Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal - OB/GYN
Laparoscopic
Intraoperative (abdominal organs and vascular)
Abdominal
Small Organ (breast, thyroid, testicle)
Trans-vaginal
Trans-rectal
Musculo-skeletal (conventional)
Musculo-skeletal (superficial)
Neonatal Cephalic
Pediatric
Cardiac-(adult and pediatric)
Trans-esophageal (non-cardiac)
Peripheral Vessel
Other

Gastrointestinal tract and the surrounding Organs
The airways and tracheobronchial tree

Device Description

The EU-C60 is a general purpose, compact, software-controlled, diagnostic ultrasound system. The EU-C60 has compatibility with SonoSite transducers (such as abdominal or intracavital transducers) and Olympus Ultrasound videoscope. Its function is to acquire ultrasound data and display it on a monitor in several modes. ( 2D, Color Power Doppler, PowerMap™ Directional Color Power Doppler, or in a combination of modes.) The EU-C60 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes. The GF-UC160P-OL5/GF-UCT160-OL5 give the operator the ability to perform Endocopic Ultrasound(EUS) guided fine needle aspiration(FNA).

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for the Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center. This document's primary purpose is to demonstrate substantial equivalence to previously marketed devices, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner that a clinical trial for a novel AI algorithm would.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in this type of regulatory submission. The document focuses on demonstrating that the new device performs within the expected parameters of existing, legally marketed ultrasound systems.

Here's an analysis of what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

The document does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds) as would be found in a performance study for an AI device. Instead, the "performance" is implicitly demonstrated by stating that the device "operates identically to the predicate devices" and "complies with the standards listed below."

Acceptance Criteria Category	Reported Device Performance (from text)
Intended Use Equivalence	The device's intended uses are substantially equivalent to those of the predicate devices.
Technological Characteristics Equivalence	"This device operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves… Sound waves are reflected back to the transducer and converted to electric signals, which 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 predicated devices identified in item 3."
Design Standards Compliance	"The EU-C60 is designed to comply with the standards listed below: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, CISPR11."
Material Biocompatibility	"The material of Balloon3 is a new patient-contacting material. The biocompatibility test reports of the new material show that the new material is safe for its intended use."

2. Sample size used for the test set and the data provenance:

Not provided. This document is not a clinical study report with a test set of patient data. The "study" here refers to the process of demonstrating substantial equivalence, which primarily involves comparing the device's technical specifications and intended uses to those of predicate devices.

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

Not applicable. There is no mention of an external test set with ground truth established by experts.

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

Not applicable. No test set or adjudication process is described.

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:

Not conducted/applicable. This is not an AI device, and no MRMC study is mentioned.

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

Not conducted/applicable. This is a diagnostic ultrasound system, not an algorithm, and the concept of "standalone performance" in the AI sense does not apply.

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

Not applicable. The "ground truth" in this context is the performance and safety profiles of the predicate devices and compliance with established medical device standards.

8. The sample size for the training set:

Not applicable. This document describes a medical device, not a machine learning model, so there is no "training set."

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

Not applicable. See above.

In summary:

This document is a regulatory submission demonstrating substantial equivalence for a physical medical device (an ultrasound system). It leverages comparison to existing, legally marketed predicate devices and compliance with relevant safety and performance standards. It does not contain information about clinical performance studies with specific acceptance criteria, test sets, or ground truths as would be expected for an AI-based diagnostic tool.

Summary

{0}------------------------------------------------

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

JUL 2 7 2015

Olympus America, Inc. % Mark Job Program Manager . TUV Product Service 1775 Old Highway 8 N.W., Suite 104 New Brighton, MN 55112-1891

K010591 Re:

Trade/Device Name: Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ODG Dated (Date on orig SE Itr): February 27, 2001 Received (Date on orig SE ltr): February 28, 2001

Dear Mr. Job.

This letter corrects our substantially equivalent letter of March 15, 2001.

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/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

{2}------------------------------------------------

System: Olympus EU-C60 EUS EXERA Compact 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	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal	N	N				B+M	Note 1
	Abdominal	N	N				B+M	Note 1
	Intra-operative (Abdominalorgans and vascular)	N	N				B+M	Note 1
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic	N	N				B+M	Note 1
	Pediatric	N	N				B+M	Note 1
	Small Organ (breast,thyroid, testicles.)	N	N				B+M	Note 1
	Neonatal Cephalic	N	N				B+M	Note 1
	Adult Cephalic
	Trans-rectal	N	N				B+M	Note 1
	Trans-vaginal	N	N				B+M	Note 1
	Trans-urethral
	Trans-esoph. (non-Card.)	N	N				B+M	Note 1
	Musculo-skel. (Convent.)	N	N				B+M	Note 1
	Musculo-skel. (Superfic.)	N	N				B+M	Note 1
	Other (spec.) (Note2)	N	N				B+M	Note 1
	Cardiac Adult	N	N				B+M	Note 1
Cardiac	Cardiac Pediatric	N	N				B+M	Note 1
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N				B+M	Note 1
	Other (spec.)

