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.
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.
{0}
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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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
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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
{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.
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:
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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."
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K243894
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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: +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.
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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 |
3
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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. |
4
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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).
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Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
