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510(k) Data Aggregation
(134 days)
The Micro Therapeutics, Inc. Over the Wire (OTW) Thrombolytic Brush Catheter is intended for percutaneous dissolution of acute thrombus located in arteriovenous (A-V) fistula. The Over the Wire (OTW) Thrombolytic Brush Catheter is designed to augment the area of interface between clot and pharmacologic augment 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 Over the Wire (OTW) 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 of pulmonary hypertension.
The Micro Therapeutics, Inc. Over the Wire (OTW) Thrombolytic Brush Catheter is intended for the percutaneous dissolution of acute thrombus located in artificial The OTW Thrombolytic Brush Catheter is designed to arteriovenous (A-V) fistula. augment the area of interface between clot and pharmacologic agent by simultaneous thrombolysis and clot maceration. The integral system utilizes a catheter with proximal Yconnector, a soft brush attached at the distal end of a hollow drive shaft, and a hand-held battery-powered motor drive.
The provided 510(k) summary (K973664/K973669) describes the Micro Therapeutics, Inc. Over the Wire (OTW) Thrombolytic Brush Catheter. This submission establishes substantial equivalence to a predicate device, the Thrombolytic Brush Catheter (K963925) also manufactured by Micro Therapeutics, Inc., rather than providing a performance study against specific acceptance criteria for a novel device. Therefore, a table with acceptance criteria and reported device performance, and details of studies involving human readers, training sets, and ground truth establishment, are not applicable in the typical sense for this submission.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
Not explicitly provided as acceptance criteria for a novel device. The submission focuses on demonstrating equivalence to a predicate device through a series of tests. The "performance" is inferred to be "equivalent" to the predicate.
| Acceptance Criteria (Implied Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Dimensional characteristics equivalent to predicate device | In vitro tests confirmed dimensional measurements. |
| Bristle and wire cable strength equivalent to predicate device | In vitro tests confirmed bristle and wire cable strength characterization. |
| Motor drive integrity equivalent to predicate device | In vitro tests confirmed motor drive integrity testing. |
| Catheter flow rates equivalent to predicate device | In vitro tests confirmed catheter flow rates. |
| Bond strengths equivalent to predicate device | In vitro tests confirmed bond strengths. |
| Burst pressure equivalent to predicate device | In vitro tests confirmed burst pressure. |
| Performance under simulated conditions equivalent to predicate device | In vitro tests confirmed performance under simulated conditions. |
| Electromagnetic and patient safety equivalent to predicate device | Independent laboratory tests covered electromagnetic and leakage current potential. |
| In vivo performance in dissolving thrombus in A-V fistulas equivalent to predicate device | In vivo animal studies demonstrated OTW Thrombolytic Brush Catheter performed the same as the predicate device. |
| Biocompatibility compliant with standards | All components tested per ISO 10993-1. |
2. Sample Size Used for the Test Set and Data Provenance:
- In Vitro Tests: "Sample sterile devices were subjected to extensive physical bench testing." No specific number of samples is provided.
- In Vivo Tests: "In vivo animal tests were performed..." No specific number of animals is provided for the test set. Given it's animal testing, the data provenance is presumably from the testing facility where the study was conducted; it is not stated as retrospective or prospective in relation to human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The studies performed were bench tests and animal studies, not human clinical studies requiring expert ground truth for interpretation of outcomes.
4. Adjudication Method for the Test Set:
Not applicable. There are no human readers or subjective interpretations that would require an adjudication method. The tests are objective measurements and observations in laboratory and animal settings.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a mechanical catheter and does not involve AI or human image interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm. Its performance is assessed through physical and biological tests.
7. The type of ground truth used:
- In Vitro Tests: The "ground truth" was based on established engineering specifications, physical integrity, and performance metrics for medical devices, implicitly benchmarked against the predicate device's characteristics.
- In Vivo Tests: The "ground truth" was the observed performance of the device in dissolving thrombus in A-V fistulas within the animal model, compared directly to the predicate device's performance.
8. The Sample Size for the Training Set:
Not applicable. This product is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device submission.
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(312 days)
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.
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.
