To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, . popliteal, infra popliteal, renal arteries)
For the treatment of obstructive lesions of native or synthetic . arteriovenous dialysis fistulae.
For post deployment optimization of the 28 mm GUIDANT . MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters).

The OTW VIATRAC™ 18 Peripheral Dilatation Catheter is intended:

. To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries)
For the treatment of obstructive lesions of native or synthetic . arteriovenous dialysis fistulae.
For post deployment optimization of the 28 mm GUIDANT . MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters).

Device Description

The RX VIATRACTM 18 and the OTW VIATRACTM 18 Peripheral Dilatation Catheters were developed in parallel as two platforms, a Rapid Exchange (RX) platform and an Over-the-Wire (OTW) platform. The distal 20 cm of both catheters are identical however, the proximal portions are modified to accommodate either the RX or OTW platform.

The RX catheter is a rapid exchange catheter with an integrated shaft system. The design is based upon the RX VIATRACTM 14 Peripheral Dilatation Catheter, manufactured by Guidant (K983055, 12/30/98). The RX VIATRAC™ 18 Peripheral Dilatation Catheter has catheter lengths of 75 and 135 cm, with balloon diameters of 6.0, 7.0, 8.0, 9.0 and 10.0 mm.

The OTW platform is an over-the-wire, coaxial design catheter that is similar to that of the RX catheter. However, the OTW catheter has an inner member extending the entire length of the catheter, and therefore has no mid-catheter junction. The OTW VIATRAC™ 18 Peripheral Dilatation Catheter has catheter lengths of 75 and 135 cm, with balloon diameters of 6.0, 7.0, 8.0, 9.0 and 10.0 mm.

The XCELON™ balloon, which is identical on both RX and OTW VIATRAC™ 18 Peripheral Dilatation Catheters has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of know diameter and length at specific pressures.

AI/ML Overview

The provided text describes the performance data and acceptance criteria for the RX and OTW VIATRAC™ 18 Peripheral Dilatation Catheters through bench testing. It does not contain information about a study involving human readers, AI, or specific details for training sets.

Here's an analysis based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria	Reported Device Performance
Accelerated Aging Testing	Not explicitly stated, implied to ensure device integrity over time.	Met acceptance criteria and performed similar to predicate devices.
Catheter Preparation Test	Not explicitly stated, implied to assess ease and safety of preparation.	Met acceptance criteria and performed similar to predicate devices.
Crossing Profile/Collapsed Profile	Not explicitly stated, implied to assess lubricity and ability to navigate vessels.	Met acceptance criteria and performed similar to predicate devices.
Balloon Compliance Test	Not explicitly stated, implied to ensure balloon expands to known diameter and length at specific pressures.	Met acceptance criteria and performed similar to predicate devices.
Balloon Inflation/Deflation Times	Not explicitly stated, implied to ensure efficient operation.	Met acceptance criteria and performed similar to predicate devices.
Balloon Fatigue Test	Not explicitly stated, implied to ensure durability under repeated inflation/deflation cycles.	Met acceptance criteria and performed similar to predicate devices.
Balloon Rupture Test	Not explicitly stated, implied to ensure balloon integrity at specified pressures.	Met acceptance criteria and performed similar to predicate devices.
Catheter Soft Tip Tensile Test	Not explicitly stated, implied to ensure tip integrity and prevent detachment.	Met acceptance criteria and performed similar to predicate devices.
Catheter Tensile Test	Not explicitly stated, implied to ensure overall catheter shaft integrity.	Met acceptance criteria and performed similar to predicate devices.
Catheter Bend Integrity Test	Not explicitly stated, implied to ensure the catheter can navigate tortuous anatomy without kinking.	Met acceptance criteria and performed similar to predicate devices.
Catheter Shaft Pressure Test	Not explicitly stated, implied to assess pressure resistance of the shaft.	Met acceptance criteria and performed similar to predicate devices.
Inner Member Collapse Test	Not explicitly stated, implied to ensure the inner member remains patent.	Met acceptance criteria and performed similar to predicate devices.
Catheter Wall/Mandrel Penetration Test	Not explicitly stated, implied to ensure no unintended penetration.	Met acceptance criteria and performed similar to predicate devices.
Support Mandrel Pull Test	Not explicitly stated, implied to assess integrity of support elements.	Met acceptance criteria and performed similar to predicate devices.
In-Stent Balloon Rupture Test	Not explicitly stated, implied to ensure safe operation within a stent.	Met acceptance criteria and performed similar to predicate devices.
In-Stent Balloon Fatigue Test	Not explicitly stated, implied to ensure durability when expanded within a stent.	Met acceptance criteria and performed similar to predicate devices.

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

The provided text describes bench testing, not a clinical study involving human patients or real-world data. Therefore, the concept of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) in the context of clinical data is not applicable here. The tests were performed on the device itself.

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

Not applicable. The ground truth for this device (a catheter) is established through engineering and material science specifications, not through expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. This was bench testing against predetermined engineering specifications, not a study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The provided text describes bench testing of a physical medical device (catheter), not a comparative effectiveness study involving human readers, AI, or diagnostic performance.

