FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700

K063847 · Fujinon, Inc. · FDS · Mar 1, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K063847
• Device Name: FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
• Applicant: Fujinon, Inc.
• Product Code: FDS · Gastroenterology, Urology
• Decision Date: Mar 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas) using an Ultrasonic endoscope, observation and diagnosis of submucosal and perioheral organs using ultrasonic images, and endoscopic treatment.

Device Story

System comprises ultrasonic gastrointestinal endoscopes (EG-530UR, EG-530UT) and ultrasonic processor (SU-7000). Endoscopes feature integrated ultrasonic transducers; used with single-use balloons to maintain position. Processor drives transducer to emit ultrasound into body cavities; receives reflected signals; converts signals into ultrasonic images for display. Used in medical facilities by physicians for visualization of upper GI tract, submucosal, and peripheral organs. Output viewed by clinicians to guide diagnosis and endoscopic treatment. Benefits include enhanced visualization of internal structures and surrounding organs during endoscopic procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Device passed electrical safety, thermal, and EMC testing requirements. Biocompatibility of materials confirmed.

Technological Characteristics

System includes ultrasonic endoscopes and SU-7000 processor. Endoscopes feature ultrasonic transducers for pulsed echo and pulsed Doppler imaging. Processor performs signal processing for B-mode, M-mode, PWD, and Color Doppler modes. Materials are biocompatible. Connectivity includes processor, light source, cart, and video printer. Sterilization/reprocessing not specified beyond biocompatibility.

Indications for Use

Indicated for observation and diagnosis of the upper digestive tract (esophagus, stomach, duodenum, underlying areas), submucosal and peripheral organs, and endoscopic treatment in medical facilities under physician management. Used for diagnostic ultrasound imaging or fluid flow analysis (B, M, PWD, Color Doppler modes) in abdominal, intraoperative (gastrointestinal tract and surrounding organs), and transesophageal (non-cardiac) applications.

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.

Predicate Devices

• Pentax EG-3630UR Ultrasound Video Gastroscope (K013640)
• Olympus GF-UE160-AL5 Endoscope (K051541)
• Hitachi EUB-6000 (K994026 and K011252)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "FUJIFILM" in a bold, sans-serif font. The letters are black and the background is white. The letters are slightly distorted, giving the image a textured appearance.

Image /page/0/Picture/1 description: The image shows the word "FUJINON" in large, bold, black letters. Above the word, there is a handwritten inscription that appears to be "K063847". The text is clear and legible, with a simple, straightforward design.

MAR 0 1 2007

# 510 (k) Summary

Date Prepared [21 CFR 807.92(a)(1)] 12/18/06

#### Submitter's Information [21 CFR 807.92(a)(1)]

This 510(k) is being submitted by Joseph Azary on behalf of Fujinon Inc.

Contact: Joseph Azary 543 Long Hill Avenue Shelton, CT 06484 Tel: [phone] Fax: [phone].

.

Sponsor / U.S. Distributor: Fujinon Inc. 10 High Point Drive Wayne, NJ 07470 FDA Establishment Registration# 2431293.

Manufacturer: Fujinon Corporation 1-324 Uetake-Cho Kita-Ku, Saitama-Shi Saitama 331-9624, Japan FDA Establishment Registration# 9610875

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#### Trade Name, Common Name, Classification [21 CFR 807.92(2)(2)]

Device Trade Name: Fujinon Ultrasonic Endoscope & Processor, EG-530UR, EG-530UT, SU-7000 Device Common, Usual, or Classification Names: Ultrasonic gastrointestinal endoscope, ultrasonic processor

#### Classification:

| Product<br>Code | Regulation<br>Number | Description | Class |
|-----------------|----------------------|------------------------------------------|-------|
| FDS | 876.1500 | Gastroscope | II |
| IYN | 892.1550 | Ultrasonic Pulsed Doppler Imaging System | II |
| IYO | 892.1560 | Ultrasonic Pulsed Echo Imaging System | II |
| ITX | 892.1570 | Diagnostic Ultrasonic Transducer | II |

#### Predicate Device [21 CFR 807.92(a)(3)]

Ultrasonic Endoscopes

- Pentax EG-3630UR Ultrasound Video Gastroscope (K013640) .
- Olympus GF-UE160-AL5 Endoscope (K051541) .

The subject devices are substantially equivalent to the predicate devices. The indications for use are similar. There are only minor differences in field of view, viewing direction, diameter, and bending. The working length and total length are almost identical. Each endoscope uses different ultrasonic processors.

Ultrasound Processors

- Hitachi EUB-6000 (K994026 and K011252) .
The subject device is substantially equivalent to the predicate device. The indications for use are similar. There are some minor differences in size and frequency.. The display modes, scanning mode, and display are almost identical.

