(68 days)
No
The description focuses on a manually operated, reusable surgical device with mechanical components and does not mention any software, image processing, or AI/ML terms.
Yes
The device is described as being used for "therapeutic procedures in the transurethral resection of tissue."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used for "diagnostic and therapeutic procedures".
No
The device description clearly outlines a physical, manually operated surgical instrument with various hardware components (telescope, working element, sheath, cutting loops, etc.). It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "diagnostic and therapeutic procedures in the transurethral resection of tissue in the ureters and renal pelvis." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical instrument used for cutting and manipulating tissue within the body. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue biopsies, etc.) outside of the body.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for direct intervention within the body.
N/A
Intended Use / Indications for Use
The KSEA ureter resectoscope is designed to be used for diagnostic and therapeutic procedures in the transurethral resection of tissue in the ureters and renal pelvis.
Product codes
Not Found
Device Description
The KSEA ureter resectoscope is a manually operated, reusable surgical device consisting of a straight forward view telescope (0), a working element, a sheath, cutting loops, electrodes, a cold knife and high frequency cables. The instrument is long enough to gain access to the surgical area and is designed to be used as an urological endoscope. The body contact materials are surgical grade stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureters and renal pelvis
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 appears to be a high-contrast, black and white image with a grainy texture. The composition features a mix of dark and light areas, creating a somewhat abstract pattern. The dark areas are concentrated in the center and right side of the image, while the left side is predominantly white with scattered dark spots.
SISTIN ndos opy-Ame ica, Inc
600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
Foll Free 800 421 0837 Fax 310 4 * 0 5527
510(k) SUMMARY OF SAFETY AND EFFECTIVENES
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 Resectoscope
Trade Name Karl Storz Ureter Resectoscope
Indication: The KSEA ureter resectoscope is designed to be used for diagnostic and therapeutic procedures in the transurethral resection of tissue in the ureters and renal pelvis.
Device Description: The KSEA ureter resectoscope is a manually operated, reusable surgical device consisting of a straight forward view telescope (0), a working element, a sheath, cutting loops, electrodes, a cold knife and high frequency cables. The instrument is long enough to gain access to the surgical area and is designed to be used as an urological endoscope. The body contact materials are surgical grade stainless steel.
Substantial Equivalence: The KSEA ureter resectoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in dimensions between the KSEA ureter resectoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed:
Betty M. Johnson
Manager, Regulatory Affairs