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A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Plastic Port Implantable Venous Access Systems consist of a plastic portal (standard or Low Profile™ size), silicone or polyurethane catheter connector, PORT-A-CATH® access needle, blunt needle, and vein pick. The systems will be made available with and without introducer sets.

The provided 510(k) summary (K994216) describes the "Plastic Port Implantable Venous Access Systems" and evaluates their safety and effectiveness through in-vitro functional testing and biocompatibility testing. It explicitly states that clinical studies were not deemed necessary due to the device's similarity to existing, legally marketed predicate devices. Therefore, the device performance is primarily assessed against functional specifications and material properties rather than clinical outcomes or diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the in-vitro functional tests. It generally refers to "In-vitro testing" and "Biocompatibility testing."
• Data Provenance: The data provenance is from "In-vitro testing" and refers to laboratory tests, not human or animal subjects. As it's in-vitro testing performed by the manufacturer, it's considered retrospective in the sense that the test results would be analyzed after the experiments were conducted. There is no country of origin specified for the testing data itself, assumed to be internal to the manufacturer (SIMS Deltec, Inc. in St. Paul, MN, USA).

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

• Not applicable. This study primarily involved in-vitro functional testing and biocompatibility testing, not diagnostic or clinical accuracy evaluations requiring expert interpretation of ground truth. The "ground truth" for these tests would be established by engineering specifications and established material testing standards, not by human experts interpreting clinical data.

4. Adjudication Method for the Test Set

• Not applicable. As described above, this study focused on in-vitro functional and biocompatibility testing, which typically relies on objective measurements against predefined specifications rather than expert adjudication of interpretations.

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

• No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical studies were not deemed necessary regarding Plastic Port Implantable Venous Access Systems due to their similarity in materials, design and function to current SIMS Deltec systems and other commercially available systems." Therefore, there is no information on human reader improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, a standalone performance study was done in the form of in-vitro functional testing and biocompatibility testing. This assessment was purely on the device's physical and material properties against specifications without any human-in-the-loop interaction for performance evaluation.

7. Type of Ground Truth Used

• Engineering specifications and material science standards. For functional testing (catheter to port connection, septum puncture, system leakage, clearance), the ground truth is defined by the device's design specifications and industry standards for performance. For biocompatibility testing, the ground truth is established by recognized biocompatibility standards and material properties deemed safe for human contact.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm requiring a training set. The performance evaluation was based on traditional in-vitro testing.

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

• Not applicable. As mentioned above, there is no training set as this is not an AI/ML device.

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A system is indicated when a patient requires prolonged or repeated intra-arterial infusion.

A PORT-A-CATH® II Trans-Arterial Percutaneous System consists of a portal with a self-sealing silicone septum, accessible by percutaneous needle puncture, and single lumen catheter. The following accessories are provided with the portal and catheter: PORT-A-CATH® access needle, blunt needle, extra-thin wall introducer needle, dilator/sheath assembly, guidewire and syringe.

The provided text describes a 510(k) submission for the PORT-A-CATH® II Trans-Arterial Percutaneous System. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials with specific acceptance criteria as would be the case for novel devices.

Therefore, the requested information on acceptance criteria and a study proving those criteria are met for this specific device is largely not applicable in the traditional sense of a performance study. Instead, the submission argues that the device's similarity to existing, legally marketed devices implies its safety and effectiveness.

Here's how to address the request based on the provided text:

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

Since no specific performance acceptance criteria or direct performance data for the PORT-A-CATH® II Trans-Arterial Percutaneous System is reported for this 510(k), we can infer the "acceptance criteria" were related to demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for the test set: Not applicable. No clinical or functional performance test set was used for this device as part of the 510(k) submission. The submission relied on the established safety and effectiveness of the predicate devices and biocompatibility testing of the materials.
• Data provenance: Not applicable.

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. No ground truth was established by experts for a test set for this device in this submission, as no new performance study was conducted.

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

• Not applicable. No test set requiring adjudication was used.

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 medical device, not an AI-assisted diagnostic tool.

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

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

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

• Not applicable for performance evaluation in this 510(k). The "ground truth" for the submission's approval was essentially the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable. No training set was used for this device in this submission.

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

• Not applicable. No training set was used.

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A P.A.S. PORT® system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

The P.A.S. PORT® Elite System is similar to the current commercially available P.A.S. PORT System. The systems have the identical outlet tube, catheter connector and catheter. The P.A.S. PORT® Elite System differs from the current commercially available P.A.S. PORT System as follows: modified portal shape, increased septum diameter, new portal housing material, and a pierceable rear suture hole. The P.A.S. PORT® Elite System will be made available with a sensor assembly and/or introducer set.

