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The SureConnect Closed Drug Reconstitution and Transfer System is a closed system to be used by pharmacists or other healthcare professionals to prepare and administer drugs, including cytotoxic drugs, for intravenous infusion or injection.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the SureConnect® Closed Drug Reconstitution and Transfer System, indicating its substantial equivalence to a predicate device. It defines the device's indications for use but does not include details about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot generate the table or answer the specific questions about the device's performance study.

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The Swabbable Cap provides temporary aseptic closure of the male luer connector of the IV tubing while disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure. The device is designed to be permanently attached to an IV administration set and used over the life of the administration set.

Provides temporary aseptic closure of the male luer connector of the IV tubing while disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure.

This looks like a 510(k) premarket notification for a medical device called the "PadLock™ Swabbable Cap." This document does not describe a study involving AI or machine learning. It describes a traditional medical device and its predicate device. Therefore, many of the requested fields related to AI study design and performance evaluation are not applicable.

Here's an analysis based on the provided text, focusing on what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit acceptance criteria or a detailed report of device performance from a study. It describes the device, its intended use, classification, and predicate device. The 510(k) process primarily demonstrates substantial equivalence to a predicate device, which often involves comparison of technological characteristics and performance specifications rather than a new study with explicit acceptance criteria provided in this summary.

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

Not applicable, as no clinical study or test set for an algorithm is described in this document. This is a traditional medical device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable.

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 is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, 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.

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The Repeater Pump II tube set tube sets are fluid transfer tube sets used in conjunction with the Repeater Pump II pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.

The Repeater Pump II tube set provides the fluid pathway, pump cavity, valving, and tube set for the Repeater Pump II system. The tube set and pump platform work together to provide sterile transfer and reconstitution of pharmaceutical liquids. The tube set utilizes a plastic piston to mechanically pump required amounts of fluid from 0.2mL to 10mL with each piston stroke. A plastic pump core works in conjunction with the piston to provide appropriate fluid pathways for the draw and discharge strokes. There are two tube set connections for inlet and outlet fluid pathways. The Repeater Pump II tube set will be available in eight (8) unique configurations to accommodate various source and final container connections.

This is an interesting case where the provided text is a 510(k) summary for a medical device, which means it describes the device itself and its equivalence to a predicate device, but it does not include a detailed study proving the device meets specific acceptance criteria in the way a clinical or performance study report would. Instead, it lists various types of testing that will be included to demonstrate the device's substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested items regarding specific study methodologies (sample size for test/training sets, data provenance, number of experts, adjudication, MRMC studies, standalone performance) cannot be extracted directly from this document. This summary outlines the plan for testing and the performance characteristics of the device, rather than the results of a conducted study with defined acceptance criteria.

Here's an analysis based on the provided text, highlighting what is present and what is not:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for a study in the form of pre-defined thresholds. Instead, it provides performance specifications for the submitted device and compares them to the predicate device. The implicit acceptance criterion is that the new device performs at least as well as, or better than, the predicate device, especially regarding volume accuracy and pumping life.

It's crucial to understand that for a 510(k) submission, the "study" is often a series of verification and validation activities (testing) to demonstrate substantial equivalence to a predicate device, rather than a single clinical trial with pre-defined primary and secondary endpoints.

Study Details (Based on the provided K062909 Summary)

As noted, the document outlines the types of testing that will be included, rather than presenting the results of a specific study with the requested details.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified. The document is a 510(k) submission from Baxa Corporation in Englewood, CO, USA. The testing listed (Biocompatibility, Sterilization validation, Endotoxin Test, Human Factors/System Validation Disposable Design Verification Microbial Ingress Validation System Design Verification, Packaging validation) are general categories of testing typically performed to demonstrate device safety and performance according to U.S. FDA requirements. It is a prospective submission about the device, but the testing itself would be conducted prospectively on manufactured units.

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

• Not applicable as this is a device performance verification document, not a diagnostic algorithm. The "ground truth" here would relate to whether the device meets its engineering specifications.

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

• Not applicable for this type of device performance verification.

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 an IV fluid transfer set, not an AI diagnostic tool involving human readers.

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

• Not applicable. This device does not involve an algorithm separate from its mechanical function. Its performance is inherent to its design and manufacturing.

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

• The "ground truth" for this device would be established by engineering and quality standards, such as:
  • Precisely measured fluid volumes using calibrated equipment.
  • Sterility testing according to established protocols (e.g., absence of microbial growth).
  • Biocompatibility testing against recognized standards (e.g., ISO 10993-1).
  • Physical strength and leak testing.
  • The "ground truth" is adherence to these measurable, objective criteria.

8. The sample size for the training set

• Not applicable. This device does not use an AI model 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 an AI model.

Summary of what the document confirms:

• Device: Repeater Pump II Tube Sets (IV fluid transfer set, Class II device).
• Intended Use: Fluid transfer in hospital pharmacies for repeatable drug dosage distribution and reconstitution.
• Comparison: Substantially equivalent to the Repeater™ Pump Tube Sets (predicate device).
• Key Performance Improvements over Predicate:
  • Piston pump methodology (vs. peristaltic) eliminates need for recalibration with different viscosities/flow rates.
  • Improved volume accuracy (+/- 0.02mL for 0.2-2mL, +/- 1% for >2mL, compared to +/- 10% for 0.2mL, +/- 5% for 0.5mL, +/- 3% for 1.0mL for predicate).
  • Higher max flow rate (over 21mL/sec vs. over 14mL/sec).
  • Longer pumping life (200L vs. 150L).
  • Sterilized by Gamma Radiation (vs. ETO for predicate).
• Planned Testing: Biocompatibility, Sterilization validation, Endotoxin Test, Human Factors/System Validation, Disposable Design Verification, Microbial Ingress Validation, System Design Verification, Packaging validation.

