Search Results
Found 5 results
510(k) Data Aggregation
(86 days)
Boston Scientific's Tracker™ Excel™-14 Pre-Shaped Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils into the peripheral, coronary, and neuro vasculature.
The Tracker™ Excel™-14 Pre-Shaped Microcatheter is a single lumen device designed to aid the physician in accessing the distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft astifiess ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the catheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces friction during manipulation in the vessel. The catheter is packaged individually with a variety of pre-shaped tips.
The provided text describes a 510(k) submission for a modified microcatheter and does not contain information about an AI-powered device or a study involving AI. Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or AI effectiveness studies.
The document focuses on demonstrating substantial equivalence of the modified microcatheter to a predicate device based on in-vitro testing and biological safety testing, as well as a comparison of product characteristics.
Regarding the specific questions you asked, based on the provided text, the following cannot be answered:
- A table of acceptance criteria and the reported device performance: Not available as it pertains to AI-powered devices.
- Sample sized used for the test set and the data provenance: Not relevant for this type of device modification submission. The text mentions "in-vitro testing" but doesn't detail sample sizes.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as it pertains to AI ground truth.
- Adjudication method: Not applicable.
- 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, as this is not an AI device.
- If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable for an AI device. The ground truth for this device's performance would be the physical properties and biological safety as measured in the in-vitro tests.
- The sample size for the training set: Not applicable as this is not an AI device.
- How the ground truth for the training set was established: Not applicable.
Summary of the provided information:
- Device: Tracker™ Excel™-14 Pre-Shaped Microcatheter
- Modification: The predicate device (Tracker™ Excel™-14 Microcatheter) was modified to include pre-shaped tips, as opposed to a straight, steam-shapeable tip.
- Purpose of Modification: Ease of use for physicians.
- Testing Conducted: In-vitro testing (tip shape retention, appearance of the tip, tip dimensions, static rupture, tensile strength of tip, buckling test, and coil, guidewire and guide catheter compatibility) and biological safety testing.
- Conclusion of Testing: The results support the claim of substantial equivalence to the predicate device.
- Substantial Equivalence Claims: Functionality, intended use, indications for use, materials, method of operation, and biological safety.
- Predicate Device: Tracker™ Excel™-14 Microcatheter (K994155).
Ask a specific question about this device
(24 days)
Boston Scienfitic's Excelsior™ SL-10 Pre-Shaped Microcatheter and Excelsion™ 1018" Pre-Shaped Microcatheter are intended to assist in the delivery of diagnostic agents, therapeutic agents, such as occlusion coils to the peripheral, coronary, and neuro vasculature.
The Excelsior " 1018" Pre-Shaped Microcatheter and the Excelsior" SL-10 Pre-Shaped Microcatheter are intended to assist the physician in accessing the distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semirigid proximal section aids the physician in tracking over selectively placed guidewires without displacement of the wire. A luer fitting located on the cather hub is used for the attachment of accessories. A radiopague tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces tip tachitatis nuoroscopic 75the catheters are packaged individually with a variety of Pre-Shaped tips.
This document describes the 510(k) summary for the Excelsior™ 1018™ and SL-10 Pre-Shaped Microcatheters. The core of the submission is to demonstrate substantial equivalence to predicate devices, where the primary modification is the pre-shaped tips for ease of use.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the typical quantitative sense (e.g., a specific percentage accuracy or precision). Instead, the acceptance criteria are implicitly that the modified devices (with pre-shaped tips) retain the same performance characteristics and safety profile as the predicate devices. The study performed is a "testing in support of substantial equivalence determination."
| Characteristic/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functionality | Equivalent to predicate devices | "Same as predicate device" for all listed characteristics (materials, design, dimensions, markers, coating, effective length, GDC compatibility) |
| Materials | Equivalent to predicate devices | "Same as predicate device" |
| Method of Operation | Equivalent to predicate devices | Stated as "substantially equivalent" |
| Intended Use | Equivalent to predicate devices | Stated as "substantially equivalent" |
| Indications for Use | Equivalent to predicate devices | Stated as "substantially equivalent" |
| Biological Safety | Equivalent to predicate devices | "Biological safety testing support the claim of substantial equivalence," stated as "substantially equivalent." |
| Tip configuration | Ability to offer pre-shaped tips with secondary shaping option | "Offered with Pre-Shaped Tips with the option of secondary shaping... As compared to the predicate which was cleared with straight tip, steam shapeable by physician prior to use." |
| In-vitro testing results (various) | Performance equivalent to predicate devices / safety thresholds | "The results of in-vitro testing (tip shape retention, appearance of the tip, tip dimensions, static rupture, tensile I ho reading of the worling test, and coil, guide catheter compatibility) ... support the claim of substantial equivalence." |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not specified. The document refers to "in-vitro testing" but does not detail the number of units tested for each characteristic.
