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 Story
Heli-FX EndoAnchor System provides mechanical fixation between endovascular aortic grafts and native arterial walls. System components: helical nickel-cobalt EndoAnchor implants; catheter-based Heli-FX Applier; deflectable Heli-FX Guide sheath. Physician operates system under fluoroscopic guidance to deploy anchors through graft material into vessel wall. Sharpened leading end of anchor penetrates tissue; proximal crossbar prevents over-penetration. Used in OR/cath lab settings. Benefits include reduced risk of graft migration and endoleak, maintaining aneurysm exclusion. This submission specifically addresses a change in sterilization facility.
Clinical Evidence
No clinical data. Substantial equivalence supported by sterilization validation testing performed at the new facility to ensure equivalent sterility assurance levels compared to the previous site.
Technological Characteristics
Implant: medical-grade nickel-cobalt wire, helical shape. Applier: 12Fr OD catheter. Guide: 12Fr ID sheath, 16Fr/18Fr OD, deflectable tip, compatible with 0.035" guidewire. Sterile, single-use, disposable. Mechanical fixation principle.
Indications for Use
Indicated for patients with endovascular aortic grafts exhibiting or at risk of migration or endoleak requiring augmented radial fixation/sealing to maintain aneurysm exclusion. May be used during initial endograft placement or secondary repair.
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.
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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
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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) | |
|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| <div> <span> <b> × </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <b> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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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.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
