(71 days)
Not Found
No
The device description focuses on the physical characteristics and intended use of a guiding catheter and inner catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is described as a "guiding catheter" intended to "provide a pathway through which therapeutic and diagnostic devices are introduced into the peripheral vasculature." It facilitates the passage of other devices but does not itself provide therapy.
No
The device is a guiding catheter that provides a pathway for therapeutic and diagnostic devices. It does not perform diagnostic functions itself.
No
The device description clearly details a physical catheter with specific dimensions, materials (implied by the description of a catheter), and intended use as a physical pathway within the body. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a pathway for introducing therapeutic and diagnostic devices into the peripheral vasculature. This is an in-vivo procedure, meaning it's performed within the living body.
- Device Description: The description details a physical catheter designed to be inserted into blood vessels. It facilitates the passage of other devices and allows for contrast medium injections. This is consistent with an in-vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body's internal structures in the way a guiding catheter does.
N/A
Intended Use / Indications for Use
The peripheral guiding catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced into the peripheral vasculature.
The inner catheter is intended to provide support during the introduction and withdrawal of a guiding catheter.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The VERIPATH™ Peripheral Guiding Catheter is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices such as balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices, etc.
Guiding Catheter
The guiding catheter is a single lumen catheter that allows contrast medium iniections and facilitates the intravascular passage of diagnostic and therapeutic devices into the vascular system.
The guiding catheter has a standard working length of 50 cm and a standard overall length of 56 cm, but can be produced in overall lengths from 40 to 80 cm, depending upon physician preference and patient size.
The guiding catheter is available in three diameters/French sizes (F), as follows: 6F (0.068" ID, 0.82" OD), 7F (0.078" ID, 0.93" OD), 8F (0.088" ID, 0.105" OD). The guiding catheter is available in varying tip shapes designed for peripheral use. Each shape is specific for patient anatomy and physician preference, and therefore a wide range of shapes is available.
Inner Catheter
Also included in the VERIPATH™ device package is an inner catheter. The inner catheter is a single lumen catheter with a luer at the proximal end and is recommended for use with the guiding catheter to aid in the introduction and withdrawal of the guiding catheter.
The inner catheter has a standard working length of 65 cm and a standard overall length of 67 cm, but can be produced in lengths from 55 to 95 cm depending upon physician preference and patient size. The inner catheter is straight and available in three diameters/French sizes (F), as follows: 6F (0.062" OD), 7F (0.072" OD), and 8F (0.082" OD) and may be sold either with or without a taper at the tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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 VERIPATH™ Peripheral Guiding Catheter have been demonstrated through data collected from nonclinical 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
Appendix A - 510(k) Summary
| Submitter | Guidant Corporation, Vascular Intervention
Advanced Cardiovascular Systems, Inc.
26531 Ynez Road, Temecula CA 92591
Contact: Stacey Simon
Phone: (909) 914-2800, Fax: (909) 914-2146 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date | December 15, 1999 |
| Device name | Device Trade Name: VERIPATH™ Peripheral Guiding Catheter
Device Common Name: Percutaneous Catheter
Device Classification Name: Guiding Catheter
Device Classification: Class II |
| Summary of
substantial
equivalence | The design, materials, method of operation, and intended use features
of the Guidant VERIPATH™ Peripheral Guiding Catheter are
substantially equivalent with regard to these features in the predicate
device, the ACS VIKING™ Guiding Catheter (K972484). |
| Device
description | The VERIPATH™ Peripheral Guiding Catheter is recommended for
use during vascular procedures in conjunction with interventional
and/or diagnostic devices such as balloon dilatation catheters,
atherectomy devices, stent delivery systems, intravascular ultrasound
devices, etc. |
1
Appendix A - 510(k) Summary, Continued
Device description, Continued
Guiding Catheter
The guiding catheter is a single lumen catheter that allows contrast medium iniections and facilitates the intravascular passage of diagnostic and therapeutic devices into the vascular system.
The guiding catheter has a standard working length of 50 cm and a standard overall length of 56 cm, but can be produced in overall lengths from 40 to 80 cm, depending upon physician preference and patient size.
The guiding catheter is available in three diameters/French sizes (F), as follows: 6F (0.068" ID, 0.82" OD), 7F (0.078" ID, 0.93" OD), 8F (0.088" ID, 0.105" OD). The guiding catheter is available in varying tip shapes designed for peripheral use. Each shape is specific for patient anatomy and physician preference, and therefore a wide range of shapes is available.
Inner Catheter
Also included in the VERIPATH™ device package is an inner catheter. The inner catheter is a single lumen catheter with a luer at the proximal end and is recommended for use with the guiding catheter to aid in the introduction and withdrawal of the guiding catheter.
The inner catheter has a standard working length of 65 cm and a standard overall length of 67 cm, but can be produced in lengths from 55 to 95 cm depending upon physician preference and patient size. The inner catheter is straight and available in three diameters/French sizes (F), as follows: 6F (0.062" OD), 7F (0.072" OD), and 8F (0.082" OD) and may be sold either with or without a taper at the tip.
2
Appendix A - 510(k) Summary, Continued
| Intended use | The peripheral guiding catheter is intended to provide a pathway
through which therapeutic and diagnostic devices are introduced into
the peripheral vasculature. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
statement | Please see above for intended use statement. |
| Technological
characteristics | The Guidant VERIPATH™ Peripheral Guiding Catheter incorporates
similar design, components, method of operation, and intended use of
the predicate device, the ACS VIKING™ Guiding Catheter, with
exception of the dimensions. |
| Performance
data | The safety and effectiveness of the VERIPATH™ Peripheral Guiding
Catheter have been demonstrated through data collected from
nonclinical bench tests and analyses. |
3
920
Boo
FEB 25 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Stacey Simon Guidant Corporation Vascular Intervention Group 26531 Ynez Road Temecula, CA 92591-4628
Re: K994229 VERIPATH™ Peripheral Guiding Catheter Regulatory Class: II (two) Product Code: DQY February 9, 2000 Dated: February 10, 2000 Received:
Dear Ms. Simon:
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 requlations affecting your device can be found in the Code of Federal Regulations, 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 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 Failure to comply with the GMP regulation may result in assumptions. regulatory 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 - Ms. Stacey Simon
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) 594-4648. 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"(21 CFR 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,
Autry Smith for
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
FEB 2 5 2000
GUIDANT
Indications for Use Statement
| 510(k) number (if known): | The 510(k) number has not been issued yet. |
|---|---|
| Device name | VERIPATH™ Peripheral Guiding Catheter |
| Intended Use | The peripheral guiding catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced into the peripheral vasculature. |
| The inner catheter is intended to provide support during the introduction and withdrawal of a guiding catheter. |
Division Sign-Off), vascular, Respiratory, Respiratory,
Division of Cardiovascular, Respiratory,
Division of Carcal Devices
Bod Neurological Devices Off)
(Division Sign-Off Cardio)
(Division of Cardios Division of Cardio devices
Division of Cardiogical Devices
Division of Cardiogical Devices
and Neurological Devices Devices
and Neurological Devices
(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 (Optional Format 1-1-96)
Guidant Corporation Vascular Intervention Group 26531 Ynez Road, Temecula, CA 92591-4628 Mailing Address: P.O. Box 9018, Temecula, CA 92589-9018 Tel 909.914.2400