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
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.
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.
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.
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Image /page/0/Picture/0 description: The image shows the logo for "Aptus Endosystems". The logo consists of a stylized wave-like graphic to the left of the word "APTUS" in bold, sans-serif font. Below "APTUS" is the word "ENDOSYSTEMS" in a smaller, sans-serif font.
# 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: (408) 530-9050 Fax: (408) 530-9051
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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Image /page/2/Picture/0 description: The image shows the logo for "Aptus Endosystems". The logo is in black and white. The word "Aptus" is in large, bold letters, and the word "Endosystems" is in smaller letters below it.
# 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 (800) 638-2041 or (301) 796-7100 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> |
|-----------------------------------------|
|-----------------------------------------|
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:
Page 4-1
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.
