F88 URE-SD/RD Flexible Ureteroscope

K243894 · Sg Endoscopy Pte, Ltd. · FGB · May 2, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K243894
• Device Name: F88 URE-SD/RD Flexible Ureteroscope
• Applicant: Sg Endoscopy Pte, Ltd.
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: May 2, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The F88 URE-SD/RD Flexible Ureteroscope and the F88 Flexible Camera Control Unit are indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Device Story

Handheld flexible ureteroscope (670 mm length, 3.05 mm OD) with 1.2 mm working channel; distal tip features CMOS imaging sensor and LED light source. Control body includes deflection lever (up to 270° up/down) and programmable buttons for image/system control. Used with F88 Flexible Camera Control Unit (FCCU) and surgical display monitors to visualize urinary tract/kidney interior. Operated by physicians in clinical settings. Device transforms optical input from CMOS sensor into live video output via FCCU. Provides real-time visualization to assist clinicians in diagnostic and therapeutic interventions. Reusable device; requires reprocessing.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1), reprocessing validation, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software verification/validation, cybersecurity assessment, and design verification.

Technological Characteristics

Reusable flexible ureteroscope; CMOS imaging sensor; LED light source; 1.2 mm working channel; 270° deflection. Biocompatible materials. Sterilization via Vaporized Hydrogen Peroxide. FCCU processes video; connectivity via standard surgical display interfaces. Software documentation level: basic.

Indications for Use

Indicated for endoscopic examination of the urinary tract and interior of the kidney, and for performing diagnostic and therapeutic procedures using additional accessories.

Regulatory Classification

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.

Predicate Devices

• Flexible Video-Uretero-Renoscope System (K141250)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 2, 2025

SG Endoscopy Pte Ltd
% Samantha Eakes
Vice President, Regulatory Affairs
Eliquent Life Sciences
1055 Thomas Jefferson St.
Suite 450
Washington, District of Columbia 20007

Re: K243894
Trade/Device Name: F88 URE-SD/RD Flexible Ureteroscope
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FGB
Dated: December 18, 2024
Received: April 11, 2025

Dear Samantha Eakes:

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.

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"

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

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(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 (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 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.

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

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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 ([e-mail]) or phone [phone] 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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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.

Submission Number (if known)
K243894

Device Name
F88 URE-SD/RD Flexible Ureteroscope

Indications for Use (Describe)
The F88 URE-SD/RD Flexible Ureteroscope and the F88 Flexible Camera Control Unit are indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

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.

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510(k) Summary for the F88 URE-SD/RD Flexible Ureteroscope SG Endoscopy Pte Ltd

I. SUBMITTER

SG Endoscopy Pte Ltd.

Address: 79 Loyang Way, Singapore, 508766

Contact: John Woo Yeng Jie, Director

Phone Number: [phone]

Date Prepared: December 18, 2024

II. DEVICE

Name of Device: F88 URE-SD/RD Flexible Ureteroscope

Common or Usual Name: Flexible Ureteroscope

Classification Name: Endoscope and Accessories (21 CFR 876.1500)

Regulatory Class: Class II

Product Code: FGB – Ureteroscope and Accessories, Flexible/Rigid

III. PREDICATE DEVICE

510(k) Number: K141250

Submitter: Karl Storz Endoscopy-America, Inc.

Name of Device: Flexible Video-Uretero-Renoscope System

Common or Usual Name: Flexible Ureteroscope

Classification Name: Endoscope and Accessories (21 CFR 876.1500)

Regulatory Class: Class II

Product Code: FGB – Ureteroscope and Accessories, Flexible/Rigid

IV. DEVICE DESCRIPTION

F88 URE-SD/RD Flexible Ureteroscope

The F88 URE-SD Flexible Ureteroscope, Standard Deflection and the F88 URE-RD Flexible Ureteroscope, Reverse Deflection (both also collectively referred to as the “F88 URE-SD/RD Flexible Ureteroscope”) is a handheld flexible ureteroscope with a flexible insertion portion length of 670 mm and a maximum outer diameter of 3.05 mm. The device includes a working channel of 1.2 mm diameter for the insertion of various compatible flexible instruments and irrigation systems. The distal tip is equipped with a CMOS imaging sensor and an LED light source for live videos. The control body has a deflection lever to deflect the distal tip up to at least 270° in the up or down directions for navigation and access to targeted areas. The push buttons can be programmed to perform functions such as white balance, brightness, picture, record, zoom and to provide access to the setup menu.

