OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P

K021886 · Olympus Optical Co., Ltd. · FDS · Jun 19, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021886
• Device Name: OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P
• Applicant: Olympus Optical Co., Ltd.
• Product Code: FDS · Gastroenterology, Urology
• Decision Date: Jun 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Olympus GF-UC140P-D05 Ultrasonic Gastrovideoscope has been designed to be p used with the AI5200S and Envision Plus Ultrasound Imaging Systems Obraised I Products, Inc.), Olympus EVIS Video System Center, Olympus Light Sources, Olympus Accessories(such នន Aspiration Biopsy Needles) and Endo-Therapy Olympus Electrosurgical Units(except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic ultrasound imaging, EUS guided Fine Needle Aspiration(FNA), and for endoscopic ultrasound guided or assisted intervention within the upper digestive tract. The Olymous GF-UC30P Ultrasonic Gastrofiberscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Domier Surgical Products, Inc.), Olympus Light Source, Olympus Endo-Therapy Accessories(such as Aspiration Bionsy Needles) and Olympus Electrosurgical Units(except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic ultrasound imaging, EUS guided Fine Needle Aspiration (FNA), and for endoscopic ultrasound guided or assisted intervention within the upper digestive tract.

Device Story

Ultrasonic gastrovideoscope and gastrofiberscope; used with external ultrasound imaging systems (AI5200S/Envision Plus), video centers, light sources, and electrosurgical units. Inputs: real-time ultrasound signals and endoscopic visual data. Outputs: ultrasound images and visual endoscopic views for clinician observation. Used in clinical settings by physicians for upper digestive tract procedures; enables EUS-guided FNA of submucosal/extramural lesions (pancreatic/mediastinal masses, lymph nodes) and endoscopic surgery. Facilitates diagnostic imaging and therapeutic intervention; assists in clinical decision-making by providing visualization of internal structures and biopsy guidance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endoscopic ultrasound transducers integrated into gastrovideoscope/gastrofiberscope form factors. Compatible with external ultrasound imaging systems, video processors, and light sources. Supports EUS-guided FNA and electrosurgical accessories. Sterilization via standard endoscopic reprocessing protocols.

Indications for Use

Indicated for patients requiring real-time endoscopic ultrasound imaging, EUS-guided fine needle aspiration (FNA), and endoscopic ultrasound-guided or assisted intervention within the upper digestive tract.

Regulatory Classification

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.

Special Controls

*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.

Reference Devices

• AI5200S Ultrasound Imaging System
• Envision Plus Ultrasound Imaging System

Submission Summary (Full Text)

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KD 21886 p. 1/2

## 510(k) SUMMARY Olympus Ultrasonic Gastrovideoscope GF TYPE UC140P-DO5 and Ultrasonic Gastrofiberscope GF TYPE UC30P

## A. Submitter's Name, Address, Phone and Fax Numbers

## 1. Manufacturer of the subject devices

Name & Address of manufacturer:

Registration No .: Address, Phone and Fax Numbers: of R&D Department, Endoscope Division

Olympus Optical Co., Ltd. 2-3-1 Shinjyuku Monolis Nishishinjyuku Shinjuku-ku, Tokyo, Japan 8010047 2951 Ishikawa-Cho, Hachioji-shi, Tokyo 192-8507 Japan TEL [phone] FAX [phone]

## B. Name of Contact Person

Name: Address, Phone and Fax Numbers: . Ms. Laura Storms-Tyler Olympus America Inc. Director, Regulatory Affairs Two Corporate Center Drive Melville, New York 11747-3157 TEL: [phone] FAX: [phone]

## C. Device Name, Common Name, Classification Name and Predicate Devices

Device Name:

Common Name:

Olympus Ultrasonic Gastrovideoscope GF TYPE UC140P-DO5 and Olympus Ultrasonic Gastrofiberscope GF TYPE UC30P

Olympus Ultrasonic Gastrovideoscope and Olympus Ultrasonic Gastrofiberscope

Classification Name:

21 CFR876.1500 Endoscope and accessories

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#### D. Description of the Device(s)

## Olympus Ultrasonic Gastrovideoscope GF Type UC140P-D05

The Olympus GF-UC140P-D05 Ultrasonic Gastrovideoscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Domier Surgical Products, Inc.) Olympus EVIS Video System Center, Light Source, Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Electrosurgical Unit (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for endoscopic ultrasonic imaging and treatment in the gastrointestinal wall, biliary and pancreatic ducts, and surrounding organs. These instruments also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract, i.e., pancreatic masses, mediastinal masses, and lymph nodes).

