(66 days)
Not Found
No
The device description focuses on the physical components and mechanical function of a balloon catheter for dilation, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated to "dilate stenosis" and treat "obstructive lesions," which are therapeutic actions.
No
The device is a dilatation catheter used to treat stenosis in peripheral vasculature by dilating lesions, not to diagnose them.
No
The device description clearly details a physical catheter with a balloon, shaft, and other hardware components, indicating it is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Description and Intended Use: The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is a device designed to be inserted into the body (specifically, into blood vessels) to physically dilate stenoses (narrowings). It is a therapeutic device used for intervention, not for testing samples.
The description clearly indicates it's a catheter with a balloon for mechanical dilation within the peripheral vasculature and arteriovenous fistulae. This is an invasive procedure performed in vivo, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is indicated for dilatation of stenoses in the peripheral vasculature (iliac, femoral, popliteal, infra-popliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is a rapid exchange catheter with an integrated shaft system and an XCELON™ (nylon blend) balloon bonded at the distal end. The shaft has a combination of a single lumen design at the proximal end a coaxial lumen at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The distal lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal shaft has a tapered stainless steel mandrel, which provides support and flexibility to the shaft and is attached at the proximal end.
The balloon, which has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.
The proximal end of the catheter has a single arm adaptor that provides access to the inflation lumen. It is designed with a luer-lock fitting for connection with an inflation device.
The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is available with balloon diameters of 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 mm, with lengths of 15, 20, 30, and 40 mm and in catheter lengths of 80 cm and 135 cm.
On the 135 cm catheter length, there are two proximal shaft markers (95 cm and 105 cm from the distal tip). On the 80 cm catheter length, there is a single proximal marker (55 cm from the distal tip). Both indicate the relative position of the catheter to the end of a brachial, femoral or renal guiding catheter. An additional marker is located at the guide wire exit notch and aids in locating the guide wire exit notch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature (iliac, femoral, popliteal, infra-popliteal and renal arteries), native or synthetic 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the VIATRAC™ 14 PLUS Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
0/2050
SEP = 6 2001
510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | Guidant Corporation
Advanced Cardiovascular Systems, Inc. |
|-----------------------------|--------------------------------------------------------------|
| Submitter's Address: | 3200 Lakeside Drive
Santa Clara, CA 95052 |
| Telephone:
Fax: | 408/845-1067
408/845-3743 |
| Contact Person: | Saba Modjarrad |
| Date Prepared: | June 29, 2001 |
| Device Trade Name: | VIATRAC™ 14 PLUS Peripheral Dilatation Catheter |
| Device Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Device Classification Name: | LIT |
| Device Classification: | Class II |
Summary of Substantial Equivalence:
The design, materials, and intended use features of VIATRACTM PLUS Peripheral Dilatation Catheter are substantially equivalent with regard to these features in the predicate device, the RX VIATRACTM 14 Peripheral Dilatation Catheter (K983055 and K000101).
Device Description:
The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is a rapid exchange catheter with an integrated shaft system and an XCELON™ (nylon blend) balloon bonded at the distal end. The shaft has a combination of a single lumen design at the proximal end a coaxial lumen at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The distal lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal shaft has a tapered stainless steel mandrel, which provides support and flexibility to the shaft and is attached at the proximal end.
The balloon, which has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.
The proximal end of the catheter has a single arm adaptor that provides access to the inflation lumen. It is designed with a luer-lock fitting for connection with an inflation device.
1
The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is available with balloon diameters of 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 mm, with lengths of 15, 20, 30, and 40 mm and in catheter lengths of 80 cm and 135 cm.
On the 135 cm catheter length, there are two proximal shaft markers (95 cm and 105 cm from the distal tip). On the 80 cm catheter length, there is a single proximal marker (55 cm from the distal tip). Both indicate the relative position of the catheter to the end of a brachial, femoral or renal guiding catheter. An additional marker is located at the guide wire exit notch and aids in locating the guide wire exit notch.
Intended Use:
The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is indicated for dilatation of stenoses in the peripheral vasculature (iliac, femoral, popliteal, infra-popliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Technological Characteristics:
Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate devices.
Performance Data:
The safety and effectiveness of the VIATRAC™ 14 PLUS Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. 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 abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 6 2001
Ms. Saba Modjarrad Regulatory Affairs Coordinator Guidant Corporation 3200 Lakeside Drive Santa Clara, CA 95054-2807
Re: K012050
Trade Name: VIATRAC™ 14 PLUS Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 10, 2001 Received: August 13, 2001
Dear Ms. Modjarrad:
We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application(PMA). 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 (PMA), 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 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Saba Modjarrad
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast of advised and I DTP blishing of your device complies with other requirements of the Act that I Dri has made a covernment and inistered by other federal agencies. You must comply or all the Act's requirements, including, but not limited to: registration (21 CFR Part 807); with an the Hot Progant 807); labeling (21 CFR Part 801); good manufacturing practice nstilly (21 OF Icroover), as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in as qualify tion control provisions (section 531-542 of the Act, 21 CFR 1000-1050).
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 nothloate 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 If you desire specific diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This alaguestions on the promotion and advertising of your device, (2017) 591-1010. Traditional (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 mormation on Jour responsal and Consumer 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,
Dala Tell
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number (if known) | K012050 |
|---|---|
| Device Name | VIATRACTM 14 PLUS Peripheral Dilatation Catheter |
| Indications for Use | The VIATRACTM 14 PLUS Peripheral Dilatation Catheter is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. |
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 Use__________________________________________________________________________________________________________________________________________________________
Division of Cardiovascular & Respiratory Devices
510(k) Number K012050