Elation Pulmonary Balloon Dilation

K161392 · Merit Medical Systems, Inc. · KTI · Sep 1, 2016 · Ear, Nose, Throat

Device Facts

• Record ID: K161392
• Device Name: Elation Pulmonary Balloon Dilation
• Applicant: Merit Medical Systems, Inc.
• Product Code: KTI · Ear, Nose, Throat
• Decision Date: Sep 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Elation™ Pulmonary Balloon Dilation Catheter is intended to endoscopically dilate strictures of the trachea and bronchi.

Device Story

Multi-lumen catheter with distal dilation balloon; designed for use with endoscope working channel and 0.035-inch guidewire. Two redundant inflation lumens enable balloon inflation/deflation. Features include endoscopic and radiopaque marker bands for visualization and a glow-in-the-dark shaft tag indicating diameter/pressure. Used by clinicians in clinical settings to dilate airway strictures; provides mechanical dilation to improve airway patency. Benefits include relief of airway obstruction.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included radiopacity, tip perforation, guidewire pushability, simulated insertion/withdrawal, balloon diameter, deflation time, burst/leakage, tensile strength, pushability, kink/kink recovery, and high tensile load balloon deflation. Biocompatibility testing (cytotoxicity, sensitization, irritation) and sterilization validation (EO) performed per ISO standards.

Technological Characteristics

Multi-lumen catheter; Pebax balloon material; 7.5F diameter; 100 cm length; 6-20 mm balloon diameters. Compatible with 2.8 mm endoscope working channels and 0.035 in guidewires. Radiopaque and endoscopic markers. Sterilized via ethylene oxide (ISO 11135:2014). Standards: ISO 594-1/2, ISO 10555-1/4, ASTM F640-12, ISO 10993 series.

Indications for Use

Indicated for endoscopic dilation of tracheal and bronchial strictures in patients requiring airway management.

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

• CRE™ Pulmonary Balloon Dilatation Catheter (K023337)

Submission Summary (Full Text)

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

September 1, 2016

Merit Medical Systems, Inc. Mr. David Thomas Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095

Re: K161392

Trade/Device Name: Elation Pulmonary Balloon Dilation Catheter Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: KTI Dated: August 3, 2016 Received: August 4, 2016

Dear Mr. Thomas:

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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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

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# Indications for Use

510(k) Number (if known) K161392

Device Name

Elation(TM) Pulmonary Balloon Dilation Catheter

Indications for Use (Describe)

The Elation™ Pulmonary Balloon Dilation Catheter is intended to endoscopically dilate strictures of the trachea and bronchi.

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)

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# K161392 - 510(k) Summary

| General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date of Preparation:<br>Registration Number: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>[phone]<br>[phone]<br>David Thomas<br>August 29, 2016<br>1721504 |
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| Subject Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | Elation™ Pulmonary Balloon Dilation<br>Catheter<br>Pulmonary Balloon Dilation Catheter<br>Bronchoscope (flexible and rigid) and<br>accessories |
| Predicate Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | CRE™ Pulmonary Balloon Dilatation Catheter<br>Bronchoscope (flexible and rigid) and<br>accessories<br>K023337<br>Boston Scientific Corporation |
| Classification | Class II<br>21 CFR § 874.4680<br>FDA Product Code: KTI<br>Review Panel: Ear, Nose & Throat | |
| Intended Use | The Elation™ Pulmonary Balloon Dilation Catheter<br>is intended to be used to endoscopically dilate strictures of the trachea<br>and bronchi. | |

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The Elation™ Pulmonary Balloon Dilation Catheter is a multi-lumen catheter with a dilation balloon on the distal tip. The catheter is designed to pass through the working channel of an endoscope and accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. Two redundant inflation lumens are used to inflate and deflate the dilation balloon.

The dilation balloon will be available in a 7.5F catheter with a length of Device 100 cm, balloon lengths of 2.0 cm, 3.0 cm or 5.5 cm and in six balloon Description diameter ranges from 6 mm to 20 mm. Each balloon size will inflate to three different diameters for the specified inflation pressures. The balloon will be identifiable with both endoscopic and radiopaque marker bands. A glow-in-the-dark tag that can be read in low light conditions is attached to the catheter shaft. The tag indicates diameter and corresponding pressure of the balloon.

> The balloon will be available in eleven configurations of multiple lengths and diameters. The balloon will be identifiable with both endoscopic and fluoroscopic markers and will be provided sterile.

