(244 days)
Not Found
No
The summary describes a standard B-mode pulsed-echo ultrasound device for bladder volume measurement. There is no mention of AI, ML, or any advanced image processing techniques that would typically indicate the use of such technologies. The performance studies focus on standard electrical, acoustic, and biocompatibility testing, not AI/ML model validation.
No
The device is used to calculate bladder volume noninvasively, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended to obtain images of the bladder to calculate bladder volume noninvasively. This calculation of bladder volume can be used by healthcare professionals to assess a patient's condition and make clinical decisions.
No
The device description explicitly states the equipment consists of a main unit, 3D probe, battery, and adapter, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the body (in vitro).
- Device Function: The Bladder Scanner described is an ultrasound device that uses sound waves to image the bladder within the body (in vivo) and calculate its volume. It does not analyze samples taken from the patient.
The device is a medical imaging device used for non-invasive measurement, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Bladder Scanner (model: PadScan Z3, PadScan Z3, PadScan Z5) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The 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 Bladder Scanner is intended to be used only by qualified medical professionals.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The PadScan Series manufactured by AvantSonic Technology Co., Ltd. provides non-invasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. The equipment consists of the main unit, 3D probe, battery and adapter.
It features:
- . Two Operation Modes: Expert Mode and Easy Mode
- . Non-invasive, comfortable, correct, reliable, fast and simple operation
- . Printouts with ultrasound images and various parameters through PC software
- . Touch screen keyboard operation
- . Urine volume setting and alarm setting
- . Multi-language selection
- . Combined power supply with AC adapter and a built-in battery
The difference between these models is the size of the LCD screen and enclosure structure. PadScan DS3 is provided 7-inch LCD screen. PadScan Z3 is provided 7-inch LCD screen and LCD screen stand. PadScan Z5 is provided 8-inch LCD screen and LCD screen which has a handle.
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
Intended User / Care Setting
Qualified medical professionals.
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)
Clinical testing is not required.
The PadScan DS3, PadScan Z3 and PadScan Z5 Bladder Scanner comply with:
(1) IEC 60601-1 Electrical Safety
(2) IEC 60601-1-2 Electromagnetic Compatibility
(3) IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
(4) NEMA UD 2 Standard for real-time display of thermal and mechanical acoustic output indies on diagnostic ultrasound equipment.
(5) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
The following biocompatibility standards are conducted on the subject device:
(1) ISO 10993-1, ISO 10993-5 and ISO 10993-10
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Volume measurement accuracy: ±10%, ±10ml
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
January 24, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
AvantSonic Technology Co., Ltd. % Mr. Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. 22A. Haijing Square. No. 18. Taizi Road Nanshan District, Shenzhen, 518067 CHINA
Re: K171528
Trade/Device Name: Bladder Scanner (model: PadScan ZS3. PadScan Z3. PadScan Z5) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: December 18, 2017 Received: December 18, 2017
Dear Mr. 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 (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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171528
Device Name
Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)
Indications for Use (Describe)
The Bladder Scanner (model: PadScan Z3, PadScan Z3, PadScan Z5) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The 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 Bladder Scanner is intended to be used only by qualified medical professionals.
| 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: PadScan DS3
Transducer: MP2A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined (Specify) | Other (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal / Obstetrics | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Bladder) | N | |||||||
| Adult Cardiac | ||||||||
| Cardiac | Pediatric Cardiac | |||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
4
System: PadScan Z3
Transducer: MP2
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | Other |
| (Specify) | (Specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Fetal | Neonatal Cephalic | |||||||
| Imaging | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Bladder) | N | |||||||
| Adult Cardiac | ||||||||
| Cardiac | Pediatric Cardiac | |||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | |||||||
| vascular | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
5
System: PadScan Z5
Transducer: MP2
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined (Specify) | Other (Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / Obstetrics | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro logical) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Bladder) | N | ||||||||
| Cardiac | Adult Cardiac | ||||||||
| Pediatric Cardiac | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra- cardiac | |||||||||
| Peripheral | |||||||||
| vascular | Peripheral vascular | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
6
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2017/05/08
- Submission sponsor
Name: AvantSonic Technology Co., Ltd. Address: No.394, Jingdongfang Avenue, Beibei District, Chongqing, P.R. China 400714 Contact person: Cuiling Wu Title: R&D manager E-mail: wucuiling@sina.com Tel: +86-755 88271976
Submission correspondent 2.
Name: Chonconn Medical Device Consulting Co., Ltd. Address: 22A, Haijing Square, No. 18, Taizi Road, Nanshan District, Shenzhen, P.R. China 518067 Contact person: Kevin Wang E-mail: kevin@chonconn.com Tel: +86-755 33941160
| Trade/Device Name | Bladder Scanner |
|---|---|
| Model | PadScan DS3, PadScan Z3, PadScan Z5 |
| Common Name | Diagnostic Ultrasound System with Accessories |
| Regulatory Class | Class II |
| Classification | 21CFR 892.1560/Ultrasonic Pulsed Echo Imaging System/IYO |
| 21CFR 892.1570/Diagnostic Ultrasound Transducer/ITX | |
| Submission type | Traditional 510(K) |
3. Subject Device Information
Predicate Device 4.
| 510(K) number | K131227 |
|---|---|
| Device Name | PadScan HD series Bladder Scanner |
| Manufacturer | Caresono Technology Co., Ltd |
| Product Code | IYO, ITX |
Device Description 5.
