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Non-Power Injectable:

Extension Sets with an attached BD Q-Syte™ Luer Access Split Septum are intended to be used with intravascular catheters to aspirate blood or administer fluids, including medications and blood or blood products. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.

Power Injectable:

The Power Injectable Extension Set with an attached BD Q-Syte™ Luer Access Split Septum is intended to be used with intravascular catheters to aspirate blood or administer fluids, including medications and blood or blood products. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.

The Power Injectable Extension Set is also indicated for use with intravascular catheters indicated for power injection of contrast media. The Power Injectable Extension Set is suitable for use with power injectors set to a maximum pressure of 325 psi (2,240 kPa) when the BD Q-Syte device is removed and a direct connection is made.

The Extension Sets with BD Q-Syte™ Luer Access Split Septum consist of a length(s) of flexible non-DEHP PVC clear tubing with a non-removable slide clamp. The devices include an ISO male Luer lock connection with a protection cap on the distal end an ISO female Luer lock connection on the proximal end(s) with a removable BD Q-Syte device or end cap. The Extension Sets with BD Q-Syte™ Luer Access Split Septum are provided in lengths from 5 in (127 mm) to 21 in (533 mm) with tubing diameters ranging from 0.035 in ID (0.89 mm) x 0.094 in OD (2.40 mm) to 0.110 in ID (2.80 mm) x .161 in OD (4.10 mm). Select Extension Sets include injection sites with a permanently attached BD Q-Syte device. The BD Q-Syte device is a needleless access device provided to aid in reducing the risk of accidental needlestick injuries. The Extension Sets with BD Q-Syte™ Luer Access Split Septum do not contain natural rubber latex.

The Power Injectable Extension Set with BD Q-Syte™ Luer Access Split Septum is suitable for use with power iniectors set to a maximum of 325 psi (2,240 kPa) when the BD Q-Syte device is removed and a direct connection is made. This device has a label attached to the tubing stating "Power Injectable Max 325 PSI".

The provided document is a 510(k) Premarket Notification for "Extension Sets with BD Q-Syte™ Luer Access Split Septum." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a new study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Specifically:

• It does not present a table of acceptance criteria and reported device performance.
• It does not describe a study involving a test set, its sample size, or data provenance.
• It does not mention experts establishing ground truth, adjudication methods, or MRMC studies.
• It explicitly states that "Performance testing was conducted for the predicate devices" and that the "results of the predicate testing indicate that the subject Extension Sets... are substantially equivalent." This means new performance data for this specific device against new acceptance criteria is not presented.
• It does not detail the sample size or ground truth establishment for a training set, as it relies on predicate device data for performance.

The document's primary purpose is to justify substantial equivalence based on the similarity of the new device to existing predicate devices, implying that the performance criteria for those predicate devices are met by extension.

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The Enteral Nutrition Warmer is an electronically powered dry warmer, which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7mL/min.

The Enteral Nutrition Warmer is an electronically powered dry warmer, which supplies external heat to the outside of the administration set tubing. The warmer includes an LED light to indicate the warmer is operating and a switch that will turn the warmer on and off. The Enteral Nutrition Warmer is reusable and provided non-sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Enteral Nutrition Warmer:

Acceptance Criteria and Device Performance

The provided 510(k) summary focuses primarily on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria derived from clinical performance trials for the proposed device's efficacy in warming enteral fluid. The "acceptance criteria" can be inferred from the comparative table where the proposed device's characteristics are presented against those of the predicate. The "reported device performance" is then what the proposed device demonstrated in the non-clinical tests.

Inferred Acceptance Criteria Table:

Study Proving Acceptance Criteria:

The document describes non-clinical tests that were performed to demonstrate that the device is capable of meeting the predicate device's specifications, particularly for the addition of enteral fluids to the intended use.

1. Sample Size for Test Set and Data Provenance:

   • The document does not specify a sample size for any "test set" in terms of cases or patients. The performance data section refers to "non-clinical tests" and a "human factors study."
   • The document implies laboratory-based, engineering performance testing rather than clinical trials with patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the traditional sense.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

   • This information is not provided. The study mentioned in the document is a human factors study and non-clinical performance tests, not a diagnostic study requiring expert ground truth for interpretation of cases.

