K Number

Device Name

FG-36UX FIBER ULTRASOUND GASTROSCOPE

Manufacturer

PENTAX PRECISION INSTRUMENT CORP.

Date Cleared

2004-06-09

(14 days)

Product Code

ITX

Regulation Number

892.1570

Intended Use

The FG-36UX, Fiber Ultrasound 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. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy

Device Description

The endoscope has a flexible insertion tube, a control body, and Umbilicus is bifurcated where one endoscope nas a nextion miscrion table a contains connections for air/water and suction. The other umbilicus Connector is connected to the ultrasound scanner. The control body includes controls for up/ down/ left/ right angulation, an accessory elevator control, air/water delivery, suction selection/ control, forward water jet port, balloon insulflation, an accessory interport, and the endoscopic image viewing occular. The device contains light banoon insurration, an accessory inter port, another to optically visualize the anatomy, and an ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy transacer of concer annasonia mage cause the instrument is supplied with two biopsy forceps). A convex linear devices, of other us views, may of and adoced (the pulses are received and signals are passed to the array transadeer dor 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).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K961974, K032503, K013722

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard fiber ultrasound gastroscope and ultrasound scanner, focusing on optical and ultrasonic visualization and therapeutic access. There is no mention of AI, ML, or any advanced image processing beyond basic signal processing for ultrasound display. The performance studies section indicates substantial equivalence was not based on clinical performance data, which would be expected if AI/ML algorithms were being evaluated.

Therapeutic

Yes.
The "Intended Use / Indications for Use" section explicitly states that the device offers "therapeutic access to, the Upper Gastrointestinal Tract."

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is for "ultrasonic visualization" and "diagnostic ultrasound imaging". The "Device Description" also mentions an "ultrasound transducer to collect ultrasonic image data." These clearly indicate its role in diagnosing conditions within the gastrointestinal tract.

SaMD (Software as a Medical Device)

The device description clearly outlines physical hardware components including a flexible insertion tube, control body, umbilicus, light source, ultrasound transducer, and working channel. It is a physical endoscope with integrated ultrasound capabilities, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to provide optical and ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. This is a procedure performed in vivo (within the living body) for diagnostic and therapeutic purposes.
Device Description: The description details a flexible endoscope with optical and ultrasound capabilities, designed for insertion into the body. It also mentions a working channel for therapeutic access (like biopsy).
Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the living body) to provide information for diagnostic purposes. This device does not perform such analysis on specimens.

The device is an endoscopic ultrasound system, which is a medical device used for imaging and intervention within the body. While it provides diagnostic information through imaging, it does so through direct visualization and ultrasound scanning in vivo, not by analyzing samples in vitro.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FG-36UX, Fiber Ultrasound 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.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy

Product codes (comma separated list FDA assigned to the subject device)

90 ITX, 78 FDS

Device Description

The endoscope has a flexible insertion tube, a control body, and Umbilicus is bifurcated where one endoscope has a nextion miscrion table a contains connections for air/water and suction. The other umbilicus Connector is connected to the ultrasound scanner. The control body includes controls for up/ down/ left/ right angulation, an accessory elevator control, air/water delivery, suction selection/ control, forward water jet port, balloon insulflation, an accessory interport, and the endoscopic image viewing occular. The device contains light banoon insurration, an accessory inter port, another to optically visualize the anatomy, and an ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy transacer of concer annasonia mage cause the instrument is supplied with two biopsy forceps). A convex linear devices, of other us views, may of and adoced (the pulses are received and signals are passed to the array transadeer dor 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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound, Optical (endoscopic)

Anatomical Site

Upper Gastrointestinal Tract, including Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas.

Indicated Patient Age Range

Adult and Pediatric patient populations.

Intended User / Care Setting

Not Found

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)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K961974, K032503, K013722

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

Summary

K041396

510(k )Summary FG-36UX, Fiber Ultrasound Gastroscope for use with EUB-5500 and EUB-8500 Ultrasound Diagnostic Scanner

Submitter Information:

Pentax Precision Instrument Corporation (PPIC) 30 Ramland Road Orangeburg, NY, 10962 Tel: (914)-365-0700

Name of Device:

Trade Name	FG-36UX, Fiber Ultrasound 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
EUB-5500, Ultrasound Diagnostic Scanner	Hitachi America	K032503
EUB-8500, Ultrasound Diagnostic Scanner	Hitachi America	K013722

The FG-36UX, Fiber Ultrasound Gastroscope, can be used with any Lightsource (with the Device Description: Device Description: endoscope has a flexible insertion tube, a control body, and Umbilicus is bifurcated where one endoscope nas a nextion miscrion table a contains connections for air/water and suction. The other umbilicus Connector is connected to the ultrasound scanner. The control body includes controls for up/ down/ left/ right angulation, an accessory elevator control, air/water delivery, suction selection/ control, forward water jet port, balloon insulflation, an accessory interport, and the endoscopic image viewing occular. The device contains light banoon insurration, an accessory inter port, another to optically visualize the anatomy, and an ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy transacer of concer annasonia mage cause the instrument is supplied with two biopsy forceps). A convex linear devices, of other us views, may of and adoced (the pulses are received and signals are passed to the array transadeer dor 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 FG-36UX, Fiber Ultrasound Gastroscope, is intended to provide optical visualization of , ultrasone 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):

Comparison for substantial equivalence included FG-36UX literature including specifications, the identification I in submitsion for substantial of optional accessories, comparison tables were provided to illustrate of standard set componens; and devices in summary. The submission for substantial equivalence was not based on an assessment of clinical performance data.

