(100 days)
Not Found
No
The summary describes a mechanical access system and its performance testing, with no mention of AI, ML, image processing, or data-driven decision making.
No
The device is intended to provide access for other devices and promote hemostasis, not to treat a disease or condition itself.
No
The device is described as providing access for introduction of other devices and promoting hemostasis, specifically "for use in patients undergoing diagnostic femoral artery catheterization procedures." It is an access tool for a diagnostic procedure, not a diagnostic device itself.
No
The device description explicitly states it is comprised of physical components like a flexible tip, anchor mechanism, shaft, and handle, indicating it is a hardware device. The performance studies also detail bench testing on these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing access for the percutaneous introduction of devices into the peripheral vasculature and promoting hemostasis. This is a procedural device used in vivo (within the body) during a medical procedure.
- Device Description: The description of the device components (flexible tip, anchor mechanism, shaft, handle) aligns with a physical medical device used for access and hemostasis, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The focus is on facilitating a medical procedure.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Product codes
DYB
Device Description
The AXERA RX is a device that is comprised of a flexible tip, anchor mechanism, shaft and handle with control features.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery
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
Bench testing of the AXERA RX Access System was performed for device specifications affected by the modifications described above, following sterilization of test units. The following tests were performed: device functionality, tip flexibility, flex conditioning (flexible tip), tensile strength of flexible tip to anchor, compressive strength (handle/anchor), torque loading (handle/anchor), and corrosion resistance (needle lumen anchor). Simulated use testing was performed on a cadaveric model.
Additional bench testing of the unmodified AXERA RX design features included accessory functionality, deployment forces (heel, needle, plunger), release forces (heel), tensile strength of multiple. joints (needle lumen anchor, heel, plunger, plunger tube, access needle, guidewire, dilator adapter), access needle integrity, compressive strength (plunger lockout), corrosion resistance testing (guidewire), guidewire resistance to fracture, guidewire resistance to flexing, biocompatibility testing, preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations.
Simulated use testing of the unmodified AXERA RX design features was performed previously on a cadaveric model and in multiple clinical evaluations. The short term safety and clinical performance of the device were established. The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients.
Key Metrics
Not Found
Predicate Device(s)
AXERA 2 Access System (K132263)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a series of intersecting lines of varying thicknesses. The lines are primarily black against a white background, creating a high-contrast visual. The thicker lines stand out prominently, while the thinner lines add complexity to the composition. The overall effect is abstract and geometric.
SECTION 2. 510(k) SUMMARY
| Sponsor/Submitter: | Arstasis, Inc. |
|---|---|
| 740 Bay Road | |
| Contact Person: | Grace Li |
| Director of Quality | |
| Phone: (650) 261-8039 | |
| Date of Submission: | February 4, 2014 |
| Device Trade Name: | AXERA RX Access System |
| Common Name: | Catheter Introducer |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 870.1340 |
| Classification Name: | Catheter Introducer |
| Product Code: | DYB |
| Predicate Device: | AXERA 2 Access System (K132263) |
| Device Description: | The AXERA RX is a device that is comprised of a flexible tip, |
| anchor mechanism, shaft and handle with control features. | |
| Indications for Use: | The AXERA Access System is intended to provide access for the |
| percutaneous introduction of devices into the peripheral vasculature | |
| and to promote hemostasis at the arteriotomy site as an adjunct to | |
| manual compression. AXERA is indicated for use in patients | |
| undergoing diagnostic femoral artery catheterization procedures | |
| using 5F or 6F introducer sheaths. | |
| Technological | |
| Characteristics | The AXERA RX Access Device is designed to create a shallow |
| access path through the arterial wall for the guidewire to enter the | |
| vessel lumen. | |
| Performance Data | The AXERA RX Access Device met all performance testing |
| acceptance criteria. |
・
Redwood City, CA 94063
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Arstasis
MAY 1 6 2014
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Summary of Substantial Equivalence: Modifications to the AXERA 2 Access System consist of replacing the user-attached Latchwire with a permanently attached flexible tip, adding a guidewire exit port in the needle-lumen-anchor assembly, replacing the 19 gauge access needle with a 20 gauge access needle, and adding a lock symbol to the device handle. The modified device is known as the AXERA RX Access System.
There are no changes to the Indications for Use resulting from the changes described within this submission. The procedural steps have been updated accordingly for the subject device.
Bench testing of the AXERA RX Access System was performed for device specifications affected by the modifications described above, following sterilization of test units. The following tests were performed: device functionality, tip flexibility, flex conditioning (flexible tip), tensile strength of flexible tip to anchor, compressive strength (handle/anchor), torque loading (handle/anchor), and corrosion resistance (needle lumen anchor). Simulated use testing was performed on a cadaveric model.
Additional bench testing of the unmodified AXERA RX design features included accessory functionality, deployment forces (heel, needle, plunger), release forces (heel), tensile strength of multiple . joints (needle lumen anchor, heel, plunger, plunger tube, access needle, guidewire, dilator adapter), access needle integrity, compressive strength (plunger lockout), corrosion resistance testing (guidewire), guidewire resistance to fracture, guidewire resistance to flexing, biocompatibility testing, preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations. '
Simulated use testing of the unmodified AXERA RX design features was performed previously on a cadaveric model and in multiple clinical evaluations. The short term safety and clinical performance of the device were established. The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients.
In summary, the data provided herein demonstrate that the AXERA RX Access System is substantially equivalent to its predicate in providing access to the arterial lumen and facilitating the introduction and placement of devices into the peripheral vasculature and promoting hemostasis as an adjunct to manual compression.
I The preliminary Animal Studies and Cadaver Assessments were conducted using prototypes of a similar design and configuration.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2014
Arstasis, Inc. Ms. Grace Li Director of Quality 740 Bay Road Redwood City, CA 94063
K140287 Re:
Trade/Device Name: AXERA RX Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 15, 2014 Received: April 16, 2014
Dear Ms. Li,
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 10 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
3
Page 2 - Ms. Grace Li
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) 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 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.
for
Sincerely yours.
Kenneth J. Cavanaugh -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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বাহাট্যবাদ
SECTION 1. INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K140287 |
|---|---|
| Trade Name: | AXERA RX Access System |
| Common Name: | Catheter Introducer |
| Indications For Use: | The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths. |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Image /page/4/Picture/10 description: The image shows the name "Kenneth" in a bold, sans-serif font. The letters are black, and the name is followed by what appears to be the letters "J.Cavanaugh -S", but the letters are stylized and difficult to read. The text is horizontally oriented and appears to be part of a larger document or sign.
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