(75 days)
K-981-999, K-961-343
Not Found
No
The description focuses on the hardware specifications of a video monitor and its intended use as a display device. There is no mention of any software processing, analysis, or learning capabilities.
No
The device is a video monitor designed for viewing images from other medical devices, not for directly providing therapy. Its function is display-centric, enabling medical professionals to see video output while observing the surrounding area.
No
The device is described as a video monitor that allows a medical person to view a monitor picture and the surrounding area simultaneously, particularly useful in procedures like endoscopic surgery. It is a display device, not one that performs diagnostic analysis itself.
No
The device description clearly outlines physical hardware components such as an LCD display, optical system, controller unit, and mounting eyeglasses, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Eastgate Trading Personal Monitor is a video display device. Its intended use is to provide a visual display of video output from other medical devices, allowing a medical person to view the display and the surrounding area simultaneously.
- Lack of Biological Sample Analysis: The device does not interact with or analyze any biological samples from a patient. It simply displays video information.
The device is a display accessory for other medical devices that generate video output, such as endoscopes. Its function is purely visual and does not involve any diagnostic testing of biological materials.
N/A
Intended Use / Indications for Use
THE USE OF THE PERSONAL MONITOR FOR MEDICAL FIELDS ARE AS A MONITORING DEVICE ATTACHED TO ANY VIDEO OUTPUT MEDICAL EQUIPMENT IN CONJUNCTION WITH EXISTING MONITORS OR ALONE. S AN EXAMPLE THE PERSONAL MONITOR CAN BE ATTACHED TO ENDOSCOPIC DEVICES THRU THERE NORMAL MONITORING EQUIPMENT.
THE EASTGATE TRADING PERSONAL MONITOR CAN BE USED FOR ANY PROCEDURE HAT REQUIRES A VIDEO DISPLAY.IT IS DESIGNED TO SIT ON THE BRIDGE OF THE NOSE.IN THIS POSITION A MEDICAL PERSON ABLE TO SEE THE MONITOR PICTURE AND THE SURROUNDING AREA AT THE SAME TIME.
THE PERSONAL MONITOR IS PROVIDED WITH ACCESSORIES TO PLUG INTO ANY VIDEO OUTPUT.IT CAN BE USED BY ITSELF OR IN CONJUNCTION WITH OTHER VIDEO MONITORS.
AS AN EXAMPLE IN ENDOSCOPIC SURGERY THE DOCTOR WOULD ATTACH THE VIDEO FEED TO THE REGULAR MONITOR DEVICE.BY DOING THIS THE DOCTOR COULD VIEW THE PATIENT AND THE CAMERA IMAGE AT THE SAME TIME.
AS THIS MONITOR HAS A UNIVERSAL VIDEO PLUG IT COULD BE ATTACHED TO ANY MEDICAL DEVICE WITH A VIDEO OUTPUT.
Product codes
GCJ
Device Description
THE PERSONAL MONITOR IS A BIOCULAR VIDEO MONITOR. DISPLAY-BIOCULAR,SINGLE LCD RESOLUTION-180,000 PIXEL OPITCAL SYSTEM-ACHROMATIC FIELD OF VIEW-18.750 DIAGONAL BRIGHTNESS 20FL CONTRAST 200:1 EYE RELIEF 28MM INTER-PUPILARY DISTANCE 58MM-77 MM ADJUSTABLE HORIZONTAL ANGULAR RESOLUTION 3,37 INTERFACE NTSC/PAL COMPOSITE POWER 7-9V DC FOCUS ADJUSTMENT- NO MONITOR BLOCK WT- 36 GRAMS MONITOR BLOCK SIZE-9.5X4X3.5CM MOUNTING EYEGLASSES. SEE THROUGH-NO SEE-AROUND-YES CONTROLLER NIT WT-80 GRMS ONTROLLER UNIT SIZE-2.0X11X5 CM &BLE DISTANCE OPTIONAL
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video output from medical equipment
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
MEDICAL PERSON / Not Found (implied medical fields/endoscopic surgery)
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)
K-981-999, K-961-343
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
MAY 19 1999
K990731 EASTGATE TRAI
EXECUTIVE OFFICE: 990 AVE. OF AMERICAS NEW YORK, N.Y. 10018 SUITE 15D
PHONE: (212) 947-8388 FAX 212-629-6310
510 (K) SUMMARY ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
SUBMITTER-EASTGATE TRADING CORP 990 AVE OF AMERICAS NEW YORK,N.Y. 212-947-8388 212-629-6310 FAX MORRIS CORN CONTACT
3/5/99
TRADE NAME- PERSONAL MONITOR COMMON NAME-HEADSUP-MONITOR CLASSIFICATION-BIOCULAR MONITOR
SGATE'S PERSONAL MONITOR IS THE IDENTICAL MONITOR NOW BEING MARKETED BY ALBATECH PERSONAL MONITOR (K-981-999)AND MEDIVISION PERSONAL MONITOR (K-961-343).
