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The catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from peripheral venous site, but the catheter may be placed via subclavian cutdown as well. The catheter may be used to administer fluids for hydration and parenteral nutrition, as well as other commonly used intravenous medications.

The Argyle™ Peripherally Inserted Central Catheter is a sterile, single use indwelling catheter inserted into a venous access site for the infusion of fluids, medications and/or nutritional products.

The provided document K132567 is a 510(k) premarket notification for Peripherally Inserted Central Catheters (PICCs). It describes modifications to existing devices and seeks to demonstrate substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance:

The document primarily focuses on non-clinical performance data to support substantial equivalence, rather than setting specific clinical performance acceptance criteria for a new device. The acceptance criteria for the modified devices are that they "continue to meet the requirements of the product specifications" and "support the determination of substantial equivalence" to the predicate devices.

The study that proves the device meets these criteria is a series of laboratory tests.

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

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

The document does not specify the sample size used for the non-clinical laboratory tests. The data provenance is laboratory testing conducted by Covidien. The source of the data is non-clinical (laboratory).

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. For non-clinical laboratory testing, the "ground truth" is established by adherence to documented test methodologies and physical measurements/observations, rather than expert interpretation of medical images or patient data.

4. Adjudication method for the test set:

This information is not applicable for non-clinical laboratory testing. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving expert review of cases.

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 MRMC comparative effectiveness study was done. This document is for a physical medical device (PICC), not an AI-assisted diagnostic or imaging device.

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

This is not applicable as the device is a physical medical device and not an algorithm or AI.

7. The type of ground truth used:

For the non-clinical laboratory testing, the "ground truth" is based on engineering specifications, material properties, and established testing standards. For example, tensile strength measured against a specified limit, or biocompatibility assessed against established material standards.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not a machine learning or AI device.

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

This information is not applicable. There is no "training set" for a physical medical device.

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The Arrow Antimicrobial Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Arrow Antimicrobial Pressure Injectable PICC may not exceed 300 psi. Antimicrobial treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization. Antimicrobial effectiveness was evaluated using in vitro methods, and no correlation between in vitro and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.

The Arrow Antimicrobial Pressure Injectable PICC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in 4.5 Fr. single lumen and 5.5 Fr. double lumen configurations with usable lengths of 40 - 55 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based antimicrobial technology.

The catheters will be packaged sterile in both nursing and radiology The canoters will be passfigurations will include components to facilitate insertion. .

The Arrow Antimicrobial Pressure Injectable PICC underwent extensive nonclinical (bench, in vitro, and in vivo animal) testing to demonstrate its safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance

2. Sample size and data provenance for the test set

The document does not explicitly state the exact sample sizes for each test in the provided "Summary of Verification Activities." However, it specifies confidence levels and LTPD (Lot Tolerance Percent Defective) for several tests, indicating sample-based testing.
For example:

• Air Leakage, Collapse Resistance, Liquid Leakage: "All catheters must pass to achieve a 5% LTPD with 95% confidence."
• Force at break: "There must be a 95% confidence level that 95% of the population meets the specification."
• Catheter Body Kink, Central Venous Pressure Monitoring: "This requirement shall be met with 95% assurance."
• Trim Tool: "With a sample size of n=60, zero failures are required to show a 95% confidence level and LTPD=5%."
• Luer Hub Slip/Lock: "with 95% confidence and a LTPD of 10%".
• Catheter Securement: "Demonstrate a 95% confidence level and LTPD=5%".

The data provenance is from nonclinical testing, including bench testing, in vitro testing, and in vivo animal infection studies. No specific country of origin is mentioned for the data, but the testing was performed by Arrow International, Inc. (a subsidiary of Teleflex Inc.) in the USA. These are laboratory studies, not clinical (human) studies.

3. Number of experts and qualifications for ground truth

Not applicable. This submission describes nonclinical "bench" and "in vitro/in vivo animal" testing. There is no mention of experts establishing ground truth for a test set in the context of human data or diagnoses. The "ground truth" for these tests comes from objective measurements and predefined engineering or biological criteria.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for human data (e.g., medical imaging) to establish ground truth. The tests described are objective nonclinical measurements.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

No MRMC study was done. This is a 510(k) summary for a medical device (PICC catheter), focusing on nonclinical safety and performance, not diagnostic effectiveness with human readers.

6. Standalone (algorithm only without human-in-the-loop performance)

This is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not applicable. The device's performance was evaluated inherently "standalone" in bench, in vitro, and in vivo animal tests against predefined criteria.

7. Type of ground truth used

The ground truth used for these nonclinical studies is based on:

• Objective physical measurements: Electrical resistance, force at break, optical density, flow rates, pressure measurements, mechanical integrity assessments (e.g., kink resistance, leakage).
• Standardized protocols and specifications: Adherence to ISO standards (ISO 10555-1, 10555-3), BS EN standards (BS EN 13868, BS EN 20594-1, BS EN 1707), JIS T standards (JIS T 3218), and FDA Guidance documents.
• Biological efficacy criteria: For antimicrobial tests, a "minimum 4 log reduction of adherent biomass (microbial colonization)" compared to initial inoculum concentration. This is a predefined microbiological efficacy threshold.

