APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH

K121168 · Aptus Endosystems, Inc. · OTD · Aug 8, 2012 · Cardiovascular

Device Facts

• Record ID: K121168
• Device Name: APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
• Applicant: Aptus Endosystems, Inc.
• Product Code: OTD · Cardiovascular
• Decision Date: Aug 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3460
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aptus 18Fr HeliFX Aortic Securement System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The 18Fr HeliFX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.

Device Story

System provides endovascular fixation/sealing for aortic grafts; comprises EndoAnchor implants, 18Fr HeliFX Applier, and 18Fr HeliFX Guide. EndoAnchor (nickel-cobalt wire, helical shape) acts as suture to attach graft to native vessel wall; sharpened tip facilitates deployment; crossbar prevents over-penetration. Applier (12Fr catheter) delivers one anchor at a time. Guide (deflectable sheath) directs Applier to target site; compatible with 0.035" guide wire. Used in clinical setting by physicians; provides mechanical securement to prevent graft migration/endoleak. Benefits patient by maintaining aneurysm exclusion.

Clinical Evidence

Bench testing only. Evidence includes performance and simulated use testing, mechanical integrity and characterization testing, endograft compatibility testing, and evaluations of sterilization, biocompatibility, and shelf-life.

Technological Characteristics

Materials: medical-grade nickel-cobalt wire. Components: helical EndoAnchor, 12Fr Applier catheter, deflectable guide sheath. Energy: mechanical deployment. Connectivity: none. Sterilization: sterile. Form factor: catheter-based delivery system.

Indications for Use

Indicated for patients with endovascular aortic grafts exhibiting or at risk of migration or endoleak requiring augmented radial fixation or sealing to maintain aneurysm exclusion.

Regulatory Classification

Identification

An endovascular suturing system is a medical device intended to provide fixation and sealing between an endovascular graft and the native artery. The system is comprised of the implant device and an endovascular delivery device used to implant the endovascular suture.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) The device should be demonstrated to be biocompatible; (2) Sterility and shelf life testing should demonstrate the sterility of patient-contacting components and the shelf-life of these components; (3) Non-clinical and clinical performance testing should demonstrate substantial equivalence in safety and effectiveness, including durability, compatibility, migration resistance, corrosion resistance, and delivery and deployment; (4) Non-clinical testing should evaluate the compatibility of the device in an magnetic resonance (MR) environment; (5) Appropriate analysis and non-clinical testing should validate electromagnetic compatibility (EMC) and electrical safety; (6) The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109 of this chapter; and (7) Labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the non-clinical and clinical evaluations pertinent to use of the device.

In addition to the general controls of the Food, Drug & Cosmetic Act, the Endovascular Suturing System is subject to the following special controls: (1) The device should be demonstrated to be biocompatible; (2) Sterility and shelf life testing should demonstrate the sterility of patient-contacting components and the shelf-life of these components; (3) Non-clinical and clinical performance testing should demonstrate substantial equivalence in safety and effectiveness, including durability, compatibility, migration resistance, corrosion resistance, and delivery and deployment; (4) Non-clinical testing should evaluate the compatibility of the device in an MR environment; (5) Appropriate analysis and non-clinical testing should validate electromagnetic compatibility (EMC) and electrical safety; (6) The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109; and (7) Labeling must bear all information required for the safe and effective use of the device as outlined in 801.109(c), including a detailed summary of the non-clinical and clinical evaluations pertinent to use of the device.

Predicate Devices

• Aptus HeliFX Aortic Securement System (K102333)

Submission Summary (Full Text)

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# 510(k) SUMMARY PER 21 CFR 807.92

AUG 8 2012

121168 510(k) Number: K

#### GENERAL INFORMATION:

#### Manufacturer:

Aptus Endosystems, Inc. 777 North Pastoria Avenue Sunnyvale, CA 94085 Tel: [phone] Fax: [phone]

Contact Person:

Burt Goodson Director, Scientific and Regulatory Affairs

Date Prepared:

April 16, 2012

### DEVICE DESCRIPTION:

The Aptus 18Fr HeliFX Aortic Securement System comprises the EndoAnchor with EndoAnchor Cassette, the 18Fr HeliFX Applier, and the 18Fr HeliFX Guide.

Generic/Common Name and Classification:

Endovascular suturing system (OTD) per 21 CFR 870.3460

Trade Name:

Aptus 18Fr HeliFX Aortic Securement System

- . Aptus EndoAnchor with EndoAnchor Cassette
- . Aptus 18Fr HeliFX Applier
- Aptus 18Fr HeliFX Guide

### PREDICATE DEVICES:

Aptus HeliFX Aortic Securement System (formerly Aptus EndoStapling System) per K102333

### INTENDED USE:

The Aptus 18Fr HeliFX Aortic Securement System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The 18Fr HeliFX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.

