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The Empty Fluid Container is used to hold an admixture of compatible fluids for intravenous administration to a patient. Medication transfer in and out of the container is done using aseptic technique.

The eZSURE™ Empty Fluid Container (EFC) is a sterile, nonpyrogenic, single-use intravenous (IV) bag constructed from flexible, non-PVC film. It is designed for the preparation and administration of IV fluids and is intended for disposal after a single use.

Two previously cleared subgroups include:

• eZSURE™ EFC with Needle-Free Valve (NFV) Additive Port (K223674)
• eZSURE™ EFC with ProSeal™ Injection Site Additive Port (K241442)

Both subgroups are currently available in 100 mL, 250 mL, and 500 mL capacities. This Submission introduces a new 1,000 mL capacity option for each subgroup.

Each EFC consists of a flexible plastic film bag with two (2) ports:

• Additive (filling) port – for introducing compatible fluids
• Spiking (administration/access) port – for accessing the infusate using a standard IV spike

The NFV model features a self-sealing needle-free valve additive port compatible with male Luer lock syringes. The Injection Site model incorporates a closed-system injection site with a double elastomeric membrane, compatible with the ProSeal™ Injector, which is also compatible with male Luer lock syringes. Both configurations support secure medication addition and maintain a sealed system after device removal.

The provided FDA 510(k) clearance letter describes a medical device, the eZSURE™ Empty Fluid Container, which is an IV bag. The submission primarily focuses on the device's technical characteristics and performance, particularly concerning the introduction of a new 1,000 mL capacity option.

Based on the provided document, the device in question (eZSURE™ Empty Fluid Container) is a Class II medical device (an I.V. container). The validation described heavily relies on bench testing and conformance to established international and national standards rather than clinical studies involving human patients or complex AI algorithms requiring extensive ground truth establishment and multi-reader studies.

Therefore, the acceptance criteria and study that proves the device meets them are focused on these engineering and biocompatibility aspects.

Here's the breakdown as requested, tailored to the information available in the 510(k) letter:

Acceptance Criteria and Device Performance for eZSURE™ Empty Fluid Container

The acceptance criteria for this device are primarily based on meeting the requirements of various recognized national and international standards related to IV containers, fluid transfer, and biocompatibility. The "study" proving acceptance consists of a series of bench tests and evaluations against these standards.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device (an IV container) with an extension of capacity, the performance criteria are primarily related to its physical and material properties, and its ability to safely contain and dispense fluids. The provided document details a comprehensive set of tests performed.

• Accelerated aging of above tests (ASTM F1980-21)
• Resistance to dropping (ISO 15747:2018, Annex A.4)
• Accelerated aging of above test (ASTM F1980-21)
• Hanger tensile strength (ISO 15747:2018, Annex A.11)
• Accelerated aging of above tests (ASTM F1980-21) | Conformant: All specified tests were performed on the Subject device (1000 mL capacity) and leveraged data from predicate devices. The Submitter's Comment indicates that functional testing was conducted and data summarized, concluding that performance results met intended use, and determined the difference in volume to be insignificant. |
  | Additive Port (Common) | - Infusion container transparency (ISO 15747:2018)
• Water vapor impermeability (ISO 15747:2018)
• Access port cover test (ISO 15747:2018)
• Access port penetration ability of insertion point (ISO 15747:2018)
• Access port adhesion strength of infusion device and impermeability of insertion point (ISO 15747:2018)
• Access port liquid tightness of insertion point (ISO 15747:2018)
• Identification test (ISO 15747:2018)
• Raw container and test fluids requirements (ISO 15747:2018)
• Impermeability to microorganism and migration (ISO 15747:2018)
• 7-day microbial ingress (FDA guidance and AAMI CN27:2021) | Conformant: These tests were performed with the NFV filling port version (under K223674) or demonstrated to be equivalent. Results implied conformance, as the submission states no substantial differences raised concerns and performance met intended use. |
  | Additive Port (ProSeal™ Specific) | - Additive port air and liquid tightness (ISO 15747:2018)
• Impermeability to microorganism (ISO 15747:2018)
• Additive port positive pressure fluid leakage (ISO 80369-7:2021)
• Sub-atmospheric pressure air leakage (ISO 80369-7:2021)
• Stress cracking (ISO 80369-7:2021)
• Resistance to separation from axial load (ISO 80369-7:2021)
• Resistance to unscrewing (ISO 80369-7:2021)
• Resistance to overriding (ISO 80369-7:2021)
• Device leakage integrity (ISO 8536-4:2019)
• Vapor containment test (NIOSH 2016 draft protocol)
• Microbial ingress (FDA guidance and AAMI CN27:2021) | Conformant: These tests were performed with the Injection Site filling port version (under K241442 and K240433) or demonstrated to be equivalent. Results implied conformance, as the submission states no substantial differences raised concerns and performance met intended use. |
  | II. Biocompatibility | - Cytotoxicity (ISO 10993-5:2009)
• Sensitization (ISO 10993-10:2010)
• Intracutaneous reactivity (ISO 10993-23:2021)
• Acute systemic toxicity (ISO 10993-11:2017)
• Subacute/subchronic systemic toxicity (ISO 10993-11:2017)
• In-vitro hemolysis (ISO 10993-4:2017)
• Material mediated pyrogenicity (ISO 10993-11:2017)
• Chemical characterization and toxicological risk assessment (ISO 10993-18:2020 & ISO 10993-17:2002)
• Particulate matter testing (ISO 15747:2018 & USP )
• EO residues limits (ISO 10993-7:2008, Amd.1:2019) | Acceptable Biological Risks Established: Testing was conducted under predicate devices (K223674/S001, K241442, K240433) and the Subject device. The Submitter's Comment explicitly states: "The biocompatibility testing and chemical characterization as well as risk analysis data on cleared device were evaluated for the Subject device... The difference was determined to be insignificant as results were determined to have met the device's biological safety specifications." Testing also confirmed compliance with EO residue limits for special patient populations. |
  | III. Sterility, Shipping, and Shelf-Life | - Sterilization validation (ISO 11135:2014)
• Simulated shipping testing (ASTM D 4169-16)
• Package integrity (ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009)
• Pyrogen tests (ANSI/AAMI ST72/2019, USP 42-NF 37 , , )
• Shelf-life validation (3 years, ASTM 1980-21) | Conformant: The Subject device complies with ISO 11135:2014. Shipping and package integrity tests leveraged data from prior submissions (K151650/S004, K223674/S001, K151650). Pyrogen tests performed under K151650 will be conducted on every lot. A 3-year shelf-life was validated on the Subject device. |

