FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US

K121035 · Fujifilm Medical System U.S.A., Inc. · EOQ · Jun 4, 2012 · Ear, Nose, Throat

Device Facts

• Record ID: K121035
• Device Name: FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
• Applicant: Fujifilm Medical System U.S.A., Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Jun 4, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with Fujinon/Fujifilm ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.

Device Story

The EB-530US is an ultrasonic bronchoscope used for visualization and ultrasound-guided procedures in the trachea and bronchial tree. It functions as an endoscope integrated with an ultrasonic transducer. The device emits ultrasound waves and scans reflected signals to generate ultrasonic images when connected to a compatible Fujinon/Fujifilm ultrasonic processor, video processor, and light source. A single-patient-use balloon, inflated with sterile water, is used to eliminate air between the transducer and target tissue to improve signal transmission. The device supports ultrasound-guided needle aspiration. It is operated by clinicians in a clinical setting. The output consists of real-time endoscopic and ultrasonic images displayed on a monitor, which assist the physician in diagnosing and treating pulmonary conditions. The device benefits patients by enabling minimally invasive visualization and targeted sampling of tissues within the bronchial tree and surrounding structures.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence is supported by bench testing, including compliance with IEC 60601-1 (general safety), IEC 60601-2-18 (endoscopic equipment), IEC 60601-2-37 (ultrasonic diagnostic equipment), and ISO 10993-1 (biocompatibility). Reprocessing instructions were validated.

Technological Characteristics

Flexible bronchoscope with integrated electrical curved linear array ultrasonic transducer. Operating frequencies: 5, 7.5, 10, 12 MHz. Viewing direction: 10-degree forward oblique. Field of view: 120 degrees. Distal end diameter: 6.7 mm. Forceps channel: 2.0 mm. Connectivity: Compatible with Fujinon/Fujifilm ultrasonic and video processors. Biocompatible patient contact materials. Sterilization: Reprocessing instructions provided.

Indications for Use

Indicated for observation, diagnosis, and endoscopic treatment of trachea, bronchial tree, and surrounding organs in adult patients using ultrasonic imaging. Contraindicated for use on children and infants.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

• EVIS EXERA Ultrasonic Bronchofibervideoscope (K042140)
• OLYMPUS BF type UC160F-OL8 (K042140)

Submission Summary (Full Text)

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K121035

# FUJIFILM

JUN - 4 2012

## 510(k) Summary

## Date: June 4, 2012

## Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wavne, NJ 07470 USA FDA Establishment Registration Number: 2431293

### Contact Person:

| Name: | Gina Walljasper |
|------------|---------------------------------------------|
| Title: | Director, Quality and Regulatory Compliance |
| Telephone: | [phone] Ext. 484 |
| Facsimile: | [phone] |
| E-Mail: | [e-mail] |

## Identification of the Proposed Device:

Proprietary/Trade Name: Common Name: Device Class: Review Panel:

Fuiinon/Fuiifilm Ultrasonic Endoscope EB-530US Ultrasonic Bronchoscope Class 2 Ear Nose & Throat

Classification Information:

| Classification Name | CFR Section | Product Codes |
|--------------------------------------------------|-----------------|---------------|
| Bronchoscope (flexible or rigid) and accessories | 21 CFR 874.4680 | EOQ |
| Diagnostic Ultrasonic Transducer | 21 CFR 892.1570 | ITX |

#### INDICATIONS FOR USE l,

The Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with Fujinon/Fujifilm ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.

### DEVICE DESCRIPTION II.

Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. EB-530US is used in combination with the Fujinon/Fujifilm's ultrasonic processor, video endoscope processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices. When used with a Fujinon/Fujifilm's ultrasonic processor, EB-530US emits ultrasound wave and scans the reflected signals to orovide ultrasonic images. For ultrasound procedure, EB-530US can be used with a

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K12/035

# FUJKFILM

single-patient-use balloon inflated with sterile water for an ultrasonic endoscope eliminates air between the ultrasonic transducer and target tissue so that the ultrasound wave can travel with little interference. Additionally EB-530US supports ultrasound guided needle aspiration.

