(91 days)
No
The device description and intended use focus on the mechanical aspects of a dilatation catheter and balloon. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are bench tests comparing the device to predicates, not evaluating algorithmic performance.
Yes
The device is intended to treat medical conditions like stenosis and obstructive lesions, which aligns with the definition of a therapeutic device.
No
The device is a peripheral dilatation catheter, intended for therapeutic procedures such as dilating stenoses and treating obstructive lesions. It is not used for diagnosing medical conditions.
No
The device description clearly describes physical components like catheters, balloons, and radiopaque markers, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to dilate blood vessels and treat lesions. This is an interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a catheter with a balloon designed for physical manipulation within the vascular system. This is consistent with a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the RX VIATRAC™ 18 and OTW VIATRAC™ 18 Peripheral Dilatation Catheters are medical devices used for therapeutic purposes, not IVDs.
N/A
Intended Use / 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).
Product codes
LIT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries), arteriovenous dialysis fistulae.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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, 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.
Key Metrics
Not Found
Predicate Device(s)
RX VIATRAC™ 14 Peripheral Dilatation Catheter (K983055)
Reference Device(s)
Cordis OPTA 5TM PTA Catheter (K972825)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
JAN 2 7 2000
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
Advanced Cardiovascular Systems, Inc. |
|----|-----------------------------|-------------------------------------------------------------------------------|
| | Submitter's Address: | 3200 Lakeside Drive
Santa 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™ 14
Peripheral Dilatation Catheter (K983055) |
4. 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.
Cordis OPTA 5TM PTA Catheter (K972825)
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.
1
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.
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).
-
- 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 |
2
| 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.
-
- 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.
- Conclusions:
3
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.
4
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
5
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