(24 days)
Not Found
No
The description focuses on standard ultrasound technology and signal processing to calculate bladder volume. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is used to non-invasively measure urine volume, which is a diagnostic function, not a therapeutic one. It provides images and data for calculation but does not treat a condition.
No
The device is described as a bladder volume measurement system, which gathers data for measurement rather than diagnosing a disease or condition. While it provides information to aid clinical decisions, its primary function is measurement, not diagnosis.
No
The device description explicitly states it consists of a probe and a console, which are hardware components. It is a B-mode ultrasound device, which inherently involves hardware for generating and receiving ultrasound waves.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the living body (in vitro).
- BioCon-1100 Function: The BioCon-1100 uses ultrasound to non-invasively measure the volume of urine within the bladder inside the patient's body. It does not analyze a sample taken from the body.
The BioCon-1100 is a medical device, specifically an ultrasound device, but it falls under a different regulatory category than IVDs.
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 and 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 (Contraindications for the BioCon-1100 are fetal use and use on pregnant patients, implying adult non-pregnant patients)
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.
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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March 27, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Mcube Technology Co., Ltd. % Mr. Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd. WARREN NJ 07059
Re: K200548
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: February 28, 2020 Received: March 3, 2020
Dear Mr. Yungvirt:
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200548
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 and 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
This summary of 510(k) safety and effectiveness information is being submitted 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, 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: | | Feb 15, 2020 |
2) SUBJECT DEVICE
| Trade/Proprietary Name: | CUBEScan TM 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-900 (K171591, 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. Measurement results can be transferred to a computer, and data can be managed using CubePro-1100.
5) INTENDED FOR USE/INDICATIONS FOR USE
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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 technological characteristics are substantially equivalent to that of the predicate.
The subject and the predicate devices are based on the following same technological elements:
- The material of patient contact -
- -Mode of operation:
- -Acoustic Output
The following technological differences exist between the CUBEScan™ BioCon-1100 and predicate devices.
- Transducer resonant frequency -
- -Measurement Accuracy
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.
The CUBEScan™ BioCon-1100 comply with the following standards:
- ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment, Part 1: General requirements for safety IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012)
- -IEC 60601-1-2: 2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests.
- IEC 60601-2-37:2007+A1:2015, Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasound medical diagnostic and monitoring equipment.
- AIUM/NEMA UD-2:2004, Acoustic Output Measurement Standard for Diagnostic -Ultrasound Equipment.
- ISO 10993-1 Biological Evaluation Of Medical Devices Part 1: Evaluation And Testing -Within A Risk Management Process [Including: Technical Corrigendum 1 (2010)]
- -ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
- ANSI AAMI IEC 62304:2006/A1:2016 Medical device software Software life cycle processes [Including Amendment 1 (2016)]
- IEC 60601-1-6:2013 Medical Electrical Equipment Part 1-6: General Requirements For -
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Basic Safety And Essential Performance - Collateral Standard: Usability
- ANSI AAMI IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to medical devices
- AAMI ANSI Human Factors Engineering - Design of medical devices -HE75 2009/(R)2013
The CUBEScan™ BioCon-1100 comply with the following guidance:
- Guidance for Industry and FDA Staff Marketing Clearance of Diagnostic Systems and -Transducers (June 27, 2019)
- -General Principles of Software Validation (Jan 11, 2002)
- Guidance for the Content and Premarket Submission for Software Contained in Medical -Devices (May 11, 2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, -(Oct 2, 2014)
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
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