FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The HOTWIRETM is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal electrode segment for the creation of an atrial septal defect in the heart. The HOTWIRE is intended to be used in conjunction with compatible third-party intravascular sheaths and/or dilators, such as the Agilis NXT Steerable Introducer, St. Jude Medical (K081645), and third-party RF electrosurgical generator(s), such as the Valleylab FT10 Electrosurgical Platform (K151649) which utilizes a commercially-available Patient Return Electrode (PRE) which is in compliance with IEC 60601-2-2, such as the Valleylab E7507DB (K822572).

The HOTWIRETM is comprised of a stainless steel core wire. The main body of the wire is jacketed with an insulating polymer that provides electrical insulation and facilitates smooth movement of the device through vascular dilators and/or sheaths. The floppy distal segment of the wire has an atraumatic tip with an uninsulated stainless-steel coil, which serves as an electrode, and also provides fluoroscopic visualization. A tungsten marker coil at the tip provides additional radiopacity. The stiff body of the HOTWIRE™ provides support for advancing wire-guided devices into the left atrium after the distal segment has traversed the septum. The proximal insulated portion of the wire has visual markers that align the electrode tip with 3rd party transseptal sheaths and/or dilators. A portion of the proximal wire is uninsulated for placement of an included Adapter Pin that connects to hand pieces used with compatible third-party RF electrosurgical generators.

AI/ML Overview

The provided document is a 510(k) summary for the HOTWIRE™ RADIOFREQUENCY (RF) GUIDEWIRE, demonstrating its substantial equivalence to a predicate device. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance bench testing, animal testing, biocompatibility testing, EMC + Electrical Safety testing, shelf life testing, packaging validation, sterilization validation, and bacterial endotoxin testing conducted to show the device is safe and effective and comparable to the predicate.

Here's the information requested, based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are primarily established by demonstrating compliance with recognized performance standards and showing substantial equivalence to a legally marketed predicate device. The reported device performance is presented as a summary of various tests, all of which "passed testing" or "met the requirements."

Test Category	Acceptance Criteria (Implicit from Test Method Summary)	Reported Device Performance
Performance Bench Testing
Visual and Dimensional Inspection	No damage, dimensions meet product specifications.	All test samples passed testing.
Simulated Use	In vitro performance under simulated use conditions.	All test samples passed testing.
Arc Integrity	No visual damage after successful arcing.	All test samples passed testing.
Tensile Strength	Minimum force to break guidewire per ISO 11070.	All test samples passed testing.
Corrosion Resistance	No visual evidence of corrosion after immersion.	All test samples passed testing.
Torque Strength	Number of turns-to-failures meets standard.	All test samples passed testing.
Torqueability	Rotational input to output ratio comparable to predicate.	All test samples passed testing.
Fracture Resistance and Flexing Test	Resistance to damage by flexing and fracture per ISO 11070.	All test samples passed testing.
Tip Flexibility	Force required to induce buckling deformation comparable to predicate.	All test samples passed testing.
Particulate Characterization	Quantity of particulate matter in injections meets standards.	All test samples passed testing.
Design Verification and Packaging Validation	Meets product specification requirements at t=1 year after gamma irradiation.	All test samples passed testing.
Performance Animal Testing
Animal Testing (GLP)	Satisfactory in vivo performance, trackability, handling, radiopacity, compatibility, and absence of thrombogenicity in acute porcine model.	All test samples passed testing.
Biocompatibility Testing
MEM Elution Cytotoxicity Assay	No cell lysis or toxicity (grade =30% above positive control.	Passed.
Other Performance Testing
EMC + Electrical Safety	Meets applicable requirements of IEC 60601-1 Ed. 3.2, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-1-6, and IEC 62366-1.	HOTWIRE™ is safe and meets applicable requirements.
Shelf Life	Meets all acceptance criteria for 1-year accelerated aging.	All acceptance criteria were met, 1-year shelf life.
Packaging Validation	Meets acceptance criteria from accelerated aging.	All acceptance criteria were met, adequate protection and sterile barrier.
Sterilization	Achieves an SAL of 10^-6.	Validated to achieve SAL of 10^-6.
Bacterial Endotoxin (LAL)	Meets regulation requirements, device does not inhibit or enhance detection of bacterial endotoxins.	All acceptance criteria were met.

Study Details:

The document describes pre-market testing to establish substantial equivalence for a medical device (HOTWIRE™ RF Guidewire) rather than a study typically associated with AI/software devices (which would involve human readers, ground truth establishment, etc.). Therefore, many of the requested points are not applicable in this context.

Here's how the information aligns with the provided document:

A table of acceptance criteria and the reported device performance: Provided above.
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 repeatedly states "All test samples passed testing," but does not specify the exact number of samples used for each test. This information is typically detailed in the full test reports, not the 510(k) summary.
- Data Provenance: Not explicitly stated but assumed to be laboratory testing conducted by or for the device manufacturer (Atraverse Medical, Inc.). The animal testing was a GLP (Good Laboratory Practice) study, implying a controlled, prospective design for that component. Country of origin not specified, but the submission is to the U.S. FDA.
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 guidewire, not an AI/software device requiring human expert annotation for ground truth. "Ground truth" here refers to objective measurements and biological responses verified through standard laboratory and animal testing protocols.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This pertains to expert review and consensus for data labeling/ground truth in AI/software studies, not physical device performance testing.
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: Not applicable. This device is a physical medical device (guidewire), not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical medical device. The "standalone" performance is established through bench and animal testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is established through:
- Validated Test Methods and Standards: (e.g., ISO 11070 for tensile strength, ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety).
- Visual Inspection and Dimensional Measurements: Objective assessments against defined specifications.
- Biological Responses: Measured in in vitro and in vivo (animal) models, such as cytotoxicity, sensitization, pyrogenicity, hemolysis, and thrombogenicity.
- Functional Performance: Assessment of characteristics like trackability, handling, and radiopacity in simulated and animal use.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

Regulation Number and Section

§ 870.5175 Septostomy catheter.

(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).