This Hi-Torque Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA) in arteries such as the femoral, popliteal, and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.

The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

Device Description

The Abbott Vascular Hi-Torque (HT) Command 18 Guide Wire with hydrophilic coating is a guide wire with a maximum diameter of 0.0180'' and is provided in 210 cm and 300 cm lengths.

The Abbott Vascular HT Command 18 Guide Wire consists of a 304V stainless steel proximal core and a nitinol distal core. The distal core is attached to the stainless steel proximal core using a dissimilar metal solid-state resistance weld. The core wire at the tip is processed to optimize flexibility, steering, and tip shaping. There are four nitinol lengths of the HT Command 18 family, each having multiple tip load options. HT Command 18 has a straight (shapeable) tip.

The distal portion of the wire is coated with a polyurethane jacket and a hydrophilic coating. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE) and a single coat of a silicone-based hydrophobic coating. Brachial and femoral markers are located on the proximal segment of the 210 cm and 300 cm guide wires.

A Torque Device and Guide Wire Introducer are supplied with the wire to facilitate the procedures as physician's aids, if desired.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Hi-Torque Command 18 Guide Wire. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive details about a complete clinical study with detailed acceptance criteria and performance metrics for an AI/algorithm-based device.

Therefore, much of the requested information regarding AI/algorithm performance, such as sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, and standalone performance, is not applicable or available in this document. This document details the engineering and safety performance of a physical medical device.

Here's what can be extracted and inferred from the provided text regarding acceptance criteria and performance, as appropriate for this type of device submission:

Acceptance Criteria and Device Performance for Hi-Torque Command 18 Guide Wire

Acceptance Criteria Category	Reported Device Performance
Functional Bench Testing	Met all acceptance criteria for:
Catheter Compatibility	Successfully completed
Radiopacity	Successfully completed
Tip Tensile Strength	Successfully completed
Torsional Wire Strength	Successfully completed
Dissimilar Metal Weld Strength	Successfully completed
Rotary Bend Strength	Successfully completed
Tip Load	Successfully completed
Rotational Accuracy	Successfully completed
Coating Adherence & Integrity (Particulate Testing)	Successfully completed
Friction Testing	Successfully completed
Biocompatibility Testing	Met all acceptance criteria for:
Cytotoxicity	Successfully completed
Sensitization	Successfully completed
Acute Systemic Toxicity	Successfully completed
Material-Mediated Pyrogen	Successfully completed
Hemolysis	Successfully completed
Coagulation	Successfully completed
Complement Activation	Successfully completed
Substantial Equivalence	Demonstrated substantial equivalence to the predicate device in regards to indications for use, materials, fundamental technology, design, performance, biocompatibility, sterilization, and packaging.

Additional Information based on the Provided Text:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified for individual bench and biocompatibility tests. It would typically be a specific number of guide wire units tested under controlled laboratory conditions, not a "test set" of patient data as implied for AI.
- Data Provenance: The tests are described as "In vitro functional bench testing" and "Biocompatibility testing." This indicates lab-based, controlled testing of the physical device components and assembled product. No patient-derived data (e.g., country of origin, retrospective/prospective) is involved for these types of tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For mechanical and material properties of a guide wire, "ground truth" is established by physical measurements and standardized test methods, not by expert interpretation of medical images or clinical data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this pertains to expert review of clinical data, which is not relevant for this device's performance testing 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 device is a physical guide wire, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the functional bench tests, the "ground truth" is determined by established engineering specifications, mechanical test standards (e.g., ASTM, ISO), and predefined physical or chemical property thresholds.
- For biocompatibility, the "ground truth" is determined by compliance with biological safety standards (e.g., ISO 10993 series) and specific observable biological reactions (or lack thereof) in laboratory models.
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. Not an AI device.

In summary, the provided document details the testing of a physical medical device (a guide wire) for its engineering performance and biocompatibility. The acceptance criteria and performance data reflect these aspects, not those typically associated with the validation of an AI-powered medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and well-being. The logo is simple, clean, and easily recognizable.

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

September 21, 2015

Abbott Vascular Shu Chi Hsu, Ph.D. Project Manager, Regulatory Affairs 3200 Lakeside Drive Santa Clara, CA 95054

Re: K152404

Trade/Device Name: Hi-Torque Command 18 Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: August 24, 2015 Received: August 25, 2015

Dear Dr. Hsu:

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

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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,

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)

Device Name Hi-Torque Command 18 Guide Wire

Indications for Use (Describe)

This Hi-Torque Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, poplited and infra-poplited arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures. The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

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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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) 845-1256
4.	Fax	(408) 845-3743
5.	Contact Person	Shu Chi Hsu
6.	Date Prepared	August 24, 2015
7.	Device Trade Name	Hi-Torque Command 18 Guide Wire
8.	Device Common Name	Guide Wire
9.	Device Classification Name	Catheter Guide Wire (DQX)
10.	Predicate Device Name	Hi-Torque Command Guide Wire Family(K122573, cleared on November 20, 2012)

11. Device Description

The Abbott Vascular Hi-Torque (HT) Command 18 Guide Wire with hydrophilic coating is a guide wire with a maximum diameter of 0.0180'' and is provided in 210 cm and 300 cm lengths.

A Torque Device and Guide Wire Introducer are supplied with the wire to facilitate the procedures as physician's aids, if desired.

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12. Indications for Use

13. Technological Characteristics

Comparison of the new device and predicate device 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 device.

14. Performance Data

Performance testing was successfully completed on the Hi-Torque Command 18 Guide Wire. In vitro functional bench testing conducted on the subject device included:

Catheter compatibility, ●
Radiopacity. ●
Tip tensile strength, ●
Torsional wire strength,
. Dissimilar metal weld strength,
. Rotary bend strength,
Tip load, ●
Rotational accuracy, ●
Coating adherence and integrity (particulate testing), and ●
Friction testing ●

Biocompatibility testing included cytotoxicity, sensitization, acute systemic toxicity. material-mediated pyrogen. hemolysis. coagulation and complement activation.

15. Conclusions

Test results from the non-clinical in vitro bench testing conducted on the Hi-Torque Command 18 Guide Wire family met all acceptance criteria and show that it performed similarly to the predicate devices. There were no new safety or effectiveness issues raised during the testing program.

The Hi-Torque Command 18 Guide Wire is substantially equivalent to the predicate device in regards to the indications for use, materials, fundamental technology, design, performance, biocompatibility, sterilization, and packaging.

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.