(172 days)
Lake Region's steerable guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature, including the renal vasculature. The steerability feature allows the guidewire to be torqued to facilitate navigation through the vasculature.
Utilizing a proprietary process, LRM produces a PTFE coated stainless steel steerable core. The proximal portion of the core wire is coated with PTFE to provide lubricity and improve wire handling. A platinum alloy coil provides radiopacity in the distal tip. The coil is secured in its location by solder, which is attached to the core. The proximal end of the coil is attached to the core with solder. Additionally, two sections of PTFE are removed from the proximal end of the core to aid in estimating guidewire positioning. The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are optionally coated with MDX (silicone). The guidewires are bound by the following parameters: Outside Diameter: .018", Lengths: 130cm - 300cm, Tips: Straight or shaped with various tip flexibilities, Flexibility: Floppy to Support.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a guidewire, and the submission emphasizes its substantial equivalence to previously cleared predicate devices (K970376 and K011968), rather than detailing specific numerical performance metrics for acceptance criteria and results. The "performance" is primarily demonstrated through meeting established requirements and the absence of adverse effects due to minor modifications.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance (How the device meets the criteria) |
|---|---|---|
| Design Specifications | Same basic design criteria as predicate devices (K970376 and K011968). | "The design specifications are the same for the proposed device as they are for the LRM predicate device [reference 510(k) K970376 and K011968]. The finished devices must meet the same basic design criteria." (Section 2.4.2) |
| Physical Characteristics | Expand overall length from 175cm-300cm to 130cm-300cm. | |
| Allow radiopaque coil length from 2cm-30cm (was either 2cm or 30cm). | "No change except to expand the scope of the overall length parameters from: 175cm – 300cm to: 130cm – 300cm and to allow radiopaque coil length ranges from 2 cm to 30 cm (was either 2 cm or 30 cm)." (Table in Section 2.5.1) Testing was done to ensure these changes met predetermined performance criteria. | |
| Material Equivalence | Raw materials (Core, Coil, Extension system) identical to predicate. | "No change" for Core, Coil, Extension system raw materials. (Table in Section 2.5.1). "The materials for the proposed device are identical to the predicate device cleared under K011968 and are identically processed and sterilized." (Section 2.6.3) |
| Process Equivalence | No significant change to assembly processes. | "No significant change to assembly processes." (Table in Section 2.5.1) |
| Intended Use | No change to intended use, but to clarify use in renal peripheral vasculature. | "No change to intended use except to clarify the guidewire can be used in the renal peripheral vasculature." (Table in Section 2.5.1). The final "Indications for Use" statement explicitly includes "coronary and peripheral vasculature, including the renal vasculature." (Section 2.8 and 510(k) Letter) |
| Biocompatibility | No new biocompatibility issues compared to predicate. | "No change" (Table in Section 2.5.1). "Biocompatibility testing for the proposed device is not required" because materials are identical and identically processed/sterilized as the predicate. (Section 2.6.3) |
| Performance Testing | Meet requirements of FDA guidance "Coronary and Cerebrovascular Guidewire Guidance" (Jan 1995) and ISO 11070. Internally defined protocols for peripheral/renal vasculature. Inspection criteria for visual/tactile, dimensional, and mechanical attributes. | "LRM performed testing to established requirements listed in FDA guidance document entitled Coronary and Cerebrovascular Guidewire Guidance, issued January 1995, and ISO 11070 Sterile Single-use Intravascular Catheter Introducers." (Section 2.5.2) "Additionally, internal test protocol requirements were utilized to verify the guidewire can be used in the peripheral vasculature, including the renal vasculature." (Section 2.5.3) "Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes." (Section 2.5.4) |
| Safety Characteristics | No change from predicate device. | "No change" (Table in Section 2.5.1). |
| Risk Analysis | No change from predicate device; conformance with design control, FMEA used. | "No change" (Table in Section 2.5.1). "LRM is in conformance with the design control procedure requirements as specified in 21 CFR 820.30. Risk analysis was completed by means of a Failure Mode and Effect Analysis (FMEA) and all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria could be met." (Section 2.6.1) |
| Quality Systems | Assurance that proposed product remains equivalent and changes have no adverse effect on safety/effectiveness. | "LRM has formal quality systems in place to assure that the proposed steerable product will remain equivalent to the predicate product, and that the changes will not have an adverse affect on the safe and effective use of the product." (Section 2.6.2) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial or large-scale performance study. It mentions "Test pieces were tested and inspected" (Section 2.5.4) and "testing was done to ensure the changes to the device met the predetermined performance criteria" (Section 2.5.1), but without a number. This submission relies heavily on a "substantial equivalence" argument, meaning much of the "proof" comes from the established performance of the predicate devices combined with verification of the minor changes.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing appears to be primarily non-clinical bench testing and in-house verification against established standards and internal protocols. There's no mention of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The "ground truth" for guidewire performance in this context would likely be defined by the established engineering specifications and performance standards (FDA guidance, ISO 11070, internal protocols) rather than expert consensus on individual cases. The document refers to "established specific inspection criteria requirements" (Section 2.5.4) which would have been defined by qualified engineers and regulatory specialists during the design control process.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication typically refers to the process of resolving disagreements among experts when establishing ground truth from clinical data. Since the testing described is primarily non-clinical bench testing and verification against standards, such a method wouldn't typically be used.
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 is relevant for AI-powered diagnostic devices where human readers interpret medical images with and without AI assistance. This submission pertains to a physical medical device (guidewire), not an AI algorithm. Therefore, there is no mention of human readers, AI assistance, or effect sizes in this context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is a submission for a physical medical device (guidewire), not a standalone AI algorithm. Therefore, this question is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Engineering Specifications: Conformance to the design and performance criteria set for guidewires, identical to the predicate device.
- Regulatory Standards: Compliance with requirements of the FDA guidance document "Coronary and Cerebrovascular Guidewire Guidance, issued January 1995," and ISO 11070 "Sterile Single-use Intravascular Catheter Introducers."
- Internal Protocol Requirements: Verification against LRM's own internal test protocols, especially for verifying use in peripheral and renal vasculature.
- Visual/Tactile, Dimensional, and Mechanical Attributes: Established specific inspection criteria for these physical properties. (Section 2.5.4)
Essentially, the ground truth is a combination of validated engineering requirements and compliance with recognized industry and regulatory standards.
8. The Sample Size for the Training Set
This information is not applicable/provided. The concept of a "training set" is relevant for machine learning or AI algorithms. This submission is for a physical medical device (guidewire), which does not involve a training set in this context. The "training" for the device's design would be the extensive R&D and manufacturing experience of LRM that led to the predicate devices.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided for the reasons stated in point 8.
§ 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.