Dillard Airway Dilatation System

K153484 · Intuit Medical Products, LLC · KTI · Jul 27, 2016 · Ear, Nose, Throat

Device Facts

• Record ID: K153484
• Device Name: Dillard Airway Dilatation System
• Applicant: Intuit Medical Products, LLC
• Product Code: KTI · Ear, Nose, Throat
• Decision Date: Jul 27, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dillard Airway Dilatation System is intended to dilate strictures of the airway tree.

Device Story

Dillard Airway Dilatation System is a balloon catheter used to dilate airway strictures. The device features a balloon at the distal end, a central lumen for guidewire use, and a proximal hub with a luer connector for inflation. It is operated by a clinician who uses a standard inflation device to apply hydraulic pressure to the balloon, expanding it to dilate the stricture. Radiopaque markers on the balloon assist with radiographic positioning. The device is supplied sterile for single use. By mechanically dilating the airway, the system aims to improve patient breathing and airway patency.

Clinical Evidence

Bench testing only. Performance testing included dimensional specifications, joint separation strength, accessory compatibility, balloon burst pressure, inflation/deflation times, balloon cycle fatigue, and balloon deflation challenge. Biocompatibility testing was conducted in compliance with ISO 10993-1 and FDA Bluebook Memorandum G-95-1, including cytotoxicity, sensitization, and mucosal irritation.

Technological Characteristics

Balloon catheter system; materials include Nylon (balloon), Nylon, Pebax/Plexar/HDPE tri-extrusion (catheter), and Platinum-Iridium (marker bands). Operates via hydraulic pressurization. Dimensions: 25cm/100cm working lengths, 5-12mm balloon diameters. Single-use; sterilized via 100% Ethylene Oxide gas. Compatible with 0.035" guidewires.

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 Dilation Catheter (Inspira®) (K090660)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, ribbon-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Public Health Service

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

July 27, 2016

Intuit Medical Products, LLC Mr. Jack Griffis VP, Research & Development 6018 Eagles Rest Trail Sugar Hill, GA 30518

Re: K153484

Trade/Device Name: Dillard Airway Dilatation System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: KTI Dated: June 22, 2016 Received: June 29, 2016

Dear Mr. Griffis:

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.

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

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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Eric A. Mann -S

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

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

## Indications for Use

510(k) Number (if known) K153484

Device Name Airway Dilatation System

Indications for Use (Describe) The Dillard Airway Dilatation System is intended to dilate strictures of the airway trees.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Image /page/3/Picture/1 description: The image shows a profile view of a person's head and neck, with the internal structures of the nasal passages, mouth, and throat visible. These structures are highlighted in shades of blue and purple. To the right of the head is a blue rectangle containing the text "IMP" in large, bold letters, followed by "Intuit Medical Products, LLC" in smaller text below.

## 510(k) Summary

510(k) Number: K153484

July 25th, 2016 Date Revised:

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

- A. Submitter: Intuit Medical Products (IMP), LLC 6018 Eagles Rest Trail Sugar Hill, Georgia 30518
- B. Company Contact: Jack Griffis Vice President, Research & Development [phone] (direct) [e-mail]

| C. | Device Information: | |
|----|---------------------|--------------------------------------------------------------------------|
| | Trade Name: | Dillard Airway Dilatation Catheter |
| | Common Name: | Airway Dilatation System |
| D. | Classification: | Bronchoscope (flexible or rigid) and accessories<br>KTI, 21 CFR 874.4680 |

- E. Predicate Device: Acclarent Airway Dilation Catheter (Inspira®), K090660
Class II

#### F. Physical Description:

The Dillard Airway Dilatation System includes a balloon catheter whose working length is 25cm or 100cm, and is available in balloon diameters from 5mm to 12mm and balloon lengths of 20mm and 40mm. The balloon component of the catheter has radiopaque markers to assist with radiographic positioning (as applicable). The proximal end of the device is a common catheter design consisting of a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector integrated into the hub is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends through the central lumen back to the proximal hub and through the distal tip. All catheters and accessories are supplied sterile and intended for single use.

