STARCLOSE HEX-HUB DILATOR by ABBOTT VASCULAR INC.

The Abbott Vascular StarClose 6F Dilator is a tapered plastic tube with a hub to facilitate handling and an interior channel sized to accept a 0.038 inch guidewire. The dilator goes inside one of the StarClose sheaths to provide support while gaining access to blood vessels prior to catheterization procedures.

AI/ML Overview

This is a premarket notification (510(k)) for a medical device (dilator) and does not include information about artificial intelligence (AI) or machine learning (ML). Therefore, many of the requested categories related to AI/ML studies are not applicable.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes a 510(k) submission for a traditional medical device (StarClose 6F Dilator), not an AI/ML device. Therefore, there are no specific "acceptance criteria" in terms of performance metrics like accuracy, sensitivity, or specificity that would be reported for an AI model.

Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device. The performance is assessed through non-clinical testing to ensure:

Biocompatibility: No new adverse effects introduced.
Physical Properties: Appropriate for the intended use.

The document does not provide specific numerical results or acceptance criteria for these non-clinical tests within the summary. It broadly states that "Results of scientific testing have ensured that all materials are biocompatible no new adverse effects were introduced and physical properties are appropriate for the intended use."

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

This section is not applicable as the device is not an AI/ML system requiring a test set for performance evaluation. The testing conducted appears to be non-clinical (e.g., laboratory or engineering tests).

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

This is not applicable as there is no mention of a test set with ground truth established by experts.

4. Adjudication Method for the Test Set:

This is not applicable.

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

This is not applicable. There is no mention of human readers or AI assistance in this submission.

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

This is not applicable as the device is a physical medical instrument, not an algorithm.

7. Type of Ground Truth Used:

This is not applicable as the device is a physical medical instrument. The "truth" for this type of device is typically its physical specifications meeting design requirements and safety/biocompatibility standards, not a diagnostic outcome.

8. Sample Size for the Training Set:

This is not applicable as the device is not an AI/ML system.

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

This is not applicable as the device is not an AI/ML system.

Summary of the Study for Substantial Equivalence:

The study referenced is a premarket notification (510(k)) submission demonstrating substantial equivalence for the StarClose 6F Dilator to predicate devices (Encapsulon Vessel Dilators (K840641) and Super Sheath Introducer Sheath (K052557)).

Objective: To show that the StarClose 6F Dilator has the same intended use, is biocompatible, and has appropriate physical properties for its intended use, thus being as safe and effective as legally marketed predicate devices.
Methodology: The submission states that "Abbott Vascular has submitted information on indications for use, design and principle of operation, biocompatibility and performance characteristics." It further indicates that "Non-clinical testing was conducted." While details are not provided in the summary, this non-clinical testing would typically involve:
- Biocompatibility testing: To ensure the materials used do not cause adverse biological reactions (e.g., ISO 10993 series of standards).
- Physical and mechanical testing: To verify the dilator's strength, flexibility, dimensions, and other physical properties meet design specifications and are suitable for percutaneous introduction of intravascular devices.
Conclusion: The submission concluded that the StarClose 6F Dilator "has been shown to be substantially equivalent to the Class II predicate devices upon which the dilator is based." The FDA concurred with this determination.

In essence, the "study" for this device is the collection of non-clinical, engineering, and biocompatibility tests required to demonstrate substantial equivalence under the 510(k) pathway for a traditional medical device.

Summary

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K062 554

APPENDIX A. 510(k) SUMMARY

…

A. Sponsor/Submitter:	Abbott Vascular Devices400 Saginaw DriveRedwood City, CA 94063	FEB 6 200
B. Contact Person:	Daun PutnamRegulatory Project ManagerPhone:(650) 474-3323Fax:(650) 474-3041
Date of Submission:	August 25, 2006
Device Trade Name:	StarClose 6F Dilator
Device Common Name:	Vessel Dilator
Device Classification:	Class II
Regulation Number:	21 CFR 874.1310
Classification Name:	Vessel, Dilator, for Percutaneous Catheterization
Product Code:	DRE
Predicate Device:	Encapsulon Vessel Dilators (K840641) and Super Sheath Introducer Sheath (K052557)
Intended Use:	The StarClose 6F Dilator is intended for use in procedures requiring percutaneous introduction of intravascular devices.
Device Description:	The Abbott Vascular StarClose 6F Dilator is a tapered plastic tube with a hub to facilitate handling and an interior channel sized to accept a 0.038 inch guidewire. The dilator goes inside one of the StarClose sheaths to provide support while gaining access to blood vessels prior to catheterization procedures.
Summary of SubstantialEquivalence:	Abbott Vascular has submitted information on indications for use, design and principle of operation, biocompatibility and performance characteristics to establish that StarClose 6F Dilator is substantially equivalent to currently marketed predicate devices.StarClose 6F Dilator has the same intended use as the predicate devices. Results of scientific testing have ensured that all materials are biocompatible no new adverse effects were introduced and

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physical properties are appropriate for the intended use. Non-clinical testing was conducted.

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In conclusion, StarClose 6F Dilator has been shown to be substantially equivalent to the Class II predicate devices upon which the dilator is based.

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. . .

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 6 2007

Abbott Vascular Inc. c/o Veronica Kocken 400 Saginaw Drive Redwood City, CA 94063

Re: K062554

Trade Name: Vessel Dilator Regulation Number: 21 CFR 874.1310 Regulation Name: Vessel, Catheter, for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: December 19, 2006 Received: December 20, 2006

Dear Ms. Kocken:

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

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Page 2 - Mr. Wagner

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 systems (OS) 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

R. lochner

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): K__________________________________________________________________________________________________________________________________________________ 062554

Device Name:

The StarClose 6F Dilator

Indications For Use: The StarClose 6F Dilator is intended for use in procedures requiring percutaneous introduction of intravascular devices.

× Prescription Use

OR (Per 21 CFR 801.109) (Optional Format 1-2-96) Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

uma R. W. Wainer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K062554

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).