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EasyFinder™ Fixed Curve Diagnostic Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies.

The EasyFinder™ Fixed Curve Diagnostic Catheter is a sterile, single-use diagnostic catheter with multiple electrodes and a fixed distal curve. It has been designed to facilitate electrophysiological mapping of cardiac structures in 28 models and 6 kinds of curves.

The catheter has a high-torque shaft with a fixed curve section containing an array of platinum electrodes. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

The catheter is connected to separately cleared diagnostic electrophysiology equipment via an accessory, the FORLNK™ Cable for Mapping Catheter.

The provided document, a 510(k) summary for the EasyFinder™ Fixed Curve Diagnostic Catheter, indicates that no clinical study was included in the submission. Therefore, information regarding acceptance criteria derived from a clinical study, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as requested, is not available from this document.

The substantial equivalence determination for this device is based on non-clinical performance testing and comparison to a predicate device.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative sense as might be seen for a new AI/software device. Instead, it states that the device complies with specific industry standards and regulatory guidance, which serve as the "acceptance criteria" for demonstrating safety and effectiveness. The "reported device performance" is its compliance with these standards.

2. Sample size used for the test set and the data provenance:

• Not Applicable. No clinical study or separate test set in the context of an AI/software device performance evaluation was conducted or reported. Performance was based on non-clinical (bench) testing against established standards and comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No clinical study or expert-adjudicated test set in the context of an AI/software device performance evaluation was conducted or reported.

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

• Not Applicable. No expert adjudication was conducted or reported.

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 a hardware medical device (diagnostic catheter), not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or reported.

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

• Not Applicable. This is a hardware medical device, not an algorithm.

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

• Not Applicable. For the non-clinical tests, the "ground truth" was established by the specifications defined in the referenced international standards (e.g., ISO, IEC). For equivalence to the predicate, the characteristics of the predicate device served as the reference.

8. The sample size for the training set:

• Not Applicable. No training set, in the context of an AI/software device, was used or reported.

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

• Not Applicable. No training set was used.

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The PathBuilder™ Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.

PathBuilder™ Transseptal Needle is consisted of thin section, curved section, main body, pointer flange, hub and stylet. The distal end of PathBuilder™ Transseptal Needle is curved for easy positioning within the heart when used together with the catheter introducer. The outer diameter of needle stepped down within the curved section for better fitness to the dilator which fixes the maximum length of the needle into the dilator. The distal tip of the needle is beveled to facilitate the transseptal process. The proximal end of PathBuilder™ Transseptal Needle is with a pointer flange which indicates the curve orientation of the needle. And a hub is equipped for aspiration, fluid injection/infusion etc. The stylet is straight. The proximal end of the stylet is curved to lock on the hub when inserted into the needle lumen. The stylet is used to help insert the needle into the dilator.

The provided document is a 510(k) premarket notification for the "PathBuilder™ Transseptal Needle". This document describes the device and its equivalence to a predicate device, but it does not include any information about an AI/ML device.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study proving an AI/ML device meets acceptance criteria. The document explicitly states: "No clinical study was used to support this submission."

The closest information provided related to performance testing is for the transseptal needle device (not an AI/ML system):

Non-Clinical Performance Testing:

• Biocompatibility Verification: Verified as per ISO 10993-1:2018 and FDA guidelines. Tests included Cytocompatibility, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Complement Activation, and Thrombogenicity.
• Bench Validation: Included visual inspection, dimensional verification, packaging testing (visual inspection, sealing strength, dye penetration), and mechanical failure/performance (joint forces). Compatibility of the needle and dilator was validated with compatibility, puncture force, radio detectability, and luer fitting. All samples were sterilized and aged prior to testing. All tested samples passed bench testing.
• Cleaning and Sterilization Validation: Performed in accordance with ISO 11135:2014, AAMI TIR 28:2009, and FDA guidance.
• Shelf Life Validation: Demonstrated a shelf life of three years.