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

• Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., "n=X units") for each specific test conducted on the 1000 mL subject device. It lists the types of tests performed and the standards they adhere to. For physical device testing, sample sizes are typically defined by the standards themselves (e.g., a certain number of units per lot, or a statistical sampling plan to achieve confidence). The statement "functional testing have been conducted and their data are summarized in section VII.A" implies sufficient samples were used to meet the standards' requirements.
• Data Provenance: The data provenance is primarily from bench testing conducted by the manufacturer or authorized test labs. The document mentions leveraging "relevant testing data from the Predicate devices and the existing device: K223674/S001, K241442 and K230343/S001" for many of the functional and biocompatibility tests, with specific tests performed "On Subject device" (the new 1000 mL version). The country of origin of the data is not specified beyond the company being in Singapore. All data is retrospective in the sense that it's historical data generated for the submission, but the tests themselves were designed to prospectively evaluate the device's performance against defined criteria.

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

This type of device (an IV container) does not typically involve expert "ground truth" establishment in the way AI/radiology devices do. The "ground truth" is established by adherence to pre-defined, internationally recognized engineering and scientific standards (e.g., ISO, ASTM, USP) and their associated test methods. Experts involved would be engineers, material scientists, and quality assurance professionals responsible for designing, executing, and interpreting these standardized tests. Their qualifications would be in engineering, chemistry, biology, or related fields, with experience in medical device testing and regulatory compliance. The document does not specify the number or specific qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is based on established technical standards, not on subjective human interpretation requiring adjudication. Performance is measured against quantitative or qualitative acceptance criteria defined by these standards.

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. This type of study is relevant for diagnostic devices, especially those involving image interpretation (e.g., AI in radiology), where human performance (with and without AI assistance) needs to be assessed. This device is a physical IV container and does not involve human readers for diagnostic interpretation.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used is primarily based on:

• Engineering and Performance Standards: The device's ability to meet specified physical, mechanical, and chemical properties as defined by ISO, AAMI, ASTM, and USP standards.
• Biocompatibility Standards: The device's materials and their extracts demonstrating acceptable biological compatibility as per ISO 10993 series.
• Sterility Assurance: Validation of the sterilization process and maintenance of sterility as per ISO 11135.

This is fundamentally different from ground truth for AI algorithms which might use expert consensus or pathology results.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set" of data.

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

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

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The TECHNOFLEX DMRX Empty solution container is empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique. After use the bag is discarded.