8. Sample size for the training set

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for a physical medical device.

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This product is intended for use in the neonatal and small pediatric patient. PICC Catheters are indicated when: medications, TPN nutritional solutions, and intravenous infusion of fluids are needed.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a Peripherally Inserted Central Catheter (PICC). It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring the submission of new clinical studies with defined acceptance criteria for novel performance metrics unless specifically requested by the FDA or if the device introduces new technology or indications that raise new questions of safety and effectiveness.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided document.

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This product is intended for use in the neonatal and small pediatric patient. PICC Catheters are indicated when: medications, TPN nutritional solutions, and intravenous infusion of fluids are needed.

Peripherally Inserted Central Catheter

This document is a 510(k) clearance letter from the FDA for a Peripherally Inserted Central Catheter. It is not an AI/ML device, and therefore the requested information about acceptance criteria and study details related to AI/ML performance is not present in the document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than meeting specific performance criteria demonstrated by a clinical study in the context of AI/ML.

Therefore, I cannot provide the requested information.

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The proposed Boston Scientific power injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

The proposed PICC is designed for intravenous therapy and for use with power injectors at settings of 300 psi for the administration of contrast media for imaging studies (including, but not limited to, CT scans, MRIs). The proposed PICC is an open ended, non-valved catheter with proximally located luer lock hub(s), extension tube(s) and suture wing for catheter securement; available in single and dual lumen configurations (4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL); with a reverse tapered shaft to aid in staunching bleeding at the insertion site; and usable length of 45 cm lengths for the 4 Fr SL, 5 Fr DL lengths and 55 cm lengths for the 4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL. The radiopaque catheter is marked with depth indicators every 1 cm along its length and with a "0" indicator to serve as a reference during catheter insertion and for user convenience in catheter sizing. The lumens are differentiated by proximally located colored clamps and hubs that indicate lumen size. Maximum power injection flow rates are indicated on the clamp(s). As is the predicate device, the proposed BSC PICC will be offered in convenience kits with other legally marketed products.

This document, K070002, is a 510(k) summary for the Boston Scientific Peripherally Inserted Central Catheter (PICC). It focuses on substantial equivalence to a predicate device, rather than a standalone performance study with acceptance criteria.

Therefore, it does not contain the information required to populate the fields related to acceptance criteria and device performance as it pertains to AI/algorithm performance. The device described in this document is a physical medical device (PICC), not an AI algorithm.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. This document demonstrates substantial equivalence through a comparison of technological characteristics and performance characteristics tested to a predicate device, not by defining and meeting specific acceptance criteria for a new, AI-based functionality.
2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI algorithm with a test set of data.
3. 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. Ground truth establishment is irrelevant for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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. This device is not an AI.
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 (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information from the document:

• Device Name: Boston Scientific Peripherally Inserted Central Catheter (PICC)
• Predicate Device: AngioDynamics, Inc. Morpheus™ CT PICC (K041420 and K060887)
• Intended Use: Short or long-term peripheral access to the central venous system for intravenous therapy (fluids, medications, nutrients, blood sampling) and power injection of contrast media.
• Substantial Equivalence Basis: Comparison of intended use, technological characteristics, and performance characteristics tested to the predicate device. The document states a "direct comparison of key characteristics demonstrates that the proposed device is substantially equivalent." However, the specific results of these characteristic tests or the defined criteria for "substantial equivalence" regarding measured performance are not detailed in this summary.

To obtain specific performance data and acceptance criteria for a physical device like a PICC, one would typically need to review the full 510(k) submission, which would include detailed testing protocols and results (e.g., burst pressure, flow rates, material compatibility, functional durability). This summary document does not provide those specifics.

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The BD OneCath™ peripherally inserted central catheters are used to sample blood and administer fluids into the central vascular system such as medication, fluids, nutrients, blood and blood products.

The BD OneCath PICC products are similar in design to other PICC products. The catheter tubing is a radiopaque, polyurethane material that is inserted into the vascular system via a catheter introducer. The BD OneCath PICC is available in both single and dual lumens.

I am sorry, but based on the provided document, I cannot fulfill your request for information on the acceptance criteria and a study proving the device meets them.

The document is a Premarket Notification [510(k)] Summary for the BD OneCath™ Peripherally Inserted Central Catheter. It primarily focuses on demonstrating "substantial equivalence" to a predicate device (BD L-Cath PICC), rather than presenting specific acceptance criteria and a detailed study proving the device meets those criteria for performance metrics like accuracy, sensitivity, or specificity.

