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 PROGRESS Guide Wire Family is a new 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 190cm extendable and 300cm exchange lengths. The distal core segment of the PROGRESS is offered in 5 configurations: PROGRESS 40, PROGRESS 80, PROGRESS 120, PROGRESS 140T and PROGRESS 200T. Each configuration is identical in design except for those design features that impact tip stiffness.

AI/ML Overview

The provided text describes a 510(k) summary for the HI-TORQUE PROGRESS Guide Wire Family. It details the device, its intended use, and states that in vitro bench testing was performed to demonstrate substantial equivalence to predicate devices. However, the document does not contain the specific information requested in the prompt regarding acceptance criteria, a detailed study description, sample sizes, ground truth establishment, or expert involvement.

Here's a breakdown of why each requested point cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance:
- The document states: "In vitro bench testing performance evaluations demonstrated that the HI-TORQUE PROGRESS Guide Wire Family met the acceptance criteria and performed comparable to the matching predicate devices."
- Missing Information: It does not provide the specific acceptance criteria (e.g., tensile strength, kink resistance, pushability thresholds) or the measured performance values for the device against these criteria.
Sample sized used for the test set and the data provenance:
- The document mentions "in vitro bench testing" but does not specify the sample size (number of guide wires tested) or the provenance of any data (e.g., country of origin, retrospective/prospective).
- Missing Information: No details on sample size or data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is typically relevant for studies involving human judgment (e.g., image interpretation). For a physical medical device like a guide wire, "ground truth" usually refers to objective physical measurements or established engineering standards.
- Missing Information: The document does not describe any expert involvement in establishing a "ground truth" in the context of human interpretation. The "ground truth" for bench testing would typically be the physical properties measured.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication methods are used to resolve disagreements among multiple experts, usually in subjective assessments. Since bench testing is objective and not based on expert interpretation, this concept is not applicable here.
- Missing Information: Not applicable to this type of testing.
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:
- MRMC studies are typically for diagnostic AI devices where human readers interpret medical images. This device is a physical guide wire, not a diagnostic AI tool.
- Missing Information: No MRMC study was done, as it's not relevant for this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question pertains to AI algorithms. The HI-TORQUE PROGRESS Guide Wire is a physical medical device.
- Missing Information: Not applicable to this device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a guide wire, the "ground truth" for bench testing would be the objective physical and mechanical properties measured (e.g., tensile strength, flexibility, lubricity, torque response). These are determined by calibrated instruments and established test methods, not expert consensus, pathology, or outcomes data in the typical sense.
- Missing Information: The document states "in vitro bench testing" which implies objective physical measurements, but it does not explicitly detail the specific ground truth types beyond that.
The sample size for the training set:
- "Training set" is a concept primarily used in machine learning for AI algorithms. This is a physical medical device.
- Missing Information: Not applicable.
How the ground truth for the training set was established:
- Again, this relates to AI/machine learning.
- Missing Information: Not applicable.

In summary, the provided 510(k) summary only states that "in vitro bench testing performance evaluations demonstrated that the HI-TORQUE PROGRESS Guide Wire Family met the acceptance criteria and performed comparable to the matching predicate devices." It lacks the detailed study information, specific acceptance criteria, performance data, sample sizes, and other ground truth establishment methods requested in the prompt, as these details are typically found in the full test reports, not the summary document itself.

Summary

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510(k) Summary

SEP 2 5 2009

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
1. Submitter's Address
1. Telephone
1. Fax

Contact Person
Date Prepared

1. Device Trade Name
  Device Common Name 8.

Device Classification Name 9.

Predicate Device Name

Abbott Vascular 26531 Ynez Road, Temecula, CA 92591 (951) 914-3246 (951) 914-0339 Michele Walz June 15, 2009 HI-TORQUE PROGRESS Guide Wire Family Guide Wire Catheter Guide Wire (DOX)

HI-TORQUE PILOT Guide Wire (K030549, cleared May 14, 2003), HI-TORQUE ADVANCE Guide Wire (K060449, cleared May30, 2006), HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire, (K072460, cleared April 11, 2008) and Asahi guide wire families.

11. Device Description

Indication for Use

The HI-TORQUE PROGRESS Guide Wire Family 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

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Comparisons of the new and predicate devices 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

In vitro bench testing performance evaluations demonstrated that the HI-TORQUE PROGRESS Guide Wire Family met the acceptance criteria and performed comparable to the matching predicate devices. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE PROGRESS Guide Wire · Family may be considered substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 pattern around the eagle.

Public Health Service

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

Abbott Vascular c/o Ms. Michele Walz Senior Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92591-4628

SEP 2 5 2009

Re: K091825

Trade/Device Name: HI-TORQUE PROGRESS Guide Wire Common Name: Guide wire Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DOX Dated: September 14, 2009 Received: September 15, 2009

Dear Ms. Walz:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 (reporting of medical

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Page 2 -- Ms. Michele Walz

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/CDRH/CDRHOffices/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. bohner

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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): K091825

Device Names:

HI-TORQUE PROGRESS 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)

Dummer R. Vochner

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K0 91825

Page of

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.