The EG-3670URK, 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.

Device Description

The EG-3670URK, 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 Connector is connected at the Ultrasound Scanner. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon injection/ evacuation, 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, may be introduced. The Video Processor contains a lamp that provides white light that is focused at the PVE Connector Lightguide Prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects image data. 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 as described in the Endoscope operator Manual cleaning instructions).

AI/ML Overview

This is an interesting case where the provided document is a 510(k) summary for a medical device, but it explicitly states that the submission for substantial equivalence was not based on an assessment of clinical performance data. Instead, it relied on a comparison of specifications and standard components to predicate devices. Therefore, the device was cleared without a study demonstrating that it meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity.

As a result, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving the device meets them, because such a study was not performed or submitted for this particular 510(k) clearance.

Here's a breakdown of what can be extracted from the document in relation to your request, and why other parts cannot be answered:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The 510(k) summary explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical, performance, data." Therefore, there are no reported device performance metrics against acceptance criteria related to clinical efficacy or diagnostic accuracy. The substantial equivalence was based on a comparison to predicate devices, implying that if the new device is sufficiently similar to an already cleared device, it is considered safe and effective for its intended use without new performance data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. No test set data was used because no study assessing clinical or performance data was conducted for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. As no test set was used, no ground truth was established by experts for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No test set, no adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. This device is an ultrasound video gastroscope, not an AI-powered diagnostic tool. No MRMC study or AI-related comparative effectiveness study was performed or is relevant to this traditional medical device clearance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Cannot be provided. Not applicable. This is a physical medical device (endoscope with ultrasound capability), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. No ground truth was established for performance evaluation.

8. The sample size for the training set

Cannot be provided. No training set was used as no performance study was conducted.

9. How the ground truth for the training set was established

Cannot be provided. No training set, no ground truth establishment for it.

Summary of Device and 510(k) Clearance:

The EG-3670URK Ultrasound Video Gastroscope was cleared based on substantial equivalence to existing predicate devices (Pentax EG-3630UR Video Ultrasound Gastroscope and Hitachi EUB-5500 Ultrasound Diagnostic Scanner). The manufacturer provided specifications, standard components, and accessories, along with comparison tables to illustrate similarity to the predicates. This type of clearance, common for many medical devices, does not require new clinical performance data if the device is deemed sufficiently similar to a legally marketed predicate device.

The FDA's clearance letter (K061068) confirms this, stating the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." The only specific post-clearance requirement mentioned is a "special report" containing acoustic output measurements based on production line devices, which relates to safety rather than clinical efficacy or diagnostic performance in a clinical study context.

Summary

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KD61068

510(k) Summary EG-3670URK, Ultrasound Video Gastroscope for use with EUB-5500 Ultrasound Diagnostic Scanners

Submitter Information:	Pentax Medical Company102 Chestnut Ridge Road	MAY	3 2006
	Montvale, NJ 07645-1856Tel: 800-431-5880

Name of Device:

Trade Name:	EG-3670URK, Ultrasound Video Gastroscope
Classification Name:	Diagnostic Ultrasound Transducer (90ITX) (892.1570),Endoscope and Accessories (78KOG) (876.1500)

Predicated Device(s) Information:

Model, Description	Manufacturer	PMN#
EG-3630UR, Video Ultrasound Gastroscope	Pentax Corporation	K041395
EUB-5500, Ultrasound Diagnostic Scanner	Hitachi America	K032503

The EG-3670URK, 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 Connector is connected at the Ultrasound Scanner. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon injection/ evacuation, 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, may be introduced. The Video Processor contains a lamp that provides white light that is focused at the PVE Connector Lightguide Prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects image data. 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 as described in the Endoscope operator Manual cleaning instructions).

Intended Use: The EG-3670URK, 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, 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-3670URK literature including specifications, the identification of standard set components, and identification of optional accessories, comparison tables were provided to illustrate the comparisons to the predicated devices in summary. The submission for substantial equivalence was not based on an assessment of clinical, performance, data.

Signature: Paul Silie

Date: 2-6-2006

Control Number: EG-3670URK.EUB-5500

Prepared by: Paul Silva

page I of 1

Revision: a

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pentax Medical Company % Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America, Inc. 12 Commerce Road NEWTOWN CT 06470

Re: K061068

Trade Name: EG-3670URK Ultrasound Video Gastroscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: KOG and ITX Dated: Apri 13, 2006 Received: April 17, 2006

Dear Mr. Borsai:

We have reviewed your Section 510(k) premarket 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 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). 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.

3 2006

MAY

This determination of substantial equivalence applies to the EG-3670URK Ultrasound Video Gastroscope with the EUB-5500 Ultrasound Scanner.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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

Image /page/1/Picture/12 description: The image is a circular logo with the letters "FDA" in the center. Above the letters, the numbers "120" and "XXX" are displayed. Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by a dotted border.

Protecting and Promoting Public Health

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Page 2 - Mr. Borsai

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.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special reror is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Andrew Kang at (301) 594-1212.

Sincerely vours.

David h. Ingram

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

Enclosure(s)

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510(k) Number (if known): Device Name:

EG-3670URK, Ultrasound Video Gastroscope

Endoscope Intended Use Statement

The EG-3670URK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic I is a sualization of, and therapeutic access to, the Upper Gastrointestinal Track includes but is not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small mendes but is not roursed to the organism is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Diagnostic Ultrasound Indications For Use Statement

EUB-2200 System: EG-3670URK Probe:

I 1000.

Clinical Application		Mode of Operation
General(Track I only)	Specific(Track I & III)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler
Ophthalmic
Fetal Imagingand other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laproscopic
	Pediatric
	Small Organ
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vagina
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convert.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Endoscopy	N	N	N		N	N
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (Spec.)

P = previously cleared by FDA; E = added under Appendix E N = new application;

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Timt A. Layson
(Division Sign-Off)

Division of Seproductive, Abdominal,
and Panological Devices
510(k) Number K061068

Prescription Use (Per 21 CFR 801.109)

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.