BRONCHIAL CATHETER SYSTEM

K980046 · Broncus Technologies, Inc. · EOQ · May 1, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K980046
• Device Name: BRONCHIAL CATHETER SYSTEM
• Applicant: Broncus Technologies, Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: May 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bronchial Catheter System is intended to be used for foreign body removal and bronchial hemostasis.

Device Story

Bronchial Catheter System facilitates foreign body removal and bronchial hemostasis; used in clinical settings by physicians. Device functions as accessory to electrosurgical generators for hemostasis or as mechanical tool for foreign body retrieval. Operates via insertion into bronchial tree; provides physician with means to manage airway obstructions or bleeding. Benefits include minimally invasive intervention for airway management.

Clinical Evidence

Bench testing only. In vitro performance evaluation demonstrated equivalence to predicate devices. Biocompatibility of materials confirmed.

Technological Characteristics

Catheter-based system; utilizes balloon technology for foreign body removal and RF energy (via external generator) for hemostasis. Materials possess proven biocompatibility.

Indications for Use

Indicated for patients requiring foreign body removal or bronchial hemostasis.

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

• Disposable Balloon Catheters (Olympus)
• Microvasive Gold Probe Direct (Boston Scientific)
• Force 2 Electrosurgical Generator (Valleylab, Inc.)

Submission Summary (Full Text)

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Bronchial Catheter System

#### 510(k) Summary of Safety and Effectiveness 10000 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------MAY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: k180046

# Applicant Information:

| Date Prepared: | January 5, 1998 |
|----------------|-------------------------------------------------------|
| Name: | Broncus Technologies, Inc. |
| Address: | 1400N. Shoreline Boulevard<br>Mountain View, CA 94043 |

| Contact Person: | Glendon E. French |
|-----------------|-------------------|
| Phone Number: | [phone] |
| Fax Number: | [phone] |

# Device Information:

| Classification | Class II |
|----------------------|-------------------------------------------------|
| Trade Name: | Bronchial Catheter System |
| Classification Name: | Bronchoscope and Accessories<br>21 CFR 874.4680 |

# Equivalent Devices:

The subject device is substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices:

- Disposable Balloon Catheters 1. Olympus
- Microvasive Gold Probe Direct Boston Scientific 2.
- 3. Valleylab, Inc. Force 2 Electrosurgical Generator

## Intended Use:

The Bronchial Catheter System is intended to be used for foreign body removal and bronchial hemostasis.

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# 510(k) Summary of Safety and Effectiveness, continued

## Comparison To Predicate Devices:

The Broncus Technologies Bronchial Catheter System is equivalent in intended use and operational characteristics to the Olympus Disposable Balloon Catheters and the Microvasive Gold Probe when used with the Valleylab Force 2 RF Generator.

## Non-Clinical Test Results:

#### Performance

The performance of the Bronchial Balloon Catheter was evaluated in vitro and shown to be equivalent to the performance of the predicate devices.

## Biocompatibility

The materials used in the Bronchial Balloon Catheter have proven biocompatibility.

## Summary:

Based on the intended use, product, performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to currently marketed predicate devices.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, serif font. The words are arranged on a single line and centered.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1998

Bronchus Technologies, Inc.

Mountain View, California 94043

1400 N. Shoreline Blvd. Building A. Suite 8

Glendon E. French

President and CEO

Re:

K980046 Bronchial Catheter System Dated: April 10, 1998 Received: April 13, 1998 Regulatory class: II 21 CFR 874.4680/Procode: 77 EOO 21 CFR 878.4400/Procode: 79 GEI

Dear Mr. French:

We have reviewed your Section 510(k) 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 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.

If your device is classified (see above) into either class II (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K980046 510(k) Number (if known):

Device Name:

Bronchial Catheter System

Indications for Use:

The Bronchial Catheter System is intended for foreign body removal and bronchial hemostasis.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devj 510(k) Number Prescription Use OR Over- The Counter Use _______ (Per 21 CFR 801.109) -

(Optional Format 1-2-96)