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The standard deflection (SD) and reverse deflection (RD) models are functionally identical, with one primary difference: the direction of the distal tip deflection in response to the deflection lever’s movement. When the deflection lever of the standard model moves upward, the distal tip deflects upward. In the reverse model, when the deflection lever moves upward, the distal tip deflects downward. The model is selected depending on the handling preference of the user.

The F88 URE-SD/RD Flexible Ureteroscope is a reusable device.

The F88 URE-SD/RD Flexible Ureteroscope is compatible for use with the F88 Flexible Camera Control Unit (FCCU) and several accessories, listed below:

- Single Luer Stopcock
- Vent Cap with Sterilization Card
- Manual Leak Tester
- Luer Port Cleaning Brush
- Cleaning Brush
- URE Working Channel Cleaning Brush

**F88 Flexible Camera Control Unit (FCCU)**

The F88 Flexible Camera Control Unit (FCCU) or F88 flexible camera console is a device that processes and produces live video images during endoscopic procedures. It is used together with the F88 URE-SD/RD Flexible Ureteroscope and compatible surgical display monitors to form the F88 Flexible Camera System.

## V. INDICATIONS FOR USE

The F88 URE-SD/RD Flexible Ureteroscope and the F88 Flexible Camera Control Unit are indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device, the F88 URE-SD/RD Flexible Ureteroscope, and the predicate device, the Karl Storz Flexible Video-Uretero-Renoscope, have the identical intended use and indications for use and very similar technological characteristics. The differences in technological characteristics between the two devices are minor and do not raise different questions of safety and effectiveness. Comprehensive performance testing has been conducted on the subject device to address the minor differences in technological characteristics and to demonstrate that the subject device performs as intended and has

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the same or better performance than the predicate device. This includes comparative testing with the predicate device.

| Device | Flexible video endoscope with video processor (Subject device) | Flexible Video-Uretero-Renoscope System (Predicate device) | Comparison |
| --- | --- | --- | --- |
| Trade Name | F88 URE-SD/RD Flexible Ureteroscope | FLEX-XC Flexible Video-Uretero-Renoscope System | N/A |
| 510(k) Number | TBD | K141250 | N/A |
| Device Classification | Class II | Class II | Identical |
| FDA Regulation number | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Product Code | FGB | FGB | Identical |
| Indications for Use | The F88 URE-SD/RD Flexible Ureteroscope and the F88 Flexible Camera Control Unit are indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney and using additional accessories, to perform various diagnostic and therapeutic procedures. | The KARL STORZ Flexible Video-Uretero-Renoscope System is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. | Identical (except for device names) |
| Patient contact materials | Biocompatible materials | Biocompatible materials | Similar Biocompatibility testing was successfully conducted in accordance with ISO 10993-1 on all patient contacting materials |
| Reusable | Yes | Yes | Identical |
| Sterilization method | Vaporized Hydrogen Peroxide | Vaporized Hydrogen Peroxide | Identical |
| No. of working channel(s) | 1 | 1 | Identical |
| Working channel diameter | 1.2mm | 1.2mm | Identical |
| Working channel length | 670 mm | 675 mm | Similar. The minor difference in working length does not affect safety or effectiveness.
Performance testing demonstrated that the subject device met its required specifications. |
| Outer Diameter of distal tip | 9.15 Fr | 8.5 Fr | Similar. The minor difference in outer diameter |

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| | | | of the distal tip does not affect safety or effectiveness.

Performance testing demonstrated that the subject device met its required specifications. |
| --- | --- | --- | --- |
| Outer Diameter of insertion tube | 2.85 mm | 2.9 mm | Similar. The minor difference in outer diameter of the insertion tube does not affect safety or effectiveness.

Performance testing demonstrated that the subject device met its required specifications. |
| Configuration | F88 URE-SD > Standard Deflection;
F88 URE-RD > Reverse Deflection | 11278 VSA > Positive Deflection;
11278 VSUA > Contrapositive Deflection | Identical. Both ureteroscopes are available in standard and reverse deflection models. |
| Deflection angles | ≥ 270° Up / ≥ 270° Down | ≥ 270° Up / ≥ 270° Down | Identical |
| Image sensor at distal tip | CMOS | CMOS | Identical |
| Light source | LED integrated in handle | LED integrated in handle | Identical |
| Direction of view | 0° | 0° | Identical |
| Field of view (diagonal) | 106° | 90° | Similar

The subject device has a slightly wider field of view. This difference does not affect safety or effectiveness. |
| Depth of view | 2 – 50 mm | 4 – 60 mm | Similar.