The subject device DMRX Empty Solution Container are IV bags for hospital use which consist of two tubes necessary for the filling of the bag itself and the administration of the solution to the patient. a) fill port to fill the container/injection port for additions of other medications and; b) a spike port to connect an intravascular administration set to the bag to dispense medication. One port is an injection port, which will be used for filling the bag with the solution. The filling will be made with a needle, using aseptic technics by a laboratory personnel or pharmacist. The elastomeric plug is auto sealable and does not require a cap after filling. The administration will be performed by nurses or personnel appropriately trained. They will connect an administration set to the second port which is a twist-off port (spike port). The device is an empty flexible container (bag) made of PP (Polypropylene), SEBS (Styrene Butadiene Copolymer), Thermoplastic Elastomer, PC (Polycarbonate), and Polyisoprene with silicone. One port is an injection port. The empty bag is filled by connecting a needle into the injection port. Using aseptic technics by a trained laboratory personnel or pharmacist, the filling is done by the tube with the injection port connector. After filling, the bag remains closed due to the self-sealing plug which secures the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration set via the second port (spike port). When the bag is already filled, other medications can be added using the injection port. The device will be available in four containment volumes (100mL, 250mL, 500mL, and 1000mL). Bags are double packed and proposed sterilized with e beam radiation.

The FDA 510(k) clearance letter K250459 describes a new device, the DMRX Empty Solution Container, which is an I.V. container for administering intravenous solutions. This clearance document focuses on establishing substantial equivalence to a predicate device, the Gilero, LLC SmartSite Bag (K201936), rather than providing a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, or ground truth details common in clinical or AI algorithm studies.

Based on the provided text, the acceptance criteria are implicitly met through a series of non-clinical tests demonstrating safety and performance comparable to the predicate device. The information is primarily focused on mechanical, material, and sterility aspects, not on AI algorithm performance or human reader studies.

Here's an attempt to structure the information as requested, though it's important to note the document is a regulatory clearance and not a research paper on device performance against specific, quantitatively defined acceptance metrics as might be found for a novel diagnostic device or AI tool.

Acceptance Criteria and Study Details for DMRX Empty Solution Container (K250459)

The device, the DMRX Empty Solution Container, is an I.V. container. Its acceptance criteria are centered on demonstrating safety, effectiveness, and substantial equivalence to a legally marketed predicate device (Gilero, LLC SmartSite Bag, K201936). The study performed is a non-clinical evaluation, primarily consisting of laboratory testing against recognized standards and comparative analysis of materials and design.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance statistics. Instead, the acceptance is based on demonstrating compliance with relevant ISO and USP standards and showing that differences from the predicate do not raise new questions of safety or effectiveness. The "reported device performance" in this context refers to the successful completion and compliance with these tests.

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test performed (e.g., how many bags were tested for leakage or particulate matter). The testing is typically performed on a statistically representative number of units according to the respective standards.
• Data Provenance: The data is generated from laboratory testing of the subject device (DMRX Empty Solution Container) in accordance with recognized international and national standards (ISO, USP, ANSI/AAMI, EN). The country of origin for the testing facilities is not explicitly stated, but the manufacturer is Technoflex SAS, located in Bidart, France. The studies are prospective in the sense that they are conducted specifically to validate the device for regulatory submission.

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

This question is not applicable in the context of this device and submission. The ground truth for these non-clinical tests is based on objective measurements against established technical standards (e.g., ISO for biocompatibility, USP for particulates). There is no "ground truth" derived from human expert consensus or clinical judgment for these types of physical and chemical performance tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective and based on direct measurement or observation against predetermined pass/fail criteria defined by the standards. There is no human adjudication process involved as there would be in, for example, a clinical trial or a diagnostic imaging study.

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

Not applicable. This is a non-clinical submission for an I.V. container, not an AI-assisted diagnostic or therapeutic device that would involve human readers or comparative effectiveness studies of human performance with and without AI assistance.

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

Not applicable. The DMRX Empty Solution Container is a physical medical device (an I.V. bag), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests performed is defined by:

• Objective measurement against established international and national standards: e.g., the limits for particulates specified by USP , the biological response criteria in ISO 10993, or the sterility assurance level (SAL 10⁻⁶) in ISO 11137. These are scientifically and statistically validated criteria, not expert consensus or pathology in a clinical sense.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable. As above, this is a physical device, not an AI algorithm.

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The Empty Fluid Container is used to hold an admixture of compatible fluids for intravenous administration to a patient. Medication transfer in and out of the container is done using aseptic technique.

