(28 days)
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.
The AXERA 2 is a device that is comprised of a Latchwire, anchor mechanism, shaft and handle with control features.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the changes made to the AXERA 2 Access System.
It's important to note that the provided documents are a 510(k) summary and acceptance letter, which typically focus on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with acceptance criteria usually seen for novel devices or significant changes. The information available is based on the description of testing performed for the modifications.
Acceptance Criteria and Reported Device Performance
The provided text states: "The AXERA 2 Access Device met all performance testing acceptance criteria." However, specific numerical acceptance criteria and their corresponding reported device performance values are not explicitly detailed in the text. The summary lists the types of tests performed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device Functionality | Met all criteria |
| Corrosion Resistance (Latchwire) | Met all criteria |
| Flex Conditioning (Latchwire) | Met all criteria |
| Latchwire Resistance to Flexing | Met all criteria |
| Tensile Strength of Latchwire to Anchor (parallel and non-parallel) | Met all criteria |
| Tensile Strength of Latchwire Distal Coil to Core Wire | Met all criteria |
| Tensile Strength of Latchwire Proximal Coil, Latch, and Core Wire | Met all criteria |
| Compressive Strength (Handle/Anchor) | Met all criteria |
| Accessory Functionality (prior testing) | Met all criteria |
| Deployment Forces (heel, needle, plunger) (prior testing) | Met all criteria |
| Release Forces (heel) (prior testing) | Met all criteria |
| Tensile Strength of Multiple Joints (anchor, heel, plunger, plunger tube, needle, guidewire, dilator adapter) (prior testing) | Met all criteria |
| Access Needle Integrity (prior testing) | Met all criteria |
| Compressive Strength (plunger lockout) (prior testing) | Met all criteria |
| Torque Loading (handle/anchor) (prior testing) | Met all criteria |
| Corrosion Resistance (guidewire) (prior testing) | Met all criteria |
| Guidewire Resistance to Fracture (prior testing) | Met all criteria |
| Guidewire Resistance to Flexing (prior testing) | Met all criteria |
| Biocompatibility (prior testing) | Met all criteria |
| Preliminary Animal Studies (non-GLP) (prior testing) | Established short-term safety and clinical performance |
| Cadaver Assessments (prior testing) | Established short-term safety and clinical performance |
| Clinical Investigations (prior testing) | Established short-term safety and clinical performance; long-term safety and re-access ability retrospectively studied in a smaller cohort |
Note: The document states that "all performance testing acceptance criteria" were met, but it does not specify what those criteria were (e.g., minimum tensile strength, maximum deployment force range).
Study Details
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Sample size used for the test set and the data provenance:
- Bench Testing: The document mentions "test units" were used for the various bench tests (device functionality, tensile strength, corrosion, etc.). The specific number of units used for each test is not provided.
- Preliminary Animal Studies & Cadaver Assessments: Not specified, but referred to as "prototypes of a similar design and configuration."
- Clinical Investigations: The document mentions "multiple clinical evaluations were conducted" for short-term safety and performance. For long-term safety and re-access ability, it was "retrospectively studied in a smaller cohort of patients." The specific number of patients or cases in these clinical evaluations and the retrospective study is not provided.
- Data Provenance: Not explicitly stated for all studies. Clinical investigations imply human data, likely from medical centers. The animal studies and cadaver assessments are explicitly mentioned. The country of origin for the clinical data is not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For device performance testing, "ground truth" is typically established by engineering specifications and objective measurements rather than expert consensus on individual cases. For clinical studies, the "ground truth" would be clinical outcomes, and the experts involved (e.g., physicians conducting the procedures, interpreting results) are implied but not explicitly detailed in terms of number or specific qualifications (like "radiologist with 10 years of experience").
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable to the descriptions of bench testing provided. For clinical studies, no adjudication method is mentioned.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- An MRMC comparative effectiveness study is not relevant here as the AXERA 2 Access System is a medical device (catheter introducer), not an AI-powered diagnostic imaging tool. Therefore, terms like "human readers" and "AI assistance" do not apply.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The AXERA 2 Access System is a mechanical medical device, not an algorithm or software. It requires human-in-the-loop for its intended use.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Testing: The ground truth for bench tests would be the established engineering specifications and physical measurements, designed to ensure the device performs as intended (e.g., materials withstand certain forces, dimensions are correct, no corrosion).
- Clinical/Animal/Cadaver Studies: The ground truth would be clinical outcomes related to safety and performance (e.g., ability to access the vessel, hemostasis, absence of complications, confirmed by medical observation and records).
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The sample size for the training set:
- This question is not applicable to a mechanical medical device. The device is not "trained" in the machine learning sense. Design and development are based on engineering principles and iterative testing.
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How the ground truth for the training set was established:
- This question is not applicable for the reasons stated above (not an AI/ML device).
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SECTION 2. 510(k) SUMMARY
| Sponsor/Submitter: | Arstasis, Inc.740 Bay Road |
|---|---|
| Contact Person: | Debra CoganDirector, Quality Assurance, Regulatory & Clinical AffairsPhone: (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, anchormechanism, shaft and handle with control features. |
| Indications for Use: | The AXERA Access System is intended to provide access for thepercutaneous introduction of devices into the peripheral vasculatureand to promote hemostasis at the arteriotomy site as an adjunct tomanual compression. AXERA is indicated for use in patientsundergoing diagnostic femoral artery catheterization proceduresusing 5F or 6F introducer sheaths. |
| TechnologicalCharacteristics | The AXERA 2 Access Device is designed to create a shallowaccess path through the arterial wall for the guidewire to enter thevessel lumen. |
| Performance Data | The AXERA 2 Access Device met all performance testingacceptance criteria. |
| AUG 1 9 2013 |
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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.
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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
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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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§ 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).