Search Results

The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.

Device Description

The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle and covered with a PTFE extrusion. The distal tip of the MRWire is marked with discrete ring markers for MRI and X-Ray visibility and comes in different configurations such as straight and angled. Guide wires are supplied sterile and nonpyrogenic. The MRWire's diameter is 0.035" (0.89 mm).

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "MRWire Guide Wire." This section outlines the device, its modifications from a predicate device, and the non-clinical tests performed to demonstrate its substantial equivalence and safety.

Here's an analysis of the provided text in relation to the requested information:

Key Takeaway: The provided document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance testing. It explicitly states that no clinical tests were performed or included in this submission. Therefore, much of the requested information regarding human-in-the-loop performance, expert ground truth, and patient-data-driven studies is not applicable to this specific submission.

However, I can extract information related to the physical performance testing of the device for manufacturing and safety purposes.

Acceptance Criteria and Device Performance (Non-Clinical)

The document primarily focuses on a comparison to a predicate device and adherence to established standards and in-house criteria for physical and material properties. The "acceptance criteria" here refer to the device meeting or surpassing the performance of the predicate device and complying with relevant ISO standards and FDA guidance documents.

Here's a table summarizing the modifications and the performance outcomes, which serve as the "acceptance criteria" for demonstrating substantial equivalence for these specific changes:

Modification Feature	Technological Difference	Benchmark Test	Acceptance Criteria (Performance vs. Predicate)	Reported Device Performance / Outcome
Modification 1:	PTFE heat shrink tube instead of Pebax® outer extrusion	Simulated Use Test	No differences expected compared to predicate.	No differences in the Simulated Use Test.
		Flexing and Bending Resistance	No differences expected compared to predicate.	No differences in Flexing and Bending Resistance Test.
		Biocompatibility Testing	Device should be free from biological risks under applied conditions (per ISO 10993-1).	Under the applied conditions, the device is free from biological risks. (Evaluated through extended biocompatibility testing for new blood-contacting materials).
		Torquability Test	Comparable or improved torquability compared to predicate.	The torqueability of the subject device is slightly increased compared to the predicate.
		Particulate Testing	No generation of particles.	Both (subject and predicate) generate no particles.
		U-Turn Test	No differences expected compared to predicate.	No differences in the U-turn test.
		Usability Scoring Test	No difference in usability expected compared to predicate.	No difference in usability.
Modification 2:	Glass fiber core diameter decreased (0.52mm to 0.50mm) for PTFE extrusion	Simulated Use Test	No differences expected compared to predicate.	No differences in the Simulated Use Test.
		Fracture Test	No differences expected compared to predicate.	No differences in the Fracture Test.
		Tensile Strength Test	Comparable or improved tensile strength compared to predicate to withstand normal tensile loading.	The tensile strength is slightly higher than the predicate device, making it better to withstand normal tensile loading for the intended use.
		Bending Module Test (shaft)	Shaft stiffness in the same order of magnitude as predicate.	Shaft stiffness is in the same order of magnitude.
		Torquability Test	Comparable or improved torquability compared to predicate.	The torqueability of the subject device is slightly increased compared to the predicate.
		Torque Strength Test	Comparable or improved torque strength compared to predicate to withstand normal rotational loading.	The torque Strength of the subject device is increased compared to the predicate making it better to withstand normal rotational loading for the Intended use.
		U-Turn Test	No differences expected compared to predicate.	No differences in the U-turn test.
		Usability Scoring Test	No difference in usability expected compared to predicate.	No difference in usability.
Modification 3:	Tip is preformed instead of grinding, no need for Pebax® tip extrusions	Simulated Use Test	No differences expected compared to predicate.	No differences in the Simulated Use Test.
		Tensile Strength Test	Comparable or improved tensile strength compared to predicate.	The tensile strength is slightly higher than the predicate device, making it better to withstand normal tensile loading for the intended use.
		Radiopacity Testing	Both should have radiopaque elements in the tip.	Both have radiopaque elements in the tip.
		Torquability Test	Comparable or improved torquability compared to predicate.	The torqueability of the subject device is slightly increased compared to the predicate.
		Tip Flexibility Test	Tip flexibility comparable to predicate.	The tip flexibility of the subject devices is comparable to the predicate.
		Torque Strength Test	Comparable or improved torque strength compared to predicate.	The torque Strength of the subject device is increased compared to the predicate making it better to withstand normal rotational loading for the Intended use.
		Usability Scoring Test	No difference in usability expected compared to predicate.	No difference in usability.
		MRI Compatibility	No difference in MRI labeling.	No difference in MRI labelling. (MR Conditional status; Max temp rise < 0.6 °C after 15 min; image artifact extends ~8mm from device at 3T).
Overall (General)	Compliance with standards and guidance	Various Performance Tests	Conform to recognized consensus ISO standards, FDA guidance documents, or in-house standards; substantially equivalent to predicate device for its shelf life; no new issues of safety and effectiveness.	Performance testing demonstrated that the MRWire Guide Wire conformed to the recognized consensus ISO standards, FDA guidance documents or in-house standards, is substantially equivalent to the predicate device for its shelf life. No new risks identified from risk analysis.
	Biocompatibility	Biocompatibility Testing	Free from biological hazards under applied conditions based on ISO 10993-1.	Evaluated by extended biocompatibility testing in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Showed that under the applied conditions, the device is free from biological hazards.
	Sterilization	Sterilization Validation	Achieve a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135: 2014.	Device adopted into an existing sterilization cycle validated in accordance with ISO 11135: 2014, to provide a SAL of 10-6.
	Risk Analysis	Risk Assessment	No new risks identified in accordance with ISO 14971: 2007.	A Product Risk Analysis was conducted in accordance with ISO 14971: 2007, and no new risks were identified.

