This Hi-Torque Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.

The guide wire may also be used to reach and cross a target lesion, provide a pathway within a vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

Device Description

The Abbott Vascular 0.014" Hi-Torque Command (HT Command) Guide Wire with hydrophilic and hydrophobic coatings is a stainless steel and nitinol steerable guide wire with a maximum diameter of 0.0145", provided in 190 cm extendable, 250 cm, and 300 cm exchange lengths. The distal tip has a radiopaque length of 3.0 cm. The distal tip is straight and shapeable. The HT Command Guide Wire Family consists of two models with differing flexibility and performance; the HT Command and the HT Command ES. The proximal end of the 190 cm model is plunge ground and coined to fit into the hypotube portion of the DOC® Guide Wire Extension. The HT Command guide wire family is compatible with devices designed for use with 0.014" guide wires.

AI/ML Overview

The provided text describes the Abbott Vascular Hi-Torque Command Guide Wire Family. The information focuses on the device's substantial equivalence to predicate devices based on in vitro bench testing. There is no information about a clinical study, AI/algorithm performance, ground truth establishment for a training set, or expert-based evaluations for this specific medical device submission. The submission relies solely on bench testing to demonstrate substantial equivalence.

Here's a breakdown based on the input requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Acceptance Criteria	Reported Device Performance
Catheter Compatibility	Met all acceptance criteria.	Performed similarly to predicate devices; met all criteria.
Radiopacity	Met all acceptance criteria.	Performed similarly to predicate devices; met all criteria.
Tensile Strength	Met all acceptance criteria.	Performed similarly to predicate devices; met all criteria.
Torque Strength	Met all acceptance criteria.	Performed similarly to predicate devices; met all criteria.
Torque Accuracy	Met all acceptance criteria.	Performed similarly to predicate devices; met all criteria.
Coating Adherence and Integrity	Met all acceptance criteria.	Performed similarly to predicate devices; met all criteria.
Friction Testing	Met all acceptance criteria.	Performed similarly to predicate devices; met all criteria.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as in vitro bench testing.

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

Sample Size: Not explicitly stated. The document refers to "in vitro bench testing" without specifying the number of test units.
Data Provenance: Not applicable in the context of clinical data. These are laboratory bench tests.

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

Not applicable. The evaluation was based on objective physical and mechanical properties measured during bench testing, not on expert interpretations of data or images.

4. Adjudication method for the test set:

Not applicable. There was no human interpretation or adjudication involved, as the tests were objective measurements.

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. This was not an MRMC study. There is no AI component or human reader evaluation described.

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

No. This device is a physical medical device (guide wire); an algorithm-only performance study is not relevant.

7. The type of ground truth used:

The "ground truth" for the in vitro bench testing would be the established scientific and engineering principles and standards for evaluating the physical and mechanical properties of guide wires (e.g., standard methods for measuring tensile strength, torque, etc.). The acceptance criteria are based on these predefined thresholds.

8. The sample size for the training set:

Not applicable. This submission is for a physical medical device and relies on bench testing, not machine learning or AI, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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510(k) Summary

NOV 2 0 2012

K122573

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.

Submitter's Name
Submitter's Address
Telephone
Fax
Contact Person
Date Prepared
Device Trade Name
Device Common Name
Device Classification Name
Predicate Device(s) Name

Abbott Vascular Inc.

P.O. Box 9018, Temecula, CA 92589

(951) 914-3242

(951) 914-0339

Kay Setzer

August 22, 2012

Hi-Torque Command Guide Wire Family

Guide Wire

Catheter Guide Wire (DQX)

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire (K072460, cleared April 11, 2008); HI-TORQUE BALANCE HEAVYWEIGHT (K021228, cleared May15, 2002), HI-TORQUE BMW ELITE (K103101, cleared Feb. 10, 2011), HI-TORQUE WHISPER, (K101116, cleared June 23, 2010); and HI-TORQUE POWERTURN (K112957, cleared Feb. 8, 2011).

11. Device Description

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12. Indication for Use

The Hi-Torque Command Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.

The guide wire may also be used to teach and cross a target lesion, provide a pathway within a vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

13. Technological Characteristics

Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design and indications for use are substantially equivalent to the currently marketed predicate devices.

14. Performance Data

In vitro bench testing conducted on the subject device included:

. catheter compatibility,
radiopacity. .
tensile strength, .
torque strength, .
torque accuracy, ●
coating adherence and integrity (particulate testing), and .
friction testing. .

The in vitro bench tests demonstrated that the Hi-Torque Command Guide Wire met all acceptance criteria and performed similarly to the predicate devices.

15. Leveraged testing

Biocompatibility, packaging, and sterilization testing were not necessary as the Hi-Torque Command is identical in materials, packaging, and sterilization as the predicate devices.

16. Conclusions

Test results from the non-clinical in vitro bench testing conducted on the Hi-Torque Command Guide Wire met all acceptance criteria and performed similarly to the predicate devices. There were no new safety or effectiveness issues raised during the testing program.

The Hi-Torque Command Guide Wire Family is substantially equivalent to the predicate devices in regards to the indications for use, materials, fundamental technology, design, performance, shelf life, biocompatibility, sterilization, and packaging and is safe and effective for clinical use.

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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 consists of a stylized eagle or bird-like figure with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird in a circular fashion.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Abbott Vascular, Inc. c/o Ms. Kay Setzer Sr. Regulatory Affairs Specialist P.O. Box 9018 Temecula, CA 92589

NOV 2 0 2012

Re: K122573

Trade/Device Name: Hi-Torque Command Guide Wire Family Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: August 22, 2012 Received: August 23, 2012

Dear Ms. Setzer:

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. 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 (reporting of medical

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Page 2 - Ms. Kay Setzer

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Matthew G. Hillebrenner

for 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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INDICATIONS FOR USE

510(k) Number (if known): F122573

Device Name:

Hi-Torque Command Guide Wire Family

Indications for Use:

Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

CMA Stelle

ivision Sign-C (Division Sign-Om)
Division of Cardiovascular Devices
Division of Cardiovascular 2

510(k) Number_

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.