(22 days)
No
The description focuses on basic imaging components (light source, camera, monitor) and does not mention any AI/ML terms or functionalities like image analysis, pattern recognition, or automated detection.
No
The device's intended use is for providing illumination for endoscopic procedures and transmitting images, which is purely for visualization and diagnosis, not therapy.
No
The device's description indicates its purpose is to provide illumination and transmit an image for visualization, not to interpret or analyze medical data for diagnostic purposes.
No
The device description explicitly lists hardware components: a light source, CCD camera, and 10.4" flat panel monitor, all housed in a single unit.
Based on the provided information, this device 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 for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is used for providing illumination for endoscopic procedures and transmitting images from an endoscope to a monitor. This is a system for visualizing internal body structures in vivo (within the living body), not for analyzing in vitro (outside the body) specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
The device is an endoscopic visualization system, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The IVS is used in providing illumination for endoscopic procedures and transmitting an image from an endoscope to a viewing monitor, which is integral to the system.
Product codes
Not Found
Device Description
The Integrated Visualization System is comprised of a light source, CCD camera, and 10.4" flat panel monitor, all housed in a single unit weighing approximately seven pounds. It has an immersible camera head with minimum illumination requirements of _1 lux. The light source uses 24 watts and outputs a color temperature of 5460°K.
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)
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
K970598/S001
510(k) Notification
February 17, 1997
Integrated Visualization System
UROHEALTH Systems, Inc. Costa Mesa, CA
MAR | 2 1997
510(k) SUMMARY
COMPANY NAME AND ADDRESS
UROHEALTH Systems, Inc. 3050 Redhill Ave. Costa Mesa, CA. 92626
CONTACT PERSON
Ronald H. Bergeson Corporate Director, Regulatory Affairs
(714) 708-7748, ext. 248 Telephone (714) 708-7795 Fax
DEVICE TRADE NAME
Integrated Visualization System
COMMON NAME
Light Source, Camera, and Monitor in one unit
PREDICATE DEVICE
- Device Name: Welch Allyn Hi Lux Illuminator 1. Classification: II Manufacturer: Welch Allyn 510(k) #: K951647
- Device Name: Integrated Video System 2. Classification: II Manufacturer: BEI Medical Systems Company, Inc. unknown 510(k) #:
- Device Name: Camera, Accessory to endoscope 3. Classification: I Manufacturer: Corin U.S.A. 510(k) #: K963046
DEVICE DESCRIPTION
000057
1
UROHEALTH Systems, Inc. Costa Mesa, CA
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proje 510(k) Notification Integrated Visualization System February 17, 1997
11970598
The Integrated Visualization System is comprised of a light source, CCD camera, and 10.4" flat panel monitor, all housed in a single unit weighing approximately seven pounds. It has an immersible camera head with minimum illumination requirements of _1 lux. The light source uses 24 watts and outputs a color temperature of 5460°K.
INDICATIONS FOR USE
The IVS is used in providing illumination for endoscopic procedures and transmitting an image from an endoscope to a viewing monitor, which is integral to the system.
BIOCOMPATIBILITY
The materials and components of the proposed Integrated Visualization System do not have patient or body fluid contact and therefore biocompatibility testing is not applicable.