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The SecurAcath device is intended to secure catheters by means of a subcutaneous anchor.

The SecurAcath Device is indicated for catheter securement to the access site by means of subcutaneous anchors in:
a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
b) Short and long-term securement of percutaneous indwelling catheter for abscess/general drainage

The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.

The provided text is a 510(k) summary for a medical device called SecurAcath. It focuses on demonstrating substantial equivalence to a previously cleared device, not on proving the device meets general acceptance criteria through a specific clinical study with detailed performance metrics like sensitivity, specificity, or accuracy, which is typical for AI/ML-based medical devices or diagnostics.

The changes described are primarily related to manufacturing processes and materials (e.g., laser marking instead of pad printing, slight material formulation change in polypropylene, different anti-block additive in packaging, and an extended shelf life). The "performance data" section mentions engineering tests to confirm the device still meets product specifications after these changes.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth types, training set details) are not applicable (N/A) for this type of submission because the device is a physical medical device (catheter securement system), not an AI/ML diagnostic or imaging device. The "acceptance criteria" here refer to ensuring the manufacturing changes do not negatively impact the device's original functionality and safety.

Here's an attempt to answer the questions based on the provided text, indicating N/A where information is not present or relevant to this type of device:

Description of Acceptance Criteria and Proving Device Meets Criteria (SecurAcath Device)

The device in question, SecurAcath, is a physical medical device (a catheter securement system), not a software or AI/ML-based diagnostic device. The acceptance criteria and "study" described in the provided document revolve around demonstrating that manufacturing/material changes to the device do not negatively impact its performance, safety, or effectiveness compared to its predicate device. The study performed is a series of engineering performance tests and material characterizations, not a clinical trial or AI model validation study.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with specific thresholds (e.g., tensile strength > X N) alongside numerical reported performance values. Instead, it states that tests were performed to demonstrate the device "meets product specifications" and "is not negatively impacted by the material change or marking process change." The acceptance is qualitative in the sense that the new device performs "as intended" and "continues to meet the same specifications as its predicate devices."

• Joint Tensile Strength
• Base & Cover Interaction
• Hinge performance
  (No specific numerical data provided, but it states results demonstrate "device functions as intended.") |
  | Marking Durability | Testing performed per IEC 60601-1 for durability of markings. The laser marking does not impact safety and effectiveness. |
  | Biocompatibility | Meets ISO 10993-1. (Same as predicate) |
  | Sterilization & Sterility | EtO and SAL of 10-6. (Same as predicate, new packaging configuration passed testing) |
  | Shelf Life | Extended to 4 years. Shelf life product was 2X sterilized, passed design verification testing including pouch seal peel and bubble leak tests. The extension does not impact safety and effectiveness. |
  | Packaging Integrity | New packaging configuration passed ISTA 2A, ASTM D4169, sterile barrier performance testing and ISO 10993-7 testing. The new configuration does not impact safety and effectiveness. |

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

• Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML model. The "tests" mentioned are engineering and material verification tests (e.g., dimensional, functional, durability). The number of samples used for these engineering tests is not specified in this summary.
• Data Provenance: N/A for this type of device; no patient data or clinical data is mentioned for performance evaluation in this premarket notification. The tests are lab-based.

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

• N/A. This is an engineering/manufacturing change submission for a physical device. There is no "ground truth" derived from expert interpretation (e.g., radiologists, pathologists) in the context of a diagnostic or imaging study. The "truth" is established through engineering specifications and industry standards.

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

• N/A. No expert adjudication of data is mentioned or relevant.

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:

• N/A. This is a physical medical device, not an AI/ML-assisted diagnostic device. No MRMC study was performed.

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

• N/A. Not an algorithm.

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

• N/A. The "ground truth" for this device's "performance" is its adherence to engineering specifications, material compatibility standards (e.g., ISO 10993), and functional requirements that ensure continuous safe and effective operation after manufacturing changes.

8. The sample size for the training set:

• N/A. This is a physical device, not an AI/ML model that requires training data.

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

• N/A. Not applicable as no training set exists for this type of device submission.

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The SecurAcath device is indicated for catheter securement to the access site by means of subcutaneous anchors in:
a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
b) Short or long-term securement of percutaneous indwelling catheters for abscess/general drainage

The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.

The provided text is a 510(k) Summary for the SecurAcath device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel AI/ML device.

Therefore, I cannot fully answer your request as it pertains to AI/ML device evaluation criteria. The document describes a medical device for catheter securement and its equivalence to a predicate, not an AI/ML system.

However, I can extract the general type of performance data mentioned and explain why it doesn't fit the AI/ML framework you've outlined:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "Performance tests" that were conducted, but it does not provide specific acceptance criteria or quantitative performance metrics for these tests. Instead, it makes a general statement: "Test results demonstrate that the device functions as intended."

