(90 days)
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 or therapeutic devices, rather than performing a therapeutic function itself.
No
Explanation: The device description states its purpose is to provide a pathway for introducing other medical instruments, not to diagnose conditions. It facilitates therapeutic procedures rather than identifying or characterizing diseases.
No
The device description clearly details a physical catheter with multiple material layers and radiopacity, 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 a guide catheter used to provide a pathway for introducing medical instruments into the body for general intravascular and coronary applications.
- Device Description: The description details the physical construction of the catheter, designed for insertion and manipulation within blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue.
This device is a medical device used in vivo (within the body) for interventional procedures.
N/A
Intended Use / Indications for Use
The 6 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 6 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 (comma separated list FDA assigned to the subject device)
DOO
Device Description
The shaft of the 6 F Wiseguide guide catheter utilizes 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 transitional flexibility to the distal curve area of the catheter.
The catheter 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
Not Found
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)
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 6 F Wiseguide catheter is adequate for its intended use.
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.
Not Found
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.
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
AUG / 8 1998
510(k) Notification SCIMED® 6 F Wiseguide Guide Catheter
11981788
Section 4
Summary of Safety and Effectiveness
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
General Provisions I.
| 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® 6 French Wiseguide™ Guide
Catheter | |
| Name of Predicate Devices | SCIMED® 7 French Wiseguide™ and 6
French Cyber Guide Catheters,
and Cordis® Corporation 6 French Vista
Brite Tip™ Guide Catheters | |
III. Device Description
II.
The shaft of the 6 F Wiseguide guide catheter utilizes 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 transitional flexibility to the distal curve area of the catheter.
The catheter 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 6 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.
V. Summary of Technological Characteristics:
The 6 F Wiseguide catheter is similar to SCIMED's currently marketed 7 F Wiseguide catheter (K974684).
Non-clinical Test Summary VI.
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 6 F Wiseguide catheter is adequate for its intended use. The 6 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
1280
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized bird or human figure.
AUG 1 8 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Melanie Raska Regulatory Affairs Specialist Scimed Life Systems, Inc. One Scimed Place Maple Grove, MN 55311-1566
Re: K981788 Scimed 6 French Wiseguide Guide Catheter Trade Name: Requlatory Class: II Product Code: DOO Dated: May 19, 1998 Received: May 20, 1998
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 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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
3
Page 2 - Ms. Melanie Raska
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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. Callehan
Thomas J. Callahan, Director Division of Cardiovascular, Respirator and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
AUG | 8 1998
510(k) Notification SCIMED® 6 F Wiseguide Guide Catheter
Section 2
Indications for Use
510(k) Number (if known)
Device Name: SCIMED® 6 French Wiseguide™ Guide Catheter
Indications for Use:
SCIMED 6 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
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices |
| 510(k) Number | K981788 |
|---|---|
| --------------- | --------- |
| Over The Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
2-1