(63 days)
AXERA 2 Access System (K140201)
Not Found
No
The summary describes a mechanical device for vascular access and hemostasis, with no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device's intended use is to provide access for the introduction of other devices and to promote hemostasis, which are supportive functions for a medical procedure rather than directly treating a disease or condition itself.
No
The device is intended to provide access for the percutaneous introduction of devices and promote hemostasis during diagnostic femoral artery catheterization procedures. It is an access system for procedures, not a diagnostic device itself.
No
The device description explicitly states it is comprised of physical components (Latchwire, anchor mechanism, shaft, handle with control features) and the performance studies describe bench testing of 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 is to provide access for introducing devices into the peripheral vasculature and promote hemostasis. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device is a mechanical system with a Latchwire, anchor mechanism, shaft, and handle. These are components used for physical manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body for a procedural purpose.
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 2 is a device that is comprised of a Latchwire, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing of the AXERA 2 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, deployment forces (needle, plunger), tensile strength of Latchwire to Anchor (parallel and nonparallel), compressive strength (handle/anchor), torque loading (handle/anchor), access needle functionality, access needle integrity, and tensile strength of access needle.
Additional prior bench testing of the unmodified AXERA 2 design features included accessory functionality, deployment forces (heel), 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 (Latchwire/guidewire), guidewire resistance to fracture, Latchwire/guidewire resistance to flexing, tensile strength of Latchwire distal coil to core wire, tensile strength of Latchwire proximal coil, latch, and core wire, biocompatibility testing, preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations.
Prior simulated use testing of the unmodified AXERA 2 design features was performed on a cadaveric model and multiple clinical evaluations were conducted. 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.
The AXERA 2 Access Device met all performance testing acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AXERA 2 Access System (K140201)
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/1 description: The image contains the word "Arstasis" in a stylized, sans-serif font. The letters are bold and have a slightly futuristic or technical appearance. The word is presented in a single line and is the primary focus of the image.
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: | April 3, 2014 |
| Device Trade Name: | AXERA 2 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 (K140201) |
| Device Description: | The AXERA 2 is a device that is comprised of a Latchwire, 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 2 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 2 Access Device met all performance testing acceptance criteria. |
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Summary of Substantial Equivalence:
Modifications to the AXERA 2 Access System consist of reshaping the Needle Lumen Anchor (NLA) component and lengthening the Integrated Needle. An alternate Access Needle accessory device manufactured by another supplier is also added.
There are no changes to the Indications for Use or procedural steps resulting from the changes described within this submission.
Bench testing of the AXERA 2 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, deployment forces (needle, plunger), tensile strength of Latchwire to Anchor (parallel and nonparallel), compressive strength (handle/anchor), torque loading (handle/anchor), access needle functionality, access needle integrity, and tensile strength of access needle.
Additional prior bench testing of the unmodified AXERA 2 design features included accessory functionality, deployment forces (heel), 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 (Latchwire/guidewire), guidewire resistance to fracture, Latchwire/guidewire resistance to flexing, tensile strength of Latchwire distal coil to core wire, tensile strength of Latchwire proximal coil, latch, and core wire, biocompatibility testing, preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations. T
Prior simulated use testing of the unmodified AXERA 2 design features was performed on a cadaveric model and multiple clinical evaluations were conducted. 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 2 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.
1 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 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 abstract symbol that resembles an eagle or bird-like figure with three stylized wing segments.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2014
Arstasis, Inc. Ms. Grace Li Director of Quality 740 Bay Road Redwood City, CA 94063
Re: K140871
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: May 6, 2014 Received: May 7, 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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" (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 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,
Kenneth J. Cavanaugh -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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SECTION 1. INDICATIONS FOR USE STATEMENT
K140871 510(k) Number (if known): Trade Name: AXERA 2 Access System Common Name: Catheter Introducer The AXERA Access System is intended to provide access for the Indications For Use: 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)
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