The eZSURE™ Empty Fluid Container (EFC) devices are empty single-use, sterile, nonpyrogenic flexible IV container devices/ bags. These are discarded after use. The Subject EFC is made of non-PVC materials. The Nexcel Film for IV bag of the Subject EFC device is composed of a flexible plastic film bag and the device is provided in a two-port configuration with closures. A closed system inlet-/ entry-/ additive- port is used for filling one or more compatible fluid(s) into the bag by a transfer set/ syringe without needle with the ProSeal™ Injector or ProSeal™ Injector Plus (cleared K240171) attached, and another port, the spiking/ administration port, is used for accessing the infusate in the bag with a standard bag spike in an IV therapy administration from the EFC. The transfer device with a male Luer lock attached with the ProSeal™ Injector (or ProSeal™ Injector Plus) is used to connect to the filling-/ additive- port for filling. The additive port incorporates a ProSeal™ Injection Site (cleared K240433) as its integrated subcomponent; hence no other injection needle/ cannula is needed. The transfer device is removed at the end of the preparation step, and the self-sealing additive-/ injection-/ filling- port secures the admixture contents until their administration.

The provided text describes the 510(k) summary for the eZSURE™ Empty Fluid Container with ProSeal™ Injection Site. It details the device's modification from a predicate device, its indications for use, and a comparison of technological characteristics. The document primarily focuses on verifying the safety and effectiveness of the modified device by leveraging testing performed on existing cleared devices and conducting additional benchtop performance verifications.

However, the provided text does not contain information about a study proving the device meets acceptance criteria in the context of diagnostic accuracy, which is what the requested questions (2, 3, 4, 5, 6, 7, 8, 9) are geared towards. These questions are typically relevant for AI/ML-based diagnostic devices where performance is measured against a ground truth and involves human experts. This device, being an "Empty Fluid Container with ProSeal™ Injection Site," is a physical medical device for fluid administration, not a diagnostic or AI-driven system.

Therefore, many of the requested fields cannot be answered from the provided input as they are not applicable to this type of device.

Here's what can be extracted and inferred based on the nature of the device:

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

The acceptance criteria are primarily based on conformance to recognized international and FDA standards, and successful performance in benchtop verification tests. The "reported device performance" is that it conforms to these standards and passed the tests.

For the remaining questions, they are not applicable or the information is not provided in the text for this medical device:

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. The document describes benchtop performance verifications, which typically involve a specified number of units tested according to the method, rather than "test sets" of patient data. Details on the exact number of units tested for each benchmark are not explicitly stated.

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 does not involve expert interpretation or ground truth establishment in the diagnostic sense. Performance is assessed against engineering and biological standards.

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

• Not applicable. This relates to diagnostic interpretation, not physical device performance.

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 for AI-assisted diagnostic devices.

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

• Not applicable. This is for AI-driven algorithms.

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

• The "ground truth" for this medical device is adherence to established international and FDA recognized standards for medical devices (e.g., ISO, ASTM, USP standards for material safety, sterility, physical integrity, leakage, etc.). For biocompatibility, the ground truth is the biological response meeting safety thresholds according to ISO 10993.

8. The sample size for the training set

• Not applicable. This is for AI/ML models; this device is a physical product.

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

• Not applicable. This is for AI/ML models.

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The Empty Fluid Container is used to hold an admixture of compatible fluids for intravenous administration to a patient. Medication transfer in and out of the container is done using aseptic technique.

The eZSURE™ Empty Fluid Container (EFC) devices are empty single-use, sterile, nonpyrogenic flexible IV container devices/ bags. These are discarded after use. The Subject EFC device is composed of a flexible plastic film bag and two separate ports with closures, one for injection and another, infusion. An inlet-/ entry-/ additive- port is used for filling one or more compatible fluid(s) into the bag by a transfer set/ syringe without needle, and another port, the spiking/ administration port, is used for accessing the infusate in the bag with a standard bag spike. A transfer device with a male luer lock is used to connect to the filling-/ additive- port for filling. The additive port incorporates a needle-free valve; hence no injection needle/ cannula is needed. The transfer device is removed at the end of the preparation step, and the needle-free self-sealing additive-/ injection-/ filling- port secures the admixture contents until their administration. For administration to a patient, the device is then connected to an external IV set /IV line, via a bag spike. The IV bag is piped by inserting the spike point of a bag spike into the spiking-/administration- port of the IV bag, doing this by performing a twisting motion. When the bag is already filled, other medications can be added using the additive/ injection/ filling port, even during administration. Medication transfer in and out of the container is done using aseptic technique. The bags range in volume capacity of 100 mL, and 500 mL. The device has a hanger hole so it can be placed on an IV bag holder. The EFC is made of non-PVC materials and provided in a two-port configuration: The needle free additive port which is used for filling the container and the other, the spiking -/ administration port, which is used for IV therapy administration from the EFC. The EFC sub-components are externally communicating devices with no contact to the blood path. The contact duration is categorized as B-prolonged, (>24h to 30d), per ISO 10993-1 :2018 biocompatibility guidelines.

