(100 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 RX is a device that is comprised of a flexible tip, anchor mechanism, shaft and handle with control features.
The provided text describes modifications to an existing device (AXERA 2 Access System to AXERA RX Access System) and various tests performed to demonstrate substantial equivalence to its predicate. However, it does not provide explicit acceptance criteria in a table format, nor does it detail a study that proves the device meets specific numerical acceptance criteria in the way an AI/ML device would be evaluated for metrics like sensitivity, specificity, or AUC.
Instead, the document focuses on engineering and performance testing for a medical device (catheter introducer). Therefore, much of the requested information regarding AI/ML device evaluation is not applicable or cannot be extracted from this text.
Here's an attempt to answer the questions based on the provided text, highlighting where information is absent or not applicable:
1. Table of acceptance criteria and reported device performance
The document states: "The AXERA RX Access Device met all performance testing acceptance criteria." However, it does not provide a table detailing those acceptance criteria or specific numerical performance results. It only lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical/Physical Performance: | "met all performance testing acceptance criteria" |
| Device Functionality | Met (implied) |
| Tip Flexibility | Met (implied) |
| Flex Conditioning (flexible tip) | Met (implied) |
| Tensile Strength (flexible tip to anchor) | Met (implied) |
| Compressive Strength (handle/anchor) | Met (implied) |
| Torque Loading (handle/anchor) | Met (implied) |
| Corrosion Resistance (needle lumen anchor) | Met (implied) |
| Accessory Functionality | Met (implied) |
| Deployment Forces (heel, needle, plunger) | Met (implied) |
| Release Forces (heel) | Met (implied) |
| Tensile Strength (multiple joints) | Met (implied) |
| Access Needle Integrity | Met (implied) |
| Compressive Strength (plunger lockout) | Met (implied) |
| Corrosion Resistance (guidewire) | Met (implied) |
| Guidewire Resistance to Fracture | Met (implied) |
| Guidewire Resistance to Flexing | Met (implied) |
| Biocompatibility: | Met (implied) |
| Biocompatibility Testing | Met (implied) |
| Clinical/Simulated Use: | "met all performance testing acceptance criteria" |
| Simulated Use (cadaveric model) | Performed (stated to have established safety/performance) |
| Clinical Investigations (unmodified AXERA RX) | Established short term safety and clinical performance |
| Retrospective Study (unmodified AXERA RX) | Established long term safety and ability to access/re-access |
2. Sample size used for the test set and the data provenance
- Test Set Description: The document refers to "Bench testing," "Simulated use testing on a cadaveric model," and "Clinical investigations."
- Sample Size for Bench Testing: Not specified.
- Sample Size for Cadaveric Model: Not specified.
- Sample Size for Clinical Investigations: Not specified, but a "smaller cohort of patients" was used for the retrospective study.
- Data Provenance:
- Bench testing: Likely in-house laboratory.
- Simulated use testing: Cadaveric model (source/country not specified).
- Clinical investigations: Patients, but country of origin and whether prospective or retrospective for the initial investigations are not specified. The long-term safety study was explicitly retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical instrument, not an AI/ML imaging device requiring expert ground truth for interpretation. The "ground truth" (or "reference standard") for this device would be direct physical measurement, engineering standards, and direct observation of device performance in simulated and clinical settings.
4. Adjudication method for the test set
Not applicable. This device is a physical medical instrument. Adjudication methods like "2+1" are relevant for expert review of AI/ML outputs, not for device performance testing like tensile strength or functionality.
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 is not an AI/ML device that assists human readers.
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 an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the various tests performed, the "ground truth" would be:
- Bench Testing: Engineering specifications, ISO standards, validated measurement techniques (e.g., force gauges, calipers, visual inspection for functionality).
- Simulated Use (cadaveric): Observable performance relative to intended function (e.g., successful access, no damage to surrounding tissue, hemostasis).
- Clinical Investigations: Clinical outcomes data, typically adverse event rates, success rates of access, and achievement of hemostasis.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set. The "unmodified AXERA RX design features" mentioned undergoing preliminary animal studies, cadaver assessments, and clinical investigations could be considered analogous to prior data that informed the design, but this is distinct from AI/ML training data.
9. How the ground truth for the training set was established
Not applicable (as it's not an AI/ML device). For the foundational understanding of the device's design and performance (which could be loosely considered 'training' in an engineering context), the ground truth was established through:
- Engineering principles and design specifications.
- Pre-clinical studies (animal and cadaveric models) where physiological responses and anatomical interactions serve as the "truth."
- Prior clinical evaluations of the unmodified device, where actual patient outcomes and medical assessments provided the "truth."
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SECTION 2. 510(k) SUMMARY
| Sponsor/Submitter: | Arstasis, Inc. |
|---|---|
| 740 Bay Road | |
| Contact Person: | Grace LiDirector of QualityPhone: (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 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 RX Access Device is designed to create a shallowaccess path through the arterial wall for the guidewire to enter thevessel lumen. |
| Performance Data | The AXERA RX Access Device met all performance testingacceptance criteria. |
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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.
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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
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
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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" (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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§ 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).