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Pencylcap is intended for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products.

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The provided document is a 510(k) clearance letter from the FDA for a device called "Pencylcap," which is a hypodermic single lumen needle. This document does not contain any information about acceptance criteria or performance studies that would typically be associated with an AI/ML medical device.

The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination for a traditional medical device (like a needle) does not involve the type of performance metrics, clinical studies, or AI-specific evaluations you've requested.

Therefore, I cannot provide the requested information, such as:

1. Table of acceptance criteria and reported device performance: This document does not specify any performance criteria for the Pencylcap needle or report any specific performance data.
2. Sample size used for the test set and data provenance: No test sets or data provenance are mentioned.
3. Number of experts used to establish ground truth and qualifications: No ground truth establishment is described.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI-powered device.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

This document is a regulatory approval notice based on substantial equivalence to existing predicate devices, not a performance study report for an AI/ML algorithm.

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ExtaviPro™ Sterican™ 30G Hypodermic needles, when attached to a male connector, are intended to be used to inject fluid into, or withdraw fluids from, parts of the body below the surface of the skin.

ExtaviPro™ Sterican™ 30G hypodermic needles are comprised of a steel cannula that is sharpened to a point at one end. The other end is bonded to a vellow color-coded female Luer Lock hub designed for attachment to a corresponding male connector, such as a syringe. A protective cap must be removed before injection.

Here's an analysis of the acceptance criteria and study information for the ExtaviPro™ Sterican™ 30G device based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (hypodermic needle). Unlike AI/software devices, the acceptance criteria and performance evaluation for this type of hardware device fundamentally differ. There are no AI/ML components, human-in-the-loop scenarios, or ground truth establishment in the traditional sense of AI studies. Instead, the evaluation focuses on meeting established engineering standards and functional performance specific to the physical device.

Acceptance Criteria and Device Performance

Study Details (Interpreted for a Hardware Medical Device)

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

   • Sample Size: Not explicitly stated as a number of devices (e.g., "N=100 needles"). However, the tests were performed on "samples" before EtO-Sterilization and after 3 sterilization cycles, as well as after accelerated aging. This implies a sufficient number of samples were used to meet the statistical requirements of the listed ISO standards.
   • Data Provenance: The tests were conducted internally by B. Braun Melsungen AG, a German company ("B. Braun Melsungen AG Dr. Stefan Seidel... Germany"). This would be considered internal company data. The source is retrospective in the sense that the testing was completed prior to the 510(k) submission.

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

   • Not applicable in the AI/ML sense. "Ground truth" for this device is established by objective measurements against engineering standards (e.g., cannula dimensions, hub connection strength, flow rates). These are not determined by expert consensus in the same way as diagnosing medical images. The expertise lies in the engineers performing and interpreting the physical and chemical tests according to the standards.

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

   • Not applicable. This concept pertains to resolving discrepancies in expert opinions, which isn't relevant for objective physical measurements against engineering standards. The results of the tests are binary (pass/fail) based on predefined criteria in the ISO standards.

4. 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 device is a hypodermic needle, a physical medical instrument, not an AI or software-based diagnostic tool. There are no "human readers" or "AI assistance" involved in its functional evaluation.

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

   • Not applicable. This is a hardware device, not an algorithm.

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

   • Objective engineering standards and measurements. The "ground truth" for this device relates to its physical properties and functional performance as defined by international standards (ISO 7864, ISO 9626, ISO 594-1, ISO 594-2). For example, a needle's bending strength is measured against a specified force, not determined by expert opinion.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not applicable. There is no "training set" or "ground truth" establishment in the context of AI/ML for this device.

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Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure or administer fluids and blood intravascularly.

The 18-22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi with a luer lock connection only.

The Introcan Safety® 3 Closed IV Catheter consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, an integrated bidirectional septum, a stabilization platform, and a passive safety needle-shielding mechanism.

The Introcan Safety® 3 will be offered in the following gauge sizes and lengths:
18ga x 1-3/4" (45mm)
18ga x 1-1/4" (32 mm)
20ga x 1-1/4" (32mm)
20ga x 1" (25mm)
22ga x 1" (25mm)
24ga x ¾" (19mm)

Introcan Safety® 3 design is described as a closed IV catheter since it protects clinicians and patients from blood exposure. Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 3 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure.

The Introcan Safety® 3 catheter has an integrated stabilization platform is designed to improve catheter stability while minimizing catheter movement within the vessel.

The passive safety needle-shielding mechanism of the Introcan Safety® 3 is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle which aids in the prevention of catheter shearing.

The provided document [K111236](https://510k.innolitics.com/search/K111236) is a 510(k) premarket notification for a medical device (Introcan Safety® 3 Closed IV Catheter) and includes a summary of the device, its intended use, and a conclusion about its substantial equivalence to predicate devices. However, the document does not contain detailed information regarding acceptance criteria, the specific study design, sample sizes for test or training sets, ground truth establishment, or expert involvement as requested in your prompt.

The document states:
"Testing was conducted to demonstrate the performance of the Introcan Safety® 3 Closed IV Catheter and substantial equivalence with the predicate devices: B. Braun Medical Inc.'s Introcan Safety® and BD's Nexiva™ Closed IV Catheter System Closed IV Catheter System. The functional performance testing conducted with the proposed device demonstrates that the Introcan Safety® 3 Closed IV Catheter is as safe and effective as the predicate devices."

This indicates that functional performance testing was performed to show substantial equivalence, but the specifics of that testing (e.g., acceptance criteria, study methodologies, statistical analyses, or specific performance metrics) are not provided within the given text.

