(234 days)
Not Found
No
The summary describes a standard ultrasound device for bladder volume measurement and does not mention any AI or ML capabilities.
No
The device is described as an ultrasound device that obtains images and calculates bladder volume, which are diagnostic functions, not therapeutic ones.
Yes
The device is described as projecting ultrasound energy to obtain images of the bladder which is used to calculate bladder volume noninvasively. The performance studies mention "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" and the predicate device is a "Bladder Scanner," all of which indicate its role in diagnosis.
No
The device description explicitly states it is a "B-mode pulsed-echo ultrasound device" and mentions hardware components like a "Combined power supply with AC adapter and a battery," indicating it is a hardware device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BVT02 Bladder Scanner uses ultrasound energy to noninvasively image and measure the volume of the bladder within the patient's body. It does not analyze samples taken from the patient.
The description clearly states it's a "B-mode pulsed-echo ultrasound device" that "projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder." This is a form of medical imaging, not an in vitro diagnostic test.
N/A
Intended Use / 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 facilities.
Product codes (comma separated list FDA assigned to the subject device)
IYO,ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Bladder (lower abdomen)
Indicated Patient Age Range
Not Found. Contraindications mention "Fetal use or pregnant patients."
Intended User / Care Setting
qualified medical professionals. Intended use environment: Professional health care facilities.
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)
Study Type: Bench Testing (Performance-Bench Testing)
Sample Size: Not specified.
Key Results:
- 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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±15%, ±15ml
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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) |
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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 (Track | ||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||
| Doppler | 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) | ||||||||
| Peripheral | ||||||||
| Vessel | 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 Of
Comparison | Proposed Device | Predicate Device-K131227 |
|------|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Trade Name | Bladder Scanner | PadScan HD series Bladder
Scanner |
| 2 | Model | BVT02 | PadScan HD 5, PadScan HD 3 |
| 3 | 510k submitter | Xuzhou Kaixin Electronic
Instrument Co., Ltd. | Caresono Technology Co., Ltd. |
| 4 | 510(K) Number | K223448 | K131227 |
| 5 | Classifications
Name &
Citations | 21 CFR 892.1560 Ultrasonic
Pulsed Echo Imaging System
(Product code: IYO)
21 CFR 892.1570 Diagnostic
Ultrasonic Transducer
(Product code: ITX) | 21 CFR 892.1560 Ultrasonic
Pulsed Echo Imaging System
(Product code: IYO)
21 CFR 892.1570 Diagnostic
Ultrasonic Transducer
(Product code: ITX) |
| 6 | 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 non-invasively.
The BVT02 Bladder Scanner is
intended to be used only by
qualified medical professionals. | The PadScan HD series 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 PadScan HD
series Bladder Scanner is
intended to be used only by
qualified medical professionals. |
| 7 | 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 | The PadScan HD series Bladder
Scanner is B-mode pulsed-echo
ultrasound device. It intended as
a portable battery-operated
device. The PadScan HD series
Bladder Scanner projects
ultrasound energy through the |
| Item | Element Of
Comparison | Proposed Device | Predicate Device-K131227 |
| | | images of the bladder which is
used to calculate
bladder volume non-invasively.
The BVT02 Bladder Scanner is
intended to be used only by
qualified medical professionals.
Intended use environment:
Professional health care facilities. | lower abdomen of the patient to
obtain images of the bladder
which is used to calculate
bladder volume noninvasively.
The PadScan HD series Bladder
Scanner is intended to be used
only by qualified medical
professionals. |
| 8 | Contraindicatio
ns | Do not use the BVT02 Bladder
Scanner on following cases:
a) Fetal use or pregnant patients.
b) Patients with ascites.
c) Patients with open or damaged
skin.
d) Wounds in the suprapubic
region. | Do not use the PadScan HD
series Bladder Scanner on
following cases:
a) Fetal use or pregnant patients
b) Patients with ascites
c)Patients with open or damaged
skin
d) Wounds in the suprapubic
region |
| 9 | Modes of
operation | B mode | B mode |
| 10 | System
Characteristics | a)Portable
b)LCD Display
c)Power source: Battery or
AD-DC adapter | a) Portable
b) LCD Display
c) Thermal Printer
d) Power source: Battery or
AD-DC adapter |
| 11 | Display | 3.5" TFT-LCD | PadScan HD5: 8" TFT-LCD
PadScan HD3: 7" TFT-LCD |
| 12 | Controls for
Change of
acoustic output | No | No |
| Item | Element Of
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
Comparison | Proposed Device | Predicate Device-K131227 |
| | electric shock | | |
| 26 | Real-time
scanning | Yes (Pre-scan) | Yes (Pre-scan) |
| 27 | Scan time |