(121 days)
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No
The summary describes a rigid endoscope for visualization and does not mention any image processing, AI, ML, or related terms.
No
The device is described as a visualization tool to view the interior of body cavities, not to treat a condition or disease.
No
The device is described as an endoscope used for visualization during surgical procedures, not for diagnosing medical conditions. It aids in surgical procedures by providing a view of the body cavity.
No
The device description explicitly states it is a "rigid endoscopic device which is comprised of a shaft, scope body, illuminator port, eyepiece, light fiber optics, image rod, and front window," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to visualize the interior of body cavities or surgical working cavities during endoscopic procedures. This is a direct visualization of the body, not an analysis of samples taken from the body.
- Device Description: The description details a rigid endoscope used for visualization. It does not mention any components or functions related to testing or analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, performing tests on biological materials, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This endoscope's function is purely for direct visual inspection.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The 5mm Endoscope is a rigid endoscopic device which is comprised of a shaft, scope body, illuminator port, eyepiece, light fiber optics, image rod, and front window. The 5mm Endoscope is a rigid endoscope which may be used to visualize the interior of body cavity or surgical working cavity during endoscopic procedures. The endoscope may also be used in conjunction with surgical devices which accept a 5mm diameter endoscope as their visualization component.
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
body cavity or surgical working cavity
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 (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)
the ORIGIN Small Diameter Endoscope
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
Class II
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.
21 CFR §807.92 a(1)
Submitter:
ORIGIN® Medsystems, Inc. 135 Constitution Avenue Menlo Park, CA 94025 (415) 617-5142 contact person: Mr. Anthony Durso date prepared: February 7, 1996
21 CFR 8807,92 a(2)
Trade name: Common name: Classification name: 5mm Endoscope Endoscope Endoscope and/or Accessories
21 CFR $807.92 a(3)
Identification of predicate(s): Substantial equivalence for the 5mm Endoscope is based on its similarities to the predicate: the ORIGIN Small Diameter Endoscope. The 5mm Endoscope shares the same intended use as the predicate device. The 5mm Endoscope also is similar to the predicate device in terms of materials and technological characteristics.
21 CFR §807.92 a(4)
Device Description-parts and function/concept: The 5mm Endoscope is a rigid endoscopic device which is comprised of a shaft, scope body, illuminator port, eyepiece, light fiber optics, image rod, and front window. The 5mm Endoscope is a rigid endoscope which may be used to visualize the interior of body cavity or surgical working cavity during endoscopic procedures. The endoscope may also be used in conjunction with surgical devices which accept a 5mm diameter endoscope as their visualization component.