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510(k) Data Aggregation
K Number
K113289Device Name
ORION MICRO CATHETERManufacturer
Date Cleared
2012-08-01
(268 days)
Product Code
Regulation Number
870.1210Type
TraditionalPanel
CardiovascularWhy did this record match?
Device Name :
ORION MICRO CATHETER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Orion™ Micro Catheter device is intended for the controlled selective infusion of physician-specified therapeutics agents or contrast media into the vasculature of the peripheral and neuro anatomy.
Device Description
The Orion™ Micro Catheter is a .021 inch size delivery catheter. The construction consists of a proximal stainless steel hypotube for pushability, and a distal multi-durometer Pebax shaft with progressive pitch Nitinol braid reinforcement. A continuous PTFE liner provides an uninterrupted, smooth inner diameter for low friction stent delivery. The proximal hub is molded from a DMSO compatible polymer. The distal shaft incorporates 2 radiopaque marker bands to aid with stent or coil detachment.
AI/ML Overview
The provided document is a 510(k) summary for the Orion™ Micro Catheter, which is a medical device for controlled selective infusion. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (biocompatibility, bench testing, in-vitro design validation, and shelf-life testing).
Because this is a 510(k) for a physical medical device (a catheter) and not an AI/ML-driven diagnostic or prognostic tool, the types of studies, acceptance criteria, and specific metrics (like sensitivity, specificity, AUC) typically associated with AI/ML systems or diagnostic devices are not present. The document describes engineering, material, and performance tests for the catheter.
Therefore, many of the requested fields are not applicable or cannot be extracted from this specific document.
Here's an attempt to answer based on the provided text, indicating "N/A" where the information is not present or not relevant to this type of device submission:
**1. Table of acceptance criteria and the reported device performance**
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance / Outcome |
| :------------------------------ | :---------------------------------------- | :------------------------------------------------------------------------------------ | :--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| **Biocompatibility Testing** | Cytotoxicity | Pass (implied, no specific numeric criteria provided) | Included in the submission. The "Substantial Equivalence Determination" section states the information presented shows the device is substantially equivalent, implying successful completion of these tests. |
| | Sensitization | Pass (implied) | Included in the submission. |
| | Intracutaneous | Pass (implied) | Included in the submission. |
| | Systemic Toxicity | Pass (implied) | Included in the submission. |
| | Pyrogen | Pass (implied) | Included in the submission. |
| | Coagulation UPPT | Pass (implied) | Included in the submission. |
| | Thromboresistance | Pass (implied) | Included in the submission. |
| | Complement Activation C3a and SC5b-9 Assy | Pass (implied) | Included in the submission. |
| **Bench Testing** | Aspiration Testing | Pass (implied) | Included in the submission. |
| | Catheter Particle Testing | Pass (implied) | Included in the submission. |
| | Catheter Tip Shape Retention | Pass (implied) | Included in the submission. |
| | Catheter Trackability Coating Performance | Pass (implied) | Included in the submission. |
| | Catheter Coating Integrity | Pass (implied) | Included in the submission. |
| | Dimensional Inspection | Pass (implied) | Included in the submission. |
| | Distribution Simulation | Pass (implied) | Included in the submission. |
| | DMSO Compatibility Testing | Pass (implied) | Included in the submission. |
| | Dynamic Pressure Burst Test | Pass (implied) | Included in the submission. |
| | Enterprise Stent Compatibility Testing | Pass (implied) | Included in the submission. |
| | Flow Rate Test | Pass (implied) | Included in the submission. |
| | Kink Diameter and Lumen Concentricity | Pass (implied) | Included in the submission. |
| | Static Pressure Test | Pass (implied) | Included in the submission. |
| | Tensile Strength Test | Pass (implied) | Included in the submission. |
| | Tortuous Neurovascular Model | Pass (implied) | Included in the submission. |
| **In-Vitro Design Validation Study** | Pushability | Pass (implied) | Included in the submission. |
| | Navigability | Pass (implied) | Included in the submission. |
| | Radiopacity | Pass (implied) | Included in the submission. |
| | Stent Delivery Friction | Pass (implied) | Included in the submission. |
| | Stability | Pass (implied) | Included in the submission. |
| | Ability to Cross Clot | Pass (implied) | Included in the submission. |
| **Shelf-life Testing** | 6-month Accelerated Aging | Pass (implied for demonstrating shelf-life equivalent to predicate or specified life) | Included in the submission. |
*Note: The document states "The information presented in the 510k shows that the Orion™ Micro Catheter is substantially equivalent to the Rebar® Micro Catheter and PROWLER® SELECT® Plus in regards to the similar indications for use, device design, device materials, device dimensions, and materials comprising its accessories and final packaging, and design specifications." This implies that all listed tests were successfully completed and met appropriate acceptance criteria for substantial equivalence.*
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**2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)**
* **Sample Size:** Not explicitly stated for each test, but standard engineering and in-vitro testing often involves multiple samples. The document lists the types of tests performed.
* **Data Provenance:** The tests are non-clinical (bench, in-vitro, biocompatibility) and therefore no country of origin for human data or retrospective/prospective designation is applicable. These are laboratory-based studies.
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**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)**
* **N/A.** This device submission for a catheter does not involve establishing ground truth from expert readings (e.g., medical images). The "ground truth" for these tests would be defined by engineering specifications, material properties, and biological compatibility standards.
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**4. Adjudication method (e.g. 2+1, 3+1, none) for the test set**
* **N/A.** Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers interpreting data (e.g., medical images). This is not relevant for the type of bench and biocompatibility testing described.
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**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**
* **N/A.** This is a physical medical device (catheter), not an AI/ML diagnostic system. No MRMC study was conducted or is applicable for this type of submission.
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**6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done**
* **N/A.** This is a physical medical device (catheter), not an algorithm.
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**7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)**
* For Biocompatibility, the "ground truth" is established by adherence to recognized biocompatibility standards and test protocols (e.g., ISO 10993 series).
* For Bench Testing, the "ground truth" is defined by engineering specifications, design requirements, and performance characteristics compared to predicate devices or established safety/efficacy benchmarks for similar catheters.
* For In-Vitro Design Validation, the "ground truth" is based on functional performance against established design criteria and comparison with predicate device performance in a controlled simulated environment.
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**8. The sample size for the training set**
* **N/A.** This is a physical medical device, not an AI/ML system that requires a "training set."
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**9. How the ground truth for the training set was established**
* **N/A.** As no training set is applicable, no ground truth for a training set was established.
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