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

Additional Comments:

Note 1: Other includes Color Power Doppier, combined B and Color Power Doppler, Note 1. Other Includes Only Fower Deppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy.

Note 2:

(1) the gastrointestinal tract and the surrounding organs.
(2) the airways and tracheobronchial tree.

Prescription Use (Per 21 CFR 801.109)

Hinid li. Slym

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number.

{3}------------------------------------------------

System: Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

Transducer: ICT/7-4 7.0-4.0 MHz Intracavitary Transducer

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	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	P	P				B+M	Note 3
	Abdominal
	Intra-operative (Abdominalorgans and vascular)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (breast,thyroid, testicles.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P				B+M	Note 3
	Trans-vaginal	P	P				B+M	Note 3
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel.
	Other (spec.)

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

Additional Comments:

Note 3: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(k) K003399.

Prescription Use (Per 21 CFR 801.109)

Voriel Ci. Sgomm
(Division Sign-Off)

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

{4}------------------------------------------------

System: Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

Transducer: L38/10-5 10.0-5:0 MHz Linear Array

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	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P				B+M	Note 3
	Abdominal	P	P				B+M	Note 3
	Intra-operative (Abdominalorgans and vascular)	P	P				B+M	Note 3
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic	P	P				B+M	Note 3
	Pediatric.	P	P				B+M	Note 3
	Small Organ (breast,thyroid, testicles.)	P	P				B+M	Note 3
	Neonatal Cephalic	P	P				B+M	Note 3
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P				B+M	Note 3
	Musculo-skel. (Superfic.)	P	P				B+M	Note 3
	Other (spec.)
	Cardiac Adult	-	-
Cardiac	Cardiac Pediatric	P	P				B+M	Note 3
	Trans-esophageal (card:)
	Other (spec.)
PeripheralVessel	Peripheral vessel.	P	P				B+M	Note 3
	Other (spec.)

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

Additional Comments:

Vimil C. Symon
Division Sign-Off

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

Prescription Use (Per 21 CFR 801.109)

{5}------------------------------------------------

System: Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

Transducer: C60/5-2 5.0-2.0 MHz Curved Array

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	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	P	P				B+M	Note 3
	Abdominal	P	P				B+M	Note 3
	Intra-operative (Abdominalorgans and vascular)	P	P				B+M	Note 3
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P				B+M	Note 3
	Small Organ (breast,thyroid, testicles.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other (spec.)
Cardiac	Cardiac Adult	P	P				B+M	Note 3
	Cardiac Pediatric	P	P				B+M	Note 3
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel .
	Other (spec.)

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

Additional Comments:

Gird li. Slysion

(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109)

{6}------------------------------------------------

System: Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

Transducer: C15/4-2 MHz Curved Array

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P				B+M	Note3
	Abdominal	P	P				B+M	Note3
	Intra-operative (Abdominalorgans and vascular)	P	P				B+M	Note3
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P				B+M	Note3
	Small Organ (breast,thyroid, testicles.)	P	P				B+M	Note3
	Neonatal Cephalic	P	P				B+M	Note3
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P				B+M	Note3
	Musculo-skel. (Superfic.)
	Other (spec.)
	Cardiac Adult	P	P				B+M	Note3
Cardiac	Cardiac Pediatric	P	P				B+M	Note3
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P				B+M	Note3
	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:

Note3: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, S-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510() K00339. Prescription Use {Per 21 CFR 801.109}

Yorid C. Nygren

(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological Devices

510(k) Number

Prescription Use (Per 21 CFR 801.109)

{7}------------------------------------------------

System: Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

Transducer: Olympus GF TYPE UC160P-OL5 EUS EXERA 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	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Abdominalorgans and vascular)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (breast,thyroid, testicles.)
Fetal Imaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)	N	N				B+M	Note 1
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other (spec.)(Note 2)	N	N				B+M	Note 1
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec,)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Note 1: Other Includes Color Power Doppier, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging for guidance of biopsy.

Note 2:

(1) the gastrointestinal tract and the surrounding organs.
(2) the airways and tracheobronchial tree.

Prescription Use (Per 21 CFR 801.109)

Yionil Ci. Veymm

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Device 510(k) Number .

