Bladder Scanner
Device Facts
| Record ID | K153581 |
|---|---|
| Device Name | Bladder Scanner |
| Applicant | Caresono Technology Co., Ltd. |
| Product Code | IYO · Radiology |
| Decision Date | Apr 8, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
Indications for Use
The Bladder Scanner (model: PadScan HD2) 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 HD2 Bladder Scanner is intended to be used only by qualified medical professionals.
Device Story
Handheld, battery-operated B-mode ultrasound device; main unit and probe integrated. Projects ultrasound energy through lower abdomen; captures bladder images; calculates bladder volume noninvasively. Used by qualified medical professionals in clinical settings. Features 2.5-inch LCD, SD card storage, voice recording, and alarm settings. Provides real-time pre-scan imaging. Output used by clinicians to assess bladder volume; aids in clinical decision-making regarding urinary management. Benefits patient through non-invasive, fast, and reliable volume measurement.
Clinical Evidence
Bench testing only. Compliance with ES 60601-1:2005, IEC 60601-2-37:2007, IEC 60601-1-2:2007, and NEMA UD 2:2004. Biocompatibility testing per ISO 10993-5:2009 and ISO 10993-10:2010. Volume accuracy testing performed; results met pre-set acceptability criteria consistent with the predicate device.
Technological Characteristics
Handheld mechanical sector probe (1 element, 120-degree angle, 3.5 MHz resonant frequency). B-mode pulsed-echo imaging. 2.5-inch TFT-LCD display. PC (polycarbonate) patient-contacting material. Battery-powered (Li-ion). Data storage via SD card. Complies with ES 60601-1, IEC 60601-2-37, IEC 60601-1-2, and NEMA UD 2 standards.
Indications for Use
Indicated for use as a B-mode pulsed-echo ultrasound device for noninvasive bladder volume calculation in patients. Contraindicated for fetal use, pregnant patients, patients with ascites, patients with open/damaged skin, or wounds in the suprapubic region.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- PadScan HD series Bladder Scanner (K131227)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2016
Caresono Technology Co., Ltd. % Mr. Long Yang, COO Shenzhen Hlongmed Biotech Company R15-08, East Building, Yihai Plaza, Chuangye Road Nanshan District Shenzhen, Guangdong 518054 CHINA
Re: K153581
Trade/Device Name: Bladder Scanner Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: March 15, 2016 Received: March 25, 2016
Dear Mr. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known)
K153581
Device Name
Bladder Scanner
Indications for Use (Describe)
The Bladder Scanner(model: PadScan HD2) is B-mode pulsed-echo ultrasound device. It intended as a handheld batteryoperated device. The PadScan HD2 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 HD2 Bladder Scanner is intended to be used only by qualified medical professionals.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <div style="display:inline-block; vertical-align:middle;"> <div style="display:inline-block; border: 1px solid black; width: 10px; height: 10px; text-align: center;"> <span><b>X</b></span> </div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <div style="display:inline-block; vertical-align:middle;"> <div style="display:inline-block; border: 1px solid black; width: 10px; height: 10px; text-align: center;"> </div> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# Diagnostic Ultrasound Indications for Use Form
System: PadScan HD2 Bladder Scanner
Transducer: N3
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | Other*<br>(Specify) |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other(Bladder) | N | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
N=new indication; P= previously cleared by FDA; E=added under this appendix
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Image /page/4/Picture/1 description: The image shows the word "Caresono" in orange color. The font is sans-serif and the letters are closely spaced. The word is horizontally oriented and appears to be a logo or brand name.
# 510(k) Summary
(as required by 807.92(c))
The assigned 510(K) number is: Date of Summary:
# 1. Submitter information
Manufacturer Name: Caresono Technology Co., Ltd. Address: 4th Floor, No.11 Building Initiating Zone Instruments and Meters Industry Base, Near Port Industry Zone, Dandong, Liaoning, CHINA 118009 Contact Person and Title: Yuzhong Ma / Management Representative Tel: 0086-415-6123779 Fax: 0086-415-6123769 Email: myz6178456@163.com
### 2. Contact person
### 2.1 Primary Contact Person
Long Yang (COO) Shenzhen Hlongmed Biotech Company R1508, East Building, Yihai Plaza, Chuangye Road, Nanshan District,Shenzhen, P.R. China Tel: 0086-755-86664986 Fax: 0086-755-86664933 E-mail: yanglong@hlongmed.com
# 2.2 Secondary Contact Person
Yuzhong Ma (Management Representative) Caresono Technology Co., Ltd. 4th Floor, No.11 Building Initiating Zone Instruments and Meters Industry Base, Near Port Industry Zone, Dandong, Liaoning, CHINA 118009 Tel: 0086-415-6123779
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Image /page/5/Picture/0 description: The image shows the word "Caresono" in orange font. The font is sans-serif and the letters are evenly spaced. The background is white. The word is likely a brand name or company name.
