ARSTASIS ACCESS SYSTEM by ARSTASIS, INC.

The Arstasis®16 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 Arstasis 000 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 a medical device, the "Arstasisone Access System," and its submission for 510(k) clearance. However, the document primarily focuses on regulatory approval and substantial equivalence to a predicate device, rather than a clinical study designed to establish acceptance criteria for device performance in terms of metrics like sensitivity, specificity, or accuracy.

The information given relates to the safety and performance of the device, not an AI or algorithm's performance. Therefore, many of the requested points regarding AI device criteria, training sets, ground truth establishment, and expert involvement are not applicable to this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., success rate for hemostasis, access rate) with specific thresholds as would be found in a clinical trial report with defined endpoints. Instead, the "acceptance criteria" appear to be implicit in demonstrating substantial equivalence to an existing predicate device for safety and effectiveness.

Acceptance Criteria (Inferred from regulatory context)	Reported Device Performance (Summary)
Premarket Acceptance: Substantial Equivalence to Predicate Device (Arstasisone Access System K100615) regarding:	The cumulative data (including bench testing, animal studies, cadaver assessments, and clinical evaluations) demonstrates that the Arstasis 006 Access System is substantially equivalent to its predicate in providing access to the arterial lumen and facilitating introduction/placement of devices and achievement of hemostasis.
- Functionality	Bench testing performed (functionality, torque loading, flexibility, tensile strength of core wire assembly and sheath). Prior bench testing on predicate included deployment forces, flexibility, tensile, compression, and torque loading.
- Torque Loading	Covered by bench testing.
- Flexibility	Covered by bench testing.
- Tensile Strength	Covered by bench testing.
- Biocompatibility	Prior testing on predicate included biocompatibility testing pursuant to ISO-10993-1.
- Safety (short-term & long-term)	"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."
- Clinical Performance (hemostasis, access)	"The cumulative data provided herein demonstrates that the Arstasis 006 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."

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

The document refers to "Multiple clinical evaluations" and a "smaller cohort of patients" for retrospective long-term safety studies. Specific numerical sample sizes for these clinical evaluations are not provided.

Data Provenance: The document does not specify the country of origin.
Retrospective/Prospective: "Multiple clinical evaluations were conducted" (implies prospective or mixed). "The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients."

Given that this is a medical device (catheter introducer) and not an AI algorithm, the concept of a "test set" in the context of machine learning performance metrics is not directly applicable. The "test set" here refers to the patients involved in the clinical evaluations.

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

This information is not provided in the document. For a medical device like this, "ground truth" would typically refer to clinical outcomes (e.g., successful hemostasis, complication rates), which are observed directly or documented by clinicians, rather than established by expert consensus on interpretations of data.

4. Adjudication Method for the Test Set

This information is not provided. Clinical outcomes are generally observed and recorded, rather than adjudicated in the same way imaging interpretations might be.

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 document describes a physical medical device (catheter introducer), not an AI algorithm for interpretation or assistance. Therefore, an MRMC study related to AI performance is not relevant.

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 a software algorithm.

7. The Type of Ground Truth Used

Based on the nature of the device and the statements:

Clinical Outcomes: The "ground truth" for the clinical evaluations would be actual patient outcomes, such as successful hemostasis, ability to access/re-access the vasculature, and safety events (complications). The short-term and long-term safety and clinical performance were established through these evaluations.

8. The Sample Size for the Training Set

Not Applicable. This document describes a physical medical device, not an AI algorithm that requires a training set. The "training" for such a device would involve bench testing, animal studies, and cadaver assessments to refine the device design.

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

Not Applicable. As per point 8, there's no "training set" in the AI sense. However, the "ground truth" for the development of the device was established through:

Bench Testing: Evaluation against engineering specifications and performance standards (e.g., torque, tensile strength).
Animal Studies (non-GLP): Observation of device function and biological response in animal models.
Cadaver Assessments: Evaluation of device performance in human cadavers.

These methods served to inform and refine the device design prior to human trials.

Summary

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Arstasis

	APPENDIX A: 510(k) SUMMARY
Sponsor/Submitter:	Arstasis, Inc.1021 Howard Avenue, Suite CSan Carlos, CA 94070	OCT 7 2010
Contact Person:	Debra CoganDirector, Regulatory & Clinical AffairsPhone: (650) 508-1549 x273Fax: (650) 594-4326
Date of Submission:	September 20, 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:	Arstasisone Access System (K100615)
Device Description:	Arstasisone is a device that is comprised of a sheath, anchormechanism, shaft and handle with control features.
Indications for Use:	Arstasisone 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. The Arstasisone Access System is indicatedfor use in patients undergoing diagnostic femoral arterycatheterization procedures using 5F or 6F introducer sheaths.
TechnologicalCharacteristics	Arstasisone is designed to create a shallow access path through thearterial wall for the guidewire to enter the vessel lumen.
Summary ofSubstantialEquivalence:	Selective bench testing was performed on the subject device asfollows: functionality, torque loading, flexibility and tensilestrength of the core wire assembly and sheath.
	Prior bench testing included deployment forces, flexibility, tensile,compression, and torque loading, were conducted on the predicatedevice. Additional prior testing included biocompatibility testingpursuant to ISO-10993-1, Biological Evaluation of MedicalDevices Part 1: Evaluation and Testing (1995), preliminary animalstudies (non-GLP) and cadaver assessments, as well as clinical

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investigations.1 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 Arstasis 006 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.

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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

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

OCT 7 2010

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

Re: K102728

Trade/Device Name: Arstasis Access System Regulation Number: 21 CFR §870.1340 Regulation Name: Catheter, Introducer Regulatory Class: Class II (Two) Product Code: DYB Dated: September 20, 2010 Received: September 22, 2010

Dear Ms. Su-Mien Chong:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) it itgang actment date of the Medical Device Amendment, or to connineres prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Tier) that to hot required to the general controls provisions of the Act. of the 1 ou may, ulciclore, market the act include requirements for annual registration, listing of general controls provisions of the Provibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Flease note. CDICT does not ovarant must be truthful and not misleading.

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Page 2 - Ms. Su-Mien Chong

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 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,

Duna R. Vuchner

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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Special 510(k): Device Modification

APPENDIX B: INDICATIONS FOR USE STATEMENT

K102728 510(k) Number (if known):

Trade Name:

Arstasis 90€ Access System

Catheter Introducer

Common Name:

Arstasis

Indications For Use:

Prescription Use (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)

Annual

(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices

Page [ of \

510(k) Number

(Posted November 13, 2003)

Confidential

Page 30 of 36

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).