Search Results

The Administration Sets are intravenous administration sets intended for delivery of medications and fluids from a container into a patient's vascular system.

The EZ™ IV Administration Set is a gravity, single use, disposable, intravenous administration set designed to deliver fluids from a container into a patient's vascular system. The device includes a vented bag spike (air vent 0.1µm) integrated to a drip chamber (not made with DEHP*) featuring a 5-μm particulate filter, a roller clamp, flexible IV tubing (not made with DEHP*), and one (1), two (2) or three (3) needle-free valve (NFV) Y-site connectors. It also features a Luer connector and a priming cap with a 3-μm filter.

The EZ™ IV Administration Set may be used in combination with standard IV therapy devices commonly used throughout the healthcare settings, such as bag spike, Luer lock adaptor, syringe (MLL) (without needle), and IV extension sets. It is configured to achieve the intended use when used with these standard complementary products.

*DEHP – Di (2-ethylhexyl) phthalate (DEHP), a plasticizer to make PVC soft and flexible. It is a substance known to cause cancer or reproductive toxicity.

The provided FDA 510(k) clearance letter and summary for the EZ™ IV Administration Set (K251814) describe the device's acceptance criteria and the studies conducted to demonstrate substantial equivalence to a predicate device. However, this document primarily focuses on demonstrating substantial equivalence rather than proving the device meets specific acceptance criteria for a novel device. It also describes a medical device rather than a software or AI-driven device, so several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable.

Here's an analysis based on the provided text, focusing on the available information:

Acceptance Criteria and Device Performance for EZ™ IV Administration Set (K251814)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EZ™ IV Administration Set are primarily defined by adherence to recognized international and national standards for intravascular administration sets and specific functional performance metrics derived from these standards. The reported device performance indicates compliance with these standards.

• ISO 8536-4:2019
• ISO 22413:2021
• ISO 10993-1:2018
• ANSI/AAMI CN27:2021
• ISO 80369-7:2021
• ISO 80369-20:2015
• FDA Guidance for Intravascular Administration Sets | Comprehensive performance verification & validation testing performed; met the intended use. |
  | Air-inlet device tests | ISO 8536-4:2019 | Conformed to standard. |
  | Flow rate test | ISO 8536-4:2019 | Conformed to standard. |
  | Piercing device penetration force test | ISO 22413:2021 | Conformed to standard. |
  | Protective cap removal test | ISO 8536-4:2019 | Conformed to standard. |
  | Drip chamber and drip tube tests | ISO 8536-4:2019 | Conformed to standard. |
  | Leak integrity tests | ISO 8536-4:2019 (air leakage under positive pressure, air leakage under negative pressure and fluid leakage) | Conformed to standard. |
  | Tensile strength test | ISO 8536-4:2019 | Conformed to standard. |
  | Particulate contamination level | ISO 8536-4:2019, Annex A, A.2
  USP Particulate Matter in Injections | Met contamination index, N≤90. Conformed to standard. |
  | Drops/mL | 20 gtt/mL (as per Predicate) | 20 gtt/mL |
  | Tubing transparency | Sufficiently clear to observe air/water interface (normal/corrected vision) | Conformed to standard. |
  | Connector type | External Fitting Male Luer Lock (ISO 80369-7:2021) | Conformed to standard. |
  | Sterile barrier packaging | Medical grade paper and plastic film, heat sealed | Conformed to standard. |
  | Sterilization process | Ethylene Oxide (EO), SAL 10⁻⁶ | Ethylene Oxide (EO), SAL 10⁻⁶. Complies with ISO 11135:2014. |
  | Shelf-life validation | 3 years (36 months) via ASTM 1980-21 | 3 years (36 months) validated. |
  | Biocompatibility | ISO 10993-1:2018 (Externally Communicating Device, Blood Path Indirect, Prolonged Contact)
  (Specific ISO 10993 parts for various tests) | Met biological safety specifications. |
  | EO residues limits | ISO 10993-7:2008 & amendments | Conformed to standard. |
  | Shipping | ASTM D 4169-16 | Simulated shipping testing performed on K151650/S004. |
  | Package integrity | ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009 | Testing performed on K151650. |
  | Pyrogen tests | ANSI/AAMI ST72/2019, USP , USP , USP | Testing performed on K151650 and "will be conducted on every lot." |

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

• Sample Size: The document does not specify the exact sample sizes (number of devices/batches) used for each specific performance test mentioned (e.g., flow rate, leak integrity, tensile strength). The studies are focused on product characteristics and compliance with engineering standards, not clinical patient data.
• Data Provenance: Not explicitly stated for each test. The submitter is "Epic Medical Pte. Ltd." based in Singapore, suggesting the testing data likely originated from or was managed by facilities associated with this company. The testing is for a medical device component, not a diagnostic algorithm, so there is no patient data involved in these performance tests.
• Retrospective or Prospective: Not applicable, as these are engineering and materials performance tests conducted on the physical device itself.

