(30 days)
Not Found
No
The description focuses on standard ultrasound technology and image processing for volume calculation, with no mention of AI or ML algorithms.
No.
The device is used to obtain images and measure urine volume, which are diagnostic functions, not therapeutic.
Yes
The device obtains images of the bladder and measures urine volume, which provides information about a patient's medical condition (urine volume in the bladder) without being explicitly described as for diagnosis.
No
The device description explicitly states it consists of a probe and a console, which are hardware components that send, receive, and process ultrasonic signals.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- BioCon-1100 function: The CUBEScan BioCon-1100 is an ultrasound device that uses non-invasive imaging of the bladder within the patient's body to measure urine volume. It does not analyze a specimen taken from the patient.
Therefore, based on the provided information, the CUBEScan BioCon-1100 falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CUBEScan BioCon-1100 is a B-mode pulsed-echo ultrasound device. The BioCon-1100 projects ultrasonic energy through the lower abdomen of a patient to obtain images of the bladder to calculate the urine volume non-invasively. The BioCon-1100 is intended to be used by a qualified medical professional in hospitals and other healthcare facilities to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-1100 are fetal use on pregnant patients.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The CUBEScan BioCon-1100 (Bladder volume measurement system) is a safe, easy to use, noninvasive system for measuring bladder volume (residual volume). The CUBEScan BioCon-1100 is a B-mode ultrasound device, which consists of a probe that sends and receives ultrasonic waves, and a console that processes ultrasonic signals and converts them into the desired data. The 3Dmechanical sector transducer take the bladder in 12 sections and calculate the volume of the bladder based on the images which appear on the LCD screen. In addition, the pre-scan function allows users to easily locate the location of the bladder before scanning, making measurement easier. Measurement results can be transferred to a computer, and data can be managed using CubePro-1100.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
B-mode pulsed-echo ultrasound
Anatomical Site
lower abdomen / bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical professional in hospitals and other healthcare facilities
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 subject of this premarket submission, CUBEScan BioCon-1100, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
CUBEScan BioCon-1100 (K200548, IYO, ITX)
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.
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August 19, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Mcube Technology Co., Ltd. % Hye-Ri Choi RA Manager #803, 123, Bonghwasan-ro, Jungnang-gu Seoul. 02048 REPUBLIC OF KOREA
Re: K201995
Trade/Device Name: CUBEScan BioCon-1100 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: July 17, 2020 Received: July 20, 2020
Dear Hye-Ri Choi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201995
Device Name CUBEScan BioCon-1100
Indications for Use (Describe)
The CUBEScan BioCon-1100 is a B-mode pulsed-echo ultrasound device. The BioCon-1100 projects ultrasonic energy through the lower abdomen of a patient to obtain images of the bladder to calculate the urine volume non-invasively. The BioCon-1100 is intended to be used by a qualified medical professional in hospitals and other healthcare facilities to noninvasively measure the urine volume in the bladder. Contraindications for the BioCon-1100 are fetal use on pregnant patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K201995
The following summary of information is provided in accordance with requirements of 21 CFR 807.92.
1) SUBMITTER
| 510(k)
(Manufacturer) | Owner: Mcube Technology Co., Ltd.
#803, 123 Bonghwasan-ro, Jungnang-gu, Seoul, 02048 Korea
Phone: +82 2 3421 7780
Fax: +82 2 3421 7076
E-mail: mcube@mcubetech.co.kr |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hye-Ri Choi
Assist Manager, Regulatory Affairs
Phone: +82 2 3421 7780
E-mail: chr@mcubetech.co.kr |
| Alternative Contact Person: | Chang-Hyun Kim
Manager, QMR
E-mail: kch@mcubetech.co.kr |
| Date Prepared: | July 17, 2020 |
2) SUBJECT DEVICE
| Trade/Proprietary Name: | CUBEScan BioCon-1100 |
|---|---|
| Common/Usual Name: | Bladder Scanner, Bladder volume Measurement System |
| Product Code/ | |
| Regulation Number/ | |
| Classification Names | Main code: IYO, 892.1560, Ultrasonic Pulsed Echo Imaging System |
| Secondary code: ITX, 892.1570, Diagnostic Ultrasonic Transducer | |
| Classification Panel | Radiology |
3) PREDICATE DEVICE
| Predicate Devices: | CUBEScan BioCon-1100 (K200548, IYO, ITX) |
|---|
4) DEVICE DESCRIPTION
The CUBEScan BioCon-1100 (Bladder volume measurement system) is a safe, easy to use, noninvasive system for measuring bladder volume (residual volume). The CUBEScan BioCon-1100 is a B-mode ultrasound device, which consists of a probe that sends and receives ultrasonic waves, and a console that processes ultrasonic signals and converts them into the desired data. The 3Dmechanical sector transducer take the bladder in 12 sections and calculate the volume of the bladder based on the images which appear on the LCD screen. In addition, the pre-scan function allows users to easily locate the location of the bladder before scanning, making measurement easier.
4
Measurement results can be transferred to a computer, and data can be managed using CubePro-1100.
5) INTENDED FOR USE/INDICATIONS FOR USE
The CUBEScan BioCon-1100 is a B-mode pulsed-echo ultrasound device. The BioCon-1100 projects ultrasonic energy through the lower abdomen of a patient to obtain images of the bladder to calculate the urine volume non-invasively. The BioCon-1100 is intended to be used by a qualified medical professional in hospitals and other healthcare facilities to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-1100 are fetal use and use on pregnant patients.
6) COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technical characteristics in the new device is the same as that of the predicate device and the differences from the predicate device are as below;
-
Change of operating system (Linux) of console
-
Change of graphical user interfaces (GUIs) of console
-
Change of graphical user interfaces(GUIs) of CubePro (PC Program)
-
Change of height and width of rolling cart (MRC-1100).
-
Change of IPX degree
7) Summary of Non-Clinical Testing Performed
The device has been evaluated for acoustic output, biocompatibility as well as thermal, electrical, electromagnetic and mechanical safety and have been found to conform to applicable medical device safety standards and guidance documents.
8) Summary of Clinical Tests
The subject of this premarket submission, CUBEScan BioCon-1100, did not require clinical studies to support substantial equivalence.
9) Conclusions
The new addition of Linux Operating System and change the liquid safety level to IPX 5 do not affect the device performance characteristics and does not change the device Indication for use. 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 CUBEScan BioCon-1100 to be as safe, as effective, and performance is substantially equivalent to the predicative devices.