INSPIRA AIR BALLOON DILATION SYSTEM

K110218 · Acclarent, Inc. · KTI · Mar 31, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K110218
• Device Name: INSPIRA AIR BALLOON DILATION SYSTEM
• Applicant: Acclarent, Inc.
• Product Code: KTI · Ear, Nose, Throat
• Decision Date: Mar 31, 2011
• Decision: SESE
• Submission Type: Special
• 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.

Device Story

The Inspira AIR Balloon Dilation System (Modified Airway Balloon Catheter) is a catheter featuring a high-pressure balloon at its distal tip. Designed with a coaxial lumen, it allows for balloon inflation and optional stylet access. The device is used by clinicians to dilate strictures in the airway tree. By inflating the balloon to a specified pressure (8 ATM), the device mechanically expands the narrowed airway, potentially improving patient breathing. The system is characterized by an 18x40mm balloon size and a reduced deflation time specification compared to previous iterations. It is intended for use in a clinical setting.

Clinical Evidence

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

Technological Characteristics

Coaxial lumen catheter with high-pressure balloon (18x40mm). Maximum inflation pressure: 8 ATM. Deflation time: ≤15 seconds. Flexible shaft design. Optional stylet access. Sterilization method not specified.

Indications for Use

Indicated for patients requiring dilation of strictures within the airway 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

• Acclarent Airway Balloon Catheter and Accessories (K090660)
• Boston Scientific CRE Pulmonary Balloon Dilation Catheter (K023337)

Submission Summary (Full Text)

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KII 0218

MAR 3 1 2011

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| | APPENDIX A: 510(k) SUMMARY |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 |
| Contact Person: | Keri Yen<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone] |
| Date of Submission: | January 24, 2011 |
| Device Trade Name: | Inspira AIR Balloon Dilation System |
| Common Name: | Airway Balloon Catheter |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 874.4680 |
| Classification Name: | Bronchoscope (flexible or rigid) and accessories |
| Product Code: | KTI |
| Predicate Devices: | Acclarent Airway Balloon Catheter and Accessories (K090660) |
| | Boston Scientific CRE Pulmonary Balloon Dilation Catheter<br>(K023337) |
| Device Description: | The Modified Airway Balloon Catheter is a catheter with a high<br>pressure balloon on the distal tip. The device is designed with a coaxial<br>lumen for inflation and stylet access, if required. The Modified Airway<br>Balloon Catheter encompasses a 18x40mm balloon catheter and reduces<br>the deflation time specification. |
| Indications for Use: | The Modified Airway Balloon Catheter is an instrument intended to<br>dilate strictures of the airway tree. |

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Technological Characteristics: The technological characteristics of the subject device are similar to its predicate devices.

| Attribute | Airway Balloon<br>Catheter<br>(K090660) | CRE Pulmonary<br>Balloon Dilation<br>Catheter<br>(K023337) | Modified Airway<br>Balloon Catheter |
|----------------------------------|-----------------------------------------|---------------------------------------------------------------------------|----------------------------------------|
| Balloon Diameters | 5 mm<br>7 mm<br>10 mm<br>14 mm | 8-9-10 mm<br>10-11-12 mm<br>12-13.5-15 mm<br>15-16.5-18 mm<br>18-19-20 mm | 18mm |
| Balloon Length | 24 mm<br>40 mm | 30 mm<br>55 mm | 40 mm |
| Deflation Time | ≤15 seconds<br>≤25 seconds | Unknown | ≤15 seconds |
| Maximum<br>Inflation Pressure | 10-16 ATM | 6-9 ATM | 8 ATM |
| Flexible | Yes | Yes | Yes |
| Shaft Design | Coaxial Lumen | Coaxial Lumen | Coaxial Lumen |
| Used with Stylet | Optional | Yes (Guidewire) | Optional |
| Technological<br>Characteristics | To dilate strictures<br>of airway tree | To dilate strictures<br>of airway tree | To dilate strictures<br>of airway tree |

## Performance Data:

The Modified Airway Balloon Catheter and Accessories met all performance acceptance criteria.

Summary of Substantial Equivalence:

The Modified Airway Balloon Catheter is substantially equivalent to the predicate device as confirmed through relevant tests.

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

Acclarent, Inc. c/o Ms. Keri Yen Manager, Regulatory and Clinical 1525-B O'Brien Dr. Menlo Park, CA 94025

MAR 3 1 200

Re: K110218

Trade/Device Name: Inspira AIR Balloon Dilation System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Dated: March 2, 2011 Received: March 3, 2011

Dear Ms. Yen:

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.

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Page 2 - Ms. Keri Yen

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.

Sincercly yours.

Ridettenm f

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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## APPENDIX B: INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K110218 | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------|--|
| Trade Name: | Inspira AIR Balloon Dilation System | |
| Common Name: | Airway Balloon Catheter | |
| Indications For Use: | The Airway Balloon Catheter is an instrument intended to dilate strictures of the airway tree. | |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | |
| AND/OR | Over-The-Counter Use<br>(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)

Page / of /

(Posted November 13, 2003)

Daniel C. Cepp
(Division Sign-Off)

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

K110218
510(k) Number