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The Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

The Micrus Microcoil System cach consist of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single usc, sterile).

This 510(k) premarket notification for the Micrus Microcoil Delivery System does not contain a study that establishes performance against acceptance criteria in the manner typically seen for AI/ML devices or novel technologies with specific performance metrics. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The provided document does not specify quantitative acceptance criteria or report device performance against such criteria. The basis for clearance is "substantial equivalence" to predicate devices, implying that the device performs similarly to devices already on the market.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. There is no mention of a "test set" or specific study data, as the submission relies on substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth establishment is not relevant in a substantial equivalence filing for this type of medical device where performance is based on similarity to existing products, rather than novel diagnostic or interventional outcomes requiring expert-driven validation.

4. Adjudication Method

Not applicable. There is no mention of a study involving adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned. This type of study is typically used for diagnostic devices involving human interpretation of data, often comparing AI-assisted performance to unassisted performance. This device is an interventional tool, not a diagnostic one.

6. Standalone Performance Study

No. A standalone performance study for the algorithm (without human-in-the-loop) is not applicable or mentioned, as the device itself is a physical medical instrument, not software.

7. Type of Ground Truth Used

Not applicable. The concept of "ground truth" as it applies to diagnostic or prognostic AI/ML algorithms is not relevant here. The "truth" in this context is that the device functions as intended and is safe and effective similarly to its predicates.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device that learns from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of the Document's Approach:

The core of this 510(k) submission for the Micrus Microcoil Delivery System is the argument of substantial equivalence to predicate devices. This means the manufacturer is asserting that:

• Intended Use: The device shares the same intended use as legally marketed predicate devices (endovascular embolization of intracranial aneurysms, neurovascular abnormalities, and peripheral arterial/venous embolizations).
• Design and Specifications: The design, specifications, and materials are comparable to the predicate devices.
• Safety and Effectiveness: Because of the similarities in intended use, technology, and materials, the device is considered as safe and effective as the predicate devices.

The clearance letter from the FDA confirms this determination: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, the "study that proves the device meets the acceptance criteria" in this case is the comparison to predicate devices and the FDA's agreement that this comparison demonstrates substantial equivalence, rather than a clinical trial with specific performance metrics against pre-defined acceptance criteria.

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Micrus MicroCoil Systems are intended for endovascular embolization of intracranial aneurysms.

Micrus MicroCoil Systems are platinum embolic coils ("MicroCoils") attached to Device Positioning Units (DPUs (single use, sterile). The Micrus MicroCoil Systems are available in a 10-System size (compatible with 10 and 14 sized microcatheters) and 18-System size (compatible with 14 and 18 sized microcatheters). Both 10 and 18 sizes are available in various diameters/dimensions. Shapes can be spherical, helical, or straight. Lengths range from 1 to 30 centimeters and diameters range from 2 to 20 millimeters. Implant material for the non stretch resistant MicroCoils is a platinum alloy: implant material for the stretch resistant MicroCoils is a platinum alloy and a stretch resistant member (non-absorbable polypropylene suture).

A MicroCoil is detached from its Device Positioning Unit through heat shearing of a highly oriented, high tensile strength polyethylene (PE) fiber upon the clinician's command. The Device Positioning Unit is then removed from the microcatheter and discarded.

A Micrus MicroCoil System connects to a Micrus Connecting Cable (single use, sterile) which traverses the sterile field to connect to a Micrus Detachment Control Box (DCB) (reusable, non-sterile). The Connecting Cable and Detachment Control Box are sold separately. A MicroCoil System plus Connecting Cable and Detachment Control Box is referred to as a Micrus MicroCoil Delivery System.

This response is structured based on the provided document, K031578. The information regarding acceptance criteria and the study that proves the device meets them is primarily found in sections G and H.

Acceptance Criteria and Device Performance Study for Micrus MicroCoil Systems

This submission focuses on a labeling change for the Micrus MicroCoil Systems, specifically a change to the "Indication for Use" statement based on clinical outcomes from the International Subarachnoid Aneurysm Trial (ISAT). The device itself (Micrus MicroCoil System) remains unchanged from its predicate devices K002056 and K022420. Therefore, the device's technical acceptance criteria were established and met in the predicate device clearances, and the current submission provides a summary of those non-clinical tests. The "study that proves the device meets the acceptance criteria" in this context refers to the clinical evidence (ISAT) used to justify the broader indication for use.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Tests)

The following table summarizes the non-clinical tests and results, previously reviewed for the predicate devices, for which the Micrus MicroCoil System was found "Equivalent." These represent the fundamental performance acceptance criteria for the device itself.

