(150 days)
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.
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.
The provided FDA 510(k) clearance letter pertains to guide wires, which are physical medical devices, not AI/software systems. Therefore, the questions related to AI/software performance (e.g., ground truth establishment, MRMC studies, training/test sets, expert adjudication) are not applicable to this document.
For a physical device like a guide wire, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to non-clinical performance testing to demonstrate that the device performs as intended and is substantially equivalent to a predicate device, ensuring its safety and effectiveness.
Here's an analysis based on the provided document for the guide wires:
Analysis of Acceptance Criteria and Performance for Abbott Medical Guide Wires (K250552)
The substance of this 510(k) clearance is that the subject devices are identical to predicate devices, and the submission is primarily for a labeling change. This means extensive new performance testing demonstrating equivalence to a new set of criteria beyond what was already established for the predicate is not explicitly detailed as part of "new" acceptance criteria in this document. Instead, the testing listed serves to confirm that the labeling changes do not negatively impact the device's safe and effective use, and that the subject device remains substantially equivalent to its predicate.
Given that the device design, materials, and technological characteristics are identical between the subject and predicate devices, the "acceptance criteria" for this specific 510(k) are implicitly tied to confirming that the existing performance characteristics (established for the predicate) are maintained and that the labeling changes introduce no new risks or compromises to performance.
1. Table of Acceptance Criteria and Reported Device Performance
Since this 510(k) is for a device identical to its predicate and addressing labeling changes, the "acceptance criteria" are implied to be meeting established performance standards for guide wires and demonstrating no negative impact from labeling updates. Actual numerical performance data is not typically a part of the publicly available 510(k) summary, but rather part of the internal design verification and validation report submitted to the FDA.
| Acceptance Criteria Category (Implied) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Mechanical/Physical Performance | Substantial equivalence demonstrated through: |
| Friction performance | Testing completed to support labeling changes. |
| Kink resistance | Data support conclusion that labeling updates do not negatively impact safe and effective use. |
| Bending durability | Subject and predicate devices are substantially equivalent. |
| Fracture resistance | |
| Torsional wire strength | |
| Tip tensile strength | |
| Particulate generation | |
| Rotational accuracy | |
| Coating integrity | |
| Simulated use | |
| Safety and Effectiveness | "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." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for each of the non-clinical tests (Friction, Kink resistance, etc.). These details are typically found in the full test reports submitted to the FDA, not in the 510(k) summary.
- Data Provenance: The document does not specify the country of origin of the data. For physical device performance testing, this often occurs in internal labs or contract research organizations. It is inherently prospective for the specific tests performed to support the 510(k) submission, as new data is generated to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable. For physical device testing (mechanical, durability, etc.), "ground truth" is established by direct measurement against engineering specifications and industry standards, not by expert human interpretation like in medical imaging AI.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are relevant for subjective human interpretations of data, such as medical image readings, typically in AI/software performance studies. They are not used for objective physical device performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. MRMC studies are specific to evaluating the diagnostic performance of software or imaging systems, often comparing human readers with and without AI assistance. This is a physical guide wire, so such a study is irrelevant.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. "Standalone performance" refers to the performance of an algorithm or software system without human interaction. This document describes a physical medical device.
7. The Type of Ground Truth Used
For physical device testing, the "ground truth" is based on:
- Engineering Specifications: The design parameters and tolerances the device is intended to meet.
- Industry Standards: Recognized standards for guide wire performance (e.g., ISO, ASTM).
- Predicate Device Performance: The established, acceptable performance of the legally marketed predicate device.
Data from the listed tests (Friction, Kink resistance, etc.) are measured and compared against these objective criteria.
8. The Sample Size for the Training Set
This question is not applicable. "Training set" refers to data used to train AI models. This document describes a physical medical device.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above.
In summary, the provided 510(k) clearance letter is for a physical medical device (guide wires) that is stated to be identical in design, materials, and characteristics to a legally marketed predicate device, with the clearance primarily relating to labeling changes. Therefore, the "acceptance criteria" and "proof" focus on demonstrating that these labeling changes do not adversely affect the device's established safety and performance, and that the device remains substantially equivalent to its predicate through standard non-clinical performance testing. The concepts of AI/software-specific studies, ground truth establishment by experts, and training/test sets are not relevant to this type of device and clearance.
FDA 510(k) Clearance Letter - Abbott Medical Guide Wires
Page 1
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 Page 2
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 Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LYDIA S. GLAW -S
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 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.
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Page 5
510(k) Summary
Per 21 CFR §807.92
| 510(k) Number | K250552 |
|---|---|
| Date Prepared | February 25, 2025 |
| Submitter Name & Address | Abbott Medical3200 Lakeside DriveSanta Clara, CA 95054 |
| Contact Person | Irina IgnatenkoPhone: (774) 613-1131 |
| 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. |
§ 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.