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.

Device Description

The AXERA 2 is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AXERA 2 Access System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device "met all performance testing acceptance criteria." However, it does not explicitly list the specific quantitative acceptance criteria alongside the reported performance for each individual test. It's implied that for each test listed, the device's performance was deemed acceptable.

Acceptance Criteria (General)	Reported Device Performance
Device functionality satisfactory	Met acceptance criteria
Flex conditioning (Latchwire)	Met acceptance criteria
Latchwire resistance to flexing	Met acceptance criteria
Tensile strength of Latchwire to Anchor (parallel and non-parallel)	Met acceptance criteria
Tensile strength of Latchwire distal coil to core wire	Met acceptance criteria
Tensile strength of Latchwire proximal coil, latch, and core wire	Met acceptance criteria
Accessory functionality	Met acceptance criteria
Deployment forces (heel, needle, plunger)	Met acceptance criteria
Release forces (heel)	Met acceptance criteria
Flex conditioning (guidewire)	Met acceptance criteria
Tensile strength of multiple joints (anchor, heel, plunger, plunger tube, needle, guidewire, dilator adapter)	Met acceptance criteria
Access needle integrity	Met acceptance criteria
Compressive strength (handle/anchor, plunger lockout)	Met acceptance criteria
Torque loading (handle/anchor)	Met acceptance criteria
Corrosion resistance	Met acceptance criteria
Guidewire resistance to fracture	Met acceptance criteria
Guidewire resistance to flexing	Met acceptance criteria
Biocompatibility	Met acceptance criteria
Safety (from simulated use, animal, and clinical studies)	Confirmed safety (simulated use, animal studies, clinical investigations)
Clinical performance (short-term)	Established (clinical investigations)
Ability to access and re-access (long-term safety)	Retrospectively studied in a smaller cohort of patients, implying acceptable long-term safety and access/re-access.

2. Sample Size Used for the Test Set and Data Provenance:

Bench Testing: No specific sample sizes are provided for the bench tests.
Simulated Use Testing: Performed on a "cadaveric model." The exact number of cadavers is not specified.
Preliminary Animal Studies: No specific sample size is provided. The studies were conducted using "prototypes of a similar design and configuration."
Cadaver Assessments: No specific sample size is provided. The assessments were conducted using "prototypes of a similar design and configuration."
Clinical Investigations: The document mentions "Multiple clinical evaluations were conducted" and "The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients." No specific sample sizes for these cohorts are provided.
Data Provenance: The document does not explicitly state the country of origin for any of the studies or if they were retrospective or prospective, beyond the "smaller cohort" for long-term safety being studied retrospectively.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not provide details on the number or qualifications of experts used to establish ground truth for any of the testing. For cadaveric and clinical studies, it can be inferred that healthcare professionals (e.g., surgeons, interventionalists) would have evaluated the device, but their specific roles, number, or qualifications are not mentioned.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth from experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done, as this device is a medical access system, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is inherent to its design and how it's used by a human operator, not a standalone AI algorithm.

7. The Type of Ground Truth Used:

Bench Testing: The ground truth for bench testing would be objective measurements and defined engineering specifications.
Simulated Use Testing (Cadaveric Model): The ground truth would be the observed physical outcomes and successful performance of the device in a cadaver, likely assessed by medical professionals.
Preliminary Animal Studies: The ground truth would be physiological and anatomical observations in live animals regarding safety and performance.
Clinical Investigations: The ground truth would be clinical outcomes, safety endpoints, and successful procedural completion, as determined by medical professionals treating patients.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This device is a physical medical device and does not have a training set.

Summary

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SECTION 2. 510(k) SUMMARY

Arstesss

K123618 p.1 of 2

MAR 2 4 2013

Sponsor/Submitter:	Arstasis, Inc.
	740 Bay Road
Contact Person:	Debra Cogan
	Director, Quality Assurance, Regulatory & Clinical Affairs
	Phone: (650) 261-8073
Date of Submission:	November 21, 2012
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) manufactured by Arstasis,Inc., Prelude Sheath Introducer (K070159) manufactured by MeritMedical Systems, Inc .; Pinnacle Introducer Sheath (K984260)manufactured by Terumo Medical Corporation; and AvantiCatheter Sheath Introducer (K945616) manufactured by CordisCorporation.
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.

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Performance Data

The AXERA 2 Access Device met all performance testing acceptance criteria.

Summary of Substantial Equivalence:

Modifications to the AXERA 2 Access System consist of changes to the Latchwire, including change to the length of the latchwire, process changes for manufacturing the latchwire, and modifications to the shape of the tip. These design modifications both streamline manufacturing and provide the Physician with the option of using a shorter device to gain arterial access.

There are no changes to the Indications for Use or procedural steps resulting from the changes described within this submission.

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, 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, and tensile strength of Latchwire proximal coil, latch, and core wire. Simulated use testing was performed on a cadaveric model and confirmed safety of the modified tip shape.

Additional prior bench testing of the AXERA 2 device included accessory functionality, deployment forces (heel, needle, plunger), release forces (heel), flex conditioning (guidewire), tensile strength of multiple joints (anchor, heel, plunger, plunger tube, needle, guidewire, dilator adapter), access needle integrity, compressive strength (handle/anchor, plunger lockout), and torque loading (handle/anchor), corrosion resistance testing, guidewire resistance to fracture, guidewire resistance to flexing, biocompatibility testing, preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations. 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 is a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol, composed of three curved lines, which is positioned to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 24, 2013

Arstasis. Inc. c/o Ms. Debra Cogan Director, Ouality Assurance, Regulatory and Clinical Affairs 740 Bay Road Redwood City, CA 94063

Re: K123618

Device Name: AXERA 2 Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 12, 2013 Received: February 13, 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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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for . the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Matthew G. Hillebrenner

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

510(k) Number (if known):	K123618
Trade Name:	AXERA 2 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 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page __ of ___________________________________________________________________________________________________________________________________________________________________

Matthew G. Hillebrenner

Regulation Number and Section

§ 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).