Therefore, I cannot fulfill your request for the following information based on the provided document:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly stated. The document only mentions "functional performance testing" demonstrating the device is "as safe and effective as the predicate devices."
2. Sample sizes used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device is not an AI/diagnostic imaging device and "ground truth" in this context would refer to objective physical or mechanical performance standards rather than expert interpretation.
4. Adjudication method: Not applicable.
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, as this is a physical medical device (catheter), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not explicitly stated, though it would likely be based on engineering specifications and objective measurements of the catheter's physical and mechanical properties.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

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The B. Braun Combitrans Monitoring Sets are intended for the extravascular measurement of venous, arterial, or pulmonary arterial blood pressure by converting hemodynamic waveforms into electrical signals.

The Combitrans flush device provides a continuous flush rate from approximately 3 ml/hr and allows a switch to approximately 300 ml/hr. When using the Combitrans device in neonates, infants or small children. A syringe pump should be used to control the flow rate, which should not exceed 3 ml/hr.

The Combitrans Monitoring Set is a pre-calibrated blood pressure transducer designed to transform physiological pressure waveforms into electrical signals using a piezoresistive sensor. The set is supplied in 6 configurations:

1. Combitrans Monitoring Set, Venous (blue striped tubing).

2. Combitrans Monitoring Set, Arterial (red striped tubing).

3. Combitrans Monitoring Set, Pulmonary-Arterial (yellow striped tubing).

4. Exadyn Combitrans Monitoring Set (blue and red striped tubing with additional stopcock for the measurement of venous and arterial blood pressure with one transducer).

5. Combitrans Add-On Set (consists only of the transducer, flush device, three-way stopcock and pressure tubing for customized set design and extension.

6. Combitrans Fixation Tape (includes a hook and loop band/Velcro fixation tape used to fix the Combitrans transducer to the patient forearm or a stand).

Each set has the same basic intended use and transducer components, but varies according to the features indicated above. With each of the sets, a fluid (saline) filled pressure transmitting catheter can be connected to a venous, arterial or pulmonary-arterial patient catheter that is in indirect contact with the patient's bloodstream.

Each of the six Combitrans Monitoring Sets listed above are composed of the following components: a disposable extra-vascular blood pressure transducer, a sensor that converts hemodynamic pressure waveforms into electrical signals, a transducer cable which is connected to a pressure transmitting catheter system, a flush device and a three-way stopcock. The Combitrans transducer and the sensor function together such that physiologic waveforms are transmitted from a fluid filled cavity inside the transducer housing onto the sensor via a silicone gel cushion.

The Combitrans Monitoring Set finger-activated flush device provides a continuous flush from approximately 3 mL/hr and allows a switch to approximately 300 ml/hr. The Combitrans Monitoring Set interfaces with a standard infusion set and a transducer cable, which transmits electrical signals onto a monitor or into a computer for further processing, graphic presentation or storage. When using the Combitrans device in neonates, infants or small children, the standard gravity infusion set is not used but is exchanged for a syringe pump to control the flow rate. which should not exceed 3 ml/hr.

Combitrans disposable transducers, as well as catheters and infusion systems, are indirectly in contact with the blood stream. They are supplied sterile, individually packaged and for single use only.

Accessories available for use with the Combitrans Monitoring Sets include attachment plates for the attachment of the transducer to an infusion stand. A wide range of interface cables using different plug design and configurations are also available to facilitate storage or visualization of blood pressure measurements on patient monitors.

The provided text describes the Combitrans Monitoring Set, a blood pressure transducer, and its 510(k) premarket notification (K102033). It outlines the device's intended use, components, and confirms its substantial equivalence to a predicate device.

The acceptance criteria and study information provided mainly focus on the device's compliance with established standards for performance, electromagnetic compatibility, and biocompatibility, rather than a clinical study establishing specific accuracy metrics against a ground truth.

Here's an analysis of the provided information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for the performance testing. The provenance of the data is implicit: it's from internal testing performed by B. Braun Melsungen AG to support their 510(k) application. There is no indication of country of origin for the data or whether it was retrospective or prospective. The studies mentioned are engineering and laboratory tests against standards, not clinical trials with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or provided. The "ground truth" for these tests are the requirements and specifications defined by the referenced international and national standards (e.g., ANSI/AAMI BP22, IEC 60601-2-34, ISO 594-2, ISO 10993-1). Compliance is determined by the device's physical and functional performance against these objective standards, not through expert consensus on medical data.

4. Adjudication method for the test set
Not applicable. Testing performed was against established engineering and performance standards, not against a human-interpreted ground truth requiring adjudication.

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 a blood pressure transducer, a medical device for measuring physiological parameters. It does not involve "readers," "cases," or Artificial Intelligence (AI) in the context of diagnostic interpretation, therefore no MRMC or AI effectiveness study was performed or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no "algorithm" in the sense of AI or image analysis involved with this device. It is a physical transducer that converts pressure into electrical signals. Its performance is inherent to its design and manufacturing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is compliance with the objective requirements outlined in consensus standards such as ANSI/AAMI BP22-1994/(R)2006 (for blood pressure transducers), IEC 60601-2-34 (for electromagnetic compatibility), ISO 594-2:1998 (for conical fittings), and ISO 10993-1:2003 (for biocompatibility). These standards define measurable parameters and acceptable ranges.

8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

9. How the ground truth for the training set was established
Not applicable, as no training set was used.

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