(65 days)
Not Found
Not Found
No
The description focuses on the physical construction and functional performance of a guide catheter, with no mention of AI or ML capabilities.
No
The device is a guide catheter that provides a pathway for other medical instruments, including therapeutic devices, but it is not therapeutic itself.
No
The device, a guide catheter, is explicitly described as providing a pathway for introducing medical instruments and therapeutic devices. It is not designed to gather information about a patient's condition for diagnosis.
No
The device description clearly details a physical catheter with multiple material layers and a radiopaque tip, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "general intravascular and coronary applications" and provides a pathway for introducing medical instruments. This describes a device used within the body for therapeutic or interventional procedures.
- Device Description: The description details the physical construction of a catheter designed to be inserted into blood vessels.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
The device is a medical device used for interventional procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The 7 F Wiseguide catheter is designed to provide a pathway through which medical instruments, such as stents, balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.
SCIMED 7 French Wiseguide guide catheter is intended for use in general intravascular and coronary applications. It provides a pathway through which medical instruments, such as stents, balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.
Product codes
73 DQY
Device Description
The shaft of the 7 F Wiseguide guide catheter utilizes common biocompatible materials and consists of the following three layers: 1) the inner layer that provides a low coefficient of friction and facilitates passage of medical devices such as stents, balloon dilatation catheters, guide wires or other therapeutic devices, 2) the middle layer that extends from the shaft to the tip to provide kink resistance and torque control; and 3) the outer layer which provides stiffness, backup support, curve retention and radiopacity.
In addition, the outer primary catheter shaft is constructed of various material durometers providing a distal curve area of the catheter with transitional flexibility.
The distal tip is radiopaque to allow visualization under fluoroscopy during a procedure.
The devices will be provided sterile and are intended for one procedure use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravascular and coronary applications, not intended for use in the cerebral 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
Functional testing consisted of pressure burst, tip bond tensile, shaft tensile, hub tensile, material adhesion, tip coefficient of friction, force transmitted by catheter tip, torque response and dye flow. Test results verified that the 7 F Wiseguide catheter is adequate for its intended use.
Key Metrics
Not Found
Predicate Device(s)
SCIMED® 8 French Wiseguide™ and 7 French Triguide® -Max Guide Catheters, and Cordis® Corporation 7 French Vista Brite Tip™ Guide Catheters
Reference Device(s)
Not Found
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
Section 4
Summary of Safety and Effectiveness
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
FEB 1 9 1998
I. General Provisions
| Submitter's Name
and Address | SCIMED Life Systems, Inc.
One SCIMED Place
Maple Grove, Minnesota 55311 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Melanie Raska
(612) 494-2962 |
| Classification Name | Similar to Diagnostic Intravascular
Catheters (21CFR Part 870.1200) |
| Common or Usual Name | Coronary Guide Catheter |
| Proprietary Name | SCIMED® 7 French Wiseguide™ Guide
Catheter |
| Name of Predicate Devices | SCIMED® 8 French Wiseguide™ and 7
French Triguide® -Max Guide Catheters,
and Cordis® Corporation 7 French Vista
Brite Tip™ Guide Catheters |
III. Device Description
II.
The shaft of the 7 F Wiseguide guide catheter utilizes common biocompatible materials and consists of the following three layers: 1) the inner layer that provides a low coefficient of friction and facilitates passage of medical devices such as stents, balloon dilatation catheters, guide wires or other therapeutic devices, 2) the middle layer that extends from the shaft to the tip to provide kink resistance and torque control; and 3) the outer layer which provides stiffness, backup support, curve retention and radiopacity.
In addition, the outer primary catheter shaft is constructed of various material durometers providing a distal curve area of the catheter with transitional flexibility.
The distal tip is radiopaque to allow visualization under fluoroscopy during a procedure.
The devices will be provided sterile and are intended for one procedure use only.
1
Section 4
Summary of Safety and Effectiveness (cont.)
IV. Intended Use
The 7 F Wiseguide catheter is designed to provide a pathway through which medical instruments, such as stents, balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.
Summary of Technological Characteristics: V.
The 7 F Wiseguide catheter is similar to SCIMED's currently marketed 8 F Wiseguide catheter.
VI. Non-clinical Test Summary
Functional testing consisted of pressure burst, tip bond tensile, shaft tensile, hub tensile, material adhesion, tip coefficient of friction, force transmitted by catheter tip, torque response and dye flow. Test results verified that the 7 F Wiseguide catheter is adequate for its intended use. The 7 F Wiseguide catheter is considered substantially equivalent to guide catheters currently marketed by SCIMED and Cordis based on a comparison of intended use, the design, and the results of in-vitro testing and evaluation.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of a circular emblem containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
FEB 1 9 1998
Ms. Melanie Raska Requlatory Affairs Specialist Scimed Life System, Inc. Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311-1566
Re : K974684 Scimed® 7 French Wiseguide™ Guide Catheter Regulatory Class: II (Two) Product Code: 73 DQY December 15, 1997 Dated: Received: December 16, 1997
Dear Ms. Raska:
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 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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality and him 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
3
Page 2 - Ms. Melanie Raska
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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Notification SCIMED® 7 F Wiseguide Guide Catheter
Section 2
Indications for Use
510(k) Number (if known) _
Device Name: SCIMED® 7 French Wiseguide™ Guide Catheter
Indications for Use:
SCIMED 7 French Wiseguide guide catheter is intended for use in general intravascular and coronary applications. It provides a pathway through which medical instruments, such as stents, balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.
(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 __
(Optional Format 1-2-96)
(Division Sign-Off) Division of Cardinvasc Dar and Neurological Devices 510(k) Number