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.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the BubbleView™ Single-Use Digital Flexible Cystoscope and ViewHub® Video Processor. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for an AI/ML-driven device. As such, it does not contain the detailed information requested regarding acceptance criteria, study methodologies for AI/ML performance, ground truth establishment, or multi-reader multi-case studies.

The document primarily describes:

The device and its intended use.
A comparison to a legally marketed predicate device (Pusen Single Use Flexible Video Cystoscope System K222602) to establish substantial equivalence based on indications for use and technological characteristics.
Non-clinical performance tests for mechanical and optical characteristics. These tests are to support the safety and effectiveness of the hardware (the cystoscope and video processor) itself, not an AI component.

Therefore, I cannot extract the information requested about acceptance criteria and study data for an AI/ML device from this specific FDA submission document. The questions you posed are highly relevant for AI/ML medical devices, but this document appears to be for a traditional medical imaging device without an explicitly stated AI/ML component.

Summary

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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.

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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

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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

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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)

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."

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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);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

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:

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Snapshot, white balance, zoom and HD video output
supports HDMI video output formats
Touch Panel
Reusable

Intended Use/Indications for Use

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)

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.