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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the CUBEScan BioCon-1100, a medical device for non-invasive bladder volume measurement. It clarifies that no clinical studies were required or performed to support substantial equivalence for this specific submission (K201995). The changes in this submission relate to the operating system, graphical user interfaces, rolling cart dimensions, and IPX rating, which were deemed not to affect device performance or indications for use.

Therefore, many of the typical acceptance criteria and study details for an AI/ML device (like those related to ground truth, expert consensus, MRMC studies, effect sizes, etc.) are not applicable to this submission, as it is for a traditional ultrasound device with minor technical updates, not an AI/ML product.

Based on the provided text, here's what can be extracted:

Acceptance Criteria and Device Performance (Not applicable for AI/ML performance, but for general device safety and effectiveness)

The document primarily states that the specific changes (Linux OS, GUIs, cart dimensions, IPX rating) "do not affect the device performance characteristics and does not change the device Indication for use." The underlying performance relates to accuracy of urine volume measurement, which is inherent to this type of device.

Acceptance Criteria	Reported Device Performance
Device Intent Met	The CUBEScan BioCon-1100 is "as safe, as effective, and performance is substantially equivalent to the predicative devices." The changes "do not affect the device performance characteristics and does not change the device Indication for use."
Acoustic Output Conformance	The device has been evaluated for acoustic output and found to conform to applicable medical device safety standards and guidance documents.
Biocompatibility Conformance	The device has been evaluated for biocompatibility and found to conform to applicable medical device safety standards and guidance documents.
Thermal, Electrical, Electromagnetic, and Mechanical Safety Conformance	The device has been evaluated for thermal, electrical, electromagnetic, and mechanical safety and found to conform to applicable medical device safety standards and guidance documents.
IPX Rating	Changed to IPX 5 (specific performance not detailed beyond the rating itself).
Operating System	Changed to Linux (performance impact stated as none).
Graphical User Interfaces	Changed (performance impact stated as none).
Rolling Cart Dimensions	Height and width changed (performance impact stated as none).

Study Details (based on the provided 510(k) Summary)

Sample size used for the test set and the data provenance: Not applicable. The document explicitly states: "The subject of this premarket submission, CUBEScan BioCon-1100, did not require clinical studies to support substantial equivalence." The testing was non-clinical (acoustic, biocompatibility, electrical, thermal, electromagnetic, mechanical safety).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies were performed requiring independent ground truth establishment by experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical studies were performed.
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. This is not an AI/ML device, and no MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical studies were performed. For non-clinical testing, ground truth would refer to engineering specifications and compliance with standards.
The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Conclusion from the document:

The CUBEScan BioCon-1100, as described in K201995, is cleared based on demonstrating substantial equivalence to a predicate device (CUBEScan BioCon-1100, K200548) through non-clinical testing (acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety) and by asserting that the minor technical changes (OS, GUI, cart, IPX) do not alter the device's performance characteristics or indications for use. The document explicitly states that no clinical studies were required or performed for this submission. Therefore, information typically requested for AI/ML device studies (like expert adjudication, MRMC, training/test set details, ground truth methods) is not present because it's not relevant to this specific 510(k) clearance.

Summary

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August 19, 2020

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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

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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 KoreaPhone: +82 2 3421 7780Fax: +82 2 3421 7076E-mail: mcube@mcubetech.co.kr
Contact Person:	Hye-Ri ChoiAssist Manager, Regulatory AffairsPhone: +82 2 3421 7780E-mail: chr@mcubetech.co.kr
Alternative Contact Person:	Chang-Hyun KimManager, QMRE-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 SystemSecondary code: ITX, 892.1570, Diagnostic Ultrasonic Transducer
Classification Panel	Radiology

3) PREDICATE DEVICE

Predicate Devices:	CUBEScan BioCon-1100 (K200548, IYO, ITX)

4) DEVICE DESCRIPTION

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Measurement results can be transferred to a computer, and data can be managed using CubePro-1100.

5) INTENDED FOR USE/INDICATIONS FOR USE

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.

END of 510(k) Summary

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.