The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX 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. The EndoAnchor may be implanted at the time of the initial endograft placement, or during a secondary (i.e., repair) procedure.

Device Description

The Aptus® Heli-FX™ and Heli-FX Thoracic EndoAnchor Systems are each comprised of the respective Heli-FX™ Applier with EndoAnchor Cassette (containing ten EndoAnchors™), the respective Heli-FX™ Guides, and the Ancillary EndoAnchor Cassette (containing five EndoAnchors).

The Heli-FX EndoAnchor System comprises the EndoAnchor implant (an intravascularly-applied suture, supplied with the Heli-FX Applier in a Cassette containing 10 EndoAnchors or separately in an Ancillary Cassette containing 5 EndoAnchors), the Heli-FX Applier (a catheter-based device for placement of the EndoAnchor), and the Heli-FX 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 with the Heli-FX Applier. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter. An EndoAnchors are also supplied separately in an Ancillary Cassette containing five (5) additional EndoAnchors.

The Heli-FX 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 Applier is designed for use with the Heli-FX Guide. The Applier is a 12Fr (OD) catheter with an integrated control handle. Two Applier lengths are available for anchoring in different regions of the aorta.

The Heli-FX Guide is a sterile, single use, disposable device designed to direct the Heli-FX Applier to the desired location for EndoAnchor implantation. The device is compatible with a 0.035" guide wire. The Heli-FX 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. The Guide is available in both 62cm (16Fr OD) and 90cm (18Fr OD) working lengths. 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.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Aptus Heli-FX Ancillary EndoAnchor Cassette based on the provided text:

This submission is for an Ancillary EndoAnchor Cassette, which is essentially additional EndoAnchors packaged separately. The core device (Heli-FX EndoAnchor System) has been previously cleared. Therefore, the testing focuses on demonstrating that the new packaging and configuration of the Ancillary Cassette are substantially equivalent to the existing device.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria (e.g., specific tensile strength values, leakage rates, etc.) and corresponding performance data. Instead, it describes overarching performance categories evaluated for substantial equivalence. The acceptance criterion is implied as "no new risks" and "substantially equivalent" to the predicate devices.

Acceptance Criteria Category (Implied)	Reported Device Performance
Biocompatibility	Not explicitly detailed for this submission; presumed met by predicate device.
Sterility and Shelf-Life	Not explicitly detailed for this submission; presumed met by predicate device.
Performance Testing (Packaging Integrity)	Bench testing demonstrated substantial equivalence in packaging integrity.
Visual Inspection	Passed (implied "no adverse findings" from the text).
Bubble Emission Testing	Passed (implied "no adverse findings" from the text).
Pouch Seal Strength	Passed (implied "no adverse findings" from the text).
Transportation Simulation	Packaging integrity maintained after simulated transportation.
Simulated Use Testing of EndoAnchors	Functionality of EndoAnchors maintained after being from Ancillary Cassettes.
MR Compatibility	Not explicitly detailed for this submission; presumed met by predicate device.
Electromagnetic Compatibility	Not explicitly detailed for this submission; presumed met by predicate device.
Electrical Safety	Not explicitly detailed for this submission; presumed met by predicate device.
Labeling	Complies with general controls (implied).

Study Details

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated as a numerical value (e.g., N=X units). The text mentions "samples that underwent exposure to transportation simulation." This suggests a sufficient number of units were tested to support the claims.
- Data Provenance: The testing was "bench top testing." The country of origin of the data is not specified, but the manufacturer is based in Sunnyvale, CA, USA. The testing is prospective as it was conducted specifically for this submission to evaluate the new configuration.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This was bench testing of packaging and device functionality, not a clinical study requiring expert ground truth for diagnostic or clinical outcomes.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This was bench testing, not a clinical study requiring adjudication of expert interpretations.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This submission is for a medical device (endovascular suturing system component), not an AI/imaging diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a medical device, not an algorithm. However, the bench testing did evaluate the device's performance in a standalone manner (without a human in a clinical setting).
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this bench testing was the established performance and integrity benchmarks for medical device packaging and functionality. These benchmarks are based on industry standards and regulatory requirements.
7. The sample size for the training set
- Not applicable. This is not an AI/machine learning model but a physical medical device.
8. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning model.

In summary, the study presented for this 510(k) submission primarily consisted of bench-top testing to demonstrate the substantial equivalence of the new Ancillary EndoAnchor Cassette packaging to existing predicate devices. The focus was on ensuring that the new packaging configuration did not introduce new risks regarding visual integrity, seal strength, and the subsequent functionality of the EndoAnchors after transportation simulation. The assessment relied on comparing the new configuration's performance to the known and cleared performance of the predicate devices.

