(90 days)
The AGILITY® Steerable Guidewires are intended for selective placement of microcathers and other devices in the neuro and peripheral vasculature.
The NEUROSCOUT® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature.
The hydrophilically coated AGILITY® and NEUROSCOUT® Steerable Guidewires consists of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. Guidewire length, diameter, and distal tip configuration are indicated on the product label. A steering/torquing device and a guidewire introducer are packaged with the AGILITY® and NEUROSCOUT® Guidewires.
The provided text describes a 510(k) submission (K133625) for a packaging change to the AGILITY® and NEUROSCOUT® Steerable Guidewires. It largely focuses on demonstrating that the packaging changes only do not alter the fundamental technology or intended use of the previously cleared predicate devices (K121776).
Therefore, the study described is not for the performance of the guidewires themselves in their intended clinical use, but rather for the integrity and safety of the new packaging. The acceptance criteria and "device performance" consequently pertain to packaging validation, sterilization validation, and biocompatibility, not to the clinical efficacy or accuracy of an AI or medical device for which such metrics usually apply.
Given this context, the request cannot be fully answered as it typically would for a device demonstrating clinical performance or AI algorithm performance. Many of the requested fields (e.g., multi-reader multi-case study, effect size of human readers with AI, training set size, ground truth for training set) are not applicable to this type of submission focused on packaging changes for a steerable guidewire.
However, I will extract the information that is present concerning the validation of the packaging changes.
Acceptance Criteria and Study for Packaging Modifications of AGILITY® and NEUROSCOUT® Steerable Guidewires (K133625)
The study described in this 510(k) submission (K133625) is not for the device's functional performance in a clinical setting, but rather for the packaging modifications to the AGILITY® and NEUROSCOUT® Steerable Guidewires, demonstrating substantial equivalence to the predicate device. The primary objective was to ensure that the new packaging maintained sterility, integrity, and safety.
1. Table of Acceptance Criteria and Reported Device Performance (Packaging)
| Category | Acceptance Criteria | Reported Device Performance (Based on "Bench Testing" and "Sterilization Validation" sections for packaging) |
|---|---|---|
| Packaging Validation | Visual Inspection: (Implied: No defects, damage, or compromise to sterile barrier) | |
| Dye Leak: (Implied: No leaks to indicate compromise of sterile barrier) | ||
| Seal Strength: (Implied: Seals meet predefined strength requirements to maintain package integrity) | "Verification and validation activities were focused on demonstrating package integrity of the proposed pouches... all testing was performed on final sterile product." (Implied: All tests passed, as package was deemed substantially equivalent and cleared.) | |
| Sterilization Validation | EO/ECH Residuals: (Implied: Residuals of Ethylene Oxide (EO) and its byproducts (e.g., Ethylene Chlorohydrin - ECH) must be below acceptable limits according to ISO 11135-1:2007 and ISO 10993-7:2008 standards to ensure patient safety and product biocompatibility.) | "EO/ECH Residuals" testing was conducted. (Implied: Results met the acceptance criteria, as the submission states, "does not raise any new questions of safety and effectiveness.") |
| Sterile Pouch Shelf-Life Stability Validation | Visual Inspection: (Implied: No degradation, damage, or compromise to sterile barrier over time) | |
| Dye Leak: (Implied: No leaks over time) | ||
| Seal Strength: (Implied: Seals maintain required strength over the stated shelf-life) | ||
| (Stated Shelf-Life: Two (2) years) | Testing conducted for two (2) years shelf-life. (Implied: All stability tests passed for the two-year shelf-life, as the device was cleared without new safety or effectiveness concerns.) | |
| Biocompatibility Testing | In vitro Cytotoxicity: (Implied: Absence of cytotoxic effects, meeting ISO 10993-5:2009 standards for any leachable substances from the new packaging interacting with the device or patient.) | "In vitro Cytotoxicity" testing was conducted. (Implied: Results met the acceptance criteria, as the submission states that the device is "substantially equivalent" and raises "no new questions of safety and effectiveness.") |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the document. The text indicates "appropriate testing was identified" and "all testing was performed on final sterile product" for packaging validation, sterilization validation, and shelf-life stability. Specific numbers of units tested are not provided.
- Data Provenance: The studies were prospective bench tests performed by the manufacturer, Codman & Shurtleff, Inc. The country of origin for the data is not specified but is presumably where the manufacturing and testing facilities of Codman & Shurtleff, Inc. are located (e.g., USA, as the company is based in Raynham, MA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not applicable to this submission concerning packaging modifications. "Ground truth" in the requested sense (e.g., expert consensus on medical images or diagnoses) is not relevant for testing packaging integrity, sterilization residuals, or biocompatibility.
4. Adjudication Method for the Test Set
- This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used for clinical endpoints or image interpretations where multiple experts assess a case. The tests performed here (e.g., dye leak, seal strength, chemical residuals) are objective, quantitative measurements that do not require expert adjudication in that manner.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC study was not done. This type of study is for evaluating the clinical performance of a diagnostic or therapeutic device by comparing human reader performance with and without AI assistance. This submission is for packaging changes to a guidewire, not an AI-enabled diagnostic device.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, this is not applicable. The device is a steerable guidewire; it does not involve an algorithm or AI.
7. Type of Ground Truth Used
- For the packaging validation, the "ground truth" would be established by objective technical standards and specifications (e.g., dye penetration not exceeding a certain limit, seal strength within a defined range, chemical residuals below a specified ppm). These are based on recognized industry standards (listed in Table 4) and regulatory requirements for medical device packaging and sterilization.
8. Sample Size for the Training Set
- This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.