(339 days)
Not Found
No
The description focuses on the display technology and its ergonomic benefits for surgeons, with no mention of AI or ML for image analysis, processing, or any other function.
No
The device is described as a personal monitor intended to display video images, not to treat or mitigate a disease or condition. It serves as an aid for surgeons by improving the visibility of endoscopic images, but it does not directly perform any therapeutic action.
No
The device is described as a display unit for video images, not a tool for analyzing, interpreting, or diagnosing medical conditions. It serves as an improved monitor for surgeons during endoscopic procedures.
No
The device description explicitly details hardware components such as a monitor block, eyeglasses, controller box, LCD/AMEL displays, lenses, mirrors, and cables, indicating it is a hardware device with integrated electronics for displaying video.
Based on the provided information, the MedVision Personal Monitor Models A and B are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is to "display video image while mounted on the user's head." This is a display device for visual information, not a device used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description focuses on how the device displays video signals from an endoscopic procedure to the surgeon. It describes the components (monitor block, eyeglasses, controller box) and how they function to project the video image. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- Input Imaging Modality: The input is "Video signals," which are visual representations, not data derived from in vitro analysis of biological specimens.
- Intended User / Care Setting: The intended users are "Surgeons" in the context of "Endoscopic procedures." This aligns with a surgical tool, not a diagnostic device.
- Predicate Device: The predicate device is a "Head Mounted Display," which is consistent with a display technology, not an IVD.
In summary, the MedVision Personal Monitor is a display technology designed to improve the surgeon's view during endoscopic procedures. It does not perform any in vitro analysis of biological samples, which is the core function of an IVD device.
N/A
Intended Use / Indications for Use
The MedVision Personal Monitor Models A and Models B are intended to display video image while mounted on the user's head.
Product codes
Not Found
Device Description
In endoscopic procedures the conventional video monitors are placed away from the site of the operation. As a result, the surgeon has to constantly divide his/her attention between the conventional monitor that shows the endoscopic image and the site of the operation. The remote location of the monitor and its orientation in the surgical setting have an effect on both the doctor's perception of the surgical field, and the difficulties encountered when interacting with it. Much of the difficulty encountered by a surgeon when learning the techniques videoendoscopy, relate to the disconnection between instrument movements on the video monitor and their hand movements. With the displacement and axial rotation of the monitor, the doctor must relearn the image to tissue relationship at each procedure, and with each manipulation of the camera. With this decoupled image, the hand-eye coordination of the doctor suffers. For example, with a 90 degree rotation of the camera, an intended movement South North direction, will result in a display movement in an East to West direction, presenting the doctor with a working field that is difficult to comprehend.
The Med Vision Personal Monitors project a high resolution color video image that appears in a the surgeon's line of sight in a viewing angle comparable to watching a 26" television from 2 meters (6.5 feet) away. The video image is see-around; it blocks only the area the image appears, otherwise users are free to view the surrounding environment. The MedVision Personal Monitors provide an added convenience to surgeons compared to conventional monitors. They enables the surgeon to maintain the endoscopic image in the surgeon's line of site regardless of where he/she is looking. The MedVision Personal Monitor Model B can receive video signals from any video source. The signals are converted in the controller unit into signals the driving electronics of LCD/AMEL displays require.
The MedVision Personal Monitors (MPM) Model B are monoscopic binocular displays with a relatively narrow field of view. The MPMs take standard video signals and display them on a small TFT LCD display (Model A) or AMEL display (Model B) that can be connected to any standard video source. The MPM consist of a monitor block, eyeglasses and controller box. The monitor block contains the display, for MPM Model A only, a backlight and its driver for the LCD, and a system of lenses and mirrors that project the display image onto the retina of the eyes. The light beams coming from the display are reflected in two directions by dividing mirrors placed in front of the display. The monitor block has a mounting slot that fits into the vertical nose piece of the eyeglasses. The controller box contains the video input demodulator unit and the driving electronics of the LCD/AMEL display. The LCD/AMEL direct display control signals are sent through a flexible shielded cable to the displays.
The eyeglasses have adjustable temple pieces and each unit comes with a commercially available 9V DC adaptor with low EMI ..
All components and accessories of the device are marketed as non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video image
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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.
