← Product Code [FGB](/productcode/FGB) · K260516

# BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) (K260516)

_MacroLux Medical Technology Co., Ltd. · FGB · Jul 20, 2026 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260516

## Device Facts

- **Applicant:** MacroLux Medical Technology Co., Ltd.
- **Product Code:** [FGB](/productcode/FGB.md)
- **Decision Date:** Jul 20, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Indications for Use

The BubbleView Single-Use Digital Flexible Cystoscope is a sterile, single-use, flexible endoscope intended to be used for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. 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.

## Device Story

Sterile, single-use, flexible digital cystoscope; used in hospital or medical office settings by clinicians. Input: light signal captured at distal tip via lens module. Transformation: CMOS module converts light to electrical signal; transmitted via cable to ViewHub video processor for image processing. Output: real-time visualization on external display. Features: handle with control lever for tip articulation; instrument channel for accessories/suction; integrated LED illumination. Clinical utility: enables visualization and surgical access to urinary tract/kidney; single-use design eliminates reprocessing requirements and reduces cross-contamination risk.

## Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including mechanical performance (tensile, fatigue, bending, reliability), optical performance (resolution, SNR, FOV, depth of field, color), biocompatibility (ISO 10993-5, -10, -11, -23), electrical safety (IEC 60601-1, -2-18), EMC (IEC 60601-1-2), and photobiological safety (IEC 62471). Sterilization validated per ISO 11135.

## Technological Characteristics

Flexible endoscope with CMOS sensor and LED illumination. Single-use, EO-sterilized. Connects to external ViewHub processor. Features include steerable distal tip, instrument channel, and suction connector. Complies with IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, IEC 62471, and ISO 10993 series for biocompatibility.

## Regulatory 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.

## Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:

1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
   1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
   2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
   3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

## Predicate Devices

- Medical Video Endoscope System ([K172098](/device/K172098.md))

## Reference Devices

- ViewHub Video Processor ([K240283](/device/K240283.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

![LOGO](U.S. Food & Drug Administration)

July 20, 2026

MacroLux Medical Technology Co., Ltd.
Ye Linbin
Regulatory Compliance
301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.,
Shenzhen, Guanfdong 518107
CHINA

Re: K260516

Trade/Device Name: BubbleView Single-Use Digital Flexible Cystoscope
(C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)

Regulation Number: 21 CFR 876.1500

Regulation Name: Endoscope and accessories

Regulatory Class: II

Product Code: FGB, FAJ

Dated: July 6, 2026

Dear Ye Linbin:

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: The Center for Devices and Radiological Health (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, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K260516 - Ye Linbin

Page 2

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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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}

K260516 - Ye Linbin

Page 3

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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}

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120

Expiration Date: 07/31/2026

See PRA Statement below.

510(k) Number (if known)

K260516

Device Name

BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)

Indications for Use (Describe)

The BubbleView Single-Use Digital Flexible Cystoscope is a sterile, single-use, flexible endoscope intended to be used for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. 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.

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."

FORM FDA 3881 (8/23)

Page 1 of 1

PSC Publishing Services (301) 443-6740

EF

{4}

K260516, Page 1 of 3

|  510(k) #: K260516 | 510(k) Summary | Prepared on: 2026-07-06  |
| --- | --- | --- |
|  Contact Details |   | 21 CFR 807.92(a)(1)  |
|  Applicant Name | MacroLux Medical Technology Co., Ltd.  |   |
|  Applicant Address | 301, Building 3, NamTai Inno Park In Guang Ming Avenue Shenzhen Guanfdong 518107 China  |   |
|  Applicant Contact Telephone | +8613430891962  |   |
|  Applicant Contact | Mr. Ye Linbin  |   |
|  Applicant Contact Email | yelinbin@microlite.cn  |   |
|  Device Name |   | 21 CFR 807.92(a)(2)  |
|  Device Trade Name | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)  |   |
|  Common Name | Endoscope and accessories  |   |
|  Classification Name | Ureteroscope And Accessories, Flexible/Rigid  |   |
|  Regulation Number | 876.1500  |   |
|  Product Code(s) | FGB, FAJ  |   |
|  Legally Marketed Predicate Devices |   | 21 CFR 807.92(a)(3)  |
|  Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code  |
|  K172098 | Medical Video Endoscope System | FGB  |
|  |   |   |
|  Device Description Summary |   | 21 CFR 807.92(a)(4)  |
|  The 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. The BubbleView is provided sterile (sterilized by EO) and intended to be single-use. 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 handle connected 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 suction connector allows for connection of suction tubing. The BubbleView is intended to used combined with ViewHub Video Processor to perform its intended function and the ViewHub has been 510(k) cleared in the K240283. 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  |   |   |

{5}

K260516, Page 2 of 3

|  Intended Use/Indications for Use | 21 CFR 807.92(a)(5)  |
| --- | --- |
|  The BubbleView Single-Use Digital Flexible Cystoscope is a sterile, single-use, flexible endoscope intended to be used for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. 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.  |   |
|  Indications for Use Comparison | 21 CFR 807.92(a)(5)  |
|  The indications for use of the subject device and the predicate devices are the same.  |   |
|  Technological Comparison | 21 CFR 807.92(a)(6)  |
|  The subject and predicate devices have the same Indications for use, Population, Anatomic site, Prescription, Performance, Direction of view, Digital video technology, Illumination source, Sterilization, Biocompatibility and Electrical performance. The subject device differs from the predicate device in Field of view, Depth of view, Working length, Maximum insertion portion width, Minimum working channel width, Deflection angle. The difference will not raise new questions on safety and effectiveness of the subject device.  |   |
|  Non-Clinical and/or Clinical Tests Summary & Conclusions | 21 CFR 807.92(b)  |
|  Mechanical Performance Mechanical characteristics were tested and include: - Physical features - Tensile stress testing of the joints - Fatigue testing of the articulation section and control lever - Insertion/extraction cycle testing of connection cable - Bending reliability testing of connection cable - Reliability testing of buttons Optical Performance Comparative testing was performed for the subject device and predicate device to support substantial equivalence, including: - Field of view (FOV) - Direction of view (DOV) - Image intensity uniformity (IIU) - Resolution - Depth of field - Geometric distortion - Signal-to-noise ratio (SNR) - Dynamic range - Color performance Sterility The sterilization validation was conducted according to ISO 11135. Biocompatibility The biocompatibility was assessed according to FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process" and the standard ISO 10993-1. Also, the following tests were conducted based contact category of "Surface - Mucosal Membrane" with a contact duration of "Limited (< 24 hours): - Cytotoxicity (ISO 10993-5) - Sensitization (ISO 10993-10) - Intracutaneous reactivity (ISO 10993-23) - Material-mediated pyrogenicity (ISO 10993-11) - Acute systemic toxicity (ISO 10993-11) EMC The EMC was assessed according to FDA guidance document "Electromagnetic Compatibility (EMC) of Medical Devices" and tested  |   |

{6}

K260516, Page 3 of 3

according to IEC 60601-1-2 and IEC 60601-2-18.

Electrical Safety

The electrical safety was tested according to IEC 60601-1 and IEC 60601-2-18.

Photobiological Safety

The photobiological safety was tested according to IEC 62471.

The clinical data is not applicable.

The nonclinical test were conducted to demonstrate that the subject device is as safe and effective as the predicate device.

---

**Source:** [https://fda.innolitics.com/device/K260516](https://fda.innolitics.com/device/K260516)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com