• Detachment reliability. | - No filling defects evident on angio.
• No premature detachment / auto-detach caused by exposure to blood, body fluids, body temperatures or repeated manipulation.
• 100% first detach-cycle detachment achieved. |
  | Coil Stability / Aneurysm Occlusion | - Positional stability and aneurysm occlusion. | - Positional stability and aneurysm occlusion maintained through 6 months of implant.
• No coil compaction present at 6-month angio. |
  | GDC Bench Marking | - Established specifications for delivery force, tensile strength, and stiffness.
• Micrus Stretch Resistant MicroCoil must be substantially equivalent to predicates. | - Showed substantial equivalence in delivery force, tensile, and stiffness. |
  | Coil Stiffness/Softness | - Stiffness limit desired for Finishing Stretch Resistant MicroCoil. | - Finishing Stretch Resistant MicroCoil and Helical Stretch Resistant MicroCoil stiffness is within desired stiffness limit. |
  | Friction in the Microcatheter (Delivery Force) | - Average push force must be substantially equivalent to predicates. | - Finishing Stretch Resistant MicroCoil and Helical Stretch Resistant MicroCoil average push force exhibit comparable delivery forces. |
  | MDR Database Review | - Review for clinical risks. | - MSR01 risk assessment includes and addresses all risks encountered in review of predicate device MDR review. |
  | Biocompatibility of Materials | - Meets the requirements of ISO 10993. | - The only new material in the Micrus Stretch Resistant MicroCoil is polypropylene monofilament # 6523, which is identical to the pre-approved GDC stretch resistant suture. (Implies compliance by equivalence to approved material). |
  | Sterilization Validation | - Minimum Sterility Assurance Level of 10-6. | - Passed minimum sterility assurance level of 10-6. |
  | Shelf Life Test | - No performance degradation after 1 year of shelf life aging. | - Minimum tensile strength after 1 year accelerated aging shows no degradation. |
  | Tensile Strength | - Tensile strength of suture ball tip and MicroCoil to DPU must be substantially equivalent to predicates. | - Tensile strength meets desired strength criteria. |
  | Durability (Reliability after Fatigue) | - Withstand deployment and retraction 6 times in a tortuous anatomy. | - No knotting, no breakage, no stretching occurred.
• Durability meets desired durability criteria. |
  | MRI Compatibility of Implant | - No change impacting MRI compatibility. | - No change was made which would impact MRI compatibility. (Implies existing compatibility from predicates is maintained, thus meets this inherent criterion). |

Acceptance Criteria for Clinical Outcomes (New Indication for Use):

The acceptance criteria for the expanded "Indication for Use" are implicitly derived from the results of the ISAT study, which demonstrated clinical superiority of endovascular coiling over surgical clipping for ruptured intracranial aneurysms.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for the Clinical Test Set (ISAT):
  • Total patients enrolled: 2143
  • Patients randomly assigned to endovascular treatment with platinum coils: 1073
  • Patients randomly assigned to neurosurgical clipping: 1070
• Data Provenance: The study was a "multi-center study published in the Lancet," referred to as the International Subarachnoid Aneurysm Trial (ISAT). It involved patients with ruptured intracranial aneurysms. The data is prospective as it involved random assignment and follow-up. The document does not explicitly state the countries of origin for all participating centers, but "International" implies multiple countries, likely involving European and other centers given its publication in The Lancet and prior clinical practice in Europe. Micrus Corporation received CE Marking in May 2000 and FDA clearance in January 2001, joining ISAT in February 2001, indicating its international scope prior to US market entry.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ISAT study was a large, randomized controlled trial comparing two treatment modalities for ruptured intracranial aneurysms. The "ground truth" for the primary outcome (neurological assessment of dependency at 1 year) was established through clinical outcomes data collected directly from patients. The document states, "The primary outcome was a neurological assessment of dependency at 1 year (using the Rankin neurological outcome scale)." This implies that trained clinical personnel (e.g., neurologists, nurses, or other healthcare professionals) conducted these assessments. The exact number of experts/assessors is not specified, but for a trial of this magnitude, it would involve numerous qualified healthcare professionals at each participating center, following standardized protocols for outcome assessment. Their qualifications would be as medical professionals trained in neurological assessment and the use of the Rankin scale.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the primary outcome assessment itself (neurological assessment of dependency). For large, multi-center trials like ISAT, it is common best practice to have:

• Standardized training for assessors.
• Centralized review of case report forms.
• Possibly masked outcome assessment (though not explicitly stated whether assessors were blinded to treatment arm).
• A Clinical Events Committee (CEC) to adjudicate serious adverse events or difficult-to-classify outcomes.
  The text primarily focuses on the direct "Findings" from the collected data, implying a robust methodology for data collection and analysis rather than a specific "adjudication" of the primary outcome by external experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done as part of this submission or the ISAT. ISAT was a randomized controlled trial comparing treatment modalities (endovascular coiling vs. surgical clipping) and their clinical outcomes, not comparing human reader performance with or without AI assistance. The Micrus MicroCoil System is a physical device, not an AI diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

No, a standalone (algorithm only) performance study was not conducted. The Micrus MicroCoil System is a medical device, not an algorithm or AI system for diagnosis or standalone analysis. Its performance is assessed through its physical characteristics and clinical outcomes when used in patients.

7. Type of Ground Truth Used for the Clinical Test Set (ISAT)

The ground truth used for the clinical test set (ISAT) was outcomes data, specifically:

• Clinical outcomes: Neurological assessment of dependency at 1 year using the Rankin neurological outcome scale.
• Survival data: Implied by "dependent or dead at 1 year."
• Rebleeding events: Documented occurrence of rebleeding at 1 year.
  This is direct patient outcome data, collected prospectively as part of the randomized controlled trial.

8. Sample Size for the Training Set

• For the non-clinical tests (physical performance, durability, etc.): Not applicable in the context of "training set" as these are engineering and materials tests, not machine learning based.
• For the clinical justification (ISAT): Not applicable. ISAT was a clinical trial used for validation/comparison, not a "training set" for a device, as the Micrus MicroCoil System is a physical medical device and not a data-driven model requiring a training phase for its core function.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no explicit "training set" in the context of an AI/ML algorithm or data-driven model described in this submission. The "ground truth" for evaluating the clinical efficacy of the device (as part of endovascular coiling) was established through the rigorous, prospective data collection and follow-up within the ISAT clinical trial design.

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