Who is the manufacturer of CUBESCAN / BIOCON-700?

Mcube Technology Co., Ltd. filed the 510(k) submission for CUBESCAN / BIOCON-700 (K111021).

What is the FDA product code for CUBESCAN / BIOCON-700?

ITX. It is classified under 21 CFR 892.1570 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for CUBESCAN / BIOCON-700?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CUBESCAN / BIOCON-700?

BladderScan® BVI 9400 (K071217); CUBEscan / BioCon-500 (K091518).

Who can help prepare an FDA 510(k) submission like CUBESCAN / BIOCON-700?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CUBESCAN / BIOCON-700

K111021 · Mcube Technology Co., Ltd. · ITX · Apr 27, 2011 · Radiology

Device Facts

Record ID	K111021
Device Name	CUBESCAN / BIOCON-700
Applicant	Mcube Technology Co., Ltd.
Product Code	ITX · Radiology
Decision Date	Apr 27, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1570
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended 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.

Device Story

Portable B-mode ultrasound system; measures urine volume non-invasively. Device projects ultrasonic energy through patient abdomen; receives echoed signals via 2.6MHz mechanical sector probe. System performs automated bladder outline detection and volume calculation across 12 B-mode planes (120-degree sector view). Includes 'Pre-scan' function for real-time visualization to assist user in probe positioning. Operated by qualified medical professionals in clinical settings. Results displayed on integrated LCD; printable via built-in thermal printer. Optional CubePro software allows data review and printing. Benefits include rapid, non-invasive bladder volume assessment, reducing need for catheterization.

Clinical Evidence

Bench testing only. Performance evaluated via safety (UL 60601-1, IEC 60601-2-37), EMC (IEC/EN 60601-1-2), biocompatibility (ISO 10993-1, -5, -10), and acoustic output (NEMA UD2) testing. All results satisfactory.

Technological Characteristics

Portable B-mode ultrasound; 2.6MHz mechanical sector probe; 12-plane scan; 120-degree sector angle. Power: battery or AC/DC adapter. Patient contact material: PC plastic. Connectivity: SD card for data transfer to PC. Software: IEC 62304 compliant. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for non-invasive measurement of urine volume in the bladder of non-pregnant patients by qualified medical professionals. Contraindicated for fetal use and use on pregnant patients.

Regulatory Classification

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.

Predicate Devices

BladderScan® BVI 9400 (K071217)
CUBEscan / BioCon-500 (K091518)

Related Devices

K091518 — CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM · Mcube Technology Co., Ltd. · Jun 18, 2009
K223448 — Bladder Scanner Model: BVT02 · Xuzhou Kaixin Electronic Instrument Co., Ltd. · Jul 7, 2023
K131227 — PADSCAN HD SERIES BLADDER SCANNER · Carenoso Technology Co., Ltd. · Jul 12, 2013
K130229 — PALM BLADDER SCANNER · Mianyang Meike Electronic Equipment Co., Ltd. · Mar 20, 2013
K143493 — SignosRT Bladder Ultrasound System · Signostics, Ltd. · Jan 14, 2015

Submission Summary (Full Text)

{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 1. 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 | - 2. Device: | Trade/proprietary name | : CUBEscan BioCon-700 | |------------------------|-------------------------------------------------| | Common Name | : Diagnostic Ultrasound System with Accessories | | Classification Name | : system, imaging, pulsed echo, ultrasonic | - 3. 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) | 4. Classifications Names & Citations: 21CFR 892.1560, 1570, ITX, system, imaging, pulsed echo, ultrasonic, Class2 {1}------------------------------------------------ - 5. 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. - 6. 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. - 7. 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 | 0~999: ±15%, ±15ml | 0~999: ±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.. - 8. 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. - 9. 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. - 10. 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {8}------------------------------------------------ ## 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 7-2