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The CADD® Medication Cassette Reservoir with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids.

The CADD® Administration Set with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids.

The CADD® Medication Cassette Reservoirs with Flow Stop are a modification to the current CADD® Medication Cassette Reservoirs. The reservoirs will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the reservoirs are accidentally placed onto the pump incorrectly or become detached from the pump.

The Flow Stop will be located on the reservoir housing, which is attached to the pump. The reservoir will be provided to the user in an open state. Before the reservoir can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the reservoir to the pump, the user can still remove the reservoir from the pump and prime it by holding the Flow Stop in the open position.

The CADD® Administration Sets with Flow Stop is a modification to the current CADD® Administration Sets. The sets will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump.

The Flow Stop will be located on the set housing, which is attached to the pump. The set will be provided to the user in an open state. Before the set can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the set to the pump, the user can still remove the set from the pump and prime it by holding the Flow Stop in the open position.

The Add-on Integral Anti-siphon Valve, which is included with current sets will not be provided with the new sets. This valve is no longer necessary because of the addition of the Flow Stop.

The provided document describes two devices: the CADD® Medication Cassette Reservoir with Flow Stop and the CADD® Administration Set with Flow Stop. Both devices are modifications of existing products and incorporate a "Flow Stop" component designed to occlude the tube if the reservoir/set is accidentally placed onto the pump incorrectly or becomes detached.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • The document states "In-vitro testing was conducted," but does not specify the sample size for the functional testing.
   • The data provenance is in-vitro testing, implying a laboratory setting, not human or animal data. The country of origin is not explicitly stated, but the applicant's address is in St. Paul, Minnesota, USA.

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

   • This information is not provided. The studies were described as "in-vitro testing," suggesting a focus on engineering and material science rather than expert-based ground truth.

3. Adjudication method for the test set:

   • This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic studies where human expert consensus is needed. The testing described is functional and biocompatibility testing.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical studies were not deemed necessary regarding the CADD® Medication Cassette Reservoirs with Flow Stop due to their similarity in materials, design and function to the current CADD® Medication Cassette Reservoirs." The same statement is made for the Administration Set.

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

   • This question is not applicable. The device is a medical accessory (medication cassette reservoir/administration set), not an algorithm or AI system.

6. The type of ground truth used:

   • The ground truth for the functional performance was based on specifications established for the device's function (i.e., the Flow Stop effectively occluding the tube).
   • For biocompatibility, the ground truth was based on established biocompatibility standards and tests for medical device materials.

7. The sample size for the training set:

   • This question is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for physical device performance and material properties.

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

   • This question is not applicable for the reasons stated above.

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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-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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The Extension Set with 0.2u filter and anti-siphon valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps.

The CADD® Administration Set with 0.2u filter and anti-siphon valve is intended for use with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps for the administration of fluids or medications.

The purpose of this submission is to offer an alternate 0.2u filter, as a matter of customer preference, for use with the SIMS Deltec Extension Set with Anti-Siphon Valve and CADD® Administration Set with 0.2u Filter and Anti-Siphon Valve. The 0.2u filter is similar to the filter on the Abbott Laboratories' Filter Set with 0.22u Filter. An integral anti-siphon valve is included and is designed to protect against unregulated gravity infusion that may result from an improperly attached reservoir.

The provided text is a 510(k) summary for a medical device (Extension Set with 0.2µ Filter and Anti-Siphon Valve and CADD® Administration Set with 0.2µ Filter and Anti-Siphon Valve). However, it describes the device and its intended use but does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document states that the purpose of the submission is to offer an alternate 0.2µ filter, similar to one on an existing Abbott Laboratories' product. It focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices, rather than presenting a detailed performance study with acceptance criteria.

Therefore, I cannot provide the requested table and detailed study information based on the given text. The provided document is a regulatory submission for premarket notification, not a performance study report.

No information is available in the provided text for the following requests:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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