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 to this type of device submission. The "ground truth" here is defined by objective engineering specifications and international standards, rather than expert consensus on medical images or diagnoses. Qualification involves expertise in medical device testing, engineering, and regulatory compliance.

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

Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical readings or evaluations where human interpretation introduces variability. These are objective physical and chemical tests on a medical device.

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 physical medical device (IV administration set), not an AI-powered diagnostic tool, and therefore no MRMC studies were conducted or are relevant.

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

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

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

The "ground truth" for the performance tests conducted on the EZ™ IV Administration Set is based on established international and national standards and their specific test methods and acceptance criteria. This includes standards like ISO 8536-4 for infusion sets, ISO 10993 for biocompatibility, and USP for particulate matter. These standards provide objective, measurable criteria for device performance and safety.

8. The sample size for the training set

Not applicable. This pertains to the training of an algorithm or AI model. This submission is for a physical medical device.

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

Not applicable. As above, this is for a physical medical device and does not involve a training set for an algorithm.

Summary of Study that Proves Device Meets Acceptance Criteria:

The study that proves the EZ™ IV Administration Set meets its acceptance criteria is a comprehensive set of performance verification and validation tests conducted on the subject device and, in some cases, leveraging data from the predicate device (K230343/S001) or an existing device (K151650 and K151650/S004).

These tests address:

• Functional Performance: Evaluated against ISO 8536-4:2019, ISO 22413:2021, and FDA guidance documents, covering aspects like flow rate, leak integrity, piercing device penetration force, protective cap removal, drip chamber performance, and tensile strength.
• Connection Integrity: Evaluated against ANSI/AAMI CN27:2021 (for luer-activated valves) and ISO 80369 series (for small-bore connectors like Luer lock).
• Biocompatibility: Evaluated against ISO 10993 series (e.g., -5, -10, -11, -17, -18, -23) to assess cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, and chemical characterization. This classification was for "Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24 hr to 30 d)."
• Sterility and Shelf-Life: Compliance with ISO 11135:2014 for Ethylene Oxide sterilization, ASTM D 4169-16 for shipping, and ASTM F1980-21 for accelerated aging (shelf-life validation of 3 years). Package integrity, pyrogen, and EO residue tests were also part of this.
• Material Composition: Analysis and risk assessment were conducted given differences in materials between the subject and predicate devices, leveraging biocompatibility and chemical characterization data.

The submitter states that "All performance testing demonstrated and confirmed the safety and effectiveness of the Subject device" and that the results "met the intended use." They explicitly noted for material and dimension differences that "analytical and functional testing were conducted" and "the results...demonstrated that the performance of the Subject devices met the intended use. Therefore, the differences were considered not significant." This body of evidence constitutes the study proving the device meets its acceptance criteria, which are primarily compliance with the listed international and national standards.

Ask a specific question about this device

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.

Ask a specific question about this device

The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

The ProSeal™ Bag Spike with Additive Port (or "and Seal Tab" (suffixed ST model no.)) serves as an adaptor between I.V. bags and ProSeal™ CSTD components, facilitating closed system fluid transfer. The spiking port of this device is compatible with generic I.V. spikes. Additionally, the additive port (injection site) allows medication to be added to the bag using the cleared ProSeal™ Injector or Injector Plus (both Syringe Adaptors).

The injection site of the ProSeal™ Bag Spike with Additive Port (or "and Seal Tab") and all corresponding interface membranes ensure a dry connection during fluid transfer. Utilizing this component and its appropriate ProSeal™ CSTD connecting component reduces the risk of microbial ingress for up to 168 hours (7 days).

This document describes a 510(k) clearance for a medical device called "ProSeal™ Bag Spike with Additive Port." 510(k) clearances are for medical devices that are substantially equivalent to a legally marketed predicate device. This process primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Important Note: The provided FDA 510(k) clearance letter and summary do not describe a study involving a medical device with Artificial Intelligence (AI) or machine learning (ML) capabilities. The document pertains to a physical medical device (an intravascular administration set) and its mechanical and material properties. Therefore, the questions related to AI/ML specific criteria (e.g., sample size for training set, number of experts for ground truth, MRMC studies, AI assistance) are not applicable to this specific clearance.

I will focus on the acceptance criteria and performance data provided for this physical medical device.

Acceptance Criteria and Device Performance for ProSeal™ Bag Spike with Additive Port

Since this 510(k) is for a physical medical device and not an AI/ML device, the "acceptance criteria" are based on meeting established national and international standards for medical device safety and performance, as well as demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

The device performance is demonstrated by conformance to various ISO standards and validation testing. The table below summarizes the key performance areas and the general nature of the reported performance, as specific quantitative acceptance criteria or detailed results are not explicitly listed in this type of summary document, but rather conformance to the standards is stated.

