AIRWAY BALLOON CATHETER INFLATION DEVICE

K090660 · Acclarent, Inc. · KTI · Jun 12, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K090660
• Device Name: AIRWAY BALLOON CATHETER INFLATION DEVICE
• Applicant: Acclarent, Inc.
• Product Code: KTI · Ear, Nose, Throat
• Decision Date: Jun 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Airway Balloon Catheter is an instrument intended to dilate strictures of the airway tree. The Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus procedures and dilation of the airway tree.

Device Story

The Airway Balloon Catheter is a manual surgical instrument featuring a high-pressure balloon at its distal tip and a coaxial lumen for inflation and optional guidewire access. It is used in conjunction with an inflation device to dilate airway tree strictures. The inflation device allows the clinician to inflate, deflate, and monitor pressure within the balloon. The system is intended for use by physicians in a clinical setting. By mechanically dilating strictures, the device aims to improve airway patency. The procedure is performed under direct visualization using a bronchoscope.

Clinical Evidence

Bench testing only. The device met all performance acceptance criteria.

Technological Characteristics

Manual surgical instrument. Features a high-pressure balloon catheter with a coaxial lumen for inflation and guidewire access. Includes an inflation device for pressure monitoring and control. No electronic or software components described.

Indications for Use

Indicated for patients requiring dilation of strictures within the airway tree. The inflation device is indicated for use in sinus procedures and airway tree dilation.

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

• Boston Scientific CRE Pulmonary Balloon Dilation Catheter (K023337)
• Acclarent Relieva Sinus Balloon Catheter (K073041)
• Acclarent Relieva Sinus Inflation Device (K052198)
• Boston Scientific Alliance II Inflation System (K Number Unknown)

Submission Summary (Full Text)

{0}------------------------------------------------

K090660

Acclarent

# APPENDIX A: 510(k) SUMMARY

Sponsor/Submitter:

Contact Person:

Acclarent, Inc. 1525-B O'Brien Drive Menlo Park, California 94025

Keri Yen Sr. Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

Airway Balloon Catheter and Accessories

Airway Balloon Catheter (21 CFR 874.4680)

Relieva Inflation Device (21 CFR 874.4420)

Bronchoscope (flexible or rigid) and accessories Ear, nose, and throat manual surgical instrument

Airway Balloon Catheter (Class II)

Relieva Inflation Device (Class I)

Date of Submission:

March 11, 2009

TBD

Device Trade Name:

Common Name:

Device Classification:

Regulation Number:

Classification Name:

Product Code:

Predicate Devices:

Device Description:

KTI LRC

Boston Scientific CRE Pulmonary Balloon Dilation Catheter (K023337) Acclarent Relieva Sinus Balloon Catheter (K073041) Acclarent Relieva Sinus Inflation Device (K052198) Boston Scientific Alliance II Inflation System (K Number Unknown)

The Airway Balloon Catheter is a catheter with a high pressure balloon on the distal tip. The device is designed with a coaxial lumen for inflation and guidewire access, if required. There are two accessories for the Airway Balloon Catheter: Inflation Device and Relieva Vigor Guidewire (optional).

JUN 122009

{1}------------------------------------------------

| Indications for Use: | The Airway Balloon Catheter is an instrument intended to<br>dilate strictures of the airway tree.<br><br>The Inflation Device is an instrument intended to inflate,<br>deflate and monitor pressure in balloon catheters used in sinus<br>procedures and dilation of the airway tree. |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics: | The Airway Balloon Catheter and Accessories enlarge<br>strictures in the airway tree. The technological characteristics<br>of the subject device are similar to its predicate devices. |
| Performance Data: | The Airway Balloon Catheter and Accessories met all<br>performance acceptance criteria. |
| Summary of Substantial<br>Equivalence: | The Airway Balloon Catheter is substantially equivalent to the<br>predicate device as confirmed through relevant tests. |

1. September 19.

. .

:

:

and the state of the state of the states of the states

.

.

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Acclarent, Inc. c/o Debra Cogan Sr. Regulatory Affairs Manager 1525-B O'Brien Drive Menlo Park, CA 94025

# Re: K090660

Trade/Device Name: Airway Balloon Catheter Inflation Device Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and Accessories Regulatory Class: II Product Code: KTI Dated: May 21, 2009 Received: May 22, 2009

Dear Ms. Cogan:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

JUN 1 2 2009

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.

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.

{3}------------------------------------------------

#### Page 2 – Ms. Debra Cogan

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Kesia Alexander for

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

Enclosure

{4}------------------------------------------------

Acclarent

090660

# APPENDIX B: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K090660

Trade Name:

TBD

Common Name:

Airway Balloon Catheter Inflation Device

Indications For Use:

The Airway Balloon Catheter is an instrument intended to dilate strictures of the airway tree.

The Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus procedures and dilation of the airway tree.

Prescription Use X (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)

Amalul

(Division Sign-Off) (Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number k096660

Page **_ of _**

(Posted November 13, 2003)