(57 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 described as an ultrasound device used to obtain images of the bladder and calculate urine volume non-invasively for diagnostic purposes, not for treating any condition.
Yes
The device obtains images of the bladder to calculate urine volume, which is a measurement used for diagnostic purposes (e.g., assessing urinary retention or bladder function).
No
The device description explicitly states that the device consists of a probe and various components, including a hand-held, wireless, battery-operated probe with a 3D-mechanical sector transducer. This indicates the presence of significant hardware components, not just software.
Based on the provided information, the CUBEScan BioCon-900S is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The CUBEScan BioCon-900S uses ultrasound to non-invasively measure urine volume within the bladder inside the patient's body. It does not analyze a sample taken from the patient.
- The intended use and device description clearly state it's an ultrasound device for non-invasive measurement. There is no mention of analyzing biological samples or performing tests on specimens.
Therefore, the CUBEScan BioCon-900S falls under the category of a medical device, specifically an ultrasound device, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CUBEScan BioCon-900S is a B-mode pulsed-echo ultrasound device. The BioCon-900S 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-900S 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-900S are fetal use and use on pregnant patients.
Product codes
IYO, ITX
Device Description
CUBEScan BioCon-900S is a safe and easy, non-invasive system to measure the bladder volume. The device consists of a probe and various components. The probe is a B-mode instrument, which is hand-held, wireless and battery-operated. A 3D-mechanical sector transducer provides crosssectional images of the bladder from up to 12 scan planes which users can check through the screen and bladder volume is calculated based upon those images. In addition, the Pre-scan function allows users to easily locate the bladder before scanning, making measurement easier. CUBEScan BioCon-900S consists of a probe and CUBEscan Charger or a probe and CUBEScan Docking Station, with an optional mobile cart and a barcode module.
- CUBEScan Charger is used to recharge the probe's internal battery.
- CUBEScan Docking Station is used to recharge the probe's internal battery, transfer scan results to a PC which can run CubePro-900S (PC software for data processing), and print a scan results with installed thermal printer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
B-mode pulsed-echo ultrasound
Anatomical Site
lower abdomen of a patient (to obtain images of the 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
The subject of this premarket submission, CUBEScan BioCon-900S, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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May 19, 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Mcube Technology Co., Ltd. % Hye-Ri Choi RA Manager #803, 123, Bonghwasan-ro, Jungnang-gu, Seoul. 02048 REPUBLIC OF KOREA
Re: K200749
Trade/Device Name: CUBEScan BioCon-900S Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: March 20, 2020 Received: March 23, 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for 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) K200749
Device Name CUBEScan BioCon-900S
Indications for Use (Describe)
The CUBEScan BioCon-900S is a B-mode pulsed-echo ultrasound device. The BioCon-900S 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-900S 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-900S 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.
| 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: | |
| Alternative
Person: | Contact | Chang-Hyun Kim
Manager, QMR
E-mail: kch@mcubetech.co.kr |
| Date Prepared: | | March 20, 2020 |
1) APPLICANT INFORMATION
2) SUBJECT INFORMATION
| 2) SUBJECT INFORMATION | |
|---|---|
| Trade/Proprietary Name: | CUBEScan BioCon-900S |
| Common/Usual Name: | Bladder Scanner, Bladder volume Measurement System |
| Product Code/ | Main code: IYO, 892.1560, Ultrasonic Pulsed Echo Imaging System |
| Regulation Number/ | Secondary code: ITX, 892.1570, Diagnostic Ultrasonic Transducer |
| Classification Names | |
| Classification Panel | Radiology |
3) PREDICATE DEVICE
| Predicate Devices: | CUBEScan BioCon-900 (K171591, IYO, ITX) |
|---|
4) DEVICE DESCRIPTION
CUBEScan BioCon-900S is a safe and easy, non-invasive system to measure the bladder volume. The device consists of a probe and various components. The probe is a B-mode instrument, which is hand-held, wireless and battery-operated. A 3D-mechanical sector transducer provides crosssectional images of the bladder from up to 12 scan planes which users can check through the screen and bladder volume is calculated based upon those images. In addition, the Pre-scan function allows users to easily locate the bladder before scanning, making measurement easier. CUBEScan BioCon-900S consists of a probe and CUBEscan Charger or a probe and CUBEScan Docking Station, with an optional mobile cart and a barcode module.
- CUBEScan Charger is used to recharge the probe's internal battery. -
4
- -CUBEScan Docking Station is used to recharge the probe's internal battery, transfer scan results to a PC which can run CubePro-900S (PC software for data processing), and print a scan results with installed thermal printer.
5) INTENDED FOR USE/INDICATIONS FOR USE
The CUBEScan BioCon-900S is a B-mode pulsed-echo ultrasound device. The BioCon-900S 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-900S 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-900S are fetal use and use on pregnant patients.
6) COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological characteristics are substantially equivalent to the predicate device (K171591) based on the same indications for use, the same fundamental scientific technology.
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-900S comply with the following safety standards:
- ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 -ANSI and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- -IEC 60601-1-2: 2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - 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.
- -ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- -AIUM/NEMA UD-2:2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
- ANSI AAMI IEC 62304:2006/A1:2016 Medical device software Software life cycle processes [Including Amendment 1 (2016)]
- 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.
- -IEC 62359: 2017 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
- IEC 60825-1:2007 Safety of laser products Part 1 : Equipment classification and requirements
Miscellaneous Standards:
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- IEC 60601-1-6:2013 Medical Electrical Equipment Part 1-6: General Requirements For -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 HE75 Human Factors Engineering - Design of medical devices 2009/(R)2013
8) Summary of Clinical Tests
The subject of this premarket submission, CUBEScan BioCon-900S, 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-900S to be as safe, as effective, and performance is substantially equivalent to the predicative devices.
END of 510(k) Summary