Since no AI/ML device is described, I cannot answer questions 2 through 9 regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

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The PathBuilder™ Transseptal Guiding Introducer is introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

PathBuilder™ Transseptal Guiding Introducer is comprised of a sheath, a dilator and a guidewire. At the distal end of the sheath, a marker band is embedded to mark the position of the sheath during the procedure. Near the marker band, there are three vent holes to reduce cavitation during aspiration and device withdrawal. At the proximal end of the sheath, a sideport with three-way stopcock is located for aspiration, fluid infusion, blood sampling and pressure monitoring. Sheath is fitted with a valve to provide hemostasis during catheter introduction and/or exchange over a guidewire. The dilator, which is mainly used to expand the opening during the inter-atrial septal puncture, is a straight tube with a specially curved portion. The distal end of the dilator is designed to a tip and there is a hub at the proximal end where the needle goes through. The internal lumen of dilator is tapered at the distal tip to fix the location of the needle. Both the sheath and dilator are with a specially curved portion to accommodate positioning against the atrial septum. When the dilator is inserted into the sheath, the sheath tip fit that of dilator well, which help the set to enter the sheath. Guidewire is a thin wire leading the introducer set to the desired position.

The provided text is a 510(k) summary for the PathBuilder™ Transseptal Guiding Introducer and does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

This document describes a conventional medical device (catheter introducer) and its comparison to a predicate device for substantial equivalence. The "Non-Clinical Performance Testing" section details various bench tests and validations performed on the physical device, not an AI/ML algorithm.

Therefore, I cannot provide the requested information for an AI/ML device based on this document. The document explicitly states: "No clinical study was used to support this submission."

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The PathBuilder™ Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

PathBuilder™ Steerable Introducer is composed of a steerable sheath, a dilator and a guidewire. It is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The steerable sheath is introduced into a body vessel, along with the dilator, over the guidewire, it is available in a variety of lengths, sizes and curve configurations; Dilator is assembled with the sheath and introduced into a body vessel over the guidewire. It is used to provide support to the sheath and ensure smooth advancement; the guidewire is percutaneously placed into the body vessel to function as a guide for the introduction into the chambers of the heart.

The distal end of steerable sheath is embedded with a marker band and vent holes. The steerable sheath is finished at the proximal end with a hemostasis valve and sideport with a three-way stopcock. By turning the rotating collar on handle, the steerable sheath can be bidirectionally bended to facilitate the steerable sheath to reach complex heart structures more conveniently. The distal end of dilator has a tip, while its proximal end is connected with luer fitting. The inner diameter of dilator distal end is smaller than the main body for the purpose of locking the position of a puncture needle. The distal end of dilator has a fixed curve to adapt to the heart structure.

The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise ≥180° and counter-clockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

The PathBuilder™ Steerable Introducer is a medical device designed for introducing various cardiovascular catheters into the heart, including into the left side of the heart through the interatrial septum. The device did not undergo clinical studies to prove these claims but a series of non-clinical, benchtop tests and analyses to establish substantial equivalence to a predicate device (Agilis™ NxT Steerable Introducer (K081645)).

Here's the breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:
   The document does not specify the exact sample sizes for each non-clinical test (biocompatibility, bench validation, cleaning and sterilization, shelf life). It states that "All samples were sterilized and aged prior to testing. All tested samples passed bench testing." As these are bench tests and not clinical studies, the data provenance is from laboratory testing performed by the manufacturer, Shanghai MicroPort EP MedTech Co., Ltd., presumably in China as that is their location.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. This was a non-clinical evaluation comparing device properties to established standards and a predicate device. There was no expert-derived "ground truth" for the test set in the way it would be for a diagnostic AI device. The ground truth was based on the performance standards themselves and the characteristics of the predicate device.

4. Adjudication method for the test set:
   Not applicable. There was no adjudication method described as it was not a study involving human interpretation of results. The tests measured physical and material properties against predefined specifications and standards.

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 device is a steerable introducer (a physical medical device), not an Artificial Intelligence (AI) device, and thus an MRMC comparative effectiveness study was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used:
   The "ground truth" in this context refers to established national and international standards (e.g., ISO 10993-1, ISO 11135, ISO 11070, AAMI TIR 28) and the characteristics of the legally marketed predicate device (Agilis™ NxT Steerable Introducer K081645). The device's performance was compared against these benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set:
   Not applicable. As this is not an AI/machine learning device, there is no training set.

9. How the ground truth for the training set was established:
   Not applicable. There is no training set for a physical medical device.

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