The provided text describes a 510(k) submission for the P.A.S. PORT® Elite Implantable Venous Access System. This is a medical device, not a diagnostic AI/ML algorithm. Therefore, the questions related to AI/ML specific criteria (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets in the context of AI, data provenance for AI) are not applicable to this document.

However, I can extract the acceptance criteria and the study that proves the device meets those criteria, based on the information provided for this medical device.

Acceptance Criteria and Device Performance for P.A.S. PORT® Elite Implantable Venous Access System

The submission indicates that the P.A.S. PORT® Elite System is a modification of an existing device and is compared to two predicate devices. The acceptance criteria are largely implied by the functional and biocompatibility testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The studies were in-vitro (laboratory) functional and biocompatibility tests, not studies involving human or animal subjects that typically have "sample sizes" in this context.
• Data Provenance: Not specified, but the testing was "in-vitro," meaning in a controlled laboratory environment, likely at the manufacturer's facility. The country of origin of the data is not mentioned, but the manufacturer is SIMS Deltec, Inc. based in St. Paul, MN, USA.
• Retrospective or Prospective: Not applicable, as these were laboratory tests.

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

• Not applicable. Ground truth for in-vitro functional and biocompatibility tests is typically established by engineering and materials science standards and measurements, not by expert consensus from medical professionals in a diagnostic context.

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

• Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human interpretation. This submission describes engineering verification and validation testing.

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/ML algorithm. No MRMC comparative effectiveness study was performed.

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

• Not applicable. This device is not an AI/ML algorithm.

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

• The "ground truth" for the functional tests was compliance with the FDA "Guidance on 510(k) Submissions for Implanted Infusion Ports" (October 1990), implying established engineering and performance specifications.
• For biocompatibility, the ground truth was meeting established biocompatibility standards for materials used in implantable devices.

8. The sample size for the training set

• Not applicable. There is no "training set" for this type of medical device submission, as it does not involve AI/ML.

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

• Not applicable, as there is no training set.

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The luer activated needleless injection site is designed for use with various SIMS Deltec, Inc. administration sets or syringes for fluid delivery.

The purpose of this submission is to offer an alternate injection site ("Luer Activated Needleless Injection Site") for use with various Deltec administration sets. The injection site is a valve and is accessed using needleless syringes or IV administration sets.

The provided document is a 510(k) summary for a medical device (a Luer Activated Needleless Injection Site). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a medical claim for an AI/ML device. Therefore, the requested information geared towards AI/ML device studies (such as the number of experts used for ground truth, adjudication methods, MRMC studies, training set size, etc.) is not applicable to this document.

However, I can extract the information that is relevant to the functional and biocompatibility testing mentioned in the summary.

Acceptance Criteria and Device Performance (Based on available information):

Study Details (as per the provided document):

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

   • The document does not specify sample sizes for either functional or biocompatibility testing.
   • Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These tests typically involve laboratory testing rather than patient data.

2. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth, in the context of AI/ML, refers to clinically verified labels. For functional and biocompatibility testing of a physical medical device, "ground truth" is established by adherence to predefined engineering specifications and regulatory standards.

3. Adjudication method for the test set: Not applicable. This concept pertains to resolving discrepancies in expert labeling, which is not relevant for functional and biocompatibility testing.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical component, not an AI/ML diagnostic or assistive tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) study 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.): Not applicable in the AI/ML context. For this device, "ground truth" for functional testing refers to meeting predefined engineering performance parameters, and for biocompatibility, it refers to compliance with established biological safety standards.

7. The sample size for the training set: Not applicable. This device does not involve machine learning; therefore, a "training set" is not relevant.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device submission.

Summary of Studies from the Document:

• Functional Testing: "Functional specification testing was performed on the alternate injection site."
• Biocompatibility Testing: "Biocompatibility testing was conducted."
• Clinical Studies: "Clinical studies were not deemed necessary regarding the alternate injection site due to its similarity in materials, design and function to current commercially available injection sites."

The conclusion states: "The results of the testing indicated that the alternate injection site functions according to specification and it meets the biocompatibility requirements. Therefore, the alternate injection site is considered acceptable for human use."

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The CADD-TPN® Administration Set is designed for use with the CADD-TPN® pump for the administration of nutritional and other solutions or fluids intravenously from an IV bag.

The purpose of this submission is to offer an alternate CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve. The set is made up of the following components: bag spike, tubing, set plate, 1.2 u filter, tubing clamp, injection site, male luer connector with protective cap, and anti-siphon valve. The anti-siphon valve is designed to protect against unregulated gravity infusion that can result from an improperly attached set plate to the CADD-TPN® Ambulatory Infusion Pump.