#### Description of the Device [21 CFR 807.92(a)(4)]

The EG-530UR and EG-530UT are medical ultrasonic gastrointestinal endoscopes. They are intended for the observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas) using an Ultrasonic endoscope, observation and diagnosis of submucosal and perioheral organs using ultrasonic images, and endoscopic treatment at medical facilities under the management of physicians.

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These endoscopes are used in combination with a processor, light source, cart, ultrasonic processor (SU-7000), and video printer.

The endoscopes are used with a single use balloon. The endoscopes have a groove on the tip to hold the balloon in place.

The SU-7000 is an ultrasonic processor that is used with a medical ultrasonic endoscope (EG-530UR or EG-530UT). The processor connects to the ultrasonic endoscope, which emits ultrasound in a body cavity by driving an ultrasonic transducer of the endoscope. It also processes the reflection ultrasonic signal received by the transducer and coverts it to an ultrasonic image.

#### Intended Use [21 CFR 807.92(a)(5)]

Observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas) using an Ultrasonic endoscope, observation and diagnosis of submucosal and perioheral organs using ultrasonic images, and endoscopic treatment

#### Technological Characteristics [21 CFR 807.92(a)(6)]

Fujinon, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device have similar indications for use.

#### Performance Data [21 CFR 807.92(b)(1)]

The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The materials in the endoscope are biocompatible and are identical to the materials used in the predicate device.

#### Conclusion [21 CFR 807.92(b)(3)]

We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 1 2007

Fujinon, Inc. % Mr. Joseph M. Azary Azary Technologies, Inc. 543 Long Hill Avenue SHELTON CT 06484

Re: K063847

Trade/Device Name: Fujinon Ultrasonic Endoscope & Processor (SU-7000 / EG-530UR / EG-530UT) Regulation Number: 21 CFR \$876.1500 Regulation Name: Endoscope and accessories Product Code: FDS Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: IYN Regulation Number: 21 CFR \$892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: IYO Regulation Number: 21 CFR 8892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulatory Class: II Dated: December 18, 2006 Received: December 27, 2006

Dear Mr. Azary:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the Fujinon Ultrasonic Endoscope & Processor SU-7000, as described in your premarket notification:

Transducer Model Number

EG-530UT EG-530UR

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### Page 2 - Mr. Joseph Azary

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may If your as not 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.

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D., at [phone].

Sincerely yours,

David le. Sgmm

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

Enclosures

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### Indications for Use

510(k) Number (if known):

063847

Device Name: Fujinon Ultrasonic Endoscope & Processor (SU-7000 / EG-530UR / EG-530UT)

Indications For Use:

The EG-530UR and EG-530UT ultrasonic endoscopes are intended to be used with the SU-7000 ultrasound I ho system is used for the observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas), as well as observation and diagnosis of submucosal and peripheral organs using ultrasonic images, and endoscopic treatment.

Prescription Use X (Part 21 CFR 801 Subpart D)

Image /page/5/Picture/7 description: The image shows the text "AND/OR" in a bold, serif font. The letters are black against a white background. The slash between "AND" and "OR" is slightly tilted.

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Seymour

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

510(k) Number.

Page 1 of 1

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SU-700

K063847

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

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

| Mode of Operation | | | | | | | | | | |
|---------------------------------------------------------------|-------------------------------|---|---|-----|-----|---------------|-------------------|------------------------|-----------------------|-----------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | | | See below | |
| Intraoperative (specify) | | N | N | N | | N | | | See below | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | | | See below | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | N | N | N | | N | | | See below non-cardiac | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N= new indication; P= previously cleared by FDA; | E= added under Appendix E | | | | | | | | | |
| Additional Comments: | Mixed mode includes B/M B/PWD | | | | | | | | | |
| Intraoperative: Gastro-intestinal tract & surrounding organs. | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |

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

David A. Bergman
(Division Sign Off)

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

Radiological Devices,
510(k) Number K063847

Prescription Use (Per 21 CFR 801.109)

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#### Appendix F

# G-530UT

K063847

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

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

| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | N | N | N | N | | N | | | See below | |
| Intraoperative (specify) | N | N | N | N | | N | | | See below | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | N | N | N | | N | | | See below | Non-Cardiac |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments: Mixed mode includes B/M B/PWD

Intraoperative: Gastro intestinal tract & surrounding abdominal organs.

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

Gavin A. Ingram
(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109)

510(k) Number _

F-3

Page VI

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# EG-530UR

Ko63847

### Diagnostic Ultrasound Indications for Use Form

## Fill out one form for each ultrasound system and each transducer.

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

| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | | | See below | |
| Intraoperative (specify) | | N | N | N | | N | | | See below | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | | N | | | See below | non cardiac |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments: Mixed mode includes B/M, B/PWD

Intraoperative: Gastro intestinal tract & surrounding abdominal organs.

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

Daniel M. Lyons
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K063847

Prescription Use (Per 21 CFR 801.109)

Page VII