(29 days)
The Cruiser-18 Guidewires are intended for use in the peripheral vasculature. The Cruiser-18 guide wire is not intended for use in the coronary or cerebral vasculature. Patients judged not acceptable for percutaneous intervention (PPCI).
The guide wire is a disposable medical device designed for single use only. It consists of a 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over a 13cm segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness. This reduced section is covered with a spring coil of equivalent diameter to the main core body. The coiled segment consists of a stainless steel coil placed over a radiopaque coil made of a platinum tungsten alloy. This coil provides greater visibility on x-ray equipment. The profile of the reduced section is varied to provide a range of products with mixed stiffness.
Here's an analysis of the provided text regarding the Cruiser-18 Guidewire, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) Summary for a medical device. This type of submission relies heavily on bench testing and comparison to predicate devices to demonstrate substantial equivalence, rather than extensive clinical studies or AI algorithm performance evaluations as might be found for software as a medical device. Therefore, many of the requested points related to AI, clinical trials, and multi-reader studies will not be applicable.
Acceptance Criteria and Study Overview for Cruiser-18 Guidewire
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Mechanical Performance | - Tensile Strength | Met acceptance criteria defined in product specification; performed comparably to predicate device. |
| - Torque Strength | Met acceptance criteria defined in product specification; performed comparably to predicate device. | |
| - Outer Diameter measurement | Met acceptance criteria defined in product specification; performed comparably to predicate device. | |
| - Torque Response | Met acceptance criteria defined in product specification; performed comparably to predicate device. | |
| - Tip Flexibility | Met acceptance criteria defined in product specification; performed comparably to predicate device. | |
| Material/Integrity | - Coating Adherence/Coating Integrity | Met acceptance criteria defined in product specification; performed comparably to predicate device. |
| Compatibility | - Catheter Compatibility | Met acceptance criteria defined in product specification; performed comparably to predicate device. |
| Biological Safety | - Biocompatibility Testing | Followed ISO 10993-1. |
Study that Proves the Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "In vitro bench tests" carried out to demonstrate equivalence with reference to the FDA's guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995." The results demonstrated that the Cruiser-18 Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "in vitro bench tests" and "performance evaluations" but does not detail the number of units or samples tested for each criterion.
- Data Provenance: The tests are in vitro bench tests, meaning they were conducted in a laboratory setting, not with human subjects. The data does not originate from a specific country in terms of patient data, but rather from laboratory testing performed by Brivant Ltd (located in Ireland). The study is inherently prospective in the sense that the tests were designed and executed to evaluate the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This is not applicable as the device is a physical medical device (guidewire) being evaluated through bench testing against engineering specifications, not an AI algorithm requiring expert consensus for ground truth on medical images or diagnoses. The "ground truth" here is defined by engineering specifications and predicate device performance.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation involves physical measurements and functional tests against predefined specifications, not subjective expert judgment that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical guidewire, not an AI algorithm intended to assist human readers in interpreting medical cases. No MRMC study was conducted or is relevant.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This device is not an algorithm. Its performance is inherent to its physical properties and function as a guidewire, operated manually by a clinician.
7. Type of Ground Truth Used
The ground truth used for these performance evaluations is based on:
- Product Specifications: Predefined engineering and performance criteria for the guidewire.
- Predicate Device Performance: Performance characteristics established from the legally marketed predicate devices (Brivant Guidewire K060551 and Courier Guidewire K073082).
- Regulatory Guidance: Referenced the FDA's "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995."
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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.