This Hi-Torque guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

Device Description

The Hi-Torque Winn Guide Wire Family is a family of guide wires, designed to provide improved torque response and crossing while maintaining tactile feedback in stenotic vessels. The subject wire is a core to tip design, where the core material runs through the entire length of the wire. This family of guide wires have a maximum diameter of 0.0140" with a stainless steel core and are provided in 190 cm extendable and 300 cm exchange lengths. The distal core segment of the Winn is offered in 5 configurations: Winn 40. Winn 80. Winn 120, Winn 140T and Winn 200T. Each configuration is identical in design except for those design features that impact tip stiffness.

AI/ML Overview

This document describes a 510(k) summary for the Hi-Torque Winn Guide Wire Family. The submission leverages performance data from a predicate device, the HI-TORQUE PROGRESS Guide Wire Family, arguing substantial equivalence due to identical materials, design, and manufacturing processes. Therefore, no new performance testing was conducted specifically for the Hi-Torque Winn Guide Wire Family.

Here's an analysis based on the provided text, addressing your questions:

1. Table of acceptance criteria and the reported device performance

Since new performance testing was not conducted for the Hi-Torque Winn Guide Wire Family, the acceptance criteria and reported performance are implicitly those established for the predicate device, the HI-TORQUE PROGRESS Guide Wire Family. The document lists the types of performance characteristics that were tested on the predicate.

Acceptance Criteria (Performance Characteristic)	Reported Device Performance (Predicate)
Tensile Strength (Tip Pulls)	Successfully completed
Torque Strength (Turns to Separation)	Successfully completed
Torqueability (Rotational Accuracy)	Successfully completed
Tip Flexibility	Successfully completed
Friction/Lubricity Test (Pig Aorta)	Successfully completed
Coating Adhesion and Integrity Test (Particulate)	Successfully completed
Biocompatibility (Cytotoxicity ISO Elution Test, Hemolysis Test Direct Contact Method, Hemolysis Test Extraction Method, Complement Activation, Coagulation, Intracutaneous Reactivity Test, USP Systemic Injection Test, Sensitization Maximization Test, Material Mediated Rabbit Pyrogen Test, Bacterial Endotoxins (LAL))	Successfully completed

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set of the predicate device. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for the tests conducted on the predicate device. The only noted data provenance is the "Pig Aorta" for the Friction/Lubricity Test, indicating an animal model was used for that specific test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in the document. The performance tests listed are mechanical, chemical, and biological characterization tests, not clinical studies requiring expert ground truth for interpretation.

4. Adjudication method for the test set

This information is not applicable and not provided. Performance tests like tensile strength or biocompatibility do not typically involve adjudication in the way clinical image interpretation studies do.

5. 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

No such study was done. This device is a guide wire, a physical medical device, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No such study was done. This device is a physical medical device, not an algorithm.

7. The type of ground truth used

For the performance tests conducted on the predicate device, the "ground truth" would be established by the predefined acceptance criteria for each test (e.g., a specific tensile strength value, acceptable biocompatibility results according to ISO standards). It's based on engineering specifications, regulatory standards, and biological safety profiles.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for this type of device.

Summary

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510(k) Summary

JUL - 8 2010

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
2. Submitter's Address	3200 Lakeside Drive, Santa Clara, CA 95054
3. Telephone	(408) 845-0688
4. Fax	(408) 845-3743
5. Contact Person	Laarni Ricafort
6. Date Prepared	June 10, 2010
7. Device Trade Name	Hi-Torque Winn Guide Wire Family
8. Device Common Name	Guide Wire
9. Device Classification Name	Catheter Guide Wire (DQX)
10. Predicate Device Name	HI-TORQUE PROGRESS Guide Wire (K091825,cleared September 25, 2009)

11. Device Description

Indication for Use

This Hi-Torque Winn guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

13. Technological Characteristics

Comparisons of the new and predicate device show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate device.

14. Performance Data

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Performance testing was successfully completed on the predicate device, the HI-TORQUE PROGRESS Guide Wire Family. The following performance characteristics were leveraged for the proposed device:

. Tensile Strength (Tip Pulls)
Torque Strength (Turns to Separation) .
Torqueability (Rotational Accuracy) .
Tip Flexibility .
Friction/Lubricity Test (Pig Aorta) .
Coating Adhesion and Integrity Test (Particulate) .
Biocompatibility .
- Cytotoxicity ISO Elution Test (MEM Extract) ਼
- Hemolysis Test Direct Contact Method o
  - Hemolysis Test Direct Contact Method I
  - Hemolysis Test Extraction Method ■
  - . Complement Activation (C3a & SC5b9)
  - Coagulation (PT & PTT) 트
- Intracutaneous (Intradermal) Reactivity Test o
- USP Systemic Injection Test o
- Sensitization Maximization Test O
- Material Mediated Rabbit Pyrogen Test o
- Bacterial Endotoxins (LAL) for Medical Devices o

The Hi-Torque Winn is identical to the predicate device with respect to the materials, design, and manufacturing processes. Since no changes were made to the predicate device, no additional performance testing was conducted. The test results of the predicate device provide sufficient evidence to demonstrate the performance and safety of the device.

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL - 8 2010

Abbott Vascular clo Ms. Laarni Ricafort Regulatory Affairs Associate 3200 Lakeside Drive Santa Clara, CA 95054

Re: K101648

Trade Name: Hi-Torque Winn Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: June 10, 2010 Received: June 10, 2010

Dear Ms. Ricafort:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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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Page 2 - Ms. Laarni Ricafort

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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance: Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

R.Vohmer

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

510(k) Number (if known):

Device Names: Hi-Torque Winn Guide Wire Family

Indications for Use:

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter (Optional Format 1-1-96)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ge to victims

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K101648

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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.