The provided text is a 510(k) Summary for a medical device called eZSURE™ Empty Fluid Container. It does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case studies, or the establishment of ground truth by experts.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for a Class II medical device (an empty IV fluid container). The "acceptance criteria" and "study" described in the document relate to physical and biological performance testing of the container itself, not the performance of an AI algorithm in diagnostic imaging.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI.
• Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for an AI test set.
• MRMC comparative effectiveness study details.
• Standalone AI performance details.
• Training set size or ground truth establishment for an AI.

The document describes the following types of acceptance criteria and studies for the physical medical device:

1. A table of acceptance criteria and the reported device performance (for the physical device, not AI):

The document does not provide a single, consolidated table directly mapping acceptance criteria to quantitative performance results for each test. Instead, it lists the types of tests performed and states that the device "met their respective acceptance criteria" or "complies with" relevant standards.

Summary of Acceptance Criteria and Reported Performance (extracted from Section VII):

2. Sample size used for the test set and the data provenance:
The document does not specify exact sample sizes for each test listed. It mentions "testing done" and "test methods" but not the number of units tested. Data provenance is not applicable here as it refers to physical testing of a manufactured device, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the "ground truth" for this device's performance relates to physical and biological properties (e.g., whether it leaks, whether materials are biocompatible, whether it is sterile), which are established through standardized laboratory testing, not by expert human readers interpreting data.

4. Adjudication method for the test set:
Not applicable for physical/biological performance testing.

5. If a Multi-reader Multi-case (MRMC) comparative effectiveness study was done:
No, this type of study is for evaluating diagnostic performance of imaging devices or AI, which is irrelevant to an empty fluid container.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as there is no AI algorithm being evaluated for this physical device.

7. The type of ground truth used:
For the physical device, the "ground truth" is defined by the technical specifications and performance limits set by various ISO, ASTM, ANSI/AAMI, EN, and USP standards (e.g., a certain burst pressure, a specific level of particulate matter, absence of microbial growth).

8. The sample size for the training set:
Not applicable, as this is not an AI model requiring a training set.

9. How the ground truth for the training set was established:
Not applicable, as there is no AI model or training set.

In conclusion, the provided FDA 510(k) summary is for a standard medical device (an empty fluid container) and demonstrates its substantial equivalence based on physical, chemical, and biological performance testing, rather than the performance of an AI algorithm.

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The Disposable Infusion Bag for Parenteral Nutrition is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set.

The device is not intended to store the fluids for 24 hours or greater.

The proposed device is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The proposed device is provided sterile and single use.

The proposed device is available in 7 series due to different bag capacities, different tube locations and different tube materials.

The provided text describes the 510(k) premarket notification for the "Disposable Infusion Bag for Parenteral Nutrition" (K222622) and compares it to a predicate device (K101412). However, it focuses on non-clinical tests and does not include information about clinical studies with human readers or AI performance metrics. Therefore, several sections of your request cannot be fulfilled by the provided document.

Here's an analysis based on the available text:

1. Table of acceptance criteria and the reported device performance

The document lists performance standards met by the proposed device, which serve as acceptance criteria. The "reported device performance" is a statement that the device complied with these standards. Specific numerical results or detailed performance metrics are not provided in this summary.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria consists of a series of non-clinical tests conducted by the manufacturer, Beijing L&Z Medical Technology Development Co., Ltd. These tests aimed to verify that the proposed device met all design specifications and complied with established international and US national standards relevant to medical devices, particularly for I.V. containers.

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

The document does not specify sample sizes for each non-clinical test performed. It generally states that "Non clinical tests were conducted," implying that an appropriate number of samples were tested to achieve statistical confidence for each standard.

• Sample sizes: Not specified in the provided summary.
• Data provenance: The tests were conducted by the manufacturer, Beijing L&Z Medical Technology Development Co., Ltd., which is located in Beijing, P.R. China. The tests are non-clinical, meaning they involve laboratory or bench testing rather than human subjects. They are inherently prospective in the context of device development and verification.

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

This section is not applicable as the described study is a non-clinical device performance test, not a study involving interpretation by human experts or ground truth in the context of diagnostic performance (e.g., radiology). The "ground truth" here is adherence to the specified technical and biological safety standards.

4. Adjudication method for the test set

This section is not applicable for the same reason as point 3. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or when establishing ground truth from expert opinions.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (infusion bag), not an AI-powered diagnostic or assistive technology. Therefore, there is no information on human reader improvement with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this device's performance is defined by the established international and national standards (e.g., ISO 15747, ASTM F1886, ISO 10993 series, USP ) and the specific design specifications of the device. The compliance with these objective, measurable standards constitutes the "ground truth" that the non-clinical tests were designed to verify.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no training set in the context of data used to train a model.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.

