ARSTASIS DILATOR ADAPTER by ARSTASIS, INC.

The Adapter is intended to allow the use of a .018" guidewire with a 0.035" or 0.038" guidewire compatible dilator up to 23 cm in overall length and to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Device Description

The Adapter is a sterile, single use device that is hollow and has a tapered increase in outer diameter on one end. This shape allows the Adapter to fill the excess space between .018" guidewires and dilators with larger inner diameters.

The Dilator Adapter is a polyethylene bump extrusion that fits into a .035"-.038" compatible vessel dilator with an internal diameter-sized-- to an .018" guidewire.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Arstasis Dilator Adapter based on the provided text, formatted to address your specific questions.

Important Note: The provided text is a 510(k) summary document for a medical device. These types of documents are generally focused on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data with detailed statistical analyses often associated with AI/software performance studies. As such, information regarding AI-specific criteria (like MRMC studies, training set details, or complex ground truth establishment) is not present. The document focuses on performance testing of the physical properties and usability of the dilator adapter.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance	Comments
Material & Physical Properties	Tensile strength	Met ISO11070-1998 specifications for dilators.	-
Dimensional Specifications	(Specific dimensions not detailed)	Met specifications.	-
Design Verification & Validation	(Specific tests not detailed)	Met specifications.	-
Usability	Insertion forces	Acceptable.	Assessed on a simulated clinical bench model.
Usability	Overall usability	Acceptable.	Assessed on a simulated clinical bench model.

Study Details

A table of acceptance criteria and the reported device performance:
See table above.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated in the provided text for individual tests. The document refers to "the Dilator Adapter" and its "performance testing," implying sufficient samples were used for the various physical and bench tests.
- Data Provenance: Not specified. The testing was likely conducted in a controlled lab environment. The document is for a US FDA submission, so the tests were likely performed or overseen in the USA.
- Retrospective/Prospective: Not applicable in the traditional sense for this type of device. The testing described is a prospective evaluation of the manufactured device's physical properties and function on a bench model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This device is a physical medical tool, not an AI or diagnostic software. Therefore, the concept of "ground truth" established by human experts for diagnostic purposes (e.g., radiologists interpreting images) is not applicable.
- The "ground truth" here is determined by engineering specifications, material standards (ISO11070-1998), and direct physical measurement/testing. For usability, it would involve qualified personnel performing the simulated procedures. The number and qualifications of individuals performing these tests are not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 refer to expert consensus processes for diagnostic interpretations, which is not relevant for this physical device testing. The results of the physical and mechanical tests are objective measurements against defined standards.
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:
- A MRMC study was not done. This is a physical dilator adapter, not an AI or imaging diagnostic device where human reader performance would be a primary metric.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not an algorithm or AI device. "Standalone" performance as an algorithm is not applicable. The device itself is a standalone physical component designed to facilitate a medical procedure.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance testing is based on:
  - Objective Engineering Standards: Adherence to "ISO11070-1998 specifications for dilators" for tensile testing.
  - Defined Dimensional Specifications: Meeting pre-defined measurements.
  - Functional Performance Criteria: Acceptable insertion forces and overall usability as determined by bench model testing against performance expectations.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of machine learning for this physical medical device. The device's design is based on engineering principles and material science, not learned from data.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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Arstasis

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	SECTION 4: 510(K) SUMMARY	MAY 24 2011
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:	November 19, 2010
Device Trade Name:	Arstasis Dilator Adapter
Common Name:	Dilator Adapter
Device Classification:	Class II
Regulation Number:	21 CFR 870.1310
Classification Name:	dilator, vessel, for percutaneous catheterization
Product Code:	DRE
Predicate Device:	Prelude Sheath Introducer (K070159)
Device Description:	The Adapter is a sterile, single use device that is hollow and has atapered increase in outer diameter on one end. This shape allows theAdapter to fill the excess space between .018" guidewires anddilators with larger inner diameters.
Indications for Use:	The Adapter is intended to allow the use of a .018" guidewire with a.035" or .038" guidewire compatible dilator up to 23cm in overalllength.
TechnologicalCharacteristics	The Dilator Adapter is a polyethylene bump extrusion that fits into a.035"-.038" compatible vessel dilator with an internal diameter-sized--to an .018" guidewire.
Performance Data	The Dilator Adapter was subjected to tensile testing to demonstratethat it met ISO11070-1998 specifications for dilators. The Adapteralso underwent testing for dimensional specifications, designverification and validation including insertion forces and useability asassessed on a simulated clinical bench model.
Summary ofSubstantialEquivalence:	The Arstasis Dilator Adapter is substantially equivalent to thepredicate device as confirmed through performance testing.

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SECTION 3: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	K103421
Trade Name:	Arstasis Dilator Adapter
Common Name:	dilator, vessel, for percutaneous catheterization
Indications For Use:	The Adapter is intended to allow the use of a .018" guidewire with a.035" or .038" guidewire compatible dilator up to 23cm in overall length.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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 of __ of _

(Posted November 13, 2003)

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(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_ 165992

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads, representing health, human services, and the department's commitment to serving the nation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The seal is in black and white.

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

JUN 2882011

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

Re: K103421

Trade Name: Arstasis Dilator Adapter Regulation Number: 21 CFR 870.1310 Regulation Name: Dilator, Vessel, for Percutaneous Catheterization Regulatory Class: II (two) Product Code: DRE Dated: May 12, 2011 Received: May 13, 2011

Dear Ms. Cogan:

This letter corrects our substantially equivalent letter of May 24, 2011.

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.

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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 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,

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

Enclosure Indications for Use Statement

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Arstasis Dilator Adaptor K103421/A001 Attachment A

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Trade Name: Arstasis Dilator Adapter

dilator, vessel, for percutaneous catheterization Common Name:

"The Adapter is intended to allow the use of a .018" guidewire with a Indications For Use: 0.035" or .038" guidewire compatible dilator up to 23 cm in overall length and to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures."

Prescription Use (Part 21 CFR 801 Subpart D)	X
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 ___
(Posted November 13, 2003)

Division Sign-Off

Division of Cardiovascular Devices

510(k) Number	K103421
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Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).