The difference in depth of view is minor and does not affect safety or effectiveness. The depth of view of the subject device is within the range for other 510(k) cleared ureteroscopes. |
| Powered by | FCU-200 | IMAGE 1 S X-LINK (TC301);
IMAGE 1 S CONNECT (TC 200) | Similar

Each device is powered by its own method specific to the device. The difference in power source does not impact safety and effectiveness. |

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| Power source | 100 – 240VAC
50 – 60Hz | 100 – 240VAC
50 – 60Hz | Identical |
| --- | --- | --- | --- |
| White balance | Manual | Manual | Identical |
| Brightness control | Yes | Yes | Identical |
| Image enhancement | Yes | Yes | Identical |
| Image/Video capture | No | Yes | Different
Unlike the predicate device, the subject device is designed to not store any images or video recordings. This difference does not impact safety and effectiveness. |
| Record to memory card | No | USB Flash Drive 32 GB | Different
Unlike the predicate device, the subject device does not have a feature to record data to a memory card. This difference does not impact safety and effectiveness. |
| Water ingress protection | IPX0 | IPX0 | Identical |

## VII. PERFORMANCE DATA

The following performance testing was successfully completed for the F88 URE-SD/RD Flexible Ureteroscope and the F88 Flexible Camera Control Unit (FCCU) to establish the safe and effective use of the device and to demonstrate substantial equivalence to the predicate device:

### Biocompatibility Testing:

The biocompatibility evaluation for the F88 URE-SD/RD Flexible Ureteroscope was conducted in accordance with ISO 10993-1 and FDA's guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The device is considered an external communicating device, tissue/bone/dentin contacting with a limited contact duration ≤ 24 hours. Testing was conducted on both non-sterile and cleaned/sterilized devices reprocessed after the recommended number of reprocessing cycles. Testing included the following:

- Cytotoxicity
- Sensitization

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- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity

Cytotoxicity testing was also conducted for the Single Luer Stopcock.

## Reprocessing Validation:

Reprocessing validation including cleaning and sterilization validation and human factors testing was completed for the F88 URE-SD/RD Flexible Ureteroscope. Cleaning validation was completed for the F88 Flexible Camera Control Unit (FCCU). Steam Sterilization Validation was also completed for the Single Luer Stopcock.

## Electrical Safety and Electromagnetic Compatibility (EMC):

Electrical Safety and EMC testing was completed for the F88 Flexible Camera Control Unit (FCCU). The device complies with the IEC 60601-1 standard for electrical safety and the IEC 60601-1-2 standard for EMC.

## Software Verification and Validation Testing:

Software verification and validation testing was completed for the F88 Flexible Camera Control Unit (FCCU), and documentation was provided in accordance with FDA's guidance, Content of Premarket Submissions for Device Software Functions. The software documentation level was basic. Software testing included system verification, installation testing, integration testing, unit testing and user acceptance testing.

## Cybersecurity Testing:

Cybersecurity testing was completed for the F88 Flexible Camera Control Unit (FCCU), and documentation was provided in accordance with FDA's guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. A vulnerability assessment was conducted, and penetration testing was completed.

## Additional Performance Testing:

Additional performance testing was completed for the F88 URE-SD/RD Flexible Ureteroscope and the F88 Flexible Camera Control Unit (FCCU) as outlined below:

### F88 URE-SD/RD Flexible Ureteroscope

- Design Verification
- Simulated Transportation Validation in accordance with ASTM D4169-23e1
- Comparative testing with the predicate device

### F88 Flexible Camera Control Unit (FCCU)

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- Design Verification
- Electromagnetic Compatibility in accordance with IEC 60601-1-2:2014+A1:2020 (Ed4.1) and IEC TR 60601-4-2
- Control Unit Feature Verification
- System Reliability Testing
- Video Performance and Timing
- RF Interference
- Simulated Transportation Validation in accordance with ASTM D4169-23e1

## Animal Testing:

Animal testing was not required to demonstrate substantial equivalence to the predicate device.

## Clinical Testing:

Clinical testing was not required to demonstrate substantial equivalence to the predicate device.

## VIII. CONCLUSIONS

The information provided in this 510(k) submission demonstrates that the F88 URE-SD/RD Flexible Ureteroscope has the identical indications for use and the same overall technological characteristics as the predicate device. The performance testing demonstrates that the device is as safe, as effective, and performs as well or better than the predicate device. In conclusion, the subject device is substantially equivalent to the predicate device, the Karl Storz Flexible Video-Uretero-Renoscope (K141250).