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

Device Description

The ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wires with a maximum diameter of 0.014" 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 tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. The wire is constructed from a stainless steel core wire, with varying core lengths and diameters for each design. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with polytetrafluoroethylene.

AI/ML Overview

The provided document describes the acceptance criteria and performance of the ACS HI-TORQUE CROSS-IT™ XT family of guide wires with HYDROCOAT™ Hydrophilic Coating.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Functional Tests)	Reported Device Performance
Distal Tip Pull Test	The results demonstrated that the new ACS HI-TORQUE CROSS-IT™ XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent to the predicate ACS HI-TORQUE CROSS-IT™ and the Commander, Standard, Steerable Guide Wire. No new safety or effectiveness issues were raised during the testing program.
Distal Tip Turns-to-Failure Test	The results demonstrated that the new ACS HI-TORQUE CROSS-IT™ XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent to the predicate ACS HI-TORQUE CROSS-IT™ and the Commander, Standard, Steerable Guide Wire. No new safety or effectiveness issues were raised during the testing program.
Rotational Accuracy Test	The results demonstrated that the new ACS HI-TORQUE CROSS-IT™ XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent to the predicate ACS HI-TORQUE CROSS-IT™ and the Commander, Standard, Steerable Guide Wire. No new safety or effectiveness issues were raised during the testing program.
Tip Flexibility Test	The results demonstrated that the new ACS HI-TORQUE CROSS-IT™ XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent to the predicate ACS HI-TORQUE CROSS-IT™ and the Commander, Standard, Steerable Guide Wire. No new safety or effectiveness issues were raised during the testing program.

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

The document mentions "in vitro bench testing and in vivo performance evaluations" were performed for the test set. However, it does not specify the sample size used for these tests. It also does not specify the country of origin of the data or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the document. The study described is a device performance study focusing on physical and functional characteristics, not an AI/imaging study requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided as the study is not an AI/imaging study requiring human adjudication for ground truth. The acceptance criteria were met through direct measurement and evaluation of device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not performed as this is a medical device performance study, not an AI assistance study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This concept is not applicable as the document describes the performance of a physical medical device (guide wire), not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" for this device performance study was established through in vitro bench testing and in vivo performance evaluations comparing the new devices against established predicate devices. This implies direct measurement of physical properties and observed performance in relevant settings. It is not expert consensus, pathology, or outcomes data in the typical sense applied to diagnostic tools, but rather objective performance metrics against predefined criteria and predicate device performance.

8. Sample Size for the Training Set:

This information is not applicable/not provided. The study describes the testing of a physical medical device, not a machine learning model, so there is no training set in the context of AI.

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

This information is not applicable/not provided as there is no training set mentioned.

Summary

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3/25/99

K990639

ATTACHMENT 4

510(k) Summary

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

	1. Submitter's Name:	Guidant CorporationAdvanced Cardiovascular Systems, Inc.
2.	Submitter'sAddress:	3200 Lakeside DriveSanta Clara, CA 95054
	3. Telephone:	408-235-3995
4.	Fax:	408-235-3743
5.	Contact Person:	Margaret Anderson
6.	Date Prepared:	February 25, 1999
7.	Device TradeName:	• ACS HI-TORQUE CROSS-IT™ 100XT Guide Wire withHYDROCOAT™ Hydrophilic Coating• ACS HI-TORQUE CROSS-IT™ 200XT Guide Wire withHYDROCOAT™ Hydrophilic Coating• ACS HI-TORQUE CROSS-IT™ 300 XT Guide Wire withHYDROCOAT™ Hydrophilic Coating
8.	Device CommonName:	Guide Wire
9.	DeviceClassificationName:	Catheter Guide Wire (74DQX)
10. Predicate Device:		ACS HI-TORQUE CROSS-IT™ Guide Wire withHYDROCOAT™ Hydrophilic Coating (K981381)
		ACS HI-TORQUE BALANCE HEAVYWEIGHT™ GuideWire with HYDROCOAT™ Hydrophilic Coating (K982083)
		Commander, Standard, Steerable Guide Wire; C.R. Bard, Inc.(K961271)

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1. Device Description:
  The ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wires with a maximum diameter of 0.014" 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 tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. The wire is constructed from a stainless steel core wire, with varying core lengths and diameters for each design. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with polytetrafluoroethylene.
1. Intended Use:
  To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
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 wires compared to that of the predicate wire are the lengths and diameters of the core wire sections. The 300XT design is manufactured with a gold solder.

Performance Data:

In vitro bench testing and in vivo performance evaluations were performed to demonstrate that the ACS HI-TORQUE CROSS-IT™ XT family of guide wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate devices. The following functional tests were performed: Distal Tip Pull Test, Distal Tip Turns-to-Failure Test, Rotational Accuracy Test and Tip Flexibility Test.

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

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15. Conclusions

Since the new guide wires have 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™ 100XT, 200XT and 300XT Guide Wires with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate ACS HI-TORQUE CROSS-IT™ Guide Wires with HYDROCOAT™ Hydrophilic Coating, the ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the Commander, Standard, Steerable Guide Wire.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 1999

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

Re: K990639

ACS HI-TORQUE CROSS-IT™ 100XT, 200XT and 300XT Guide Trade Name: Wires with HYDROCOAT™ Hydrophilic Coating Requlatory Class: II Product Code: DOX Dated: February 25, 1999 Received: February 26, 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 leqally 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning

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Page 2 - Ms. Margaret Anderson

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.

This letter will allow you to begin marketing your device as described in vour 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,

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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ATTACHMENT 2

Indications for Use Statement 510(k) Number (if known) ACS HI-TORQUE CROSS-IT™ 100XT Guide Wire with HYDROCOAT™ Device Name Hydrophilic Coating ACS HI-TORQUE CROSS-IT™ 200XT Guide Wire with HYDROCOAT™ Hydrophilic Coating ACS HI-TORQUE CROSS-IT™ 300XT Guide Wire with HYDROCOAT™ Hydrophilic Coating The ACS HI-TORQUE CROSS-IT™ 100XT, 200XT and 300XT Guide Wire Indications for with HYDROCOAT™ Hydrophilic Coating family of guide wires' intended Use use is: To facilitate the placement of balloon dilatation catheters during percutaneous 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)

المل المستمبر المسلم المستمبر المسلمين والمسلمين المستقل المستقل المستوى المستوى المستوى المستوى المستقل المستقل المستقل المستوى المستوى المستوى المستقل المستقل المستقل المس Prescription Use __

Use (Per 21 CFR 801.109)

OR Over-The-Counter

(Division Sign-Off)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K990639 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.