ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK

K081518 · Pentax Medical Company · EOQ · Sep 5, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K081518
• Device Name: ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK
• Applicant: Pentax Medical Company
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Sep 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to the organs, tissues, and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Device Story

EB-1970UK is an ultrasound video bronchoscope; features flexible insertion tube, control body, and umbilical connectors for video processor and ultrasound scanner. Inputs: optical image data via CCD; ultrasonic pulses via radial array transducer. Operation: endoscope illuminates body cavity; CCD captures video; transducer emits/receives ultrasonic pulses. Outputs: endoscopic video and ultrasound images displayed via external processor/scanner. Used in clinical settings by physicians for visualization and therapeutic access (e.g., biopsy via working channel). Benefits: enables combined optical and ultrasonic assessment of pulmonary structures; facilitates minimally invasive diagnostic/therapeutic procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Flexible video bronchoscope with radial array ultrasound transducer. Includes CCD for optical imaging, light-carrying bundles for illumination, and working channel for accessories. Connects to external video processor and ultrasound scanner. Immersible design (excluding scanner connector).

Indications for Use

Indicated for optical and ultrasonic visualization and therapeutic access to the pulmonary tract (nasal passage, pharynx, larynx, trachea, bronchial tree) in adult and pediatric patients.

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

• BF type UC-160F, Ultrasound Brochofiberscope (K070983)
• EB-1830T3, Video Bronchoscope (K023376)
• EUB-5500 Diagnostic Ultrasound Scanner (K063518)

Submission Summary (Full Text)

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K081518

SEP - 5 2008

## 510(k) Summarv

## Submitter Information:

Pentax Medical Company 102 Chestnut Ridge Road Montvale, New Jersey 07645-1856

# Name of Device

| Trade Name: | EB-1970UK, Ultrasound Video Bronchoscope |
|----------------------|--------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Diagnostic Ultrasound Transducer (ITX) {892.1570}; track3, tier2<br>Bronchoscope and Accessories (EOQ) {874.4680}; tier2 |

# Predicated Device(s) Information

| Model, Description | Manufacturer | PMN # |
|----------------------------------------------|--------------|---------|
| BF type UC-160F, Ultrasound Brochofiberscope | Olympus | K070983 |
| EB-1830T3, Video Bronchoscope | Pentax | K023376 |
| EUB-5500 Diagnostic Ultrasound Scanner | Hitachi | K063518 |

# Device Description:

The EB-1970UK, Ultrasound Video Bronchoscope, must be used with a Pentax Video Processor (a software controlled device) and must be used with an Ultrasound Scanner (a software controlled device). The endoscope has a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, and suction. The ultrasound umbilical connector will be attached to the ultrasound scanner unit. The control body includes controls for up/ down angulation, suction control, video processor remote control buttons, and ports for manual balloon insufflation/ evacuation and accessory inlet. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic image data, and a radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced. The video processor contains a lamp that provides white light focused at the endossope PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and the signals are passed to the ultrasound scanner for processing and display. The instrument is immersable (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope operator manual cleaning instructions).

#### Intended Use:

The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to the organs, tissues, and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

## Comparison to Predicated Device(s)

The submission for substantial equivalence included literature describing the system including; specifications, the identification of standard set components and optional accessories, tables to summarize the comparisons to the predicated device(s), and system performance testing. The substantial equivalence is not based on an assessment of clinical performance data.

Prepared by: Paul Silva

Signature: Paul Silva Date: 8-5-2008

Control Number: EB-1970UK.EUB-5500

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Revision: d

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2008

Mr. Paul Silva Regulatory Affairs Director Pentax Medical Company 102 Chestnut Ridge Road MONTVALE NJ 07645

Re: K081518

Trade/Device Name: EB-1970 Ultrasound Video Bronchoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: EOQ and ITX Dated: May 29, 2008 Received: June 9, 2008

Dear Mr. Silva:

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 EB-1970 Ultrasound Video Bronchoscope, as described in your premarket notification:

## Transducer Model Number

## EB-1970UK

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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);

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Page 2 - Mr. Silva

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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices. requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 Paul Hardy at [phone].

Sincerely yours,

forpt Matheras

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

Enclosure(s)

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# Diagnostic Ultrasound Indications For Use Statement

| System: | EUB-5500 | | | | | | |
|----------------------------|-------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|
| Probe: | EB-1970UK | | | | | | |
| | Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows | | | | | | |
| Clinical Application | | Mode of Operation | | | | | |
| General<br>(Track I only) | Specific<br>(Track I & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler |
| Ophthalmic | | | | | | | |
| Fetal Imaging<br>and other | Fetal | | | | | | |
| | Abdominal | | | | | | |
| | Intra-operative (Spec.) | | | | | | |
| | Intra-operative (Neuro.) | | | | | | |
| | Laproscopic | | | | | | |
| | Pediatric | | | | | | |
| | Small Organ | | | | | | |
| | Neonatal Cephalic | | | | | | |
| | Adult Cephalic | | | | | | |
| | Trans-rectal | | | | | | |
| | Trans-vagina | | | | | | |
| | Trans-urethral | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | |
| | Musculo-skel. (Convert.) | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | |
| | Intra-luminal | | | | | | |
| | Endoscopy | N | N | N | | N | N |
| Cardiac | Cardiac Adult | | | | | | |
| | Cardiac Pediatric | | | | | | |
| | Trans-esophageal (card.) | | | | | | |
| | Other (spec.) | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | |
| | Other (Spec.) | | | | | | |

P = previously cleared by FDA; E = added under Appendix E ew application;

> (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 Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________