- Data Provenance: The data appears to be prospective as it involves "in-vitro testing" conducted specifically for this 510(k) submission. No information is given about the country of origin of the data beyond "Boston Scientific" which is a US-based company, suggesting the testing was likely conducted in the US or by a US-affiliated entity.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This submission is for a medical device (microcatheter) and relies on engineering and biocompatibility testing, not on expert interpretations of medical images or clinical data to establish a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this isn't a study involving human interpretation of data where adjudication would be necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is typically performed for diagnostic devices where the performance of human readers, with and without AI assistance, is evaluated. This submission is for a microcatheter, which is an interventional device, not a diagnostic one.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical microcatheter, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation is based on engineering specifications, material science, and established safety standards for medical devices (e.g., biocompatibility standards, mechanical testing standards for catheters). The predicate devices serve as the reference point for equivalence.
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI/ML-driven device.
9. How Ground Truth for the Training Set was Established
Not applicable, for the same reason as point 8.
Ask a specific question about this device
(238 days)
The Excelsior 1018 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature.
The Excelsior 1018 Microcatheter is a single lumen device designed to aid the physician in accessing the distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires without displacement of the wire. A luer fitting located on the catheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces friction during manipulation in the vessel. The catheter is packaged with a steam shaping mandrel accessory.
The provided text describes a 510(k) submission for the Excelsior™ 1018 Microcatheter, focusing on its substantial equivalence to a predicate device, the TurboTracker-18 Infusion Catheter. The submission primarily details performance testing and biocompatibility to support this claim, rather than a clinical study with traditional acceptance criteria for a new AI/software device.
Therefore, many of the requested categories for AI/ML device studies (such as MRMC studies, ground truth establishment for training sets, number of experts for ground truth, sample sizes for test/training sets, data provenance, and adjudication methods) are not applicable to this 510(k) summary, as it pertains to a physical medical device.
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a physical microcatheter, the "acceptance criteria" are related to established engineering and biocompatibility standards rather than clinical performance metrics typical of an AI device. The document states that "performance testing (tensile strength, coefficient of friction, static rupture, tip buckling, dimensional inspection, critical bend radius, particulate analysis, and coil compatibility) and biocompatibility testing support this claim of substantial equivalence."
While specific numerical acceptance criteria and reported performance values for each of these tests are not provided in the given text, the submission states that the results "demonstrate that the Excelsior 1018 Microcatheter is substantially equivalent to the predicate TurboTracker-18 Infusion Catheter device." This implies that the Excelsior 1018 Microcatheter met the necessary performance and safety standards to be considered equivalent to the predicate device.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Tensile Strength | Met established engineering standards for medical catheters and was comparable to predicate. | Met. |
| Coefficient of Friction | Met established engineering standards for medical catheters and was comparable to predicate. | Met. |
| Static Rupture | Met established engineering standards for medical catheters and was comparable to predicate. | Met. |
| Tip Buckling | Met established engineering standards for medical catheters and was comparable to predicate. | Met. |
| Dimensional Inspection | Conformed to specified dimensions and was comparable to predicate. | Met. |
| Critical Bend Radius | Met established engineering standards for medical catheters and was comparable to predicate. | Met. |
| Particulate Analysis | Met established safety standards for particulate matter in medical devices. | Met. |
| Coil Compatibility | Compatible with target coils (GDC-10 & GDC-18). | Met. |
| Biocompatibility | Met ISO 10993 standards for biological evaluation of medical devices. | Met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable to this type of device submission. Performance testing usually involves a defined number of units per test, but these are engineering tests, not clinical studies with "test sets" in the AI/ML sense. Data provenance would be from internal lab testing at Boston Scientific.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth in this context refers to established engineering specifications and biocompatibility standards, not expert assessments of clinical data for AI performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies, particularly for AI, to resolve discrepancies in ground truth labeling. This submission relies on objective engineering measurements and standard biocompatibility assessments.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing is based on established engineering specifications, industry standards (e.g., for biocompatibility), and comparison to the predicate device's characteristics. For coil compatibility, the "ground truth" is whether the microcatheter can successfully deliver the specified GDC coils.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Ask a specific question about this device
(90 days)
Used for arterial and venous embolization in the peripheral vasculature.
The Flipper™ Detachable Embolization Coil is used for arterial and venous embolization for the peripheral vasculature. This device is used in conjunction with the Flipper Detachable Coil Delivery Wire. The detachable coil delivery system provides safe delivery of embolization coils where the size of embolization coil is difficult to predetermine. A handle facilitates manipulation and provides safe and easy detachment of embolization coils. This device is provided sterile and is intended for one-time use.
The Flipper™ Detachable Embolization Coil consists of the embolization coils and the delivery wire. The embolization coils are manufactured using stainless steel wire with synthetic fibers. The delivery wire is manufactured using stainless steel with TFE coating. The device will be available in the following sizes and is compatible with catheters of 80 and 110 cm lengths.
Delivery Wire Diameter: 0.035"
Extended Embolus Diameter: 0.035"
Coil Length: 3cm, 4cm, 5cm, 6cm, 8cm, 10cm, 12cm
Coil Embolus Diameter: 3mm, 5mm, 6.5mm, 8mm
The provided document describes a medical device, the Flipper™ Detachable Embolization Coil, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a typical AI/software device would.