Comparison to Predicate Device

The Elation™ Pulmonary Balloon Dilation Catheter has the same technological features as the CRE™ Pulmonary Balloon Dilatation Catheter by Boston Scientific Co.( K023337). Both balloons are multistage that come in three distinct diameters ranging from 6 to 20 mm for six balloon sizes. Both catheters pass through a minimum 2.8 mm working channel endoscope. Both systems utilize a 0.035 inch floppy tip quidewire. The balloons for the CRE™ Balloon and the Elation™ Pulmonary Balloon Dilation Catheter are both manufactured from Pebax material. The primary differences are that the Elation™ Pulmonary Balloon Dilation Catheter is available in 2.0 cm, 3.0 cm and 5.5 cm balloon length sizes where the CRE™ Pulmonary Balloon Dilatation Cather has only the 5.5 cm and 3.0 cm sizes and the catheter length for the Elation™ Pulmonary Balloon Dilation Catheter is 100 cm instead of the 75 cm length for which the CRE™ Pulmonary Balloon Dilatation Catheter is available.

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No performance standards have been established under Section 514 of the Food, Druq and Cosmetic Act for these devices. Performance testing of the subject Elation™ Pulmonary Balloon Dilation Catheter was conducted based on the risk analysis and based on the requirements of the following international standards and guidance documents:

ISO 594-1: 1986 (E) Conical fittings with a 6% (Luer) taper for svringes, needles, and certain other medical equipment - Part 1: General Requirements

ISO 594-2: 1998 (E) Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment – Part 2: Lock fittings

ISO 10555-1: 2013 - Intravascular catheters - Sterile and single use catheters - Part 1: General Requirements

ISO 10555-4: 2013 - Intravascular catheters - Sterile and single use catheters - Part 4: Balloon dilatation catheters

Safety & Performance Tests

ASTM F 640 – 12 Standard Test Methods for Determining Radiopacity for Medical Use

Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010.

ISO 11135:2014, Sterilization of health care products – Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO 10993-1:2009. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process.

FDA guidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995

ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

ISO 10993-7:2008. Biological Evaluation of Medical Devices – Part 7 Ethylene Oxide sterilization residuals

ISO 10993-10:2010, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.

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AAMI/ANSI/ISO 11607-1:2006. Packaging for terminally sterilized medical devices – Part 1 – Requirements for materials, sterile barrier systems and packaging systems (Sterility)

ASTM D4169-09, Standards Practice for Performance Testing of Shipping Containers and Systems (Sterility)

ISO 2233 (2000), Packaging - Complete, filled transport packages and unit loads - conditions for testing

# Performance Testing-Bench

- Radiopacity ●
- . Tip Perforation
- Guidewire Pushability .
- Simulated Bronchoscope Catheter Insertion and Withdrawal
- Balloon Diameter ●
- Balloon Deflation Time
- . Balloon Burst / Freedom from Leakage
- Distal Catheter Joints Tensile
- . Proximal Catheter Joints Tensile
- . Catheter Pushability
- Catheter Kink
- Kink Recovery ●
- High Tensile Load Balloon Deflation ●

## Sterilization Validation

The Elation™ Pulmonary Balloon Dilation Catheter will be sterilized using a validated 100% ethylene oxide (EO) sterilization process that is also used for other devices manufactured by Merit, including the predicate device. The EO sterilization cvcles employed by Merit Medical are validated by the half cycle / over-kill approach and meet the requirements of ISO 11135:2014 – Sterilization of health care products – Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices. Validation and annual revalidation have demonstrated a robust program that exceeds the minimum sterility assurance level of 10-6 as well as limiting residual sterilant levels to within limits established in EN ISO 10993-7:2008 - Biological Evaluation of Medical Devices, Part 7: Ethylene Oxide Sterilization Residuals.

Biological indicators, which are included with each sterilization lot. are sterility tested as part of the product release process.

Safetv & Performance Tests cont.

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## Shelf Life Validation

Merit determines shelf life for the packaging and device based on accelerated aging studies conducted according to the Arrhenius Model (Q10). An initial shelf life of 6 months was selected for the subject Elation™ Pulmonary Balloon Dilation Catheter based on the results of the accelerated aging studies. These studies were performed according to approved protocols and procedures following EO sterilization. The accelerated aging testing supported a 6-month shelf life of the product. Upon successful completion of requisite accelerated aging studies, the Elation™ Pulmonary Balloon Dilation Catheter may be labeled with a longer shelf life. Accelerated aging will be supported by real time aging studies which are ongoing.

# Packaging Performance

Sterile barrier maintenance was tested after exposure to simulated transportation and storage conditions up to 3 vears of accelerated and real time aging. All samples tested passed the tests listed below.

- Seal Peel Strength
- Burst Strength
- Visual Inspection ●
- Bubble Emission ●
- Dye Penetration ●

## Biocompatibility

The biocompatibility evaluation for the Elation™ Pulmonary Balloon Dilation Catheter was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

- Cytotoxicity
- Sensitization ●
- Irritation ●

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| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, design, safety and performance<br>testing, the subject Elation™ Pulmonary Balloon Dilatation Catheter<br>meets the requirements that are considered essential for its intended<br>use and is substantially equivalent to the predicate device, the CRE™<br>Pulmonary Balloon Dilatation Catheter, K023337. |
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