Search Results

The BD Alaris™ Pump Epidural Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through the epidural route for adults, pediatrics and neonates.

The BD Alaris™ Pump Epidural Infusion Set is an administration set consisting primarily of bag spike, vent cap, drip chamber, tubing (including pump segment), safety clamp, roller clamp, male NRFit™ connector, and male NRFit™ cap. The drip chamber cap located at the proximal end of the administration set, and the male NRFit™ cap, located at the distal end of the administration set, maintain sterility of the fluid path prior to usage. The spike located on the proximal end of the drip chamber is inserted into a prepared fluid container. The male NRFit™ connector enables connection of the administration set to a compatible female NRFit™ connector on the patient's epidural catheter. The BD Alaris™ Pump Epidural Infusion Set is intended to interface with the BD Alaris™ Pump Module. The device is supplied fluid-path sterile using gamma irradiation, in a perforated pouch, is non-pyrogenic, and is for single-use only. The device tubing is color-coded with a yellow stripe to signify administration of medication intended for an epidural route of administration. The BD Alaris™ Pump Epidural Infusion Set is not intended for gravity administration. The device is intended for prescription use only. DEHP or natural rubber latex are not part of the material formulation.

The BD Alaris™ Pump Epidural Infusion Set is designed to deliver medications intended for the epidural route of administration. The NRFit™ connector conforms to ISO 80369-6, Small-bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The NRFit™ connector is not compatible with the standard luer connector commonly used for intravenous infusion. The addition of the NRFit™ connector eliminates the risk of misconnection that may result in infusion of medications not intended for an epidural route of administration.

The provided document is a 510(k) summary for the BD Alaris™ Pump Epidural Infusion Set. It describes non-clinical safety and performance testing to demonstrate substantial equivalence to a predicate device, rather than a study proving that an AI device meets acceptance criteria. Therefore, most of the requested information regarding AI device evaluation is not applicable or available in this document.

However, I can extract information related to the general acceptance criteria and studies performed for this medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All testing met pre-established acceptance criteria and successfully demonstrated that the device... is safe for its intended use and performs as intended." However, it does not provide a specific table with detailed numerical acceptance criteria for each test and the corresponding device performance results. The testing was conducted according to various FDA recognized and internal consensus standards, implying that the acceptance criteria are inherent within these standards.

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

The document does not specify the sample sizes used for the various non-clinical safety and performance tests. It also does not mention data provenance in terms of country of origin or whether the tests were retrospective or prospective since these are non-clinical bench and lab tests.

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. This is a submission for a mechanical medical device (infusion set), not an AI device that requires expert-established ground truth for performance evaluation such as image interpretation.

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

This information is not applicable. Adjudication methods are typically relevant for clinical studies involving human interpretation or decision-making, which is not the case for this non-clinical submission.

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. An MRMC study is relevant for AI devices assisting human readers/interpreters, which is not what the BD Alaris™ Pump Epidural Infusion Set is.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

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

For this device, "ground truth" would correspond to the established physical and chemical properties, functionality, and safety requirements defined by international standards (e.g., ISO, AAMI, ASTM) and FDA guidance documents. The device's performance was measured against these predefined specifications. For example, for biocompatibility, the ground truth is defined by the passing criteria of ISO 10993 tests.

8. The sample size for the training set:

This information is not applicable. This is not an AI device that requires a training set.

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

This information is not applicable. This is not an AI device that requires a training set or its associated ground truth establishment.

Summary of relevant information from the document (focused on device evaluation):

• Acceptance Criteria: Implicitly defined by the numerous FDA recognized and internal consensus standards followed, including:
  • Human Factors: ANSI/AAMI HE75: 2009 (R2013), IEC 62366-1: Edition 1.0 2015.
  • Functional/Bench/System Testing: ISO 8536-4: 2010/Amd1: 2013(E), ISO 8536-8: 2015, ISO 80369-1: 2018, ISO 80369-6: 2016, ISO 80369-20: 2015. Specific tests listed: Flow Rate Accuracy, Bolus Accuracy, Air-in-Line, Upstream Occlusion Time-to-Alarm, Post Occlusion Bolus & Downstream Occlusion Time to Alarm.
  • Biocompatibility: ISO 10993-1, ISO 10994-5, ISO 10993-10, ISO 10993-23, ISO 10993-11, ASTM F756-2017, ISO 10993-4, USP 41 General Chapter , ISO 10993-3, ISO 10993-12, ISO 10993-17, ISO 10993-18.
  • Sterilization and Shelf Life/Packaging: ISO 11137-1, ISO 11137-2, ISO 11737-1, ANSI/AAMI ST72, ASTM D4728-17, ASTM D4169-16, ASTM D5276-19, ASTM F1980-16, USP 41 General Chapter , USP 41 General Chapter .
• Studies Performed: Non-clinical safety and performance testing were conducted to demonstrate substantial equivalence to the predicate device. These included:
  • Human factors testing.
  • Functional, bench, and system testing (e.g., flow rate accuracy, air-in-line, occlusion time-to-alarm).
  • Biocompatibility testing.
  • Sterilization and shelf life/packaging testing.
• Device Performance: All testing met pre-established acceptance criteria, demonstrating that the device is safe for its intended use and performs as intended. Specific quantitative results are not provided in this summary.
• Ground Truth: For non-clinical tests, the "ground truth" is defined by the pass/fail criteria and specifications outlined in the referenced national and international standards.
• Clinical Data: No clinical data were included in the submission.

