The intended use of the ACS HI-TORQUE WIGGLE™ Guide Wire with MICROGLIDE® Coating is to facilitate the placement of the catheter by orienting the catheter tip during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) and other interventional diagnostic or therapeutic procedures.

Device Description

The ACS HI-TORQUE WIGGLE™ Guide Wire with MICROGLIDE® Coating is a guide wire with a nominal diameter of 0.014″ and available in two lengths: a 190 cm extendable length and a 300 cm exchange length. The proximal end of the 190 cm models are tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension.

The wire is constructed from stainless steel, the distal end of this guide wire has a radiopaque tip that is available either as a straight, shapeable configuration or as a preshaped J. The distal end of the wire has sinusoidal waves manufactured approximately 4.5 cm - 6.5 cm from to the distal tip. The guide wire has proximal markers at 90 and 100 cm from the distal tip. MICROGLIDE® Coating is applied to the distal section of the guide wire, the proximal shaft is coated with polytetrafluoroethylene.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state quantitative acceptance criteria. Instead, it describes a comparative approach where the new device's performance is expected to be "similar to" or "substantially equivalent" to the predicate device. The performance data section lists the types of tests performed.

Acceptance Criteria (Implied)	Reported Device Performance
Distal Tip Pull Strength/Integrity similar to predicate	Bench testing performed (Distal Tip Pull Test). Results showed new device is "substantially equivalent to the predicate wires and performs as intended."
Distal Tip Durability ("Turns-to-Failure") similar to predicate	Bench testing performed (Distal Tip Turns-to-Failure Test). Results showed new device is "substantially equivalent to the predicate wires and performs as intended."
Rotational Accuracy similar to predicate	Bench testing performed (Rotational Accuracy Test). Results showed new device is "substantially equivalent to the predicate wires and performs as intended."
Tip Flexibility similar to predicate	Bench testing performed (Tip Flexibility Test). Results showed new device is "substantially equivalent to the predicate wires and performs as intended."
Performs as intended for facilitating catheter placement & orientation	In vitro heart model studies were performed to substantiate the intended use. "The results of the heart model study demonstrated that the new wire performs as intended." This implies it successfully facilitated catheter placement and orientation in the model.

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

Sample Size: The document does not specify the numerical sample sizes for the bench tests (e.g., number of wires tested for each bench test) or the in vitro heart model studies.
Data Provenance: The studies were described as "Bench testing" and "in vitro heart model studies," indicating laboratory-based testing. There is no information about the country of origin of the data provided in the 510(k) summary. The studies are prospective in nature as they involve testing of the device for submission.

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

This information is not applicable to the studies described. The performance assessment was based on objective bench tests and in vitro model studies, not on expert interpretation of diagnostic images or clinical outcomes that would require a "ground truth" established by experts in that context. The "ground truth" here is the physical performance measurement and functional demonstration in a model.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements (e.g., pull strength, turns-to-failure) that do not typically require expert adjudication in the way clinical studies or 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

Not applicable. This device is a guide wire, not a diagnostic AI device requiring human reader interaction or interpretation. Therefore, an MRMC study is irrelevant.

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

Not applicable. This is a medical device, not an algorithm. The "standalone" performance refers to the device's physical and functional characteristics.

7. The type of ground truth used

The ground truth used for these studies was based on the physical performance measurements of the device against predefined engineering specifications (implied by "acceptance criteria" and "similar to predicate") and the functional demonstration of its intended use in an in vitro model. It's essentially a form of empirical measurement and functional validation.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set. The "training" for a physical device is its design and manufacturing process.

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

Not applicable, as there is no "training set" in the context of this physical medical device.

Summary

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K984394 3/8/99

510(k) SUMMARY

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

1.	Submitter's Name:	Guidant Corporation
	Submitter's Address:	Advanced Cardiovascular Systems, Inc.3200 Lakeside DriveSanta Clara, CA 95052
	Telephone:	408-235-3995
	Fax:	408-235-3743
	Contact Person:	Margaret Anderson
	Date Prepared:	March 3, 1999
2.	Device Trade Name:	ACS HI-TORQUE WIGGLE™ Guide Wire withMICROGLIDE® Coating
	Device Common Name:	Guide Wire
	Device Classification Name:	Catheter Guide Wire (74DQX)
3.	Predicate Device:	ACS HI-TORQUE FLOPPY II® EXTRASUPPORT Guide Wire with MICROGLIDE®Coating (K913353)
		ACS Angioscone Guide Wire (K883000)

4. Device Description:

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Intended Use: న్న

Technological Characteristics: Q.

Compansons of the Wiggle Guide Wire and predicate Hi-Torque Floppy II® Extra Support Guide Wire show that technological characteristics such as materials, biocompatibility, performance properties, sterilization, and packaging are identical or substantially equivalent to the predicate device. Similar in design to the Angioscope Guide Wire, the WIGGLE™ Guide Wire has a sinusoidal wave design manufactured in the distal tip section of the wire.

7. Performance Data:

Bench testing was performed to demonstrate that the ACS HI-TORQUE WIGGLE™ Guide Wire with MICROGLIDE® Coating met the acceptance criteria and performed similar to the predicate ACS HI-TORQUE FLOPPY II® EXTRA SUPPORT Guide Wire with MICROGLIDE® Coating. The following tests were performed: Distal Tip Pull Test, Distal Tip Turns-to-Failure Test, Rotational Accuracy Test, Tip Flexibility Test.

Additionally, in vitro heart model studies were performed to substantiate the intended use of the ACS HI-TORQUE WIGGLE™ Guide Wire. The results of the heart model study demonstrated that the new wire performs as intended.

The results from the bench tests showed that the new ACS HI-TORQUE WIGGLE™ Guide Wire with MICROGLIDE® Coating is substantially equivalent to the predicate wires and performs as intended. No new safety or effectiveness issues were raised during the testing program.

8. Conclusions:

The ACS HI-TORQUE WIGGLE™ Guide Wire has shown to have similar design and technological characteristics, identical materials, sterilization and packaging, and no new safety or effectiveness issues compared to the predicate wires, therefore, the ACS HI-TORQUE WIGGLE™ Guide Wire with MICROGLIDE® Coating may be considered safe and effective for its intended use.

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 1999

Ms. Margaret Anderson Guidant Corporation 3200 Lakeside Drive Santa Clara, CA 95054

Re: K984394 ACS HI-TORQUE WIGGLE™ Guide Wire with MICROGLIDE® Coating Regulatory Class: II (two) 74 DQX Product Code: December 7, 1998 Dated: Received: December 8, 1998

Dear Ms. Anderson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Margaret Anderson

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K984394

ACS HI-TORQUE WIGGLE™ Guide Wire with Device Name: MICROGLIDE® Coating

Indications for Use:

The intended use of the ACS HI-TORQUE WIGGLE™ Guide Wire with The michded use of the YOB TIL Total the placement of the catherer by orienting the MICKOGEDEE Couting is to resarthminal coronary angioplasty (PTCA) and cather up Guring porculances of PTA) and other interventional diagnostic or therapeutic procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	✓
	OR
Over-The-Counter(Optional Format 1-1-96)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) Number
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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.