(64 days)
Not Found
Not Found
No
The summary describes a light source with manual or automatic brightness control, which is a standard feature and does not indicate the use of AI/ML. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is described as a light source for diagnostic and surgical procedures, which indicates it assists in the visualization process rather than providing a therapeutic effect (treatment or healing).
Yes
The "Intended Use / Indications for Use" section states that the device is "designed to supply light for endoscopic diagnostic and surgical procedures," directly indicating its use in diagnostic procedures.
No
The device description clearly states it is a "300W xenon light source," which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to supply light for endoscopic diagnostic and surgical procedures." This describes a device used during a procedure to illuminate the internal body, not a device used to test samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description of a "300W xenon light source" further supports its role as an illumination tool for procedures.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting specific analytes (like proteins, DNA, or chemicals).
- Providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a medical device used for illumination during endoscopic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is designed to supply light for endoscopic diagnostic and surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
This light source is a 300W xenon light source with manually or automatically controlled brightness. This device is not for use with flash photography.
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
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
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
SEP - 4 1996
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 documents 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 | |
| 300W Xenon Light Source |
Trade Name Karl Storz Xenon 300 Light Source for Non-Flash Applications
Indication:
This device is designed to supply light for endoscopic diagnostic and surgical procedures.
Device Description:
This light source is a 300W xenon light source with manually or automatically controlled brightness. This device is not for use with flash photography.
Substantial Equivalence:
The KSEA light source is substantially equivalent to the predicate device, since the basic features, design and intended uses are the same. The minor differences between the Xenon light source and the predicate device raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices.
Signed: Betty M. Johnson
Manager, Regulatory Affairs
0000995