(135 days)
Not Found
No.
The document describes the device's functions, which are primarily image capture, processing for live video, and mechanical control. There is no mention of AI, machine learning, or any adaptive/learning capabilities in the device's operation or software validation.
Yes
The "Intended Use / Indications for Use" section states that the device can be used to "perform various diagnostic and therapeutic procedures" using additional accessories.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for endoscopic examination in the urinary tract" and can be used to "perform various diagnostic and therapeutic procedures," making it a diagnostic device.
No
The device description clearly outlines hardware components such as a flexible ureteroscope with a working channel, CMOS imaging sensor, LED light source, deflection lever, and physical push buttons. It also mentions a Camera Control Unit (FCCU) which processes and produces live video images. The performance studies section details extensive physical testing for both the ureteroscope and the FCCU, including biocompatibility, reprocessing validation, electrical safety, EMC, and design verification, all of which are characteristic of a physical medical device. While software verification and validation are mentioned for the FCCU, this indicates that software is an integrated component of a larger hardware system, not the sole component of the medical device.
No.
This device is an endoscope used for direct visualization of the urinary tract and for performing diagnostic/therapeutic procedures, not for in vitro examination of specimens derived from the human body.
N/A
Intended Use / 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.
Product codes
FGB
Device Description
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.
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
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract, kidney
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)
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
§ 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.
FDA 510(k) Clearance Letter - F88 URE-SD/RD Flexible Ureteroscope
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
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"
Page 2
K243894 - Samantha Eakes Page 2
(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
Page 3
K243894 - Samantha Eakes 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
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.
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."
Page 5
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: +65 8518 3338
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.
K243894
Page 1 of 7
Page 6
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
K243894
Page 2 of 7
Page 7
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 |
K243894
Page 3 of 7
Page 8
| Device | Flexible video endoscope with video processor (Subject device) | Flexible Video-Uretero-Renoscope System (Predicate device) | Comparison |
|---|---|---|---|
| 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. |
K243894
Page 4 of 7
Page 9
| 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