The provided 510(k) summary for the CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve indicates that this is a Class II medical device. For such devices, the primary demonstration of safety and effectiveness often relies on substantial equivalence to a predicate device, supported by functional testing rather than extensive clinical studies.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The document states "Functional specification testing was performed on the alternate filter and antisiphon valve" and "Biocompatibility testing was conducted." The exact number of units or tests performed is not mentioned.
• Data Provenance: Not specified. It's internal testing conducted by SIMS Deltec, Inc. There is no indication of country of origin for the data or whether it was retrospective or prospective. It is implied to be prospective testing for regulatory submission.

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

• Not applicable. The ground truth for functional and biocompatibility testing is established by technical specifications and standardized testing protocols, not by expert consensus in the clinical sense.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes. For functional and biocompatibility testing, results are determined by adherence to pre-defined technical thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. The document explicitly states: "Clinical studies were not deemed necessary regarding the new set due to its similarity in materials, design and function to current commercially available CADD® Administration Sets and Extension Sets."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device is an administration set, not an algorithm. Performance is assessed through physical and biological testing, not through algorithmic evaluation.

7. The Type of Ground Truth Used:

• Functional Testing: The ground truth for functional testing is the adherence to the device's technical specifications and intended performance (e.g., filter efficacy, anti-siphon valve operation). These specifications would be derived from engineering requirements and industry standards.
• Biocompatibility Testing: The ground truth for biocompatibility is compliance with established biological safety standards (e.g., ISO 10993 series) for medical devices, demonstrated through a battery of tests (e.g., cytotoxicity, irritation, sensitization).

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set. The "design and function" similarity to existing devices serves as the basis for demonstrating safety and effectiveness, leveraging the established performance of the predicate devices.

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

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

Summary of the Study:

The study proving the device meets acceptance criteria primarily consisted of functional testing and biocompatibility testing.

• Functional Testing: This testing assessed whether the "alternate filter and antisiphon valve" performed according to their designed specifications. The conclusion was that "the filter functions according to specification." While specific parameters or pass/fail criteria are not detailed in this summary, it implies that the device achieved its intended functional performance for these key components.
• Biocompatibility Testing: This testing evaluated the materials of the device to ensure they are safe for human contact and use without causing adverse biological reactions. The conclusion was that "the set meets the biocompatibility requirements," suggesting compliance with relevant biological safety standards.

The 510(k) submission relied heavily on substantial equivalence to predicate devices. The justification for not conducting clinical studies explicitly states it was "due to its similarity in materials, design and function to current commercially available CADD® Administration Sets and Extension Sets." This means the historical safety and effectiveness data of the predicate devices implicitly served as a basis for the new device's acceptance, supplemented by the targeted functional and biocompatibility tests on the new features (the specific filter and the added anti-siphon valve).

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The CADD-Prizm® High Volume Administration Set is designed for use with the CADD-Prizm® pump to allow fluid delivery from an IV bag.

The CADD® Administration Set is designed to be used with a variety of CADD® pumps to allow fluid delivery from an IV bag.

The purpose of this submission is to offer an alternate 1.2 µ Filter for manufacturing standardization and use with the current SIMS Deltec Administration Sets. The Administration Sets are made up of the following components: bag spike, tubing, housing, 1.2 µ filter, tubing clamp, injection site (found on the CADD-Prizm® High Volume Administration Set only), male luer connector with protective cap, and antisiphon valve.

The provided 510(k) summary for the CADD-Prizm® High Volume Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve and the CADD® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve does not contain information related to a study proving the device meets acceptance criteria.

This document is a 510(k) summary of safety and effectiveness aiming to demonstrate substantial equivalence to previously marketed devices, not a report of a study specifically designed to prove acceptance criteria for a new, unique device.

However, based on the provided text, we can infer some information about acceptance criteria and the "study" conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission, the "acceptance criteria" are implied by the functional and biocompatibility requirements. The "device performance" is a statement that these criteria were met.

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

• Sample Size: Not specified. The document states "Functional specification testing was performed on the alternate filter when used with the anti-siphon valve" and "Biocompatibility testing was conducted" but does not give sample sizes for these tests.
• Data Provenance: The testing was implicitly performed by SIMS Deltec, Inc. (the manufacturer). No country of origin is specified, but given the company's US address, it's likely US-based. The testing is retrospective in the sense that it's reported after completion as part of the submission.

