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The Medline Integrated Arterial Catheter permits access to the peripheral arterial circulation system for short-term access (less than 30 days).

The Medline Integrated Arterial Catheter is a single-use device supplied sterile and nonpyrogenic; it will be packaged inside convenience kits alongside various components outside the scope of this 510(k) submission. The proposed device is a single lumen peripherally inserted catheter device designed to permit short-term access to the peripheral arterial circulatory for less than 30 days. The device assembly comprises a 20-Gauge catheter, 22-Gauge introducer needle, and a 0.018" guidewire with slide advancer. The catheter is made of radiopaque polyurethane tubing, echogenic needle, and removable stainless steel guidewire with slide advancer. The subject device has a kink-resistant catheter design. The device features dual flash with two distinct points of visualization, one with the clear introducer needle proximal hub and the second point at the notch cutout in the needle shaft. The final finished device is packaged with a suture wing (ALCS004). The suture wing is a Class I, 510(k) exempt device.

I'm sorry, but the provided text describes a medical device submission (a 510(k) for the Medline Integrated Arterial Catheter) to the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance and technological characteristics, rather than clinical studies with acceptance criteria for an AI/CADe device.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance for an AI/CADe system.
• Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods for an AI/CADe system.
• MRMC studies, standalone AI performance, or effect sizes for human reader improvement with AI assistance.
• Details on training set sample size or how ground truth for the training set was established for an AI/CADe system.

The document discusses non-clinical functional performance testing (e.g., stress cracking, leakage, kink resistance) and biocompatibility testing for a physical medical catheter, along with a comparison to predicate catheter devices. It explicitly states: "Summary of Clinical Testing: Not applicable. No clinical testing was conducted on the proposed device."

Without information about an AI/CADe device's clinical performance or a corresponding study, I cannot provide the details you've requested.

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The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

The Compass CT and Compass CT Port are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The devices have a distal male luer fitting to connect to a needle or catheter, and a proximal female luer fitting that can be connected to accessory devices (e.g. syringes, caps, or infusion tubing). The devices measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD. The Compass CT Port has an additional, sealed proximal port through which commercially available guidewires can be inserted during pressure measurement.

The Compass CT Port device is being modified to add wireless Bluetooth capability to the point-of-use Compass Cast device, in order to allow for optional display of acquired pressure data and information to a separate display monitor. The modified product will consist of two components that are packaged separately, the compass Cast (Subject Device) and MAP (Monitor Accessory Plug - Accessory).

The Compass Cast (Subject Device) is a single-use, sterile pressure transducer that is physically identical to the predicate device Compass CT Port (510(k) K133624) with the exception of a slight modification to the main CT Port circuit board to accommodate the secondary Bluetooth radio board. All components and functionality of the main circuit board remain identical.

The MAP (Accessory) is a non-sterile, reusable monitor accessory plug that receives a digital pressure signal from the Compass Cast and converts the digital pressure signal to an analog output that is identical to the analog output of a traditional wired pressure transducer. There are two versions of the MAP device:

1. Wireless Pressure Receiver - GE Monitor (CWMG001-5)
2. Wireless Pressure Receiver Philips Monitor (CWMP001-5)

The provided text describes information about the submission of the "Compass Cast and MAP System" for FDA clearance. However, it does not contain explicit acceptance criteria and device performance data in a tabular format, nor does it detail a study that proves the device meets specific performance criteria related to its core function of physiological pressure measurement beyond stating adherence to existing standards.

The document focuses heavily on demonstrating substantial equivalence to a predicate device (Compass CT Port) by highlighting the technological characteristics and the modifications made (addition of Bluetooth capability and a reusable Monitor Accessory Plug - MAP). Performance data mentioned primarily concerns safety aspects due to these modifications, such as sterility, EO residuals, and electromagnetic compatibility.

Therefore, many of the requested items cannot be fully answered from the provided text.

