K Number

Device Name

OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE

Manufacturer

OLYMPUS MEDICAL SYSTEMS CORPORATION

Date Cleared

2010-06-17

(230 days)

Product Code

IYN ITX IYO NWB ODG

Regulation Number

892.1550

Intended Use

This instrument has been designed to be used with an Olympus universal endoscopic ultrasound center or a diagnostic ultrasound system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment. This instrument is designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

Device Description

OLYMPUS GF-UCT180 EVIS EXERA II ULTRASOUND GASTRO VIDEOSCOPE have been designed to be used with the SSD-a10(K043196) diagnostic ultrasound systems (ALOKA CO.,LTD.), video system center, light source, documentation equipment, monitor, Endo-Therapy accessories such as aspiration biopsy needle and other ancillary equipment. The subject devices are designed for endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

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

K011314, K043196

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound gastro videoscope and associated equipment, with no mention of AI, ML, or advanced image processing features that would typically indicate the presence of such technology.

Therapeutic

No
The device is described as being for "real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures," which are diagnostic or procedural guidance functions, not therapeutic in themselves. It is explicitly coupled with "Endo-Therapy accessories such as aspiration biopsy needle," suggesting the device itself is for guidance, while the accessories perform any therapeutic action.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that the instrument is designed to be used with a "diagnostic ultrasound system" and for "real-time ultrasound imaging" and "ultrasound guided needle aspiration," which are diagnostic procedures. The "Device Description" also mentions its use with "diagnostic ultrasound systems."

SaMD (Software as a Medical Device)

The device description clearly identifies the device as a "ULTRASOUND GASTRO VIDEOSCOPE," which is a physical hardware instrument used for endoscopic procedures. It is designed to be used with other hardware components like ultrasound systems, video centers, and light sources.

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 describes the device for "endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs." This is a procedure performed in vivo (within the living body) for diagnostic and therapeutic purposes.
Device Description: The description reinforces the use for "endoscopic procedures within the upper gastrointestinal tract and surrounding organs."
Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on specimens.

The device is an endoscopic ultrasound system, which is used for imaging and procedures directly within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

IYN, IYO, ITX, ODG and NWB

Device Description

The subject devices are designed for endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

upper gastrointestinal tract and surrounding organs

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.

K011314, K043196

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle.

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

Olympus Medical Systems Corporation % Ms. Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway, PO Box 610 Center Valley, PA 18034-0610

JUL 2 7 2013

Re: K093395

Trade/Device Name: Olympus GF Type UCT180, Olympus GF Type UST180 Evis Exera II Ultrasound Gastrovideoscope used with ALOKA SSD-α 10 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, ODG and NWB Dated (Date on orig SE ltr): May 26, 2010

Received (Date on orig SE ltr): May 27, 2010

Dear Ms. Kluesner,

This letter corrects our substantially equivalent letter of June 17, 2010.

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

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/ReportaProblem/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

Indications for Use

510(k) Number (if known): K093395

Device Name: OLYMPUS GF-UCT180

Indications For Use:

This instrument is designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

S.N.B.

(Division Sign-On)
Division of Radiological Devices
Health Diagnostic Device Evaluation and Safety

Page 1 of

1.3.1 Diagnostic Ultrasound Indications for Use Form

OLYMPUS GF TYPE UCT180 ULTRASOUND·GASTROVIDEOSCOPE used with the ALOKA SSD-a10 ULTRASOUND SYSTEM

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)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal		N	N	N		N	N
	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	N		N	N
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intravascular
	Other (spec.)
(Note 1)		N	N	N		N	N
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (card.)
	Trans-esophageal (card.)
	Intra-cardiac
	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 and Surrounding Organs

(Division Sign On) Division of Radiological De gnostic Device Evalue Office of in Vits