4021886

## Olympus Ultrasonic Gastrofiberscope GF Type UC30P

The Olympus GF-UC30P Ultrasonic Gastrofiberscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.) Olympus EVIS Video System Center, Light Source, Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Electrosurgical Unit (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for endoscopic ultrasonic imaging and treatment in the gastrointestinal wall, biliary and pancreatic ducts, and surrounding organs. These instruments also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract, i.e., pancreatic masses, mediastinal masses, and lymph nodes).

#### Intended Use of Device(s) E.

The Olympus GF-UC140P-D05 Ultrasonic Gastrovideoscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.) Olymous EVIS Video System Center, Light Source, Endo-Therapy Accessories (such as Aspiration Blopsy Needles) and Electrosurgical Unit (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for endoscopic real-time ultrasound imaging, for performing EUS guided Fine Needle Aspiration (FNA) and for endoscopic surgery within the upper digestive tract.

## Olympus Ultrasonic Gastrofiberscope GF Type UC30P

The Olympus Ultrasonic Gastrofiberscope GF Type UC30P has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Domier Surgical Products, Inc.) Olympus EVIS Video System Center, Light Source, Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Electrosurgical Unit (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for endoscopic real-time ultrasound imaging, for performing EUS guided Fine Needle Aspiration (FNA) and for endoscopic surgery within the upper digestive tract.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines beneath them, possibly representing water or movement.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 9 2002

Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive MELVILLE NY 11747-3157 Re: K021886

Trade/Device Name: Olympus Gastrovideoscope GF TYPE UC140P-D05 and Olympus Ultrasonic Gastrofiberscope GF TYPE UC30P Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Product Code: 78 FDS Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Product Code: 78 ITX Regulatory Class: II Dated: May 7, 2002 Received: June 7, 2002

Dear Ms. Storms-Tyler:

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.

If vour 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 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); 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.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy Brogdon

Nancy C. Brogdon

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO21886

/ ﺃﻧﻪ ﺗﻘﺪﻳﻤﻪ ﺍﻟﻤ

| (Division Sign-Off) | |
|--------------------------------------|---------|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K021886 |

# Indications for Use Statement

510(k) Number(if known): _____________________________________________________________________________________________________________________________________________________ Not assigned vet. Device Name: Olympus Ultrasonic Gastrovideoscope GF TYPE UC140P-D05 Olympus Ultrasonic Gastrofiberscope GF TYPE UC30P

Indications for Use:

## Olympus Ultrasonic Gastrovideoscope GF TYPE UC140P-DO5

The Olympus GF-UC140P-D05 Ultrasonic Gastrovideoscope has been designed to be p used with the AI5200S and Envision Plus Ultrasound Imaging Systems Obraised I Products, Inc.), Olympus EVIS Video System Center, Olympus Light Sources, Olympus Accessories(such នន Aspiration Biopsy Needles) and Endo-Therapy Olympus Electrosurgical Units(except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic ultrasound imaging, EUS guided Fine Needle Aspiration(FNA), and for endoscopic ultrasound guided or assisted intervention within the upper digestive tract.

Olympus Ultrasonic Gastrofiberscope GF TYPE UC30P

The Olymous GF-UC30P Ultrasonic Gastrofiberscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.), Olympus Light Source, Olympus Endo-Therapy Accessories(such as Aspiration Bionsy Needles) and Olympus Electrosurgical Units(except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic ultrasound imaging, EUS guided Fine Needle Aspiration (FNA), and for endoscopic ultrasound guided or assisted intervention within the upper digestive tract.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per21 CFR 801.109)

OR

Over-The-Counter Use_