{8}------------------------------------------------

System: Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

Transducer: Olympus GF TYPE UCT160-OL5 EUS EXERA 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	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Abdominalorgans and vascular)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (breast,thyroid, testicles.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)	N	N				B+M	Note 1
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other (spec.)(Note 2)	N	N				B+M	Note 1
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Power Directional Color Power Doppler, 3-D Imaging, Hamonic Imaging, and innaging, and imaging for guidance of biopsy.

Note 2:

(1) the gastrointestinal tract and the surrounding organs.

(2) the airways and tracheobronchial tree.

Prescription Use (Per 21 CFR 801.109)

David G. Layson

ivision of Reproductive, Abdominal. ENT and Radiological Devices 510(k) Number

{9}------------------------------------------------

MAR 1 5 2001

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.

A. Submitter's name, address, telephone number, initial importer, contact person

1. Manufacturer of the subject device

Name & Address of Manufacturer;

Registration Number : Address, Phone and Fax Of R & D Department Endoscope Division

Olympus Optical Co,. Ltd. 2-3-1 Shinjukuku Monolis Nishi-Shinjuku Shinjuku-ku, Tokyo, 163-0914 Japan 810047 2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507 Japan TEL 81-426-42-2891 FAX 81-426-46-5613

2. Initial Importer

Name : Address : Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL 516-844-5688 FAX 516-844-5416

3. Name of Contact Person

Name :

Tsuyoshi Yanai Manager Regulatory Affairs Quality Assurance Department Endoscope Division

Address, Phone and Fax :

2951 Ishikawa-cho Hachioji-shi, Tokyo 192-85 TEL 81-426-42-2891 FAX 81-426-46-5613

י נורד התנועה ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצ

SKII

{10}------------------------------------------------

B. Device Name, Common Name

1. Common/Usual Name

Diagnostic Ultrasound System with Accessories

2. Device Name

Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

3.Classification Name

	FR Number	ProductCode	Class
Bronchoscope and accessories	874.4680	KIT	II
Endoscope and accessories	876.1500	KOG	II
Ultrasonic Pulsed Doppler Imaging System	892.1550	IYN	II
Ultrasonic Pulsed Echo Imaging System.	892.1560	IYO	II
Diagnostic Ultrasound Transducer	892.1570	ITX	II

C. Identification of the predicate or legally marketed device

The following devices information demonstrates that this device is substantially equivalent to a legally marketed ,predicate medical device.

1. Ultrasound System

Device Name	#K
SonoSite™ Hand-Carried Ultrasound System	K003399
SonoSite SonoHerat™ Hand-Carried Echocardiography System	K994096
Advanced Technology Laboratories(ALT) HDI 5000 Ultrasound System	K961459

2. Ultrasonic Gastrovideoscope

Device Name	#K
Olympus GF Type UM30P Ultrasonic Gastrofiberscope	K963023
Olympus GF Type UM130 Ultrasonic Gastrovideoscope	K971660
Olympus UM-2R/UM-3R Ultrasonic Probes	K982323
Olympus BF Type 240 Bronchovideoscopes	K963033
Olympus GIF-1T140 Video Gastroscope	K954451
Pentax FG-36UX, Ultrasound Upper Gl Fiberscope	K961974

{11}------------------------------------------------

D. Device Description

1. Summary

( 2D, Color Power Doppler, PowerMap™ Directional Color Power Doppler, or in a combination of modes.)

The EU-C60 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes.

The GF-UC160P-OL5/GF-UCT160-OL5 give the operator the ability to perform Endocopic Ultrasound(EUS) guided fine needle aspiration(FNA).

2. Design

The EU-C60 is designed to comply with the standards listed below.

IEC 60601-1
IEC 60601-1-1
IEC 60601-1-2
IEC 60601-2-18
CISPR11

3. Materials

The material of Balloon3 is a new patient-contacting material. The biocompatibility test reports of the new material show that the new material is safe for its intended use.

E. Intended Use:

The intended uses of the EU-C60, as defined by FDA guidance documents, are:

Fetal - OB/GYN	Musculo-skeletal (conventional)
Laparoscopic	Musculo-skeletal (superficial)
Intraoperative (abdominal organs and vascular)	Neonatal Cephalic
Abdominal	Pediatric
Small Organ (breast, thyroid, testicle)	Cardiac-(adult and pediatric)
Trans-vaginal	Trans-esophageal (non-cardiac)
Trans-rectal	Peripheral Vessel
Other1) Gastrointestinal tract and the surrounding Organs2) The airways and tracheobronchial tree

{12}------------------------------------------------

F. Technological Characteristics:

This device operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves matomal in the body. Sound waves are reflected back to the transducer and converted to into the bough "Count are processed and displayed as images. Doppler shift crosed by blood flow is displayed as Color Flow, or as spectrum analysis.

Technological Characteristics of this device is identical to the predicated devicesidentified in item 3.

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.