The Hi-Torque Steelcore™ Bare Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not in the cerebral vasculature.

Device Description

The HT Steelcore Bare Guide Wire is classified under the product code DOX, with the regulation number 21 CFR 870.1330, Catheter guide wire. The HT Steelcore Bare Guide Wire is a steerable wire offered in only one configuration and is designed to be used with devices compatible with 0.018" guide wires.

The HT Steelcore Bare Guide Wire is developed with 300 cm length and has a maximum diameter of 0.019". The distal tip has a radiopaque length of 5.0 cm. The HT Steelcore Bare Guide Wire will be available with the features as listed below:

Proximal Coating Single Coat Silicone Based hydrophobic coating. ●
Distal Coating Dual Coat Silicone Based Hydrophobic Coating. .

AI/ML Overview

This document describes the premarket notification (510(k)) for the HI-TORQUE Steelcore™ Bare Guide Wire. The information provided outlines the device's characteristics, its intended use, and the testing conducted to demonstrate its substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "performance testing passed with results meeting acceptance criteria." However, it does not provide a specific table detailing the quantitative acceptance criteria for each test and the corresponding quantitative reported device performance. It generally asserts that the device passed all tests and met acceptance criteria, but lacks specific numerical metrics for these criteria or the test results.

The acceptance criteria are implicitly defined by the chosen performance tests and the relevant FDA guidance and standards. The reported "performance" is the qualitative statement that the device "passed" these tests.

Performance Test Category	Acceptance Criteria (Implicit)	Reported Device Performance (Qualitative)
Biocompatibility	Meets specified biocompatibility standards (e.g., cytotoxicity, sensitization, irritation) for patient contact.	Passed
Sterilization	Achieves a Sterility Assurance Level (SAL) of 10⁻⁶ (as indicated for the predicate device, likely applies here through equivalence).	Passed
Pyrogen Validation	Meets pyrogenicity limits.	Passed
Shelf life and Packaging	Maintains integrity, sterility, and performance throughout its asserted shelf life (2 years) and under specified packaging conditions.	Passed
Non-clinical bench testing	Meets functional and physical specifications (e.g., diameter, length, radiopacity, coating performance, various mechanical properties relevant to guide wires). The text mentions adherence to FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling: 2019."	Passed

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

The document does not specify the sample sizes used for the performance testing (biocompatibility, sterilization, pyrogen validation, shelf life/packaging, and non-clinical bench testing).

Regarding data provenance:

Country of origin: Not explicitly stated, but given the submission is to the FDA, it is implied to be relevant to the US regulatory framework.
Retrospective or Prospective: Not applicable in the context of bench testing. These are controlled laboratory tests, not clinical studies involving patient data.

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

This information is not applicable as the "test set" here refers to physical performance characteristics of a medical device (a guide wire), not a dataset for an AI algorithm or a clinical study requiring expert consensus for ground truth. The "ground truth" is established by the specifications, standards, and validated test methods themselves.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or AI algorithm validation where multiple human readers assess data and discrepancies need to be resolved. For bench testing of a physical device, the "adjudication" is inherent in the adherence to validated test protocols and the objective measurement of physical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools or AI systems, often involving human readers' interpretations of medical images. This submission is for a physical medical device (a guide wire) and relies on bench testing and substantial equivalence to a predicate device, not clinical effectiveness in a diagnostic or interpretive context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a "standalone" study in the context of an algorithm or AI was not done. This submission is for a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" or reference standard for evaluation was based on:

Established engineering specifications and design requirements for guide wires.
Relevant FDA guidance documents: Specifically, "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling: 2019."
Pertinent consensus standards (though not explicitly listed, implied by "as recommended by the FDA guidance document as applicable").
Comparison to the predicate device: The device is considered substantially equivalent if its performance demonstrates it is "as safe and as effective" as the predicate.

This is not ground truth derived from expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device where a "training set" would be used to develop an algorithm.

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

Not Applicable. As above, there is no AI/ML training set.

Summary

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April 8, 2020

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Abbott Vascular Shilpa Satishchandra Project Manager, Regulatory Affairs 3200 Lakeside Drive Santa Clara, California 95054

Re: K200144

Trade/Device Name: HI-TORQUE Steelcore Bare Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: February 10, 2020 Received: February 11, 2020

Dear Shilpa Satishchandra:

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. 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 located 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.

