Search Results

The Percutaneous Introducer is intended to allow for the percutaneous placement of devices, needles or probes, in close proximity to nerves and around or into surgical wound or non-surgical wound sites. It may be used to inject or aspirate the introduction area via the luer hub of the needle/introducer.

The Percutaneous Introducer is a single-use, disposable device consisting of a flexible polymer sheath with a molded plastic hub. The device incorporates a stainless steel needle inside the flexible cannula and is removed after the introducer is placed. The inserted stainless steel introducer needle has a sharp distal point. The flexible cannula acts as a conduit for percutaneous introduction of medical devices, such as catheters, needles, or probes. A stylet or porous plug (to prevent aspiration during insertion) comes seated in the standard 6 degree luer fitting of the proximal end of the needle hub. The Percutaneous Introducers are used for a short period of time and are supplied sterile and non-pyrogenic. The Percutaneous Introducer is available in four lengths and a 14 gauge.

This document is a 510(k) summary for a "Percutaneous Introducer" device. It outlines the device description, intended use, technological characteristics, and non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets and corresponding "reported device performance" in the way a clinical study might. Instead, it describes various tests performed and states that the device "meets the requirements" or "performs comparably" or has "successful results."

The tests and their reported outcomes are:

The study concludes that based on these results, the Percutaneous Introducer "performs comparably to, and is substantially equivalent to predicate device (K102460)."

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

The document does not specify the sample sizes used for any of the non-clinical tests (e.g., number of introducers tested for tensile strength, burst testing, etc.).
The data provenance is from non-clinical bench and laboratory testing, not human or animal studies. The data would originate from the manufacturing and testing facilities of Epimed International, Inc. or their contracted labs. It is inherently prospective in the sense that the tests were conducted specifically for this submission.

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

This section is not applicable in the traditional sense of clinical or diagnostic device ground truth. The "ground truth" for non-clinical performance and biocompatibility tests is established by adherence to recognized international standards (e.g., ISO, ASTM) and FDA guidance documents. The "experts" would be the qualified personnel within the testing laboratories who perform the tests according to these standards, generate the data, and interpret the results to ensure compliance. Their specific number or qualifications are not detailed here, as the focus is on adherence to standardized testing protocols.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers for diagnostic image interpretation or similar subjective assessments. The tests described are objective, standardized laboratory and bench tests where results are determined by measurement against specified criteria in the standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission is for an interventional medical device (introducer) and focuses on its physical performance, material safety, and substantial equivalence, not diagnostic accuracy or human reader performance.

6. Standalone (Algorithm Only) Performance

No, a standalone (algorithm only) performance assessment was not done because the device is a physical medical instrument (a Percutaneous Introducer), not a software algorithm or AI-driven diagnostic tool. The concept of "algorithm only performance" does not apply to this type of device.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established international standards and regulatory guidelines. For example:

• Mechanical properties: Defined by performance criteria within ASTM and ISO standards (e.g., specific force values, absence of collapse/peelback).
• Biocompatibility: Defined by the requirements and endpoints outlined in ISO 10993 series of standards (e.g., non-cytotoxic, non-sensitizing, non-irritating).
• Sterility and Packaging: Defined by standards like ASTM F1140, ASTM F1929, and general sterility assurance principles.
• Functional standards: Defined by the specific requirements of ISO 594-1, ISO 594-2, and ISO 10555-5.

Essentially, the "ground truth" is compliance with these widely accepted benchmarks for medical device safety and performance.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI or machine learning model. Therefore, there is no "training set" in the context of an algorithm. The development and testing process involves engineering design, material selection, and verification/validation testing, not data-driven machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The CIMPAX C-CAT Anesthesia Catheter, along with related accessory devices, is intended for the delivery of continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.

The CIMPAX® C-CAT catheter kit is a sterile, single use, closed tip, multi-perforated catheter with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. The kit is intended for adult patients requiring the delivery of contiguous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management or as perineural delivery. Routes of administration may be intraoperative or percutaneous. The device is intended to be used in healthcare /hospital facilities.

The CIMPAX® C-CAT catheter is a multi-perforated catheter supplied in a kit which contains components for catheter placement. The drug infusion segment is placed between the blue tip of the catheter and the first blue marking after the tip. The catheter is designed with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. Attached to the catheter is a standard female luer lock that is compatible with and can be used with infusion pumps as well as with syringes for bolus injections with standard make luer connections.

The catheter is placed usually through an incision or wound in order to provide continuous or intermittent administration of local anesthetic to the area affected. This allows only the local nerve endings (pain receptors) to be anesthetized as opposed to giving a systemic pain relief medication to the patient.

The provided text is a 510(k) Premarket Notification from the FDA, specifically concerning the CIMPAX C-CAT Anaesthesia Catheter kit. This document is a regulatory submission for medical devices, demonstrating substantial equivalence to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria for an AI/ML product.

Therefore, the document does not contain any information related to:

• Acceptance criteria for an AI/ML device (e.g., performance metrics like accuracy, sensitivity, specificity, AUC).
• A study proving an AI/ML device meets acceptance criteria.
• Sample sizes for test sets or data provenance for AI/ML model evaluation.
• Number of experts, qualifications of experts, or adjudication methods for establishing ground truth in the context of AI/ML.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone AI algorithm performance.
• Type of ground truth used for AI/ML model evaluation (e.g., pathology, outcomes data).
• Sample size for training sets or how ground truth was established for training sets in an AI/ML context.

The document discusses acceptance criteria and studies, but these relate to the physical and biological safety and performance of a medical catheter, not an AI/ML device. For example, it mentions:

• Non-Clinical Testing: Bench testing including mechanical and performance testing (e.g., peak tensile force, burst pressure, kink testing, liquid leakage under pressure, radiopacity, flow testing), biocompatibility, sterilization, packaging, and shelf-life testing.
• Biocompatibility Testing: According to ISO 10993-1 series, covering cytotoxicity, sensitization, irritation, systemic toxicity, Ames Test, in vitro mammalian chromosome aberration, hemolytic properties, and material mediated rabbit pyrogen.
• Flow Test: Performed according to DS/EN 1618, measuring water flow through the catheter.
• Tensile strength: Tested in accordance with ISO 10555-1.
• Packaging: Complies with ISO 11607-1:2014 and EN 865-5:2009.
• Stability: Tested according to ASTM F 1980 Accelerated Aging and ISO 11607-1:2009.
• Sterilization: Method is Ethylene Oxide (EO), complying with EN ISO 11135-1.

In summary, the provided text describes the regulatory process for a physical medical device (an anesthesia catheter) and outlines its non-clinical performance and safety testing to demonstrate substantial equivalence, not information relevant to the performance and acceptance of an AI/ML device.

Ask a specific question about this device