EASTGATE PERSONAL MONITOR

K990731 · Eastgate Trading Corp. · GCJ · May 19, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990731
• Device Name: EASTGATE PERSONAL MONITOR
• Applicant: Eastgate Trading Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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.

Device Story

Personal Monitor is a biocular video display device worn on the bridge of the nose; accepts NTSC/PAL composite video input from medical equipment (e.g., endoscopes); displays video feed to the clinician via a single LCD; allows clinician to view both the camera image and the surrounding environment simultaneously; intended for use in clinical settings by physicians or medical staff; facilitates real-time visualization during procedures; provides a portable, hands-free alternative or supplement to standard stationary monitors.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Biocular video monitor; single LCD; 180,000 pixel resolution; 18.75 degree diagonal field of view; 20fL brightness; 200:1 contrast; 28mm eye relief; 58-77mm adjustable inter-pupillary distance; NTSC/PAL composite interface; 7-9V DC power; 36g monitor block; 9.5x4x3.5cm dimensions; mounts to eyeglasses; non-see-through display; see-around capability.

Indications for Use

Indicated for use by medical personnel during procedures requiring video display, such as endoscopic surgery, to view camera images while maintaining visibility of the surrounding area.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Albatech Personal Monitor (K981999)
• Medivision Personal Monitor (K961343)

Submission Summary (Full Text)

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MAY 19 1999

K990731 EASTGATE TRAI

EXECUTIVE OFFICE: 990 AVE. OF AMERICAS NEW YORK, N.Y. 10018 SUITE 15D

PHONE: [phone] FAX [phone]

#### 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).

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# EASTGATE TRADING CORP.

EXECUTIVE OFFICE: 990 AVE. OF AMERICAS NEW YORK, N.Y. 10018 SUITE 15D

PHONE: [phone] FAX [phone]

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.

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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# EASTGATE TRADI GT (

EXECUTIVE OFFICE: 990 AVE. OF AMERICAS NEW YORK, N.Y. 10018 SUITE 15D

PHONE: [phone] FAX [phone]

### 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