3. Adjudication Method for the Test Set:

   • Not applicable, as the tests described are non-clinical engineering and human factors assessments, not diagnostic performance studies requiring adjudication of results against a ground truth from experts.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was done or reported. The submission is a 510(k) for a medical device (warmer) where the primary comparison is technical specifications and safety with a predicate device, not diagnostic efficacy with or without AI assistance for human readers.

5. Standalone (Algorithm Only) Performance Study:

   • Not applicable. This device is an enteral nutrition warmer, not an AI algorithm.

6. Type of Ground Truth Used:

   • For the non-clinical tests, the "ground truth" would be the engineered specifications and measurements (e.g., target temperature ranges, maximum surface temperatures, flow rates, time to reach temperature). These are determined by physics and engineering principles, not expert consensus, pathology, or outcomes data in a clinical sense.
   • For the human factors study, the "ground truth" would relate to identifying and mitigating risks related to usability and safety, likely against established human factors engineering principles and standards.

7. Sample Size for the Training Set:

   • Not applicable. This device is a physical warmer, not a machine learning model, so there is no "training set."

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

   • Not applicable. As there's no training set, there's no ground truth to establish for it in this context.

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1.0 The Medi-SIS Syringe Infusion System is indicated for the delivery of enteral fluids through clinically accepted routes of administration.
2.0 The Medi-SIS Administration Extension Set is intended for single patient use only.
3.0 The Medi-SIS Syringe Driver can be reused up to 5,000 times

The Medi-SIS Syringe Infusion System consists of a Syringe Driver (mechanical syringe pump), proprietary administration extension set, and compatible syringe.

The Medi-SIS Syringe Driver consists of a mechanical syringe pump assembly that is manufactured from plastic housings and end caps, and steel spring (mechanical force from the spring presses against the syringe plunger), and holds a 30mL or 60mL Becton Dickinson syringe (preamendment device) or a 30mL or 60mL Acacia syringe (K092986). The Medi-SIS Syringe Driver must be used in conjunction with a Medi-SIS Administration Extension Set, which controls the time the infusion will occur (by flow restrictor) for the entire volume of the filled syringe. The Medi-SIS Syringe Infusion System infuses fluids in a continuously decreasing rate and the user can calculate the average flow rate based from volume and time infused.

The Medi-SIS Syringe Driver is reusable and provided non-sterile.

The Medi-SIS Administration Set consists of various lengths of flexible non-DEHP PVC tubing. on/off clamp, flow restrictor, and male and female connectors. The male and female connectors meet Acacia's internal specifications for enteral applications to ensure cross connections do not occur between IV and Enteral infusions. Additional componentry may be added and configurations modified based on the needs of clinicians.

The following Administration Extension Sets will be available:

60mL Syringe Size, 1.0mL per minute delivery rate 60mL Syringe Size, 2.0mL per minute delivery rate 30mL Syringe Size, 0.5mL per minute delivery rate 30mL Syringe Size, 1.0mL per minute delivery rate 30mL Syringe Size. 2.0mL per minute delivery rate

The approximate residual volume for the syringe/administration set combination is approximately 2.20mL for all configurations. The Medi-SIS Administration Extension Set is provided sterile, single use, and non-pyrogenic.

The provided 510(k) summary (K111381) describes performance testing for the Medi-SIS Syringe Infusion System, specifically for the addition of enteral fluid delivery to its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size (e.g., number of tests, number of devices) used for the non-clinical tests assessing enteral fluid delivery time and residual volume. It also does not specify the provenance of the data (country of origin, retrospective or prospective). It simply states that "non-clinical tests were performed."

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

Not applicable. The tests performed were non-clinical, evaluating device performance (fluid delivery and residual volume) against specifications, not requiring expert human interpretation or ground truth establishment in a medical context.

4. Adjudication Method for the Test Set

Not applicable. As the tests were non-clinical performance evaluations, no adjudication method (like 2+1 or 3+1 used for expert consensus in medical image analysis) was required.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on non-clinical performance, not human reader performance with or without AI assistance. The device is an infusion pump, not an AI-powered diagnostic tool.

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

Yes, in a sense, a "standalone" performance study was done for the device itself, as the tests focused on the physical device's ability to deliver enteral fluids as specified. However, this isn't in the context of an "algorithm" or AI. The device's performance was evaluated independently of human interaction during the test, purely on its mechanical and fluid delivery capabilities.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on predicate device specifications and internal Acacia specifications for performance. For example, enteral fluid delivery was verified against the specified time and the residual volume had a specific measurable value.

