K Number

Device Name

OLYMPUS BF TYPE UC160-OL8

Manufacturer

OLYMPUS CORPORATION

Date Cleared

2004-08-18

(9 days)

Product Code

ODG EOQ FDS ITX

Regulation Number

876.1500

Intended Use

This instrument has been designed to be used with an OLYMPUS compact i nici intrasound center, video system center, light source, documentation endoscopic uitraoound ochter, wtterrapy accessories and other ancillary equipment equipment, video mornior, Endo trony . for endoscopic real time ultrasonic imaging, ultrasound guided needle aspiration and for ondoscopic rour and and within the airway and trancheobronchial tree and the gastrointestinal tract and surrounding organs.

Device Description

The subject device has been designed to be used with the OLYMPUS EU-C60 EUS EXERA Compact Endoscopic ultrasound center, OLYMPUS video system center, light source, documentation equipment, display monitor, Endo-therapy accessories such as an aspiration biopsy needle. The subject device is designed for endoscopic real-time ultrasonic imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) within the airways and trancheobronchial tree and the gastrointestinal tract.

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

K010591, K021204, K033225, K031347

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasonic imaging device and its accessories. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections. The image processing described is standard for ultrasound technology.

Therapeutic

No
The device is described for imaging and guiding needle aspiration for diagnostic purposes, not for treating a disease or condition.

Diagnostic

Yes

The device is designed for "endoscopic real time ultrasonic imaging, ultrasound guided needle aspiration." Imaging and aspiration for diagnosis are stated in the intended use.

SaMD (Software as a Medical Device)

The device description explicitly states it is designed to be used with various hardware components, including an ultrasound center, video system center, light source, and display monitor, and is used for real-time ultrasonic imaging and guided procedures, indicating it is a hardware-based device with associated software.

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 a device for real-time ultrasonic imaging and ultrasound-guided procedures (needle aspiration) within the body (airway, tracheobronchial tree, and gastrointestinal tract). This is a diagnostic imaging and interventional procedure, not a test performed in vitro (outside the living body) on biological specimens.
Device Description: The description reinforces the use for endoscopic ultrasound imaging and guided procedures within the body.
Image Processing: While it mentions processing sound waves into images, this is part of the imaging process itself, not a diagnostic test performed on a sample.
Anatomical Site: The specified anatomical sites are within the living body.

IVD devices are designed to examine specimens (like blood, urine, tissue) in vitro to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the living body).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended use of these devices, as defined by FDA guidance documents is:

This instrument has been designed to be used with an OLYMPUS compact i nici intrasound center, video system center, light source, documentation endoscopic uitraoound ochter, wtterrapy accessories and other ancillary equipment equipment, video mornior, Endo trony .
for endoscopic real time ultrasonic imaging, ultrasound guided needle aspiration and for ondoscopic rour and and within the airway and trancheobronchial tree and the gastrointestinal tract and surrounding organs.

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

N= new indication

Additional Comments:

Additional Onlinene.
Note 1: Other includes Color Power Doppier, combined B and Color Power Doppler, combined B and Other "highues" Only" Fower Doppler, and imaging for guidance of biopsy.
Note 2: Specification for "Other"

(1) the gastrointestinal tract and the surrounding organs.

(2) the airways and tracheobronchial tree.

Intended Use: Endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures as follows:

N= new indication

Additional Comments:

Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Other "Instational Color Power Doppler, and imaging for guidance of biopsy.

Note 2: Specification for "Other"

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

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

KOG, ITX

Device Description

The subject device is designed for endoscopic real-time ultrasonic imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) within the airways and trancheobronchial tree and the gastrointestinal tract.

Mentions image processing

Sound waves are reflected back to the transducer and Sound waves the the the that are processed and displayed as ultrasonic images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic, Video

Anatomical Site

airway, trancheobronchial tree, gastrointestinal tract, 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.

K010591, K021204, K033225, K031347

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

§ 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.

Summary

K042140

Park 1 of 3

May 11.2004

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is being submitted in This Summary of Salety and Shockverland Microsoft Start 807, Subpart E, Section 807.92.

A. Applicant, Submission Correspondent, Initial Importer, Official Correspondent

| 1. Applicant
& Manufacture : | OLYMPUS CORPORATION
34-3 Hirai Hinode-machi,
Nishitama-gun, Tokyo, 190-0182, Japan
(Registration Number: 3003637092) |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Submission Correspondent : | Masao Wada
OLYMPUS CORPORATION
2951 Ishikawa-cho, Hachiouji-shi, Tokyo
192-8507, Japan
Telephone : 81-426-42-2891
Facsimile : 81-426-42-2291
E-mail : m_wada@ot.olympus.co.jp
(Registration Number: 8010047) |
| 3. Initial Importer : | OLYMPUS AMERICA INC.
Two Corporate Center Drive, Melville,
NY 11747-3157
(Registration Number: 2429304) |
| 4. Official Correspondent : | Tina-Steffanie-Oak
Associate Manager Regulatory Affair
Clinical Monitor
OLYMPUS AMERICA INC.
Two Corporate Center Drive, Melville,
NY 11747-3157
Telephone : 631-844-5477
Facsimile : 631-844-5416
E-mail : Tina.Steffainie-Oak@olympus.com
(Registration Number: 2429304) |

B. Device Name, Common Name

1. Common/Usual Name

Ultrasonic endoscope

K42/40

fig 74-3

2. Device Name

· EVIS EXERA Ultrasonic Bronchofibervideoscope OLYMPUS BF type UC160F-OL8

3.Classification Name

| | CFR
Number | Product
Code | Class |
|----------------------------------|---------------|-----------------|-------|
| Endoscope and accessories | 876.1500 | KOG | II |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX | II |

C. Identification of the predicate or legally marketed device

The following devices are the predicate medical devices.