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The Empty EVA Bag is an empty container used for administration of solutions to the patients using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

The product is an empty flexible container (bag) in plastic material, that is to be filled before use, intended for the administration of intravenous infusion solutions), and provided sterile. It is provided in two different configurations, with three tubes or one tube:

• bag with 3 tubes: The empty bag is filled by connecting it to containers (generally glass bottles) filled with the solutions to be administered. The filling is done through the tube with the big bore connector where the non- re-opening clamp is located; this tube is closed with a screwed cap (air-tight closure). After filling, the bag is clamped by means of the non-re-opening clamp and closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration set via the access port (spike port). When the bag is filled, other drugs can be added using the second access port (injection port). The device is available in multiple containment volumes ranging from 250mL to 5000mL.
• bag with 1 tube: the bag is provided with one tube used both for the filling of the bag and the administration of the solution to the patient. The tube is closed with a screwed male Luer cap (air-tight closure). The filling is done by connecting the female Luer connector of the tube to the containers filled with the solutions to be administered. After filling, the bag is clamped by means of a pinch clamp and closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration line via the same female Luer connector. It is available in multiple containment volumes of 50mL, 100mL, and 250mL.

The provided text is a 510(k) summary for the Haemotronic S.p.a. Empty EVA Bag. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, many of the requested elements for an acceptance criteria study report are not explicitly available in the provided document.

However, I can extract the information related to the non-clinical tests performed to support the substantial equivalence claim, which serves a similar purpose in demonstrating device safety and performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria with corresponding performance results in a table format. Instead, it lists standards the device meets or tests that were performed to confirm performance. The general acceptance criterion for all these tests is that the device meets the requirements of the specified standards, implying successful completion without adverse findings.

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

The document does not specify the sample sizes used for any of the non-clinical tests. The data provenance is associated with laboratory testing to "demonstrate substantial equivalence," implying a prospective nature (testing performed specifically for this submission). The country of origin of the data is not specified, but the company is based in Italy.

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

This is not applicable as the study is a non-clinical, laboratory-based testing of a medical device, not an AI or diagnostic study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set:

This is not applicable for non-clinical, laboratory-based testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the performance of diagnostic devices or AI algorithms where human interpretation is a factor.

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

No, this is a purely physical medical device (an empty bag), not an algorithm or software-based device.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by the standards and specifications outlined in documents like ISO 10993, ISO 15747, ISO 80369-7, and USP monographs. Compliance with these established scientific and regulatory benchmarks forms the basis of the "truth" for device performance.

8. The Sample Size for the Training Set:

This is not applicable. There is no training set as the device is not an AI/ML algorithm.

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

This is not applicable. There is no training set.

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The SmartSite™ Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

The SmartSite™ Bag is a single-use, empty IV container, which will be available in 100mL, 250mL, and 500mL product sizes. The SmartSite™ Bag is labeled as sterile fluid path, and contains both an add port and a spike port. The add port facilitates aseptic transfer of medication(s) into or out of the bag. The spike port contains a twist-off protective seal. Either the add port or the spike port can be connected to an intravenous (IV) administration set for medication delivery to the patient. The add port may be repeatedly accessed in accordance with the Directions for Use (DFU). The SmartSite™ Bag may be used for up to 24 hours after the initial access of the add port, consistent with prescribing information for the medications used.

The provided text describes the 510(k) submission for the SmartSite Bag, an empty IV container. It outlines the device's indications for use, comparison to a predicate device, and non-clinical tests conducted to demonstrate substantial equivalence. However, the document does NOT contain a formal "study" proving the device meets acceptance criteria in the sense of a clinical trial or a structured performance study with defined acceptance criteria and reported numerical performance measures like sensitivity, specificity, or accuracy for a diagnostic device.

Instead, the document details various engineering and biocompatibility tests designed to ensure the SmartSite Bag functions as intended and is safe for its stated use, thereby demonstrating equivalence to the predicate device. The acceptance criteria are implicitly met by passing these tests and standards.

Here's a breakdown of the information that is present, organized as requested where applicable, and noting where the requested information is not available in the given text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit acceptance criteria in a table format with corresponding numerical performance for the device for a specific clinical outcome. Instead, it lists various non-clinical tests and standards the device was evaluated against, implying that meeting these standards constitutes "acceptance."

2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes for each test in a numerical format (e.g., "n=X bags"). It refers to "testing" performed. The data provenance is internal to Gilero, LLC as it refers to non-clinical laboratory testing. There is no mention of country of origin of data or whether it was retrospective or prospective in a clinical sense, as these are non-clinical engineering tests.

