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.

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.

AI/ML Overview

The PadScan HD series Bladder Scanner (Models: PadScan HD 5, PadScan HD 3) is a diagnostic ultrasound system designed for non-invasive bladder volume calculation.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Range)	Reported Device Performance (Accuracy)
Bladder volume: 0-999ml	±15%, ±15ml (0-999ml)

The device performance, with an accuracy of ±15% or ±15ml (within the 0-999ml range), meets its own specified acceptance criteria.

The provided document, a 510(k) summary for the PadScan HD series Bladder Scanner, focuses on demonstrating substantial equivalence to a predicate device (CUBEscan BioCon-700) and compliance with various safety and performance standards. While it outlines the device's accuracy specifications, it does not include a detailed study proving the device meets these acceptance criteria.

The document mentions "Performance: 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." This primarily relates to acoustic safety testing, not clinical accuracy in bladder volume measurement.

Therefore, many of the requested details about a clinical study demonstrating the device's accuracy are not available in the provided text.

Based on the provided document, the following information is not available:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No information on a specific clinical test set for accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable as no specific clinical test is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is an ultrasound device for volume calculation, not an AI-assisted diagnostic imaging interpretation system.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done: The device calculates bladder volume automatically, implying a standalone algorithmic performance. However, there is no detailed study methodology provided to confirm this or elaborate on its performance without human interaction within a clinical validation context. The document refers to "Expert operating mode and Easy operating mode," which suggests human interaction is part of its intended use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned for any accuracy testing.
The sample size for the training set: Not applicable, as no details of an AI/machine learning model training are provided.
How the ground truth for the training set was established: Not applicable.

Summary

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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)

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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:

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

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,

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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 BladderScanner	CUBEscan BioCon-700
Model	PadScan HD 5, PadScanHD 3	BioCon-700
510(K) Submitter	Caresono Technology Co.,Ltd.	Mcube Technology Co.,Ltd.
510(K) Number	--	K111021
ClassificationsName & Citations	21 CFR 892.1560 UltrasonicPulsed Echo ImagingSystem (90-IYO)21 CFR 892.1570Diagnostic UltrasonicTransducer (90-ITX)	21 CFR 892.1560Ultrasonic Pulsed EchoImaging System (90-IYO)21 CFR 892.1570Diagnostic UltrasonicTransducer (90-ITX)
Indications forUse	The PadScan HD seriesBladder Scanner is B-modepulsed-echo ultrasounddevice. It intended as aportable battery-operateddevice. The PadScan HDseries Bladder Scannerprojects ultrasound energythrough the lower abdomenof the patient to obtainimages of the bladder whichis used to calculate bladdervolume noninvasively. ThePadScan HD series BladderScanner is intended to beused only by qualifiedmedical professionals.	The BioCon-700 is aB-mode pulsed-echoultrasound device. TheBioCon-700 is intended asa portable battery-operateddevice. The BioCon-700projects ultrasonic energythrough the abdomen of thepatient obtaining images ofthe bladder in order tocalculate the urine volumenon-invasively BioCon-700is intended to be used by aqualified medicalprofessional.Contraindications for theBioCon-700 are fetal useand use on pregnantpatients.
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-LCDPadScan 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 EditionCAN/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
PatientContactingMaterial	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 ofprotection againstelectric shock	- Class II equipment- Type B equipment	- Class II equipment- Type BF equipment
Real-timescanning	Yes (Pre-scan)	Yes (Pre-scan)
PC S/W function	Data ReviewData Printing	Data ReviewData Printing
PC Data Upload	Using USB flash disk	Using SD card
Power	AC/DC Adapter:Input: AC100-240V,50/60Hz,Output: DC14V±0.5VBattery: Li-ion rechargeable	AC/DC Adapter:Input: AC 100-240V,50-60HzOutput: DC 9Vdc, 3ABattery: Li-ionrechargeable

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510(k) Summary

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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:

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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.

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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

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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

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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

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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	ColorDoppler	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)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N=new indication; P= previously cleared by FDA; E=added under this appendix

Page 2 of ____________________________________________________________________________________________________________________________________________________________________

Indications for Use

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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	ColorDoppler	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)
PeripheralVessel	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

Regulation Number and Section

§ 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.