To facilitate the placement of balloon dilatation catheters during percutancous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Device Description

The ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wires with a nominal diameter of 014" and available in: 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 190 cm models are tapcred to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. The wire is constructed from a stainless steel core wire. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. A hydrophilic coating is applied to the distal portion of the guide wire and the proximal section is coated with polytetrafluoroethylene.

AI/ML Overview

The provided 510(k) summary describes a medical device, the ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire, and its performance evaluation. The summary is for a traditional medical device, not an AI/ML-powered device, so several of the requested sections regarding AI-specific evaluation criteria (like MRMC studies, ground truth establishment for training sets, and data provenance for AI models) are not applicable.

Here's an analysis of the provided text based on your request, focusing on the information available for this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that in vitro bench testing and in vivo performance evaluations were conducted to demonstrate that the new guide wire met acceptance criteria and performed similarly to predicate devices. Specific tests mentioned are:

Test	Acceptance Criteria	Reported Device Performance
Tensile Strength	Not explicitly stated, but implied to be "met the acceptance criteria" and "performed similar/equivalent to predicate devices."	"The results from the tests demonstrated that the new ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACC HI-TORQUE CROSS-IT™ 300XT Guide Wire, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable Guide Wire."
Torque Strength	Not explicitly stated, but implied to be "met the acceptance criteria" and "performed similar/equivalent to predicate devices."	"The results from the tests demonstrated that the new ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACC HI-TORQUE CROSS-IT™ 300XT Guide Wire, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable Guide Wire."
Torqueability	Not explicitly stated, but implied to be "met the acceptance criteria" and "performed similar/equivalent to predicate devices."	"The results from the tests demonstrated that the new ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACC HI-TORQUE CROSS-IT™ 300XT Guide Wire, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable Guide Wire."
Tip Flexibility Test	Not explicitly stated, but implied to be "met the acceptance criteria" and "performed similar/equivalent to predicate devices."	"The results from the tests demonstrated that the new ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACC HI-TORQUE CROSS-IT™ 300XT Guide Wire, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable Guide Wire."

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

The document mentions "in vitro bench testing and in vivo performance evaluations" but does not specify the sample sizes used for these tests. The data provenance (e.g., country of origin, retrospective/prospective) is also not provided. This type of detail is often found in the full submission, not typically summarized in the 510(k) summary itself.

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

This information is not applicable/provided as this is a physical medical device and not an AI/ML detection or diagnostic device that would require expert-established ground truth for a test set in that context. The "ground truth" here would relate to the physical properties of the guide wire meeting predefined engineering specifications and functional requirements.

4. Adjudication Method for the Test Set:

This information is not applicable/provided for the same reasons as #3. Adjudication methods are typically used for establishing ground truth in image analysis or diagnostic studies.

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 relevant for AI-assisted diagnostic tools where human readers' performance with and without AI assistance is evaluated. This submission is for a physical medical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No, a standalone algorithm performance study was not done. This concept applies to AI/ML algorithms, not physical guide wires.

7. The Type of Ground Truth Used:

For this device, the "ground truth" is established through objective engineering specifications and functional performance criteria derived from the intended use and comparison to legally marketed predicate devices. This includes physical properties (tensile strength, torque strength, flexibility) and performance under simulated use conditions (in vitro) and potentially animal or human studies (in vivo, though details are not provided in the summary).

8. The Sample Size for the Training Set:

This information is not applicable/provided. There is no "training set" in the context of an AI/ML algorithm for this physical medical device. The "training" for such a device would be its design and manufacturing process to meet specifications.

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

This information is not applicable/provided for the same reasons as #8.

Summary

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1992169

OCT 28 1999

510(k) SUMMARY

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

1.	Submitter's Name:	Guidant CorporationAdvanced Cardiovascular Systems, Inc.
	Submitter's Address:	3200 Lakeside DriveSanta Clara, CA 95054
	Telephone:	408-845-3995
	Fax:	408-845-3743
	Contact Person:	Margaret Anderson
	Date Prepared:	July 20, 1999
2.	Device Trade Name:	HI-TORQUE CROSS-IT™ 400XT Guide Wirewith HYDROCOAT™ Hydrophilic Coating
	Device Common Name:	Guide Wire
	Device Classification Name:	Catheter Guide Wire (74DQX)
3.	Predicate Device:	HI-TORQUE CROSS-IT™ 300XT Guide Wirewith HYDROCOAT™ Hydrophilic Coating
		Wholey Hi-Torque Standard® 0.035" Guide Wire
		Commander, Standard, Steerable Guide Wire

4. Device Description:

న్. Intended Use:
To facilitate the placement of balloon dilatation catheters during percutancous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

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1. Technological Characteristics:
  Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization, and packaging are identical or substantially equivalent to the currently marketed predicate devices. The design modifications of the new guide wire compared to that of the predicate wire arc the coils and the dimensions of the core wire sections.
1. Performance Data:
  In vitro bench testing and in vivo performance evaluations were performed to demonstrate that the ACS HI-TORQUE CROSS-IT™ 400XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate devices. The following functional tests were performed: Tensile Strength, Torque Strength, Torqueability and Tip Flexibility Test.

The results from the tests demonstrated that the new ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACC HI-TORQUE CROSS-IT™ 300XT Guide Wire, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable Guide Wire. No new safety or effectiveness issues were raised during the testing program.

1. Conclusions:
  Since the new guide wire has the same intended use, technological characteristics, performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the ACS HI-TORQUE CROSS-IT™ 400XT Guiler Guiler with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate ACS HI-TORQUE CROSS-IT™ 300XT Guide Wire with IIYDROCOAT™ Hydrophilic Coating, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable Guide Wire.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the three branches of government.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 28 1999

Ms. Margaret Anderson Regulatory Affairs Coordinator Guidant Corporation Vascular Intervention Group 3200 Lakeside Drive Santa Clara, CA 95054

K992169 Re :

R Frade Name: HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating Requlatory Class: II Product Code: DQX Dated: September 13, 1999 Received: September 14, 1999

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 commerce prior of har ee that have been reclassified in accordance with rhe 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulatory action. In addition, FDA may publish further announcements concerning your device in the

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Page 2 - Ms. Margaret Anderson

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.

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) 594-4586. 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" (21CFR 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,

Arthur A. Ciarlusli.

Jo, Wolf Sapirstein, M.D. Acting 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):

Device Name:

ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating

Indications for Use:

To facilitate the placement of balloon dilatation catheters during percutancous angin To facilitate the placement of banoon chalaton catherers and in all angloplasty
transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K992169

X Prescription Use (Per 21 CFR 801.109)

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

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.