Ask a specific question about this device

For the administration of anesthetics and/or analgesics from a syringe into the patient's epidural space through an epidural access device.

The proposed device is a patient controlled epidural analgesia (PCEA) syringe set. It is a single use disposable device intended for the administration of anesthetics and/or analgesics from a syringe into the patient's epidural space through an epidural access device. It is a non-pyrogenic, sterile device that can be directly attached to a syringe. The PCEA syringe set consists of non-DEHP PVC tubing/bushing, female NRFit cap, female NRFit lock, anti-siphon valve, on-off clamp, male NRFit lock, and male NRFit cap. It is used to administer anesthetics and/or analgesics from a syringe to the patient's epidural space through an epidural access device.

Here's a breakdown of the acceptance criteria and study information for the Baxter Healthcare Corporation PCEA Syringe Set (K211649), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes "bench tests" and does not specify a separate "test set" in the context of clinical data, human readers, or image analysis. The tests appear to be conducted on the device itself. The provenance of the data is from Baxter Healthcare Corporation's internal testing. There is no information regarding country of origin or retrospective/prospective nature as this refers to device performance testing rather than clinical study data.

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

Not applicable. The "ground truth" for these tests relates to engineering and manufacturing standards (e.g., ISO standards, USP chapters) rather than human expert interpretation of medical images or conditions.

4. Adjudication Method for the Test Set:

Not applicable. The tests are based on objective measurements against established engineering and regulatory standards, not human opinion requiring adjudication.

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 medical administration set, not an AI-powered diagnostic or assistive tool.

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.):

The "ground truth" is established by:

• International and national standards bodies (e.g., ISO 80369-6, ISO 8536-9, ISO 8536-12, ISO 8536-14, ISO 10993, ANSI/AAMI/ISO 11137-2)
• Pharmacopeial standards (e.g., USP Chapter , USP )
• Baxter Test Methods, which are company-specific internal procedures developed to ensure quality and compliance.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable, as no training set is used.

Ask a specific question about this device

CADD® Yellow High Volume Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, excluding subarachnoid/spinal block, and are designed for use with CADD® pumps (see CADD® pump Operator's Manual for compatibility).

The intended population is pediatrics and adults.

The CADD® Yellow High Volume Administration Set with NRFit™ connector device is designed to deliver local or regional anesthetics indicated for regional anesthetic infusion applications. The CADD® Yellow High Volume Administration Set with NRFit™ connector consists of components that have a non-Luer taper that allows connection of compatible components that, when used together as a system, help reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.

The NRFit™ connector of the neuraxial ISO 80369-6 compliant non-Luer system is incompatible with standard Luer tapers; therefore, the two systems cannot mate together effectively. The NRFit™ connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.

The CADD® Yellow High Volume Administration Set with NRFit™ connector devices are colorcoded yellow to indicate medication intended for regional anesthetic delivery.

All CADD® Yellow High Volume Administration Set with NRFit™ connector devices are intended for prescription use only.

The provided text describes a 510(k) premarket notification for a medical device called the "CADD® Yellow High Volume Administration Set with NRFit™ connector." This document is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study in the way one might evaluate a diagnostic or AI-driven device.

Therefore, the requested information points, particularly those pertaining to acceptance criteria and studies specifically designed to prove device performance in a comparative effectiveness or standalone clinical context with human interaction or disease detection, are not directly addressed in this type of regulatory submission. This submission primarily focuses on bench testing and biocompatibility to show that the new device, with its modified connector, is as safe and effective as the previously approved device.

However, I can extract information related to the non-clinical testing performed and the standards met, which serve as the "acceptance criteria" for this type of device modification.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (an administration set), the "acceptance criteria" are defined by compliance with recognized international standards for medical device safety, biocompatibility, and connector functionality, as well as pre-established internal specifications for certain tests. The "reported device performance" is that all testing met these pre-established specifications.

The core "acceptance criterion" for the primary modification (the NRFit™ connector) is its compliance with ISO 80369-6:2016 (Small bore connectors for liquids and gases in healthcare Applications - Part 6: Connectors for Neuraxial Applications) and its intentional incompatibility with standard Luer connectors (addressed by adherence to ISO 80369-1:2010 for general requirements). The reported performance is that the device conforms to these standards and the connectors are not compatible with standard luer connectors, achieving the risk mitigation objective.

The remaining information requested is largely not applicable or not explicitly stated for this type of 510(k) submission, which evaluates a physical administration set largely through non-clinical (bench) testing and biocompatibility assessments, rather than clinical studies involving patient outcomes, diagnostic accuracy, or human reader performance.

