The Ultrasound Video Gastroscope EG-3630UR is intended to provide ultrasonic and optical visualization of, and therapeutic access to, the Upper GI tract including esophagus, stomach, duodenum/small bowel in adult and pediatric patient populations.

Device Description

The EG-3630UR, Ultrasound Video Gastroscope, must be used with a Pentax Video Processor (software controlled device) and must be used with Ultrasound Scanner (software controlled device). The endoscope has a Flexible Insertion Tube, a Control Body, PVE Umbilical Connector, and Scanner Umbilical Connector. The PVE Connector connects to the Video Processor and has connections for illumination, video signals, air/water and suction. The Scanner Connected at the Ultrasound Scanner. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon insufflation, and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect image data, and a radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a lamp that provides white light that is filtered, via a Red, Green, and Blue color filter wheel, and is focused at the PVE Connector Lightguide Prong. The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The Video Processor stores the CCD information until all three color strobes are completed and a full color image frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the Video Processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and signals are passed to the Ultrasound Scanner for display. The instrument is immersable (with the use of supplied cleaning accessories) except for the Ultrasound Scanner Connector (as described in the Endoscope operator Manual cleaning instructions).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Ultrasound Video Gastroscope EG-3630UR". However, it explicitly states:

"The submission for substantial equivalence was not based on an assessment of clinical performance data."

This means the submission did not include a study to prove the device meets acceptance criteria based on clinical performance. Instead, the substantial equivalence was based on a comparison of specifications, standard components, and optional accessories to predicate devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study proving these criteria, as such a study was not part of this 510(k) submission.

Summary of what can be derived from the provided text:

Device: EG-3630UR, Ultrasound Video Gastroscope
Intended Use: To provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract (Esophagus, Stomach, Duodenum, Small Bowel) in adult and pediatric patient populations.
Basis for 510(k) Clearance: Substantial equivalence to predicate devices (FG-36UX, EG-2940, EPM-3300, EUB-525, EUB-6000) based on specifications and features, not clinical performance data.

Therefore, the following information is NOT available from the provided text:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
If a standalone (algorithm only) performance study was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The sample size for the training set
How the ground truth for the training set was established

Summary

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KD13640

510(k )Summary EG-3630UR. Ultrasound Video Gastroscope for use with EUB-525 and EUB-6000 Ultrasound Diagnostic Scanner

Submitter Information:

Pentax Precision Instrument Corporation (PPIC) 30 Ramland Road Orangeburg, NY, 10962 Tel: (845)-365-0700

FEB 0 4 2002

Name of Device:

Trade Name:	EG-3630UR, Ultrasound Video Gastroscope
Classification Name:	Diagnostic Ultrasound Transducer (74JOP) {892.1570},
	Endoscope and Accessories (78KOG) {876.1500}

Predicated Device(s) Information:

Model, Description	Manufacturer	PMN#
FG-36UX, Fiber Ultrasound Gastroscope	PPIC	K961974
EG-2940, Video Gastroscope	PPIC	K961564
EPM-3300, Video Processor	PPIC	K934918
EUB-525, Ultrasound Diagnostic Scanner	Hitachi America	K981434
EUB-6000, Ultrasound Diagnostic Scanner	Hitachi America	K994026

The EG-3630UR, Ultrasound Video Gastroscope, must be used with a Pentax Video Device Description: Processor (software controlled device) and must be used with Ultrasound Scanner (software controlled device). The endoscope has a Flexible Insertion Tube, a Control Body, PVE Umbilical Connector, and Scanner Umbilical Connector. The PVE Connector connects to the Video Processor and has connections for illumination, video signals, air/water and suction. The Scanner Connected at the Ultrasound Scanner. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon insufflation, and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect image data, and a radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a lamp that provides white light that is filtered, via a Red, Green, and Blue color filter wheel, and is focused at the PVE Connector Lightguide Prong. The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The Video Processor stores the CCD information until all three color strobes are completed and a full color image frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the Video Processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and signals are passed to the Ultrasound Scanner for display. The instrument is immersable (with the use of supplied cleaning accessories) except for the Ultrasound Scanner Connector (as described in the Endoscope operator Manual cleaning instructions).

Intended Use: The EG-3630UR, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.

Comparison To Predicated Device(s):

The submission for substantial equivalence included EG-3630UR literature including specifications, the identification of standard set components, and identification of optional accessories, comparison tables were novided to illustrate the comparisons to the predicated devices in summary. The submission for substantial equivalence was not based on an assessment of clipical performance data.

Prepared by: Paul Silva

Signature: Paul Silva

Date: 11-01-01

Control Number: PS-726

Revision. a

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 4 2002

Mr. Paul Silva Regulatory Affairs Coordinator PENTAX Precision Instrument Corp. 30 Ramland Road ORANGEBURG NY 10962-2699

Re: K013640 Trade/Device Name: Ultrasound Video Gastroscope EG-3630UR Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Procode: 76 FDS Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasound transducer Procode: 90 ITX Dated: November 1, 2001 Received: November 5, 2001

Dear Mr. Silva:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page	of
__________	__________

510(k) Number (if known): K013640

Device Name: Ultrasound Video Gastroscope EG-3630UR

Indications For Use: The Ultrasound Video Gastroscope EG-3630UR is intended to provide ultrasonic and optical visualization of, and therapeutic access to, the Upper GI tract including esophagus, stomach, duodenum/small bowel in adult and pediatric patient populations.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

(Optional Format 3-10-98)

Prescription Use

Regulation Number and Section

§ 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.