(21 days)
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No
The summary describes a standard video camera system for endoscopy with voice and pendant control features, but there is no mention of AI or ML capabilities for image analysis, diagnosis, or other functions.
No
The device is a camera system used for visualization during endoscopic procedures; it does not directly treat or prevent a disease or condition.
No
The device is a video camera system used to visualize internal body structures during endoscopic surgical procedures. Its primary function is to capture and transmit video images for visualization, not to diagnose conditions or diseases.
No
The device description explicitly mentions a "3 CCD Camera" which is a hardware component. The device is a system that includes both hardware and software.
Based on the provided information, the Smith & Nephew Dyonics® Vision 325Z DV 3-CCD Color Video Camera System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device function: The Dyonics® Vision 325Z DV Camera System is used to capture and transmit video images during endoscopic surgical procedures to visualize internal body structures in situ. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states visualization of internal cavities and organs during surgery, not the analysis of biological specimens.
Therefore, this device falls under the category of a surgical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Smith & Nephew Dyonics® Vision 325Z DV 3-CCD Color Video Camera System is indicated for use in endoscopic surgical procedures to allow visualization of the articular cavities, body cavities, hollow organs and canals, when used with an appropriately indicated endoscope.
Additionally, when used in conjunction with a Dyonics® light source and light cable, the 325Z DV Camera System is indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.
Product codes
GCJ
Device Description
The Smith & Nephew Dyonics® Vision 325Z DV Hermes- Ready™3 CCD Camera is used in endoscopic surgical procedures to capture and transmit video images. The Hermes-Ready™ feature will enable voice and pendant control of white balance, zoom, shutter control, enhancement and on/off ability from a central location when used in conjunction with a Hermes™ Digital O.R. Control Center.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Video
Anatomical Site
articular cavities, body cavities, hollow organs and canals, thoracic cavity
Indicated Patient Age Range
Not Found
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)
All verification and validation data demonstrates that the device is safe and effective and performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Images Digital 3-Chip Color Video Camera.
Reference Device(s)
Not Found
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
031379
Endoscopy Division
Smith & Nephew, Inc. 150 Minuteman Road, Andover, MA 01810-1031 U.S.A. Telephone: 978-749-1000 Fax: 978-749-1599