(312 days)
Not Found
No
The description focuses on the mechanical action of a brush catheter and its use with a pharmacologic agent, with no mention of AI or ML capabilities.
Yes
The device is intended for the percutaneous dissolution of acute thrombus, which is a medical treatment.
No
The device is intended for the treatment (dissolution and maceration) of acute thrombus, not for diagnosis.
No
The device description explicitly states it includes hardware components such as a catheter, brush, drive cable, and a battery-powered motor drive.
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 for diagnosis, monitoring, or screening.
- Device Function: The Micro Therapeutics Thrombolytic Brush Catheter is a medical device used within the body (in vivo) to physically interact with and dissolve thrombus in artificial arteriovenous grafts. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "percutaneous dissolution of acute thrombus," which is a treatment, not a diagnostic test performed on a sample outside the body.
The information provided describes a device used for a medical procedure performed directly on a patient, not a test performed on a biological sample in a laboratory setting.
N/A
Intended Use / Indications for Use
The Micro Therapeutics Thrombolytic Brush Catheter is intended for percutaneous dissolution of acute thrombus (i.e., less than two weeks old) located in artificial arteriovenous (A-V) grafts. The Thrombolytic Brush Catheter is designed to augment the area of interface between clot and pharmacologic agent by simultaneous thrombolysis and clot maceration. Clinical studies demonstrate effective dissolution of thrombus in A-V grafts when this product is used in conjunction with urokinase. The Thrombolytic Brush Catheter is not intended for use in native vessels. The device should not be used on patients with a history of significant pulmonary disease or pulmonary hypertension.
Product codes
MCW
Device Description
The Micro Therapeutics Thrombolytic Brush Catheter is intended for the percutaneous dissolution of thrombus located in arteriovenous (A-V) grafts. The Micro Therapeutics Thrombolytic Brush Catheter is designed to augment the area of interface between clot and pharmacologic agent by simultaneous thrombolysis and clot maceration. The integral system utilizes a catheter with proximal Y-connector, a soft nylon brush attached to a stainless steel flexible drive cable, and a hand-held battery-powered motor drive.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
artificial arteriovenous (A-V) grafts
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
In Vitro Tests: Sample devices were subjected to extensive physical bench testing. In vitro tests were conducted which included complete dimensional measurements, bristle and wire cable strength characterization, motor drive integrity testing, catheter flow rates, bond strengths, burst pressure and performance under simulated conditions. Additionally, electromagnetic and patient safety tests were conducted by an independent laboratory to evaluate the electromagnetic and leakage current potential of the battery operated motor drive handle. Based on the results from these tests, it was concluded that the design offered a considerable safety margin in critical areas and is suitable for its intended use.
Radiopacity Testing: The radiopacity of the Thrombolytic Brush Catheter is comparable to other vascular catheters. The materials used in the manufacture of the Thrombolytic Brush Catheter are the same as the predicate devices listed in the 510(k), utilizing medical grade plastic, stainless steel and radiopaque positioning markers. The stainless steel cable drive and brush tip of the Thrombolytic Brush Catheter are adequately visualized under fluoroscopy and the catheter body has a platinum alloy marker band at the distal tip. Adequate radiopacity was demonstrated in both the animal trial and in the clinical study by the ability of all investigators to visualize the device under fluoroscopy.
Biocompatibility Tests: Tests for biocompatibility of materials for the Micro Therapeutics Thrombolytic Brush Catheter were performed to establish that the materials used in the device met the qualifications for short-term use in the vascular system in accordance with ISO 10993-1. Biocompatibility testing was performed on sterile product. In determining biocompatibility test design, testing was selected as deemed appropriate for the type of tissue/device interface and the duration of patient exposure. The results of these tests demonstrate the toxicological safety of the Thrombolytic Brush Catheter for its intended use.
In Vivo Tests (Animal Study): In vivo animal tests were performed to assess ease of use, suitable flexibility/stiffness required, safety and efficacy. Histologic examinations were performed both in the arterial and venous portion of the anastomosis as well as macro- and microscopic examination of sliced 3mm sections of lung. Animal studies were performed at the University of Illinois College of Medicine at Peoria in Peoria, Illinois. The study was approved by the Animal Research Committee of the above-mentioned institution and all studies were performed under GLP guidelines. Animal studies demonstrated the Micro Therapeutics Thrombolytic Brush Catheter to be a safe and efficacious device for percutaneous administration of pharmacologicals for dissolution of thrombus located in artificial A-V grafts.
Clinical Trials: Randomized clinical trial with 81 patients (45 in Thrombolytic Brush Treatment Group, 36 in Pulse-Spray Infusion Control Group) with thrombosed artificial looped hemodialysis grafts at five institutions in the United States.
Initial success was defined as
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).