DESCRIPTION
THE PERSONAL MONITOR IS A BIOCULAR VIDEO MONITOR. DISPLAY-BIOCULAR,SINGLE LCD RESOLUTION-180,000 PIXEL OPITCAL SYSTEM-ACHROMATIC FIELD OF VIEW-18.750 DIAGONAL BRIGHTNESS 20FL CONTRAST 200:1 EYE RELIEF 28MM INTER-PUPILARY DISTANCE 58MM-77 MM ADJUSTABLE HORIZONTAL ANGULAR RESOLUTION 3,37 INTERFACE NTSC/PAL COMPOSITE POWER 7-9V DC FOCUS ADJUSTMENT- NO MONITOR BLOCK WT- 36 GRAMS MONITOR BLOCK SIZE-9.5X4X3.5CM MOUNTING EYEGLASSES. SEE THROUGH-NO SEE-AROUND-YES CONTROLLER NIT WT-80 GRMS ONTROLLER UNIT SIZE-2.0X11X5 CM &BLE DISTANCE OPTIONAL
THESE ARE THE IDENTICAL TECHNOLOGICAL CHARACTERISTICS AS ALBATECH PERSONAL MONITOR(K981-999).
1
Image /page/1/Picture/0 description: The image shows a black and white illustration of a globe. The globe is depicted with a grid-like pattern, suggesting a map or representation of the Earth. The overall impression is a simple, graphic representation of the world.
EASTGATE TRADING CORP.
EXECUTIVE OFFICE: 990 AVE. OF AMERICAS NEW YORK, N.Y. 10018 SUITE 15D
PHONE: (212) 947-8388 FAX 212-629-6310
510(K)SUMMARY ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
USE OF MONITOR
THE USE OF THE PERSONAL MONITOR FOR MEDICAL FIELDS ARE AS A MONITORING DEVICE ATTACHED TO ANY VIDEO OUTPUT MEDICAL EQUIPMENT IN CONJUNCTION WITH EXISTING MONITORS OR ALONE. S AN EXAMPLE THE PERSONAL MONITOR CAN BE ATTACHED TO ENDOSCOPIC DEVICES THRU THERE NORMAL MONITORING EQUIPMENT.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three distinct lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 19 1999
Mr. Morris Corn President Eastgate Trading Corporation 990 Avenue of the Americas, #15D New York, New York 10018
Re: K990731 Trade Name: Personal Monitor Regulatory Class: II Product Code: GCJ Dated: March 5, 1999 Received: March 5, 1999
Dear Mr. Corn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Morris Corn
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Russell Sage
In Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
EASTGATE TRADI GT (
EXECUTIVE OFFICE: 990 AVE. OF AMERICAS NEW YORK, N.Y. 10018 SUITE 15D
PHONE: (212) 947-8388 FAX 212-629-6310
STATEMENT OF INDICATIONS FOR USE ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
IE EASTGATE TRADING PERSONAL MONITOR CAN BE USED FOR ANY PROCEDURE HAT REQUIRES A VIDEO DISPLAY.IT IS DESIGNED TO SIT ON THE BRIDGE OF THE NOSE.IN THIS POSITION A MEDICAL PERSON ABLE TO SEE THE MONITOR PICTURE AND THE SURROUNDING AREA AT THE SAME TIME.
THE PERSONAL MONITOR IS PROVIDED WITH ACCESSORIES TO PLUG INTO ANY VIDEO OUTPUT.IT CAN BE USED BY ITSELF OR IN CONJUNCTION WITH OTHER VIDEO MONITORS.
AS AN EXAMPLE IN ENDOSCOPIC SURGERY THE DOCTOR WOULD ATTACH THE VIDEO FEED TO THE REGULAR MONITOR DEVICE.BY DOING THIS THE DOCTOR COULD VIEW THE PATIENT AND THE CAMERA IMAGE AT THE SAME TIME.
AS THIS MONITOR HAS A UNIVERSAL VIDEO PLUG IT COULD BE ATTACHED TO ANY MEDICAL DEVICE WITH A VIDEO OUTPUT.
(SEE SAMPLE APPLICATION ATTACHED).
Prescription Use
(Per 21 CFR 801.109)
Thun Vogare for Jzo