(209 days)
Not Found
No
The summary describes a standard digital ureteroscope system with video processing capabilities, but there is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
The device explicitly states that it "can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract."
Yes
The "Intended Use / Indications for Use" states that the device can be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract. The device itself visualizes organs, which is a key part of diagnosis.
No
The device description clearly outlines both hardware components (CoralView® Single-Use Digital Flexible Ureteroscope and ViewHub® Video Processor) and software/processing functions. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "visualize organs, cavities and canals in the urinary tract" and to "perform various diagnostic and therapeutic procedures in the urinary tract" using transurethral access. This describes a device used for direct visualization and intervention within the body.
- Device Description: The description details a ureteroscope system that captures optical images from within the urinary tract. It involves a flexible scope, a video processor, and accessories for visualization and manipulation.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
This device operates inside the body (in vivo) for direct visualization and procedural purposes, which is characteristic of an endoscopic device, not an IVD.
N/A
Intended Use / Indications for Use
The device is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
Product codes
FGB
Device Description
The Single-Use Digital Flexible Ureteroscope System consists of CoralView® Single-Use Digital Flexible Ureteroscope (consists of a handle with control lever, endoscope cable and accessories, and a flexible body portion) and ViewHub® Video Processor with its accessories power cable and connector cables. The Coralliew® is provided sterile (sterilized by EO) 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 CoralView® Single Ureteroscope provides a light source, the lens module captures the light signal, then the CMOS module converts the light signal; the endoscope cable connects the CoralView® 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 ViewHub® Video Processor is a video imaging system that receives video signals from the light at the endoscope tip and outputs this signal including a graphical user interface to a connected external video monitor.
The CoralView® Single-use Digital Flexible Ureteroscope 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
- For single use
The ViewHub® Video Processor has the following physical and performance characteristics
- Snapshot, white balance, zoom and HD video output
- supports HDMI, DVI, CVBS and S-VIDEO video output formats
- Touch Panel
- Reusable.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract (urethra, bladder, ureter, calyces and renal papillae)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Biocompatibility testing
Biocompatibility of the Single-Use Flexible Ureteroscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "breached or compromised surface" with a contact duration of "Limited (
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
January 11, 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, 518107 CHINA
Re: K231774
Trade/Device Name: CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B): CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: August 4, 2023 Received: December 8, 2023
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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 medical devices and radiation-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 J. Antonino -S
Mark 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: 06/30/2023 See PRA Statement below.
| Submission Number (if known) | |
|---|---|
| ------------------------------ | -- |
Device Name
CoralView® Single-use Digital Flexible Ureteroscope (U10): CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR); ViewHub® Video Processor
Indications for Use (Describe)
The device is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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) #: | K231774 | 510(k) Summary | Page 1 of 3 | Prepared on: 2023-12-12 | |
|---|---|---|---|---|---|
| ----------- | --------- | -- | ---------------- | ------------- | ------------------------- |
| 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 Guangming Shenzhen 518107 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 | CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR); ViewHub® Video Processor | |
| Common Name | Endoscope and accessories | |
| Classification Name | Ureteroscope And Accessories, Flexible/Rigid | |
| Regulation Number | 876.1500 | |
| Product Code | FGB |
| 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 Single-Use Digital Flexible Ureteroscope System consists of CoralView® Single-Use Digital Flexible Ureteroscope (consists of a handle
with control lever, endoscope cable and accessories, and a flexible body portion) and ViewHub® Video Processor with its accessories power cable and connector cables. The Coralliew® is provided sterile (sterilized by EO) 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 CoralView® Single Ureteroscope provides a light source, the lens module captures the light signal, then the CMOS module converts the light signal; the endoscope cable connects the CoralView® 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 ViewHub® Video Processor is a video imaging system that receives video signals from the light at the endoscope tip and outputs this signal including a graphical user interface to a connected external video monitor.
The CoralView® Single-use Digital Flexible Ureteroscope has the following physical and performance characteristics:
図 Maneuverable tip controlled by the user
� Flexible insertion cord
� Camera and LED light source at the distal tip
5
| ☑ For single use |
|---|
| The ViewHub® Video Processor has the following physical and performance characteristics |
| ☑ Snapshot, white balance, zoom and HD video output |
| ☑ supports HDMI, DVI, CVBS and S-VIDEO video output formats |
| ☑ Touch Panel |
| ☑ Reusable. |
| Intended Use/Indications for Use |
The device is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It canjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
Indications for Use Comparison
The device has same indications for use in comparison to the predicate device.
Technological Comparison
� Sterilized by Ethylene Oxide
The subject and predicate devices have the same indications for use, type of scope, direction of view, field of view, depth of field, illumination source, sterlization method and energy source. The subject device in distal end outer diameter, maximum insertion portion section length, maximum deflection angle and patient-contacting materials. 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)
Biocompatibility testing
Biocompatibility of the Single-Use Flexible Ureteroscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "breached or compromised surface" with a contact duration of "Limited (