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

This information is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic or image-analysis AI devices. For an administration set, "ground truth" is determined by objective functional and material testing against established standards or specifications.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical evaluations, particularly for diagnostic accuracy. For functional and biocompatibility testing of a medical device like an administration set, the results are typically objectively measured and do not require expert adjudication in this manner.

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 evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The device in question is a medical administration set, not an AI or diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study of an algorithm was not done. This device is a physical administration set, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation was based on functional specifications and biocompatibility requirements. These are objective, technical standards and tests, rather than expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical administration set, not an AI or machine learning model that requires a training set.

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

Not applicable. As stated above, there is no "training set" for this type of device.

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The CADD® Administration Set is designed to be used with Deltec CADD® Pumps to allow fluid delivery from a flexible remote bag with female luer connector.

The purpose of this submission is to offer an additional CADD® Administration Set that can be used with three new accessories; i.e. a 250 ml Flexible Medication Reservoir, a Modified Security Shell, and a Security Shell Adapter; for the delivery of fluids with SIMS Deltec CADD® ambulatory infusion pumps. The Modified Security Shell and Security Shell Adapter provide a "locked" compartment for the 250 ml Flexible Medication Reservoir to deter unauthorized access to its contents. An add-on antisiphon valve is included with the set. This valve is designed to protect against unregulated gravity infusion that can result from an improperly attached reservoir.

The provided text describes a 510(k) premarket notification for a medical device, the CADD® Administration Set and Accessories. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through extensive studies.

Therefore, the typical structure for reporting acceptance criteria and study details for an entirely new device (including metrics like sensitivity, specificity, or reader performance improvement) is not directly applicable here. Instead, the "acceptance criteria" can be inferred as demonstration of "substantial equivalence" to the predicate device, supported by functional testing and comparisons.

Here's how the information can be organized based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Length: 69 in. (Predicate CADD®: 77 in., Sabratek: 56 in.)
• Tubing I.D.: 0.040 in. (Predicate CADD®: 0.040 in., Sabratek: Unknown)
• Tubing O.D.: 0.105 in. (Predicate CADD®: 0.105 in., Sabratek: Unknown)|
  | Priming Volume: Priming volume of the administration set. | Similar: 2 ml (Predicate CADD®: 2.3 ml, Sabratek: 3 ml) |

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

• Sample Size: Not explicitly stated as a numerical sample size for "test sets" in the typical sense of clinical trials. The evaluation was primarily based on comparative analysis of design specifications and functional testing (biocompatibility).
• Data Provenance: The biocompatibility testing would have been conducted in a laboratory setting, likely in the US (as the applicant is SIMS Deltec, Inc. in St. Paul, MN). The comparison data for predicate devices is based on their known specifications.
• Retrospective or Prospective: Primarily retrospective comparison to predicate device specifications and prospective laboratory testing for biocompatibility.

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 to this type of submission. "Ground truth" in the context of clinical device performance, expert consensus, or pathology is not established for this 510(k). The evaluation relies on engineering and material science principles, and comparison to existing, legally marketed devices.

4. Adjudication Method for the Test Set

• Not applicable. No clinical adjudication process involving human reviewers or experts for specific cases is mentioned.

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. This is a medical device for fluid administration, not an imaging or diagnostic AI-powered device that would involve human readers or AI assistance.

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

• No. This is a physical medical device. There is no "algorithm" or AI component.

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

• The "ground truth" for the comparison of functional and design specifications is the published specifications and documented performance of the legally marketed predicate devices.
• For biocompatibility, the "ground truth" is established by biocompatibility testing standards and protocols.

8. The Sample Size for the Training Set

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

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

• Not applicable. There is no "training set."

Summary of the Study:

The "study" presented here is a functional and comparative analysis rather than a clinical trial.

• Functional Testing: Biocompatibility testing was performed on the fluid path components of the new CADD® Administration Set and Accessories.
• Comparative Analysis: The new device was compared to two predicate devices: an existing CADD® Administration Set (manufactured by SIMS Deltec, Inc.) and the Sabraset™ 560500-100 Administration Set (manufactured by Sabratek). This comparison covered intended use, compatibility with remote reservoirs and security enclosures, free-flow protection, and physical dimensions (length, tubing diameter, priming volume).

Conclusion:

The results of the biocompatibility testing indicated that the materials were acceptable for human use. The comparison demonstrated that the new CADD® Administration Set and Accessories are substantially equivalent to the predicate devices in terms of materials, design, and function, thereby meeting the requirements for 510(k) clearance. Clinical studies were not deemed necessary due to this demonstrated similarity.

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