Here's a breakdown of the specific points requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

(Provided above in detail)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the precise sample sizes (N-values) used for each non-clinical test (e.g., how many guide wires were tested for tensile strength or torquability). It mentions "MRWire Guide Wire Samples" for performance testing.
Data Provenance:
- Country of Origin: Not explicitly stated for the testing location or data collection, but the manufacturer is Nano4Imaging GmbH, located in Aachen, Germany.
- Retrospective or Prospective: This distinction is not applicable as these are non-clinical, controlled laboratory performance tests on manufactured devices, not studies involving patient data or clinical observation. The tests were performed on "non-aged and accelerated-aged MRWire Guide Wire Samples" to evaluate performance throughout the labeled shelf life.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This device is a physical guide wire, and the testing described is non-clinical performance and material testing (e.g., tensile strength, flexibility, torquability, biocompatibility, MRI compatibility based on physical properties). There is no "ground truth" established by clinical experts in the context of diagnostic interpretation, as this is not an AI/imaging diagnostic device requiring human evaluation of outputs. The "experts" would be the engineers, scientists, and technicians conducting the physical tests and analyzing the results against engineering specifications and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As explained in point 3, this is non-clinical performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation studies where multiple human readers disagree on a diagnosis or finding, and an independent expert or panel resolves the discrepancy to establish a "ground truth." This is not relevant for testing a physical device's mechanical or material properties.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document explicitly states: "This 510(k) does not include data from clinical tests." Therefore, no MRMC study was performed, and this device is not an AI diagnostic tool designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device (guide wire), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is irrelevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable in the traditional sense of clinical data. For this device, the "ground truth" for its performance and safety is established by:
- Engineering specifications: The design parameters and expected performance characteristics of the guide wire.
- Predicate device performance: The previously cleared device serving as a benchmark.
- Consensus standards: ISO 11070:2014, ASTM F640-12, EN ISO 14125:2011, ISO 10993-1:2009, ISO 11135:2014, ISO 14971:2007.
- FDA guidance documents: "Coronary and Cerebrovascular Guidewire Guidance, January 1995" and "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, issued December 11, 2014."
- In-house standards: Developed by Nano4Imaging GmbH to ensure specific performance metrics.
The "ground truth" is that the device meets or exceeds the performance of the predicate and complies with all relevant safety and performance standards.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is a physical device being evaluated through non-clinical performance testing, not an AI/machine learning model that learns from data.

9. How the ground truth for the training set was established

Not Applicable. (See point 8).

Ask a Question

Ask a specific question about this device

Page 1 of 1