Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire

K250552 · ABBOTT MEDICAL · DQX · Jul 25, 2025 · Cardiovascular

Device Facts

• Record ID: K250552
• Device Name: Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
• Applicant: ABBOTT MEDICAL
• Product Code: DQX · Cardiovascular
• Decision Date: Jul 25, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire are indicated to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. The guide wires may also be used with compatible stent devices during therapeutic procedures. The guide wires 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 Story

Guide wires (0.0144" diameter; 210 cm or 300 cm lengths) used to navigate vasculature; facilitate placement of balloon dilatation catheters and stents during PTA procedures. Features shapeable straight or angled distal tips. Used by physicians in clinical settings to reach/cross lesions, provide vessel pathways, and enable device exchange. Operates as a mechanical guide; no electronic or software components. Benefits include improved access to target lesions and streamlined interventional device delivery.

Clinical Evidence

No clinical data; substantial equivalence supported by non-clinical bench testing including friction, kink resistance, bending durability, fracture, torsional strength, tip tensile strength, particulate analysis, rotational accuracy, coating integrity, and simulated use.

Technological Characteristics

Mechanical guide wire; 0.0144" (0.366 mm) diameter; 210 cm or 300 cm lengths; shapeable straight or angled distal tips. Materials and design identical to predicate. No energy source, software, or connectivity.

Indications for Use

Indicated for patients undergoing percutaneous transluminal angioplasty (PTA) in femoral, popliteal, and infra-popliteal arteries to facilitate balloon catheter or stent placement, cross lesions, provide vessel pathways, and assist in device exchange.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (K240997)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 25, 2025

Abbott Medical
Irina Ignatenko
Senior Regulatory Affairs Specialist
3200 Lakeside Drive
Santa Clara, California 95054

Re: K250552
Trade/Device Name: Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
Regulation Number: 21 CFR 870.1330
Regulation Name: Catheter Guide Wire
Regulatory Class: Class II
Product Code: DQX
Dated: February 25, 2025
Received: June 27, 2025

Dear Irina Ignatenko:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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K250552 - Irina Ignatenko
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K250552 - Irina Ignatenko
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

LYDIA S. GLAW - Digitally signed by LYDIA S. GLAW
S
Date: 2025.07.25 16:52:31 -04'00'

Lydia Glaw
Assistant Director
DHT2C: Division of Coronary and Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250552 | |
| Device Name Hi-Torque Command 14 ST Guide Wire, Hi-Torque Command 14 MT Guide Wire | |
| Indications for Use (Describe) The Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire are indicated to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. The guide wires may also be used with compatible stent devices during therapeutic procedures. The guide wires 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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Page 1 of 2
K250552

# 510(k) Summary
# Per 21 CFR §807.92

| 510(k) Number | K250552 |
| --- | --- |
| Date Prepared | February 25, 2025 |
| Submitter Name & Address | Abbott Medical
3200 Lakeside Drive
Santa Clara, CA 95054 |
| Contact Person | Irina Ignatenko
Phone: [phone] |
| Proprietary / Trade Name | Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire |
| Common / Usual Name | Wire, Guide, Catheter |
| Product Classification | Class II |
| Product Code | DQX |
| Product Regulation Number | 21 CFR 870.1330 |
| Predicate Device | K240997: Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire |
| Device Description | The Hi-Torque Command™ 14 ST Guide Wire (guide wire with short taper) and Hi-Torque Command™ 14 MT Guide Wire (guide wire with medium taper) have a maximum diameter of 0.0144" (0.366 mm) and are provided in 210 cm and 300 cm lengths. The distal tip of the guide wire is available as a straight tip or an angled tip, both of which are shapeable. |
| Indications for Use | The Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire are indicated to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. The guide wires may also be used with compatible stent devices during therapeutic procedures.

The guide wires 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. |
| Comparison of Subject to Predicate Device | The intended use and indications for use for the subject device is identical to the predicate device. Device design, materials composition, and technological characteristics are identical between the subject and predicate devices. |

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Page 2 of 2
K250552

| Summary of Non-Clinical Testing | The following verification and validation testing were completed to support the labeling changes in scope of this 510(k) submission. Data support the conclusion that the labeling updates do not negatively impact the safe and effective use of the subject device; and that the subject and predicate devices are substantially equivalent.

• Friction
• Kink resistance
• Bending durability
• Fracture
• Torsional wire strength
• Tip tensile strength
• Particulates
• Rotational accuracy
• Coating integrity
• Simulated use |
| --- | --- |
| Summary of Clinical Testing | Clinical studies were not needed to support substantial equivalence between subject and predicate devices. |
| Statement of Equivalence | The subject and predicate devices have the identical intended use, indications for use, device design, material composition, and technological characteristics. Testing data to evaluate the labeling changes in scope of the 510(k) submission demonstrate that the subject and predicate devices are substantially equivalent in safety and effectiveness. |