Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound image processing and does not mention AI, ML, or related terms.

Therapeutic

No
The device is described as a "Diagnostic ultrasound imaging or fluid flow analysis" system, and its purpose is to acquire and display "real-time ultrasound B-mode endoscopic images," which are diagnostic rather than therapeutic.

Diagnostic

Yes
The Intended Use/Indications for Use section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "combination" of hardware components (Endoscopic Ultrasound Center, Ultrasonic Probes, Ultrasonic Gastrovideoscopes) and describes the acquisition and display of images, indicating a system that includes physical hardware for image capture and processing.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that this device uses ultrasound imaging to visualize internal structures of the human body in real-time. It involves the direct application of sound waves to the body and the processing of reflected signals to create images.
Lack of Sample Analysis: There is no mention of analyzing samples taken from the body. The diagnostic process is based on imaging the body itself.

Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

XEU-M60A ENDOSCOPIC ULTRASOUND CENTER - Clinical Application: Trans-rectal (B, Color Doppler), Trans-urethral (B, Color Doppler), Trans-esoph. (non-Card.) (B, Color Doppler), Other (spec.) (Note 1) (B, Color Doppler). Note 1: Specification for "Other" : Gastrointestinal tract, biliary, pancreatic duct and surrounding organs. Intraluminal ultrasound for upper airways and tracheobronchial tree. Additional Comment: 3-D Imaging.

UM-2R / 3R ULTRASONIC PROBES - Clinical Application: Trans-rectal (B), Trans-urethral (B), Trans-esoph. (non-Card.) (B), Other (spec.) (Note 1) (B). Note 1: Specification for "Other" : Gastrointestinal tract, billiary, pancreatic duct and surrounding organs. Intraluminal ultrasound for upper airways and tracheobronchial tree

UM-DP12/20-25R ULTRASONIC PROBES - Clinical Application: Trans-rectal (B), Trans-urethral (B), Trans-esoph. (non-Card.) (B), Other (spec.) (Note 1) (B). Note 1: Specification for "Other" : Gastrointestinal tract, billary, pancreatic duct and surrounding organs. Intraluminal ultrasound for upper airways and tracheobronchial tree

ULTRASONIC GASTROVIDEOSCOPE GF TYPE UM130 - Clinical Application: Fetal (B), Abdominal (B), Intra-operative (specify) (B), Intraoperative (Neuro.) (B), Laparoscopic (B), Pediatric (B), Small Organ (specify) (B), Neonatal Cephalic (B), Adult Cephalic (B), Trans-rectal (B), Trans-vaginal (B), Trans-urethral (B), Trans-esoph. (non-Card.) (B), Musculo-skel. (Convent.) (B), Musculo-skel. (Superfic.) (B), Other (spec.) (Note 1) (B), Cardiac Adult (B), Cardiac Pediatric (B), Trans-esophageal (card.) (B), Other (spec.) (B). Note1: Specification for "Other": Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.

EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM160 - Clinical Application: Trans-esoph. (non-Card.) (B), Other (spec.) (Note 1) (B). Note 1: Specification for "Other" Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.

ULTRASONIC GASTROVIDEOSCOPE OLYMPUS XGF TYPE UM180 - Clinical Application: Trans-esoph. (non-Card.) (B), Other (spec.) (Note 1) (B). Note 1: Specification for "Other" Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.

GF-UE160-AL5 ULTRASONIC GASTROVIDEOSCOPE - Clinical Application: Trans-esoph. (non-Card.) (B, Color Doppler), Other (spec.) (Note 1) (B, Color Doppler). Note 1: Specification for "Other" Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.

GF-UCT140-AL5 ULTRASONIC GASTROVIDEOSCOPE - Clinical Application: Trans-esoph. (non-Card.) (B, Color Doppler), Other (spec.) (Note 1) (B, Color Doppler). Note1: Specification for "Other" Gastrointestinal tract, billiary, pancreatic duct and surrounding organs.

GF-UC140P-AL5 ULTRASONIC GASTROVIDEOSCOPE - Clinical Application: Trans-esoph. (non-Card.) (B, Color Doppler), Other (spec.) (Note 1) (B, Color Doppler). Note1: Specification for "Other" Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.