K093395
$10K

ULTRASOUND SYSTEM SSD-a10

Clinical Application		Mode of Operation
General
(Track I
only)	Specific
(Tracks I & III)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmi
c	Ophthalmic
	Fetal		P	P	P		P	P	(Note 3)
	Abdominal		P	P	P		P	P	(Note 3)
	Intra-operative (specify)
(Note 4)		P	P	P		P	P	(Note 3)
	Intraoperative (Neuro.)
Fetal
Imaging
&
Other	Laparoscopic
	Pediatric		P	P	P		P	P	(Note 3)
	Small Organ (specify)
(Note 4)		P	P	P		P	P	(Note 3)
	Neonatal Cephalic		P	P	P		P	P	(Note 3)
	Adult Cephalic
	Trans-rectal		·P	P	P		P	P	(Note 3)
	Trans-vaginal		P	P	P		P	P	(Note 3)
	Trans-urethral
	Trans-esoph. (non-Card.)		P	P	P		P	P	(Note 2)
	Musculo-skel. (Convent.)		.P	P	P		P	P	(Note 3)
	Musculo-skel. (Superfic.)
	Other (spec.)
(Note 1)		P	P	P		P	P	(Note 2)
Cardiac	Cardiac		P	P	P		P	P	(Note 3)
Peripheral
Vessel	Peripheral vessel		P	P	P		P	P	(Note 3)
	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:

Note 1: Specification for "Other" :

Airways and tracheobronchial tree, Upper Gastrointestinal Tract and Surrounding Organs

Note 2: Specification for "Combined mode operation" includes:B/M,B/PWD,B/CD/PWD

Note 3: Specification for "Combined mode operation" includes :

B/M, P/PWD, M/CD, B/CD/PWD, B/CWD, B/CD/CWD

Note 4: Specification for "Small Organ" and "Intraoperative" :

Small Parts-breast/ testes/ thyroid, ·

Intra-operative-liver/ pancreas/ gall-bladder/ abdominal, gynecological, fetal, neonatal, cardiac.

cardiac.

SICK

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

6 of 77

K093395
JUN 17 2010

510(k) SUMMARY

March 9, 2010

1 General Information

		GF-UCT180	SSD-a 10
1.2.1	Manufacture's Name:	OLYMPUS MEDICAL SYSTEMS
CORP.
HINODE PLANT	ALOKA CO., LTD.
	Address:	34-3 Hirai Hinode-Machi,
Nishitama-gun, Tokyo
190-0182, Japan	6-22-1, Mure Mitaka-Shi
Tokyo 181-8622, Japan
	Corresponding Official:	Stacy Abbatiello Kluesner, RAC
Regulatory Affairs & Quality
Assurance	Richard J Cehovsky
RA/QA Coordinator
	Address:	Olympus America Inc.
3500 Corporate Parkway
PO Box 610
Center Valley, PA 18034-0610.	ALOKA CO. LTD USA
10 Fairfield blvd.
Wallingford, CT 06492
	Telephone:	484-896-5405	203-269-5088
	Facsimile:	484-896-7128
	E-mail:	stacy.kluesner@olympus.com
	Applicant's Name:	OLYMPUS MEDICAL SYSTEMS
CORP.
	Address:	2951 Ishikawa-cho, Hachioji-shi,
Tokyo, Japan 192-8507
1.2.2	Initial Distributor
Name/Title/Firm:	Olympus America Inc.
	Address:	3500 Corporate Parkway
PO Box 610
Center Valley, PA 18034-0610,
	Telephone:	484-896-5688

2 Device Identification

Device Trade Name:

EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180

Common Name:	Ultrasonic Endoscope
Regulation Number:	892.1570 Diagnostic Ultrasound Transducer
892.1550 Ultrasonic Pulsed Doppler Imaging System
892.1560 Ultrasonic Echo Imaging System
876.1500 Endoscope and Accessories
Regulatory Class:	II

Product Code: ITX/ IYN/ KOG/ NWB/ IYO

3 Predicate Device Information

Ultrasonic Endoscope

Subject device	Predicate devices
	Name	Control number
GF-UCT180
EVIS EXERA II ULTRASOUND
GASTROVIDEOSCOPE	GF-UC140P-AL5
ULTRASONIC
GASTROVIDEOSCOPE	K011314
SSD-α 10	ALOKA SSD-α 10 ULTRASOUND
SYSTEM	K043196

4 Device Description

The subject devices are designed for endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

5 Indications for Use

This instrument has been designed to be used with an Olympus universal endoscopic ultrasound center or a diagnostic ultrasound system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment, This instrument is designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

6 Comparison of Technological Characteristics

When the OLYMPUS GF-UCT180 used with the ALOKA SSD-a10 ULTRASOUND SYSTEM is compared to its predicate device does not incorporate any significant changes in its intended use, method of operation, material or design that could affect the safety and effectiveness, Technological characteristics of ALOKA SSD-a10 ULTRASOUND SYSTEM is identical to the predicate devices identified in above item 3.