This document is a 510(k) premarket notification for a traditional medical device (an embolization coil). For such devices, "acceptance criteria" and "performance studies" are typically related to engineering and material testing, not statistical performance metrics like sensitivity, specificity, or reader agreement that are common for AI/software devices.
Here's an analysis based on the provided text, indicating what information is present and what is notably absent for an AI-focused request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the format expected for a statistical performance study (e.g., "sensitivity must be > X%"). The document refers to "requirements of the design plan" but doesn't detail these as specific, quantifiable acceptance criteria for clinical performance.
- Reported Device Performance: The document lists "Performance Data" as:
- In-Vitro Performance Test: Loading, Passage and Deployment
- Tensile Test: Coil Thread/Delivery System
- Tensile Test: Torque Wire to Braid Solder
- Performance Results: The document generally states, "The results of these tests provide reasonable at the device has been designed and tested to assure conformance to the requirer to its use for arterial and venous embolization in the peripheral vasculature." However, no specific numerical results or metrics of these tests are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The document does not describe a clinical test set in the context of diagnostic or AI performance evaluation. The "tests" mentioned are in-vitro performance and tensile tests, which would apply to the device components themselves, not to patient data. Therefore, concepts like data provenance or retrospective/prospective studies do not apply here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: There is no mention of human experts establishing ground truth, as the document concerns the mechanical and functional aspects of an embolization coil, not the interpretation of medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No adjudication method is mentioned, as there is no human interpretation or expert panel involved in the described testing.
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 / Not Provided: No MRMC study was conducted. This device is an embolization coil, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This question is for AI algorithms. The device is a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: The ground truth for the "Performance Data" cited would relate to engineering specifications (e.g., coil integrity under tension, successful deployment in an in-vitro model) rather than clinical "ground truth" derived from patient outcomes or expert pathological review. The document does not specify how conformance to design requirements was definitively "ground-truthed."
8. The sample size for the training set
- Not Applicable / Not Provided: Training sets are relevant for AI/machine learning models. This document describes a physical medical device.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: As above, this is not relevant to the described device.
In summary: The provided 510(k) notification focuses on demonstrating "substantial equivalence" of a mechanical embolization coil to existing predicate devices based on design, materials, intended use, and general performance testing (in-vitro and tensile). It does not present information relevant to the statistical performance evaluation criteria or study design typically associated with AI/software devices as outlined in your request.
Ask a specific question about this device
(261 days)
The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be:
a)very high risk for management by traditional operative techniques, or,
b) inoperable,
and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature.
The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
Fibered GDC is intended for the embolization of vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. Fibered GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
Boston Scientific/Target's Guglielmi Detachable Coil (GDC) Power Supply is intended for use with all versions of Boston Scientific/Target's Guglielmi Detachable Coils in the embolization of intracranial anewrysms and other vascular malformations of the neuro and peripheral vasculature.
The GDC system consists of
- · GDC power supply
- · GDC occlusion coil attached to a delivery wire
- · set of GDC connecting cables
- · patient return electrode
- · two 9-volt batteries
each of which is sold separately.
The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.
GDC occlusion coils are manufactured from platinum wire which is first wound into a primary coil and then formed into a secondary helical shape. Coils are attached to a delivery wire, which consists of a ground stainlesssteel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is the same as that employed for the predicate GDC cleared under K962503.
The GDC Power Supply is a self-contained, battery-operated unit designed to initiate and control detachment of a GDC coil. It has an on/off button, connections for the GDC cables, and the following controls and displays:
· Current setting switch and display - Allows for selection of the different current settings. The selected current (mA) is briefly displayed after which the unit displays the current flowing through the system.
· Voltage diplay and indicator - Displays the DC output voltage.
• Time display - Displays the elapsed time that the current has been flowing through the GDC system.
• Check indicator - Flashes on and off at the beginning of a detachment procedure if there is a poor connection to the patient.
· Detach indicator - Flashes on and off when the power supply has detected detachment. Detachment is accompanied by five beeps.
· Battery indicator - Illuminates when the voltage of the internal 9-volt batteries falls below specification.
This document describes a 510(k) premarket notification for the Guglielmi Detachable Coil (GDC) Power Supply and does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.
The information provided outlines:
- Trade Name: Guglielmi Detachable Coil (GDC), Class III
- Common Name: Occlusion Coil
- Classification Name: Artificial Embolization Device (21 CFR Section 882.5950)
- Predicate Devices: K962503, K971395, K914786, K930738
- Intended Use: Embolizing intracranial aneurysms and other vascular malformations of the neuro vasculature, and for arterial and venous embolizations in the peripheral vasculature. Fibered GDC is also intended for embolization of vascular malformations.
- Device Description: The GDC system consists of a power supply, occlusion coil attached to a delivery wire, connecting cables, patient return electrode, and batteries. The occlusion coil is detached by electrolytically dissolving a portion of the delivery wire. The power supply allows for current setting, displays voltage, elapsed time, and has indicators for poor connection, detachment, and battery status.
This document is a regulatory submission for substantial equivalence, focusing on safety and effectiveness based on comparison to predicate devices, rather than a performance study with specific acceptance criteria. Therefore, the requested details about acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies are not present in this text.
Ask a specific question about this device
Page 1 of 1