(100 days)
K5885042
None
No
The summary describes a video display system and does not mention any AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No
The device is a display system for medical images, primarily for use in surgery. It does not exert any direct therapeutic action on the patient. Its function is to facilitate medical procedures rather than treat conditions.
No
The device displays video images for medical applications but does not process or analyze them to inform a diagnosis. Its function is purely for visualization during procedures like surgery, microscopy, and endoscopy.
No
The device description explicitly mentions "advanced video projection technology" and a "sterile, disposable screen," indicating hardware components beyond just 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 produce high-quality video images for use in medical applications like surgery, microscopy, and endoscopy. This is about displaying visual information during a procedure, not about testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on displaying an image on a screen within the surgical field. This aligns with a display device used for visualization during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for visual display during medical procedures.
N/A
Intended Use / Indications for Use
The LSI Videoscopic Display System produces high quality video images for use in a wide range of medical applications, including surgery, microscopy and endoscopy.
Product codes
Not Found
Device Description
The LSI Videoscopic Display System utilizes advanced video projection technology to display an image on a sterile, disposable screen appropriately positioned within the surgical field.
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)
K5885042
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
JAN 8 1997
Premarket Notification [510(k)] Summary
LSI Solutions 2144 Brighton-Henrietta Town Line Road Rochester, NY 14623 Phone: 716-427-7979 Fax: 716-427-7482 Contact: Jude S. Sauer, M.D.
September 27, 1996
| Trade Name: | LSI Videoscopic Display System | |
|---|---|---|
| Common Name: | Color Video Monitor | |
| Classification Name: | Surgical Camera and Accessories (per 21 CFR Section | |
| 878.4160) | ||
| Predicate Device: | The legally marketed device (predicate) to which substantial | |
| equivalence is claimed is the Sony Trinitron Color Video | ||
| Monitor, Model Number PVM-1343MD (K5885042). | ||
| Description: | The LSI Videoscopic Display System utilizes advanced video | |
| projection technology to display an image on a sterile, | ||
| disposable screen appropriately positioned within the surgical | ||
| field. | ||
| Intended Use: | The LSI Videoscopic Display System produces high quality | |
| video images for use in a wide range of medical applications, | ||
| including surgery, microscopy and endoscopy |
1
Comparison:
Summary of the technological characteristics of how this device compares to the predicate device:
| Specification | LSI Videoscopic Display
System (Model 001) | Sony Color Video Monitor
(PVM-1343MD) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For
Use | The LSI Videoscopic Display
System produces high quality
video images for use in a wide
range of medical applications,
including surgery, microscopy
and endoscopy. | The PVM-1343MD Color Video
Monitor produces high quality
video images for use in a wide
range of medical applications,
including surgery, microscopy,
endoscopy and A/V. |
| Diagonal Picture
Measure (in.) | 14 | 13 |
| Sterile
Disposables | Plastic screen for placement in
the surgical field. | None |
| Image Source | Texas Instruments Digital
Micromirror Projector | SMPTE C (American standard
phosphor) |
| Resolution | 800 (H) x 600 (V) active pixels | 2000 Characters (50
characters/line x 25 lines)
600 (H) TV lines |
| Video Input | 1.0V p-p, 75 ohms | 1.0V p-p, 75 ohms |
| Audio input | Phono jack | Phono jack |
| Power
Requirements | 120V AC at 60 Hz
230V AC at 50 Hz | 110-130 V AC at 50-60 Hz |
| Power
Consumption | 600 W (approx.) | 99W (approx.) |
| Dimensions (in.) | 8.04 (H) x 12.2 (W) x 16.38 (D) | 13.5 (H) x 13.63 (W) x 16.25 (D) |
| Weight (lb.) | 28.5 | 36.4 |
Summary:
The LSI Videoscopic Display System is a safe and effective device which is equivalent to the Sony Color Video Monitor (PVM-1343MD). The LSI Videoscopic Display System has a slightly larger screen when measured diagonally with 800 horizontal lines of resolution versus 600 horizontal lines of resolution for the Sony device. In addition the LSI Videoscopic Display System projects the video image into the surgical field, on a sterile screen, where it may be more easily viewed by the surgeon and others.