#### 3. Device Information
| Trade/Device Name | Bladder Scanner |
|------------------------------|--------------------------------------------------------------------------------------|
| Model | PadScan HD2 |
| Common Name | Diagnostic Ultrasound System with Accessories |
| Classification Name | Ultrasonic Pulsed Echo Imaging System(IYO)/<br>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 Bladder Scanner (model: PadScan HD2) 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 HD2 Bladder Scanner is intended to be used only by qualified medical professionals.
#### 6. Indications for Use
The Bladder Scanner (model: PadScan HD2) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The PadScan HD2 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 HD2 Bladder Scanner is intended to be used only by qualified medical professionals.
#### 7. Device Description
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Image /page/6/Picture/0 description: The image shows the word "Caresono" in orange color. The font is bold and sans-serif. The background is white.
The PadScan HD2 Bladder Scanner manufactured by Caresono Technology provides real-time ultrasound imaging and measuring, and also provides non-invasive volume measurement of the bladder. It is a handheld bladder scanner, the main unit and the probe are all-in-one.
It features:
- · Expert operating mode and Easy operating mode
- · Non-invasive, comfortable, correct, reliable, fast and simple operation
- SD card storage
- Voice recording function
- Urine volume setting and alarm setting
- Multi-language selection
- · Injection molded shell, the main unit and the probe are all-in-one, 2.5-inch LCD screen(240x320pixels)
- Power supply with built-in battery.
# 8. Contraindications
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
# 9. Comparison to Predicate Device
Caresono Technology Co., Ltd believes the PadScan HD2 Bladder Scanner described in this submission is substantially equivalent to the predicate device as follows:
PadScan HD series Bladder Scanner (K131227)
The ultrasound power transmitted from the device is not user adjustable, and PadScan HD2 Bladder Scanner is Track 1 System and meets the FDA's pre-amendment acoustic output limits, So as the predicate devices are. Although there are some differences such as resonant frequency, power source and size of display screen, appearance, there is no significant differences in technological characteristics that affecting the safety and efficiently. These are evaluated by safety test and acoustic output test.
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Image /page/7/Picture/0 description: The image features the word "Caresono" in a bold, sans-serif font. The text is rendered in a vibrant orange color, which makes it stand out against the white background. The overall impression is clean and modern, with a focus on the brand name.
| Items | Proposed Device | Predicate Device-K131227 |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Bladder Scanner | PadScan HD series Bladder Scanner |
| Model | PadScan HD 2 | PadScan HD 5, PadScan HD 3 |
| 510k submitter | Caresono Technology Co., Ltd. | Caresono Technology Co., Ltd. |
| 510(K) Number | ------------- | K131227 |
| Classifications<br>Name & Citations | 21 CFR 892.1560 Ultrasonic Pulsed<br>Echo Imaging System<br>(Product code: IYO)<br><br>21 CFR 892.1570 Diagnostic<br>Ultrasonic Transducer<br>(Product code: ITX) | 21 CFR 892.1560 Ultrasonic Pulsed<br>Echo Imaging System<br>(Product code: IYO)<br><br>21 CFR 892.1570 Diagnostic<br>Ultrasonic Transducer<br>(Product code: ITX) |
| Intended Use | The Bladder Scanner (model:<br>PadScan HD2) 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<br>PadScan HD2 Bladder Scanner is<br>intended to be used only by qualified<br>medical professionals. | The PadScan HD series Bladder<br>Scanner projects ultrasound energy<br>through the lower abdomen of the<br>patient to obtain images of the<br>bladder which is used to calculate<br>bladder volume noninvasively. The<br>PadScan HD series Bladder Scanner<br>is intended to be used only by<br>qualified medical professionals. |
