(32 days)
The DELTAMAXX™ 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 " 18 Microcoil System consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU), and is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.0165 inches and 0.019 inches. The DELTAMAXX ™ 18 Microcoils are provided in Stretch Resistant (SR) or Cerecyte® models and will be offered in lengths up to 60 cm and diameters ranging from 3 mm to 24 mm. The DELTAMAXX™ 18 Microcoils are fabricated from the same platinum alloy wire used in the DELTAPAQ® Microcoils. The wire is wound into a primary coil (containing either a polypropylene (SR) or absorbable polymer suture (Cerecyte®) inside the wind and then formed into a secondary helical coil shape. The Microcoil 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 coil is the implantable segment of the device, and is detached from the device positioning unit by the Micrus Detachment Control System.
This document focuses on the Codman & Shurtleff, Inc. DELTAMAXX™ 18 Microcoil System, a neurovascular embolization device. The submission is a Special 510(k) for a line extension.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define acceptance criteria as pass/fail thresholds for specific performance metrics in a numbered or bulleted list. Instead, it states that the device "passed equivalent bench testing as compared to the DELTAPAQ 10 System and PRESIDIO 18 System predicate devices." The inherent acceptance criterion is that the DELTAMAXX™ 18 Microcoil System performs demonstrably similarly or equivalently to its predicate devices in various bench tests.
Here's a table summarizing the types of tests conducted and the general performance outcome:
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Delivery Force | Performed equivalently to predicate devices |
| System Delivery Force | - |
| Microcatheter compatibility | - |
| Secondary Shape Retention | Performed equivalently to predicate devices |
| Coil Secondary Shape OD | - |
| Spring Constant | Performed equivalently to predicate devices |
| Primary Wind Coil Stiffness | - |
| Detachment Zone Tensile | Performed equivalently to predicate devices |
| Coil Socket Ring Tensile Strength | - |
| Detachment Fiber Tensile Strength | - |
| Stretch resistance of suture/Tensile Strength | - |
| Durability and Detachability | Performed equivalently to predicate devices |
| Durability-Cyclic advancement and retrieval of the microcoil system | - |
| Detachment of the microcoil from the delivery system | - |
| Coil damage after microcoil system delivery | - |
| Microcatheter compatibility | - |
| Biocompatibility | Continues to meet all the same biocompatibility requirements as the predicate device and as specified by ISO 10993 Part I and G95-1. |
Explanation: The document emphasizes substantial equivalence to predicate devices (DELTAPAQ® 10 and PRESIDIO® 18). Therefore, the "acceptance criteria" are implied to be that the DELTAMAXX™ 18 performs within the established safety and effectiveness profiles of these legally marketed devices for each tested characteristic. Specific quantitative pass/fail values are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document refers to "bench testing data" (Section G, page 5) but does not specify the number of devices or components tested for each category.
- Data Provenance: The data is from bench testing conducted by the manufacturer, Codman & Shurtleff, Inc. It is prospective in the sense that these tests were performed specifically to support the 510(k) submission for the DELTAMAXX™ 18. There is no information regarding the country of origin of the data beyond it being generated by the submitter.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable as the study is entirely bench testing of a physical device, not an AI/software device that requires human expert review for establishing ground truth or performance assessment.
4. Adjudication Method for the Test Set:
- This information is not applicable for bench testing. Bench tests typically involve objective measurements against predefined specifications or comparative performance with predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not required to establish substantial equivalence." (Section G, page 5). This directly indicates that no human reader studies (with or without AI assistance) were conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not an AI/algorithm-based device. The DELTAMAXX™ 18 Microcoil System is a physical medical device (embolization microcoil). Therefore, "standalone" algorithm performance is not relevant or applicable.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- For this physical medical device, "ground truth" for the bench tests would be established through engineering specifications, physical measurements, and comparison to the established performance characteristics of the predicate devices. For example, the "true" diameter of a coil is determined by precise measurement, not expert consensus or pathology. Similarly, tensile strength is measured against engineering standards.
- For biocompatibility, the ground truth is established by adherence to recognized standards like ISO 10993 Part I.
8. The Sample Size for the Training Set:
- This information is not applicable as this is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- This information is not applicable as this is a physical medical device and does not involve a training set.
In summary: The submission demonstrates substantial equivalence of the DELTAMAXX™ 18 Microcoil System to its predicate devices through comprehensive bench testing. The "acceptance criteria" are implicitly met by demonstrating performance that is equivalent to, or within the established safety and effectiveness parameters of, the predicate devices for key mechanical and material characteristics. No clinical studies, human reader studies, or AI algorithm testing were conducted or required for this 510(k) submission.
§ 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).