CUBESCAN / BIOCON-700 by MCUBE TECHNOLOGY CO., LTD.

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 to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-700 are fetal use and use on pregnant patients.

Device Description

The BioCon-700 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-700 transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines.

BioCon-700 has a Pre-scan function, which shows the ultrasound images for a horizontal plane consisted of the echoed signals. The Pre-scan function helps a user locate the bladder easily and get more accurate results.

A user can print the results using a build-in thermal printer after measurements right away. Also using the optional CubePro software, a user can review the scan results.

AI/ML Overview

The provided 510(k) summary only includes acceptance criteria for the CUBEscan BioCon-700 Diagnostic Ultrasound System. It references the fulfillment of these criteria through various tests but does not provide a detailed study or its results proving the device meets these criteria. Instead, it relies on substantial equivalence to predicate devices and adherence to regulatory standards.

Here's the information extracted and organized as requested, with explicit notes about what is not present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria (from Predicate Device/Stated)	Reported Device Performance (CUBEscan BioCon-700)
Accuracy	0~999: ±15%, ±15ml	0~999: ±15%, ±15ml
Acoustic Output	Maximum ultrasound Ispta during a scan: ≤1.0 mW/cm²	≤1.0 mW/cm²
	Maximum ultrasound Isppa during a scan: ≤10.0 W/cm²	≤10.0 W/cm²
	Maximum MI: 0.90 max	0.90 max
FDA Limits	Track 1	Track 1
Product Safety Certification	UL 60601-1, 1st EditionCAN/CSA-C22.2 No. 601.1-M90, 2005EN 60601-2-37	UL 60601-1, 1st EditionCAN/CSA-C22.2 No. 601.1-M90, 2005EN 60601-2-37
EMC Compliance	EN 60601-1-2	EN 60601-1-2
Biocompatibility	ISO10993-1, ISO 10993-5 and ISO 10993-10	(Implicitly met by testing, details not provided)
Software	IEC 62304	(Implicitly met by testing, details not provided)

Note: The document states that "All test results were satisfactory" for safety, EMC, and performance, implying these criteria were met, but it does not provide the raw data or detailed performance outcomes of these tests. The "Reported Device Performance" column reflects the criteria it is stated to align with or achieve, rather than specific numerical results from a performance study.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided document. The document refers to "performance testing" but does not detail the methodology or sample size of any patient study for accuracy.
Data Provenance: Not specified. It is unclear if any clinical data was used for testing, or if validation was purely technical. If clinical data was used, its origin (e.g., country, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Specified: The document does not describe a study involving expert-established ground truth for the device's performance (e.g., measuring urine volume). The approval is based on substantial equivalence to predicate devices and adherence to engineering and safety standards.

4. Adjudication method for the test set

Not Applicable / Not Specified: As no study involving expert interpretation or "ground truth" establishment is detailed, there is no mention of an adjudication method.

5. 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

No: The device is a diagnostic ultrasound system for automated urine volume calculation, not an AI-assisted diagnostic tool that would typically involve human reader performance comparisons. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not described or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes (Implicitly): The device's primary function is to automatically calculate urine volume. The "Accuracy" specification (0~999: ±15%, ±15ml) is a standalone performance metric for the algorithm's output. While a human initiates the scan and locates the bladder using the pre-scan function, the final volume calculation is performed by the device's algorithm. The document mentions "performance testing" was conducted, and the stated accuracy is a direct measure of this standalone performance. However, the details of the study proving this accuracy are not provided.

7. The type of ground truth used

Not explicitly stated for the accuracy claim: For a device measuring urine volume, the ground truth would typically be actual urine volume obtained via catheterization or another highly accurate measurement method. However, the document does not describe the specific ground truth method used to validate the stated ±15%, ±15ml accuracy.

8. The sample size for the training set

Not Applicable / Not Specified: This document is a 510(k) summary for a medical device that calculates bladder volume based on ultrasound images; it does not explicitly describe an AI/machine learning model that would require a distinct "training set." The algorithm's development (if it involved data-driven methods) and any associated training data are not disclosed.

9. How the ground truth for the training set was established

Not Applicable / Not Specified: As no training set is discussed, the method for establishing its ground truth is also not mentioned.

