The HI-TORQUE TurnTrac Guide Wire Family is 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 during therapeutic procedures.

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

Device Description

The HI-TORQUE (HT) TurnTrac Guide Wire Family includes steerable guide wires offered in several configurations by various support levels, tip loads, hydrophilic coating lengths, tip shape and guide wire lengths.

The HT TurnTrac Guide Wire Family will be available with the features as listed below:

2 tip loads: 0.6g and 0.9g ●
2 support levels: HT TurnTrac Moderate Support (MS) and HT TurnTrac Extra . Support (ES)
2 coating lengths: Fully Coated (HC), Uncoated Tip (pHC) ●
1 tip shape: Straight ●
2 lengths: 190 cm, 300cm ●

The HI-TORQUE TurnTrac 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 TurnTrac 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) submission for a medical device, the HI-TORQUE® TurnTrac Guide Wire Family. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive clinical trials.

Therefore, the information you're asking for, which is typical for demonstrating safety and efficacy of new and complex medical devices, especially AI/ML-driven ones, is largely not present or not applicable in this 510(k) summary. This submission primarily relies on bench testing to show the device performs similarly to its predicate.

Here's an breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The text states: "The results from the in vitro bench tests demonstrated that the HI-TORQUE TurnTrac Guide Wire met all acceptance criteria and performed similarly to the predicate device."
However, the specific acceptance criteria values (e.g., minimum tensile strength in Newtons) and the actual reported performance values are not explicitly listed in a table within this document. The document only confirms that the criteria were met.

We can infer the categories of tests conducted:

Acceptance Criteria Category	Reported Device Performance (as stated)
Tip Tensile Strength	Met all acceptance criteria
Torsional Wire Strength	Met all acceptance criteria
Torqueability	Met all acceptance criteria
Integrity (Particulate Testing)	Met all acceptance criteria
Friction Testing	Met all acceptance criteria
Biocompatibility	Considered substantially equivalent to the predicate device

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document only mentions "in vitro bench testing" was conducted on the "modified device." It doesn't provide the number of units tested.
Data Provenance: Not applicable in the context of patient data (e.g., country of origin, retrospective/prospective). These are entirely bench tests conducted in a lab setting, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For a guide wire, "ground truth" for bench testing is established by engineering specifications and quantitative measurements (e.g., force transducers, microscopes, specialized test equipment), not by human expert opinion like radiologists for image interpretation.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or annotators, typically in clinical studies or image interpretation tasks. This is a bench test, and results are quantitative.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. An MRMC study is relevant for AI-assisted human performance in tasks like interpreting medical images. This 510(k) is for a physical medical device (a guide wire), and the testing described is purely in vitro bench testing.

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

Not applicable. This is not an AI/ML algorithm. It is a physical medical device.

7. The type of ground truth used

For the bench tests, the "ground truth" would be the engineering specifications and validated measurement techniques (e.g., calibration standards for tensile strength, precise measurements of torque, particulate counts verified against specific thresholds). It's not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. There is no AI/ML model for which a "training set" would be required.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

In summary:

This 510(k) submission, typical for Class II devices like guide wires, focuses on demonstrating substantial equivalence through in vitro bench testing rather than extensive clinical studies or AI/ML model performance validation. The criteria and studies requested in your prompt are largely geared towards software as a medical device (SaMD) or other complex clinical applications, which do not apply to this specific device submission.

Summary

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January 12, 2018

Abbott Vascular Aniket Khakhadiya Regulatory Affairs Specialist 3200 Lakeside Drive Santa Clara, California 95054

Re: K173795

Trade/Device Name: HI-TOROUE TurnTrac Guide Wire Family Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: December 12, 2017 Received: December 14, 2017

Dear Aniket Khakhadiya:

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 of medical device-related adverse events) (21 CFR 803); 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.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

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

510(k) Number (if known) K173795

Device Name HI-TORQUE® TurnTrac Guide Wire Family

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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K173795 - 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	408-845-8314
4.	Fax	408-845-3689
5.	Contact Person	Aniket Khakhadiya
6.	Date Prepared	December 7, 2017
7.	Device Trade Name	HI-TORQUE® TurnTrac Guide Wire Family
8.	Device Common Name	Guide Wire
9.	Device Classification Name	Catheter Guide Wire (21 CFR 870.1330; Product Code DQX)
10.	Predicate Device Name	HI-TORQUE VersaTurn Guide Wire Family (K141782 cleared on August 7, 2014)

11. Device Description

The HT TurnTrac Guide Wire Family will be available with the features as listed below:

2 tip loads: 0.6g and 0.9g ●
2 support levels: HT TurnTrac Moderate Support (MS) and HT TurnTrac Extra . Support (ES)
2 coating lengths: Fully Coated (HC), Uncoated Tip (pHC) ●
1 tip shape: Straight ●
2 lengths: 190 cm, 300cm ●

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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.

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 subject device and predicate device demonstrates that the technological characteristics such as product performance, functional specification, operating principle, design and materials (with minor modifications), and indications for use are substantially equivalent to the currently marketed predicate device.

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 results from the in vitro bench tests demonstrated that the HI-TORQUE TurnTrac Guide Wire met all acceptance criteria and performed similarly to the predicate device. The results obtained from the biocompatibility testing indicate that the HI-TORQUE TurnTrac Guide Wire Family may be considered substantially equivalent to the predicate device.

15. Conclusions

Test results from the in vitro bench testing conducted on the subject device demonstrate that the HI-TORQUE TurnTrac Guide Wire met all acceptance criteria and performed similarly to the predicate device. Therefore, the HI-TORQUE TurnTrac Guide Wire Family may be considered substantially equivalent to the predicate device.

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.