Summary

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510(k) SUMMARY PER 21 CFR 807.92

MAY 1 6 2014

510(k) Number:

GENERAL INFORMATION:

Manufacturer:

Aptus Endosystems, Inc. 271 Gibraltar Drive Sunnyvale, CA 94089 (408) 530-9050 Tel: Fax: (408) 530-9051

Contact Person:

Burt Goodson Director, Scientific and Regulatory Affairs

Date Prepared:

April 18, 2014

DEVICE DESCRIPTION:

Generic/Common Name and Classification:

Endovascular suturing system (OTD) per 21 CFR 870.3460

Trade Name:

Aptus Heli-FX EndoAnchor System; Aptus Heli-FX Thoracic EndoAnchor System

Aptus Heli-FX Applier with EndoAnchor Cassette containing ten EndoAnchors .
Aptus Heli-FX Guide ●
Aptus Ancillary EndoAnchor Cassette containing five EndoAnchors .

PREDICATE DEVICES:

Aptus Heli-FX EndoAnchor System per K102333 �
Aptus Heli-FX Thoracic EndoAnchor System per K121168
Aptus Heli-FX EndoAnchor System and Heli-FX Thoracic EndoAnchor System per K130677 ●
Aptus Heli-FX EndoAnchor System per K140036 .

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Image /page/1/Picture/0 description: The image shows the logo for APTUS ENDOSYSTEMS. The logo is in black and features a stylized font. The word "APTUS" is in large, bold letters, with a unique design for the "A" that includes small, parallel lines on the left side. Below "APTUS" is the word "ENDOSYSTEMS" in a smaller, less bold font.

INTENDED USE:

The EndoAnchor may be implanted at the time of the initial endograft placement, or during a secondary (i.e., repair) procedure.

PRODUCT DESCRIPTION:

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Image /page/2/Picture/0 description: The image shows the logo for APTUS ENDOSYSTEMS. The logo is black and white and features the word "APTUS" in large, bold letters. Below the word "APTUS" is the word "ENDOSYSTEMS" in smaller letters. To the left of the word "APTUS" are a series of diagonal lines.

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 Heli-FX System covered in this submission are substantially equivalent in materials, method of operation, and intended use as the prior Heli-FX Systems cleared via K102333, K121168, K130677, and K140036. The implant devices themselves, the Applier and Guide used to implant them, and their indications for use are identical to those cleared via the aforementioned the submissions; the only difference is the addition of a standalone, Ancillary EndoAnchor Cassette containing five (5) additional EndoAnchors, fur use in procedures where the physician desires to place more than the ten (10) EndoAnchors supplied with the Applier. Where specific differences exist in the configuration and packaging of the Ancillary Cassette, bench testing has shown that these differences do not present new risks.

DATA RELIED UPON FOR SUBSTANTIAL EQUIVALENCE:

The performance of the Ancillary EndoAnchor Cassette was assessed via bench top testing. This testing included visual inspection of the package and product, bubble emission testing, and pouch seal strength on samples that underwent exposure to transportation simulation, and subsequent simulated use testing of EndoAnchors from these Ancillary Cassettes. The results of this testing demonstrated that Ancillary Cassette and its packaging are substantially equivalent to that of the EndoAnchor Cassette supplied within the packaging of the Heli-FX Applier.

SUMMARY:

The data and information presented in this application, including bench testing, support a determination of substantial equivalence of the Ancillary EndoAnchor Cassette as compared to the predicate Heli-FX devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.

Public Health Service

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

May 16, 2014

Aptus Endosystems % Burt Goodson Director, Scientific & Regulatory Affairs 271 Gibraltar Dr. Sunnyvale, California 94089

Re: K141041

Trade/Device Name: Aptus Heli-FX Ancillary EndoAnchor Cassette Regulation Number: 21 CFR 870.3460 Regulation Name: Endovascular Suturing System Regulatory Class: Class II Product Code: OTD Dated: April 18, 2014 Received: April 23, 2014

Dear Burt 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.

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

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Page 2 - Burt Goodson

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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kenneth J. Cavanaugh -S

for 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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APTUS
ENDOSYSTEMS

Aptus Endosystems, Inc. 271 Gibraltar Dr Sunnyvale, CA 94089

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):	K141041
Device Name:	Heli-FX EndoAnchor System
Indications for Use:	The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX 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. The EndoAnchor may be implanted at the time of the initial endograft placement, or during a secondary (i.e., repair) procedure.
Prescription Use	X
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)

Kenneth J. Cavanaugh -S

Division sign-off

Division of Cardiovascular Devices

510(k) Number:
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Page 4-1

Regulation Number and Section

§ 870.3460 Endovascular Suturing System.

(a)
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.(b)
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.