The EG-3670URK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but 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 procedure are observed in adult and pediatric patient populations.

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy with Mode of Operation B, M, PWD, Color Doppler, Amplitude Doppler.

Device Description

PENTAX EG-3670URK Ultrasound Video Gastroscope + HI VISION PREIRUS are the endoscopic ultrasound system consists of an ultrasound endoscope with a radial array type ultrasound transducer, video processor, and Hitachi ultrasound scanner. This modified new system configuration is to work together with the already cleared latest Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner (K093466).

AI/ML Overview

The provided document is a 510(k) summary for a medical device modification. It states that the submission is a "Special 510(k)" for a system configuration change, specifically replacing an older ultrasound scanner (Hitachi HI VISION 900) with a newer one (Hitachi HI VISION PREIRUS) while keeping the same PENTAX EG-3670URK Ultrasound Video Gastroscope.

Since this is a Special 510(k) for a modification that does not impact intended use, safety, and/or effectiveness, a detailed clinical study proving device performance against acceptance criteria is generally not required in the same way as a new device submission. Instead, the document focuses on demonstrating substantial equivalence to the predicate device and verification and validation of compatibility.

Therefore, the document does not contain the information requested in your numbered points about acceptance criteria and detailed study results. It primarily focuses on regulatory compliance and the demonstration that the modified system is equivalent to the predicate device.

Here's a breakdown of what can be inferred or directly stated from the document, and what is explicitly missing:

1. Table of acceptance criteria and the reported device performance:

Missing. The document does not provide a table of acceptance criteria or specific performance metrics for the device. As a Special 510(k) for a system configuration change, the focus is on maintaining existing performance, not establishing new performance.

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

Missing. No information on a test set sample size or data provenance is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Missing. No information on experts or ground truth for a test set is provided.

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

Missing. No information on an adjudication method is provided.

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:

Missing. This device is an Endoscopic Ultrasound system, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related metrics are not applicable and not mentioned.

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

Missing. This is not an AI algorithm, but a medical imaging system. Standalone performance as described is not applicable.

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

Missing. No information on ground truth type is provided for a performance study.

8. The sample size for the training set:

Missing. No information on a training set sample size is provided. This is not an AI/machine learning device.

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

Missing. No information on how ground truth was established for a training set is provided.

Summary from the document regarding the study and acceptance:

The central 'study' mentioned in this Special 510(k) is the verification and validation (V&V) activities performed to ensure compatibility between the PENTAX EG-3670URK Ultrasound Video Gastroscope and the HITACHI HI VISION PREIRUS Ultrasound Scanner.

Acceptance Criteria (Implied): The implied acceptance criterion for this submission is that the modified system configuration (Gastroscope + HI VISION PREIRUS) performs "as safe, as effective and substantially equivalent in performance to the above identified cleared predicate device/system" (Gastroscope + HI VISION 900). This is a regulatory acceptance criterion for a Special 510(k), not a clinical performance metric.
Study/Proof: "The modified system configuration has been verified and validated according to the company's design control activities as certified in this Special 510(K) Submission's declaration of conformity with design control to ensure the compatibility between the PENTAX EG-3670URK Ultrasound Video Gastroscope and the HITACHI HI VISION PREIRUS Ultrasound Scanner."

In essence, for this specific type of submission, the "proof" is the successful execution of design control activities, including verification and validation, demonstrating that the new component (HI VISION PREIRUS) is compatible with the existing device (EG-3670URK) and that the overall system maintains its previous safety and effectiveness. No new clinical performance data is presented because the fundamental performance characteristics are not expected to change, and the change is limited to swapping one compatible component for another.

Summary

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K130206 Page 1 of 2

510(k) Summary

MAR 20 2013

The following summary is provided in accordance with 21 CFR 807.92:

Date: 28 February 2013

Submitter:	PENTAX Medical Company,A Division of PENTAX America, Inc.3 Paragon DriveMontvale, New Jersey 07645-1782
Contact:	Krishna GovindarajanRegulatory ManagerPENTAX Medical Company,A Division of PENTAX America, Inc.3 Paragon DriveMontvale, New Jersey 07645-1782Phone: 800-431-5880 x 2125, 201-251-2300 x 2125Fax: 201-799-4117Email: Krishna.govindarajan@pentaxmedical.com
Device - Trade Name:	PENTAX EG-3670URK Ultrasound Video Gastroscope (RadialArray Type) + HI VISION PREIRUS
Common/Usual Name:	Endoscopic Ultrasound
Classification Name:	Endoscopic ultrasound system, gastroenterology/urology
Regulation Number:Regulation Description:Medical Specialty:Regulatory Class:Product Code:	21 CFR Part 876.1500Endoscope and accessoriesGastroenterology/UrologyClass IIODG and ITX
Predicate Device:	PENTAX EG-3670URK Ultrasound Video Gastroscope + HIVISION 900 (K090196)

Intended Use:

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K130206 Page 2 of 2

PENTAX
PENTAX Medical Company

Device Description:

Device Modification & Substantial Equivalence:

The PENTAX EG-3670URK Ultrasound Video Gastroscope with HITACHI Hi VISION 900 (HV900) Ultrasound Scanner system configuration has been previously cleared (K090196). This Special 510(k) submission is a modification with new system configuration to work together with the already cleared latest Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner (K093466) instead of old Hitachi HI VISION 900 Diagnostic Ultrasound Scanner (K063518).

There are no software or hardware changes between the PENTAX EG-3670URK Ultrasound Video Gastroscope subject and predicate device in connecting with the new Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner. In addition, there are no change in technology, including features, materials, and principles of operation.

The system configuration modification does not impact the intended use, safety and/or effectiveness. The modified system configuration has been verified and validated according to the company's design control activities as certified in this Special 510(K) Submission's declaration of conformity with design control to ensure the compatibility between the PENTAX EG-3670URK Ultrasound Video Gastroscope and the HITACHI HI VISION PREIRUS Ultrasound Scanner.

This modified system configuration is substantially equivalent to the predicate device/system with regards to both intended use and technological characteristics.

Conclusion:

The PENTAX Medical Company believes that the PENTAX EG-3670URK Ultrasound Video Gastroscope + HI VISION PREIRUS system modification as indicated in this special 510(k) premarket notification submission is to be as safe, as effective and substantially equivalent in performance to the above identified cleared predicate device/system.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2013

PENTAX Medical A Division of PENTAX America, Inc. % Mr. Krishna Govindarajan Regulatory Manager 3 Paragon Drive MONTVALE NJ 07645

Re: K130206

Trade/Device Name: PENTAX EG-3670URK Ultrasound Video Gastroscope (Radial Array Type) + HI VISION PREIRUS Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODG and ITX Dated: March 1, 2013 Received: March 4. 2013

Dear Mr. Govindarajan:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Govindarajan

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

K130206 510(k) Number (if known):

Device Name: PENTAX EG-3670URK Ultrasound Video Gastroscope (Radial Array Type) + HI VISION PREIRUS

Indications for Use:

Endoscope

Diagnostic Ultrasound

System:	Hitachi HI VISION PREIRUS
Probe:	EG-3670URK (Radial Array Type)
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows
Clinical Application	Mode of Operation

Clinical Application		Mode of Operation
	Specific	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler
General(Track I only)	(Track I & III)
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	P	P	P		P	P
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (Spec.)

N = new application; P = previously cleared by FDA; K090196 E = added under Appendix E

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

fm. P

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130206 510(k)

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.