Intended to facilitate the delivery of catheter-based interventional devices during Percutaneous transluminal angioplasty (PTA) and Percutaneous transluminal coronary angioplasty (PTCA). This guide wire may also be used with compatible stent devices.

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

Device Description

The HI-TORQUE VersaTurn Guide Wire Family includes steerable guide wires offered in several configurations by various support levels, tip offerings, hydrophilic coating lengths, tip shapes and guide wire lengths.

The HI-TORQUE VersaTurn Guide Wire Family will be available with a range of tip offerings and coating lengths. These features are listed as follows:

4 tip offerings: Extra Floppy (EF),Floppy (F), Soft (S), Complex (C) ●
3 support levels: HT VersaTurn Ultraflex, HT VersaTurn Flex, HT VersaTurn ●
2 coating lengths: Fully Coated (HC), Uncoated Tip (pHC) ●
2 tip shapes: Straight, Pre-shaped J ●
2 lengths: 190 cm, 300cm o

The HI-TORQUE VersaTurn Guide Wire Family has a maximum diameter of 0.0142" or 0.0145" depending on the support level and is compatible with devices designed for use with 0.014" guide wires. The HI-TORQUE VersaTurn Guide Wire Family includes a shaping tool, which is clipped on to the outer packaging coil after the final assembled product has been inserted into the packaging coil. This accessory is to aid the physician in shaping the distal portion of the guide wire, if desired.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically the HI-TORQUE® VersaTurn Guide Wire Family. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device's superior performance against acceptance criteria in a clinical or AI-driven context.

Therefore, much of the requested information regarding AI performance, expert adjudication, ground truth, and multi-reader multi-case studies is not applicable to this document. This is a conventional medical device submission, not an AI software submission.

However, I can extract the relevant information about the acceptance criteria and the study that "proves the device meets the acceptance criteria" in the context of this traditional medical device:

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Testing)	Reported Device Performance
Tip Tensile Strength Met	Met acceptance criteria
Torsional Wire Strength Met	Met acceptance criteria
Torqueability Met	Met acceptance criteria
Integrity (Particulate Testing) Met	Met acceptance criteria
Friction Testing Met	Met acceptance criteria
Overall Performance for Substantial Equivalence	Performed similarly to the predicate devices; no new safety or effectiveness issues.

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

The document indicates "in vitro bench testing" was conducted. It does not specify the exact sample sizes for each test. The data provenance is internal laboratory testing ("in vitro bench testing"). The terms "retrospective" or "prospective" are not applicable to this type of bench testing.

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

This is not applicable. For physical device bench testing, "ground truth" is typically established by engineering specifications, validated test methods, and industry standards, not by human experts adjudicating on data.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are relevant to clinical studies or AI algorithm ground truth establishment, not to physical bench testing.

5. 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

This is not applicable. This is a submission for a physical medical guide wire, not an AI-driven device or software for interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

For the in vitro bench testing, the "ground truth" (or reference standard) would be the established engineering specifications, performance standards, and validated test methods for guide wires.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this physical device's bench testing.

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

This is not applicable for the same reason as above.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other to create a sense of depth and unity.

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

August 7, 2014

Abbott Vascular Vivek Thakkar Regulatory Affairs Specialist 3200 Lakeside Drive Santa Clara, CA 95054

Re: K141782

Trade/Device Name: HI-TOROUE®VersaTurn Guide Wire Family Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: July 3, 2014 Received: July 7, 2014

Dear Mr. Thakkar:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman -S

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

Enclosure

{2}------------------------------------------------

INDICATION FOR USE

510(k) Number (if known): K141782

HI-TORQUE VersaTurn Guide Wire Family Device Names:

The HI-TORQUE VersaTurn Guide Wire Family is intended to Indications for Use: facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

X Prescription Use (Per 21 CFR 801.109)

Over-The-Counter (Optional Format 1-1-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.R. Hilleman

Page __ of __

{3}------------------------------------------------

510(k) Summary

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

1.	Submitter's Name	Abbott Vascular
2.	Submitter's Address	3200 Lakeside Dr. Santa Clara, CA 95054
3.	Telephone	(408) 845-0899
4.	Fax	(408) 845-3743
5.	Contact Person	Vivek Thakkar
6.	Date Prepared	June 30, 2014
7.	Device Trade Name	HI-TORQUE® VersaTurn Guide Wire Family
8.	Device Common Name	Guide Wire
9.	Device Classification Name	Catheter Guide Wire (DQX)
10.	Predicate Device Name	HI-TORQUE BALANCE MIDDLEWEIGHTELITE (K103101, cleared February 10, 2011)

11. Device Description

The HI-TORQUE VersaTurn Guide Wire Family will be available with a range of tip offerings and coating lengths. These features are listed as follows:

4 tip offerings: Extra Floppy (EF),Floppy (F), Soft (S), Complex (C) ●
3 support levels: HT VersaTurn Ultraflex, HT VersaTurn Flex, HT VersaTurn ●
2 coating lengths: Fully Coated (HC), Uncoated Tip (pHC) ●
2 tip shapes: Straight, Pre-shaped J ●
2 lengths: 190 cm, 300cm o

{4}------------------------------------------------

12. Indication for Use

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

13. Technological Characteristics

Comparison of the new device and predicate device(s) demonstrate that the technological characteristics such as product performance, design (with minor modifications) and indications for use are substantially equivalent to the current marketed predicate devices.

14. Performance Data

In vitro bench testing, including tip tensile strength, torsional wire strength, torqueability, integrity (particulate testing), and friction testing were conducted on the modified device. The in vitro bench tests demonstrated that the HI-TOROUE VersaTurn Guide Wire met all acceptance criteria and performed similarly to the predicate devices. It was not necessary to repeat biocompatibility testing as testing performed on the predicate device is applicable to the HI-TORQUE VersaTurn. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE VersaTurn Guide Wire may be considered substantially equivalent to the predicate devices.

15. Conclusions

Test results from the in vitro bench testing conducted on the subject device demonstrate that the HI-TORQUE VersaTurn Guide Wire met all acceptance criteria and performed similarly to the predicate devices and that no new safety or effectiveness issues were raised during the testing program. Therefore, the HI-TORQUE VersaTurn Guide Wire may be considered substantially equivalent to the predicate devices.

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.