(71 days)
Unfortunately, the text provided does not contain any Reference Devices or K/DEN numbers for Reference Devices. The section for "Reference Device(s)" explicitly states "Not Found".
No
The description details a standard Xenon light source and fiberoptic cable system with manual controls and basic fault indicators. There is no mention of AI or ML capabilities.
No
The device is intended to provide illumination for visualization during endoscopic and surgical procedures, not to treat a disease or condition.
No
The device is an illumination system for visualization during endoscopic procedures, not for diagnosing conditions.
No
The device description explicitly details hardware components such as a light source unit, lamp, fiberoptic cable, ports, attenuator controls, intensity level indicators, LEDs, and an LCD. This indicates it is a hardware device with potentially some software control, but not a software-only medical device.
Based on the provided information, the Vista Illumination System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for providing visible light for illumination during endoscopic and surgical procedures, and for visualization of the evacuated cardiac chamber. This is a direct interaction with the patient's body for visualization during a medical procedure.
- Device Description: The description details a light source and fiberoptic cable used to deliver light for illumination. This aligns with a device used in vivo (within the living body) for visualization.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the living body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose or monitor medical conditions. The Vista Illumination System's function is to provide light for direct visualization during a procedure on the patient.
N/A
Intended Use / Indications for Use
The Vista Illumination System is intended to provide visible light for illumination of various rigid and flexible endoscopes, laparoscopes, cameras, and headlamps age. "It is intended for use in all types of endoscopic and endoscopic assisted procedures, as well as visualization of the evacuated cardiac chamber.
Product codes
Not Found
Device Description
The Vista Illumination System, is a Xenon Light Source illumination system consisting of a light source unit which houses the lamp and a fiberoptic cable. The system provides visible light for illumination of rigid or flexible endoscopes, laparoscopes, video cameras, headlamps,etc.
The light source has 2 ports which are provided with independent attenuator controls and separate light output intensity level indicators. The front panel contains dual intensity level indicators as well as system fault and lamp fault LED's. The LED's will light if the lamp fails to start or fails during use for any reason. There is a LCD on the front panel that provides an indication of lamp life.
The fiberoptic cable produces a uniform beam profile from a single fiber. There are three different adapters to allow connection to various endoscopic devices currently available. The thread types are for Storz, ACMI and Wolfe. Custom adapters are available. The fiber is available in core diameter of 0.1mm to 1mm with a standard cable length of 10 feet.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
Vista Medical Technologies Westborough, MA
K 970217
510(k) Notification Illumination System January 1997
APR - 2 1997
510(k) SUMMARY January, 1997
COMPANY NAME AND ADDRESS
Vista Medical Technologies 134 Flanders Road Westborough, MA 01581
CONTACT PERSON
Martin Newman Director of Regulatory Affairs and Quality Assurance
......
| Telephone: | (508) 366-3668 |
|---|---|
| Fax: | (508) 366-1543 |
DEVICE TRADE NAME
Vista Illumination System
COMMON NAME
Xenon Light Source for Endoscopic Procedures
PREDICATE DEVICE
| Device Name: | Cogent Light Illuminator 10010 Xenon Light Source and
Fiberoptic Cable |
|-----------------|-------------------------------------------------------------------------------------------|
| Classification: | Illuminator, Fiberoptic for Endoscope |
| Manufacturer: | Cogent Light Technologies, Inc.
650 S. San Vicente Blvd.
Los Angeles, CA 90048-4620 |
| 510(k)#: | K933405 |
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1
DEVICE DESCRIPTION
The Vista Illumination System, is a Xenon Light Source illumination system consisting of a light source unit which houses the lamp and a fiberoptic cable. The system provides visible light for illumination of rigid or flexible endoscopes, laparoscopes, video cameras, headlamps,etc.
The light source has 2 ports which are provided with independent attenuator controls and separate light output intensity level indicators. The front panel contains dual intensity level indicators as well as system fault and lamp fault LED's. The LED's will light if the lamp fails to start or fails during use for any reason. There is a LCD on the front panel that provides an indication of lamp life.
The fiberoptic cable produces a uniform beam profile from a single fiber. There are three different adapters to allow connection to various endoscopic devices currently available. The thread types are for Storz, ACMI and Wolfe. Custom adapters are available. The fiber is available in core diameter of 0.1mm to 1mm with a standard cable length of 10 feet.
INTENDED USE
The Vista Illumination System is intended to provide visible light for illumination of various rigid and flexible endoscopes, laparoscopes, cameras, and headlamps age. "It is intended for use in all types of endoscopic and endoscopic assisted procedures, as well as visualization of the evacuated cardiac chamber.
PERFORMANCE DATA
| IEC 601-1 | "General Safety Requirements for Medical Electrical Equipment" |
|---|---|
| IEC 601-1-2 | "Electrical Magnetic Compatability" |
| UL 544 | "Standards for Safety, Medical and Dental Equipment" |
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