The indications for use for the XEU-M60A Endoscopic Ultrasound Center are as follows:

Transrectal
Transurethral
Transesophageal(non-cardiac)
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs
Intraluminal ultrasound for upper airways and tracheobronchial tree
3-D Imaging

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

IYN, IYO, ITX, ODG

Device Description

The combination of the XEU-M60A Endoscopic Ultrasound Center, UM-2R/3R Ultrasonic Probes, UM-DP12/20-25R Ultrasonic Probes, GF-UM130 Ultrasonic Gastrovideoscope, GF-UM160 Ultrasonic Gastrovideoscope, XGF-UM180 Ultrasonic Gastrovideoscope, GF-UE160-AL5 Ultrasonic Gastrovideoscope, GF-UC140P-AL5 Ultrasonic Gastrovideoscope, and GF-UCT140-AL5 Ultrasonic Gastrovideoscope enables the acquisition and display of high-resolution and high-penetration, real-time ultrasound B-mode endoscopic images.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Human body, Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, upper airways, tracheobronchial tree, Trans-rectal, Trans-urethral, Trans-esophageal (non-cardiac).

Indicated Patient Age Range

Not Found

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)

Not Found

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.

K043275, K010591

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

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

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

Olympus Medical Systems Corporation % Ms. Laura Storms-Tyler Olympus America, Inc. 3500 Corporate Parkway, PO Box 610 Center Valley, PA 18034-0610

JUL 2 7 2015

Re: K063683

Trade/Device Name: XEU-M60A Endoscopic Ultrasound Center Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX and ODG Dated (Date on orig SE ltr): December 5, 2006 Received (Date on orig SE ltr): December 14, 2006

Dear Ms. Storms-Tyler,

This letter corrects our substantially equivalent letter of February 8, 2007.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

1

Page 2 -

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 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 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. 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/ReportalProblem/default.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,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

4.3.1 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

XEU-M60A ENDOSCOPIC ULTRASOUND CENTER

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
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (specify)
	Intraoperative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N				N	Note 2
	Trans-vaginal
	Trans-urethral	N				N	Note 2
	Trans-esoph. (non-Card.)	N				N	Note 2
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other (spec.) (Note 1)	N				N	Note 2.
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Note 1: Specification for "Other" :

Gastrointestinal tract, biliary, pancreatic duct and surrounding organs. Intraluminal ultrasound for upper airways and tracheobronchial tree

Note 2: 3-D Imaging

David A. Simpson

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

Prescription Use (Per 21 CFR 801.109)

3

4.3.2 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

UM-2R / 3R ULTRASONIC PROBES

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

	Clinical Application
	General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
	Ophthalmic	Ophthalmic
		Fetal
		Abdominal
		Intra-operative (specify)
		Intraoperative (Neuro.)
	Fetal Imaging
& Other	Laparoscopic
		Pediatric
		Small Organ (specify)
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal	N
		Trans-vaginal
		Trans-urethral	N
		Trans-esoph. (non-Card.)	N
		Musculo-skel. (Convent.)
		Musculo-skel. (Superfic.)
		Other (spec.) (Note 1)	N
		Cardiac Adult
	Cardiac	Cardiac Pediatric
		Trans-esophageal (card.)
		Other (spec.).
	Peripheral
Vessel	Peripheral vessel
		Other (spec.)

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

Additional Comments:

.

Note 1: Specification for "Other" :

Gastrointestinal tract, billiary, pancreatic duct and surrounding organs. Intraluminal ultrasound for upper airways and tracheobronchial tree

Dennis K. Ingram
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __

Prescription Use (Per 21 CFR 801 109)

4

4.3.3 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

UM-DP12/20-25R ULTRASONIC PROBES

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

Clinical Application
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (specify)
	Intraoperative (Neuro.)
Fetal Imaging.
& Other	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N
	Trans-vaginal
	Trans-urethral	N
	Trans-esoph. (non-Card.)	N
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other (spec.) (Note 1)	N
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

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

Additional Comments:

Note 1: Specification for "Other" :

Gastrointestinal tract, billary, pancreatic duct and surrounding organs. Intraluminal ultrasound for upper airways and tracheobronchial tree

David B. Leggison

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

Prescription Use (Per 21 CFR 801.109) -

. .

