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The Reprocessed Electrophysiology Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures during these evaluations.

The device consists of a reprocessed catheter that has a high-torque shaft with a handle at the proximal end, and may or may not be steerable. These catheters have an outer diameter of 4F to 8F, a length ranging from 60 to 160 cm, with 2-20 platinum, radiopaque electrodes along the tip shaft and a variety of inter-electrode spacings and curve styles at the tip. The tip generally is deflectable. Specific cables, as recommended by the original manufacturer, connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiologic recorder. It should be noted that this submission pertains to the catheter only. It does not include any other components in a system such as, connector cables, external stimulators, or electrophysiologic recorders.

This is not an AI/ML device, and therefore the criteria listed in parts 1-9 do not apply. This is a reprocessed medical device (electrophysiology diagnostic catheters) that functions identically to original manufacturer devices. The 510(k) summary focuses on demonstrating that the reprocessed device is substantially equivalent to predicate devices in terms of functional design, materials, indications for use, and construction.

Here's an analysis of the provided text, addressing the requested information where applicable for a non-AI/ML device:

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

For this reprocessed device, the "acceptance criteria" are essentially demonstrating substantial equivalence to the original, predicate devices. The performance is measured against these established characteristics rather than novel AI/ML metrics.

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

The document does not specify a "test set" in the context of an AI/ML model. Instead, it refers to "Representative samples of reprocessed electrophysiology diagnostic catheters" used for design testing. The sample size is not quantified.

• Sample Size: Not specified beyond "Representative samples."
• Data Provenance: Not explicitly stated, however, the testing would be conducted internally by SterilMed, Inc. (Minneapolis, MN, USA) on their reprocessed devices. This would be prospective for the reprocessed devices.

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)

This is not applicable to this type of device. "Ground truth" in the context of this device would refer to the established performance characteristics and safety profiles of the original predicate devices, as well as the successful validation of reprocessing steps (cleaning, sterilization). These are typically established through engineering standards, clinical trials of the original devices, and scientific validation methods, not expert consensus on interpretations like in AI/ML.

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

Not applicable. Adjudication is a term relevant to resolving discrepancies in expert interpretations, typically in AI/ML or clinical trial settings where subjective assessment is involved. The testing described for this device (functional and safety) involves objective measurements and validation protocols.

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

Not applicable. This is not an AI-assisted diagnostic device, and therefore MRMC studies are irrelevant.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this reprocessed device is established by:

• Predicate Device Specifications: The known functional, material, and performance specifications of the original, legally marketed electrophysiology diagnostic catheters.
• Engineering Standards & Bench Testing: Objective measurements and tests (e.g., electrical conductivity, mechanical integrity, sterility assays) to ensure the reprocessed device meets these predefined specifications.
• Process Validation: Scientific evidence that the cleaning, sterilization, and packaging processes consistently achieve their intended outcomes without degrading the device.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" for this device.

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The intended use of the Diagnostic Deflectable Tip Catheter is to map cardiac structures using stimulation and recording techniques. The Cordis Webster Diagnostic Deflectable Tip Catheter is indicated for electrophysiology mapping of cardiac structures in adults and children 4 years of age and older; i.e. stimulation and recording only.

The Diagnostic Deflectable Tip Catheter (5 French size) modification is applicable only to the Instructions for Use. The function, component materials, and intended use of the Diagnostic Deflectable Tip Catheter as compared to the Predicate Device (of the same name - K892265) are identical. An additional indication for use and warning are added that allows the use of the catheter to not only be used in adults but in children 4 years of age and older. The additional warning is to alert the physician regarding the possibility of brachial plexus injury. These additions to the IFU were requested by FDA on behalf of P950005/S3, the pediatric indication approval for Cordis Webster's Diagnostic/Ablation Deflectable Tip Catheters, 6 and 7 French. They also apply to the 5 French diagnostic catheter. The safety or effectiveness of the subject device was not affected as the device itself has not been altered. The Diagnostic Deflectable Tip Catheter (5 French size) is essentially a smaller diameter version of the Premarket Notified 6. 7 French design. These catheters were designed to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing platinum electrodes that can be used for stimulation and recording. The 5 French Deflectable Catheter utilized the same design features that are in the present deflectable catheter with the exception of the tip electrode connection/termination method. The electrical connection is made in the same way as is done with the Predicate Device, however, the puller-wire which is normally anchored proximal to the tip is terminated (soldered) directly to the tip electrode. Since the puller-wire is attached to the tip electrode, the puller-wire replaces the safety wires that were in the 6 and 7 French Deflectable Catheters. This tip electrode connection/termination method is also utilized for the Crista Cath™ diagnostic catheter approved under K953768.

The provided text describes a 510(k) submission for a Diagnostic Deflectable Tip Catheter (5 French size) modification. The submission aims to demonstrate substantial equivalence to a predicate device (K892265). The core of the modification is an additional indication for use, allowing the catheter to be used in children 4 years of age and older, and a warning about brachial plexus injury. The device itself has not been altered in its fundamental design or function compared to the predicate device, other than being a smaller diameter version of 6 and 7 French designs. The key change is a modification in the tip electrode connection/termination method, where the puller-wire is soldered directly to the tip electrode, replacing safety wires.

Here's the information broken down as requested:

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

Based on the provided text, the acceptance criteria are not explicitly stated as numerical targets. Instead, the performance evaluation relies on demonstrating substantial equivalence to a predicate device and showing the safety and effectiveness of the modifications.

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

• Sample Size:
  • For the "process capability study" on puller wires: Not specified. The text only states that "pull tests were conducted."
  • For the "published literature" cited for pediatric use: Not specified. It's external literature, not a study performed by the applicant on this specific device.
  • For "complaint data": Not specified. "Number of complaints versus the number of units sold" is mentioned, but no actual numbers are provided.
• Data Provenance: Not explicitly stated for any of the data points.
  • The "process capability study" would likely be an internal study conducted by the manufacturer, but the location is not mentioned.
  • "Published literature" could be from various global sources.
  • "Complaint data" would be post-market surveillance data, likely collected globally wherever the predicate device was sold.
  • General information points to the applicant's address in Baldwin Park, CA, and Diamond Bar, CA, which are in the USA.

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. The submission does not describe a study involving expert review or ground truth establishment in the traditional sense for a diagnostic algorithm. The assessment relies on mechanical testing (pull tests), existing literature, and market surveillance.

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

• Not Applicable. There is no mention of expert adjudication for a test set.

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. This is a medical device (catheter), not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

• No. This is a medical device (catheter), not an algorithm. Standalone performance for an algorithm is not applicable.

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

• For the pediatric indication, the "ground truth" for safety and effectiveness appears to be derived from published literature on similar smaller French-size catheters, rather than a specific ground truth established for this device's study.
• For the mechanical integrity of the puller-wire, the ground truth is established through physical pull tests where the wire's breaking strength or securement is objectively measured against engineering specifications. No expert consensus, pathology, or outcomes data is relevant here.
• For overall safety, complaint data (post-market outcomes) indirectly serves as a measure.

8. The sample size for the training set

• Not Applicable. As this is a medical device (catheter) and not an AI/algorithmic device, there is no concept of a "training set" in the context of machine learning.

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

• Not Applicable. Same as above, no training set is relevant.

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