(60 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.
The provided text describes the AXERA 2 Access System, a catheter introducer device, and its substantial equivalence to a predicate device. The document focuses on bench testing and prior studies rather than a detailed clinical study with acceptance criteria and a "device performance" section in the traditional sense of a diagnostic or AI device.
However, I can extract the information based on the provided text's focus for a medical device regulatory submission.
1. A table of acceptance criteria and the reported device performance
For the AXERA 2 Access System, the acceptance criteria are related to specific bench tests and its ability to meet performance requirements for its intended use, based on the predicate device. The document explicitly states that the device met all acceptance criteria.
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Bench Testing (Current Submission - related to IFU changes) | Latchwire attachment | Met acceptance criteria |
| Tensile strength of Latchwire/anchor joint | Met acceptance criteria | |
| Procedural sheath insertion | Met acceptance criteria | |
| Bench Testing (Predicate Device - applicable to current device) | Device/accessory functionality | Met performance requirements for intended use |
| Deployment forces (heel, needle, plunger) | Met performance requirements for intended use | |
| Release forces (heel) | Met performance requirements for intended use | |
| Corrosion resistance testing (Latchwire/guidewire) | Met performance requirements for intended use | |
| Guidewire resistance to fracture | Met performance requirements for intended use | |
| Latchwire/guidewire resistance to flexing | Met performance requirements for intended use | |
| Flex conditioning (Latchwire) | Met performance requirements for intended use | |
| Tensile strength of multiple joints (Latchwire, guidewire, anchor, heel, plunger, plunger tube, access needle, dilator adapter) | Met performance requirements for intended use | |
| Compressive strength (handle/anchor, plunger lockout) | Met performance requirements for intended use | |
| Access needle integrity | Met performance requirements for intended use | |
| Torque loading (handle/anchor) | Met performance requirements for intended use | |
| Biocompatibility testing | Met performance requirements for intended use | |
| In Vivo/Simulated Use (Predicate Device) | Preliminary animal studies (non-GLP) and cadaver assessments | Established short-term safety and clinical performance |
| Short-term clinical investigations | Established short-term safety and clinical performance | |
| Long-term safety and re-access ability (retrospective study) | Established long-term safety and re-access ability (smaller cohort) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing (current submission): The sample sizes for each specific bench test (Latchwire attachment, tensile strength, procedural sheath insertion) are not provided. The data provenance is "following sterilization of test units," implying lab-based, controlled testing. No country of origin is specified.
- Bench Testing (predicate device): Sample sizes are not provided for the various bench tests listed. Data provenance is implied to be lab-based.
- Preliminary Animal Studies and Cadaver Assessments: The text mentions "preliminary animal studies (non-GLP)" and "cadaver assessments," stating they were "conducted using prototypes of a similar design and configuration." Sample sizes are not specified.
- Clinical Investigations: "Multiple clinical evaluations were conducted" for short-term safety and performance. Sample size is not specified.
- Retrospective Study: "The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients." The exact sample size of this "smaller cohort" is not specified. Data provenance is retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the studies described are for a medical device (catheter introducer) focusing on mechanical performance, safety, and functionality, not a diagnostic or AI device requiring expert-established ground truth on images or patient outcomes in that specific manner. The "ground truth" for bench tests would be the physical properties and performance metrics. For animal/cadaver/clinical studies, it would be direct observation of device function, safety, and patient outcomes by medical professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the types of studies described (bench testing, animal/cadaver assessments, clinical evaluations of a mechanical device). Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation of data (e.g., medical images) by multiple readers.
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 physical catheter introducer, not an AI or imaging-related diagnostic tool that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Testing: The ground truth for bench tests is the objective physical measurements and functional performance against predefined engineering specifications.
- Preliminary Animal Studies & Cadaver Assessments: The ground truth would be direct observation of the device's interaction with tissue, its ability to create an access path, and any observed complications or successes, likely assessed by researchers/medical professionals conducting the studies.
- Clinical Investigations: The ground truth would include direct observation of device functionality, success of arterial access, hemostasis, and patient outcomes (e.g., complications, adverse events) as documented by clinicians.
- Retrospective Study: The ground truth would be patient outcomes data (e.g., long-term safety, re-access capability) extracted from medical records.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm.
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K140201 MAR 2 8 2014 p. 1 of 2 Arstasis
SECTION 2. 510(k) SUMMARY
| Sponsor/Submitter: | Arstasis, Inc. |
|---|---|
| 740 Bay Road | |
| Contact Person: | Grace Li |
| Director of Quality | |
| Direct: (650) 261-8039 | |
| Email: gli@arstasis.com | |
| Date of Submission: | January 24, 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 (K132263) |
| 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 SF 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 System met all bench testing (i.e., Latchwireattachment, tensile strength of Latchwire/anchor joint, andprocedural sheath insertion) acceptance criteria related to theproposed changes to the Instructions for Use (IFU). Device isunchanged for the predicate device. The predicate device met all |
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performance testing acceptance criteria.
There are no changes to the Indications for Use. A note in the IFU Summary of was updated to provide alternate instructions for discontinuing the Substantial AXERA Access procedure. Equivalence: Bench testing of the AXERA 2 Access System was performed for device specifications related to the proposed changes to the IFU, following sterilization of test units. The following tests were performed: Latchwire attachment, tensile strength of Latchwire/anchor joint, and procedural sheath insertion. There are no changes to the AXERA 2 Access System device. Bench Testing performed for the predicate device is applicable and was not repeated for the subject AXERA 2 device. All acceptance criteria for bench testing performed for the predicate device were met and test results demonstrated that the predicate device met performance requirements for its intended use. No new issues of safety or effectiveness have been raised when compared to the predicate device. Prior bench testing of the AXERA 2 device included device/accessory functionality, deployment forces (heel, needle, plunger), release forces (heel), corrosion resistance testing (Latchwire/guidewire), guidewire resistance to fracture, Latchwire/guidewire resistance to flexing, flex conditioning (Latchwire), tensile strength of multiple joints (Latchwire, guidewire, anchor, heel, plunger, plunger tube, access needle, dilator adapter), compressive strength (handle/anchor, plunger lockout), access needle integrity, torque loading (handle/anchor), 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 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
March 28, 2014
Arstasis, Inc. Ms. Grace Li Director of Quality 740 Bay Road Redwood City, CA 94063
Re: K140201
Trade/Device Name: AXERA 2 Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DYB Dated: January 24, 2014 Received: January 27, 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 or any I 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. Grace Li
forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Arsteris
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)
Kenneth J. Cavanaugh -S
Page of of
§ 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).