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 and not available in the document. The tests described are non-clinical, laboratory-based evaluations against established standards (e.g., ISO, USP), not assessments requiring expert "ground truth" establishment in a diagnostic context.

4. Adjudication method for the test set
Not applicable. There is no mention of an adjudication method as the tests are objective, laboratory-based measurements against defined standards.

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 (IV bag), not an AI/diagnostic software.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on established industry standards and specifications (e.g., ISO 10993, USP , ISO 15747, and internal performance specifications for factors like leakage, Luer connection, and shelf life).

8. The sample size for the training set
Not applicable. This is a traditional medical device, not an AI/machine learning product that requires a training set.

9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.

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The Empty EVA Bag is an empty container used for administration of TPN (Total Parenteral Nutrition) solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

The device is an empty flexible container (bag) in EVA material (Ethylene-vinyl acetate), that is to be filled up before use and intended for the administration of intravenous infusion solutions (TPN-Total Parenteral Nutrition). The bag is provided with three tubes necessary for the filling of the bag itself and the administration of the solution to the patient. The empty bag is filled by connecting it to containers (generally glass bottles) containing one or more solutions. The filling is done by the tube with the big bore connector where the non-re-opening clamp is located. After filling, the bag is clamped by means of non-re-opening clamp ad closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration set via the access port (spike port). When the bag is already filled, other medications can be added using the second access port (injection port). The device will be available in multiple containment volumes ranging from 250mL to 5000mL.

This document describes the premarket notification (510(k)) for the "Empty EVA Bag" device. It is not an AI/ML medical device submission, so the questions regarding AI/ML-specific study design (training/test sets, expert adjudication, MRMC studies) are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device ("Empty EVA Solution Container, Acta Medical, K121161") through non-clinical testing of the physical properties and biocompatibility of the device.

Here's an attempt to answer the questions based on the provided text, noting where AI/ML specific criteria do not apply:

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

The document does not provide explicit numerical acceptance criteria values for each performance test. Instead, it states that "All the necessary safety and performance tests in support of substantial equivalence to the predicate device were conducted" and implies that the device met the requirements of the listed standards and internal specifications. The "Conclusion" for each "Feature" in the "TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE" table effectively serves as the "reported device performance" in relation to the predicate.

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

The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of bags tested for volume capacity, tensile strength, etc.). It only indicates that "Nonclinical tests were conducted."

Data provenance: The testing was conducted to support an FDA 510(k) submission, suggesting it was performed by the manufacturer (Haemotronic S.p.a. in Italy) or a qualified testing lab. The data would be prospective, as it was generated specifically for this submission to demonstrate device performance.

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

Not applicable for this type of medical device submission. Ground truth in this context refers to meeting engineering and biocompatibility standards, not clinical diagnostic accuracy assessed by experts.

4. Adjudication method for the test set

Not applicable. There is no expert adjudication process for this type of non-clinical, physical, and biocompatibility testing. The "ground truth" is determined by established engineering and biological standards.

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 driven diagnostic device, and no human reader studies were conducted or required.

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

Not applicable. There is no algorithm or AI component in this device.

7. The type of ground truth used

The "ground truth" for this device's performance is based on:

• Compliance with recognized international standards (e.g., ISO 10993 series for biocompatibility, ISO 15747 for plastic containers, ISO 11137 for sterilization, ISO 11607 for packaging).
• Compliance with internal specifications for various physical properties (Bag Volume Capacity, Resistance to hot printing removal, Hangar Tensile Force, Hydraulic seal and mechanical resistance of the non-re-opening clamp).
• Pharmacopeial standards (USP for Particulate Matter).

Essentially, the device meeting the specified quantitative and qualitative criteria defined by these standards and internal specifications constitutes the "ground truth" for its safety and performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no training set for an algorithm. Device manufacturing processes would involve quality control and validation using samples, but not like an AI 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 algorithm, this question is not relevant.

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An empty container with sterile fluid path used to hold an admixture of compatible fluids for administration to a patient. Medication transfer is done using aseptic technique.

The subject device is an empty two-port style EVA container available in sizes ranging from 50 mL to 4000 mL. The devices are provided sterile and packaged in multi-pack kits. The intended use is to hold an admixture of compatible fluids for administration to the patient. Medication transfer is done using aseptic technique.

The provided document is a 510(k) Pre-Market Notification from the FDA regarding the "HCT Empty EVA Container Pack." This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria for a novel AI/Ml medical device.

Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies is not present in this regulatory document. These types of details are typically found in validation studies for AI/ML devices, not premarket notifications for substantially equivalent medical containers.

