Bladder Scanner

{0}------------------------------------------------ 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. 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230986 Device Name Bladder Scanner ### Indications for Use (Describe) 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. | 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 - 2. 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 - 3. 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 {4}------------------------------------------------ #### 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 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. 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. {5}------------------------------------------------ #### 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. - 7. Clinical Test Conclusion No clinical study is included in this submission. {6}------------------------------------------------ #### Substantially Equivalent (SE) Comparison 8. | Item | Proposed Device | Predicate Device<br>K201316 | 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 Imaging<br>System(IYO)<br>Diagnostic Ultrasound Transducer (ITX) | Ultrasonic Pulsed Echo Imaging<br>System(IYO)<br>Diagnostic Ultrasound Transducer (ITX) | SAME | | Indications<br>for use | The Bladder Scanner is B-mode<br>pulsed-echo ultrasound device adopts a<br>3D mechanical fan scanning probe for the<br>ultrasonic scanning for bladder and<br>measures the bladder volume from the<br>abdominal surface utilizing the principles<br>of ultrasonic imaging. The Bladder<br>Scanner is intended to be used only by<br>qualified medical professionals. | The Bladder Scanner (Models: M3,<br>M3-HD, M4, M4-HD) is B-mode<br>pulsed-echo ultrasound device. It<br>intended as a handheld battery-operated<br>device. The M3, M3-HD, M4, M4-HD<br>Bladder Scanner projects ultrasound<br>energy through the lower abdomen of<br>the patient to obtain images of the<br>bladder which is used to calculate<br>bladder Volume noninvasively. The M3,<br>M3-HD, M4, M4-HD Bladder Scanner<br>is intended to be used only by qualified<br>medical professionals. | SAME | | Contraindications | Do not carry out any inspection or<br>exploration on any wounds to prevent<br>cross-infection and disease aggravation.<br>This equipment is not applicable to the<br>bladder scanning of the pregnant and<br>fetuses, patients with surgical scars or<br>scars on the abdomen (for this will affect<br>the measurement accuracy), patients with<br>ascites, and patients with bladder catheters<br>(for this will affect the measurement<br>accuracy). | Do not use the 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 skin.<br>d) Wounds in the suprapubic region | Difference<br>(1) | | System<br>Characteristics<br>and structure | Portable,<br>Power source: Battery | Portable,<br>Tablet computer display,<br>Thermal Printer,<br>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 10.5<br>inch | (2) | | Controls for<br>Change of<br>acoustic output<br>during scan | No | No | SAME | | Transducer type | Mechanical Sector Probe | Mechanical Sector Probe | SAME | | Measurement<br>place | Abdomen | Abdomen | SAME | | Nominal<br>ultrasound<br>frequency | 2.5 MHz | 2.5Mhz | SAME | | Number of<br>elements | 1 | 1 | SAME | | Sector Angle | 120° | 120° | SAME | | Number of Scan<br>Planes | 12 | M4-HD:12 ,<br>M3-HD:1 | SAME with<br>M4-HD<br>model | | Volume<br>measurement<br>range | 0 ml〜999 ml | 0ml-999ml | SAME | | Volume<br>measurement<br>accuracy | ≤ ±10 ml (measured volume < 100ml)<br>≤ ±7.5% (measured volume ≥100ml) | M4-HD:<br>under 100 mL: ±7mL;<br>100 to 999 mL: ±7%,<br>M3-HD:<br>under 100 mL: ±14mL;<br>100 to 999 mL: ±14% | Difference<br>(3) | | Classification<br>of<br>protection against<br>electric<br>shock,<br>Applied part type | Class II equipment, B type | Class II equipment , B type | SAME | | Real-time<br>scanning | Yes (Pre-scan) | Yes (Pre-scan) | SAME | | PC Data Upload | No | USB connection | Difference<br>(5) | | Power | Lithium battery:<br>PA-1S2P35R3-2T<br>3.6 V 7000 mAh<br>Charger: 100~ 240V~, 50 -60Hz 0.4A | Lithium battery:<br>NCA653864SA-2400 mAh<br>(PC015-2S1P)<br>7.4Vd.c. 2400mAh<br>Charger: HXY- 084V1500A-UL<br>AC100-240Va | Difference<br>(4) | | WIFI | No | WIFI connection. | Difference<br>(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<br>&ISO 10993-10 | Unknown | | | Safety and EMC<br>Standards<br>compliance | IEC 60601- 1:2005+A1:2012<br>IEC 60601-1-2:2014<br>IEC 60601-2-37:2015 | ES60601- 1:2005+A1:2012<br>IEC 60601-1-2:2014<br>IEC 60601-2-37:2015 | SAME | | FDA limit | Track 1 | Track 1 | SAME | ### Table 1 General Comparison {7}------------------------------------------------ {8}------------------------------------------------ ### 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.