(35 days)
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No
The description focuses on the device being a manually operated flexible fiberoptic telescope and does not mention any AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" section states that the device is designed to "perform various diagnostic and therapeutic procedures" using additional accessories.
Yes.
The "Intended Use / Indications for Use" section explicitly states "for examination of the upper urinary tract including the ureter and kidney and, using additional accessories, to perform various diagnostic and therapeutic procedures." The term "diagnostic procedures" indicates that the device has a diagnostic function.
No
The device description explicitly states it is a "manually operated surgical device" and a "flexible fiberoptic telescope," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the examination of the upper urinary tract and performing diagnostic and therapeutic procedures within the body. This is an in-vivo procedure.
- Device Description: The device is a flexible fiberoptic telescope used for direct visualization inside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) outside the body to diagnose a condition. IVDs typically involve reagents, test kits, or instruments that analyze biological samples.
This device is a surgical instrument used for direct visualization and intervention within the patient's body, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The KSEA Uretero-Reno-Fiberscope and Nephro-Fiberscope is designed to be used by qualified surgeons and physicians for examination of the upper urinary tract including the ureter and kidney and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The KSEA Uretero-Reno-Fiberscope and Nephro-Fiberscope are manually operated surgical devices. The KSEA Uretero-Reno-Fiberscope and Nephro-Fiberscope are flexible fiberoptic telescopes which utilize fiber-optic technology. The body contact portions of the KSEA Intubation Laryngoscope are composed of medical grade polyurethane.
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
upper urinary tract including the ureter and kidney
Indicated Patient Age Range
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Intended User / Care Setting
qualified surgeons and physicians
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
MAR 1 1 1997 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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 is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan
Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Flexible Urology Scopes
Trade Name: (optional)
Karl Storz Uretero-Reno-Fiberscope and Nephro-Fiberscope |
Indication: The KSEA Uretero-Reno-Fiberscope and Nephro-Fiberscope is designed to be used by qualified surgeons and physicians for examination of the upper urinary tract including the ureter and kidney and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Device Description: The KSEA Uretero-Reno-Fiberscope and Nephro-Fiberscope are manually operated surgical devices. The KSEA Uretero-Reno-Fiberscope and Nephro-Fiberscope are flexible fiberoptic telescopes which utilize fiber-optic technology. The body contact portions of the KSEA Intubation Laryngoscope are composed of medical grade polyurethane.
Substantial Equivalence: The KSEA Uretero-Reno-Fiberscope and Nephro-Fiberscope are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Uretero-Reno-Fiberscope and Nephro-Fiberscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.
Signed:
ed:
Kevin Kennan
Regulatory Affairs Specialist