(29 days)
Not Found
No
The device description focuses on mechanical components and their function in implanting anchors. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is described as an "EndoAnchor System" that provides "fixation and sealing between endovascular aortic grafts and the native artery" for patients with endovascular graft complications or risk thereof, which directly addresses a medical condition.
No
The device is described as a system for providing fixation and sealing between endovascular aortic grafts and the native artery, and for implanting an endovascularly-placed suture. Its function is to repair or maintain aneurysm exclusion, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including implants, appliers, guides, and cassettes. There is no mention of software as a component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Heli-FX EndoAnchor System is a surgical device intended for in vivo use. It is designed to be implanted directly into the body to provide mechanical fixation and sealing between endovascular grafts and the native artery. It does not analyze biological specimens in vitro.
The device description clearly outlines a system of implants, appliers, and guides used for a surgical procedure within the body, which is the opposite of an in vitro diagnostic test.
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 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-FXTM and Heli-FX Thoracic EndoAnchor™ Systems are each comprised of the respective Heli-FX Applier with EndoAnchor Cassette, containing ten EndoAnchor implants; the respective Heli-FX Guides, and the Ancillary EndoAnchor Cassette, containing five EndoAnchor implants.
The Heli-FX EndoAnchor System comprises the EndoAnchor implant, an intravascularly-applied suture, supplied with the Heli-FX Applier in a Cassette containing ten (10) EndoAnchor implants, or separately in an Ancillary Cassette containing five (5) EndoAnchor implants; 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 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) EndoAnchor impants are prepackaged 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. EndoAnchor implants are also supplied separately in an Ancillary Cassette containing five (5) additional EndoAnchor implants.
The Heli-FX Applier is designed to implant the EndoAnchor. The Applier implants one EndoAnchor at a time, and can be used to implant multiple EndoAnchor implants 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 sterilization site transfer for the Heli-FX EndoAnchor System was assessed through a new sterilization validation that was successfully executed at the new sterilization facility. The results of the sterilization validation demonstrated that sterilization of the Heli-FX EndoAnchor System at the new sterilization facility is substantially equivalent to that of the sterilization executed at the current facility.
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.
DEN100026, K121168, K130677, K140036, K141041
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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other, with a stylized representation of a human form below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 13, 2017
Medtronic Vascular, Inc. Mr. Burt Goodson Senior Principal Regulatory Affairs Specialist 3850 Brickwav Blvd Santa Rosa, California 95403
Re: K171427
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: May 8, 2017 Received: May 15, 2017
Dear Mr. 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 device
1
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 (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/ResourcesforYou/Industry/default.htm.
Sincerely,
Nicole G. Ibrahim -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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Indications for Use
510(k) Number (if known) K171427
Device Name Heli-FXTM EndoAnchor™ System
Indications for Use (Describe)
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 regain or maintain adequate aneurysm exclusion.
The EndoAnchor may be implanted at the initial endograft placement, or during a secondary (i.e., repair) procedure.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
510(k) Number: K171427
General Information
Manufacturer
Medtronic Vascular, Inc. 3576 Unocal Place Santa Rosa, CA 95403 Tel: (707) 525-0111
Contact Person
Burt Goodson Senior Principal Regulatory Affairs Specialist
Alternate Contact Person
Lucy Tan Regulatory Affairs Director
Date Prepared
June 8, 2017
Device Description
The Heli-FXTM and Heli-FX Thoracic EndoAnchor™ Systems are each comprised of the respective Heli-FX Applier with EndoAnchor Cassette, containing ten EndoAnchor implants; the respective Heli-FX Guides, and the Ancillary EndoAnchor Cassette, containing five EndoAnchor implants.
Generic/Common Name and Classification
Endovascular Suturing System (OTD) per 21 CFR 870.3460
Trade Name
Heli-FX EndoAnchor System
- Heli-FX Applier with EndoAnchor Cassette containing ten (10) EndoAnchor implants ●
- Heli-FX Guide ●
- Ancillary EndoAnchor Cassette containing five EndoAnchor implants ●
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Predicate Devices
- Aptus Heli-FX EndoAnchor System per DEN100026 (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 ●
- Aptus Heli-FX EndoAnchor Ancillary Cassette per K141041 ●
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 with the Heli-FX Applier in a Cassette containing ten (10) EndoAnchor implants, or separately in an Ancillary Cassette containing five (5) EndoAnchor implants; 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 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) EndoAnchor impants are prepackaged 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. EndoAnchor implants are also supplied separately in an Ancillary Cassette containing five (5) additional EndoAnchor implants.
The Heli-FX Applier is designed to implant the EndoAnchor. The Applier implants one EndoAnchor at a time, and can be used to implant multiple EndoAnchor implants 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.
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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 suturing 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 DEN100026, K121168, K130677, K140036 and K141041. 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 submissions; the only difference that constitutes this Special 510(k) is the change in sterilization facility for the devices. Where specific differences in the sterilization of the devices exist, sterilization validation as detailed in the Sterilization section has shown that these differences to not present new risks.
Data Relied Upon for Substantial Equivalence
The sterilization site transfer for the Heli-FX EndoAnchor System was assessed through a new sterilization validation that was successfully executed at the new sterilization facility. The results of the sterilization validation demonstrated that sterilization of the Heli-FX EndoAnchor System at the new sterilization facility is substantially equivalent to that of the sterilization executed at the current facility.
Summary
The data and information presented in this application, including the sterilization validation, support a determination of substantial equivalence of the predicate devices: Heli-FX EndoAnchor System, Heli-FX Thoracic EndoAnchor System, and the Heli-FX EndoAnchor Ancillary Cassette.