(63 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 an analysis of the provided text regarding the AXERA 2 Access System, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only states that the device "met all performance testing acceptance criteria" and lists the types of tests performed. It does not detail the specific numerical acceptance criteria (e.g., "tensile strength of X N") or the exact reported device performance values. Therefore, a complete table as requested cannot be constructed from the given information.
However, based on the text, we can infer the categories of tests and the general outcome:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing (Modified AXERA 2) | Met all criteria (specific values not provided in document) |
| - Device functionality | Met functionality requirements |
| - Deployment forces (needle, plunger) | Met deployment force requirements |
| - Tensile strength (Latchwire to Anchor) | Met tensile strength requirements (parallel and nonparallel) |
| - Compressive strength (handle/anchor) | Met compressive strength requirements |
| - Torque loading (handle/anchor) | Met torque loading requirements |
| - Access needle functionality | Met access needle functionality requirements |
| - Access needle integrity | Met access needle integrity requirements |
| - Tensile strength (access needle) | Met access needle tensile strength requirements |
| Bench Testing (Unmodified AXERA 2) | Met all criteria (specific values not provided in document) |
| - Accessory functionality | Met accessory functionality requirements |
| - Deployment forces (heel) | Met deployment force requirements |
| - Release forces (heel) | Met release force requirements |
| - Tensile strength of multiple joints | Met tensile strength requirements |
| - Access needle integrity | Met access needle integrity requirements |
| - Compressive strength (plunger lockout) | Met compressive strength requirements |
| - Corrosion resistance | Met corrosion resistance requirements |
| - Guidewire resistance to fracture | Met fracture resistance requirements |
| - Latchwire/guidewire resistance to flexing | Met flexing resistance requirements |
| - Tensile strength (Latchwire distal coil to core wire) | Met tensile strength requirements |
| - Tensile strength (Latchwire proximal coil, latch, and core wire) | Met tensile strength requirements |
| - Biocompatibility testing | Met biocompatibility requirements |
| Simulated Use Testing (Unmodified AXERA 2) | Established short-term safety and clinical performance |
| - Cadaveric model studies | Successfully performed |
| Clinical Evaluations (Unmodified AXERA 2) | Established short-term safety and clinical performance, and long-term safety/re-access (retrospective cohort) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Bench Testing): The document does not specify the exact sample sizes (number of units) used for each individual bench test. It only states that "test units" were used "following sterilization."
- Test Set (Simulated Use): "a cadaveric model" (singular) was used.
- Test Set (Clinical Evaluations):
- Short-term safety and clinical performance: "multiple clinical evaluations were conducted." The exact number of patients is not provided.
- Long-term safety and re-access: "retrospectively studied in a smaller cohort of patients." The exact number of patients for this cohort is not provided.
- Data Provenance: The document does not explicitly state the country of origin for the clinical or cadaveric data. It generally refers to "preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations." Given the FDA submission, it can be inferred that the data would be acceptable to the US regulatory body, but the origin itself is not specified as, for example, "US data." The clinical studies are described as both "preliminary" and "retrospective," indicating a blend of prospective and retrospective aspects for different evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify that "experts" were used to establish ground truth in the context of device performance in bench, cadaver, or clinical studies, nor does it list their qualifications. The testing appears to be objective measurements (e.g., tensile strength, deployment forces) and observations of safety and performance. For the clinical evaluations, the "ground truth" would likely be based on clinical outcomes, investigator assessments, and patient data rather than a separate expert panel establishing a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
Not applicable/not specified. The testing described primarily involves objective device performance measurements and clinical observations rather than subjective assessments requiring adjudication (like image interpretation).
5. 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
Not applicable. This device is a catheter introducer, not an AI-powered diagnostic or treatment assistance system. Therefore, MRMC studies with AI assistance are not relevant to its evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
- Bench Testing: Engineering specifications, physical performance metrics, and established manufacturing standards (e.g., for tensile strength, component integrity, functionality).
- Simulated Use (Cadaveric Model): Observational outcomes related to device performance in tissue (e.g., successful access, shallow path creation).
- Clinical Evaluations: Clinical outcomes, safety data (adverse events), and efficacy observations (successful vascular access, hemostasis, ability to re-access) gathered from actual patient procedures. The document mentions "short term safety and clinical performance" and "long term safety, as well as the ability to access and re-access."
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model that requires a training set in the AI sense. The development of the device would involve iterative design and testing, but not a "training set" in the context of AI.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the AI sense for this device. The "ground truth" for its design and manufacturing would be based on engineering principles, material science, clinical needs, and regulatory requirements.
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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
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| 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. |
| TechnologicalCharacteristics | 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.
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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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§ 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).