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

Not applicable. This is not an algorithm or AI device; it is a physical medical device. The "performance" described is the device's mechanical and material properties.

7. The Type of Ground Truth Used

The ground truth used for these tests would be the engineering specifications and performance characteristics of the device, with comparison to the predicate devices. For example, a balloon must inflate to a specific diameter at a given pressure, or the catheter shaft must withstand a certain tensile load. These are measurable, objective criteria.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is bench testing of a physical device, not an AI or algorithm.

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

Not applicable. There is no training set. The "ground truth" for the device's design and performance would have been established during its engineering and manufacturing process based on established standards and clinical needs.

Summary

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JAN 2 7 2000

510(k) SUMMARY

K993639

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:	408-235-3995
	Fax:	408-235-3743
	Contact Person:	Susan Silavin, Ph.D.
	Date Prepared:	August 28, 1998
2.	Device Trade Name:	RX VIATRAC™ 14 Peripheral Dilatation Catheter
	Device Common Name:	Percutaneous Transluminal Angioplasty Catheter
	Device Classification Name:	LIT
3.		Predicate Devices: RX VIATRAC™ 14Peripheral Dilatation Catheter (K983055)

4. Device Description:

Cordis OPTA 5TM PTA Catheter (K972825)

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5. Intended Use:

The RX VIATRACTM 18 Peripheral Dilatation Catheter is intended:

To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, . popliteal, infra popliteal, renal arteries)
For the treatment of obstructive lesions of native or synthetic . arteriovenous dialysis fistulae.
For post deployment optimization of the 28 mm GUIDANT . MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters).

The OTW VIATRAC™ 18 Peripheral Dilatation Catheter is intended:

. To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries)
For the treatment of obstructive lesions of native or synthetic . arteriovenous dialysis fistulae.
For post deployment optimization of the 28 mm GUIDANT . MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters).
1. Technological Characteristics:

Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties (see below), sterilization, and packaging are identical or substantially equivalent to the currently marketed predicate devices.

7. Performance Data:

Bench testing was performed to demonstrate that the met the acceptance criteria and performed similar to the predicate RX VIATRAC™ 14 Peripheral Dilatation Catheter and the OPTA 5TM PTA Catheter. The following tests were performed:

Accelerated Aging Testing
Catheter Preparation Test
Crossing Profile/Collapsed Profile
Balloon Compliance Test
Balloon Inflation/Deflation Times
Balloon Fatigue Test
Balloon Rupture Test
Catheter Soft Tip Tensile Test

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Catheter Tensile Test
Catheter Bend Integrity Test
Catheter Shaft Pressure Test
Inner Member Collapse Test
Catheter Wall/Mandrel Penetration Test
Support Mandrel Pull Test
In-Stent Balloon Rupture Test
In-Stent Balloon Fatigue Test

The results from the bench tests showed that the new RX and OTW VIATRAC™ 18 Peripheral Dilatation Catheters met acceptance criteria and performed in a manner equivalent to the predicate RX VIATRAC™ 14 Peripheral Dilatation Catheter and the Cordis OPTA 5TM PTA Catheter. No new safety or effectiveness issues were raised during the testing program.

1. Conclusions:
  Since the new RX and OTW VIATRAC™ 18 Peripheral Dilatation Catheters have the same intended use, similar design and technological characteristics, equivalent performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the RX VIATRAC™ 18 Peripheral Dilatation Catheter and the OTW VIATRACTM 18 Peripheral Dilatation Catheter may be considered substantially equivalent to the predicate RX VIATRAC™ 14 Peripheral Dilatation Catheter and Cordis OPTA 5TM PTA Catheter.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized eagle or bird-like figure with three curved lines representing its body and wings. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2000

Susan Silavin, Ph.D. Senior Regulatory Affairs Coordinator Guidant Corporation P.O. Box 58167 Santa Clara, CA 95052-8167

кадзеза Re: RX and OTW VIATRAC 18 Peripheral Dilatation Trade Name: Catheter Requlatory Class: II Product Code: LIT October 27, 1999 Dated: October 28, 1999 Received:

Dear Dr. Silavin:

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 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 requlatory action. In addition, FDA may publish further announcements 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 - Susan Silavin, Ph.D.

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) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "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,

Christopher

Celia M. Witten, Ph.D., 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): K993639

Device Name: RX VIATRAC™ 18 Peripheral Dilatation Catheter OTW VIATRACTM 18 Peripheral Dilatation Catheter

Indications for Use:

The RX VIATRAC™ 18 Peripheral Dilatation Catheter is intended:

To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, . popliteal, infra popliteal, renal arteries)
For the treatment of obstructive lesions of native or synthetic arteriovenous . dialysis fistulae.
For post deployment optimization of the 28 mm GUIDANT MEGALINK™ . Biliary Stent (6.0 to 10.0 mm diameters).

The OTW VIATRAC™ 18 Peripheral Dilatation Catheter is intended:

To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, . popliteal, infra popliteal, renal arteries)
For the treatment of obstructive lesions of native or synthetic arteriovenous . dialysis fistulae.
For post deployment optimization of the 28 mm GUIDANT MEGALINK™ . Biliary Stent (6.0 to 10.0 mm diameters).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Christopher for Witten

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).