5

4.3.4 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

ULTRASONIC GASTROVIDEOSCOPE GF TYPE UM130

Clinical Application
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
Abdominal
Intra-operative (specify)
Intraoperative (Neuro.)
Laparoscopic
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Other (spec.) (Note 1)	N
Cardiac	Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)	N
Peripheral
Vessel	Peripheral vessel
Other (spec.)

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

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

Additional Comments:

Note1: Specification for "Other"

Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.

Daniela Segmen

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

Prescription Use (Per 21 CFR 801, 109)

.

6

4.3.5 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM160

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
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (specify)
	Intraoperative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)	N
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other (spec.) (Note 1)	N
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Note 1: Specification for "Other"

Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.

Daniel R. Seymore

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

Prescription Use (Per 21 CFR 801.109)

7

4.3.6 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

ULTRASONIC GASTROVIDEOSCOPE OLYMPUS XGF TYPE UM180

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

	Clinical Application
	General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
	Ophthalmic	Ophthalmic
	Fetal Imaging
& Other	Fetal
		Abdominal
		Intra-operative (specify)
		Intraoperative (Neuro.)
		Laparoscopic
		Pediatric
		Small Organ (specify)
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)	N
		Musculo-skel. (Convent.)
		Musculo-skel. (Superfic.)
		Other (spec.) (Note 1)	N
	Cardiac	Cardiac Adult
		Cardiac Pediatric
		Trans-esophageal (card.)
		Other (spec.)
	Peripheral
Vessel	Peripheral vessel
		Other (spec.)

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

Additional Comments:

Note 1: Specification for "Other"

Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.

David h. Segner
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

Prescription Use (Per 21 CFR 801.109)

8

4.3.7 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (specify)
	Intraoperative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)	N				N
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other (spec.) (Note 1).	N				N
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.) (Note 1)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

GF-UE160-AL5 ULTRASONIC GASTROVIDEOSCOPE

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

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

Additional Comments:

Note 1: Specification for "Other"

Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.

David h. Segerson

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

Prescription Use (Per 21 CFR 801.109)

9

4.3.9 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

GF-UCT140-AL5 ULTRASONIC GASTROVIDEOSCOPE

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
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (specify)
	Intraoperative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)	N				N
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other (spec.) (Note 1)	N				N
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Note1: Specification for "Other"

mana ana mana mana mana mananta na mana d

Gastrointestinal tract, billiary, pancreatic duct and surrounding organs.

Gerral H. Leggott

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices ്ച് 1 | 14:1 Pumber .........................................................................................................................................................

Prescription Use (Per 21 CFR 801 109)

10

4.3.8 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

GF-UC140P-AL5 ULTRASONIC GASTROVIDEOSCOPE

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

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & II)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (specify)
	Intraoperative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)	N				N
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other (spec.) (Note 1)	N				N
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Note1: Specification for "Other"

Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.

David A. Seppon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 11

Prescription Use (Per 21 CFR 801.109)

. .

11

11063683

510(k) SUMMARY

8 2007 FEB

December X, 2006

ﮩ General information

트 Applicant:
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507

Establishment Registration No: 8010047

를 Official Correspondent:
Laura Storms-Tyler Executive Director Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5688 FAX: 484-896-7128 Email:Laura.storms-tyler@olympus.com Establishment Registration No: 2429304

Manufacturer: 트

OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT 34-3 Hirai Hinode-Machi, Nishitama-gun, Tokyo Japan, 190-0182 Establishment Registration No:8010047

2 Device Identification

Device Trade Name:

