This guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA) in arteries such as the femoral, popliteal, and infrapopliteal arteries. 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.

Device Description

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

The HT Proceed 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 Proceed Guide Wires are designed to be compatible with devices designed for use with 0.014" guide wires. The HT Proceed 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 510(k) submission for a medical device, the HI-TORQUE PROCEED Guide Wire Family. This submission focuses on establishing substantial equivalence to a predicate device, the HT InfilTrac Guide Wire.

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 the subject device (HI-TORQUE PROCEED Guide Wire Family) is "technologically identical" to the predicate device (HT InfilTrac). Therefore, the performance data for the predicate device is leveraged.

Acceptance Criteria Category	Reported Device Performance (Leveraged from Predicate Device)	Supporting Information in Text
Functional Specifications	Met functional acceptance criteria requirements as specified in product specification and external guidance documents.	"Results of these tests demonstrated that the HT InfilTrac Guide Wire Family...met the functional...acceptance criteria requirements..."
Dimensional Specifications	Met dimensional acceptance criteria requirements as specified in product specification and external guidance documents.	"...met the...dimensional...acceptance criteria requirements..."
Simulated Use Testing	Met simulated use testing acceptance criteria requirements as specified in product specification and external guidance documents.	"...met the...simulated use testing acceptance criteria requirements..."
Operating Principle	Identical to predicate device.	"both the subject and predicate devices use identical...operating principle..."
Materials	Identical to predicate device.	"...identical...materials..."
Design	Identical to predicate device.	"...identical...design..."
Sterilization Method	Identical to predicate device.	"...identical sterilization method..."
Shelf Life	Identical to predicate device.	"...identical...shelf life..."
Packaging Components-Materials	Identical to predicate device.	"...identical...packaging components-materials."

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

The document does not explicitly state the sample size for the test set. Instead, it refers to "in vitro bench testing and simulated use testing" performed on the predicate device (HT InfilTrac). The provenance of this data is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be laboratory-based testing conducted by the manufacturer (Abbott Vascular).

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

This information is not provided in the document. As this is a 510(k) submission primarily focused on mechanical and functional equivalence for a guide wire, the "ground truth" is established through engineering and performance testing against predefined specifications, rather than expert medical interpretation of clinical data.

4. Adjudication Method for the Test Set:

An adjudication method (e.g., 2+1, 3+1) is not applicable or mentioned in this context. The "ground truth" for this type of device is determined by the objective results of bench and simulated use testing against a set of engineering and performance specifications.

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 typically used for diagnostic imaging devices or AI algorithms where human interpretation is a key component. The HI-TORQUE PROCEED Guide Wire is a physical medical device, and its performance is evaluated through engineering tests, not human reader performance.

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

Not applicable. This device is a physical guide wire, not a software algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is based on predefined engineering and performance specifications derived from industry standards, internal product requirements, and external guidance documents. The text explicitly states: "demonstrate that HT Proceed meets all acceptance criteria requirements as specified in the product specification and external guidance documents."

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI or software-based device that requires a "training set" in the machine learning sense. The performance data is derived from testing the physical properties and functional capabilities of the device (or its identical predicate).

9. How the Ground Truth for the Training Set was Established:

Not applicable. As a physical medical device, there is no "training set" or corresponding ground truth establishment process in the context of AI or machine learning. The "ground truth" for the device's performance is established through the engineering specifications and acceptance criteria it must meet, which are determined through design, risk analysis, and regulatory requirements.

Summary

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July 30, 2020

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

Abbott Vascular Charlotte Pullman Specialist, Regulatory Affairs 3200 Lakeside Drive Santa Clara, California 95094

Re: K201834

Trade/Device Name: HI-TORQUE PROCEED Guide Wire Family Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: June 30, 2020 Received: July 2, 2020

Dear Charlotte Pullman:

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 (https://www.fda.gov/medical-devices/ device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-andcontinuing-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, PhD. 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) K201834

Device Name HI-TORQUE PROCEED GUIDE WIRE

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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Image /page/3/Picture/0 description: The image shows the logo for Abbott, a healthcare company. The logo is a stylized letter 'A' in a light blue color. The 'A' is formed by thick, rounded lines, giving it a modern and clean look. The logo is simple and recognizable, representing the company's brand identity.

510(K) SUMMARY (K201834)

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	408-845-0652
	4. Fax	408-845-3333
	5. Contact Person	Charlotte Pullman
	6. Date Prepared	June 30, 2020
	7. Device Trade Name	HI-TORQUE PROCEED Guide Wire
	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 InfilTrac (K193126, cleared on December 11, 2019)

11. Device Description

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

The HT Proceed 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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Image /page/4/Picture/0 description: The image contains the logo for Abbott Vascular. The logo consists of a blue square with a white, stylized "A" inside. To the right of the logo is the text "Abbott Vascular" in a simple, sans-serif font.

12. Indication for Use

This guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA) in arteries such as the femoral, popliteal, and infra-popliteal arteries. 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.

13. Technological Characteristics and Substantial Equivalence

The HT Proceed Guide Wire family (subject device) is technologically identical to the predicate device; both the subject and predicate devices use identical functional specifications, operating principle, materials, and design, and have an identical sterilization method, shelf life, and packaging components-materials.

The difference between the HT Proceed Guide Wire and its predicate device is the indication for use; the indication for use of the subject device is a subset of the indication for use of the originally cleared predicate device (HT InfilTrac, K193126, cleared December 11, 2019) and is not expanded outside of the currently cleared indication for the predicate device.

A comparison between the subject device 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 is substantially equivalent to the currently marketed predicate device.

14. Performance Data

The subject device is identical to the predicate device, HT InfilTrac, therefore in vitro bench testing and simulated use testing were leveraged from the predicate device to demonstrate that HT Proceed meets all acceptance criteria requirements as specified in the product specification and external guidance documents.

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Image /page/5/Picture/0 description: The image contains the Abbott Vascular logo. The logo is a blue stylized letter A. To the right of the logo is the text "Abbott Vascular".

Results of these tests demonstrated that the HT InfilTrac Guide Wire Family (and, therefore, the HT Proceed Guide Wire) met the functional, dimensional and simulated use testing acceptance criteria requirements as specified in the product specification and external guidance documents. Based on the results, Abbott Vascular considers that the HT Proceed Guide Wire Family is substantially equivalent to the predicate device- HT InfilTrac Guide Wire.

15. Conclusions

The subject device is technologically identical to the predicate device, HT InfilTrac, and therefore test results from the performance testing conducted on the predicate device (HT InfilTrac, K193126) can be leveraged. The results demonstrated that the HT Proceed Guide Wire Family met all acceptance criteria requirements. Thus, Abbott Vascular considers the subject device - the Hi-Torque Proceed Guide Wire Family - to be substantially equivalent to the currently marketed predicate device - the HT InfilTrac 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.