The Arstasis 000 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. The Arstasis006 Access System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

Device Description

Arstasisone is a device that is comprised of a sheath, anchor mechanism, shaft and handle with control features.

AI/ML Overview

The provided text describes the Arstasisone Access System, a catheter introducer. The information focuses on its regulatory submission for substantial equivalence to a predicate device. There is no information in the provided text about acceptance criteria or a study proving the device meets specific performance criteria in the format requested.

Here's a breakdown of what can be extracted based on your request, and what cannot:

Missing Information:

The provided text does not contain any information regarding:

A table of acceptance criteria and reported device performance.
Sample sizes used for a test set, data provenance, ground truth experts, or adjudication methods for any study.
Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human readers with/without AI assistance.
Standalone algorithm performance.
Types of ground truth used (expert consensus, pathology, outcomes data).
Sample size for training sets.
How ground truth for training sets was established.

Information that can be inferred/extracted about the study (though not presented as a direct acceptance criteria study):

The submission mentions various types of testing and studies conducted to establish substantial equivalence, rather than to specifically meet predefined acceptance criteria in the typical sense of a performance study for a diagnostic AI device.

1. Table of acceptance criteria and the reported device performance:

Not provided. There is no explicit table of acceptance criteria or quantitative performance metrics within the document.

2. Sample sized used for the test set and the data provenance:

Test Set Sample Size: "Multiple clinical evaluations were conducted" and "retrospectively studied in a smaller cohort of patients." No specific numbers are given.
Data Provenance: Not specified (e.g., country of origin). "Clinical investigations" and "animal studies (non GLP) and cadaver assessments" are mentioned.
Retrospective/Prospective: Clinical investigations are generally prospective, but the long-term safety study was "retrospectively studied."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not provided. The text does not detail how ground truth was established for the clinical evaluations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not provided.

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:

No. This device is a physical medical device (catheter introducer), not an AI/diagnostic software. Therefore, an MRMC study or AI assistance is not applicable.

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

No. This device is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly stated for clinical evaluations. The studies aimed to establish "short term safety and clinical performance" and "long term safety, as well as the ability to access and reaccess." This implies clinical outcomes and observations rather than a singular "ground truth" for a diagnostic task.

8. The sample size for the training set:

Not applicable/Not provided. This is a physical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

Not applicable/Not provided. This is a physical device, not an AI algorithm.

Summary of available information related to performance/testing:

The Arstasisone Access System's substantial equivalence was established through a combination of:

Bench testing: Functionality, deployment and release forces, flexibility, torque loading, tensile, compressive, and torque strengths. (No specific acceptance criteria or results are detailed).
Biocompatibility testing: Conducted pursuant to ISO-10993-1. (Results reported as "successfully conducted").
Preliminary animal studies (non GLP) and cadaver assessments: Conducted using prototypes of a similar design.
Multiple clinical evaluations: Conducted on an earlier device version of similar design. These established short-term safety and performance.
Retrospective study: On a smaller cohort for long-term safety and reaccess ability.

The overall conclusion is that the "cumulative data provided herein demonstrate that the Arstasis 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."

Summary

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Arstasis

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KOOKIS

510(k) SUMMARY

Sponsor/Submitter:	Arstasis, Inc.1021 Howard Avenue, Suite CSan Carlos, CA 94070	MAR 3 0 2010
Contact Person:	Su-Mien ChongActing VP, Regulatory & Clinical AffairsPhone: (650) 704-1632Fax: (650) 594-4326
Date of Submission:	March 3, 2010
Device Trade Name:	Arstasisone 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:	Arstasis ITG Vascular Access System (K091006)
Device Description:	Arstasisone is a device that is comprised of a sheath, anchor mechanism, shaftand handle with control features.
Indications for Use:	Arstasisone Access System is intended to provide access for the percutaneousintroduction of devices into the peripheral vasculature and to promotehemostasis at the arteriotomy site as an adjunct to manual compression. TheArstasisone Access System is indicated for use in patients undergoing diagnosticfemoral artery catheterization procedures using 5F or 6F introducer sheaths.
TechnologicalCharacteristics	Arstasisone is designed to create a shallow access path through the arterial wallfor the guidewire to enter the vessel lumen.
Summary ofSubstantialEquivalence:	Bench testing was performed on the subject device as follows: functionality,deployment and release forces, flexibility, torque loading as well as tensile,compressive and torque strengths. Biocompatibility testing was successfullyconducted pursuant to ISO-10993-1, Biological Evaluation of Medical DevicesPart 1: Evaluation and Testing (1995).

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Prior testing included preliminary animal studies (non GLP) and cadaver assessments , as well as clinical investigations.2 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 reaccess, was retrospectively studied in a smaller cohort of patients.

In summary, the cumulative data provided herein demonstrate that the Arstasis 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.

I The preliminary Animal Studies and Cadaver Assessments were conducted using prototypes of a similar design and configuration.

2 Clinical investigations were conducted on an earlier device version of similar design and configuration.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR 2 9 2010

Ms. Su-Mien Chong Acting Vice President, Research and Development Arstasis, Inc. 1021 Howard Avenue, Suite C San Carlos, CA 94070

Re: K100615 Trade/Device Name: Arstasis000 Access System Regulation Number: 21 CFR §870.1340 Regulation Name: Catheter, Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: March 3, 2010 Received: March 4, 2010

Dear Ms. Chong:

This letter corrects our substantially equivalent letter of March 30, 2010.

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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, manier the act include requirements for annual registration, listing of devices, controls provisions or morice, labeling, and prohibitions against misbranding and adulteration.

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 may or subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Su-Mien Chong

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, MD
Director
Division of Cardiovascular Devices

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/4/Picture/0 description: The image contains the word "Arstasis" in a stylized, sans-serif font. The letters are black and have a slightly futuristic or technical appearance due to their blocky and angular design. The word is presented in a simple, straightforward manner against a white background.

APPENDIX B: INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K100615

Trade Name: Arstasis 00€ Access System

Common Name: Catheter Introducer

Indications For Use:

Prescription Use V (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 1 of 1

(Posted November 13, 2003)

Dunner 2. be vision Sian-Off Division of Cardiovascular Devices

510(k) Number_K1006 | 5

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).