Here's a breakdown of why the requested information is not available in the provided text:

• Acceptance Criteria and Reported Device Performance: This document states that "Biocompatibility testing of the new polyurethane tubing and physical testing on the areas of potential failure (such as pull strength and the security of junctions between the extension tubing and molded parts) were conducted." It concludes from these nonclinical tests that the BD OneCath PICC and the predicate device are substantially equivalent. However, it does not provide specific numerical acceptance criteria for these tests (e.g., "pull strength must be X Newtons" or "biocompatibility results must meet ISO X standard with Y score") nor does it report the specific performance results against such criteria. The "Conclusion" is a qualitative statement of substantial equivalence.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set Information: These are all concepts related to the evaluation of algorithms or diagnostic devices against a "ground truth" using a test set and a training set. The BD OneCath is a physical medical device (a catheter), not an algorithm or a diagnostic tool that produces a read-out to be compared with a ground truth. Therefore, these types of studies (MRMC, standalone, etc.) are not applicable in this context and are not mentioned in the document. The "tests" mentioned are physical and biocompatibility tests on the material and components, not clinical studies in the typical sense of evaluating diagnostic performance.

In summary, the provided document is a regulatory submission for a physical device, aiming to prove substantial equivalence through non-clinical testing of materials and physical components. It does not contain the specific information you are looking for regarding acceptance criteria, study methodologies for performance metrics (like sensitivity/specificity), or details about expert-reviewed ground truth, which are typically associated with diagnostic software or imaging devices.

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The BD OneCath™ peripherally inserted central catheters are used to sample blood and administer fluids into the central vascular system such as medication, fluids, nutrients, blood and blood products.

The BD OneCath PICC products are similar in design to other PICC products. The catheter tubing is a radiopaque, polyurethane material that is inserted into the vascular system via a catheter introducer.

The provided text is a 510(k) Premarket Notification Summary for the BD OneCath™ Peripherally Inserted Central Catheter (PICC). This type of submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through extensive clinical studies with reported performance metrics like sensitivity, specificity, etc.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance measurements, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's why the requested information is absent and what the document does provide:

1. A table of acceptance criteria and the reported device performance: This is not available because 510(k) submissions for devices like PICCs typically do not involve establishing specific performance criteria like accuracy, sensitivity, or specificity as one would for an AI/CAD diagnostic device. The "performance" demonstrated here is primarily through non-clinical testing to show the new device characteristics are comparable to the predicate.

   • Acceptance Criteria (Implied): The implied acceptance criteria for a 510(k) for this type of device are met if the device can demonstrate "substantial equivalence" to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
   • Reported Device Performance:
     • Nonclinical Tests conducted: Biocompatibility testing of the new polyurethane tubing.
     • Nonclinical Tests conducted: Physical testing on areas of potential failure (such as pull strength and the security of junctions between the extension tubing and molded parts).
     • Key Technological Improvement: The new polyurethane tubing has "improved radiopacity and resistance to alcohol" compared to the predicate device (BD L-Cath PICC).

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned because there wasn't a clinical performance study in the way requested for an AI/CAD diagnostic device. The evaluation was primarily through non-clinical laboratory testing of materials and device integrity.

3. 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. There was no "ground truth" derived from expert consensus on patient data described in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.

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 device is a physical medical device (PICC), not an AI/CAD diagnostic software, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this type of submission is typically based on established engineering standards, material science testing results, and comparison to the predicate device's known performance for safety and efficacy.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of developing an AI model for this physical medical device.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is for a traditional medical device (Catheter) seeking 510(k) clearance, which focuses on demonstrating "substantial equivalence" through non-clinical testing and comparison to a predicate device. It does not involve the types of studies, metrics, or data sets that would be associated with AI/CAD diagnostic devices referenced in your prompt.

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The V-Cath® PICC is indicated for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 3.8FR or larger catheter is recommended.

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This is a medical device clearance letter for the V-Cath® PICC (Peripherally Inserted Central Catheter) from 1998. The document primarily serves to confirm that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document is a regulatory clearance letter and not a study report or clinical trial summary. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert evaluations. It simply indicates that the device has been cleared for marketing based on a determination of substantial equivalence.

Here's why the requested information cannot be extracted from the provided text:

• Acceptance Criteria & Reported Performance: Regulatory clearance letters typically don't detail the performance metrics or acceptance criteria used in specific verification or validation studies. They generally conclude that the device meets safety and effectiveness requirements based on comparison to a predicate device.
• Sample Size & Data Provenance: There's no mention of specific studies, sample sizes, or data provenance.
• Experts & Adjudication: There's no information about experts, ground truth establishment, or adjudication methods.
• MRMC Study: No mention of a multi-reader multi-case comparative effectiveness study.
• Standalone Performance: No details on standalone algorithm performance, as this device is a physical catheter, not an AI or software algorithm.
• Type of Ground Truth: Not applicable in this context.
• Training Set Sample Size & Ground Truth: Not applicable for a physical medical device.

In summary, the provided document does not contain the information necessary to complete the requested table and study details. It is a regulatory notification of clearance, not a technical report detailing performance criteria and study outcomes.

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The V-Cath® PICC is indicated for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 3.8FR or larger catheter is recommended.

Not Found

I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.

The text is a 510(k) clearance letter from the FDA for the V-Cath® PICC. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed. It discusses regulatory matters, product classification, and general controls, but it does not contain any data, results, or details of studies regarding the device's performance against specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions you've posed as the necessary information is not present in the provided document. The document only states the "Indications for Use" of the device.

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