The document does include details about performance testing, which serves a similar purpose of demonstrating the device meets certain specifications or thresholds. Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing that was conducted to ensure the device's safety and effectiveness, particularly addressing the differences in packaging from the predicate device. While explicit "acceptance criteria" values are not listed in a quantifiable table, the tests implicitly aim to demonstrate performance meeting internal specifications and relevant ISO/ASTM standards. The "Reported Device Performance" is stated by the declaration that the tests were conducted "to confirm that the differences in packaging do not affect the safety or effectiveness of the device."

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

• Sample Size: Not specified. The document only lists the types of tests performed.
• Data Provenance: Not specified, but generally implies in-house testing by the manufacturer (Health Care Technologies) or contracted labs. The tests are non-clinical.

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

• Not applicable. This is not an AI/ML device requiring clinical expert adjudication for "ground truth." The tests are physical and chemical property evaluations.

4. Adjudication method for the test set:

• Not applicable. This is not a clinical study requiring adjudication. Test results are based on objective measurements against specified standards or internal criteria.

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 empty container, not an AI/ML algorithm.

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

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

7. The type of ground truth used:

• Not applicable in the context of AI/ML. For this device, "ground truth" refers to the objective physical and chemical properties and performance characteristics measured against established industry standards (ISO, ASTM, USP) and the manufacturer's internal specifications.

8. The sample size for the training set:

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

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

• Not applicable. As this is not an AI/ML device, there is no "training set" or ground truth for its establishment.

Summary for the provided document:

The regulatory submission for the HCT Empty EVA Container Pack is a substantial equivalence determination (510(k)) for a medical device container. The document details non-clinical performance testing to demonstrate that the device, despite minor packaging differences, maintains the same safety and effectiveness as its predicate device. This involves physical and chemical tests against industry standards and internal specifications, not clinical or AI/ML-specific validation studies. Therefore, many of the questions asked, which are highly relevant to AI/ML device evaluation, are not applicable to this type of medical device and regulatory submission.

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The Additive Port Cap is indicated for use on the medication port of Baxter VIAFLEX, Baxter AVIVA, and Baxter ALL-IN-ONE EVA containers to provide both visual evidence that medication has been added and tamper evidence once the device is closed.

The Additive Port Cap (APC) is a polypropylene, single use device designed to snap over the outside of the medication port of compatible Baxter IV container (Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL-IN-ONE EVA) after the addition of medication. Once closed, the device prevents the port from being accessed without causing visible damage to the IV container. The bright red coloration serves as a clear indicator that medication has been added. The APC device is non-fluid path and non-sterile. The APC device is marketed as a stand-alone device and packaged in bulk.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Additive Port Cap" (APC) device:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details performance testing for engineering characteristics rather than clinical performance or AI/human reader studies. Therefore, many of the requested points related to AI, human readers, and ground truth for clinical outcomes will not be present in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing that was conducted, and states that "All pre-determined acceptance criteria were met." However, the specific quantitative acceptance criteria and the exact reported performance values are not explicitly provided in detail within this summary. Instead, it lists the types of tests performed.

Here's a table based on the information available, indicating where details are missing:

Information Not Found / Not Applicable Given the Device Type:

The device, an "Additive Port Cap," is a physical medical device (plastic cap) designed for tamper evidence and visual indication. It is not an AI/software device or diagnostic imaging device. Therefore, many of the requested points related to AI/ML study design are not applicable to this submission.

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

• Sample Size: The document does not specify the exact sample sizes used for each of the performance tests. It merely states that "Performance testing to demonstrate tamper evidence was conducted" and lists various tests.
• Data Provenance: Not applicable in the context of clinical data. The tests are engineering and benchtop tests of a physical product.

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

• Not applicable. This is a physical device. "Ground truth" in the sense of expert medical interpretation for a diagnostic AI is not relevant here. The "ground truth" for the performance tests would be the measurement results from the engineering tests themselves (e.g., force required to open, presence of leakage).

4. Adjudication Method for the Test Set

• Not applicable. There's no clinical "test set" requiring adjudication by multiple experts. The tests are physical measurements and observations against engineering specifications.

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

• No. This type of study is typically done for diagnostic imaging devices or AI-assisted solutions to compare human performance with and without AI. It is not relevant for a physical device like an IV port cap.

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

• Not applicable. There is no algorithm or AI component in this device.

7. The Type of Ground Truth Used

• Engineering Specifications and Physical Measurements: The ground truth for this device's performance would be derived from the mechanical properties, dimensional tolerances, and functional performance (e.g., ability to indicate tamper, withstand certain forces, prevent leakage) as defined by its design and intended use. This is established via physical testing.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

• Not applicable. There is no AI/ML device or training set.

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