(29 days)
Karl Storz Xenon Light Source
Not Found
No
The device description details standard hardware components for a light source and does not mention any software, algorithms, or capabilities related to AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
Explanation: The device is an accessory for illumination during endoscopic procedures and does not directly treat or diagnose a disease or condition.
No
The device is described as a light source for illumination during endoscopic procedures, which is an accessory function, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a power switch, light guide receptacle, lamp usage clock, light intensity control, light intensity indicator, lamp door, and cooling fan. It is a physical hardware device.
Based on the provided information, the DSP Worldwide Snowden-Pencer Xenon Lightsource is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for providing illumination during endoscopic procedures. This is a direct interaction with the patient's body (in vivo) to visualize internal structures.
- Device Description: The description details a light source and its components for illuminating fiberoptic endoscopes. This aligns with a device used for visualization within the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.) outside the body.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or treatment based on in vitro analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device's function is to provide light for direct visualization within the body.
N/A
Intended Use / Indications for Use
The DSP Worldwide Snowden-Pencer Xenon Lightsource is intended for use as an accessory to fiberoptic endoscopes to provide illumination during endoscopic procedures.
Product codes
Not Found
Device Description
The DSP Worldwide Snowden-Pencer Xenon Lightsource is a fiberoptic illuminator for use in endoscopic surgical procedures. The device includes a Power Switch/Circuit Breaker, Light Guide receptacle which accepts the fiber optic cables (designed to accept ACMI cables with Storz, Olympus, and Wolf adapters also available), Lamp Usage Clock which indicates elapsed bulb usage (in hours), Light Intensity Control which allows illumination to be adjusted (clockwise to increase intensity and counterclockwise to decrease intensity), Light Intensity Indicator which provides a graphic representation of the level of light intensity, a Lamp Door on the side of the unit to provide access for replacement of the lamp module, a Cooling Fan to cool the Xenon bulb and the power supply of the unit. Detailed specifications for the Lightsource were provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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)
Karl Storz Xenon Light Source
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
DSP Worldwide Snowden-Pencer Xenon Lightsource
Jul 18 1996
510(k) Summary (per 21 CFR 807.92)
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Date of Preparation 1.
June 18, 1996 -
Sponsor/Applicant 2.
DSP Worldwide Snowden-Pencer 5175 South Royal Atlanta Drive Tucker, GA 30084
DSP Worldwide 600 Airport Road Fall River, MA 02720
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Contact Name 3.
Timothy N. Thomas, Vice President, Regulatory Affairs and Quality Assurance DSP Worldwide Telephone: 508-677-6545 -
Device Name 4.
Trade/Proprietary Name: Xenon Lightsource Common/Usual Name: Xenon fiberoptic light source Endoscopic accessory Classification Name: -
Identification of the predicate or legally marketed device(s) to which equivalence ડ. is being claimed:
Karl Storz Xenon Light Source
1
Image /page/1/Picture/0 description: The image shows a sequence of handwritten digits and letters. The sequence appears to be "K9162365". The characters are written in a bold, somewhat stylized font, with thick strokes. The image is in black and white.
Device Description 6.
The DSP Worldwide Snowden-Pencer Xenon Lightsource is a fiberoptic illuminator for use in endoscopic surgical procedures. The device includes a Power Switch/Circuit Breaker, Light Guide receptacle which accepts the fiber optic cables (designed to accept ACMI cables with Storz, Olympus, and Wolf adapters also available), Lamp Usage Clock which indicates elapsed bulb usage (in hours), Light Intensity Control which allows illumination to be adjusted (clockwise to increase intensity and counterclockwise to decrease intensity), Light Intensity Indicator which provides a graphic representation of the level of light intensity, a Lamp Door on the side of the unit to provide access for replacement of the lamp module, a Cooling Fan to cool the Xenon bulb and the power supply of the unit. Detailed specifications for the Lightsource were provided.
Intended Use 7.
The DSP Worldwide Snowden-Pencer Xenon Lightsource is intended for use as an accessory to fiberoptic endoscopes to provide illumination during endoscopic procedures.
8. Similarities in Technological Characteristics
The DSP Worldwide Snowden-Pencer Xenon Lightsource is substantially equivalent the Karl Storz Xenon Light Source and to other legally marketed xenon light sources in design characteristics, operational principles, and technological characteristics. Any difference between devices is minor and raises no new issues of safety and effectiveness.