8. Sample Size for the Training Set

Not applicable. This device is an infusion pump, not an AI/machine learning device that requires a training set. The performance evaluation was based on non-clinical engineering tests.

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

Not applicable. There was no training set for this device.

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The Blood Sampling Set is indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

The Blood Sampling Set consists of non-DEHP PVC tubing, and configured with one or more stopcocks with needleless valves, and a male luer lock for connection with the patients catheter. An optional configuration includes check valves, non-DEHP PVC tubing and transfer spike to allow for withdrawing flush solution from an IV bag into a syringe. All sets can be ordered with a choice of various on/off clamps, depending on the clinician's and hospital protocol. The Blood Sampling Set will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and sizes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Blood Sampling Set":

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the performance tests (Bond Joint Strength, Fluid Flow Leak Testing, Flow Rate Comparison). The data provenance is implied to be directly from testing conducted by Acacia, Inc., as these tests were performed to assure substantial equivalence. It's not specified as retrospective or prospective, but as performance testing for a new device, it would inherently be prospective in nature.

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

Not applicable. The described tests are not clinical studies requiring expert ground truth establishment. They are engineering performance tests against a standard (ISO 8536-4).

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against a standard, not requiring adjudication of expert opinions.

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

No, an MRMC comparative effectiveness study was not done. The device is a medical accessory (Blood Sampling Set / IV Extension Set), not an imaging or diagnostic AI device that would typically require such a study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance tests (Bond Joint Strength, Fluid Flow Leak Testing, Flow Rate Comparison) are standalone performance evaluations of the device itself, without human-in-the-loop interaction in an interpretive sense.

7. The Type of Ground Truth Used

The ground truth for the performance tests was established by the ISO 8536-4 standard. This standard defines the requirements and acceptance criteria for infusion equipment, and the device's performance was measured against these objective, pre-defined technical specifications.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical accessory, not an AI or machine learning model that would require 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/ML model, there is no ground truth to establish for it. The "ground truth" for the device's design and manufacturing is adherence to relevant standards and established engineering best practices.

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The Acacia Piston Syringe is indicated for the injection of fluids into, or withdrawal fluids from, the body. It is also used as a dispenser, a measuring device, and a fluid transfer device.

The Acacia Piston Syringe consists of a calibrated hollow cytincrical body and movable plunger. At the tip of the barrel is a tapered male connector, which can be in a luer lock, luer slip, oral lock, and oral slip configurations.

The Acacia Piston Syringe can also be used as a dispenser without the use of a plunger.

The provided document does not contain information regarding a study that proves the device meets acceptance criteria, beyond a general statement that "All necessary verification and validation testing has been performed for the Piston Syringe to assure substantial equivalence to the predicate devices."

Therefore, I cannot provide detailed information for most of the requested points.

Here's what can be inferred from the document:

• Device Name: Acacia Piston Syringe
• Purpose: A general-purpose Piston Syringe

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

The document does not specify quantitative acceptance criteria or detailed performance data. It broadly states that the device has "similar physical and technical characteristics to the predicate devices" and that "All necessary verification and validation testing has been performed... to assure substantial equivalence."

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

Not specified in the document.

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

Not applicable as specific testing details, including ground truth establishment or expert involvement, are not provided.

4. Adjudication method for the test set

Not applicable as specific testing details are not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not mentioned. The device is a physical medical device (piston syringe), not an AI-assisted diagnostic tool where human readers would be involved in interpreting images.

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

This concept is not applicable to a physical piston syringe. Performance would be assessed through engineering and materials testing, not algorithm-only performance.

7. The type of ground truth used

Not specified. For a physical device like a piston syringe, "ground truth" would likely refer to engineering specifications, material properties, and functionality tests (e.g., fluid volume accuracy, force required for plunger movement, sterility, biocompatibility).

8. The sample size for the training set

Not applicable as this is not an AI/algorithm-based device that requires a training set in the conventional sense.

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

Not applicable.

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ACACIA'S Flow Eze Blunt Cannula for use with a sterile Acacia 3 riow mac bean medication into a Baxter's Interlink ) Injece meaze Blunt Cannula is single-use only. Split Septum.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a device named "Flow-Eze Blunt Cannula." It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews that would typically be found in a study summary or a submission to the FDA detailing performance data.

The letter is a regulatory approval notice, not a performance study report. Therefore, I cannot extract the requested information from the provided text. The questions posed pertain to the technical validation of a device's performance, which is not present in this regulatory correspondence.

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