(73 days)
Not Found
No
The document describes a standard B-mode ultrasound device for bladder volume calculation and does not mention any AI or ML capabilities in the intended use, device description, or performance studies.
No.
The device is used to obtain images of the bladder and calculate bladder volume noninvasively for diagnostic purposes, not to treat a condition.
Yes
The device is explicitly stated to calculate bladder volume noninvasively and is classified as a "Diagnostic Ultrasound System" in its performance study, indicating its role in providing information for diagnosis.
No
The device description explicitly states it is a "B-mode pulsed-echo ultrasound device" and a "portable battery-operated device" that "projects ultrasound energy". This indicates it is a hardware device that uses ultrasound technology, not a software-only device.
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 HD series Bladder Scanner uses ultrasound energy applied externally to the patient's lower abdomen to image and measure bladder volume. It does not analyze samples taken from the body.
- Intended Use: The intended use describes a non-invasive measurement of bladder volume using ultrasound, not the analysis of biological samples.
Therefore, the device's function and intended use clearly fall outside the scope of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The PadScan HD series Bladder Scanner is B-mode pulsed-echo ultrasound device. It is 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 Pad Scan HD series Bladder Scanner is intended to be used only by qualified medical professionals.
Product codes (comma separated list FDA assigned to the subject device)
90-IYO, 90-ITX
Device Description
The PadScan HD series Bladder Scanner manufactured by Caresono Technology 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 Easy operating mode.
- Correct, reliable, fast, and simple operation.
- Printouts of ultrasound images with many parameters.
- Portable
- Combined power supply with AC adapter and a built-in battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The PadScan HD series Bladder Scanner have 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bladder volume range: 0-999ml
- 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
page 1 of 6
510(K) SUMMARY
JUL 1 2 2013
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.
The assigned 510(K) number is: K131227
1. Submitter:
Caresono Technology. Co., Ltd. 4th Floor, No.11 Building Initiating Zone, Instruments and Meters Industry Base, Near Port Industry Zone, Dandong, Liaoning 118009, P.R. China
2. Contact Person:
Mr. Yang Long Chief Operating Officer ﺴﻴﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ Shenzhen Hlongmed Biotech Co., Ltd. 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
3. Date Prepared: June 2, 2013
4. Device Information
Device Name: PadScan HD series Bladder Scanner Models: PadScan HD 5, PadScan HD 3 Common Name: Diagnostic Ultrasound System with Accessories Regulatory Class: II Classification Name and Product Code: 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO) 21 CFR 892.1570 Diagnostic Ultrasonic Transducer (90-ITX)
5. Predicate Device
Manufacturer: Mcube Technology Co., Ltd. Device: CUBEscan BioCon-700 510(k) Number: K111021 (Decision Date-April 27, 2011)
1
6. Intended Use
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. Device Description:
The PadScan HD series Bladder Scanner manufactured by Caresono Technology 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 Easy operating mode. .
- Correct, reliable, fast, and simple operation. ●
- Printouts of ultrasound images with many parameters. ●
- . Portable
- . Combined power supply with AC adapter and a built-in battery.
8. Indications for Use
The PadScan HD series Bladder Scanner is B-mode pulsed-echo ultrasound device. It is 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 qualified medical professionals.
9. Contraindications
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
10. Compatible with predicate device:
The PadScan HD series Bladder Scanner is substantially equivalent in intended use and operation to following predicate devices:
CUBEscan Diagnostic Ultrasound System and Accessories K111021
The ultrasound power transmitted from the device is not user adjustable,
2
and PadScan HD series 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 display screen, there is no significant differences in technological characteristics that affecting the safety and efficiently. These are evaluated by safety test and acoustic output test.
