(28 days)
The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.
The Flexible HD Cysto-Urethroscope System (Part Number: 11272VH(U)-TL) is intended to be used with the IMAGE1 S CCU consisting of Connect / Connect II and X-Link modules (cleared in K201135). Identical to the predicates, the scope cannot be operated on its own because it produces image data output in the form of video signals which require external processing and display. When the scope is used with the compatible CCU, it becomes the Flexible HD Cysto-Urethroscope System, which can then be operated as intended and indicated.
The Flexible HD Cysto-Urethroscope System consists of the following key components:
11272VH-TL / 11272VHU-TL – Cysto-Urethroscopes with positive (VH-TL) / contra-positive (VHU-TL) deflection control and permanent T-Luer affixed to working channel
TC200US / TC201US / TC301US – Connect/Connect II/Link camera control unit (CCU) modules for image processing
The subject device is a lower cost alternative to the primary predicate and incorporates the following differences. Housing Plug: Due to lack of clinical need, the subject device replaces the suction channel of the primary predicate device with a permanent stainless steel housing plug. Fixed LUER: The subject device uses a removable T-Luer whereas the primary predicate supported a removable T-Luer or Stopcock.
The FDA 510(k) summary for the KARL STORZ Flexible HD Cysto-Urethroscope System (K212476) describes the acceptance criteria and supporting studies as follows:
This submission is a Special 510(k), indicating a modification to a previously cleared device. Therefore, the focus is on demonstrating that the modifications do not raise new questions of safety and effectiveness compared to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
For this Special 510(k), the acceptance criteria are largely based on adherence to recognized consensus standards and demonstrating that the modified device maintains the same technological characteristics and performance as the predicate devices, or that any differences do not impact safety or effectiveness.
| Acceptance Criterion | Reported Device Performance / Supporting Data |
|---|---|
| Intended Use / Indications for Use | Identical to predicate devices: "The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys." Minor modifications do not change the intended use or indications for use. |
| Physical Characteristics (e.g., Insertion Shaft Diameter, Length, Working Channel Diameter, Deflection) | Same as primary predicate (K191357) for: |
- Type of scope (Flexible)
- Insertion Shaft Diameter (5.5 mm)
- Insertion Shaft Length (37 cm)
- Working Channel Diameter (2.3 mm)
- Deflection (Up: 210°, Down: 140°) |
| Optical Characteristics (e.g., Type of Imager, Field of View, Direction of View, Depth of Field, On-axis Resolution, Light Source) | Same as primary predicate (K191357) for: - Type of Imager (CMOS)
- Field of View (100°)
- Direction of View (0°)
- Depth of Field (3-50 mm)
- On-axis Resolution (40 lp/mm @ 3 mm, 2.5 lp/mm @ 50 mm)
- Light Source (Internal LED) |
| Material / Design Characteristics (Differences from Predicate) | Suction Port / Channel: Proposed device has "No" (due to permanent stainless steel housing plug), while primary predicate has "Yes". This difference is described as due to "lack of clinical need" for the suction channel.
Luer Type: Proposed device has "Permanent T-Luer", primary predicate has "Bayonet with removable T-Luer or Stopcock assembly". This is a minor modification. |
| Cleaning, Disinfection and Sterilization Methods | Same as primary predicate for Manual Cleaning, and High-Level Disinfection (Revital-Ox RESERT).
Sterilization: Proposed device supports STERRAD 100NX (FLEX and DUO cycles), STERRAD NX (Advanced Cycle), V-PRO maX (Flexible Cycle), V-PRO 60. The primary predicate supported these with additional support for SSIE (Standard Cycle). The proposed device's methods are a recognized subset. |
| Electrical Safety and EMC | Compliance with recognized consensus standards: - IEC 60601-1:2005/(R)2012, Ed. 3.1
- IEC 60601-1-2:2014, 4th Ed.
- IEC 60601-2-18:2009, Ed. 3.0 |
| Optical/Mechanical Performance | Compliance with recognized consensus standards: - IEC 62471:2006
- ISO 8600 |
| Biocompatibility | Compliance with recognized consensus standards: - ISO 10993-1:2009/(R) 2013
- ISO 10993-5:2009/(R) 2014
- ISO 10993-10:2010
- ISO 10993-11:2006/(R) 2010 |
| Reprocessing | Compliance with recognized consensus standards: - AAMI TIR 12:2010
- ISO 15883-5:2005
- AAMI TIR 30:2011
- AAMI/ANSI/ISO 11737-1:2006/ (R)2011
- ASTM E1837-96:2014 |
| Substantial Equivalence to effectiveness | Supported by comparison of images and standard image quality characteristics, including the performance testing listed. The differences do not raise new or different questions of safety and effectiveness. |
2. Sample size used for the test set and the data provenance:
The document does not detail specific "test set" sample sizes or data provenance in the context of clinical or image-based studies for the current 510(k). This submission relies on a comparison to predicate devices and adherence to established performance standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The submission focuses on engineering specifications and adherence to standards, not a clinical study requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical or image-based test set with adjudication is described.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an endoscope system for visualization and operative access; it does not involve AI assistance for human readers in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm-only device. It is a medical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of diagnostic performance. The "ground truth" for this submission are the established performance parameters of the predicate device and the requirements of recognized consensus standards for medical devices.
8. The sample size for the training set:
Not applicable. As a medical device, and specifically a modification through a Special 510(k), there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
§ 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.