(30 days)
Not Found
No
The description focuses on the mechanical components and function of a medical device for fixing endovascular grafts. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to provide fixation and sealing and treat conditions such as graft migration or endoleak, which are medical conditions, thus making it a therapeutic device.
No
The device is described as a system for providing fixation and sealing between endovascular aortic grafts and the native artery, and is used to implant an "EndoAnchor" to attach aortic endografts to the vessel wall. These functions are therapeutic, not diagnostic.
No
The device description clearly outlines physical components including implants (EndoAnchors), a catheter-based applier, and a guide sheath. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mechanical fixation and sealing between endovascular aortic grafts and the native artery. This is a surgical/interventional procedure performed directly on the patient's anatomy.
- Device Description: The device components (EndoAnchor, Applier, Guide) are all instruments and implants used for a physical intervention within the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies described focus on the packaging and mechanical integrity of the device, not on diagnostic accuracy or analytical performance.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is designed to intervene within the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OTD
Device Description
The Heli-FX EndoAnchor System comprises the EndoAnchor with EndoAnchor Cassette, the Heli-FX Applier, and the Heli-FX Guide.
The Heli-FX EndoAnchor System comprises the EndoAnchor implant (an intravascularly-applied suture, supplied in a Cassette containing 10 EndoAnchors), the Heli-FX Applier (a catheterbased 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 sterile to the user. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
native artery, aorta
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the modified packaging for the Heli-FX devices 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 only, and again following exposure to environmental, transportation, and accelerated aging (two years’ equivalent) conditioning. The results of this testing demonstrated that the new packaging is substantially equivalent to the previous packaging.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/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 four short, horizontal lines.
510(k) SUMMARY PER 21 CFR 807.92
FEB - 6 2014
510(k) Number: K140036
GENERAL INFORMATION:
Manufacturer:
Aptus Endosystems, Inc. 271 Gibraltar Drive Sunnyvale, CA 94089 Tel: (408) 530-9050 (408) 530-9051 Fax:
Contact Person:
Burt Goodson Director, Scientific and Regulatory Affairs
Date Prepared:
February 3, 2014
DEVICE DESCRIPTION:
The Heli-FX EndoAnchor System comprises the EndoAnchor with EndoAnchor Cassette, the Heli-FX Applier, and the Heli-FX Guide.
Generic/Common Name and Classification:
Endovascular suturing system (OTD) per 21 CFR 870.3460
Trade Name:
Aptus Heli-FX EndoAnchor System
- Aptus EndoAnchor with EndoAnchor Cassette ●
- Aptus Heli-FX Applier . ●
- Aptus Heli-FX Guide t
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 .
1
Image /page/1/Picture/0 description: The image shows the logo for APTUS ENDOSYSTEMS. The word "APTUS" is in large, bold, black letters. Below "APTUS" is the word "ENDOSYSTEMS" in smaller, black letters. To the left of "APTUS" are four diagonal lines.
INTENDED 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.
PRODUCT DESCRIPTION:
The Heli-FX EndoAnchor System comprises the EndoAnchor implant (an intravascularly-applied suture, supplied in a Cassette containing 10 EndoAnchors), the Heli-FX Applier (a catheterbased 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 sterile to the user. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter.
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.
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,
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Image /page/2/Picture/0 description: The image shows the logo for "APTUS ENDOSYSTEMS". The word "APTUS" is in large, bold, sans-serif font, with a series of short, parallel lines extending from the left side of the "A". Below "APTUS", the word "ENDOSYSTEMS" is written in a smaller, sans-serif font.
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 and K121168. The devices themselves and their indications for use are identical to those cleared via the aforementioned the submissions; the only differences are in the product packaging. Where specific dimensional and performance differences exist, bench testing has shown that these differences do not present new risks.
DATA RELIED UPON FOR SUBSTANTIAL EQUIVALENCE:
The performance of the modified packaging for the Heli-FX devices 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 only, and again following exposure to environmental, transportation, and accelerated aging (two years' equivalent) conditioning. The results of this testing demonstrated that the new packaging is substantially equivalent to the previous packaging.
SUMMARY:
The data and information presented in this application, including bench testing, support a determination of substantial equivalence of the Heli-FX system with modified packaging as compared to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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" around the perimeter. Inside the seal is an abstract symbol that resembles a stylized human figure embracing or protecting another figure, often interpreted as representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609
Silver Spring, MD 20993-0002
Public Health Service
February 6, 2014
Aptus Endosystems, Inc. C/O Burt Goodson Director, Scientific and Regulatory Affairs 271 Gibraltar Drive Sunnyvale, CA 94089
Re: K140036
Trade/Device Name: Heli-FX EndoAnchor System Regulation Number: 21 CFR 870.3460 Regulation Name: Endovascular suturing system Regulatory Class: Class II Product Code: OTD Dated: January 3, 2014 Received: January 7, 2014
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.
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
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Page 2 - Mr. Burt Goodson
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Bram D. Zückerman -S
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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Image /page/5/Picture/0 description: The image shows the logo for "APTUS ENDOSYSTEMS". The word "APTUS" is in large, bold, sans-serif font, with a series of short, horizontal lines extending from the left side of the "A". Below "APTUS", in a smaller font, is the word "ENDOSYSTEMS".
Aptus Endosystems, Inc. 271 Gibraltar Dr Sunnyvale, CA 94089
STATEMENT OF INDICATIONS FOR USE
| 510(k) Number (if known): | K140036 |
|---|---|
| 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)
Bram D. Zuckerman -S
2014.02.06 10:41:07 -05'00'
Division sign-off
Division of Cardiovascular Devices
| 510(k) Number: | |
|---|---|
| ---------------- | -- |
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