(210 days)
The Arrow Stiffening Stylet is intended to be placed inside a catheter to stiffen the catheter for placement.
The Arrow Stiffening Stylet is a sterile, single use, percutaneous peripheral vasculature catheter stylet intended for transient use (up to 24 hours) to be placed within a catheter to render it stiff to aid in catheter placement. The proposed device will be delivered as a sterile accessory within a convenience kit for the Arrow Peripherally Inserted Central Catheter (PICC)s. The Stylet is a PTFE coated solid nitinol core wire with straight tip. The stylet is available in 0.015-0.017-inch diameters and in 29.5-inch length with distance markings along the stylet body.
The Arrow Stiffening Stylet is provided with an existing, commercially available flushable hub with side arm and slide clamp cleared under K790408. The flushable hub maintains the stylet position within the catheter during catheter placement, is intended to minimize blood loss during catheter introduction, and allows the clinician to flush through the catheter to aid in catheter placement, if needed. There is no change to the flushable hub cleared under K790408 introduced by this submission.
This document describes a 510(k) Pre-Market Notification for the Arrow Stiffening Stylet. The primary purpose of this submission is to demonstrate the substantial equivalence of the Arrow Stiffening Stylet to a legally marketed predicate device, the Galt Medical Corp's GaltTWS Stylet (K182660).
Acceptance Criteria and Device Performance (as derived from the provided document):
The document does not explicitly state "acceptance criteria" as a pass/fail threshold but rather lists the tests performed and implies that the device "passed all acceptance criteria" during non-clinical performance testing. The "reported device performance" is essentially that the device met the requirements of these tests.
| Acceptance Criteria (Implied by Testing) | Reported Device Performance (Implied by Conclusion) |
|---|---|
| Mechanical/Physical testing in accordance with ISO 11070, Guidance Documents, and Arrow International Internal Requirements: | Passed |
| Surface: Extraneous Matter and Defects | Passed |
| Corrosion Resistance | Passed |
| Radio-detectability | Passed |
| Guide wire Fracture | Passed |
| Guide wire Flexure | Passed |
| Guide wire Tensile | Passed |
| Retainer Leak (Flushable Hub Interface) | Passed |
| Retainer Grip (Flushable Hub Interface) | Passed |
| Coating Integrity | Passed |
| Particulate | Passed |
| Torque Test | Passed |
| Stiffness | Passed |
| Removal Force from Catheter | Passed |
| Human Factors/Usability Testing | Passed |
| Biocompatibility testing in accordance with ISO 10993-1: | Passed |
| Cytotoxicity (MEM Elution) | Passed |
| Sensitization Kligman Maximization Test (polar and non-polar extracts) | Passed |
| Intracutaneous Injection (polar and non-polar extracts) | Passed |
| Acute Systemic Toxicity (polar and non-polar extracts) | Passed |
| Materials Mediated Pyrogenicity | Passed |
| Hemolysis (direct and indirect contact) | Passed |
Study Details:
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Sample Size and Data Provenance:
- Test Set Sample Size: The document does not specify the exact sample sizes for each test. It broadly states "testing conducted" without providing numerical details for the number of units or distinct test conditions evaluated.
- Data Provenance: The data appears to be entirely from non-clinical performance testing conducted by Arrow International LLC. There is no indication of patient data or clinical trials. The country of origin for the data is not explicitly stated, but as Arrow International LLC is based in Morrisville, North Carolina, USA, the testing was likely performed there or in accordance with US regulatory standards. The data is not retrospective or prospective clinical data as no human clinical data was used.
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Number of Experts and Qualifications for Ground Truth:
- Not Applicable. This submission is for a medical device (stylet) that relies on physical and mechanical testing, not interpretation of data like images or patient records that would require expert consensus for ground truth. Therefore, there's no mention of experts establishing ground truth in the context of interpretation. Internal engineering and quality control experts at Arrow International LLC would have developed the test protocols and evaluated the results against internal requirements and relevant ISO standards.
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Adjudication Method for Test Set:
- Not Applicable. As this is non-clinical physical/mechanical testing, there isn't an "adjudication method" in the sense of resolving disagreements between human readers or experts. Test results would be objectively measured against predefined specifications.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not conducted. This type of study is typically performed for AI or diagnostic imaging devices where human interpretation is involved. This submission is for a physical medical device.
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Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Not Applicable. This is a physical medical device, not a software algorithm or AI.
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Type of Ground Truth Used:
- The "ground truth" for this device's performance is established by objective measurements against predefined engineering specifications and relevant international standards (e.g., ISO 11070, ISO 10993-1). It is based on physical and mechanical properties, not expert consensus, pathology, or outcomes data from a clinical setting.
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Training Set Sample Size:
- Not Applicable. There is no "training set" in the context of this device. This is not an AI/machine learning device. The testing described is verification testing against design specifications.
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How Ground Truth for Training Set Was Established:
- Not Applicable. As there is no training set, there is no ground truth established for one.
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).