(90 days)
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No
The summary describes manually operated, reusable surgical devices with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The text explicitly states that the uretero-renoscopes are designed to perform "various diagnostic and therapeutic procedures."
Yes
The device is described as being used to "perform various diagnostic and therapeutic procedures," indicating a diagnostic function.
No
The device description clearly states it is a semi-rigid endoscope and an attachment, both described as manually operated, reusable surgical devices made of physical materials (chromium plated Monel 400®). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "view the ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures." This describes a device used within the body for direct observation and intervention, not for testing samples outside the body.
- Device Description: The description details a "semi-rigid endoscope" and an "attachment to the irrigation/instrument channel to control the introduction and movement of accessories." These are physical instruments used for surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device is used for direct visualization and manipulation within the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The KSEA 'Gelet' uretero-renoscopes are designed to view the ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Alken motion control device attaches to an instrument channel to precisely guide the introduction of a laser fiber, electrode or small instrument into the patient.
Product codes
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Device Description
The KSEA 'Gelet' uretero-renoscopes are semi-rigid endoscopes with graduated shafts and a remote eveniece. The Alken motion control device is an attachment to the irrigation/instrument channel to control the introduction and movement of accessories. Both devices are manually operated, reusable surgical devices. The body contact materials are chromium plated Monel 400®.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
ureter
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/0 description: The image is a black and white photograph with a high level of noise and artifacts. The left side of the image has a concentration of dark spots, which gradually fade towards the right. The overall impression is that the image is of poor quality, possibly due to age, damage, or low resolution.
Karl Storz Endoscopy-America, Inc 600 Corporate Pointe Culver City, California 90230-76 Phone 310 558 1500
Toll Free 800 421 Fax 310 410 5 !;
510(k) SUMMARY OF SAFETY AND EFFECTIVENE
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.
Applicant:
Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230 (310) 558-1500
Contact:
Betty M. Johnson Manager, Regulatory Affairs
Device Identification:
Common Name Semi-rigid ureteroscope and accessory
Trade Name Karl Storz 'Gelet' Uretero-Renoscopes Karl Storz Alken motion control device
Indication: The KSEA 'Gelet' uretero-renoscopes are designed to view the ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Alken motion control device attaches to an instrument channel to precisely guide the introduction of a laser fiber, electrode or small instrument into the patient.
Device Description: The KSEA 'Gelet' uretero-renoscopes are semi-rigid endoscopes with graduated shafts and a remote eveniece. The Alken motion control device is an attachment to the irrigation/instrument channel to control the introduction and movement of accessories. Both devices are manually operated, reusable surgical devices. The body contact materials are chromium plated Monel 400®.
Substantial Equivalence: The KSEA 'Gelet' uretero-renoscopes and the Alken motion control device are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same or similar. The minor differences in dimensions between the KSEA 'Gelet' uretero-renoscopes, the Alken motion control device and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed: Bell M. Johnson
Betty M. Johnson
Manager, Regulatory Affairs