(71 days)
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.
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. 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. 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.
The provided text is a 510(k) Summary for the VERIPATH™ Peripheral Guiding Catheter. It indicates that the device's safety and effectiveness were demonstrated through nonclinical bench tests and analyses. However, it does not contain the detailed information necessary to fully answer all aspects of your request.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "The safety and effectiveness of the VERIPATH™ Peripheral Guiding Catheter have been demonstrated through data collected from nonclinical bench tests and analyses." However, it does not provide specific acceptance criteria or the reported performance data from these bench tests. This level of detail is typically included in an exhaustive test report, which is not part of this 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "nonclinical bench tests and analyses." This implies that the testing was performed in a lab setting, not on human subjects. Therefore, there is no "test set" in the sense of patient data, nor is there information about data provenance (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Since the testing was nonclinical bench tests, there wouldn't be "experts" establishing ground truth in the context of clinical interpretation or diagnosis. The ground truth for bench tests would be defined by engineering specifications and measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this refers to clinical evaluation and consensus building among human readers, which is not mentioned for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical medical instrument (a guiding catheter), not an AI-based diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for the same reason as point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For nonclinical bench tests, the "ground truth" would be the engineering specifications and performance targets for characteristics like material strength, dimensional accuracy, flow rates, flexibility, and torqueability. The document does not specify these metrics or their targets.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
In summary, based on the provided 510(k) summary, the VERIPATH™ Peripheral Guiding Catheter demonstrated safety and effectiveness through nonclinical bench tests and analyses. However, the document does not include the detailed performance data, specific acceptance criteria, or information on clinical studies that would be necessary to answer most of your questions. The nature of the device (a physical catheter) means that many of your questions related to AI, clinical imaging, and expert review are not applicable.
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Appendix A - 510(k) Summary
| Submitter | Guidant Corporation, Vascular InterventionAdvanced Cardiovascular Systems, Inc.26531 Ynez Road, Temecula CA 92591Contact: Stacey SimonPhone: (909) 914-2800, Fax: (909) 914-2146 |
|---|---|
| Date | December 15, 1999 |
| Device name | Device Trade Name: VERIPATH™ Peripheral Guiding CatheterDevice Common Name: Percutaneous CatheterDevice Classification Name: Guiding CatheterDevice Classification: Class II |
| Summary ofsubstantialequivalence | The design, materials, method of operation, and intended use featuresof the Guidant VERIPATH™ Peripheral Guiding Catheter aresubstantially equivalent with regard to these features in the predicatedevice, the ACS VIKING™ Guiding Catheter (K972484). |
| Devicedescription | The VERIPATH™ Peripheral Guiding Catheter is recommended foruse during vascular procedures in conjunction with interventionaland/or diagnostic devices such as balloon dilatation catheters,atherectomy devices, stent delivery systems, intravascular ultrasounddevices, etc. |
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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.
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Appendix A - 510(k) Summary, Continued
| Intended use | The peripheral guiding catheter is intended to provide a pathwaythrough which therapeutic and diagnostic devices are introduced intothe peripheral vasculature. |
|---|---|
| Indicationsstatement | Please see above for intended use statement. |
| Technologicalcharacteristics | The Guidant VERIPATH™ Peripheral Guiding Catheter incorporatessimilar design, components, method of operation, and intended use ofthe predicate device, the ACS VIKING™ Guiding Catheter, withexception of the dimensions. |
| Performancedata | The safety and effectiveness of the VERIPATH™ Peripheral GuidingCatheter have been demonstrated through data collected fromnonclinical bench tests and analyses. |
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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.
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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
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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
§ 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).