2. Sample Size for Test Set and Data Provenance: Not applicable as this is not an AI/ML study. The document refers to "Performance tests" but does not detail the sample sizes for these tests or the provenance of any data.

3. Number of Experts and Qualifications for Ground Truth: Not applicable as this is not an AI/ML study. The device's performance evaluation would involve engineering and clinical testing, not expert adjudication of AI outputs.

4. Adjudication Method: Not applicable.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.

6. Standalone (Algorithm Only) Performance: Not applicable as this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used: Not applicable in the AI/ML sense. The "ground truth" for this device would be established through engineering specifications, biomechanical testing outcomes, and clinical observations of catheter securement effectiveness, rather than expert interpretation of data.

8. Sample Size for Training Set: Not applicable as there is no AI/ML training involved for this device.

9. How Ground Truth for Training Set Was Established: Not applicable.

In summary, the provided FDA 510(k) summary is for a physical medical device (catheter securement device) and therefore does not contain the information requested regarding acceptance criteria and studies for an AI/ML device. The document focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and general performance testing (e.g., dimensional verification, functional tests, securement reliability, human factor design validation).

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The SecurAcath device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.

The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.

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

The provided document is a 510(k) summary for the SecurAcath medical device, specifically for an update to include new sizes (10F and 12F) and updated product specification testing. It's important to note that this document does not describe a study involving an AI algorithm or human readers analyzing medical images. Instead, it details the performance testing for a physical medical device.

Therefore, many of the requested points related to AI/algorithm performance, such as MRMC studies, ground truth establishment for training sets, and expert qualifications for adjudication, are not applicable to this document.

Here's the information that can be extracted or deduced from the provided text, structured according to your request where applicable, with an explanation of why other points are not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that the device meets product specifications and functions as intended. Specific numerical acceptance criteria are not explicitly listed in this summary, nor are the precise quantitative results ("reported device performance"). The summary states "Test results demonstrate that the device functions as intended" and "In all instances, the subject device functioned as intended and demonstrated equivalent performance to the predicate device."

Specific tests performed to demonstrate meeting criteria:

• Dimensional verification
• Joint Tensile Strength
• Base & Cover Interaction
• Hinge performance
• Catheter Securement Performance
• Catheter Interaction

The document doesn't provide the numeric pass/fail criteria for these tests or the quantitative results obtained.

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

The document does not explicitly state the sample size used for performance testing (e.g., number of devices tested for dimensional verification, tensile strength, etc.).
The data provenance is from laboratory testing performed by the manufacturer, Interrad Medical Inc. It is not patient data (retrospective or prospective), and thus no country of origin for patient data is applicable.

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

This is not applicable. The ground truth for a physical device's performance tests (e.g., tensile strength, dimensions) is established by engineering specifications and measurement standards, not by human expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable. As the tests are for physical device performance against specifications, an adjudication method for conflicting expert opinions is not relevant. The tests likely yield objective measurements.

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. This document describes performance testing for a physical medical device (catheter securement system), not an AI algorithm. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This is not applicable. This document describes performance testing for a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests are the engineering specifications and design requirements for the device. For example, a "Joint Tensile Strength" test would have an engineering specification for the minimum required tensile strength, which serves as the ground truth for that particular test. "Dimensional" tests would compare measured dimensions to specified tolerances.

8. The Sample Size for the Training Set

This is not applicable. There is no AI algorithm being trained, so no training set is relevant.

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

This is not applicable. As there is no training set, there is no ground truth for it to be established.

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The SecurAcath Device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.

The SecurAcath is a single use, sterile device for securing indwelling catheters. The device is a standalone accessory to percutaneous indwelling catheters and consists of a subcutaneous anchor that is deployed in the subcutaneous space at the catheter access site to reduce catheter migration and pull-out.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SecurAcath device:

Based on the provided text, the device is a catheter securement device, and the submission is a Special 510(k) for a device that is substantially equivalent to a previously cleared predicate device (K092306). Special 510(k)s typically involve modifications to a company's own legally marketed device for which design control activities have been completed. This means the focus of the submission is often on demonstrating that the changes do not raise new questions of safety or efficacy and that the device still meets its established performance specifications.

Due to the nature of a Special 510(k) and the content provided, the level of detail regarding acceptance criteria and a deep statistical study may be less extensive than for a novel device or a Traditional 510(k) where new clinical data might be required.

Acceptance Criteria and Reported Device Performance

Note: The provided text does not explicitly state numerical acceptance criteria (e.g., minimum tensile strength, specific pull-out force resistance values). Instead, it makes general statements about meeting specifications and demonstrating intended function. This is common for Special 510(k) submissions where the changes are often minor and the primary goal is to ensure the modified device performs comparably to the predicate.

