(115 days)
Not Found
No
The document describes a standard ultrasound device for bladder volume measurement and does not mention any AI or ML capabilities.
No
The device uses ultrasound to obtain images and calculate bladder volume non-invasively for diagnostic purposes, not to treat a medical condition.
Yes
The device uses ultrasound to calculate bladder volume non-invasively, and volume measurement accuracy is a key metric, which are all characteristics of a diagnostic device. The performance studies also refer to it as a "Diagnostic Ultrasound System."
No
The device description explicitly states it is a "B-mode pulsed-echo ultrasound device" and a "handheld bladder scanner, the main unit and the probe are all-in-one," indicating it is a hardware device that uses ultrasound technology.
Based on the provided information, 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 PadScan HD2 Bladder Scanner uses ultrasound energy applied externally to the lower abdomen to image and calculate bladder volume. It does not analyze samples taken from the body.
- Intended Use: The intended use is to non-invasively measure bladder volume using ultrasound, not to perform diagnostic tests on biological samples.
Therefore, the PadScan HD2 Bladder Scanner falls under the category of a medical device that uses imaging technology, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
IYO, ITX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
B-mode pulsed-echo ultrasound
Anatomical Site
Bladder
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
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.
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.
Key Metrics
Accuracy: +/- 15%, +/- 15ml for bladder volume range: 0-999ml
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, representing care and protection.
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
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
C information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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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*
(Specify) |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General (Track
1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color
Doppler | Combined
(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 | Cardiac Adult | | | | | | | |
| | 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
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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)/ |
| 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
6
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 | ||
| 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) |
| 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. | 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. |
| 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 | 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 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 |
| | used only by qualified medical professionals. | qualified medical professionals. |
| 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 | 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 |
| Modes of operation | B mode | B mode |
| System Characteristics | a) handheld, the main unit and the probe are all-in-one
b) LCD Display
c) Power source: Battery | a) Portable
b) LCD Display
c) Thermal Printer
d) Power source: Battery or AD-DC adapter |
| Display | PadScan HD2: 2.5" TFT-LCD | PadScan HD5: 8" TFT-LCD
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
A1:2012,, C1:2009/(R)2012 And
A2:2010/(R)2012
IEC 60601-2-37:2007 | +CORR.2(2007)
IEC 60601-2-37:2007 |
| EMC Compliance | IEC 60601-1-2:2007 | IEC 60601-1-2:2007 |
| Patient
Contacting
Material | PC(Skin Contact) | Plastic, PE (Skin Contact) |
| Range | Bladder volume range: 0-999ml
Accuracy: ±15%, ±15ml | Bladder volume range: 0-999ml
Accuracy: ±15%, ±15ml |
| Classification of
protection against
electric shock | Class II equipment
Type B equipment | Class II equipment
Type B equipment |
| Real-time
scanning | Yes (Pre-scan) | Yes (Pre-scan) |
| PC Data Upload | Using SD card | Using USB flash disk |
| Power | Battery Charger:
input: 100-240Va.c., 50/60Hz
Output: 8.4Vd.c
Battery: Li-ion rechargeable | AC/DC Adapter:
Input: AC100-240V, 50/60Hz,
Output: DC14V±0.5V
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.
9
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.
10
10.3 Performance-Bench Testing
-
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.
-
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.