(22 days)
MTI Equinox™ Occlusion Balloon Catheter
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No
The summary describes a mechanical device (balloon catheter) and its physical properties and performance, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used to temporarily occlude blood vessels to stop or control blood flow, which is a direct intervention on the body for a medical purpose.
No
Explanation: The device is an occlusion balloon catheter used to temporarily stop or control blood flow, which is a therapeutic function, not a diagnostic one. While it uses angiographic visualization for placement, this is for guidance during a therapeutic procedure, not for diagnosing a condition.
No
The device description clearly details a physical catheter with a balloon, guidewire, and other hardware components. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The MTI HyperForm™ Occlusion Balloon Catheter is a medical device used inside the body (in vivo) to temporarily block blood flow in blood vessels. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for "temporary occlusion" in blood vessels, which is a procedural action, not a diagnostic test.
- Device Description: The description details a catheter with a balloon for physical manipulation within the body, not for analyzing biological samples.
Therefore, based on the provided information, the MTI HyperForm™ Occlusion Balloon Catheter is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MTI HyperForm™ Occlusion Balloon Catheter is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The MTI HyperForm™ Occlusion Balloon Catheter offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow.
Product codes
MJN
Device Description
The HyperForm™ Occlusion Balloon Catheter is a single lumen tapered catheter with a non-detachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over the MTI 0.010" guidewire, and requires insertion of the guidewire to occlude the catheter shaft lumen to allow inflation of the balloon. Two platinum markers provide angiographic visualization of the balloon length and facilitate intravascular placement of the balloon prior to inflation. The catheter shaft is hydrophilically coated to assist catheter advancement within the vasculature. The HyperForm catheter is supplied sterile for single use as a system, which includes the required 0.010" guidewire.
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
blood vessels of the peripheral and neuro 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
Not Found
Summary of Performance Studies
Biocompatibility of the HyperForm catheter was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the HyperForm catheter when tested as an external communicating, blood contact, short duration (
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
JUN 2 0 2001
| Micro Therapeutics, Inc. | |
|---|---|
| Special 510(k): | HyperForm™ Occlusion Balloon Catheter |
Attachment 6
| 510(k) Summary | ||
|---|---|---|
| Prepared May 24, 2001 | ||
| TRADE NAME | Unknown | |
| GENERIC NAME | Occlusion Balloon Catheter | |
| CLASSIFICATION | Class II (21 CFR 870.0) | |
| SUBMITTED BY | Micro Therapeutics, Inc. | |
| 2 Goodyear | ||
| Irvine, CA 92618 | ||
| CONTACT | Eben Gordon | |
| Regulatory Affairs | ||
| (949) 837-3700 | ||
| PREDICATE DEVICE | MTI Equinox™ Occlusion Balloon Catheter | |
| DEVICE DESCRIPTION | The HyperForm™ Occlusion Balloon Catheter is a single lumen tapered catheter with a non-detachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over the MTI 0.010" guidewire, and requires insertion of the guidewire to occlude the catheter shaft lumen to allow inflation of the balloon. Two platinum markers provide angiographic visualization of the balloon length and facilitate intravascular placement of the balloon prior to inflation. The catheter shaft is hydrophilically coated to assist catheter advancement within the vasculature. The HyperForm catheter is supplied sterile for single use as a system, which includes the required 0.010" guidewire. | |
| INDICATIONS FOR USE | The MTI Occlusion Balloon Catheter is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The MTI Occlusion Balloon Catheter offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow. | |
| TESTING | Biocompatibility of the HyperForm catheter was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the HyperForm catheter when tested as an external communicating, blood contact, short duration ( |