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## PRODUCT DESCRIPTION:

The Aptus 18Fr HeliFX Aortic Securement System comprises the EndoAnchor implant (an intravascularly-applied suture, supplied in a Cassette containing 10 EndoAnchors), the HeliFX Applier (a catheter-based device for placement of the EndoAnchor), and the HeliFX Guide (a deflectable sheath to position the Applier).

The Aptus EndoAnchor is an endovascularly-placed suture designed to attach aortic endografts to the native vessel wall. The EndoAnchor is manufactured from medical-grade nickel-cobalt wire and is wound in a helical shape. The leading end is sharpened to a conical point to act as an integral needle facilitating atraumatic deployment through the graft material and vessel wall. The proximal end of the EndoAnchor includes a diagonal crossbar, which functions as a suture anchor designed to prevent over penetration of the EndoAnchor. Ten (10) EndoAnchors are pre-packaged into a cassette, which is supplied sterile to the user. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter.

The Aptus 18Fr HeliFX Applier is designed to implant the Aptus EndoAnchor. The Applier implants one EndoAnchor at a time, and can be used to implant multiple EndoAnchors in a single patient. The 18Fr Applier is designed for use with the 18F HeliFX Guide. The Applier is a 12Fr (OD) catheter with an integrated control handle.

The Aptus 18Fr HeliFX Guide is a sterile, single use, disposable device designed to direct the 18Fr HeliFX Applier to the desired location for EndoAnchor implantation. The device is compatible with a 0.035" guide wire. The 18Fr HeliFX Guide consists of a 12 Fr-compatible (inner diameter) guide sheath with integrated control handle, and a matching 12 Fr OD obturator. Deflection of the distal tip of the catheter is accomplished by rotating the Control Knob located on the control handle. Multiple deflectable tip lengths are available to accommodate a range of aortic diameters. The Obturator is used during vessel access and is designed to follow the guide wire and provide access through tortuous vasculature.

### SPECIAL CONTROLS:

Special controls have been established for endovascular substring systems per 21 CFR 870.3460(b). These special controls include specific requirements related to biocompatibility, sterility and shelf-life, performance testing, MR compatibility, electromagnetic compatibility and electrical safety, labeling, and the prescription-only status of the devices.

## SUBSTANTIAL EQUIVALENCE:

:

The various components of the 18Fr HeliFX System covered in this submission are substantially equivalent in materials, method of operation, and intended use as the prior HeliFX System cleared via K102333. Where specific dimensional and performance differences exist, bench testing has shown that these differences do not present new risks.

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# DATA RELIED UPON FOR SUBSTANTIAL EQUIVALENCE:

Data relied upon to demonstrate substantial equivalence of the Aptus 18Fr HeliFX System to the predicate, and to demonstrate conformance to special controls, includes the following:

- . Performance and simulated use testing
- . Mechanical integrity and characterization testing
- . Endograft compatibility testing
- Sterilization, biocompatibility, and shelf-life evaluations �

### SUMMARY:

The Aptus 18Fr HeliFX System covered in this submission has been shown to be substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, with three wavy lines below it.

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

> AUG 8 2012

Aptus Endosystems c/o Mr. Burt Goodson Director, Scientific & Regulatory Affairs 777 North Pastoria Avenue Sunnyvale, CA 94085

Re: K121168

Trade/Device Name: 18Fr HeliFX Aortic Securement System Regulation Number: 21 CFR 870.3460 Regulation Name: Endovascular Suturing System Regulatory Class: Class II (two) Product Code: OTD Dated: July 3, 2012 Received: July 5, 2012

Dear Mr. Goodson:

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 - Mr. Burt Goodson

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 (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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

.A.Hilleben

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

Enclosure

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WAPTUS
ENDOSYSTEMS

510(k) Submission 18Fr HeliFX Aortic Securement System

CONFIDENTIAL

Aptus Endosystems, Inc. 777 N Pastoria Ave Sunnyvale, CA 94085

| <b>STATEMENT OF INDICATIONS FOR USE</b> |
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K121168

Device Name:

510(k) Number (if known):

Aptus 18Fr HeliFX Aortic Securement System

Indications for Use:

The Aptus 18Fr HeliFX Aortic Securement System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The 18Fr HeliFX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.

× Prescription Use or Over-the-counter Use

Please Do Not Write Below This Line - Continue On Another Page If Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

unysille

Division sign-off Division of Cardiovascular Devices

121168 510(k) Number:

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