Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard ultrasound technology and image processing for bladder outline detection and volume calculation, without mentioning AI or ML algorithms.

Therapeutic

No
Explanation: The device is used to measure urine volume by acquiring images, which is diagnostic and provides information, but does not administer therapy.

Diagnostic

Yes

The device obtains images of the bladder to calculate urine volume and detects bladder outlines, which are diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "B-mode pulsed-echo ultrasound device" and a "portable ultrasound system" that "transmits ultrasound signals" and "receives the echoed signals." This indicates the presence of hardware components necessary for generating and receiving ultrasound waves, which are not software-only functions. The mention of electrical, mechanical, and environmental safety testing further supports the existence of hardware.

IVD (In Vitro Diagnostic)

No, the BioCon-700 is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body. This typically involves testing blood, urine, tissue, or other bodily fluids outside of the body to provide information about a patient's health.
The BioCon-700 is an ultrasound device that operates in vivo (within the living body). It projects ultrasonic energy through the abdomen to image the bladder and calculate urine volume non-invasively. It does not analyze any bodily specimens.

The description clearly states its function is to use ultrasound to image and measure the bladder within the patient's body. This falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

IYO, ITX

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

B-mode pulsed-echo ultrasound

Anatomical Site

Abdomen (bladder)

Indicated Patient Age Range

Not Found. Contraindications for the BioCon-700 are fetal use and use on pregnant patients.

Intended User / Care Setting

Qualified medical professional / Not Found

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy: 0~999: ±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.

K071217(Decision Date – May 17, 2007), K091518(Decision Date - June 18, 2009)

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

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.

Summary

0

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-Dong
Chungnang-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

1

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.

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.

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.

2

ﺧ

-.

| | Proposed
CUBEscan BioCon-700
Mcube Technology Co.,
Ltd. | Predicate
CUBEscan BioCon-500
Mcube Technology Co.,
Ltd. | Predicate
BladderScan® BVI 9400
Verathon, Inc. |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | | |
| FDA 510(k)
Number | | K053325 | K071217 |
| Indication 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. | The BioCon-500TM is a B-
mode pulsed-echo
ultrasound device. The
BioCon-500TM is intended
as a portable battery-
operated device. The
BioCon-500TM is intended to
project ultrasound energy
through the abdomen of the
patient to obtain images of
the bladder and to calculate
the urine volume non-
invasively using these
images. The BioCon-500TM
is intended to be used only
by qualified medical
professionals.
Contraindications for the
BioCon-500TM are fetal use
and use on pregnant
patients. | The BladderScan BVI
9400 is intended to
project ultrasound energy
through the lower
abdomen of the non-
pregnant patient to obtain
an image of the bladder
that is used to determine
bladder volume
noninvasively. The
BladderScan BVI 9400 is
contraindicated for fetal
use and for use on
pregnant patients. |
| Device
classification
name | System, Imaging, Pulsed
Echo, Ultrasonic | System, Imaging, Pulsed
Echo, Ultrasonic | System, Imaging, Pulsed
Echo, Ultrasonic |
| Modes of
operation | B mode | B mode | B mode |
| System
Characteristi
cs | - Portable

LCD Display & Control
Button
Thermal Printer
Power source: Battery-
operated or AD-DC adapter
operated | - Portable
LCD Display & Control
Button
Thermal Printer
Power source: Battery-
operated | - Portable
LCD Display & Control
Button
Thermal Printer
Power source: Battery-
operated |
| Controls for
change of
acoustic
output
during scan | No | No | No |
| Transducer
Type | Mechanical Sector Probe | Mechanical Sector Probe | Mechanical Sector Probe |
| Transducer | 2.6 MHz | 2.8 MHz | 3.0 / 1.74 MHz |
| Feature | Proposed
CUBEscan BioCon-700
Mcube Technology Co.,
Ltd. | Predicate
CUBEscan BioCon-500
Mcube Technology Co.,
Ltd. | Predicate
BladderScan® BVI 9400
Verathon, Inc. |
| FDA 510(k)
Number | - | K053325 | K071217 |
| Resonant
Frequency | | | |
| Number of
elements | 1 | 1 | 1 |
| Transducer
Diameter | 10mm | 14mm | 13 mm |
| Sector Angle | 120 degrees | 120 degrees | 120 degrees |
| Acoustic
Output | - Maximum ultrasound Ispta
during a scan: ≤1.0
mW/cm²
Maximum ultrasound Isppa,
during a scan: ≤10.0 W/cm²
Maximum MI: 0.90 max | - Maximum ultrasound Ispta
during a scan: ≤1.0
mW/cm²
Maximum ultrasound Isppa,
during a scan: ≤10.0 W/cm²
Maximum MI: 0.90 max | - Maximum ultrasound
Ispta during a scan: ≤5.0
mW/cm²
Maximum ultrasound
Isppa during a scan: ≤60.0
W/cm²
Maximum MI: 0.95 max |
| No of Scan
Planes | 12 | 12 | 12 |
| FDA Limits | Track 1 | Track 1 | Track 1 |
| Product
Safety
Certification | UL 60601-1, 1st Edition
CAN/CSA-C22.2 No. 601.1-
M90, 2005
EN 60601-2-37 | UL 60601-1, 1st Edition
CAN/CSA-C22.2 No. 601.1-
M90, 2005
EN 60601-2-37 | EN/IEC 60601-1
EN/IEC 60601-2-37
C22.2 No. 601.1-M90
UL 60601-1 |
| EMC
Compliance | EN 60601-1-2 | EN 60601-1-2 | EN/IEC 60601-1-2 |
| Patient
Contact
Material | Plastic, PC (Model: HP1)
(Skin Contact) | Plastic, PC (Model: HP1)
(Skin Contact) | Plastic, Not Known
(Skin Contact) |
| Accuracy | 0999: ±15%, ±15ml | 0999: ±15%, ±15ml | 0~999: ±15%, ±15ml |
| Marketing
History | Asia, Europe, Australia
More than 50 devices | Asia, Europe, Australia
More than 500 devices | Asia, Europe, Australia,
North America, South
America
More than 300 devices |
| Real-time
scanning | Yes (Pre-scan) | Yes (Pre-scan) | No |
| PC Software | Yes
CubePro | Yes
CubeScanPC | Yes
ScanPoint |
| PC S/W
function | Data Review
Data Printing | Data Upload
Data Review | Data Upload
Data Review |
| Feature | Proposed
CUBEscan BioCon-700
Mcube Technology Co.,
Ltd. | Predicate
CUBEscan BioCon-500
Mcube Technology Co.,
Ltd. | Predicate
BladderScan® BVI 9400
Verathon, Inc. |
| FDA 510(k)
Number | - | K053325 | K071217 |
| | Data Printing | Data Printing | Data Printing |
| PC Data
Upload | Using SD card | Using USB | BV19400 to
communication cradle:
wireless
Communication cradle to
PC: USB |
| Accessories | Medical cart
Battery pack | Medical cart
Battery pack | Medical cart
Battery pack |

3

,"人

"

4

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

5

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple, yet recognizable, representing the HHS's role in promoting the health and well-being of the nation.

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.

6

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)

7

Indications for Use

510(k) Number (if known):

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

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.

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

. . 出

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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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& 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)
Peripheral
Vessel	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

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