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
MedVision Inc. North Brunswick, NJ February 1, 1997
MAR 1 3 1997
K 961343
Section 2
510 (k) Summary
Device Trade Name
MedVision Personal Monitor Models A and B
Common /Usual Name Head Mounted Display Virtual Display Device
Classification Name
Accessory to Endoscopes
Contact Person:
Miklos S. Ruschak MedVision Inc. 257 Kempsey Drive North Brunswick, NJ 08902
(908) 297-8306 Telephone: (908) 422-7745 Fax:
Predicate Device
Trade Name: Head Mounted Display Manufacturer: Vista medical Technologies 5451 Avenida Encinas, Suite A Carlsbad, CA 92008 K961800 510 (k)#:
Summary Preparation Date: February 1, 1997
Statement of Intended Use
The MedVision Personal Monitor Models A and Models B are intended to display video image while mounted on the user's head.
Device Description
In endoscopic procedures the conventional video monitors are placed away from the site of the operation. As a result, the surgeon has to constantly divide his/her attention between the conventional monitor that shows the endoscopic image and the site of the operation. The remote location of the monitor and its orientation in the surgical setting have an effect on both the doctor's perception of the surgical field, and the difficulties encountered when interacting with it. Much of the difficulty encountered by a surgeon when learning the techniques videoendoscopy, relate to the disconnection between instrument movements on the video monitor and their hand movements. With the displacement and axial rotation of the monitor, the doctor must relearn the image to tissue relationship at each procedure, and with each manipulation of the camera. With
1
this decoupled image, the hand-eye coordination of the doctor suffers. For example, with a 90 degree rotation of the camera, an intended movement South North direction, will result in a display movement in an East to West direction, presenting the doctor with a working field that is difficult to comprehend.
The Med Vision Personal Monitors project a high resolution color video image that appears in a the surgeon's line of sight in a viewing angle comparable to watching a 26" television from 2 meters (6.5 feet) away. The video image is see-around; it blocks only the area the image appears, otherwise users are free to view the surrounding environment. The MedVision Personal Monitors provide an added convenience to surgeons compared to conventional monitors. They enables the surgeon to maintain the endoscopic image in the surgeon's line of site regardless of where he/she is looking. The MedVision Personal Monitor Model B can receive video signals from any video source. The signals are converted in the controller unit into signals the driving electronics of LCD/AMEL displays require.
The MedVision Personal Monitors (MPM) Model B are monoscopic binocular displays with a relatively narrow field of view. The MPMs take standard video signals and display them on a small TFT LCD display (Model A) or AMEL display (Model B) that can be connected to any standard video source. The MPM consist of a monitor block, eyeglasses and controller box. The monitor block contains the display, for MPM Model A only, a backlight and its driver for the LCD, and a system of lenses and mirrors that project the display image onto the retina of the eyes. The light beams coming from the display are reflected in two directions by dividing mirrors placed in front of the display. The monitor block has a mounting slot that fits into the vertical nose piece of the eyeglasses. The controller box contains the video input demodulator unit and the driving electronics of the LCD/AMEL display. The LCD/AMEL direct display control signals are sent through a flexible shielded cable to the displays.
The eyeglasses have adjustable temple pieces and each unit comes with a commercially available 9V DC adaptor with low EMI ..
All components and accessories of the device are marketed as non-sterile.
Device Comparison
The Med Vision Personal monitor Models A and B are substantially equivalent to the display component of Vista Medical Technologies' Head Mounted Display, which received clearance from FDA on September 11, 1996 (K 961800). The Med Vision Personal Monitor Model A and Model B are binocular monoscopic displays with a single LCD display (Model A) and single AMEL display (Model B). The Vista Medical Technologies' Head Mounted Display has two AMLCDs and it is a monoscopic display. While the predicate device has large field of view and low apparent resolution, the Med Vision Personal Monitors have relatively narrow field of view and relatively higher and apparent resolution. The Med Vision Personal Monitors are monoscopic displays that do not need the large virtual distance, large field of view to create the stereoscopic immersion as opposed to Vista's HMD. The tradeoff for the large field of view is the reduction in apparent resolution.
2
MedVision Inc. North Brunswick, NJ
Safety
The MedVision Personal Monitors Model A and Model B are designed, manufactured and tested in compliance with IEC-601-1, IEC-601-2, and IEC 10004-3.
The eyeglasses will have polycarbonate lenses to ensure high resistance to impact and scratch.
When compared to the predicate device the MedVision Personal Monitors Model A and Model B do not incorporate any significant change in intended use and technological characteristics that could affect the safety or effectiveness.