The Hi-Torque Versacore 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 Hi-Torque Versacore Guide Wire is not intended for use in coronary or neurovasculature.

Device Description

The Hi-Torque Versacore Guide Wire is a core-to-tip designed wire which consists of a stainless steel core, Polytetrafluoroethylene (PTFE) coated stainless steel coils on the distal 100 cm of the core, and a polyethylene coating on the remainder of the core. The core is tapered from the tip over 35cm in three successive steps in diameter until it reaches its full diameter for the Modified J Guide Wire and in two successive steps for the Floppy and the Standard Guide Wires. The coil covers the grinds and is brazed to the core at the tip and 7.5 cm (nominal) from the tip. The distal tip is radiopaque with a nominal diameter of 0.035" or 0.025". The distal tip is also shapeable or has a preshaped "J". Polyethylene coating covers the proximal end and is attached to the coil with 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. The Hi-Torque Versacore Guide Wire comes in lengths of 145 cm, 175 cm, 260 cm and 300 cm. The 0.035" diameter wires that are 145 cm and 175 cm in length are extendable using the Loc® Guide Wire Extension. Each Hi-Torque Versacore Guide Wire is packaged with a 0.025"-0.038" Torque Device.

AI/ML Overview

This document is a 510(k) summary for the Hi-Torque Versacore Guide Wire. It is a submission for substantial equivalence to a predicate device, not a study proving a device meets acceptance criteria for novel performance. Therefore, most of the requested information regarding acceptance criteria and a study demonstrating performance is not applicable or not present in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

Because this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are primarily based on demonstrating equivalence to the predicate device, not on specific performance metrics against a defined threshold. The "reported device performance" is implicitly that it performs as well as the predicate because it is virtually the same device.

Acceptance Criteria Category	Description (Based on 510(k) Summary)	Reported Device Performance (Implied)
Intended Use	Same as predicate device	The device has the same intended use.
Operating Principle	Same as predicate device	The device has the same operating principle.
Guide Wire Design	Same as predicate device	The device has the same guide wire design.
Manufacturing Processes	Same as predicate device	The device uses the same manufacturing processes.
Materials	Same as predicate device	The device uses the same materials (excluding packaging/labeling).
Shelf Life	Same as predicate device	The device has the same shelf life.
Sterilization Method	Same as predicate device	The device uses the same sterilization method.
Branding/Labeling	Branding and labeling changes only (IFU, label, chipboard box, Scotch Tape)	Changes made are cosmetic and do not impact product performance.

Study Information (Not Applicable or Not Provided)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This document is a 510(k) for substantial equivalence, not a clinical or performance study demonstrating the primary performance of the device against acceptance criteria. The basis for equivalence relies on comparing the new device to an existing, legally marketed predicate device. No new "test set" in the context of a performance study is described.
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):
- Not Applicable. No ground truth establishment for a test set is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method is described.
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:
- Not Applicable. This is not an AI-assisted device. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No ground truth for a performance study is described. The "ground truth" in this context is the performance and safety established for the predicate device.
The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not Applicable. No training set is involved.

Conclusion:

The provided 510(k) summary focuses on demonstrating that the Hi-Torque Versacore Guide Wire is "substantially equivalent" to an existing predicate device (Mallinckrodt branded Wholey Hi-Torque Guide Wire). The basis for this claim is the device's identical intended use, operating principle, design, manufacturing processes, materials, shelf life, and sterilization method. Essentially, it is stated to be the same device with only branding, packaging, and labeling changes. Therefore, a separate study to prove the device meets acceptance criteria distinct from the predicate device's established performance is not presented or required for this type of submission.

Summary

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083706

FEB - 6 2009

510(k) Summary

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

January 20, 2009

Device Information

Trade Name: Hi-Torque Versacore Guide Wire Common Name: Wire, guide, catheter Device Classification: Class II

Summary of Substantial Equivalence

The subject device. Abbott branded Hi-Torque Versacore Guide Wire is the same device as the predicate device, Mallinckrodt branded Wholey Hi-Torque Guide Wire (which is manufactured by Abbott Vascular for distribution through Conidian/Mallinckrodt Medical, Inc.)

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

Device Description

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The core is tapered from the tip over 35cm in three successive steps in diameter until it reaches its full diameter for the Modified J Guide Wire and in two successive steps for the Floppy and the Standard Guide Wires.

The coil covers the grinds and is brazed to the core at the tip and 7.5 cm (nominal) from the tip. The distal tip is radiopaque with a nominal diameter of 0.035" or 0.025". The distal tip is also shapeable or has a preshaped "J".

Polyethylene coating covers the proximal end and is attached to the coil with 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.

The Hi-Torque Versacore Guide Wire comes in lengths of 145 cm, 175 cm, 260 cm and 300 cm. The 0.035" diameter wires that are 145 cm and 175 cm in length are extendable using the Loc® Guide Wire Extension. Each Hi-Torque Versacore Guide Wire is packaged with a 0.025"-0.038" Torque Device.

The Hi-Torque Versacore Guide Wire is placed in a pouch with a peel away adhesive label placed on the film side of the pouch. They are packaged with 5 pouched guide wires per chipboard box and 9 chipboard boxes per corrugated box.

Summary of Changes to Previously Cleared Device

Abbott Branding and labeling changes include:

IFU changed to: 40# Opaque Offset Insheet Style o
o Label change to: Electronic IFU
Addition of a chipboard box (5 pouched guide wires in a box) o
O Addition of Scotch Tape 600 for sealing chipboard box

Intended Use:

The Hi-Torque Versacore 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 and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure, with three curved lines emanating from its body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Abbott Vascular c/o Ms. Nadine Smith Regulatory Affairs Associate 3200 Lakeside Drive Santa Clara, CA 95054

FEB - 6 2009

Re: K083706

Trade/Device Name: High-Torque Versacore Guide Wire Common Name: Catheter guide wire Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DQX Dated: January 23, 2009 Received: January 26, 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

r í

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Page 2 - Ms. Nadine Smith

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. 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 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 vours.

Dana R. Wulmer

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): K083706

Device Name: Hi-Torque Versacore Guide Wire

Indications for Use:

The Hi-Torque Versacore 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)

una D. Vc. Anes

.on Sign-Off) ംon Sign-Off)
sion of Cardiovascular Devices

K083206 10(k) Number_

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.