Search Results

The Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.

The Long Sheath or LS is a variable stiffness catheter and has a catheter shaft reinforced with a stainless steel braid and has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a nominal outer diameter of 0.109 inches. It is available with a nominal inner diameter of 0.088 inches. They are available in three working lengths: 70 cm, 80 cm, and 90 cm. The Long Sheath has a PTFE-lined lumen, which is braidreinforced, flexible, and has a hydrophilic coating. The LS are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provide a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a dilator. The LS is supplied sterile, non-pyrogenic, and intended for single use only.

The provided document describes the FDA 510(k) premarket notification for the "Long Sheath" device (K152876). The "study" in this context refers to a series of non-clinical performance tests conducted to demonstrate that the Long Sheath is substantially equivalent to a legally marketed predicate device (NEURON MAX SYSTEM, K111380).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document provides a table summarizing the non-clinical tests, the test methods, and a general statement about the results. The specific acceptance criteria are not explicitly detailed for each test (e.g., a specific minimum tensile strength value). Instead, the results consistently state, "All units tested must meet the acceptance criteria. All samples met the acceptance criteria." This implies that predefined, quantifiable acceptance criteria were established for each test based on the relevant ISO or ASTM standards, and the device successfully met all of them.

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

• Sample Size: The document does not explicitly state the exact "sample size" (number of units) used for each individual test. It consistently uses the phrase "All units tested" and "All samples met the acceptance criteria," implying that a sufficient number of samples were tested to meet the statistical requirements of the respective ISO/ASTM standards for product verification. Specific quantities (e.g., n=3, n=5) are not provided in this summary.
• Data Provenance: The document does not specify the country of origin of the data. It states that the studies were conducted "pursuant to 21CFR58, Good Laboratory Practices," which are U.S. federal regulations. This suggests the testing was likely performed in the U.S. or at facilities adhering to U.S. GLP standards. The data is retrospective in the sense that the testing was completed prior to the 510(k) submission.

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

This section is not applicable to this type of submission. The "Long Sheath" is a physical medical device (catheter), and its performance is evaluated through objective, non-clinical engineering and biological tests (e.g., tensile strength, biocompatibility, leak tests) against established industry standards (ISO, ASTM, USP). Ground truth, in the sense of expert consensus on interpretations or diagnoses, is typically relevant for AI/software devices or diagnostic tools. Here, the "ground truth" is defined by the objective performance requirements set forth in the recognized standards.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in studies where human experts interpret data (e.g., medical images) and their agreement is resolved to establish a gold standard. For physical device testing, the results are objectively measured and compared against predefined pass/fail criteria from the 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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses the impact of AI on human performance in diagnostic tasks and is not relevant for the non-clinical evaluation of a physical catheter.

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

No, a standalone algorithm performance study was not done. This device is a physical catheter, not an algorithm or AI system. Its performance is inherent in its physical and material properties, not an algorithmic output.

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

The "ground truth" for the performance of the Long Sheath device is established by objective engineering and biological measurement criteria defined within recognized national and international standards. These standards (e.g., ISO 10993-1, ISO 10555-1, ISO 594-1/2, USP 788, ASTM F1929-12, ASTM F88-09) specify the methods and acceptable limits for various performance parameters (e.g., biocompatibility, physical dimensions, leak integrity, tensile strength, sterility characteristics). The device is deemed to meet the acceptance criteria if its measured performance falls within these predefined limits.

8. The sample size for the training set

This section is not applicable. This submission is for a physical medical device and does not involve AI or machine learning algorithms that require a "training set."

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

This section is not applicable for the same reasons as point 8.

Ask a specific question about this device

The Intermediate Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The Intermediate Catheter is a variable stiffness catheter and has a catheter shaft reinforced with a stainless steel braid, a stainless steel coil, a Nitinol coil, and has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a nominal distal outer diameter of 0.072" and a nominal proximal outer diameter of 0.078". It is available with a nominal inner diameter of 0.060". They are available in three working lengths, 105 cm, 115 cm. and 125 cm. The Intermediate Catheters have a PTFE-lined lumen, which is braid and coil reinforced, flexible, and has a hydrophilic coating. The Intermediate Catheters are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve and a split introducer sheath. The Intermediate Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

The document describes the non-clinical testing of an Intermediate Catheter for submission K152202 to demonstrate substantial equivalence to a predicate device. This is a medical device submission, not an AI/ML device submission, and therefore the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" are interpreted in the context of typical FDA 510(k) submissions for non-AI devices.

Here's the breakdown of the information as requested, adapted for a non-AI medical device:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states, "All units tested must meet the acceptance criteria. All samples met the acceptance criteria." This implies that a sufficient number of samples were tested for each specific test according to the requirements of the referenced ISO and ASTM standards. However, the exact sample sizes for each test are not explicitly stated in this summary.

The data provenance is from non-clinical bench testing and laboratory studies conducted by TNI Manufacturing, Inc. (the submitter). These are prospective tests designed to evaluate the physical, mechanical, and biological properties of the device. The country of origin of the data is implicit to be the USA, where TNI Manufacturing, Inc. is located. The biocompatibility testing explicitly states it was conducted "pursuant to 21CFR58, Good Laboratory Practices," which are U.S. regulations for nonclinical laboratory studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as this submission is for a physical medical device (catheter) and involves non-clinical bench testing, not an AI/ML device that generates diagnoses or interpretations requiring expert consensus as ground truth. The "ground truth" for these tests is established by the objective physical, chemical, and biological properties measured according to the specified international standards.

4. Adjudication Method for the Test Set

This is not applicable as there is no human interpretation or decision-making process for the "ground truth" in these non-clinical tests that would require adjudication. The tests involve objective measurements and adherence to predefined pass/fail criteria from the 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 is not applicable. The device is a physical catheter, not an AI/ML diagnostic or assistive device. Therefore, no MRMC study, human reader improvement with AI, or effect size related to AI assistance would be conducted or relevant for this type of submission.

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

This is not applicable. As stated above, this is a physical medical device, not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on the objective measurements and pass/fail criteria defined by internationally recognized standards (e.g., ISO, ASTM, USP). For example:

• Biocompatibility: Adherence to ISO 10993-1 guidelines, meaning the material does not elicit adverse biological responses.
• Sterilization Validation: Demonstrated sterility according to ISO 11135.
• Physical/Mechanical properties (e.g., Working Length, OD, Catheter Burst, Tensile): Conformance to specified dimensions, mechanical strengths, and absence of leaks or defects as defined by ISO 10555-1 and other relevant standards.
• Particulates: Conformance to USP 788 limits.

8. The Sample Size for the Training Set

This is 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

This is not applicable. There is no "training set" for a physical medical device.

Ask a specific question about this device