Search Results

Femoral artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through artery while minimizing blood loss during interventional procedures.

Radial Artery Introducer Set. The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into the radial artery while minimizing blood loss during interventional procedures.

This set classifies two types: Femoral Artery and Radial Artery. The Femoral Artery introducer set consist of a sheath introdcuer, dilator, needle, Guidewire. The Radial Artery introducer set consist of a sheath introdcuer lubricated with/without hydrophilic coating, dilator, I.V. cannula /Introducer needle,Guidewire (with/without hydrophilic coating).

The Introducer Set consists of sheath introducer, each packaged in a set to together with a dilator, introdcuer needle, and guidewire. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with tubing connected to a 3-way stopcocks is used for injection contrast medium. The dilator is provided to aid in the introduction of sheath to the target vessel. The Introducer needle/I.V. Cannula is provided a conduit for insertion of the guidewire into the vascular system. The guidewire is utilized as a guiding mechanism for the introducer sheath into the vascular system.

The provided document is a 510(k) premarket notification summary for a medical device (KDL Introducer Set). It outlines the device's technical specifications, intended use, and comparison to a predicate device. However, this document describes a Class II medical device (a catheter introducer) and not an AI/ML-driven device. Therefore, the information typically requested in your prompt regarding acceptance criteria and studies for AI/ML device performance (such as sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone algorithm performance, training set details, etc.) is not applicable to this type of traditional medical device.

Instead, the document details non-clinical performance testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the relevant information provided in the document concerning how the device meets acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a single table with "acceptance criteria" and "reported device performance" in the way one might for an AI/ML diagnostic output (e.g., sensitivity, specificity thresholds). Instead, it lists various "Testing item" and "Reference Standard/Guidance" for different components of the Introducer Set. The document then states:

"All sample tested met the standard applicable to each test." and "Base on the result of the performance and biocompatibility testing, the proposed device, Introducer Set, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols."

Here's a re-composition of this information into a table format based on the supplied text:

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

• Sample Size: The document does not specify the exact sample size for each test. It states "The performance tests were performed on the non-aged and ages to 3 years sample." This implies that samples were tested for immediate performance and also after accelerated aging simulating 3 years of shelf life. Specific lot sizes or number of units tested per parameter are not disclosed in this summary.
• Data Provenance: Not explicitly stated, however, the manufacturer is Shanghai Kindly Medical Instruments Co., Ltd. in Shanghai, China. The testing would have been conducted by or for them, likely in China. The study is a non-clinical performance testing and biocompatibility assessment, rather than a clinical study with patient data.

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

• This question is not applicable as this is a traditional medical device undergoing physical and biological performance testing, not an AI/ML device relying on interpretation of medical images or data by experts to establish ground truth. The "ground truth" here is defined by the technical specifications and standards (e.g., ISO, ASTM).

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

• This question is not applicable for the same reason as point 3. Testing involves objective measurements against established engineering and biocompatibility 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:

• This question is not applicable as the device is not an AI-driven product nor does it involve human readers interpreting medical cases.

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

• This question is not applicable as the device is not an algorithm.

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

• The "ground truth" for this device is based on engineering specifications, established international standards (ISO, ASTM), and FDA guidance documents for medical devices (specifically catheter introducers and guidewires). For biocompatibility, it's based on standard biological test methods outlined in ISO 10993 and ASTM F756.

8. The sample size for the training set:

• This question is not applicable as this is a manufactured medical device, not an AI/ML model that requires a training set.

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

• This question is not applicable for the same reason as point 8.

Ask a specific question about this device

The Adelante® Radial Introducer Set is indicated for the introduction of diagnostic and therapeutic catheters into the human vasculature. Do not use this device for neural placements.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Adelante® Radial Introducer Set." It does not contain information about acceptance criteria or a study that proves the device meets those criteria.

The letter approves the device based on its substantial equivalence to predicate devices already on the market but does not detail the specific performance metrics or studies that established this equivalence. It's a regulatory approval, not a technical performance report.

Therefore, I cannot provide the requested information based on the provided text. The document is solely a regulatory communication.

Ask a specific question about this device

The SafeSheath MSP™ Introducer Sheath Kit with Integral Hemostasis Valve is for introduction of pacing leads or catheters during pacing lead or defibrillatory catheter placement procedures.

The introducer sets, Adelante®-S Series are intended for introduction of pacing leads or catheters into the body.

The components of the SafeSheath MSP™ Introducer Kit consists of a sheath with sideport tubing, stopcock and heomostasis valve. The distal end of the sheath may be configured for a straight sheath or with a curve. The sheath length must be able to provide a conduit from the insertion site to the epicardial target sites.