NOTE: the proposed device is identical to that previously cleared under K143738, with the exception of additional balloon sizes and indication for use in airway dilatation.

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

- G. Indications for Use: The Dillard Airway Dilatation System is intended to dilate strictures of the airway tree.
- H. Comparison of Characteristics / Performance Testing / Substantial Equivalence: The Dillard Airway Dilatation System is substantially equivalent to the predicate device in intended use, indications for use, fundamental scientific technology, and important performance specifications. Refer to the Table below for a summary:

| Parameter | DAS Air Balloon Catheter<br>(Proposed) | Acclarent Inspira® AIR Balloon Catheter<br>(Predicate, K090660) |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Intended to dilate strictures of the airway tree. | |
| Principle of Operation | Operates on the principle of hydraulic pressurization applied through an inflatable<br>balloon attached to the distal end | |
| Guidewire Style | OTW | OTW and Integrated |
| Guidewire Compatibility | OTW: 0.035" | Integrated: Unknown<br>OTW: 0.035" |
| Catheter Lengths | 25cm and 140cm | 30cm |
| Balloon Lengths | 20 and 40mm | 24 and 40mm |
| Balloon Diameters | 5.0 thru 12.0mm | 5.0 thru 16.0mm |
| Nominal Inflation<br>Pressure | 6 ATM for all catheters | 6 ATM |
| MAX Recommended<br>Inflation Pressure | 12 ATM for balloon diameters 5.0<br>thru 10.0mm<br>10 ATM for balloon diameters<br>11.0 and 12.0mm | 16 ATM for balloon diameters 5.0 thru 7.0mm<br>12 ATM for balloon diameters 8.0 thru 11mm<br>10 ATM for balloon diameters 12.0 thru 14.0mm<br>8 ATM for balloon diameter 16.0mm |
| Single Use? | Yes | |
| Sterilization Method | 100% Ethylene Oxide gas | |
| Packaging | Tyvek-Mylar Pouch, Protective Tube, Stylet | |
| Balloon Material | Nylon | Nylon blend |
| Catheter Materials | Nylon, Pebax/Plexar/HDPE Tri-<br>Extrusion, Platinum-Iridium<br>Marker Bands | Polymer Extrusions (unknown), Platinum-Iridium<br>Marker Bands |

In addition, the device was subjected to the following performance tests to support the assertion of substantial equivalence:

- Dimensional specifications (including compliance)
- l Joint separation strength
- ' Compatibility with (standard) accessories
- l Balloon burst pressure

Image /page/4/Picture/9 description: The image shows a medical illustration of the human head and neck, with the nasal passages, sinuses, and throat highlighted in blue and purple. To the right of the illustration is the text "IMP Intuit Medical Products, LLC" in a blue box. The illustration is a side view of the head and neck, showing the internal structures of the respiratory system.

{5}------------------------------------------------

- Inflation and deflation times
- Balloon cycle fatigue
- Balloon deflation challenge testing
- Biocompatibility Testing in Compliance with the ISO 10993-1 and the FDA Bluebook Memorandum (G-95-1) as follows (and where applicable):
- O Cytotoxicity
- Sensitization (Guinea Pig Maximization) o
- Mucosal (oral) Irritation O

No new questions of safety or effectiveness were identified during device testing; therefore, the Dillard Airway Dilatation System is considered substantially equivalent to the predicate device.

Jack Griffis Vice President, Research & Development

Image /page/5/Picture/11 description: The image shows a logo for Intuit Medical Products, LLC. The logo features a side profile of a person's head and neck, with the inside of the head colored in shades of blue and purple to represent the respiratory system. To the right of the head is a light blue rectangle with the letters "IMP" in large, bold, white font. Below "IMP" are the words "Intuit Medical Products, LLC" in a smaller, white font.