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 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 the study information for the AXERA Access System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a modification to an existing device (AXERA Access System, K113110). Therefore, the data presented focuses on demonstrating that the modified device still meets the safety and effectiveness criteria, often using bench testing. Clinical data for the original device serves as a foundation for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance
Mechanical Performance	Device functionality	Met all performance testing acceptance criteria.
	Deployment forces (heel, needle, plunger)	Met all performance testing acceptance criteria.
	Release forces (heel)	Met all performance testing acceptance criteria.
	Flex conditioning (latchwire)	Met all performance testing acceptance criteria.
	Resistance of latchwire to damage by flexing	Met all performance testing acceptance criteria.
	Tensile strength of multiple joints (latchwire, anchor, heel, plunger, needle)	Met all performance testing acceptance criteria.
	Compressive strength (handle/anchor)	Met all performance testing acceptance criteria.
	Torque loading (handle/anchor)	Met all performance testing acceptance criteria.
Material/Environmental	Corrosion resistance testing	Met all performance testing acceptance criteria.
(Previously Performed)	Tensile testing of multiple joints (plunger, plunger tube)	(Implicitly met as part of original device approval)
	Compressive strength testing (plunger lockout)	(Implicitly met as part of original device approval)
	Biocompatibility testing	(Implicitly met as part of original device approval)
Clinical Performance	Short term safety and clinical performance	Established (for original device, and carried over to modified device).
	Long term safety, ability to access and re-access	Retrospectively studied in a smaller cohort of patients (for original dev).

Study Details Proving Device Meets Acceptance Criteria

The provided document describes a "Special 510(k): Device Modification", meaning the primary focus is on demonstrating that changes to an already cleared device do not introduce new safety or effectiveness concerns. The "study" for this modification primarily consisted of bench testing.

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

Sample Size: Not explicitly stated for each individual bench test. The text mentions "test units" without specifying the number per test.
Data Provenance: The bench tests were performed by Arstasis, Inc. (the manufacturer) as part of their device modification review process. The studies were conducted after sterilization of test units. No information on country of origin for the data is provided, but it would presumably be from the manufacturer's testing facilities. The studies for the modification are prospective in nature (tests performed on modified devices).

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

This question is not applicable for the bench testing described in this document. Bench tests rely on engineering specifications and measurement devices, not human expert interpretation for ground truth.
For the clinical investigations mentioned (likely for the original device), details about experts are not provided in this summary.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

This question is not applicable for the bench testing described. Adjudication methods are typically used in clinical studies or image-based evaluations involving human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. The AXERA Access System is a medical device (catheter introducer), not an AI-assisted diagnostic tool, so this type of study is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. The AXERA Access System is a physical medical device, not an algorithm. Bench testing evaluates the physical device's performance against predefined engineering criteria, which is a standalone evaluation of the device itself.

7. The Type of Ground Truth Used:

For the bench testing of the modified device: Engineering specifications and predefined acceptance criteria based on the device's intended function and safety requirements.
For the prior clinical investigations (mentioned for the original device): The text refers to "short term safety and clinical performance" and "long term safety, as well as the ability to access and re-access." Without further detail, this would likely involve clinical outcomes data (e.g., successful access, hemostasis, complication rates) assessed by clinical professionals.

8. The Sample Size for the Training Set:

This question is not applicable. The AXERA Access System is a physical medical device, not a machine learning model, so there is no "training set."

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

This question is not applicable. (See point 8.)

Summary

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K12)521

Special 510(k): Device Modification

APPENDIX A: 510(k) SUMMARY

JUN 2 1 2012

ﺳﮯ

Sponsor/Submitter:	Arstasis, Inc.740 Bay RoadRedwood City, CA 94063
Contact Person:	Debra CoganDirector, Quality Assurance, Regulatory & Clinical AffairsPhone: (650) 261-8073Fax: (650) 261-8002
Date of Submission:	May 22, 2012
Device Trade Name:	AXERA 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 Access System (K113110)
Device Description:	The AXERA 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 Access Device is designed to create a shallow accesspath through the arterial wall for the guidewire to enter the vessellumen.
Performance Data	The AXERA Access Device met all performance testingacceptance criteria.
Summary ofSubstantialEquivalence:	Modifications to the AXERA Access System include changes to theNeedle Lumen Anchor (NLA) assembly to allow the IntegratedNeedle to remain centered and in contact with the anchor whendeployed. Additionally, the length of the Integrated Needle isshortened and the diameter of the Latchwire and shape of theLatchwire latch sub-component has also been adjusted to

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accommodate the change to the distal end of the NLA and to improve manufacturability.

Bench testing of the modified AXERA device was performed for device specifications affected by the modifications described above, following sterilization of test units. All acceptance criteria were met and test results demonstrated that the modified AXERA met performance requirements for its intended use. No new issues of safety or effectiveness were raised. The following tests were performed: device functionality, deployment forces (heel, needle, plunger), release forces (heel), flex conditioning (latchwire), resistance of latchwire to damage by flexing, tensile strength of multiple joints (latchwire, anchor, heel, plunger, needle), compressive strength (handle/anchor), and torque loading (handle/anchor), and corrosion resistance testing.

Additional prior testing included tensile testing of multiple joints (plunger, plunger tube), compressive strength testing (plunger lockout), 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 cumulative data provided herein demonstrates that the AXERA 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 achievement of hemostasis.

CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

JUN 2 1 2012

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

Re: K121521

Trade/Device Name: AXERA Access Systerm Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 22, 2012 Received: May 23, 2012

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

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Page 2 - Ms. Debra Cogan

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 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/ReportalProblem/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 vours.

Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Arstasis

Special 510(k): Device Modification

APPENDIX B: INDICATIONS FOR USE STATEMENT

K121521 510(k) Number (if known):

Trade Name:

AXERA Access System

Catheter Introducer

Common Name:

Indications For Use:

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
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(Posted November 13, 2003)

(Division Sign-Off)
Division: Cardiovascular Division
510(k) Number	K121541

(Posted Novem

CONFIDENTIAL

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).