(26 days)
The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neuro vasculature.
The device description of the VISTA BRITE TIP and ENVOY Guiding Catheters is as follows.
• 6 French
• Single lumen catheter featuring a nylon body reinforced with a tightly wound stainless steel braid wire
• The transition segment is designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip.
The provided text is a 510(k) summary for the VISTA BRITE TIP and ENVOY Guiding Catheters. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or reporting on a clinical study where the device performance is measured against such criteria.
Therefore, the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria is not present in the provided document.
Here's why and what information is available:
- Type of Submission: This is a 510(k) premarket notification. The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, intended use, and performance characteristics to the predicate. It does not usually require new clinical studies to establish safety and effectiveness from scratch, especially for Class II devices like this one.
- Lack of Performance Criteria and Study: The document explicitly states: "The FDA under section 514 of the Food, Drug and Cosmetic Act has not established performance standards." This indicates that there are no pre-defined quantitative performance criteria that the device must meet in a specific study format. Instead, the focus is on a comparison to an already approved device.
- Basis for Equivalence: The "Summary of Substantial Equivalence" section states: "The VISTA BRITE TIP and ENVOY Guiding Catheters are substantially equivalent to the previously cleared VISTA BRITE TIP and ENVOY Guiding Catheters." This implies that the device's characteristics (design, materials, intended use) are similar enough to existing, approved devices that no new performance study with acceptance criteria is deemed necessary for market clearance.
In summary, the document does not contain the information you requested because its purpose is to demonstrate substantial equivalence, not to report on a study meeting specific performance acceptance criteria.
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Attachment 4
AUG 1 8 1998
Summary of Safety and Effectiveness
| GeneralProvisions | Trade Name: VISTA BRITE TIP and ENVOY Guiding CatheterCommon/Classification Name: Percutaneous Catheter |
|---|---|
| Name ofPredicateDevices | • Cordis Corporation VISTA BRITE TIP Guiding Catheter• Cordis Endovascular Systems, Inc. ENVOY Guiding Catheter |
| Classification | Class II |
| PerformanceStandards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not establishedperformance standards. |
| Intended Useand DeviceDescription | The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use forintravascular introduction of interventional/diagnostic devices into the coronary,peripheral, and neuro vasculature. |
| The device description of the VISTA BRITE TIP and ENVOY Guiding Catheters isas follows.• 6 French | |
| • Single lumen catheter featuring a nylon body reinforced with a tightly woundstainless steel braid wire• The transition segment is designed with nylons of different durometers (stiffness)to provide a gradual decrease in material stiffness from the catheter body to thetip. | |
| Biocompatibility | All materials used in the VISTA BRITE TIP and ENVOY Guiding Catheters arebiocompatible. |
| Summary ofSubstantialEquivalence | The VISTA BRITE TIP and ENVOY Guiding Catheters are substantially equivalentto the previously cleared VISTA BRITE TIP and ENVOY Guiding Catheters. |
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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1998
Mr. Martine D. Schneider Sr. Regulatory Affairs Associate Cordis Corporation Cordis Endovascular 14000 N.W. 57th Court Miami Lakes, FL 33014
Re: K982770 Trade Name: 6F Envoy Guiding Catheter Requlatory Class: II Product Code: DQY Dated: July 22, 1998 Received: July 23, 1998
Dear Mr. Schneider:
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 Requlations, 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 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 Reqister. Please note: this
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Page 2 - Mr. Martine D. Schneider
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 requlations.
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) 594-4618. 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" (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,
Thomas J. Callahon
Thomas J. Callaha Director Division of Cardiovascular, Respirator and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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. Attachment 2
Indications for Use Statement
| 510(k) Number(if known) | The 510(k) number has not yet been assigned. |
|---|---|
| Device Name | VISTA BRITE TIP and ENVOY Guiding Catheters |
| Indications forUse | The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use forintravascular introduction of interventional/diagnostic devices into the coronary,peripheral, and neuro vasculature. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tia A Re
(Division Sign-Off) Division of · a ascult: and Neurologics Devices
510(k) Number K982770
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
§ 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).