(113 days)
Not Found
No
The summary describes a mechanical device for aortic securement and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as providing fixation and sealing for endovascular grafts to address migration or endoleak, which are medical conditions, and to augment radial fixation and/or sealing to maintain aneurysm exclusion, directly treating or managing a condition in a patient.
No
The device is described as a system for providing fixation and sealing for endovascular aortic grafts, indicated for use in patients with complications like migration or endoleak, which is a therapeutic rather than diagnostic function.
No
The device description explicitly lists physical components (EndoAnchor, EndoAnchor Cassette, Applier, Guide) and the intended use involves physical interaction with the body (fixation and sealing between grafts and arteries), indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for providing 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 instruments used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used in laboratories or point-of-care settings to analyze biological samples. This device is clearly designed for use within the patient's body during a medical procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OTD
Device Description
The Aptus 18Fr HeliFX Aortic Securement System comprises the EndoAnchor with EndoAnchor Cassette, the 18Fr HeliFX Applier, and the 18Fr HeliFX Guide.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
native artery, aortic, native vessel wall
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)
Performance and simulated use testing;
Mechanical integrity and characterization testing;
Endograft compatibility testing;
Sterilization, biocompatibility, and shelf-life evaluations.
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 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.
1
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.
2
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.
3
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
5
WAPTUS
ENDOSYSTEMS
510(k) Submission 18Fr HeliFX Aortic Securement System
CONFIDENTIAL
Aptus Endosystems, Inc. 777 N Pastoria Ave Sunnyvale, CA 94085
| STATEMENT OF INDICATIONS FOR USE |
|---|
| ----------------------------------------- |
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:
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