Based on the available information:

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

The document does not explicitly state a table of new acceptance criteria established for the Compass Cast and MAP system itself in terms of pressure measurement performance. Instead, it states that the device's fundamental pressure accuracy and functional performance are "identical" to the predicate device and "Meet or exceed ANSI/AAMI BP22:1994(R)2006".

The only "acceptance criteria" and "reported performance" directly stated are for safety and compatibility tests related to the new wireless functionality and sterilization.

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The Centurion® Pressure Injectable Extension set intended for the delivery and /or aspiration of fluids and may be used in conjunction with power injectors having a maximum pressure setting of 325 psi and a maximum flow rate of 10 mL/second.

The Centurion® Pressure Injectable Extension set intended for the delivery and/or aspiration of fluids and may be used in conjunction with power injectors having a maximum pressure setting of 325 psi and a maximum flow rate of 10 mL/second.

Centurion® Pressure Injectable Extension Sets consist of polyvinyl chloride (PVC) tubing with non-DEHP plasticizer. They are configured with female luer locks on the proximal and distal ends, respectively, and are available in straight, Y, and T configurations. A slide or snap clamp may be positioned over the tubing to obstruct the fluid flow when needed.

The Centurion® Pressure Injectable Extension Set is available in configurations with and without a needlefree valve. These valves are separately marketed devices and the applicable 510(k)'s are maintained by the respective manufacturers.

The Centurion® Pressure Injectable Extension Sets are prescription devices provided sterile and nonpyrogenic for single use only and may be packaged individually or in medical convenience kits.

The provided text describes a medical device, the Centurion® Pressure Injectable Extension Set, and its 510(k) submission to the FDA. It details the device's intended use, technological characteristics, and performance data from various tests. However, the document does not present acceptance criteria in a table format nor does it directly describe a study that proves the device meets specific acceptance criteria in terms of quantifiable performance metrics (like sensitivity, specificity, accuracy, etc.) for a diagnostic or AI-driven medical device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through:

• Biocompatibility testing: Ensuring the materials are safe for biological contact.
• Sterilization validation: Confirming the device is sterile and non-pyrogenic.
• Packaging validation: Ensuring the packaging maintains sterility and shelf life.
• Functional testing: Implied by the statement "the functionality, integrity, and safety and effectiveness... are sufficient for its intended use." This likely includes pressure and flow rate capabilities as per the intended use, but specific quantifiable acceptance criteria and the results directly against those are not explicitly presented.

Therefore, many of the requested elements for an AI/diagnostic device study (like sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (an extension set) and not a diagnostic algorithm or image analysis system.

Here's an attempt to fill in the table and address the questions based on the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified for any of the tests (biocompatibility, sterilization, packaging, or functional). The data provenance is also not specified (e.g., country of origin, retrospective/prospective). These are typically found in detailed test reports, not summarized 510(k) documents.

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

• Not Applicable. This device is a physical medical instrument (an extension set), not a diagnostic device or AI algorithm requiring expert-established ground truth for performance evaluation in the clinical sense. Biocompatibility, sterility, and functional tests are performed by laboratory technicians and engineers against established standards.

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

• Not Applicable. See point 3.

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 not an AI or diagnostic imaging device.

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

• Not Applicable. See point 5.

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

• Standardized Test Methods and Industry Standards: The "ground truth" for this device's performance is established by adherence to recognized international and national standards and guidelines for medical devices:
  • ANSI/AAMI/ISO 10993-1:2009 (Biological Evaluation of Medical Devices) for biocompatibility.
  • ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products – Ethylene oxide) for sterilization.
  • ISO 11607-1 (Packaging for terminally sterilized medical devices) for packaging.
  • Functional requirements (e.g., pressure and flow rate capabilities) are likely tested against internal specifications derived from the intended use and predicate device characteristics.

8. The sample size for the training set

• Not Applicable. This is not a device that involves machine learning or AI models with training sets.

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

• Not Applicable. See point 8.

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