomen ofthe patient to obtain images of thebladder which is used to calculatebladder Volume noninvasively. The M3,M3-HD, M4, M4-HD Bladder Scanneris intended to be used only by qualifiedmedical professionals.	SAME
Contraindications	Do not carry out any inspection orexploration on any wounds to preventcross-infection and disease aggravation.This equipment is not applicable to thebladder scanning of the pregnant andfetuses, patients with surgical scars orscars on the abdomen (for this will affectthe measurement accuracy), patients withascites, and patients with bladder catheters(for this will affect the measurementaccuracy).	Do not use the Bladder Scanner onfollowing cases:a) Fetal use or pregnant patientsb) Patients with ascitesc) Patients with open or damaged skin.d) Wounds in the suprapubic region	Difference(1)
SystemCharacteristicsand structure	Portable,Power source: Battery	Portable,Tablet computer display,Thermal Printer,Power source: Battery	SAME
Display screen	1.54 inch, 240*240, high-resolution IPS	M3-HD, M4-HD will be provided	Difference
	display.	customer with a Samsung SM-T590 10.5inch	(2)
Controls forChange ofacoustic outputduring scan	No	No	SAME
Transducer type	Mechanical Sector Probe	Mechanical Sector Probe	SAME
Measurementplace	Abdomen	Abdomen	SAME
Nominalultrasoundfrequency	2.5 MHz	2.5Mhz	SAME
Number ofelements	1	1	SAME
Sector Angle	120°	120°	SAME
Number of ScanPlanes	12	M4-HD:12 ,M3-HD:1	SAME withM4-HDmodel
Volumemeasurementrange	0 ml〜999 ml	0ml-999ml	SAME
Volumemeasurementaccuracy	≤ ±10 ml (measured volume < 100ml)≤ ±7.5% (measured volume ≥100ml)	M4-HD:under 100 mL: ±7mL;100 to 999 mL: ±7%,M3-HD:under 100 mL: ±14mL;100 to 999 mL: ±14%	Difference(3)
Classificationofprotection againstelectricshock,Applied part type	Class II equipment, B type	Class II equipment , B type	SAME
Real-timescanning	Yes (Pre-scan)	Yes (Pre-scan)	SAME
PC Data Upload	No	USB connection	Difference(5)
Power	Lithium battery:PA-1S2P35R3-2T3.6 V 7000 mAhCharger: 100~ 240V~, 50 -60Hz 0.4A	Lithium battery:NCA653864SA-2400 mAh(PC015-2S1P)7.4Vd.c. 2400mAhCharger: HXY- 084V1500A-ULAC100-240Va	Difference(4)
WIFI	No	WIFI connection.	Difference(5)
Bluetooth	No	Connect to the printer using Bluetooth to print a test image.	Difference (5)
Patient contact material	Polyethylene (PE), skin contact	Polycarbonate (PC), skin contact	Difference (6)
Biocompatibility	ISO 10993-5&ISO 10993-10	Unknown
Safety and EMCStandardscompliance	IEC 60601- 1:2005+A1:2012IEC 60601-1-2:2014IEC 60601-2-37:2015	ES60601- 1:2005+A1:2012IEC 60601-1-2:2014IEC 60601-2-37:2015	SAME
FDA limit	Track 1	Track 1	SAME

Table 1 General Comparison

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Analysis :

Difference (1)

The contraindications of proposed device have covered that of the predicate device, the difference would not affect the safety and effectiveness of the proposed device.

Difference (2)

The proposed device and the predicate device have different display screen size and specification design, the difference would not affect the safety and effectiveness of the proposed device.

Difference (3)

The volume measurement accuracy of proposed device is between that of the two models of the predicate device, the difference would not affect the safety and effectiveness of the proposed device.

Difference (4)

There is difference on the battery voltage, but the design of proposed device comply with electrical safety standard IEC 60601-1, and its Li-ion battery comply with the battery safety standard IEC 62133, so the voltage difference would not affect its safety and effectiveness.

Difference (5)

The proposed device does not data transmission function, such as WiFi, USB and Bluetooth, the difference would not affect the safety and effectiveness of the proposed device.

Difference (6)

The proposed device and the predicate device have different patient contact materials, but the patient contact materials of proposed device meet the ISO10993 standards, the difference would not affect its safety and effectiveness.

9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.