(186 days)
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No
The summary describes a manually operated surgical device with no mention of AI, ML, image processing, or any data-driven components.
No
The device is described as a "manually operated surgical designed for placing of bilioduodenal drains (endoprostheses) during endoscopic procedures." It is a surgical instrument used for a procedure, not a device that itself provides therapy.
No
The provided text describes a surgical device for placing drains, not for diagnosis. There is no mention of the device being used to identify or analyze diseases or conditions.
No
The device description explicitly states it is a "manually operated, reusable surgical device consisting of a handle, guide, loader and Endo-pusher," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The Karl Storz Frimberger Varioguide is a surgical instrument used inside the body during an endoscopic procedure to place drains. It is a tool for a surgical intervention, not a diagnostic test performed on a sample.
The description clearly states it's a "manually operated surgical designed for placing of bilioduodenal drains". This is a therapeutic or interventional device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Karl Storz Frimberger Varioguide is a manually operated surgical designed for placing of bilioduodenal drains (endoprostheses) during endoscopic procedures.
Product codes
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Device Description
The KSEA Frimberger Varioguide is a manually operated, reusable surgical device consisting of a handle, guide, loader and Endo-pusher. The instruments are long enough to gain access to the surgical site. The body contact materials have a long history of use in medical devices and do not pose any new issues of safety and effectiveness.
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
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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 abstract design. The image is mostly white, but there is a large black blotch in the center. The black blotch is irregular in shape and has a rough texture. The image is likely a scan of a physical object, such as a piece of paper or fabric.
Image /page/0/Picture/1 description: The image shows a logo for "Storz Endoscopy". The logo features a stylized "O" with concentric circles inside, followed by the letters "TRZ" in a connected, modern font. Below the main logo, the words "Storz Endoscopy" are printed in a simple, sans-serif font.
Kan Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
Toll Free 800 421 0837 Fax 310 410 5527
K9622/2
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 are accurate and complete to the best of KSEA's knowledge.
DEC 1 3 1996
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 Wire Guide Trade Name KSEA Varioguide
Indication: The Karl Storz Frimberger Varioguide is a manually operated surgical designed for placing of bilioduodenal drains (endoprostheses) during endoscopic procedures.
Device Description: The KSEA Frimberger Varioguide is a manually operated, reusable surgical device consisting of a handle, guide, loader and Endo-pusher. The instruments are long enough to gain access to the surgical site. The body contact materials have a long history of use in medical devices and do not pose any new issues of safety and effectiveness.
Substantial Equivalence: The KSEA Frimberger Varioguide is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between KSEA Frimberger Varioguide 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: Marika Anderson
Marika Anderson Senior Regulatory Affairs Specialist