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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatory-assistance/contact-usdivision-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.

for 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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Indications for Use

510(k) Number (if known)

K200144

Device Name HI-TORQUE Steelcore™ Bare Guide Wire

Indications for Use (Describe)

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

✓ Prescription Use (Part 21 CFR 801 Subpart D)
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☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 5 510(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(with Business Trade Name as Abbott Medical)
2.	Submitter's Address	3200 Lakeside Dr., Santa Clara, CA 95054
3.	Telephone	408-845-0775
4.	Fax	408-845-3743
5.	Contact Person	Shilpa Satishchandra
6.	Date Prepared	April 03, 2020
7.	Device Trade Name	HI-TORQUE Steelcore™ Bare Guide Wire
8.	Device Common Name	Guide Wire
9.	Device ClassificationName	Catheter Guide Wire (21 CFR 870.1330; Product Code -DQX)
10.	Predicate Device Name	HT Steelcore™ 18 Guide Wire (K982876, cleared onAugust 14, 1998)
11.	Reference Devices	HT Command®18 Guide Wire (K172073 cleared oncleared on August 25, 2017)HT InfilTrac™ Guide Wire Family (K193126, clearedon December 11, 2019)HT Steelcore 18 LT Guidewire (K982876)

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12. Device Description

Proximal Coating Single Coat Silicone Based hydrophobic coating. ●
Distal Coating Dual Coat Silicone Based Hydrophobic Coating. .

13. Indication for Use

Hi-Torque Steelcore Bare Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.

14. Technological Characteristics and Substantial Equivalence

The HT Steelcore Bare Guide Wire has the same Indications for Use and has similar technological characteristic to the predicate device - HT Steelcore 18 Guide Wire. They use the same functional specifications, operating principle, materials and design (with minor modifications). They have the same, shelf life and packaging components-materials and meet the same Sterility Assurance Levels(SAL) of 10°.

Table 14-1 illustrates comparison between the subject device - HT Steelcore Bare Guide Wire and its predicate. This comparison was performed to support a substantial equivalence determination. The substantial equivalence comparison included the device's indications for use, design, technological characteristics, materials, operating principle, sterilization, shelf life and packaging. The conclusion of the comparison analysis is that the subject device - HT Steelcore Bare Guide Wire is substantially equivalent to the currently marketed predicate device - HT Steelcore 18 Guide Wire.

Table 14-1 Comparison between HT Steelcore Bare guidewire and HT Steelcore 18
guidewire

Attribute	Subject DeviceHT Steelcore BareGuide Wire	Predicate DeviceHT Steelcore 18 Guide Wire(K982876)
Device Classification	Class II74DQXCFR § 870.1330	Class II74DQXCFR § 870.1330
Classification Name	Catheter Guide Wire	Catheter Guide Wire

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Attribute	Subject DeviceHT Steelcore BareGuide Wire	Predicate DeviceHT Steelcore 18 Guide Wire(K982876)
Overall Design	Core to Tip 0.018" Wire	Core to Tip 0.018" Wire
Tip Design	Flattened Tip	Flattened Tip
Tip Shape	Straight (shapeable)	Straight (shapeable)
Distal Coating	Silicone Based Hydrophobic Coating	Silicone Based Hydrophobic Coating
Proximal Coating	Silicone Based Hydrophobic Coating	PTFE
Diameter	0.0190" max. (0.48mm)	0.0190" max. (0.48mm)
Length	300cm	130, 190, 300cm
Radiopaque Tip	Yes	Yes
Indications for Use	The HI-TORQUE STEELCORE™ BAREGuide Wire is intended to facilitate theplacement and exchange of diagnostic andtherapeutic devices duringintravascular procedures. It is not intendedfor use in the cerebral vasculature.	All Hi-Torque Guide Wires are intended tofacilitate the placement and exchange ofdiagnostic and therapeutic devices duringintravascular procedures.
Sterilization	E-beam radiation	EtOand E-Beam
Shelf Life	2 years	2 years
Conditions of use	Single-use device for procedure performedin a catheterization laboratory or surgicalsuite	Single-use device for procedure performedin a catheterization laboratory or surgicalsuite
Preparation for Use	Flush hoop dispenser and shape guide wiretip as necessary	Flush hoop dispenser and shape guide wiretip as necessary

15. Performance Data

Performance testing was conducted in accordance with the FDA guidance: Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling: 2019, and pertinent standards as recommended by the FDA guidance document as applicable. Testing conducted included:

. Biocompatibility
Sterilization
Pyrogen Validation .

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. Shelf life and Packaging
. Non-clinical bench testing

The performance testing passed with results meeting acceptance criteria, and demonstrated that the HT SteelCore Bare Guide Wire is as safe and as effective, compared to the predicate device, in performing its intended use.

16. Conclusions

Test results from the performance testing conducted demonstrates that the HT Steelcore Bare Guide Wire met all acceptance criteria requirements. Therefore, Abbott Vascular considers the subject device - HI-TORQUE Steelcore Bare Guide Wire to be as safe and effective as the currently marketed predicate device - HT Steelcore 18 Guide Wire for its intended use.

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.