Model Name	Device Name
XEU-M60A	ENDOSCOPIC ULTRASOUND CENTER
UM-2R/3R	ULTRASONIC PROBES
UM-DP12/20-25R	ULTRASONIC PROBES
GF-UM130	ULTRASONIC GASTROVIDEOSCOPE
GF-UM160	EUS EXERA ULTRASONIC GASTROVIDEOSCOPE
XGF-UM180	ULTRASONIC GASTROVIDEOSCOPE
GF-UE160-AL5	ULTRASONIC GASTROVIDEOSCOPE
GF-UC140P-AL5	ULTRASONIC GASTROVIDEOSCOPE
GF-UCT140-AL5	ULTRASONIC GASTROVIDEOSCOPE

Common Name: 版

Diagnostic Ultrasound System

II

Regulation Number: 트

892.1550 Ultrasound Puised Doppler Imaging System 892.1560 Ultrasonic Pulsed Echo Imaging System 892.1570 Diagnostic Ultrasound Transducer 876.1500 Endoscope and Accessories

Regulatory Class:

12

I Product Code:

.

90-1YN/90-1YO/90-1TX/78-KOG

3 Predicate Device Information

:

Ultrasound System

Subject device	Predicate device
	Name	Control
number
XEU-M60A
ENDOSCOPIC ULTRASOUND
CENTER	EU-M60
EUS EXERA ENDOSCOPIC
ULTRASOUND CENTER	K043275
	EU-C60
EUS EXERA COMPACT
ENDOSCOPIC ULTRASOUND
CENTER	K010591

Ultrasonic Gastrovideoscopes and Probes

Subject device	Predicate device Name	Control number
UM-2R/3R
ULTRASONIC PROBES	UM-2R/3R
ULTRASONIC PROBES	K944610
K982323
K982610
UM-DP12/20-25R
ULTRASONIC PROBES	UM-2R/3R
ULTRASONIC PROBES	Based
upon
K944610,
K982323,
K982610,
Olympus
determined
that no
510(k) was
required
for device
changes.
GF-UM130
ULTRASONIC
GASTROVIDEOSCOPE	GF-UM130
ULTRASONIC GASTROVIDEOSCOPE	K971660
K011886
GF-UM160
EUS EXERA ULTRASONIC
GASTROVIDEOSCOPE	GF-UM160
EUS EXERA ULTRASONIC
GASTROVIDEOSCOPE	K011886
XGF-UM180
ULTRASONIC
GASTROVIDEOSCOPE	GF-UM160
ULTRASONIC GASTROVIDEOSCOPE	This
submission
GF-UE160-AL5
ULTRASONIC
GASTROVIDEOSCOPE	GF-UE160-AL5
ULTRASONIC GASTROVIDEOSCOPE	K051541
GF-UC140P-AL5
ULTRASONIC
GASTROVIDEOSCOPE	GF-UC140P-AL5
ULTRASONIC GASTROVIDEOSCOPE	K011314
GF-UCT140-AL5
ULTRASONIC
GASTROVIDEOSCOPE	GF-UCT140-AL5
ULTRASONIC GASTROVIDEOSCOPE	K012080

13

4 Device Description

The combination of the XEU-M60A Endoscopic Ultrasound Center, UM-2R/3R Ultrasonic Probes, UM-DP12/20-25R Ultrasonic Probes, GF-UM130 Ultrasonic Gastrovideoscope, GF-UM160 Ultrasonic Gastrovideoscope, XGF-UM180 Ultrasonic Gastrovideoscope, GF-UE160-AL5 Uftrasonic Gastrovideoscope, GF-UC140P-AL5 Ultrasonic Gastrovideoscope, and GF-UCT140-AL5 Ultrasonic Gastrovideoscope enables the acquisition and display of high-resolution and high-penetration, real-time ultrasound B-mode endoscopic images,

5 Indications for Use

The indications for use for the XEU-M60A Endoscopic Ultrasound Center are as follows:

Transrectal 제
1 Transurethral
199 Transesophageal(non-cardiac) .
17 Gastrointestinal tract, biliary, pancreatic duct and surrounding organs
Intraluminal ultrasound for upper airways and tracheobronchial tree 1
18 3-D Imaging

ర్ Comparison of Technological Characteristics

The XEU-M60A Endoscopic Ultrasound Center operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis.

Technological Characteristics of this device is identical to the predicate devices identified in item 3.