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

   • Not applicable / Not provided in the document. The testing described is primarily non-clinical (bench and lab testing for physical properties and biocompatibility). Sample sizes for these types of tests are typically determined by relevant ISO standards or internal quality procedures and are not usually detailed in this summary document. Data provenance is not specified for these lab tests.

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. This device is a physical administration set, not a diagnostic tool requiring expert interpretation for ground truth establishment. Engineering and lab technicians perform the non-clinical tests.

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

   • Not applicable. Adjudication methods are relevant for clinical studies, particularly those involving human reviewers of data like medical images. This document describes non-clinical 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 a medical administration set, not an AI-driven diagnostic or assistive technology for human readers.

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

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

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

   • For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria established by the international standards (e.g., ISO 80369-6 for connector dimensions and functionality, ISO 10993 series for biocompatibility) and internal engineering specifications. There is no expert consensus or pathology involved in this context.

8. The sample size for the training set

   • Not applicable. This is not a device that utilizes machine learning and therefore does not have a "training set."

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

   • Not applicable. As above, no training set.

Ask a specific question about this device

CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, and are designed for use with CADD pumps (see CADD pump Operator's Manual for compatibility) and CADD Yellow Extension Sets with NRFit™ connectors.

The CADD Filling Adapter with male NRFit™ connector and female Luer is an accessory for use in filling of the CADD Medication Cassette Reservoirs with NRFit™ Connector.

CADD Yellow Extension Sets with NRFit™ connectors are designed for use only with CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors for the delivery of regional anesthetics or narcotics.

CADD Yellow Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics and are designed for use with CADD pumps (see CADD pump Operator's Manual for compatibility).

The Male Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Medication Cassette reservoirs.

The Female Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Extension sets with NRFit™ connectors and the CADD Yellow Administration sets with NRFit™ connector.

The CADD Infusion Adapter with male NRFit™ connector and female Luer is intended to be used by clinicians to convert administration sets with Luer connectors into permanently dedicated lines for use only with NRFit connectors. The NRFit™ connector with non-luer taper is intended for the injection of regional anesthetics or narcotics and may help reduce the risk of mis-connection or mis-injection.

The CADD® Infusion devices with NRFit™ connectors are part of the CADD System. The CADD System is defined as a CADD pump with an attached CADD Medication Cassette Reservoir with an integral free-flow protection feature and CADD Extension Set with an Integral Anti-Siphon Valve; or as a CADD pump with an attached CADD Administration Set with an integral free-flow protection feature. The CADD Administration Set will be connected to a medication bag to allow for infusion.

The devices are designed to deliver local or regional anesthetics, narcotics indicated for neuraxial or regional anesthetic infusion applications. The NRFit™ connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for neuraxial or regional anesthetic use.

The CADD Infusion devices with NRFit™ connectors are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.

This 510(k) includes various configurations of CADD Infusion devices with NRFit ™ connectors.

The provided document describes a 510(k) premarket notification for the CADD® Infusion Disposables Portfolio with NRFit™ connectors. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices. The core change in the subject device is the incorporation of NRFit™ connectors, compliant with ISO 80369-6, for neuraxial applications, intended to reduce misconnection risks.

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

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

The document provides a summary of non-clinical testing categories, the evaluations performed, and the test criteria. The reported device performance is a general statement that "All testing met pre-established specifications, and successfully demonstrated that the CADD Infusion Disposables Portfolio with NRFit™ connectors performed as intended." Specific quantitative results or direct performance values are not provided in this summary.

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

The document does not specify the sample sizes used for the non-clinical tests. The tests are purely technical/engineering assessments of physical characteristics, sterility, and biocompatibility, not clinical studies involving patient data. Therefore, data provenance such as country of origin or retrospective/prospective is not applicable in this context.

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. The studies conducted are non-clinical, laboratory-based tests against established international standards (ISO, ANSI/AAMI, USP). "Ground truth" in the sense of expert medical diagnosis or interpretation is not relevant for these types of engineering and biological safety evaluations. The "ground truth" would be the specifications outlined in the referenced standards.

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

This information is not applicable, as the tests are non-clinical and do not involve human judgment or adjudication in the way clinical studies requiring ground truth establishment would.

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

A multi-reader, multi-case comparative effectiveness study was not done. This document pertains to the clearance of medical device disposables based on physical properties, materials, and safety, not on the performance of an AI algorithm or human reader interpretation.

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

A standalone performance study of an algorithm was not done. This submission is for physical medical devices (infusion disposables), not an AI algorithm.

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

The "ground truth" for the non-clinical tests conducted is defined by the specific parameters and acceptance limits set forth in the referenced international standards (e.g., ISO 80369-6, ISO 594-2, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788). These are objective, measurable standards for device characteristics such as fluid leakage, separation forces, sterility, and biocompatibility.

8. The sample size for the training set

This information is not applicable. There is no AI component or machine learning model described that would require a training set.

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

This information is not applicable, as no training set for an AI/ML model is mentioned in the document.

Ask a specific question about this device