BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)

{0}------------------------------------------------ Image /page/0/Picture/0 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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom. June 10, 2024 MacroLux Medical Technology Co., Ltd. Linbin Ye Person Responsible for Regulatory Compliance 301, Building 3, NamTai Inno Park In Guang Ming Avenue Guangming Shenzhen, Guangdong CHINA Re: K240283 > Trade/Device Name: BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Received: May 14, 2024 Dear Linbin Ye: 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 {2}------------------------------------------------ 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, Mark R. Kreitz -S for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K240283 Device Name BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) Indications for Use (Describe) The BubbleView™ Single-Use Digital Flexible Cystoscope is a sterile, single-use, flexible endoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The BubbleView™ is intended to provide visualization via ViewHub® video processor and can be used with endoscopic accessories. BubbleView™ is intended for use in a hospital environment or medical office environment. BubbleView™ is designed for use in adults. ViewHub® is designed to display live imaging data from compatible MACROLUX™ endoscopes. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ | 510(k) #: K240283 | K240283 | |-------------------|-------------------------------------------------| | | 510(k) SummaryPage 1of 2Prepared on: 2024-06-04 | Contact Details | Applicant Name | MacroLux Medical Technology Co., Ltd. | 21 CFR 807.92(a)(1) | |-----------------------------|----------------------------------------------------------------------------------------------------|---------------------| | Applicant Address | 301, Building 3, NamTai Inno Park In Guang Ming Avenue Guangming Shenzhen Guangdong Shenzhen China | | | Applicant Contact Telephone | +8613430891962 | | | Applicant Contact | Mr. Linbin Ye | | | Applicant Contact Email | yelinbin@microlite.cn | | Device Name | | 21 CFR 807.92(a)(2) | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Device Trade Name | BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR);<br>ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) | | Common Name | Endoscope and accessories | | Classification Name | Cystoscope And Accessories, Flexible/Rigid | | Regulation Number | 876.1500 | | Product Code(s) | FAJ | Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) | | |-------------|-------------------------------------------------------------------------------------------------|--------------| | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | K222602 | Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200- | FAJ | # Device Description Summary The Single-Use Digital Flexible Cystoscope System consists of BubbleView™ Single-Use Digital Flexible Cystoscope (consists of a handle with control lever, endoscope cable and access port for accessories, and a flexible body portion) and ViewHub® Video Processor with itsaccessories including power cables. The BubbleView™ is provided sterile (sterilized by EQ) and intended to be single-use. The ViewHub® is a reusable multi-patient use device. The built-in LED at the Distal tip of the BubbleView™ Single-Use Digital Flexible Cystoscope provides a light source, the lens module captures the light signal, then the CMOS module converts the light signal into an electrical signal: the endoscope cable connects the BubbleView™ to the ViewHub®, which provides power and processes video signal from the endoscope; the control lever on the handleconnected to the controllable portion by a wire rope controls the bending direction and angle of the controllable portion: the instrument channel delivers water and other instruments. The ViewHub® Video Processor is a video imaging system that receives video signals from the connected endoscope, controls the lightat the endoscope tip and outputs this signal including a graphical user interface to a connected external video monitor. AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300) 21 CFR 807.92(a)(4) The BubbleView™ Single-Use Digital Flexible Cystoscope has the following physical and performance characteristics: - Maneuverable tip controlled by the user - Flexible insertion cord - Camera and LED light source at the distal tip - Sterilized by Ethylene Oxide - For single-use K222602 The ViewHub® Video Processor has the following physical and performance characteristics: {5}------------------------------------------------ - Snapshot, white balance, zoom and HD video output - supports HDMI video output formats - Touch Panel - Reusable ## Intended Use/Indications for Use The BubbleView™ Single-Use Digital Flexible Cystoscope is a sterile, single-use, flexible endoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The BubbleView™ is intended to provide visualization via ViewHub® video processorand can be used with endoscopic accessories. BubbleView™ is intended for use in a hospital environment or medical office environment. BubbleView™ is designed for use in adults. ViewHub® is designed to display live imaging data from compatible MACROLUX™ endoscopes. # Indications for Use Comparison The indications for use of the subject device and the predicate device are the same. # Technological Comparison The subject and predicate devices have indications for use, population, type of scope, scope reusability, anatomical site, working length, type of image sensor, illumination source, sterilization, environment of use, applied standards related toperformance, biocompatibility and electrical performance. The subject differs from the predicate in maximum insertion portion width, miniment channel width, up/down deflection of view, field of view, depth of field and Suction. These differences do not raise different questions of safety and effectiveness as compared to the predicate. #### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Mechanical Performance Mechanical characteristics were tested and include: - · Tensile stress testing of the joints - · Fatigue testing of articulation section - · Reliability test of control lever - · Performance tests of irrigation plug and clamp column - · Times of connection cable being inserted and pulled out - Reliability test of handle button - · Bending times of the connection cable #### Optical Performance Comparative testing was performed for the subject device to support substantial equivalence, including: - · Field of view (FOV) - · Resolution - · Depth of field (DOF) - · Signal-to-noise ratio (SNR) - · Dynamic range - · Image intensity uniformity (IIU) - Geometric distortion - · Color performance Not applicable. It is concluded from the nonclinical tests that the subject devices are as safe, as effective, and performs as well as theleqally marketed predicate device identified above. ## K240283 Page 2 of 2 21 CFR 807.92(a)(5) ## 21 CFR 807.92(a)(6) 21 CFR 807.92(a)(5)