(68 days)
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No
The device description and performance studies focus on the physical properties and function of a catheter for infusion, with no mention of AI or ML capabilities.
No
The device infuses pharmacologic agents, but it does not directly treat a disease or condition; it is a delivery mechanism for therapeutic agents.
No
Explanation: The device is an infusion catheter, which is used to deliver substances into the body, not to diagnose a condition. Its intended use is for "controlled selective infusion," and its function is to "deliver various pharmacological agents," indicating a therapeutic rather than diagnostic purpose.
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 on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is a catheter designed to be introduced into the vasculature. This is an invasive medical device used for direct intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to detect, measure, or identify substances or characteristics in biological samples to provide information about a person's health.
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 physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature.
Product codes
FOZ
Device Description
The MTI 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 of the Reinforced Infusion Catheter 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
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Input Imaging Modality
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Anatomical Site
general vasculature
Indicated Patient Age Range
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Intended User / Care Setting
physician
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
Biocompatibility of the MTI Reinforced 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
| AUG | 2 |
|---|---|
| 8 | 2001 |
Micro Therapeutics, Inc. Special 510(k): Reinforced Infusion Catheter
Attachment 5
510(k) Summary
Prepared June 20, 2001
| TRADE NAME | TruLine™ Infusion Catheters | ||
|---|---|---|---|
| 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 | Eben Gordon | |
| Regulatory Affairs | |||
| (949) 837-3700 | |||
| PREDICATE | |||
| DEVICE | MTI Infusion Catheter | ||
| DEVICE | |||
| DESCRIPTION | The MTI 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 of the | |||
| Reinforced Infusion Catheter 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 Reinforced 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 ( |