Study Details

Based on the provided text, a comprehensive clinical study with human subjects, a test set, and ground truth established by experts, as typically seen for AI/ML devices or novel therapies, was not performed or reported in this 510(k) summary. The evaluation primarily relied on non-clinical performance testing to demonstrate substantial equivalence to the predicate device.

Here's why some requested sections cannot be filled:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   • Not applicable / Not provided. The text refers to "Performance tests" including "dimensional verification" and "securement reliability." These are laboratory-based engineering tests, not clinical studies with a patient test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
   • Not applicable / Not provided. Ground truth, in the context of expert consensus on patient data, is not relevant for the type of engineering performance tests described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   • Not applicable / Not provided. Adjudication methods are used in clinical studies when multiple human readers interpret data, which is not described here.
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:
   • No. This is not an AI/ML device, nor is it a device that directly assists human readers in interpreting clinical data. Therefore, an MRMC study is not relevant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • Not applicable. This is a physical medical device (catheter securement), not an algorithm or AI system.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   • Engineering Specifications. The "ground truth" for the performance tests would be the established engineering specifications and design requirements that the device was tested against (e.g., a specific pull-out force standard).
7. The sample size for the training set:
   • Not applicable / Not provided. As this is not an AI/ML device, a "training set" in that context does not exist. The development and testing would follow standard engineering design and verification principles.
8. How the ground truth for the training set was established:
   • Not applicable / Not provided. See above.

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The SecurAcath Universal Device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.

The SecurAcath Universal is a single use, sterile device for securing indwelling catheters. The device is a stand-alone accessory to percutaneous indwelling catheters and consists of a subcutaneous anchor that is deployed in the subcutaneous space at the catheter access site to reduce catheter migration and pull-out.

The provided 510(k) summary for the Interrad Medical, Inc. SecurAcath Universal device states that "The company performed testing to demonstrate that the device meets all product specifications. In all instances, the SecurAcath Universal functioned as intended." However, it does not provide explicit details on specific acceptance criteria values or the results of those tests. Instead, it broadly references "product specifications" and general function.

Therefore, the following information is based on the limited data available in the provided document. If a more detailed performance study report were available, this response could be more comprehensive.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "performance testing conducted" but does not specify the sample size used for the test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

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

The document does not indicate the use of experts or the establishment of ground truth in the context of human interpretation of data for the performance testing. The testing appears to be focused on the device's physical function and adherence to technical specifications.

4. Adjudication Method for the Test Set

As there's no mention of expert-based ground truth establishment or human interpretation of data, an adjudication method is not applicable in the context of the information provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted, as the device is a physical catheter securement device and not an AI-powered diagnostic or interpretive tool that would involve human readers.

6. Standalone (Algorithm Only) Performance

A standalone performance study for an algorithm was not conducted, as this device is a physical medical device, not a software algorithm. The "performance testing" referred to likely involves mechanical and biocompatibility testing, not algorithmic performance.

7. Type of Ground Truth Used

The ground truth for the "performance testing" would be the device's adherence to its predefined technical specifications and functional requirements. This would likely involve objective measurements for aspects like securement strength, material integrity, ease of deployment, and biocompatibility, rather than expert consensus on interpretive tasks or pathology/outcomes data in the traditional sense.

8. Sample Size for the Training Set

As this is a physical medical device and not an AI/ML algorithm that requires a training set, the concept of a "training set" and its "sample size" does not apply.

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

Since there is no training set for an AI/ML algorithm, this question does not apply.

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The SecurAcath PICC is indicated for short or long term peripheral access to the central venous system. The catheter may be used for intravenous therapy, power injection of contrast media, blood sampling and/or infusion therapy. The maximum recommended infusion rate is 5 m/sec and the maximum pressure of power injectors may not exceed 300 psi. The SecurAcath PICC includes means to secure the catheter via a subcutaneous anchor below the insertion site.

The SecurAcath is a single use, sterile, flexible PICC catheter with a useful lengths of up to 55 cm. The length of the catheter has markings at 1 cm interval to allow the user to trim the catheter to the required length. The catheter has a built in subcutaneous securement mechanism to stabilize and keep the catheter in place. The catheter has two lumens which are identical in properties and characteristics.

The device is compatible with all 0.018" and smaller guidewires. The proximal end of the catheter has the standard radiology PICC configuration plus the activation mechanism of the securement system built into the Y-body. The catheter has been tested to be compatible with MRI (MR conditional) and use with power contrast injectors.

This document describes the 510(k) summary for the SecurAcath PICC, a catheter used for central venous access. Since the provided text focuses on regulatory approval and substantial equivalence, the performance data section is brief, and specific acceptance criteria with reported device performance in a detailed table or a structured study narrative are not explicitly presented.