#### SUMMARY OF STUDIES lll.

Fujinon/Fujifilm Ultrasonic Endoscope EB-530US conforms to the following internal and international IEC testing requirements in addition to the applicable quality system regulations:

| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for safety |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC60601-1-1 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| IEC60601-1-2 | Medical electrical equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and tests |
| IEC60601-2-18 | Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment |
| IEC 60601-2-37 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| ISO10993-1 | Biological evaluation of medical devices |

The balloon, B20BU for the Fujinon/Fujifilm Ultrasonic Endoscope EB-530US conform to the applicable internal and international IEC testing requirements for Sterility.

The reprocessing instructions were validated.

No clinical testing was conducted.

#### SUBSTANTIAL EQUIVALENCE IV.

Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is substantially equivalent to the following device:

| Legally Marketed Device(s) | 510(k) # |
|----------------------------------------------|----------|
| EVIS EXERA Ultrasonic Bronchofibervideoscope | K042140 |
| OLYMPUS BF type UC160F-OL8 | |

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# FUJIFILM

Comparison is outlined in the table below.

| | Legally Marketed Device<br>K042140 | Proposed Device<br>Model EB-530US |
|--------------------------------|------------------------------------|------------------------------------------------------|
| Viewing direction | 35 degree forward oblique | 10 degree forward oblique |
| Observation range | 2-50 mm | 3-100 mm |
| Field of view | 80 degree | 120 degree |
| Distal end diameter | 6.9 mm | 6.7 mm |
| Flexible portion diameter | 6.2 mm | 6.3 mm |
| Bending capability Up | 120 degree | 130 degree |
| Bending capability Down | 90 degree | 90 degree |
| Forceps channel diameter | 2.0 mm | 2.0 mm |
| Working length | 600 mm | 610 mm |
| Total length | 890 mm | 880 mm |
| Scanning method | Electrical curved linear array | Electrical curved linear array |
| Scanning range | 50 degree | 60 degree (with SU-7000)<br>65 degree (with SU-8000) |
| Ultrasonic operating frequency | 7.5 MHz | 5 MHz, 7.5 MHz, 10 MHz,<br>12 MHz |

All patient contact materials used in the proposed EB-530US remain the same as the previously-cleared Fujinon/Fujifilm endoscopes.

### V. CONCLUSION

Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is substantially equivalent to the legally marketed device and conforms to applicable medical device safety and performance standards.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like strokes. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

FUJIFILM Medical Systems U.S.A., Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313

Re: K121035

Trade/Device Name: Fujinon/Fujifilm Ultrasonic Endoscope EB-530US Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOQ, ITX Dated: April 4, 2012 Received: April 5, 2012

Dear Mr. Job:

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 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.

JUN - 4 2012

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Page 2 - Mr. Mark Job

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K121035

## Indications for Use

510(k) Number (if known): __

Device Name: Fujinon/Fujifilm Ultrasonic Endoscope EB-530US To be used with Fujinon/Fujifilm Ultrasonic Processor (SU-7000/SU-8000)]

Indications for Use:

The Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, . The Tighton't ajimm Oneonent of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with Fujinon/Fujifilm ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.

× 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 OF NEEDED)

. Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

121035

510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

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## Diagnostic Ultrasound Indications For Use

510(k) Number (If Known):

Fujinon/Fujifilm Ultrasonic Processor (SU-7000/SU-8000) System Name: Ultrasonic Endoscope EB-530US Transducer:

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

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------|------------------------------------------------|-------------------|---|-----|-----|------------------|-----------|-------|
| General | Specific . | B | M | PWD | CWD | Color<br>Doppler | Combined¹ | Other |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ<br>(Thyroid, Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| General | Adult Cephalic | | | | | | | |
| Application | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Tran-esoph. (non-Card.) | N | N | N | | N | N¹ | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | N¹ | |
| | Other (Specify) | N | N | N | | N | N¹ | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Tran-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vascular | Other (Specify) | | | | | | | |

vessel

Combined modes includes B+M, B+CD, B+PWD, B+CD+PWD modes

Other (Specify): Trachea, bronchial tree and surrounding organs

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

510(k) Number

Prescription Use (Per 21 CFR 801.109)