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The Rapid-Fill Tubeset, manufactured by Baxa Corporation, is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller containers.

The Rapid-Fill Tubeset, is a tubeset used in conjunction with the Rapid-Fill pharmacy pump to fill multiple syringes.

This document describes a 510(k) premarket notification for the Rapid-Fill™ Tubeset, a medical device used for fluid transfer. The submission focuses on demonstrating substantial equivalence to a predicate device, the Exacta-Mix™ 2400 Compounding System Administration Set. The information provided outlines the device's intended use and design, and the testing conducted is primarily focused on safety and manufacturing compliance rather than performance metrics related to diagnostic accuracy or clinical outcomes.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way one would typically expect for a diagnostic or AI-powered device. Instead, the "acceptance criteria" are implied by the nature of a 510(k) submission, which aims to demonstrate substantial equivalence to a legally marketed predicate device. This equivalence is primarily shown through shared features and safety/manufacturing testing.

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

This information is not applicable and not provided in the document. The testing described (biocompatibility, packaging, sterilization) relates to manufacturing and material safety, not to clinical performance or algorithm evaluation with test sets of patient 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):

This information is not applicable and not provided. The device is an intravascular administration set, not an AI or diagnostic tool that requires ground truth established by experts for performance evaluation.

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

This information is not applicable and not provided.

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 information is not applicable and not provided. The device is an administration set, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided. The device is a physical medical device (tubing set), not an algorithm.

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

This information is not applicable and not provided. For this type of device, "ground truth" would refer to established standards for material safety, sterility, and manufacturing quality, verified through laboratory testing rather than clinical expert consensus or pathology on patient data.

8. The sample size for the training set:

This information is not applicable and not provided. The device is not an AI algorithm, so there is no "training set."

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

This information is not applicable and not provided. As there's no training set for an AI algorithm, no ground truth needs to be established in this context.

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The Baxa Corporation MicroFuse™Dual Rate Infuser is intended to be used for the intermittent administration of I.V. medication.

The Baxa Corporation MicroFuse Dual Rate Infuser, is a battery powered, portable device that automates the injection of the contents of a syringe into a patient. Each MicroFuse has two pre-determined rates that are be preset at the manufacturing facility. These preset rates can not be modified by the user or patient. The MicroFuse is used with a sterile administration set for injecting the medication into a patient. It depresses the plunger of the syringe at a controlled, pre determined rate, delivering the dose in the syringe over an extended period of time. The MicroFuse is offered in a standard dual rate model. Some custom dual rate models with the only difference being the pre-determined infusion rates are also offered.

The MicroFuse System consists of the MicroFuse Dual Rate Infuser and a syringe and administration set. Both syringe and administration sets are sterile and disposable. Since only the accessory syringes and administration sets are in the fluid path, the MicroFuse has no patient contact materials. This also means the device is not provided sterile, nor is it sterilized in the field. The accessories have been previously cleared with the predicate device in K933506.

Here's the analysis of the provided text regarding the Baxa MicroFuse™ Dual Rate Infuser, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Baxa MicroFuse™ Dual Rate Infuser was tested to and met "all applicable requirements of ANSI/AAMI ID26-1992. Standard for Infusion Devices."

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

The document does not provide specific details on:

• The exact sample size used for testing in relation to the ANSI/AAMI ID26-1992 standard.
• The data provenance (e.g., country of origin, retrospective or prospective nature).

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

This information is not provided in the document. The testing appears to be based on engineering performance against a recognized standard rather than an assessment of clinical outcomes by experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of testing against an engineering standard, a formal adjudication method by experts is unlikely to have been part of this specific safety and effectiveness summary.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to an engineering standard.

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

This question is not applicable. The device is a physical infusion pump, not an AI algorithm. The performance described is "standalone" in the sense that it's the device's inherent operation.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the device's performance was the ANSI/AAMI ID26-1992 Standard for Infusion Devices. Performance was assessed against the technical specifications and requirements outlined in this standard.

8. The Sample Size for the Training Set

This question is not applicable. The Baxa MicroFuse™ Dual Rate Infuser is a hardware device, not an AI system. Therefore, there is no "training set" in the context of machine learning.

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

This question is not applicable for the same reason as above; there is no training set for a hardware device.

Summary of Key Findings from the Document:

The acceptance criteria for the Baxa MicroFuse™ Dual Rate Infuser were compliance with the ANSI/AAMI ID26-1992 Standard for Infusion Devices. The study (or testing) performed demonstrated that the device "met all the applicable requirements of the Standard." The document does not elaborate on the specifics of this testing, such as sample sizes, expert involvement, or adjudication methods, as it primarily serves as a summary for a 510(k) submission focused on substantial equivalence to a predicate device (Baxa Syringe Infuser 510(k) K933506).

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