0
063975
510(k) SUMMARY
Micro Therapeutics, Inc. 1062-F Calle Negocio San Clemente, CA 92673 (714) 361-0616
AUG - 8 1997
Contact Person
John L. Gehrich, Ph.D. Vice President of Regulatory & Clinical Affairs
Trade Name
Thrombolytic Brush Catheter and Motor Drive
Classification Name
Graft Thrombectomy Catheter Infusion Catheter
Substantially Equivalent Devices
Fogarty® Graft Thrombectomy Catheter (Baxter Corp.) Mewissen Infusion Catheter (MediTech) Amplatz Thrombectomy Device (Microvena)
Description
The Micro Therapeutics Thrombolytic Brush Catheter is intended for the percutaneous dissolution of thrombus located in arteriovenous (A-V) grafts. The Micro Therapeutics Thrombolytic Brush Catheter is designed to augment the area of interface between clot and pharmacologic agent by simultaneous thrombolysis and clot maceration. The integral system utilizes a catheter with proximal Y-connector, a soft nylon brush attached to a stainless steel flexible drive cable, and a hand-held battery-powered motor drive.
Intended Use
The Micro Therapeutics Thrombolytic Brush Catheter is intended for percutaneous dissolution of acute thrombus (i.e., less than two weeks old) located in artificial arteriovenous (A-V) grafts. The Thrombolytic Brush Catheter is designed to augment the area of interface between clot and pharmacologic agent by simultaneous thrombolysis and clot maceration. Clinical studies demonstrate effective dissolution of thrombus in A-V grafts when this product is used in conjunction with urokinase. The Thrombolytic Brush Catheter is not intended for use in native vessels. The device should not be used on patients with a history of significant pulmonary disease or pulmonary hypertension.
Technological Characteristics
This product is equivalent in intended use as well as dimensional characteristics, composition and function to the legally marketed Baxter Fogarty® Graft Thrombectory Catheter, manufactured by Baxter Healthcare Corporation, as well as the MediTech Mewissen Infusion Catheter.
This product is equivalent in intended use as well as composition and function to the legally marketed Amplatz Thrombectorny Device, (K954205) manufactured by Microvena, Corporation,
1
Summary of Studies
Performance Data
In Vitro Tests
Sample devices were subjected to extensive physical bench testing. In vitro tests were conducted which included complete dimensional measurements, bristle and wire cable strength characterization, motor drive integrity testing, catheter flow rates, bond strengths, burst pressure and performance under simulated conditions. Additionally, electromagnetic and patient safety tests were conducted by an independent laboratory to evaluate the electromagnetic and leakage current potential of the battery operated motor drive handle. Based on the results from these tests, it was concluded that the design offered a considerable safety margin in critical areas and is suitable for its intended use.
Radiopacity
The radiopacity of the Thrombolytic Brush Catheter is comparable to other vascular catheters. The materials used in the manufacture of the Thrombolytic Brush Catheter are the same as the predicate devices listed in the 510(k), utilizing medical grade plastic, stainless steel and radiopaque positioning markers. The stainless steel cable drive and brush tip of the Thrombolytic Brush Catheter are adequately visualized under fluoroscopy and the catheter body has a platinum alloy marker band at the distal tip. Adequate radiopacity was demonstrated in both the animal trial and in the clinical study by the ability of all investigators to visualize the device under fluoroscopy.
Biocompatibility Tests
Tests for biocompatibility of materials for the Micro Therapeutics Thrombolytic Brush Catheter were performed to establish that the materials used in the device met the qualifications for short-term use in the vascular system in accordance with ISO 10993-1. Biocompatibility testing was performed on sterile product. In determining biocompatibility test design, testing was selected as deemed appropriate for the type of tissue/device interface and the duration of patient exposure. The results of these tests demonstrate the toxicological safety of the Thrombolytic Brush Catheter for its intended use.
In Vivo Tests
In vivo animal tests were performed to assess ease of use, suitable flexibility/stiffness required, safety and efficacy.
Histologic examinations were performed both in the arterial and venous portion of the anastomosis as well as macro- and microscopic examination of sliced 3mm sections of lung. Animal studies were performed at the University of Illinois College of Medicine at Peoria in Peoria, Illinois. The study was approved by the Animal Research Committee of the above-mentioned institution and all studies were performed under GLP guidelines.
Animal studies demonstrated the Micro Therapeutics Thrombolytic Brush Catheter to be a safe and efficacious device for percutaneous administration of pharmacologicals for dissolution of thrombus located in artificial A-V grafts.
2
Results of Clinical Trials
Eighty-one patients with thrombosed artificial looped hemodialysis grafts were randomized at five institutions in the United States. Forty-five subjects were randomized to treatment with the Thrombolytic Brush Catheter and thirty-six were randomized to treatment with pulse-spray infusion. Initial success was defined as