Here's a breakdown of the acceptance criteria and study details for the Micro Therapeutics Thrombolytic Brush Catheter and Motor Drive, based only on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, the "Summary of Clinical Trials" table presents various metrics of device performance for both the Thrombolytic Brush Catheter and a control group (pulse-spray infusion) and then performs statistical comparisons. The conclusion states that the clinical data "demonstrate the Thrombolytic Brush Catheter is a safe, effective and rapid alternative to pulse-spray thrombolysis." This implies that showing superiority or non-inferiority to the control group on various metrics was the implicit acceptance criteria.
| Parameter | Thrombolytic Brush Catheter (Performance) | Pulse-Spray Infusion (Control) | Statistical Comparison | Implied Acceptance Criteria (Vs. Control) |
|---|---|---|---|---|
| Duration of lytic procedure | 17 minutes | 28 minutes | Significant (p=.0001) | Shorter duration |
| Residual thrombus after lytic procedure | 6.5% | 25.5% | Significant (p=.0001) | Less residual thrombus |
| Urokinase dose used | 215,435 Units | 455,882 Units | Significant (p=.0001) | Lower urokinase dose |
| Heparin dose used | 2,570 Units | 4,926 Units | Significant (p=.0001) | Lower heparin dose |
| Acute success of lytic procedure (Graft patent within 30 minutes) | 42/43 (98%) | 15/35 (43%) | Significant (p=.0001) | Higher acute success rate |
| Stenotic lesion visualized | 41/41 (100%) | 33/33 (100%) | Not Significant (p=1.000) | Comparable visualization |
| Thrombectomy performed to remove residual thrombus | 14/41 (34%) | 14/33 (42%) | Not Significant (p=.481) | Comparable need for thrombectomy |
| PTA performed to treat stenotic lesion | 41/41 (100%) | 32/32 (100%) | Not Significant (p=1.000) | Comparable need for PTA |
| Residual thrombus after thrombectomy and/or PTA | 2.2% | 1.6% | Not Significant (p=.6607) | Comparable final residual thrombus (though slightly higher for device, p not significant) |
| Duration of entire procedure | 70 minutes | 84 minutes | Not Significant (p=.1735) | Comparable total procedure duration (though shorter for device, p not significant) |
| Procedural success after all interventions (Graft patent, no major complications) | 39/43 (91%) | 34/35 (97%) | Not Significant (p=.621) | Comparable overall procedural success (though slightly lower for device, p not significant) |
| Successful dialysis after all interventions | 34/39 (87%) | 30/34 (88%) | Lifetable analysis: Not significant | Comparable successful dialysis (though slightly lower for device, lifetable analysis not significant) |
| Primary Patency at 3 months | 16/38 (42%) | 15/31 (48%) | Lifetable analysis: Not significant | Comparable primary patency at 3 months (though slightly lower for device, lifetable analysis not significant) |
| Failures within 3 months | 22/38 (58%) | 16/31 (52%) | Lifetable analysis: Not significant | Comparable failure rate at 3 months (though slightly higher for device, lifetable analysis not significant) |
| Primary Patency at 4½ months | 14/38 (37%) | 14/30 (47%) | Lifetable analysis: Not significant | Comparable primary patency at 4.5 months (though slightly lower for device, lifetable analysis not significant) |
| Failures within 4½ months | 24/38 (63%) | 16/30 (53%) | Lifetable analysis: Not significant | Comparable failure rate at 4.5 months (though slightly higher for device, lifetable analysis not significant) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 81 patients in total, with 45 randomized to the Thrombolytic Brush Catheter treatment group and 36 to the pulse-spray infusion control group. For analysis, these translated to 43 grafts treated in the device group and 35 in the control group for some metrics, with some variations due to no follow-up or missing data for specific parameters.
- Data Provenance: Prospective, randomized clinical trial conducted at five institutions in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications used to establish ground truth for the clinical trial data. The assessment of "residual thrombus" and "patency" would typically involve physician judgment (likely interventional radiologists or nephrologists involved in AV graft management), but specifics are not provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical trial results. Data would have been collected by the investigators at each of the five institutions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for a medical device (catheter and motor drive) used by clinicians, not an AI-based diagnostic or imaging interpretation tool. Therefore, the concept of human readers improving with AI assistance is not applicable here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this question is not applicable. The device is a physical catheter and motor drive, not an algorithm. Its performance inherently requires human operation.
7. The Type of Ground Truth Used
The ground truth used in the clinical trial was primarily clinical outcomes and measurements as assessed by the treating physicians and follow-up. This included:
- Measurement of residual thrombus.
- Assessment of graft patency (ability to dialyze).
- Duration of procedures.
- Dosages of pharmacological agents.
- Incidence of interventions like thrombectomy and PTA.
- Follow-up data on primary patency and failures.
These are clinical observations and measurements, not pathology reports or a separate expert consensus on images (as would be typical for an imaging AI device).
8. The Sample Size for the Training Set
This study involves a medical device, not a machine learning model, so there is no concept of a "training set" in the context of algorithm development. The development process would have involved engineering design, in vitro testing, and animal studies.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an algorithm, this question is not applicable. For general device development, "ground truth" (e.g., for design validation) would be established through engineering specifications, validated test methods (in vitro), and histological/clinical observations from animal studies (in vivo). The text describes extensive physical bench testing, biocompatibility tests, and animal studies as part of the overall development and verification.
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