Summary

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510(k) Summary

APR 2 7 2011

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Data: Dec. 20, 2010

Company and Correspondent making the submission:

Name	: Mcube Technology Co., Ltd.
Address	: #803, Shinnae-technotown, 485 Sangbong-DongChungnang-Ku, Seoul, Korea 131-220
Telephone	: +82-2-3421-7780
Fax	: +82-2-3421-7076
Contact	: Mr. Seungtai Kim
Internet	: http://www.mcubetech.co.kr

1. Device:

Trade/proprietary name	: CUBEscan BioCon-700
Common Name	: Diagnostic Ultrasound System with Accessories
Classification Name	: system, imaging, pulsed echo, ultrasonic

1. Predicative Device:

Manufacturer	: Verathon Inc.
Device	: BladderScan® BVI 9400
510(k) Number	: K071217(Decision Date – May 17, 2007)
Manufacturer	: Mcube Technology
Device	: CUBEscan / BioCon-500
510(k) Number	: K091518(Decision Date - June 18, 2009)

Classifications Names & Citations:

21CFR 892.1560, 1570, ITX, system, imaging, pulsed echo, ultrasonic, Class2

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1. Description:
  The BioCon-700 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-700 transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines.

A user can print the results using a build-in thermal printer after measurements right away. Also using the optional CubePro software, a user can review the scan results.

1. Indications for use:
  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 to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-700 are fetal use and use on pregnant patients.
1. Compatible with predicative device:
  The BioCon-700 uses 2.6MHz mechanical sector probe. When a user initiates the scan the device rotates the ultrasound transducer, gets 12-plane B-mode images with 120 degrees sector view automatically and calculates bladder volume from the planes images. After the completion of the measurement the result is displayed on the LCD screen.

In the same manner predicative devices do take the same procedures when a user measures the bladder volume. The ultrasound power transmitted from the device is not user adjustable, and BioCon-700 is a Track 1 System and meets the FDA's pre-amendment acoustic output limits. So as the predicative devices are. Although there are some differences such as resonant frequency, acoustic power, power source and PC update, there is no significant differences in technological characteristics that affecting the safety and efficiency. These are evaluated by safety test and acoustic output test.

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ﺧ

	ProposedCUBEscan BioCon-700Mcube Technology Co.,Ltd.	PredicateCUBEscan BioCon-500Mcube Technology Co.,Ltd.	PredicateBladderScan® BVI 9400Verathon, Inc.
Feature
FDA 510(k)Number		K053325	K071217
Indication forUse	The BioCon-700 is a B-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 to non-invasively measure theurine volume in the bladder.Contraindications for theBioCon-700 are fetal useand use on pregnantpatients.	The BioCon-500TM is a B-mode pulsed-echoultrasound device. TheBioCon-500TM is intendedas a portable battery-operated device. TheBioCon-500TM is intended toproject ultrasound energythrough the abdomen of thepatient to obtain images ofthe bladder and to calculatethe urine volume non-invasively using theseimages. The BioCon-500TMis intended to be used onlyby qualified medicalprofessionals.Contraindications for theBioCon-500TM are fetal useand use on pregnantpatients.	The BladderScan BVI9400 is intended toproject ultrasound energythrough the lowerabdomen of the non-pregnant patient to obtainan image of the bladderthat is used to determinebladder volumenoninvasively. TheBladderScan BVI 9400 iscontraindicated for fetaluse and for use onpregnant patients.
Deviceclassificationname	System, Imaging, PulsedEcho, Ultrasonic	System, Imaging, PulsedEcho, Ultrasonic	System, Imaging, PulsedEcho, Ultrasonic
Modes ofoperation	B mode	B mode	B mode
SystemCharacteristics	- Portable- LCD Display & ControlButton- Thermal Printer- Power source: Battery-operated or AD-DC adapteroperated	- Portable- LCD Display & ControlButton- Thermal Printer- Power source: Battery-operated	- Portable- LCD Display & ControlButton- Thermal Printer- Power source: Battery-operated
Controls forchange ofacousticoutputduring scan	No	No	No
TransducerType	Mechanical Sector Probe	Mechanical Sector Probe	Mechanical Sector Probe
Transducer	2.6 MHz	2.8 MHz	3.0 / 1.74 MHz
Feature	ProposedCUBEscan BioCon-700Mcube Technology Co.,Ltd.	PredicateCUBEscan BioCon-500Mcube Technology Co.,Ltd.	PredicateBladderScan® BVI 9400Verathon, Inc.
FDA 510(k)Number	-	K053325	K071217
ResonantFrequency
Number ofelements	1	1	1
TransducerDiameter	10mm	14mm	13 mm
Sector Angle	120 degrees	120 degrees	120 degrees
AcousticOutput	- Maximum ultrasound Isptaduring a scan: ≤1.0mW/cm²- Maximum ultrasound Isppa,during a scan: ≤10.0 W/cm²- Maximum MI: 0.90 max	- Maximum ultrasound Isptaduring a scan: ≤1.0mW/cm²- Maximum ultrasound Isppa,during a scan: ≤10.0 W/cm²- Maximum MI: 0.90 max	- Maximum ultrasoundIspta during a scan: ≤5.0mW/cm²- Maximum ultrasoundIsppa during a scan: ≤60.0W/cm²- Maximum MI: 0.95 max
No of ScanPlanes	12	12	12
FDA Limits	Track 1	Track 1	Track 1
ProductSafetyCertification	UL 60601-1, 1st EditionCAN/CSA-C22.2 No. 601.1-M90, 2005EN 60601-2-37	UL 60601-1, 1st EditionCAN/CSA-C22.2 No. 601.1-M90, 2005EN 60601-2-37	EN/IEC 60601-1EN/IEC 60601-2-37C22.2 No. 601.1-M90UL 60601-1
EMCCompliance	EN 60601-1-2	EN 60601-1-2	EN/IEC 60601-1-2
PatientContactMaterial	Plastic, PC (Model: HP1)(Skin Contact)	Plastic, PC (Model: HP1)(Skin Contact)	Plastic, Not Known(Skin Contact)
Accuracy	0~999: ±15%, ±15ml	0~999: ±15%, ±15ml	0~999: ±15%, ±15ml
MarketingHistory	Asia, Europe, AustraliaMore than 50 devices	Asia, Europe, AustraliaMore than 500 devices	Asia, Europe, Australia,North America, SouthAmericaMore than 300 devices
Real-timescanning	Yes (Pre-scan)	Yes (Pre-scan)	No
PC Software	YesCubePro	YesCubeScanPC	YesScanPoint
PC S/Wfunction	Data ReviewData Printing	Data UploadData Review	Data UploadData Review
Feature	ProposedCUBEscan BioCon-700Mcube Technology Co.,Ltd.	PredicateCUBEscan BioCon-500Mcube Technology Co.,Ltd.	PredicateBladderScan® BVI 9400Verathon, Inc.
FDA 510(k)Number	-	K053325	K071217
	Data Printing	Data Printing	Data Printing
PC DataUpload	Using SD card	Using USB	BV19400 tocommunication cradle:wirelessCommunication cradle toPC: USB
Accessories	Medical cartBattery pack	Medical cartBattery pack	Medical cartBattery pack

