(234 days)
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.
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.
Here's an analysis of the acceptance criteria and study information for the BVT02 Bladder Scanner, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The primary performance criterion mentioned is the bladder volume accuracy.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy: ±15%, ±15ml (for volumes 20-999ml) | Complies with pre-set acceptability criterion (which is stated to be the same as the predicate device, implying ±15%, ±15ml) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the specific sample size used for the volume accuracy test set. It mentions that "All the test results comply with the pre-set acceptability criterion," but not the number of measurements or subjects involved.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that the testing was done per the FDA Guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The volume accuracy testing appears to be a bench test involving physical measurements rather than human interpretation of images, so expert consensus on bladder volume images might not have been directly applicable.
4. Adjudication Method for the Test Set
This information is not provided. Given that the volume accuracy test appears to be a bench test, an adjudication method in the context of human interpretation is unlikely and not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or performed. The device is a bladder scanner that automatically calculates volume, not an AI diagnostic aid for image interpretation by clinicians.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, a standalone performance test for volume accuracy was conducted. The "Performance-Bench Testing" section explicitly states: "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..." This indicates the algorithm's performance was evaluated independently on a test setup.
7. Type of Ground Truth Used
The type of ground truth used for the volume accuracy test would likely be precise physical measurements of known volumes (e.g., water in a phantom) or a highly accurate clinical measurement method against which the device's calculated volume is compared. While not explicitly stated, the context of "volume accuracy" in bench testing for medical devices typically relies on such objective physical ground truth.
8. Sample Size for the Training Set
This information is not applicable and not provided. As a medical device for non-invasive volume measurement using pulsed-echo ultrasound, it is a hardware-software system rather than a machine learning/AI algorithm that requires a "training set" in the conventional sense for deep learning. Its accuracy is based on the underlying physical principles of ultrasound and algorithms for volume calculation, which are validated through bench testing rather than trained on data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided since there's no mention of a "training set" for an AI or machine learning model. The device's performance is established through validation against known values in bench testing.
{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.
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
{1}------------------------------------------------
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 (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
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| ☒ 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
"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}------------------------------------------------
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 (Track1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other(Bladder) | N | |||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N=new indication; P= previously cleared by FDA; E=added under this appendix
{4}------------------------------------------------
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: 0086-516-87792599
Fax: 0086-516-87792599
Email: xingkexin@126.com
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: 0086-755-86664986 Fax: 0086-755-86664933 E-mail: yanglong@hlongmed.com
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:0086-516-87792599 E-mail: xingkexin@126.com
{5}------------------------------------------------
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)/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
{6}------------------------------------------------
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
{7}------------------------------------------------
| Item | Element OfComparison | Proposed Device | Predicate Device-K131227 |
|---|---|---|---|
| 1 | Trade Name | Bladder Scanner | PadScan HD series BladderScanner |
| 2 | Model | BVT02 | PadScan HD 5, PadScan HD 3 |
| 3 | 510k submitter | Xuzhou Kaixin ElectronicInstrument Co., Ltd. | Caresono Technology Co., Ltd. |
| 4 | 510(K) Number | K223448 | K131227 |
| 5 | ClassificationsName &Citations | 21 CFR 892.1560 UltrasonicPulsed Echo Imaging System(Product code: IYO)21 CFR 892.1570 DiagnosticUltrasonic Transducer(Product code: ITX) | 21 CFR 892.1560 UltrasonicPulsed Echo Imaging System(Product code: IYO)21 CFR 892.1570 DiagnosticUltrasonic Transducer(Product code: ITX) |
| 6 | Intended Use | The BVT02 Bladder Scannerprojects ultrasound energythrough the lower abdomen of thepatient to obtain images of thebladder which is used to calculatebladder volume non-invasively.The BVT02 Bladder Scanner isintended to be used only byqualified medical professionals. | The PadScan HD series BladderScanner projects ultrasoundenergy through the lowerabdomen of the patient to obtainimages of the bladder which isused to calculate bladder volumenoninvasively. The PadScan HDseries Bladder Scanner isintended to be used only byqualified medical professionals. |
| 7 | Indications forUse | The BVT02 Bladder Scanner isB-mode pulsed-echo ultrasounddevice. It is intended as a portabledevice. The BVT02 BladderScanner projects ultrasoundenergy through the lowerabdomen of the patient to obtain | The PadScan HD series BladderScanner is B-mode pulsed-echoultrasound device. It intended asa portable battery-operateddevice. The PadScan HD seriesBladder Scanner projectsultrasound energy through the |
| Item | Element OfComparison | Proposed Device | Predicate Device-K131227 |
| images of the bladder which isused to calculatebladder volume non-invasively.The BVT02 Bladder Scanner isintended to be used only byqualified medical professionals.Intended use environment:Professional health care facilities. | lower abdomen of the patient toobtain images of the bladderwhich is used to calculatebladder volume noninvasively.The PadScan HD series BladderScanner is intended to be usedonly by qualified medicalprofessionals. | ||
| 8 | Contraindications | Do not use the BVT02 BladderScanner on following cases:a) Fetal use or pregnant patients.b) Patients with ascites.c) Patients with open or damagedskin.d) Wounds in the suprapubicregion. | Do not use the PadScan HDseries Bladder Scanner onfollowing cases:a) Fetal use or pregnant patientsb) Patients with ascitesc)Patients with open or damagedskind) Wounds in the suprapubicregion |
| 9 | Modes ofoperation | B mode | B mode |
| 10 | SystemCharacteristics | a)Portableb)LCD Displayc)Power source: Battery orAD-DC adapter | a) Portableb) LCD Displayc) Thermal Printerd) Power source: Battery orAD-DC adapter |
| 11 | Display | 3.5" TFT-LCD | PadScan HD5: 8" TFT-LCDPadScan HD3: 7" TFT-LCD |
| 12 | Controls forChange ofacoustic output | No | No |
| Item | Element OfComparison | 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 OfComparison | Proposed Device | Predicate Device-K131227 |
| electric shock | |||
| 26 | Real-timescanning | 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:Input:AC100-240V, 50-60HzOutput: DC12.8V 3.0ABattery: Li-ion rechargeable | AC/DC Adapter:Input: AC100-240V, 50/60Hz,Output: DC14V±0.5VBattery: Li-ion rechargeable |
(PadScan HD 5, PadScan HD 3)
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
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
- 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.
{11}------------------------------------------------
- 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.
§ 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.