The 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 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 latchwire, anchor mechanism, shaft and handle with control features.

AI/ML Overview

Here's a breakdown of the acceptance criteria and supporting studies for the Arstasisone Latchwire Access System, based on the provided document:

Acceptance Criteria and Device Performance

The document states generally that the device met all acceptance criteria, but it does not provide specific quantitative acceptance criteria or detailed performance metrics. Instead, it offers a summary of testing performed.

Table 1: Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Specific Metrics/Result (if available)
Bench Testing	Met all performance testing acceptance criteria.	- Functionality testing Passed
		- Deployment forces Passed
		- Corrosion resistance Passed
		- Compression and torque loading Passed
		- Flexibility Passed
		- Tensile strength (Latchwire and Access Needle) Passed
Biocompatibility	Met acceptance criteria per ISO-10993-1.	Passed assessments
Animal Studies	Preliminary studies conducted.	Short term safety and clinical performance established.
Cadaver Assessments	Assessments conducted.	Short term safety and clinical performance established.
Clinical Investigations	Multiple evaluations conducted. Short term safety and clinical performance established. Long term safety and ability to access/re-access retrospectively studied.	Short term safety and clinical performance established. Long term safety and ability to access/re-access assessed in a smaller cohort.

Study Details:

Sample Size and Data Provenance:
- Test Set (Clinical Investigations): The document mentions "multiple clinical evaluations" and "a smaller cohort of patients" for the retrospective long-term safety and re-access study. However, specific sample sizes for these clinical investigations are not provided.
- Test Set (Bench Testing): "Test units" were used for bench testing, but the exact number of units is not specified.
- Data Provenance: Not explicitly stated, but clinical investigations typically involve human subjects from a specific region/country. Given the company (Arstasis, Inc.) is based in San Carlos, CA, USA, it's likely the clinical data originated from the United States, but this is not confirmed. The clinical investigations were both prospective (for short-term safety and performance) and retrospective (for long-term safety and re-access). Animal studies and cadaver assessments were also performed.
Number of Experts and Qualifications for Ground Truth (Test Set):
- The document does not specify the number of experts or their qualifications used to establish ground truth for the clinical investigations. Clinical studies implicitly rely on medical experts (physicians) for patient assessment and outcomes, but explicit details are absent.
Adjudication Method (Test Set):
- The document does not describe any specific adjudication method used for the test set data (e.g., 2+1, 3+1).
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This device is a medical access tool, not an imaging or diagnostic device that typically involves human readers interpreting data. Therefore, the concept of "improving human readers with AI vs. without AI assistance" does not apply.
Standalone Performance (Algorithm Only):
- No, a standalone (algorithm only) performance study was not done because this is a physical medical device, not an AI/algorithm-based diagnostic or assistive software.
Type of Ground Truth Used:
- For the clinical investigations, the ground truth would be based on clinical outcomes data (e.g., hemostasis achievement, adverse events, ability to access/re-access the vessel).
- For biocompatibility, the ground truth is established by adherence to ISO-10993-1 standards and testing results.
- For bench testing, the ground truth is based on engineering specifications and predefined performance thresholds for mechanical properties.
Sample Size for Training Set:
- This question is not applicable as the Arstasisone Latchwire Access System is a physical medical device, not a machine learning or AI algorithm that requires a "training set." The development process would involve iterative design, prototyping, and testing, rather than an AI training paradigm.
How Ground Truth for Training Set was Established:
- This question is not applicable for the same reason as point 7.

Summary

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K103143 page 1 of 2

ત્વદ્યકાર

Special 510(k): Device Modification

FEB - 2 2011

APPENDIX A: 510(k) SUMMARY

Sponsor/Submitter:	Arstasis, Inc.1021 Howard Avenue, Suite CSan Carlos, CA 94070
Contact Person:	Debra CoganDirector, Regulatory & Clinical AffairsPhone: (650) 508-1549 x273Fax: (650) 594-4326
Date of Submission:	October 22, 2010
Device Trade Name:	Arstasisone Latchwire 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 (K102728)
Device Description:	Arstasisone is a device that is comprised of a latchwire, anchormechanism, shaft and handle with control features.
Indications for Use:	The System is intended to provide access for the percutaneousintroduction of devices into the peripheral vasculature and topromote hemostasis at the arteriotomy site as an adjunct to manualcompression. The System is indicated for use in patientsundergoing diagnostic femoral artery catheterization proceduresusing 5F or 6F introducer sheaths.
TechnologicalCharacteristics	Arstasisone Latchwire device is designed to create a shallow accesspath through the arterial wall for the guidewire to enter the vessellumen.
Performance Data	Arstasisone met all performance testing acceptance criteria.
Summary ofSubstantialEquivalence:	Bench testing was performed on the Latchwire Device followingsterilization of test units. Parameters tested include functionalitytesting, deployment forces, corrosion resistance, compression andtorque loading, flexibility and tensile strength.Tensile testing for the 19 gauge Access Needle was performedfollowing gamma radiation.

CONFIDENTIAL

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Special 510(k): Device Modification

Additional prior testing included biocompatibility testing pursuant to ISO-10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (1995), preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical 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 " Latchwire 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/11 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and features an abstract eagle design in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the perimeter of the circle.

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

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

FEB - 2 201

Re: K103143

Trade/Device Name: Arstasis °°° Latchwire Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II (two) Product Code: DYB Dated: January 25, 2011 Received: January 26, 2011

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.

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Page 2 – Ms. Debra Cogan

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/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 yours

Bram D. Zuckerman, M.D.

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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APPENDIX B: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K103143

Trade Name:

Arstasisone Latchwire Access System

Common Name:

Indications For Use:

Arstasis
Latchwire Access Syste

Catheter Introducer

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)
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(Division Sign-Off)

Page of

vision Sign Off) 510(k) Number

(Posted November 13, 2003)

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).