Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter

K143609 · Olympus Surgical Technologies America · FGE · Mar 27, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K143609
• Device Name: Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
• Applicant: Olympus Surgical Technologies America
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Mar 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EZDilate 3-Stage Balloon Dilatation Catheters are indicated for use in adult populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

Device Story

The EZDilate 3-Stage Balloon Dilatation Catheter is a wire-guided, dual-lumen catheter featuring a semi-compliant nylon balloon at the distal end. It is designed for use by physicians during endoscopic procedures to dilate strictures in the alimentary tract or the Sphincter of Oddi. The device is operated via an external inflation device (e.g., Atrion K032840) which delivers fluid through the catheter shaft to expand the balloon. The balloon is engineered for progressive radial expansion to three distinct target sizes. A silicone coating on the balloon facilitates insertion, positioning, and removal. The device is supplied sterile for single-patient use. By providing controlled mechanical dilation, the catheter assists in restoring patency to narrowed anatomical structures, potentially improving patient symptoms related to strictures.

Clinical Evidence

Bench testing only. No clinical data provided. Design verification included first article inspection, tensile, fatigue, luer gauging, balloon working length, tip stiffness, compliance, burst, insertion force, friction, deflation, and endoscope compatibility testing.

Technological Characteristics

Dual-lumen catheter; nylon balloon; Pebax balloon tube, guidewire tube, and bifurcation hub; silicone balloon coating; PTFE-coated guidewire. 5.5cm balloon length, 240cm catheter length. Compatible with 0.035 in. guidewire. Sterilized via ethylene oxide. Complies with ISO 594-1/2, ISO 10993-1/5/7/10, ISO 11135-1, ISO 1138-2, ISO 14971, ISTA P2A, and ASTM D4169, F2096, F88, F1886, F1980.

Indications for Use

Indicated for adult patients requiring endoscopic dilation of alimentary tract strictures or the Sphincter of Oddi (with or without prior sphincterotomy).

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Boston Scientific CRE Dilatation Balloon (K112994)

Reference Devices

• Atrion inflation device (K032840)

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

March 27, 2015

Olympus Surgical Technologies America Gyrus ACMI, Inc. Mary Anne Patella Senior Specialist, Regulatory Affairs 136 Turnpike Road Southborough, MA 01772-2104

Re: K143609

> Trade/Device Name: EZDilate 3-Stage Balloon Dilatation Catheters Regulation Number: 21 CFR§ 876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: KNO, FGE Dated: January 16, 2015 Received: January 20, 2015

Dear Mary Anne Patella.

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.

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.

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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 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,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K143609

Device Name EZDilate 3-Stage Balloon Dilatation Catheters

#### Indications for Use (Describe)

The EZDilate 3-Stage Balloon Dilatation Catheters are in adult populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of Oddi with or without prior sphincterotomy.

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

| <span style="font-size: 100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary Gyrus ACMI, Inc. EZDilate 3-Stage Balloon Dilatation Catheter

#### General Information

| Contract Manufacturer: | Vention Medical, Inc.<br>261 Cedar Hill Drive<br>Marlborough, MA 01752<br>Phone: [phone] |
|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3004734318 |
| 510(k) Submitter: | Gyrus ACMI, Inc.<br>136 Turnpike Rd.<br>Southborough, MA 01772-2104 |
| Establishment Registration Number: | 3003790304 |
| Contact Person: | Mary Anne Patella<br>Senior Specialist Regulatory Affairs<br>508-804-2771<br>[e-mail] |
| Date Prepared: | December 16, 2014 |
| Device Description | |
| Classification Name:<br>CFR citation<br>Procode<br>Classification<br>Classification Panel | Catheter, Biliary, Diagnostic<br>Dilator, Esophageal<br>21 CFR 876.5010, 876.5365<br>FGE, KNQ<br>Class II<br>Gastroenterology/Urology |
| Trade Name: | EZDilate 3-Stage Balloon Dilatation<br>Catheter |
| Generic/Common Name: | Balloon Dilation Catheter |
| Predicate Devices | |

Boston Scientific CRE Dilatation Balloon

K112994

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## Product Description

The EZDilate 3-Stage Balloon Dilatation Catheter consists of a semi-compliant nylon blow molded balloon; and, a shaft that communicates a fluid passage for expansion and collapse of the balloon portion, operated by an inflation device. The EZDilate Wire Guided Balloon is designed to be used with a 0.035 in. (0.89mm) guidewire and has a wire lumen sized appropriately. Each balloon catheter is packaged with a soft tip 0.035 in. (0.89mm) guidewire pre-loaded into the guidewire lumen. All wire-guided balloons with have lengths of 5.5cm and a catheter length of 240cm. The balloon is inflated with a 60cc inflation device, which will be sold separately. The suggested inflation device is manufactured by Atrion (K032840).

## Technological Characteristics

The EZDilate 3-StageWire Guided Balloon Dilatation Catheter is a reinforced catheter attached to a distal dilatation balloon. The semi-compliant balloon allows for a progressive radial expansion through three target sizes using one balloon. A silicone coating applied to the balloon increases ease of insertion, positioning of the balloon within the alimentary tract, and device removal.

# Material

The EZDilate - Wire Guided 3-stage balloon dilatation catheter is a dual lumen catheter with a distal end comprising a nylon balloon and a proximal end comprising an inflation port and guidewire port. . The balloon tube, guidewire tube, and bifurcation hub are all constructed of Pebax. A silicone coating is applied to the balloon. A PTFE coated guidewire is pre-loaded into the guidewire lumen.

# Intended Uses

The EZDilate 3-Stage Balloon Dilatation Catheters are indicated for use in adult populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

## Compliance to Voluntary Standards

The design of the proposed device complies with the following standards:

ISO 594-1:1986 ISO 594-2: 1998 ISO 10993-1, 2009 ISO 10993-5, 2009

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Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter Gyrus ACMI, Inc.

- ISO 10993-7:2008(R)2012 ISO 10993-10, 2010 ANSI/AAMI/ISO 11135-1, 2007 ISO 1138-2:2006 ISO 14971, 2012 ISTA P2A, 2011 ASTM D4169-09 ASTM F2096-11 ASTM F88/F88M:2009 ASTM F1886/F1886M:2009 ASTM F1980-07 (2011)
#### Summary of Sterilization and Shelf Life Discussion

The EZDilate 3-Stage Balloon Dilatation Catheter is delivered in a sterile state and is intended for single patient use only. The sterilization method used is ethylene oxide. Six month shelf life data will be submitted to support the 510(k) submission; the product will be launched with a shelf life of three (3) years.

#### Summary of Performance Testing

During design verification, the output of the design process was evaluated against the physical and performance specifications. In general, the evaluation compared the function of the EZDilate 3-Stage Balloon Dilatation Catheter against these specified requirements.

- First Article Inspection (Dimensional Measurements) ●
- Tensile Testing
- Fatigue Testing ●
- Luer Gauging Test ●
- Balloon Working Length
- Tip Stiffness Testing
- Compliance Testing
- Balloon Burst Testing
- Balloon Insertion Force Testing
- Balloon Friction Testing ●
- Balloon Deflation Testing
- Balloon Endoscope Compatibility Testing ●

## Substantial Equivalence

The proposed EZDilate 3-Stage Balloon Dilatation Catheter has the same intended use, design, and scientific technology as the Predicate Boston Scientific CRE

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Dilatation Balloon (K112994). Both devices are of similar design and there were no new issues of safety or effectiveness with the proposed device.

## Conclusion:

In summary, the EZDilate 3-Stage Balloon Dilatation Catheter is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.