(89 days)
SCIMED guide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature
The shaft of the 8 F Wiseguide guide catheter utilizes common biocompatible materials and consists of the following three layers: 1) the inner polytetrafluoroethylene (PTFE) layer that provides a low coefficient of friction and facilitates easy passage of medical devices such as balloon dilatation catheters, guide wires or other therapeutic devices, 2) the middle layer which is made of braided stainless steel wire that extends from the shaft to the tip to provide kink resistance, torque control and support and 3) the outer layer, manufactured from Pebax® and a radiopaque filler, which provides stiffness, memory and radiopacity.
In addition, the distal 5.8 to 17.5 inches (depending on the curve style) of the outer primary catheter shaft is constructed of multiple sections of Pebax. These sections are composed of durometers of Pebax providing a distal curve area of the catheter with transitional flexibility. The catheter is assembled as components over a core mandrel. The catheter shaft is then heat fused, forming a composite catheter shaft. This process results in a continuous inner and middle layer and a seamless outer shaft layer.
The distal tip is made of Pebax and is radiopaque to allow visualization under fluoroscopy during a procedure.
The catheters utilize a one piece Pebax hub/strain relief that is molded to the proximal end of the guide catheter shaft. The 8 F Wiseguide Guide Catheters have a 0.086" ID. The catheters will be available in lengths ranging from 40 to 125 cm, with optional side holes. The devices will be provided sterile and are intended for one procedure use only.
The provided text describes a medical device, the SCIMED® 8 French Wiseguide™ Guide Catheter, and its clearance process, but it does not present specific acceptance criteria or a dedicated study proving the device meets those criteria in the way a diagnostic AI/ML device submission would.
Instead, this document (K970823) is a 510(k) premarket notification for a predicate device. The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to meet pre-defined performance acceptance criteria with a formal study as you might find for a novel diagnostic device.
However, I can extract the relevant information and present it in the requested format, interpreting "acceptance criteria" based on the functional testing mentioned to demonstrate substantial equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a physical medical device, not a diagnostic AI/ML system, "acceptance criteria" are not explicitly stated in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, acceptance is demonstrated by successfully passing functional tests and showing substantial equivalence to predicate devices. The "reported device performance" refers to the verification that these tests were passed.
| Acceptance Criteria (Implied by Functional Testing for Substantial Equivalence) | Reported Device Performance (Verification) |
|---|---|
| Maintain integrity under pressure (Pressure Burst) | Test results verified adequate for intended use. |
| Secure connection of the tip (Tip Bond Tensile) | Test results verified adequate for intended use. |
| Sufficient shaft strength (Shaft Tensile) | Test results verified adequate for intended use. |
| Secure connection of the hub (Hub Tensile) | Test results verified adequate for intended use. |
| Acceptable friction for device passage (Tip Coefficient of Friction) | Test results verified adequate for intended use. |
| Appropriate force transmission (Force Transmitted by Catheter Tip) | Test results verified adequate for intended use. |
| Adequate torque response (Torque Testing) | Test results verified adequate for intended use. |
| Biocompatibility | Biocompatibility testing conducted and passed. |
| Shelf life | Shelf life testing conducted and passed. |
| Overall design and intended use similar to predicate devices | Considered substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of diagnostic data. The evaluation was primarily through non-clinical functional testing of the physical device. The sample size for these specific engineering/functional tests (e.g., number of catheters tested for pressure burst) is not reported in the provided text.
- Data Provenance: Not applicable in the context of patient data. The tests are in-vitro (bench testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The "ground truth" for functional testing of a physical device is typically established by engineering specifications and objective measurements, not expert consensus on diagnostic images or pathology.
4. Adjudication Method for the Test Set
- Not applicable. There is no "adjudication method" in the sense of reconciling expert opinions for a ground truth dataset, as the testing involves objective physical measurements.
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
- No. This is a physical medical device (coronary guide catheter), not an AI/ML diagnostic device. Therefore, an MRMC study and AI assistance are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- No. This is a physical medical device. No algorithm or standalone performance study was conducted.
7. The Type of Ground Truth Used
- For the functional tests, the "ground truth" would be engineering specifications and established test methods (e.g., a certain pressure must be withstood, a certain tensile strength achieved, a specific coefficient of friction measured).
8. The Sample Size for the Training Set
- Not applicable. This being a physical device, there is no "training set" in the context of an AI/ML model. Device development involves design iterations and manufacturing process refinement, not algorithmic training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set as per AI/ML context.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" described in the document is a non-clinical test summary focusing on the physical and material properties of the SCIMED® 8 French Wiseguide™ Guide Catheter. This testing was conducted to demonstrate its substantial equivalence to already marketed predicate devices (SCIMED® 8 French Cyber™ Guide Catheters and Cordis® Corporation, 8 French Vista Brite Tip™ Guide Catheters).
