(188 days)
K#853997, K#862117, K#874751, K#953114, K#931335
Not Found
No
The description focuses on the physical construction and intended use of a catheter, with no mention of AI, ML, image processing, or data analysis.
No.
Explanation: The device is described as being used for "percutaneous access to small vessel, distal anatomy," which indicates it is an access tool rather than a device intended to treat a specific medical condition or disease.
No
The device description states it is "used for percutaneous access to small vessel, distal anatomy" and its construction details, but does not mention any function for diagnosis or information gathering.
No
The device description clearly describes a physical catheter made of polyethylene with a single lumen and a Luer lock hub, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for percutaneous access to small vessel, distal anatomy." This describes a device used within the body for a procedural purpose (accessing vessels), not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a catheter used for physical access and potentially infusion, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or diagnostic testing.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. This device is a tool for accessing anatomical structures during a medical procedure.
N/A
Intended Use / Indications for Use
The Microferret™ catheter is used for percutaneous access to small vessel, distal anatomy.
Product codes
74 DQY
Device Description
The Microferret™ catheter is used for percutaneous access to small vessel, distal anatomy. Its single lumen construction provides graduated stiffness, from proximal being very soft. The material used to construct this device is polyethylene with a graduated transition of flexibility along the shaft. The proximal lub of the catheter is designed to conform with Luer lock standards (ANSI) which are compatibile with commercially available syringes. These materials are widely used in catheter device manufacturing and their biocompatibility has been verified. In addition, design validation studies have been performed to assure the device can be expected to perform its intended function when used according to the recommendations in the suggested instructions for use provided with the device.
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
design validation studies have been performed to assure the device can be expected to perform its intended function when used according to the recommendations in the suggested instructions for use provided with the device.
Key Metrics
Not Found
Predicate Device(s)
K#853997, K#862117, K#874751, K#953114, K#931335
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
510(k) Premarket Notification Microferret™ Catheter COOK INCORPORATED
1996
J. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted By:
April Lavender, RAC Vice President Regulatory Affairs COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 24 April 1996
Device:
Trade Name: Proposed Classification Name: Microferret™ Catheter Class II 74 DQY
Predicate Devices:
The Microferret™ catheter is substantially equivalent to other devices intended for perculancous vascular use in terms of indications for use, design, construction and materials equivally, this device is similar to numerous pre-Amendment COOK catheters, Trackers (K#853997, K#862117, K#874751), manufactured by Target Therapeutics®, San Jose, California, Evolution™ Microcatheters (K#953114) manufactured by Boston Scientific, Watertown, Massachusetts, Venture™ Infusion Catheters (K#931335) manufactured by Scimed Life Systems and distributed by Boston Scientific, Watertown, Massachusetts and others.
Device Description:
The Microferret™ catheter is used for percutaneous access to small vessel, distal anatomy. Its single lumen construction provides graduated stiffness, from proximal being very soft. The material used to construct this device is polyethylene with a graduated transition of flexibility along the shaft. The proximal lub of the catheter is designed to conform with Luer lock standards (ANSI) which are compatibile with commercially available syringes. These materials are widely used in catheter device manufacturing and their biocompatibility has been verified. In addition, design validation studies have been performed to assure the device can be expected to perform its intended function when used according to the recommendations in the suggested instructions for use provided with the device.
Summary of Clinical Use
This device has been marketed in Europe since 1992 by a European manufacturing firm owned by COOK Group Incorporated. There has been good clinical success with the device in its worldwide use to date. The firm has identified the primary risks of devices such as the Microferret™ catheter and have included these potential risks in the device labeling. These risks are not specific to the Microferret™ catheter, but apply to vascular catheters in general. There have been no adverse health effects associated with the use of this catheter during its marketing history.
Substantial Equivalence
This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging sunilar to the devices currently marketed and distributed by COOK INCORPORATED. This device will undergo sterilization similar to the devices currently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.