The Dilator for Artisan™ Control Catheter is intended to introduce the Artisan Control Catheter into the atria and through the intraatrial septum from the right side of the heart to the left side.

Device Description

The Dilator for Artisan Control Catheter is made of a flexible tube with a tapered end on the distal outer diameter. A hemostasis valve and stopcock are attached on the proximal end. The Dilator has a through lumen for introduction over a guide wire.

AI/ML Overview

This 510(k) summary (K082075) describes a substantial equivalence claim for a medical device called the "Dilator for Artisan™ Control Catheter." It is NOT an AI/ML device, and as such, the typical acceptance criteria and study data associated with such devices (e.g., performance metrics, ground truth, expert consensus, MRMC studies) are not applicable or provided in this document.

The submission focuses on demonstrating substantial equivalence to a predicate device (Hansen Medical Transseptal Needle and Dilator, K061070) based on similar intended use and technological characteristics.

Therefore, the requested information elements related to device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, and comparative effectiveness studies cannot be extracted from this document as they are not relevant to a 510(k) submission for a non-AI/ML device demonstrating substantial equivalence.

Here's what can be extracted from the provided text, formatted as closely as possible to your request, but with recognition of its limitations:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or reported device performance metrics are provided in this document for the new device. The basis for acceptance is a claim of "substantial equivalence" to a predicate device based on similar intended use and technological characteristics.

Acceptance Criterion	Reported Device Performance	Comments
Intended Use Equivalence	The Dilator for Artisan Control Catheter has the same general intended use as the predicate device.	The intended use is "to introduce the Artisan Control Catheter into the atria and through the intraatrial septum from the right side of the heart to the left side."
Technological Characteristics Equivalence	The Dilator for Artisan Control Catheter has similar technological characteristics as the predicate device.	The device is described as a "flexible tube with a tapered end on the distal outer diameter. A hemostasis valve and stopcock are attached on the proximal end. The Dilator has a through lumen for introduction over a guide wire." The document states "minor technological differences... raise no new issues of safety or effectiveness."
Indications for Use Equivalence	The indications for use are confined to the role of the dilator without the needle, similar to the predicate's dilator component.	"The indications for use is confined to the role of the dilator without the needle."
Principle of Operation Equivalence	The Dilator has similar principles of operation as its predicate device.	Explicitly stated: "The Dilator has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device."

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

Sample Size for Test Set: Not applicable. This document does not describe a performance study with a test set of data for the new device.
Data Provenance: Not applicable. No data or studies are presented.

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

Not applicable. As no test set or performance study is described, there's no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable. No test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was one done? No. This document does not describe an MRMC study.
Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as this is not an AI-based device and no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was one done? No. This device is a mechanical medical instrument, not an algorithm.

7. Type of Ground Truth Used

Not applicable. No ground truth is established or discussed as no performance study is detailed.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no training set or ground truth in the context of this submission.

Summary

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K082075 p 1/2

SECTION 7

AUG 1 5 2008

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number:

Applicant Information:

Owner Name:	Hansen Medical, Inc.
Address:	800 East Middlefield Rd.Mountain View, CA. 94043
Office:	650-404-5800
Contact Person:	Kate Whitin
Phone Number:	650 404 5800
Facsimile Number:	650 404 5901

Date Prepared: 7/21/08

Device Information:

Classification: Class II Trade Name; Hansen Medical Dilator for Artisan™ Control Catheter Dilator for Artisan Control Catheter Common name: Classification name: Vessel Dilator (21 CFR 870.1310, Product Code DRE)

Predicate Devices:

Hansen Medical Transseptal Needle and Dilator (K061070).

Device Description:

Hansen Medical 510(k) Summary Special 510(k) Submission Section 7, Page 1 of 2

COMPANY CONFIDENTIAL DO NOT COPY

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Intended Use:

The Dilator for Artisan Control Catheter is intended to introduce the Artisan Control Catheter into the atria and through the intraatrial septum from the right side of the heart to the left side.

Comparison to Predicate Device(s):

The Dilator for Artisan Control Catheter has the same general intended use and similar technological characteristics as the predicate device. The indications for use is confined to the role of the dilator without the needle.

Substantial equivalence:

The Dilator has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Dilator and its predicate device raise no new issues of safety or effectiveness. Based upon this pre-market notification, the Dilator is substantially equivalent.

Hansen Medical 510(k) Summary

Special 510(k) Submission

Section 7, Page 2 of 2

COMPANY CONFIDENTIAL DO NOT COPY

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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 caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2008

Hansen Medical, Inc. c/o Ms. Kate Whitin Director, Regulatory Affairs 800 Middlefield Road Mountain View, CA 94043

Re: K082075

Trade/Device Name: Hanson Medical Dilator for Artisan™ Control Catheter Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator Regulatory Class: Class II Product Code: DRE Dated: July 22, 2008 Received: July 23, 2008

Dear Ms. Whitin:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality

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Page 2 -- Ms. Kate Whitin

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Qomall

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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SECTION 6

Indications for Use

510(k) Number (if known):

Device Name: Hansen Medical Dilator for Artisan™ Control Catheter

Indications for Use:

The Dilator for Artisan™ Control Catheter is intended to introduce the Artisan Control Catheter into the atria and through the intraatrial septum from the right side of the heart to the left side.

Prescription Use	x(Part 21 CFR 801 Subpart D)
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AND/OR

Over-The-Counter Use	(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

Hansen MedicalIndication for Use	Special 510(k) Submission510(k) Number K082075Section 6, Page 1 of 1
	COMPANY CONFIDENTIAL DO NOT COPY

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).