(100 days)
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.
| Test | Test Method Summary | Reported Device Performance (Results) |
|---|---|---|
| Biocompatibility | Per ISO 10993-1 | All units tested meet the acceptance criteria. All samples met the acceptance criteria. (Also noted as biocompatible and non-pyrogenic.) |
| Radiographic Detectability | Per ISO 10555-1 | All units tested must meet the acceptance criteria. All samples met the acceptance criteria. |
| Visual Inspection | Per ISO 10555-1 | All units tested must meet the acceptance criteria. All samples met the acceptance criteria. |
| Working Length | Per ISO 10555-1 | All units tested must meet the acceptance criteria. All samples met the acceptance criteria. |
| Hub Compatibility | Per ISO 594-1 and ISO 594-2 | All units tested must meet the acceptance criteria. All samples met the acceptance criteria. |
| Outside Diameter | Per ISO 10555-1 | All units tested must meet the acceptance criteria. All samples met the acceptance criteria. |
| Leak – Air | Per ISO 10555-1 | All units tested must meet the acceptance criteria. All samples met the acceptance criteria. |
| Leak - Liquid | Per ISO 10555-1 | All units tested must meet the acceptance criteria. All samples met the acceptance criteria. |
| Particulates | Per USP 788 | All units tested must meet the acceptance criteria. All samples met the acceptance criteria. |
| Catheter Burst | Per ISO 10555-1 | All units tested must meet the acceptance criteria. All samples met the acceptance criteria. |
| Tensile | Per ISO 10555-1 | All units tested must meet the acceptance criteria. All samples met the acceptance criteria. |
| Corrosion | Per ISO 10555-1 | All units tested must meet the acceptance criteria. All samples met the acceptance criteria. |
| Packaging - Dye Leak | Per ASTM F1929-12 | All units tested must meet the acceptance criteria. All samples met the acceptance criteria. |
| Packaging - Peel | Per ASTM F88-09 | All units tested must meet the acceptance criteria. All samples met the acceptance criteria. |
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.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).