NEXGEN EXPANDABLE CATHETER

K102925 · Nexgen Medical Systems, Inc. · DYB · Nov 10, 2011 · Cardiovascular

Device Facts

• Record ID: K102925
• Device Name: NEXGEN EXPANDABLE CATHETER
• Applicant: Nexgen Medical Systems, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The NexGen Peripheral Expandable Catheter is indicated for percutaneous access to the peripheral vascular system and is designed to assist in the placement and removal of devices. This device is not intended for use in the coronary or cerebral vasculature.

Device Story

The NexGen Peripheral Expandable Catheter is a sterile, single-use device designed to assist in the placement or removal of vascular catheters and devices (e.g., NexGen Mechanical Retrieval Device). The device features a Pebax/HDPE shaft with a deployable Nitinol braided funnel tip. During operation, the device is inserted via an 8F guide catheter; the Nitinol braid passively expands to the contour of the vessel lumen. A secondary medical device is inserted into the funnel; the funnel and the secondary device are then retracted together into the guide catheter for removal. A proximal female luer allows for contrast media or fluid introduction. The device is used in a clinical setting to facilitate vascular procedures, potentially benefiting patients by simplifying the retrieval of other medical devices. No software or algorithms are involved.

Clinical Evidence

Bench testing only. Testing included visual/dimensional inspection, pushability/trackability, tensile, torque, burst, leak, kink diameter, flow rate, radial force, and corrosion resistance testing to verify functional safety and structural integrity.

Technological Characteristics

Catheter shaft (Pebax/HDPE) with deployable braided Nitinol funnel. Available in 5mm, 7mm, 9mm, and 11mm expanded profiles; working lengths of 43cm and 116cm. Designed for use with 8F guide catheters. Includes female luer for fluid/contrast introduction. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for percutaneous access to the peripheral vascular system to assist in the placement and removal of devices. Not for use in coronary or cerebral vasculature. No known contraindications.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Applied Medical Expandable Vascular Sheath (K070865)
• Applied Medical Expandable Vascular Sheath (K963886)

Reference Devices

• Tear Away Sheath (B. Braun K000313)

Submission Summary (Full Text)

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## NOV 1 0 2011

# SECTION 3 - 510(k) SUMMARY

| 510(k) Number: | K102925 |
|---------------------|-----------------------------------------------------------------------------------|
| Submitted by: | NexGen Medical Systems, Inc.<br>10471 Double R Blvd, Suite A<br>Reno, NV 89521 US |
| Contact Person: | John Kucharczyk. CEO<br>Phone [phone] |
| Date Prepared: | March 18, 2011 |
| Name of the Device: | NexGen Peripheral Expandable Catheter |
| Proprietary Name: | Undetermined at this time |
| Common Name: | Catheter Introducer |
| Classification: | Catheter Introducer (870.1340) |

## SUMMARY STATEMENT:

Predicate Device: The NexGen Peripheral Expandable Catheter is substantially equivalent to the Applied Medical Expandable Vascular Sheath cleared under 510(k) K070865 and K963886.

## Device Description:

The NexGen Peripheral Expandable Catheter is a sterile single use catheter intended to facilitate the placement or removal of vascular catheters and devices including the NexGen Mechanical Retrieval Device (MRD).

The Device features a Pebax/HDPE catheter shaft attached Nitinol tip that expands as the device is deployed from the lumen of a guide catheter. The Nitinol braid passively expands to the contour shape of the vessel lumen and allows a separate medical device such as a catheter to be retracted into the Nitinol Braid. Both the Nitinol Braid and the other device are then retracted into the Guide Catheter. The retracted Expandable Catheter with the encapsulated device are then removed together via removal of the Guide Catheter.

The Expandable Catheter comes in multiple expanded profiles of 5mm, 7mm, 9mm and 11mm, each having a working length of 43cm and 116cm. The Expandable Catheter is packaged in a Tear Away Sheath (B. Braun 510(k) K000313) that is used to facilitate loading the catheter into a Guide Catheter.

Proximally located on the catheter shaft is a female luer connection for the attachment to a Hemostasis Valve Y Connector, which provides a means of introducing contrast media or other fluids. The Hemostasis Valve Y Connector is separate or a prepackaged component.

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K/o 2925 p 2/2

Intended Use: The NexGen Peripheral Expandable Catheter is indicated for percutaneous access to the peripheral vascular system and is designed to assist in the placement and removal of devices. This device is not intended for use in the coronary or cerebral vasculature.

Non-Clinical Testing: The following bench top testing was conducted to verify the device met design specifications:

- Visual / Dimension Inspection .
- Catheter Pushability / Trackability Testing .
- Catheter Tensile Testing .
- Catheter Torque Testing .
- . Catheter Burst Testing Catheter Leak Testing
- Catheter Kink Diameter Testing .
- Catheter Flow Rate Testing .
- Catheter Radial Force Testing ●
- Catheter Corrosion Resistance Testing ●

The NexGen Peripheral Expandable Catheter is a sterile Technological Characteristics: single use catheter intended for percutaneous access to the peripheral vascular system. The Expandable Catheter is designed to assist in the placement and removal of vascular catheters and devices. The device consists of 2 major components, a catheter shaft and a deployable braided nitinol funnel. The NexGen Expandable Catheter is designed for percutaneous insertion via a standard 8F Guide Catheter. The braided funnel passively expands to the contour shape of the vessel lumen and allows a separated medical device such as a catheter to be inserted and Both the braided funnel and the other device are then retracted into the Guide retracted. Catheter. The retracted Expandable Catheter with the encapsulated device is then removed together via removal of the Guide Catheter. The Expandable Catheter comes in multiple expanded profiles of 5mm. 7mm, 9mm and 11mm, each having a working length of 43cm and l 16cm.

The NexGen Expandable Catheter is substantially equivalent to the Applied Medical Expandable Vascular Sheath (K963886 and K070865).

Mechanical, safety and biocompatibility tests were performed to verify the functional safety, structural integrity and material safety. All testing demonstrated that the NexGen Expandable Catheter is comparable to the predicate devices and introduces no new safety and effectiveness issues when used as indicated.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle symbol with three curved lines representing its wings and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol.

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

NOV 1 0 2011

NexGen Medical Systems, Inc. c/o Craig Pagan Regulatory Affairs 1050 W NASA Blvd. Suite 136 Melbourne, FL 32901

Re: K102925

Trade/Device Name: NexGen Peripheral Expandable Catheter Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 25, 2011 Received: October 26, 2011

### Dear Mr. Pagan:

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

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Page 2 - Mr. Craig Pagan

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 (OS) 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.

Sincerely yours,

K L

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 4 - INDICATIONS FOR USE STATEMENT

#### K162925 510(k) Number:

#### NexGen Peripheral Expandable Catheter Device Name:

## INDICATIONS:

The NexGen Peripheral Expandable Catheter is indicated for percutaneous access to the perioheral vascular system and is designed to assist in the placement and removal of devices. This device is not intended for use in the coronary or cerebral vasculature.

#### CONTRAINDICATIONS:

No known contraindications.

Prescription Use _ V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

166

vision Sign-Off) Division of Cardiovascular Devices

510(k) Numb

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