(42 days)
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SCIMED® 6,7,8,9 and 10 French TRIGUIDE® Guide Catheters, Cordis® Corporation Vista Brite Tip™ Guide Catheter
No
The description focuses on the physical construction and materials of a guide catheter, with no mention of AI or ML capabilities.
No
The device is described as providing a pathway for other medical instruments and therapeutic devices, but not performing a therapeutic action itself.
No
The device description clearly states its purpose is to provide a pathway for introducing medical instruments. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly outlines a physical catheter with multiple material layers and components, 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 designed to provide a pathway for introducing medical instruments into the body. This is an in vivo (within a living organism) application.
- Device Description: The description details the physical construction of a catheter designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro), such as blood, urine, or tissue samples, to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a tool for delivering other medical devices within the body.
N/A
Intended Use / Indications for 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.
Product codes
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Device Description
The modified 6F-10F SCIMED guide catheter shafts consist of 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 torque control and support and 3) the outer layer, manufactured from Pebax®, which provides stiffness, memory and radiopacity. The distal tip is made of Pebax and is radiopaque. The tip is heat fused to the distal end of the shaft. The catheters utilize a one piece Pebax hub/strain relief that is molded to the proximal end of the guide catheter shaft. The devices will be provided sterile and are intended for one procedure use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Functional testing consisted of pressure burst, material adhesion and device passage testing. Test results verified that the modified catheter with the PTFE inner is adequate for its intended use. The modified SCIMED 6-10 French 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.
Key Metrics
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Predicate Device(s)
SCIMED® 6,7,8,9 and 10 French TRIGUIDE® Guide Catheters, Cordis® Corporation Vista Brite Tip™ Guide Catheter
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
K961280 MAY 15 1996
SECTION 3 SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990) Prepared April 2, 1996
| I. | General Provisions: | |
|---|---|---|
| Submitter's Name and Address: | SCIMED Life Systems, Inc. | |
| Ore SCIMED Place | ||
| Maple Grove, Minnesota 55311 | ||
| Contact Person: | Angela Raun | |
| (612) 494-2456 | ||
| Classification Name: | Similar to Diagnostic Intravascular | |
| Catheters (21CFR Part 870.1200) | ||
| Common or Usual Name: | Coronary Guide Catheter | |
| Proprietary Name: | SCIMED® 6,7,8,9 and10 French | |
| TRIGUIDE® Guide Catheters | ||
| II. | Name of Predicate Devices: | |
| SCIMED® 6,7,8,9 and 10 French | ||
| TRIGUIDE® Guide Catheters, and | ||
| Cordis® Corporation Vista Brite Tip™ | ||
| Guide Catheter |
III. Device Description:
The modified 6F-10F SCIMED guide catheter shafts consist of 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 torque control and support and 3) the outer layer, manufactured from Pebax®, which provides stiffness, memory and radiopacity. The distal tip is made of Pebax and is radiopaque. The tip is heat fused to the distal end of the shaft. The catheters utilize a one piece Pebax hub/strain relief that is molded to the proximal end of the guide catheter shaft. The devices will be provided sterile and are intended for one procedure use only.
1
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 modified 6-10 French guide catheters are identical to SCIMED's currently marketed 6-10 French guide catheters with the one exception being that the catheter's inner fluoropolymer liner is composed of polytetrafluoroethylene (PTFE) instead of fluorinated ethylene propylene (FEP).
VI. Non-clinical Test Summary:
Functional testing consisted of pressure burst, material adhesion and device passage testing. Test results verified that the modified catheter with the PTFE inner is adequate for its intended use. The modified SCIMED 6-10 French 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.