Prepared by: Paul Silva

Signature: Paul Silva

Date: 11-25-2003

Control Number: FG-36UX.EUB-5500&8500

page I of I

Revision: a

Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. 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 symbol that resembles three abstract human profiles or figures, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2004

PENTAX Precision Instrument Corporation % Mr. Matthias Heinze Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K041396

Trade Name: EUB-5500 and EUB 8500 Ultrasound Diagnostic Scanners Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 90 ITX and 78 FDS Dated: May 21, 2004 Received: May 26, 2004

Dear Mr. Heinze:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bave 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 interslate commerce prov to may 23) been reclassified in accordance with the provisions of the Amendinents, of to devices and Cosmetic Act (Act). You may, therefore, market the device, subject to I cacral controls provisions of the Act. The general controls provisions of the Act include the general controls pro risting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for This detenmination of backannal or of 00 Ultrasound Diagnostic Scanners, as described in your premarket notification:

Transducer Model Number

FG-36UX

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (360 a0070) incols. Existing major regulations affecting your device EDA it may be subject to such additional confrols: "Internet 21, Parts 800 to 898 In addition, FDA can be found in the Code of Features concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA 3 issuation of a backed complies with other requirements of the Act that FDA has made a decemination administered by other Federal agencies. You must of any Federal Statutes and regulations asnimister on the limited to: registration and listing (21 comply will an the Act stequirements, moraaling practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping I mis device, you submit a postclearance special report. This report should contain complete the first device, you submit a postolution special is based on production line devices, requested information, metuding acousine output measuremer 30, 1997 "Information for Manufacturers
in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufac In Appendix U, (enclosed) of the Center S Systems and Transducers." If the special Seeking Marketing Clearantee or Dragiosable values (e.g., acoustic output greater than approved report is incomplete or comains anaseeping has 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 The special report block of the 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 nonitication. The I Driving of Seation 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 If you desire specific at not 10-19-15-11 (301) 594-4591. Additionally, for questions on the comacion and advertising of your device, please contact the Office of Compliance at (301) 594promotion and advertising or youlation entitled, "Misbranding by reference to premarket 40.77. Also, please note the regaration ther general information on your responsibilities under the notification (21 CFR Part 60777). Saot Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Page 3 - Mr. Heinze

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

Sincerely yours,

Danillo. lezmon

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

Enclosure(s)

510(k) Number (if known): Device Name: Ultrasound Video Gastroscope FG-36UX

Endoscope Intended Use Statement:

Endoscope Intended Use Statement.
The FG-36UX, Fiber Ultrasound Gastroscope, is intended to provide optical visual Costrostination of I he FG-36UX, Fiber Ultrasound Oastrosope, Is intender to prest. The Upper Gastointestinal Tract, I rach visualization of, and therapedia accoss to, the Opper Ousinessmal sophagus, Stomach, Duodenum, Small,
includes but is not restricted to, the organs; tissues; and subsystems: includes but is not restrered to, the organs, insuced per orally when indications consistent with the Bower, and underlying arcas. The mistrance. In Adult and Pediatric patient populations.

Diagnostic Ultrasound Indications For Use Statement

System:	EUB-8500
Probe:	FG-36UX
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	Color	Amplitude
(Track I only)	(Track I & III)					Doppler	Doppler
Ophthalmic
Fetal Imaging	Fetal
& Other	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. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Endoscopy	N	N	N		N	N
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (Spec.)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymann

(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number

510(k) Number (if known): 310(k) Number (if Rhowing Video Gastroscope FG-36UX

Endoscope Intended Use Statement:

Endoscope Intended Use Statement:
The FG-36UX, Fiber Ultrasound Gastroscope, is intended to provide optical visualization of , ultrasonic The FG-36UX, Fiber Ultrasound Gastroscope, Is incenter Pract. The Upper Gastrointestinal Tract
visualization of, and therapeutic access to, the Upper Castronics Stopher Small visualization of, and therapeutic access to, the Opper Crash and Superions Stephages, Steath, Duodenum, Small includes but is not restricted to, the organs, tissus, and assessment indications consistent with the Bowel, and underlying areas. The mstument is increases patient populations.
requirement for the procedure are observed in Adult and Pediatric patient populations.

Diagnostic Ultrasound Indications For Use Statement

| System:

EUB-5500
Probe:	FG-36UX
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Track I & III)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
Ophthalmic
Fetal Imaging
& 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. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Endoscopy	N	N	N	N	N	N
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (Spec.)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lynam

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _