EB-1830T3, VIDEO BRONCHOSCOPE

K023376 · Pentax Precision Instrument Corp. · EOQ · Oct 16, 2002 · Ear, Nose, Throat

Device Facts

• Record ID: K023376
• Device Name: EB-1830T3, VIDEO BRONCHOSCOPE
• Applicant: Pentax Precision Instrument Corp.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Oct 16, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The EB-1830T3, Video Bronchoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Pulmonary Tract. The Pulmonary Tract includes, but is not restricted to, the organs; tissues; and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, and bronchial Tree (including access beyond the stem). The instrument is introduced per oral or per nasal when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.

Device Story

Flexible video bronchoscope; provides optical visualization and therapeutic access to pulmonary tract. Inputs: light from video processor; CCD captures image data. Outputs: video signal to monitor. Used in clinical settings by physicians. Features flexible insertion tube, control body for angulation/suction, and working channel for biopsy forceps. Enables diagnostic and therapeutic procedures; benefits patient via minimally invasive access to airways.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design control activities.

Technological Characteristics

Flexible video bronchoscope; includes light-carrying bundles and CCD sensor. Requires external video processor for illumination and image processing. Features working channel for accessory introduction. Sterilization method not specified.

Indications for Use

Indicated for adult and pediatric patients requiring optical visualization and therapeutic access to the pulmonary tract, including nasal passage, pharynx, larynx, trachea, and bronchial tree.

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

• VB-1830, Video Bronchoscope (K934920)

Submission Summary (Full Text)

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K023376

# EB-1830T3 Video Bronchoscope Special 510k Exhibit B

OCT 1 6 2002

## 510(k )Summarv EB-1830T3. Video Bronchoscope

| Submitter Information: | Pentax Precision Instrument Corporation (PPIC)<br>30 Ramland Road<br>Orangeburg, NY, 10962<br>Tel: [phone] |
|------------------------|-------------------------------------------------------------------------------------------------------------------|
|------------------------|-------------------------------------------------------------------------------------------------------------------|

| Name of Device. | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | EB-1830T3, Video Bronchoscope<br>Particle Production Comments of Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children |
| Classification Name: | EOO. Bronchoscope<br>and the manage of the management of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen |

### Predicated Device(s) Information:

| program and the program and the comments of the comments of the many of the many of the many of the many of the many of the many of the many of the many of the many of the ma<br> Model, Description | Manufacturer | PMN# | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------|--|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br> VB-1830, Video Bronchoscope<br>and the program and program of the program and program and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the | PPIC | K934920 | |

### Intended Use:

The EB-1830T3. Video Bronchoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Pulmonary Tract. The Pulmonary Tract includes, but is not restricted to, the organs; tissues; and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, and bronchial Tree (including access beyond the stem). The instrument is introduced per oral or per nasal when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.

# Device Description:

The EB-1830T3. Video Bronchoscope, must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube, a control body, and umbilicus. The umbilicus provides connection to the video processor and connections for suction. The umbilicus provides connection to the video processor. The control body includes controls for up/ down angulation, suction, and an accessory inlet port. The device contains light carrying bundles, to illuminate the body cavity, and a charge couple device (CCD) to collect image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The video processor contains an illumination system that is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the video processor illumination to the body cavity and the CCD collects image data and other screen display information are formatted and presented to the video outputs of the video processor for display.

# Comparison To Predicated Device(s):

The submission for substantial equivalence included comparisons to the predicated device, proposed labeling, summary of design control activities, and summary of Quality Assurance and Manufacturing Controls. The submission for substantial equivalence was not based on an assessment of clinical performance data.

Signature: Paul Silva

Date: 10-02-2002 Revision: a

Prepared by: Paul Silva Control Number: PS-726

page 1 of 1

Date: 10-0

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 6 2002

Pentax Precision Instrument Corporation c/o Paul Silva Regulatory Affairs Coordinator 30 Ramland Road Orangeburg, NY 10962

Re: K023376

Trade/Device Name: EB-1830T3, Video Bronchoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: October 4, 2002 Received: October 8, 2002

Dear Mr. Silva:

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 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); 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 - Paul Silva

This letter will allow you to begin marketing your device as described in your Section 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (21CFR 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,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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### EB-1830T3 Video Bronchoscope Special 510k Exhibit C

#### Indications for Use

| 510(k) Number (if known): | --------------------------------------------------------------------------- | Page 1 of of 1 | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---------------------------|-----------------------------------------------------------------------------|----------------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | EB-1830T3, Video Bronchoscope | | | |

#### Endoscope Intended Use Statement:

The EB-1830T3, Video Bronchoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Pulmonary Tract. The Pulmonary Tract includes, but is not restricted to, the organs; tissues; and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, and bronchial Tree (including access beyond the stem). The instrument is introduced per oral or per nasal when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.

(Please do not write below this line - continue on another page if needed Concurrence of CDRH, Office of Device Evaluation (ODE)

Karen of Baker

(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises

510(k) Number _

Prescription Use (Per 21 CFR 801.109)