(267 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a standard B-mode pulsed-echo ultrasound device with a 3D mechanical fan scanning probe. The performance studies focus on standard accuracy and compliance with relevant medical device standards, not on AI/ML model performance.
No
The device is used for measurement (diagnosis), not for treatment (therapy).
Yes
Explanation: The device is described as an ultrasound device that measures bladder volume from the abdominal surface. This measurement provides information about the patient's bladder, which is used for diagnostic purposes (e.g., assessing bladder function, identifying urinary retention).
No
The device description explicitly states it consists of a "main unit (include 3D probe), battery power adapter and USB charging cable," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the living body (in vitro).
- Bladder Scanner Function: The description clearly states the Bladder Scanner is a "B-mode pulsed-echo ultrasound device" that measures bladder volume "from the abdominal surface of ultrasonic imaging." This is a non-invasive procedure performed on the living body (in vivo). It uses ultrasound waves to create images and calculate volume, not by analyzing a sample taken from the body.
The information provided focuses on the device's ultrasound capabilities, measurement accuracy, and compliance with medical device standards, all of which are characteristic of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
IYO, ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic imaging
Anatomical Site
bladder, abdominal surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical professionals, hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Conducted the Bladder Scanner volume measurement accuracy test for the measurement range 0 ml ~999 ml, the measurement accuracy met the requirements. No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The Bladder Scanner volume measurement range is: 0 ml~999 ml;
The Bladder Scanner volume measurement accuracy is:
=100ml).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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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.
-
- Date of Preparation: 2023/12/27
-
- 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
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
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