The tests performed included:
- Pressure burst
- Tip bond tensile
- Shaft tensile
- Hub tensile
- Tip coefficient of friction
- Force transmitted by the catheter tip
- Torque testing
- Biocompatibility
- Shelf life testing
The results of these in-vitro tests "verified that the 8 F Wiseguide catheter is adequate for its intended use." The conclusion drawn from these tests, along with a comparison of the device's intended use and design, was that the new catheter is substantially equivalent to the predicate devices. This finding of substantial equivalence by the FDA (as indicated in the clearance letter K970823) allows the device to be marketed. There is no mention of a formal clinical trial or a diagnostic performance study as would be required for an imaging or AI/ML device.
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Section 4
Summary of Safety and Effectiveness
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
I. General Provisions
| Submitter's Nameand Address | SCIMED Life Systems, Inc.One SCIMED PlaceMaple Grove, Minnesota 55311 |
|---|---|
| Contact Person | Angela Raun(612) 494-2456 |
| Classification Name | Similar to Diagnostic IntravascularCatheters (21CFR Part 870.1200) |
| Common or Usual Name | Coronary Guide Catheter |
| Proprietary Name | SCIMED® 8 French Wiseguide™ GuideCatheter |
| Name of Predicate Devices | SCIMED® 8 French Cyber™ GuideCatheters and Cordis® Corporation,8 French Vista Brite Tip™ Guide Catheters |
III. Device Description
II.
The shaft of the 8 F Wiseguide guide catheter utilizes common biocompatible materials and consists of the following three layers: 1) the inner polytetrafluoroethylene (PTFE) layer that provides a low coefficient of friction and facilitates easy passage of medical devices such as balloon dilatation catheters, guide wires or other therapeutic devices, 2) the middle layer which is made of braided stainless steel wire that extends from the shaft to the tip to provide kink resistance, torque control and support and 3) the outer layer, manufactured from Pebax® and a radiopaque filler, which provides stiffness, memory and radiopacity.
In addition, the distal 5.8 to 17.5 inches (depending on the curve style) of the outer primary catheter shaft is constructed of multiple sections of Pebax. These sections are composed of durometers of Pebax providing a distal curve area of the catheter with transitional flexibility. The catheter is assembled as components over a core mandrel. The catheter shaft is then heat fused, forming a composite catheter shaft. This process results in a continuous inner and middle layer and a seamless outer shaft layer.
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Section 4
【都】【于】【
Summary of Safety and Effectiveness, cont.
The distal tip is made of Pebax and is radiopaque to allow visualization under fluoroscopy during a procedure.
The catheters utilize a one piece Pebax hub/strain relief that is molded to the proximal end of the guide catheter shaft. The 8 F Wiseguide Guide Catheters have a 0.086" ID. The catheters will be available in lengths ranging from 40 to 125 cm, with optional side holes. The devices will be provided sterile and are intended for one procedure use only.
IV. Intended Use
The SCIMED guide catheters are designed to provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.
V. Summary of Technological Characteristics:
The 8 F Wiseguide Guide Catheters are similar to SCIMED's currently marketed 8 F Cyber Guide Catheters with the exception of the distal flexible sections providing varying degrees of flexibility in the distal curve area.
VI. Non-clinical Test Summary
Functional testing consisted of pressure burst, tip bond tensile, shaft tensile, hub tensile, tip coefficient of friction, force transmitted by the catheter tip, and torque testing. Biocompatibility and shelf life testing has also been conducted. Test results verified that the 8 F Wiseguide catheter is adequate for its intended use. The 8 F Wiseguide guide catheters are 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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1997 JUN
Ms. Angela Raun --------------------------------------------------------------------------------------------------------------------------------------------------------------Sr. Requlatory Affairs Specialist Scimed Life Systems, Inc. One Scimed Place Maple Grove, Minnesota 55311-1566
K970823 Re : SCIMED® 8 French Wiseguide™ Guide Catheter Regulatory Class: II (two) Product Code: DQY Dated: March 5, 1997 Received: March 6, 1997
Dear Ms. Raun:
44
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions.
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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.
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 at (301) 443-6597.
Sincerely yours,
Thomas J. Callehan
Thomas J. Čallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Notification SCIMED® 8 F Guide Catheter
Section 2
Indications for Use
510(k) Number (if known) K910823
Device Name: SCIMED® 8 French Wiseguide™ Guide Catheter
Indications for Use:
SCIMED guide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are 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__ OR Over The Counter Use
(Per 21 CFR 801.109)
(Division Sign-Off) (Optional Format 1-2-96)
Sion of Cardiovascular, Respiratory,
Neurological Devices
(K) Number _**_ K970823
§ 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).