(90 days)
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.
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.
The provided text describes the 510(k) notification for the SCIMED® 6 French Wiseguide™ Guide Catheter. It outlines the device's description, intended use, and a summary of non-clinical testing. However, it does not contain the level of detail typically found in a study report proving acceptance criteria for an AI/ML medical device.
Based on the provided text, the device is a physical medical device (guide catheter), not an AI/ML-driven software device. Therefore, many of the requested criteria (e.g., sample sized for the test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable.
Here's the information that can be extracted and a clear indication of what is not present due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied from Functional Testing) | Reported Device Performance |
|---|---|
| Adequate Pressure burst strength | Verified |
| Adequate Tip bond tensile strength | Verified |
| Adequate Shaft tensile strength | Verified |
| Adequate Hub tensile strength | Verified |
| Adequate Material adhesion | Verified |
| Adequate Tip coefficient of friction | Verified |
| Adequate Force transmitted by catheter tip | Verified |
| Adequate Torque response | Verified |
| Adequate Dye flow | Verified |
| Biocompatibility of materials | Utilizes biocompatible materials |
| Radiopacity for visualization under fluoroscopy | Radiopaque to allow visualization |
| Kink resistance | Provided by middle layer |
| Torque control | Provided by middle layer |
| Stiffness, backup support, curve retention | Provided by outer layer |
| Transitional flexibility to distal curve area | Constructed of various material durometers |
| Maintains sterility | Provided sterile |
| Intended for one procedure use only | Intended for one procedure use only |
Explanation of "Verified": The document states: "Test results verified that the 6 F Wiseguide catheter is adequate for its intended use." Specific quantitative acceptance criteria (e.g., "pressure burst > X PSI") and the exact numerical results are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Not applicable as this is a physical medical device. Testing involved physical device properties rather than a data-based test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical medical device. Ground truth is based on engineering specifications and physical testing standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is a physical medical 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 guide catheter and does not involve AI or human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- The ground truth for this device's performance is based on engineering specifications and established functional performance standards for guide catheters, verified through non-clinical laboratory testing.
8. The sample size for the training set:
- Not applicable. This is a physical medical device; there is no training set in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device; there is no training set in the context of AI/ML.
Summary of Non-Clinical Testing Section for Confirmation:
The document clearly states: "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." This confirms the assessment that the acceptance criteria are related to the physical and mechanical properties of the catheter, not to AI/ML performance metrics. The device's equivalency was established by comparing its intended use, design, and in-vitro testing results to existing predicate devices.
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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 Nameand Address | SCIMED Life Systems, Inc.One SCIMED PlaceMaple Grove, Minnesota 55311 | |
|---|---|---|
| Contact Person | Melanie Raska(612) 494-2962 | |
| Classification Name | Similar to Diagnostic IntravascularCatheters (21CFR Part 870.1200) | |
| Common or Usual Name | Coronary Guide Catheter | |
| Proprietary Name | SCIMED® 6 French Wiseguide™ GuideCatheter | |
| Name of Predicate Devices | SCIMED® 7 French Wiseguide™ and 6French Cyber Guide Catheters,and Cordis® Corporation 6 French VistaBrite 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.
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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.
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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
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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
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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
§ 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).