(117 days)
CODMAN Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
The DELTAMAXX Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and is also intended for arterial and venous embolizations in the peripheral vasculature.
The Fill ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and is also intended for arterial and venous embolizations in the peripheral vasculature.
The Xtrasoft ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
The CODMAN® Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, and ORBIT GALAXY® G2 Microcoil Delivery System consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of an microcoil attached to a Device Positioning Unit (DPU).
The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the infusion catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable).
The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which may contain either a polypropylene suture (SR) or an absorbable polymer suture (Cerecyte®) and then formed into a secondary shape. The secondary shape may be straight, spherical, complex, or helical. The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool.
The Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB.
The detachment control box may be one of two types: the blue EnPower Detachment Control Box or the black Detachment Control Box.
The connecting cables may be one of two types: one with a remote detach button (the EnPower Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00.
The EnPower Detachment Control Box works with the EnPower Control Cable and with the standard connecting cable. The black Detachment Control Box works only with the standard connecting cable. Both cables and Detachment Control Box are sold separately.
The provided document is a 510(k) premarket notification for a medical device focusing on a packaging change. It does not contain information about the performance of the neurovascular embolization devices themselves, but rather the performance of the packaging.
Here's an analysis based on the provided text regarding the packaging acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance (Packaging):
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance (Packaging) |
|---|---|---|
| Packaging Integrity | Visual Inspection (after sterilization, handling, distribution) | Sterile barrier system maintains packaging integrity; inspected seals were complete and uniform throughout the entire seal area of the proposed pouch for each time interval (accelerated and real-time aging). |
| Dye Leak | Packaging integrity maintained. | |
| Seal Strength | No detected negative trends in seal strength; seals maintain their strength over time. | |
| Product Functional Testing (on EnPower Control Cable) | Implied successful, as the overall conclusion states the packaging does not raise new questions of safety and effectiveness, and the packaging modifications were validated. (Specific functional results are not detailed, but implied to be acceptable within packaging context) | |
| Characterization Testing: Moisture and Humidity Creep | Implied successful (no negative findings reported). | |
| Sterile Pouch Shelf-Life | Visual Inspection | Proposed pouch's integrity was maintained; inspected seals were complete and uniform throughout the entire seal area for all time intervals (time-zero, 1yr, 3yr, 5yr, 10yr accelerated, and time-zero, 1yr, 3yr real-time). |
| Seal Strength | No detected negative trends in seal strength; seals maintain their strength over time. Testing confirmed the device will remain sterile through the proposed shelf life and integrity of its packaging are not compromised. | |
| Sterilization | Bioburden measurement | Met acceptance criteria for representative products as packaged in the new pouch. |
| Identification of top three organisms | Specific results not detailed, but met acceptance criteria. | |
| Bacteriostasis/Fungistasis (B/F) | Specific results not detailed, but met acceptance criteria. | |
| Bioburden recovery study (Extraction efficiency) | Specific results not detailed, but met acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not explicitly state the specific number of units or pouches tested for each packaging integrity and shelf-life test. It mentions testing "representative products" and "each time interval" for shelf-life, implying multiple samples were used.
- Data Provenance: The studies were conducted internally by Codman & Shurtleff, Inc. This is a retrospective analysis of the modified packaging, comparing it to the predicate device's packaging characteristics and ensuring the new packaging maintains similar performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. For packaging integrity and sterilization validation, "ground truth" is established through standardized physical, chemical, and microbiological testing methods (e.g., visual inspection, seal strength measurement, dye leak tests, bioburden assays) and comparison against pre-defined engineering and regulatory specifications, rather than expert consensus on a clinical outcome.
4. Adjudication Method for the Test Set:
- Not Applicable. As the tests are objective physical and microbiological measurements of packaging performance, an adjudication method for conflicting expert opinions is not relevant. The results would be interpreted against established acceptance criteria for each test.
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:
- No. This is a packaging modification submission for an existing neurovascular embolization device. It does not involve AI, image analysis, or human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This submission is about medical device packaging, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- For the packaging validation, the "ground truth" is defined by established engineering standards, regulatory guidelines (e.g., ISO 11137 for sterilization), and predefined acceptance criteria for physical (e.g., seal strength, visual integrity) and microbiological (e.g., bioburden levels) properties of the sterile barrier system.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).