(8 days)
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Not Found
No
The document describes a physical catheter for infusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is primarily for infusion, which is a delivery mechanism, not a direct therapeutic action itself. While the infused agents may be therapeutic, the device's function is delivery.
No
The device is used for the infusion of substances into the vasculature, not for diagnosing medical conditions.
No
The device description clearly describes a physical catheter, which is a hardware component, not a software-only 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 the controlled selective infusion of pharmacologic agents or contrast media into the general vasculature. This is a therapeutic or diagnostic procedure performed in vivo (within the living body).
- Device Description: The device is a catheter designed to be introduced into the vasculature for delivery of substances. This is a medical device used for direct intervention in the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The description of the MTI Reinforced Infusion Catheter does not involve the analysis of such specimens.
Therefore, the MTI Reinforced Infusion Catheter is a medical device used for infusion within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MTI Reinforced Infusion Catheter is intended to be used for the controlled selective infusion of pharmacologic physician-specified agents or radiopaque contrast media general the into vasculature.
Product codes
FOZ
Device Description
The MTI TruLine™ Reinforced Infusion Catheter is a single-lumen plastic catheter designed to be introduced over a guidewire into the vasculature. Once positioned, various pharmacological agents may be delivered through a standard luer lock adapter at the proximal end. The infusion area is indicated by distal and proximal radiopaque markers to facilitate fluoroscopic visualization. The reinforced Infusion catheters are available in a variety of infusion lengths.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
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
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Summary of Performance Studies
Biocompatibility of the MTI TruLine™ Reinforced Valved Infusion Catheter was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the catheter when tested as an external communicating, blood contact, limited exposure (
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Micro Therapeutics, Inc.
Special 510(k): TruLine™ Reinforced Valved Infusion Catheter
Attachment 4
| 510(k) Summary | |
|---|---|
| Prepared: | April 5, 2002 |
| TRADE NAME | TruLine ™ |
| GENERIC NAME | Catheter, Intravascular, Therapeutic, Short-Term |
| CLASSIFICATION | Class II (21 CFR 880.5200) |
| SUBMITTED BY | Micro Therapeutics, Inc. |
| 2 Goodyear | |
| Irvine, CA 92618 |
| CONTACT | Tom Daughters |
|---|---|
| Regulatory Affairs | |
| (949) 837-3700 |
| PREDICATE DEVICE | TruLine™ Reinforced Valved Infusion Catheters |
|---|---|
| DEVICE DESCRIPTION | The MTI TruLine™ Reinforced Infusion Catheter is a single-lumen plastic catheter designed to be introduced over a guidewire into the vasculature. Once positioned, various pharmacological agents may be delivered through a standard luer lock adapter at the proximal end. The infusion area is indicated by distal and proximal radiopaque markers to facilitate fluoroscopic visualization. The reinforced Infusion catheters are available in a variety of infusion lengths. |
| INDICATIONS FOR USE | The MTI Reinforced Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature. |
| TESTING | Biocompatibility of the MTI TruLine™ Reinforced Valved Infusion Catheter was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the catheter when tested as an external communicating, blood contact, limited exposure ( |