A guiding dilator will accompany the straight or curved sheath, to assist with the guiding and steering of the sheath to the intended location.

A standard vessel dilator that will assist in insertion.

A .035" x 135 cm guidewire.

A standard 12cc syringe.

A 18 gauge XTW introducer needle.

A transvalvular insertion tube, which can be used to open the hemostasis valve during insertion of delicate leads or catheters, may also be packaged with the introducer kit,

A Pacing Lead Stabilizer (PLS) that can be used to facilitate the removal of the introducer sheath, may also be packaged with the introducer kit.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SafeSheath MSP™ Introducer Kit and the Adelante-S Series Introducer Set.

It's important to note that the provided text contains information for two separate devices, both of which are Introducer Sets. The first part (up to page 1 of 3) refers to the SafeSheath MSP™ Introducer Kit (K934901 is its predicate device, not its own 510(k) number which is missing). The later part (starting from "AUG 2 9 2012") refers to the Adelante®-S Series (510(k) Number K122084).

Since the request is about "the device" in the singular, and the information is fragmented across two different submissions, I will provide the acceptance criteria and study information for both devices as presented, clarifying which device each section refers to.

Analysis for the SafeSheath MSP™ Introducer Kit (Thomas Medical Products, Inc.)

This submission primarily relies on substantial equivalence to a predicate device (K934901) and includes qualification testing for the new device. It is not a clinical study demonstrating performance against clinical acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria (Test)	Reported Device Performance
   Functional Testing	All samples passed the protocol qualification testing requirements.
   Visual Testing	All samples passed the protocol qualification testing requirements.
   Leak Testing	All samples passed the protocol qualification testing requirements.
   Valve Body to Stopcock Pull Test	All samples passed the protocol qualification testing requirements.
   PVC Tubing to Valve Housing Peel Test	All samples passed the protocol qualification testing requirements.

2. Sample Size Used for the Test Set and Data Provenance

   • Sample Size: Not explicitly stated, described as "All samples."
   • Data Provenance: Not specified, but implied to be in-house laboratory testing (retrospective in the context of submission).

3. Number of Experts Used to Establish Ground Truth and Qualifications

   • Not applicable. This was engineering/qualification testing, not a clinical study requiring expert ground truth.

4. Adjudication Method

   • Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

   • No. This was not a comparative effectiveness study involving human readers or AI.

6. Standalone Performance Study (Algorithm Only)

   • No. This is a physical medical device (introducer sheath), not an algorithm.

7. Type of Ground Truth Used

   • Engineering specifications and testing protocols.

8. Sample Size for the Training Set

   • Not applicable. There's no "training set" in the context of device qualification testing.

9. How Ground Truth for the Training Set Was Established

   • Not applicable.

Analysis for the Adelante®-S Series Introducer Set (Oscor Inc.)

This document is an FDA 510(k) clearance letter for the Adelante®-S Series. It states that the device is substantially equivalent to legally marketed predicate devices, but it does not provide details about specific acceptance criteria or the study that proves the device meets those criteria. The clearance letter itself is a determination based on a submission from the manufacturer, which would have contained such details, but those details are not in the provided text.

Therefore, for the Adelante®-S Series, I can only state what is not present in the provided excerpt:

1. Table of Acceptance Criteria and Reported Device Performance

   • Not provided in the given text. The document is the FDA's clearance letter, stating substantial equivalence, but it does not detail the specific performance criteria or the results from the manufacturer's testing.

2. Sample Size Used for the Test Set and Data Provenance

   • Not provided in the given text.

3. Number of Experts Used to Establish Ground Truth and Qualifications

   • Not provided in the given text. (Likely not applicable as it's a physical device validation, similar to the SafeSheath, rather than an expert-adjudicated clinical study).

4. Adjudication Method

   • Not provided in the given text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

   • No. This type of study is not typically required for an introducer sheath and is not mentioned.

6. Standalone Performance Study (Algorithm Only)

   • No. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

   • Not provided in the given text. (Expected to be engineering specifications and testing protocols, similar to the SafeSheath).

8. Sample Size for the Training Set

   • Not applicable / Not provided in the given text.

9. How Ground Truth for the Training Set Was Established

   • Not applicable / Not provided in the given text.

Summary Limitations:

The provided text for both devices is primarily focused on the declaration of substantial equivalence for regulatory clearance. While it alludes to "Qualification Testing" for the SafeSheath, it only states that "All samples passed" without detailing the specific numeric thresholds of the acceptance criteria. For the Adelante-S Series, the provided text is solely the FDA's clearance letter, which does not contain the detailed study results or acceptance criteria themselves. Therefore, much of the requested information cannot be extracted directly from the given input.

Ask a specific question about this device

Ask a specific question about this device