The PadScan Series manufactured by AvantSonic Technology Co., Ltd. provides non-invasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. The equipment consists of the main unit, 3D probe, battery and adapter.
It features:
Bladder Scanner– 510(k) submission
7
- . Two Operation Modes: Expert Mode and Easy Mode
- . Non-invasive, comfortable, correct, reliable, fast and simple operation
- . Printouts with ultrasound images and various parameters through PC software
- . Touch screen keyboard operation
- . Urine volume setting and alarm setting
- . Multi-language selection
- . Combined power supply with AC adapter and a built-in battery
The difference between these models is the size of the LCD screen and enclosure structure. PadScan DS3 is provided 7-inch LCD screen. PadScan Z3 is provided 7-inch LCD screen and LCD screen stand. PadScan Z5 is provided 8-inch LCD screen and LCD screen which has a handle.
Intended use 6.
The Bladder Scanner (model: PadScan Z3, PadScan Z3, PadScan Z5) 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 Bladder Scanner is intended to be used only by qualified medical professionals.
7. Indication for use
The Bladder Scanner (model: PadScan Z3, PadScan Z3, PadScan Z5) is B-mode pulsed-echo ultrasound device. It intended as a handheld batterv-operated device. The 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 Bladder Scanner is intended to be used only by qualified medical professionals.
8. Contraindications
Do not use the 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. Comparison to Predicate Device
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table
| SE Comparisons | PadScan DS3, PadScan Z3,
PadScan Z5 | PadScan HD series Bladder
Scanner | Note |
|-----------------|----------------------------------------|--------------------------------------|------|
| Manufacturer/K# | AvantSonic/Present
application | Caresono/K131227 | -- |
Tahle 1
Bladder Scanner- 510(k) submission
8
AvantSonic
| Intended Use | The PadScan 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 | 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 | Same |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | used only by qualified
medical professionals. | by qualified medical
professionals. | |
| Contraindications | Do not use the 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
HD2 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 | Same |
| Modes of operation | B mode | B mode | Same |
| System
Characteristics | a) Portable
b) LCD Display
c) Thermal Printer
d) Power source: Battery or
AD-DC adapter | a) Portable
b) LCD Display
c) Thermal Printer
d) Power source: Battery or
AD-DC adapter | Same |
| Display | PadScan DS3: 7" TFT-LCD
PadScan Z3: 7" TFT-LCD
PadScan Z5: 8" TFT-LCD | PadScan HD3: 7" TFT-LCD
PadScan HD5: 8" TFT-LCD | Same |
| Controls for Change
of acoustic output
during scan | No | No | Same |
| Transducer Type | Mechanical Sector Probe | Mechanical Sector Probe | Same |
| Measurement place | Abdomen | Abdomen | Same |
| Transducer Resonant
Frequency | 2.5Mhz | 2.5Mhz | Same |
| Number of elements | 1 | 1 | Same |
| Sector Angle | 120° | 120° | Same |
| Number of Scan
Planes | 12 | 12 | Same |
| Patient Contacting
Material | PE (skin contact) | PE (skin contact) | Same |
| Volume measurement
range | 0ml-999ml | 0ml-999ml | Same |
| Volume measurement
accuracy | ±10%, ±10ml | ±15%, ±15ml | Different |
| Classification of
protection against
electric shock | Class II equipment | Class II equipment | Same |
| Applied part type | B type | B type | Same |
| Real-time scanning | Yes (Pre-scan) | Yes (Pre-scan) | Same |
| PC Data Upload | USB, Bluetooth | SD card | Different |
| Power | AC/DC Adapter:
Input: AC 100V-240V,
50/60Hz,
Output: DC13.5V±0.5V
Battery: Li-ion
rechargeable | AC/DC Adapter:
Input: AC100-240V,
50/60Hz,
Output: DC14V±0.5V
Battery: Li-ion rechargeable | Different |
| Standards compliance | IEC 60601-
1:2005+A1:2012 | IEC 60601-1:2005
+CORR.1(2006)
+CORR.2(2007) | Different |
| | IEC 60601-1-2:2014 | IEC 60601-1-2:2007 | |
| | IEC 60601-2-37:2015 | IEC 60601-2-37:2007 | Different |
| FDA limit | Track 1 | Track 1 | Same |
Bladder Scanner– 510(k) submission
9
AvantSonic
All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion.
10. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
The PadScan DS3, PadScan Z3 and PadScan Z5 Bladder Scanner comply with:
(1) IEC 60601-1 Electrical Safety
(2) IEC 60601-1-2 Electromagnetic Compatibility
(3) IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Bladder Scanner– 510(k) submission
10
(4) NEMA UD 2 Standard for real-time display of thermal and mechanical acoustic output indies on diagnostic ultrasound equipment.
(5) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
The following biocompatibility standards are conducted on the subject device: (1) ISO 10993-1, ISO 10993-5 and ISO 10993-10
The tests were selected to show substantial equivalence between the subject device and the predicate.
11. Conclusion
Based on the safety and performance testing and compliance with acceptable voluntary standards, we believe that the PadScan DS3, PadScan Z3 and PadScan Z5 Bladder Scanner are substantially equivalent to their predicate device in K131227 and does not raise any new safety and/or effectiveness issues.