(29 days)
The Fill Orbit Galaxy G2 Microdelivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is 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 ORBIT GALAXY® G2 Microcoil Delivery System consists of a Microcoil System, a Connecting Cable (CC), and an ENPOWER Detachment Control Box (DCB). Each component is sold separately. ORBIT GALAXY® G2 Microcoil Systems are provided as Stretch Resistant, with Fill and XTRASOFT™ microcoil models, and will be offered in lengths ranging from 1.5 cm to 30 cm and diameters ranging from 2 mm to 20 mm. The ORBIT GALAXY® G2 Microcoil System is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.0165 inches and v 0.019 inches.
The Microcoil System consists of an embolic microcoil attached to a device positioning unit (DPU) which is covered by an introducer sheath. The Fill ORBIT GALAXY® G2 Microcoils are provided in complex shape, and the XTRASOFT™ ORBIT GALAXY® G2 Microcoils are provided in complex and helical shapes. The DPU is a variable stiffness pushing system and has a radiopaque marker band located three (3) cm from its distal end. The introducer sheath system has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The Microcoil System is packaged individually in a protective hoop and sealed in a film pouch. A Microcoil System carton contains one Microcoil System and the associated Instructions for Use, and is provided as a sterile and single-use product.
The Connecting Cable delivers the energy needed to detach the microcoil from the Microcoil System's detachment zone. The connecting cable connects the DPU to the DCB. The DCB provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU.
The provided text describes a Special 510(k) submission for the ORBIT GALAXY® G2 Microcoil System. This type of submission is typically for modifications to a previously cleared device, asserting substantial equivalence to existing predicate devices based on non-clinical testing. Therefore, the study described here is primarily a non-clinical bench testing study.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets in a table format for a specific performance metric. Instead, it describes a comparative approach where the modified device (ORBIT GALAXY® G2 Microcoil System) is tested against the predicate devices (CASHMERE® SR Microcoil System and ORBIT GALAXY® Detachable Coil System) and is deemed to perform "equivalently" or "as designed." The acceptance criteria, therefore, are implied to be meeting the performance of the predicate devices for each test conducted.
| Acceptance Criteria Category | Reported Device Performance (ORBIT GALAXY® G2 Microcoil System) |
|---|---|
| Delivery Force | Performed according to its description and intended use, demonstrating System Delivery Force and Microcatheter compatibility. Passed equivalent bench testing as compared to the CASHMERE® SR System predicate device. |
| Secondary Shape Retention | Performed effectively, demonstrating Coil Secondary Shape OD. Passed equivalent bench testing as compared to the CASHMERE® SR System predicate device. |
| Detachment Zone Tensile Strength | Demonstrated performance for Coil Socket Ring Tensile Strength, Detachment Suture Tensile Strength, Stretch resistance of suture/Tensile Strength, and Ball Tip Tensile Strength. Passed equivalent bench testing as compared to the CASHMERE® SR System predicate device. |
| Durability and Detachability | Demonstrated Durability-Cyclic advancement and retrieval of the microcoil system, Detachment of the microcoil from the delivery system, Coil damage after microcoil system delivery, and Microcatheter compatibility. Passed equivalent bench testing as compared to the CASHMERE® SR System predicate device. |
| Biocompatibility | Successfully performed biocompatibility screening testing. Meets all the same biocompatibility requirements as the predicate devices and as specified by ISO 10993 Part I and General Program Memorandum # G95-1. (Full biocompatibility testing was previously conducted on predicate devices: ORBIT GALAXY® Detachable Coil System (K093973) and CASHMERE SR System (K072173), with the G2 system's materials, packaging, and sterilization being identical to the CASHMERE SR system, and hence, subject to screening for final confirmation). |
| Material, Packaging, and Sterilization Characteristics | Identical to the materials, packaging, and sterilization used in the current CASHMERE SR Microcoil System. |
| Overall Performance for Intended Use and Description | Bench testing data demonstrated that the ORBIT GALAXY® G2 Microcoil System performed according to its description and intended use, and established the performance characteristics of this device. Results of verification and validation testing demonstrated the system performed as designed and is suitable for the intended use and substantially equivalent to the predicate devices. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (number of coils or tests) used for each bench test conducted. It states "bench testing data" and "results of verification and validation testing."
- Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Codman & Shurtleff, Inc. No information regarding country of origin of the data beyond the manufacturer's location in Raynham, MA (USA) is provided. It's an internal test, not a retrospective or prospective study in the typical human trials sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the study is a non-clinical bench testing study of a medical device, not a study involving human data, medical imaging, or expert interpretation for ground truth. Ground truth for device performance is typically established by engineering specifications, validated test methods, and comparison to established predicate device performance.
4. Adjudication Method for the Test Set
This section is not applicable as the study is a non-clinical bench testing study. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where opinions of multiple human reviewers or experts need to be reconciled.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers evaluating cases, often in radiology or pathology, with and without AI assistance to measure reader improvement. The described study is non-clinical bench testing.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
No. This section is not applicable either in the sense of an "algorithm" or "AI." The device is a physical embolization microcoil system, not an AI or software algorithm that would have standalone performance. The testing performed is for the physical device's characteristics.
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical bench testing is engineering specifications, validated test methods, and the established performance characteristics of the predicate devices. The new device's performance in mechanical tests (delivery force, shape retention, tensile strength, durability, detachability) and material characteristics (biocompatibility, sterilization) is measured against these established benchmarks to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reason as above.
§ 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).