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Mcube Technology Co., Ltd., believes that the BioCon-700 is substantially equivalent to the BVI 9400 of Verathon Incorporated and Model BioCon-500 of Mcube Technology Co., Ltd..

1. Safety, EMC and Performance Data:
  Electrical, mechanical, environmental safety and performance testing according to standard UL 60601-1 and IEC 60601-2-37 was performed, and EMC testing was conducted in accordance with standard IEC/EN 60601-1-2. All test results were satisfactory.
1. Conclusions:
  The BioCon-700 was evaluated with safety (UL 60601-1 and IEC 60601-2-37), EMC (IEC/EN 60601-1-2), Biocompatibility (ISO10993-1, ISO 10993-5 and ISO 10993-10), Software (IEC 62304) and Acoustic Output (NEMA UD2).

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Mcube Technology Co., Ltd. concludes that The BioCon-700 is safe and effective and substantially equivalent to predicative devices as described herein.

1. Mcube Technology Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
  END

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mcube Technology Co., Ltd. % Mr. Marc M. Mouser Engineering Leader & FDA Office Coordinator, Program Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607

APR 2 7 2011

Re: K111021

Trade/Device Name: CUBEscan BioCon-700 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: March 28, 2011 Received: April 12, 2011

Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the CUBEscan BioCon-700 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

BioCon-700 Transducer

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), " it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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); good manufacturing practice requirements as set 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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.

If you have any questions regarding the content of this letter, please contact Paul Hardy at (301) 796-6542.

Sincerely Yours,

May Scotts

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Indications for Use

510(k) Number (if known):

Device Name: Diagnostic Ultrasound System and Accessories / CUBEscan BioCon-700

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Sistas

(Division Sig-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

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Diagnostic Ultrasound Indications For Use Form

CUBEscan BioCon-700 Diagnostic Ultrasound System System: Transducer: BioCon-700 Transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethreal
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (Bladder)	B

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

Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Prescription Use (Per 21 CFR 801.109)

Mery S/att
(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro

510K K111021

7-2

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.