The TAD / TAD II Guide Wire is intended for use in angiographic procedures to introduce and position diagnostic and interventional devices within the peripheral vasculature during percutaneous procedures. The wire can be torqued to facilitate navigation through tortuous vessels.

The TAD / TAD II Guide Wire is not intended for use in coronary or neurovasculature.

Device Description

The TAD/TAD II Tapered Guide Wire is a shaping ribbon designed wire that is 0.018" nominal at the distal end and is 0.035" nominal on the proximal end. The core is tapered from the tip over 40 cm in three successive steps in diameter until it reaches its full diameter for the TAD Guide Wire and is tapered from the tip over 23 cm in two successive steps in diameter until it reaches its full diameter for the TAD II Guide Wire.

The distal portion of the wire incorporates a stainless shaping ribbon inside a platinum nickel wound coil that is attached with solder at the very distal portion. The stainless steel intermediate coil tapers from 0.018" to 0.035" over a distance of 15 cm for the TAD guide wire and 10 cm for the TAD II guide wire. The proximal coil is a 0.035" PTFE coated stainless steel coil. The coils are attached to the core by solder.

Polyethylene (PE) coating covers the proximal end and is attached to the proximal coil with a medical grade glue (Cyanoacrylate Ester) to ensure a smooth transition from coil to coating. Silicon is used to coat the entire length of the polyethylene tubing. Microglide® coating covers from the distal end of the proximal coil to the distal tip. TAD/TAD II Tapered Guide Wires come in lengths of 145 cm, 200 cm, 260 cm, and 300 cm. The wires that are 145 cm, 200 cm, and 300 cm (TAD only) in length are extendible using the Loc Guide Wire Extension. Each TAD/TAD II Tapered Guide Wire comes with a 0.025"- 0.038" Torque Device.

AI/ML Overview

I'm sorry, but the provided text does not contain the information required to describe acceptance criteria and a study proving a device meets them. The document is a 510(k) summary for a guide wire, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing performance studies against specific acceptance criteria.

The document discusses:

The device's trade name and classification.
A summary of substantial equivalence, highlighting that the device is the same as a previously marketed one, implying that a new performance study to establish acceptance criteria is not necessary for this 510(k) submission.
Device description and technological characteristics.
Intended use.
Changes made (which are primarily branding, packaging, and labeling, with no impact on product performance).
The FDA's letter regarding the substantial equivalence determination.

There is no mention of:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for any test sets.
Number or qualifications of experts used for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
Standalone algorithm performance.
Type of ground truth used.
Sample size for a training set.
How ground truth for a training set was established.

This document is a regulatory submission for substantial equivalence based on a comparison to an already cleared device, not a report on a new performance study.

Summary

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510(k) Summary

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

Submitter's Information

Abbott Vascular (351931722) 3200 Lakeside Drive Santa Clara, CA 95054

Phone: 951-914-3311 Fax: 951-914-0339

Contact Person

Nadine Smith, Regulatory Affairs Associate

Date Prepared

February 4, 2009

Device Information

Trade Name: TAD Tapered Guide Wire and TAD II Tapered Guide Wire Common Name: Wire, guide, catheter Device Classification: Class II

Summary of Substantial Equivalence

The Abbott branded TAD / TAD II Guide Wires are the same device as the Mallinckrodt branded TAD / TAD II Guide Wire (which is manufactured by Abbott Vascular for distribution through Conidian/Mallinckrodt Medical, Inc.)

Same intended use, o
Same operating principle, o
Same guide wire design, o
Same manufacturing processes, o
Same materials (excluding packaging and labeling), o
Same shelf life, 0
Same sterilization method. 0

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Device Description

Summary of Changes to Previously Cleared Device

Abbott Branding and labeling changes include:

IFU changed to: Electronic IFU o
o Label change to: 50# Transfer CIS with adhesive backing
Addition of a chipboard box (5 pouched guide wires in a box) o
Addition of Scotch Tape 600 for sealing chipboard box o

Intended Use:

The TAD / TAD II Guide Wire is not intended for use in coronary or neurovasculature.

Summary of Technological Characteristics Compared to Predicate Device:

No changes were made that could impact product performance. Only branding, packaging and labeling are affected by this submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes. The image is in black and white and appears to be a scan or photocopy, as the lines are somewhat jagged and the overall quality is not high resolution.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2009

Abbott Vascular c/o Ms. Nadine Smith Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92591

Re: K083732

Trade/Device Name: TAD Tapered Guide Wire and TAD II Tapered Guide Wire Common Name: Catheter guide wire Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DQX Dated: February 3, 2009 Received: February 5, 2009

Dear Ms. Smith:

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

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Page 2 - Ms. Nadine Smith

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0210. 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,

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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Indications for Use Statement

510(k) Number (if known): K083732

Device Name: TAD Tapered Guide Wire and TAD II Tapered Guide Wire

Indications for Use:

The TAD / TAD II Guide Wire is not intended for use in coronary or neurovasculature.

Prescription Use XX (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sinn-Diff Division of Cardiovascular Devices 510(x) Number_ 11387

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.