Device Name	#K
Ultrasonic Bronchofiberscope BF type UM40	K021204
EVIS EXERA Ultrasonic Bronchofibervideoscope BF typeXP160F	K033225
EU-C60 Compact Endoscopic ultrasound Center
(EVIS EXERA Ultrasonic Gasrovideoscope GF type UC160P-OL5)	K010591
Ultrasonic Gasrovideoscope GF type UC160P-AT8	K031347

D. Device Description

1. Summary

2. Design

The subject device 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 for transducer surface of the subject device has a new patientcontacting material. The Biocompatibility test reports of the new material show that the new material is safe for its intended use.

K042140
Page 3 of 3

E. Intended Use:

The intended use of these devices, as defined by FDA guidance documents is:

This instrument has been designed to be used with an OLYMPUS compact i nici intrasound center, video system center, light source, documentation endoscopic uitraoound ochter, wtterrapy accessories and other ancillary equipment equipment, video mornior, Endo trony .
for endoscopic real time ultrasonic imaging, ultrasound guided needle aspiration and for ondoscopic rour and and within the airway and trancheobronchial tree and the gastrointestinal tract and surrounding organs.

F. Comparison Technological Characteristics:

The subject device operates identically to the predicate device (K010591) in that r re subjoc donce of in the transducer is used as an ultrasound source to transmit plozoone into the body. Sound waves are reflected back to the transducer and Sound waves the the the that are processed and displayed as ultrasonic images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis.

The subject device is basically identical to the predicate device (K021024), except that the subject device is equipped with the CCD in the control section, as well as the that the oubject do wee tion tube. Images are transmitted through the fiber bundle and the CCD in the control section changes them to video signals. then, the endoscopic image is displayed on the monitor. This is identical with EVIS EXERA Ultrasonic Bronchofibervideoscope (K033225).

G. Conclusion

When compared to the predicate device, the BF type UC160F-OL8 does not incorporate any significant changes in the intended use, method of operation, in design that could affect safety and effectiveness. Therefore, clinical data is not necessary for evaluation of safety and efficacy.

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing health and human services. The bird is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2004

Olympus Corporation % Mr. Derwyn Reuber Vice President Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K042140

Trade Name: EVIS EXERA Ultrasonic Bronchofibervideoscope OLYMPUS BF Type UC160F-OL8, OLYMPUS EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 78 KOG and 90 ITX Dated: August 4, 2004 Received: August 9, 2004

Dear Mr. Reuber:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed above and we have determined the device is substantially equivalent (for the icitied above and 170 in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to r caeral controls provisions of the Act. The general controls provisions of the Act include the Evilent Connell registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center, as described in your premarket notification:

Transducer Model Number

OLYMPUS BF Type UC160F-OL8

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (scc above) into entire major regulations affecting your device .
it may be subject to such additional controls. Existing and control differ. ED it may be subject to Such additional controls. Entrailing Might 898. In addition, FDA can be found in the Code of Peacharts 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 FDA s issualles of a succeanter requirements of the Act
that FDA has made a determination that your device complies with other may the that FDA has made a decemination administered by other Federal agencies. You must of any Federal Statures and regulations adminities. by J. 15 not limited to: registration and listing (21 comply with an the Act stequirements) morealing, and manufacturing practice requirements as set a CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic (200); and if applicable, the electronic (200 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket I his letter will anow you to begin marketing your alence of your device to a legally marketed nouncation. THCTDA inding of sacciantan vqur 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. Join (301) 594-4591. Additionally, for questions on the comact the Office of Complianted at (301) 577-11-27 11-11-2017 Compliance at (301) 594promotion and advertising of your actives plation by reference to premarket
4639. Also, please note the regulation entitled, "Misbranding by reference to premarket 46.99. Also, please note the regulation entreas, "Andress of your responsibilities under the nonicalion (21 CFA Part 007.77). Stater general Manufacturers, International and Consumer Act may be obtained from the Drillion of Since of Since of States of or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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

Sincerely yours,

David A. Loper

Nora C. Brady

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

Enclosures

4.3.2 OLYMPUS EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

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 (Abdominal
organs 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	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.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

Diagnostic Ultrasound Indications for Use Form

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

N= new indication

Additional Comments:

Additional Onlinene.
Note 1: Other includes Color Power Doppier, combined B and Color Power Doppler, combined B and Other "highues" Only" Fower Doppler, and imaging for guidance of biopsy.
Note 2: Specification for "Other"

(1) the gastrointestinal tract and the surrounding organs.

(2) the airways and tracheobronchial tree.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Layman

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

Section 4.2 Page 5

4.3 Indication for use :

4.3.1 EVIS EXERA Ultrasonic Bronchofibervideoscope OLYMPUS BF type UC160F-OL8 Diagnostic Ultrasound Indications for Use Form

Intended Use: Endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures as follows:

Clinical Application		Mode of Operation
General
(Track 1 only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Abdominal
organs 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.)	N	N			B+M	Note 1
	(Note 2)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication

Additional Comments:

Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Other "Instational Color Power Doppler, and imaging for guidance of biopsy.

Note 2: Specification for "Other"

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON __ ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR

David A. Ingram

Section 4.2 Page 4
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042146