| Indications for<br>Use | The Bladder Scanner (model:<br>PadScan HD2) is B-mode<br>pulsed-echo ultrasound device. It<br>intended as a handheld<br>battery-operated device. The PadScan<br>HD2 Bladder Scanner projects<br>ultrasound energy through the lower<br>abdomen of the patient to obtain<br>images of the bladder which is used to<br>calculate bladder Volume<br>noninvasively. The PadScan HD2<br>Bladder Scanner is intended to be | The PadScan HD series Bladder<br>Scanner is B-mode pulsed-echo<br>ultrasound device. It intended as a<br>portable battery-operated device.<br>The PadScan HD series Bladder<br>Scanner projects ultrasound energy<br>through the lower abdomen of the<br>patient to obtain images of the<br>bladder which is used to calculate<br>bladder volume noninvasively. The<br>PadScan HD series Bladder Scanner<br>is intended to be used only by |
| | used only by qualified medical professionals. | qualified medical professionals. |
| Contraindications | Do not use the PadScan HD2 Bladder Scanner on 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 | Do not use the PadScan HD series Bladder Scanner on 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 |
| Modes of operation | B mode | B mode |
| System Characteristics | a) handheld, the main unit and the probe are all-in-one<br>b) LCD Display<br>c) Power source: Battery | a) Portable<br>b) LCD Display<br>c) Thermal Printer<br>d) Power source: Battery or AD-DC adapter |
| Display | PadScan HD2: 2.5" TFT-LCD | PadScan HD5: 8" TFT-LCD<br>PadScan HD3: 7" TFT-LCD |
| Controls for Change of acoustic output during scan | No | No |
| Transducer Type | Mechanical Sector Probe | Mechanical Sector Probe |
| Measurement localization | Abdomen | Abdomen |
| Transducer Resonant Frequency | 3.5 MHz | 2.5 MHz |
| Number of elements | 1 | 1 |
| Sector Angle | 120 degree | 120 degrees |
| No. of Scan Planes | 1 | 12 |
| FDA Limits | Track 1 | Track 1 |
| Product Safety | AAMI / ANSI | IEC 60601-1:2005 +CORR.1(2006) |
| Certification | ES60601-1:2005/(R)2012 And<br>A1:2012,, C1:2009/(R)2012 And<br>A2:2010/(R)2012<br>IEC 60601-2-37:2007 | +CORR.2(2007)<br>IEC 60601-2-37:2007 |
| EMC Compliance | IEC 60601-1-2:2007 | IEC 60601-1-2:2007 |
| Patient<br>Contacting<br>Material | PC(Skin Contact) | Plastic, PE (Skin Contact) |
| Range | Bladder volume range: 0-999ml<br>Accuracy: ±15%, ±15ml | Bladder volume range: 0-999ml<br>Accuracy: ±15%, ±15ml |
| Classification of<br>protection against<br>electric shock | Class II equipment<br>Type B equipment | Class II equipment<br>Type B equipment |
| Real-time<br>scanning | Yes (Pre-scan) | Yes (Pre-scan) |
| PC Data Upload | Using SD card | Using USB flash disk |
| Power | Battery Charger:<br>input: 100-240Va.c., 50/60Hz<br>Output: 8.4Vd.c<br>Battery: Li-ion rechargeable | AC/DC Adapter:<br>Input: AC100-240V, 50/60Hz,<br>Output: DC14V±0.5V<br>Battery: Li-ion rechargeable |
# Table 6-1 Comparison to the predicate
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Image /page/8/Picture/0 description: The image shows the word "Caresono" in a bold, sans-serif font. The color of the text is a vibrant orange. The word appears to be a logo or brand name, presented in a clean and modern style.
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Image /page/9/Picture/0 description: The image shows the word "Caresono" in orange font. The word is written in all lowercase letters and is underlined with a thin black line. The font is sans-serif and the letters are closely spaced together.
Caresono Technology Co., Ltd. believes that the PadScan HD2 Bladder Scanner is substantially equivalent to the PadScan HD2 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 ES 60601-1:2005 and IEC 60601-2-37:2007.
# 10.2 EMC
Electromagnetic Compatibility data demonstrates that the device is in compliance with IEC 60601-1-2:2007.
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#### 10.3 Performance-Bench Testing
1) The PadScan HD2 Bladder Scanner had been tested as Track 1 device per the FDA Guidance document "Information for Manufactures Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2:2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
2) The PadScan HD2 Bladder Scanner had been tested volume accuracy per the FDA Guidance document "Information for Manufactures Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in September 2008. 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 PadScan HD2 Bladder Scanner was evaluated with safety (ES 60601-1:2005 and 60601-2-37:2007), EMC (IEC 60601-1-2:2007), Biocompatibility (ISO IEC 10993-5:2009, ISO10993-10:2010), Acoustic Output (NEMA UD2:2004) and volume accuracy. The conclusions drawn from testing of the PadScan HD2 Bladder Scanner demonstrate that the device is as safe and effective as the legally marketed predicate device.