Based on the provided information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The performance test data is provided in the 510(k) submission. The performance data demonstrates that the device meets all the product specifications." However, specific acceptance criteria values and corresponding reported performance metrics are not detailed in the provided text.

The document lists broader categories of performance testing:

Additionally, it states:

• Maximum recommended infusion rate: 5 ml/sec
• Maximum pressure of power injectors: 300 psi
• MRI Compatibility: MR conditional
• Guidewire compatibility: 0.018" and smaller guidewires

These points could be considered part of the performance specifications the device aims to meet.

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

The document does not specify the sample size used for the test set. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data). The performance data mentioned appears to be derived from in-house testing rather than clinical study data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The performance data seems to be based on engineering and laboratory testing rather than expert-derived ground truth from human interpretation.

4. Adjudication Method

This information is not provided in the document. Given the nature of the listed performance tests (e.g., biocompatibility, tensile strength), an adjudication method in the context of expert review would likely not be relevant.

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

There is no mention of an MRMC comparative effectiveness study, nor any assessment of human readers improving with or without AI assistance. This device is a medical catheter, not an AI-assisted diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

This information is not applicable. The SecurAcath PICC is a physical medical device, not an algorithm or software. Standalone performance for an algorithm would not be relevant in this context.

7. Type of Ground Truth Used

The "ground truth" for the device's performance appears to be established through engineering specifications, laboratory test methods, and compliance with industry standards for similar medical devices. For example, biocompatibility would be assessed against established biological safety standards, and tensile strength against predefined mechanical limits.

8. Sample Size for the Training Set

This information is not applicable. As a physical medical device, it does not involve a "training set" in the context of machine learning or AI.

9. How Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this device.

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The SecurAcath is a PICC and is indicated for short and long term use in peripheral vessels to access the central venous system. The catheter may be used for blood sampling and/or infusion therapy. The SecurAcath PICC includes means to secure the catheter via a subcutaneous anchor below the insertion site.

The SecurAcath is a single use, sterile, flexible PICC catheter with a useful lengths of up to 60 cm. The length of the catheter has markings at 1 cm interval to allow the user to trim the catheter to the required length. The catheter has a built in subcutaneous securement mechanism to stabilize and keep the catheter in place. The catheter has two lumens which are identical in properties and characteristics. The device is compatible with all 0.018" and smaller guidewires. The proximal end of the catheter has the standard radiology PICC configuration plus the activation mechanism of the securement system built into the Y-body.

The provided text describes a 510(k) premarket notification for the SecurAcath Catheter. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to existing devices rather than a detailed clinical study proving performance against specific acceptance criteria with statistical rigor in the way a clinical trial for a new drug or complex diagnostic device might.

Here's an analysis based on the provided text, addressing the requested information where applicable:

Acceptance Criteria and Device Performance

The provided text does not explicitly state quantitative acceptance criteria in a table format with specific thresholds and corresponding reported device performance. Instead, it makes a general statement about performance.

Note: The acceptance criteria here are inferred from the types of performance testing mentioned and the overall goal of a 510(k) submission, which is to show safety and effectiveness, often by demonstrating substantial equivalence to a legally marketed device. Specific numerical targets for these criteria are not provided in this excerpt.

Study Information:

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

   • The document mentions "performance test data is provided in the 510(k) submission," but it does not specify the sample size for any test set or provide details about the data provenance (e.g., country of origin, retrospective or prospective). The tests mentioned (dimensional verification, securement reliability, catheter tensile strength) are typically bench or engineering tests, not clinical studies involving human patients.

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

   • Not applicable. The performance tests mentioned (dimensional verification, securement reliability, catheter tensile strength) are engineering/bench tests and would not typically involve experts establishing "ground truth" in the clinical sense (like radiologists marking images). The "ground truth" for these tests would be derived from physical measurements and engineering standards.

3. Adjudication method for the test set:

   • Not applicable. As the tests are engineering/bench tests, there wouldn't be an adjudication method in the context of clinical expert review.

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 catheter, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and analysis of AI assistance is irrelevant.

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

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

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

   • For the mentioned performance tests, the "ground truth" would be based on engineering specifications and measurements conforming to industry standards or internal design requirements. For example, tensile strength would be measured against a predefined breaking point, and dimensions would be verified against blueprint specifications.

7. The sample size for the training set:

   • Not applicable. As this is a physical medical device and not an AI/machine learning model, there is no "training set."

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

   • Not applicable. There is no training set for a physical medical device.

In summary: The provided document is a 510(k) summary for a physical medical device. It focuses on demonstrating that the device meets its own product specifications through various performance tests (dimensional, securement, tensile strength) and is substantially equivalent to predicate devices. It does not contain information related to clinical studies, AI performance, or ground truth establishment by experts in the context of diagnostic performance, as these are not relevant to this type of device and submission.

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