Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lession, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This guide wire may also be used to crossing de novo chronic total coronary occlusions (CTO).

Device Description

The HI-TORQUE (HT) InfilTrac Guide Wire Family includes steerable guide wires offered in several tip load and guide wire length configurations.

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

2 tip loads: 11g and 14g
. 1 coating length: Uncoated Tip
1 tip shape: Pre-shaped, micro-J
2 lengths: 190 cm, 300cm

The HT InfilTrac Guide Wires are designed to be compatible with devices designed for use with 0.014" guide wires. The HT InfilTrac Guide Wire Family has a maximum diameter of 0.0144". The distal tip has a radiopaque length of 3.0 cm.

AI/ML Overview

The provided text describes a medical device submission (K193126) for the "HI-TORQUE InfilTrac Guide Wire Family." This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study to prove the device meets acceptance criteria in the context of AI/ML performance.

Therefore, many of the requested items related to AI/ML studies (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect size, standalone performance, and ground truth establishment for training) are not applicable to this document.

However, I can extract the acceptance criteria and performance data as related to the bench and simulated use testing mentioned.

Here's the information that can be extracted:

A table of acceptance criteria and the reported device performance
The document states: "Results of these tests demonstrated that the HT InfilTrac Guide Wire Family met the functional, dimensional and simulated use testing acceptance criteria requirements as specified in the product specification and external guidance documents. All the outputs tested for HT InfilTrac Guide Wire Family met specification or requirements."

This is a general statement. Specific acceptance criteria and quantitative performance results are not detailed in this publicly available 510(k) summary. The summary confirms that the device met all unspecified acceptance criteria.

Acceptance Criteria Type Reported Device Performance
Functional requirements Met specifications
Dimensional requirements Met specifications
Simulated use testing Met specifications
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as this is for a guide wire and involves in-vitro bench and simulated use testing, not clinical data sets for AI/ML.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable (no AI/ML study).
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable (no AI/ML study).
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 (no AI/ML study).
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable (no AI/ML study).
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical device testing, the "ground truth" or "specifications" were established by the "product specification and external guidance documents." These would likely include engineering design specifications and relevant international standards for medical devices.
The sample size for the training set
Not applicable (no AI/ML study).
How the ground truth for the training set was established
Not applicable (no AI/ML study).

Acceptance Criteria Type	Reported Device Performance
Functional requirements	Met specifications
Dimensional requirements	Met specifications
Simulated use testing	Met specifications

In summary: The provided document is a 510(k) submission for a physical medical device (guide wire). It states that the device successfully met "functional, dimensional and simulated use testing acceptance criteria requirements as specified in the product specification and external guidance documents." However, it does not provide the detailed acceptance criteria or the specific performance results, nor does it involve the type of AI/ML studies typically associated with the other questions.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 11, 2019

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

Re: K193126

Trade/Device Name: HI-TORQUE InfilTrac Guide Wire Family Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 8, 2019 Received: November 12, 2019

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. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,

Lydia Glaw, Ph.D. Assistant Director DHT2C: Division of Coronary and Peripheral Interventional 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) K193126

Device Name HI-TORQUE InfilTrac Guide Wire Family

Indications for Use (Describe)

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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SECTION 2 510(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	408-845-8314
	4. Fax	408-845-3743
	5. Contact Person	Aniket Khakhadiya
	6. Date Prepared	December 10, 2019
	7. Device Trade Name	HI-TORQUE InfilTrac™ 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	HT Progress Guide Wire (K123067, cleared on January29, 2013)
	11. Reference Devices	HT TurnTrac Guide Wire Family (K173795, cleared onJanuary 12, 2018)HT Cross-IT XT Guide Wire (K990639, cleared onMarch 25, 1999)

12. Device Description

The HI-TORQUE (HT) InfilTrac Guide Wire Family includes steerable guide wires offered in several tip load and guide wire length configurations.

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

2 tip loads: 11g and 14g
. 1 coating length: Uncoated Tip
1 tip shape: Pre-shaped, micro-J
2 lengths: 190 cm, 300cm

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13. Indication for Use

Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may 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. This guide wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO).

14. Technological Characteristics and Substantial Equivalence

The HT InfilTrac Guide Wire Family has the same Indications for Use and is also technologically equivalent to the predicate device - HT Progress Guide Wire. They use similar functional specifications, operating principle, materials and design (with minor modifications). They have the same sterilization method, shelf life and packaging components-materials.

A comparison between the subject device - HT InfilTrac Guide Wire Family and its predicate 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 InfilTrac Guide Wire Family is substantially equivalent to the currently marketed predicate device - HT Progress Guide Wire.

15. Performance Data

The HT InfilTrac Guide Wire Family was subjected to performance testing which included in-vitro bench and simulated use testing. Results of these tests demonstrated that the HT InfilTrac Guide Wire Family met the functional, dimensional and simulated use testing acceptance criteria requirements as specified in the product specification and external guidance documents. All the outputs tested for HT InfilTrac Guide Wire Family met specification or requirements. Based on the results, Abbott Vascular considers that the HT InfilTrac Guide Wire Family is substantially equivalent to the predicate device- HT Progress Guide Wire.

16. Conclusions

Test results from the performance testing conducted demonstrates that the HT InfilTrac Guide Wire Family met all acceptance criteria requirements. Therefore, Abbott Vascular considers the subject device - HI-TORQUE InfilTrac Guide Wire Family to be substantially equivalent to the currently marketed predicate device - HT Progress Guide Wire.

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.