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Trade Name | PadScan HD series Bladder | |
| Scanner | CUBEscan BioCon-700 | |
| Model | PadScan HD 5, PadScan | |
| HD 3 | BioCon-700 | |
| 510(K) Submitter | Caresono Technology Co., | |
| Ltd. | Mcube Technology Co., | |
| Ltd. | ||
| 510(K) Number | -- | K111021 |
| Classifications | ||
| Name & Citations | 21 CFR 892.1560 Ultrasonic | |
| Pulsed Echo Imaging | ||
| System (90-IYO) | ||
| 21 CFR 892.1570 | ||
| Diagnostic Ultrasonic | ||
| Transducer (90-ITX) | 21 CFR 892.1560 | |
| Ultrasonic Pulsed Echo | ||
| Imaging System (90-IYO) | ||
| 21 CFR 892.1570 | ||
| Diagnostic Ultrasonic | ||
| Transducer (90-ITX) | ||
| Indications for | ||
| Use | 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 qualified | ||
| medical professionals. | The BioCon-700 is a | |
| B-mode pulsed-echo | ||
| ultrasound device. The | ||
| BioCon-700 is intended as | ||
| a portable battery-operated | ||
| device. The BioCon-700 | ||
| projects ultrasonic energy | ||
| through the abdomen of the | ||
| patient obtaining images of | ||
| the bladder in order to | ||
| calculate the urine volume | ||
| non-invasively BioCon-700 | ||
| is intended to be used by a | ||
| qualified medical | ||
| professional. | ||
| Contraindications for the | ||
| BioCon-700 are fetal use | ||
| and use on pregnant | ||
| patients. | ||
| Item | Proposed Device | Predicate Device |
| Contraindications | 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 | Do not use the BioCon-700 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 | - Portable |
- LCD Display
- Thermal Printer
- Power source: Battery or AD-DC adapter | - Portable
- LCD Display
- Thermal Printer
- Power source: Battery or AD-DC adapter |
| Display | PadScan HD5: 8" TFT-LCD
PadScan HD3: 7" TFT-LCD | 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 | 2.5 MHz | 2.6 MHz |
| Number of elements | 1 | 1 |
| Sector Angle | 120 degrees | 120 degrees |
| No. of Scan Planes | 12 | 12 |
| FDA Limits | Track 1 | Track 1 |
| Product Safety Certification | IEC 60601-1:2005 +
CORR.1(2006) +
CORR.2(2007) | UL 60601 -1, 1st Edition
CAN/CSA-C22.2 No. 601.1
-M90, 2005 |
| Item | Proposed Device | Predicate Device |
| | IEC 60601-2-37:2007 | EN 60601-2-37 |
| EMC Compliance | IEC 60601-1-2 | EN 60601-1-2 |
| Patient
Contacting
Material | Plastic, PE (Skin Contact) | Plastic, PC (Skin Contact) |
| Range | - Bladder volume range:
0-999ml - Accuracy: ±15%, ±15ml | - Bladder volume range:
0-999ml - Accuracy: ±15%, ±15ml
(0-999ml) |
| Classification of
protection against
electric shock | - Class II equipment - Type B equipment | - Class II equipment
- Type BF equipment |
| Real-time
scanning | Yes (Pre-scan) | Yes (Pre-scan) |
| PC S/W function | Data Review
Data Printing | Data Review
Data Printing |
| PC Data Upload | Using USB flash disk | Using SD card |
| Power | AC/DC Adapter:
Input: AC100-240V,
50/60Hz,
Output: DC14V±0.5V
Battery: Li-ion rechargeable | AC/DC Adapter:
Input: AC 100-240V,
50-60Hz
Output: DC 9Vdc, 3A
Battery: Li-ion
rechargeable |
3
510(k) Summary
:
4
4
Caresono Technology Co., Ltd. believes that the PadScan HD series Bladder Scanner is substantially equivalent to the CUBEscan BioCon-700 of Mcube Technology Co., Ltd.
11.Safety, EMC and Performance Data:
Safety:
Electrical, mechanical, environmental safety and performance data demonstrates that the device is in compliance with IEC 60601-1:2005 and IEC 60601-2-37:2007.
EMC:
Electromagnetic Compatibility data demonstrates that the device is in compliance with IEC 60601-1-2:2007. Performance:
5
K131227
Page 6 of 6
The PadScan HD series Bladder Scanner have 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.
Biocompatibility:
The Biocompatibility testing conducted in according with standard Biocompatibility ISO 10993-5:2009 and ISO 10993-10:2010.
12. Conclusion:
The PadScan HD series Bladder Scanner was evaluated with safety (IEC 60601-1:2005 and IEC 60601-2-37:2007), EMC (IEC 60601-1-2:2007), Biocompatibility (ISO 10993-1:2010, ISO 10993-5:2009, ાડવ 10993-10:2010) and Acoustic Output (NEMA UD2:2004).
The conclusions drawn from testing of the PadScan HD series Bladder Scanner demonstrate that the device is as safe and effective as the legally marketed predicate devices.
6
Image /page/6/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2013
Caresono Technology Co., Ltd. % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062
Re: K131227
Trade/Device Name: PadScan HD series Bladder Scanner, Models: PadScan HD S and PadScan HD 3 Regulation Number: 21 CFR 892.1560 . Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: June 17, 2013 Received: June 21, 2013
Dear Mr. Devine:
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
7
Page 2 - Mr. Devine
forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDK regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safets/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 Small Manufacturers. International and Consumer Assistance 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.hun.
Sincerely yours,
Sm-h-p)
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
8
Indications for Use
510(k) Number (if known): K131227
Device Name: PadScan HD series Bladder Scanner
Indications for Use:
The PadScan HD series Bladder Scanner is B-mode pulsed-echo ultrasound device. It is 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 Pad Scan HD series Bladder Scanner is intended to be used only by qualified medical professionals.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K131227
Page 1 of _ 3
9
Diagnostic Ultrasound Indications for Use Form
System: PadScan HD 3 Bladder Scanner
- Transducer: N2
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | ||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| (Track 1 Only) | (Track 1 & 3) | |||||||
| Ophthalmic | Ophthaimic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| 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
Page 2 of ____________________________________________________________________________________________________________________________________________________________________
.
.
Indications for Use
·
10
Diagnostic Ultrasound Indications for Use Form
System: PadScan HD 5 Bladder Scanner
Transducer: N2
Intended Use: Diagnostic ultrasound imaging or fluid flow anaiysis 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 | Ophthaimic | |||||||
| 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 Pediatric | ||||||||
| Cardiac | 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
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K131227
Page 3 of 3
Indications for Use