(28 days)
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 decision-making. The performance studies focus on mechanical properties and clinical outcomes, not algorithmic performance.
Yes.
The device is intended to provide access for the percutaneous introduction of devices and to promote hemostasis, which directly contributes to the treatment or management of a medical condition.
No
The device is intended to provide access for the percutaneous introduction of devices and to promote hemostasis during existing diagnostic procedures, rather than performing any diagnostic function 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 clearly states the device is for providing access for the percutaneous introduction of devices into the peripheral vasculature and promoting hemostasis. This is a surgical/interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description of the device components (Latchwire, anchor mechanism, shaft, handle) aligns with a device used for physical access and hemostasis, not for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
- Anatomical Site: The device is used directly on the patient's body (peripheral vasculature, femoral artery). IVDs are typically used to test samples from the body.
Therefore, the AXERA Access System is a medical device used in a clinical procedure, not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
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
peripheral vasculature, 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 modified 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, corrosion resistance testing (Latchwire), flex conditioning (Latchwire), Latchwire resistance to flexing, tensile strength of Latchwire to Anchor (parallel and non-parallel), tensile strength of Latchwire distal coil to core wire, tensile strength of Latchwire proximal coil, latch, and core wire, and compressive strength (handle/anchor).
Additional prior bench testing of the AXERA 2 device included accessory functionality, deployment forces (heel. needle, plunger), release forces (heel), tensile strength of multiple joints (anchor, heel, plunger, plunger tube, needle, guidewire, dilator adapter), access needle integrity, compressive strength (plunger lockout), and torque loading (handle/anchor), 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. "
Prior simulated use testing 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.
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
§ 870.1340 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 lines radiating from a central point. The lines vary in thickness, with some being quite bold and others being thin and faint. The overall effect is one of movement and energy, as if the lines are bursting outwards from the center.
Image /page/0/Picture/1 description: The image shows the text "K132263 p. 1 of 2 Arstasis". The text "K132263 p. 1 of 2" is located at the top left of the image. The word "Arstasis" is in a larger font and is located below the text "K132263 p. 1 of 2".
SECTION 2. 510(k) SUMMARY
| Sponsor/Submitter: | Arstasis, Inc.
740 Bay Road |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Debra Cogan
Director, Quality Assurance, Regulatory & Clinical Affairs
Phone: (650) 261-8073 |
| Date of Submission: | July 19, 2013 |
| 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 (K123135 and K123618) |
| 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. |
| AUG 1 9 2013 | |
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1
Summary of Substantial Equivalence:
Modifications to the AXERA 2 Access System consist of changes to the Latchwire and the Needle Lumen-Anchor (NLA) components. Modifications to the Latchwire include incorporation of the angled-tip onto the longer Latchwire as well as process changes. The NLA assembly has also been modified with design modifications to the geometry of the tab as well as addition of a second tab.
There are no changes to the Indications for Use or procedural steps resulting from the changes described within this submission other than textual clarifications.
Bench testing of the modified 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, corrosion resistance testing (Latchwire), flex conditioning (Latchwire), Latchwire resistance to flexing, tensile strength of Latchwire to Anchor (parallel and non-parallel), tensile strength of Latchwire distal coil to core wire, tensile strength of Latchwire proximal coil, latch, and core wire, and compressive strength (handle/anchor).
Additional prior bench testing of the AXERA 2 device included accessory functionality, deployment forces (heel. needle, plunger), release forces (heel), tensile strength of multiple joints (anchor, heel, plunger, plunger tube, needle, guidewire, dilator adapter), access needle integrity, compressive strength (plunger lockout), and torque loading (handle/anchor), 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. "
Prior simulated use testing 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 predicates 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
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19, 2013
Arstasis, Inc. c/o Ms. Debra Cogan Director, Quality Assurance, Regulatory & Clinical Affairs 740 Bay Road Redwood City, CA 94063
Re: K132263
Trade/Device Name: AXERA 2 Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 19, 2013 Received: July 22, 2013
Dear Ms. Cogan:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Debra Cogan
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 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" (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
. A. Hillerman
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Arstasis
SECTION 1. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Trade Name:
AXERA 2 Access System
Catheter Introducer
Common Name:
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)
M.A. Hillerman
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