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 individual functional, biocompatibility, sterility, shipping, or shelf-life test. This level of detail is typically found in the full test reports, not in the 510(k) summary. For device clearances, compliance is often demonstrated by testing a statistically significant number of units to ensure performance within specifications, but the exact number isn't usually summarized here.
• Data Provenance: The document does not explicitly state the country of origin of the data. However, the submitter is Epic Medical Pte. Ltd. based in Singapore, suggesting the testing could have been conducted there or by affiliated labs. The testing refers to "bench performance verifications and validations" and "existing 510(k) cleared referred-to devices (K222929, K223674, K241988)" for leveraging data. This indicates the data is retrospective, drawing from previous tests on related and cleared devices, as well as specific new tests for the subject device. There is no indication of prospective clinical studies.

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

• Not Applicable: This criterion relates to AI/ML model validation, where human experts (e.g., radiologists) establish ground truth for image interpretation. For a physical medical device like an intravascular administration set, "ground truth" is established through engineering and biological testing against predefined performance standards and specifications, not through expert consensus on qualitative data. The "experts" would be the engineers, microbiologists, and other scientific and quality control personnel conducting the rigorous lab tests and validations.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or AI/ML model validation to resolve discrepancies in expert interpretations of data. For a physical device, performance is objectively measured against quantifiable technical specifications and standards (e.g., no leaks observed, flow rate within X range, microbial ingress count below threshold).

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: MRMC studies are specific to evaluating the diagnostic performance of AI-assisted systems where human readers interpret medical images or data. This device is a physical product, not an AI system.

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

• Not Applicable: This criterion is for AI/ML algorithms. The performance of this device is inherently its standalone physical function.

7. The Type of Ground Truth Used

• Objective Test Results / Conformance to Standards: The "ground truth" for this device's performance is established by objective engineering measurements, chemical analyses, and biological assays that demonstrate compliance with recognized industry standards (ISO, ASTM, ANSI, USP) and the device's design specifications. Examples include:
  • Absence of leaks under specified pressure.
  • Maintaining sterility and preventing microbial ingress for 7 days.
  • Meeting pre-defined flow rates.
  • No evidence of cytotoxicity, sensitization, or pyrogenicity in biocompatibility tests.
  • Successful vapor containment.

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" in the context of a physical medical device. This term applies to machine learning models.

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

• Not Applicable: As there is no training set for a physical device, this question is not relevant.

Summary of Study that Proves the Device Meets Acceptance Criteria for this Physical Device:

The study proving the device meets acceptance criteria is a comprehensive set of bench performance verifications and validations, along with biocompatibility, sterility, shipping, and shelf-life testing.

• Purpose: To demonstrate that the ProSeal™ Bag Spike with Additive Port is safe and effective for its intended use as an intravascular administration set component, and that any differences from its predicate device (ProSeal™ Closed System Bag Access, K241988) do not raise new questions of safety or effectiveness.
• Methodology:
  • Functional Testing: The device was subjected to various mechanical and functional tests based on ISO standards (e.g., ISO 8536-4, ISO 22413, ISO 15747, ANSI AAMI CN27), including leak integrity, tensile strength, flow rate, protective cap strength, IV bag spike penetration force, and impermeability to microorganisms (demonstrated for 7 days). Vapor containment was also assessed using a NIOSH CSTD draft protocol.
  • Biocompatibility Testing: In accordance with ISO 10993-1:2018 for externally communicating devices (blood path indirect, prolonged contact), various biocompatibility tests were performed on the device's materials, leveraging data from previously cleared predicate and similar devices (K222929, K223674, K241988). These included cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, chemical characterization, and particulate matter analysis.
  • Sterility Validation: Compliance with ISO 11135:2014 for Ethylene Oxide sterilization (SAL 10⁻⁶) was demonstrated, along with pyrogen testing.
  • Shipping and Shelf-Life Validation: Simulated shipping (ASTM D 4169-16) and package integrity tests (ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009) were conducted. Shelf-life of 3 years was validated using accelerated aging (ASTM 1980-21).
• Data Sourcing: Data was obtained from new tests performed on the subject device and by leveraging data from previously cleared devices (K222929, K223674, K241988) that share similar components or materials, indicating a retrospective data approach for certain aspects.
• Conclusion: The results of these tests and validations confirmed that the subject device meets all relevant performance standards and does not raise new questions of safety or effectiveness compared to the predicate device, thus demonstrating substantial equivalence.

Ask a specific question about this device

The ZeroClear™ Bag Access is a component of the ProSeal™ Closed System drug Transfer Device (CSTD) system. The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

The ZeroClear" Bag Access is a part of the ProSeal™ Closed System drug Transfer Device (CSTD), used for injecting and infusing IV fluids and drug solutions from a standard IV bag to a patient. It features a bi-directional Luer lock connector, compatible with ISO 80369-7:2021 male Luer connectors and an ISO 8536-4:2019 compliant IV bag spike, including the applicant's eZSURE™ Empty Fluid Container (cleared K223674) and eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (cleared K241442).

This sterile, single-use device used with the appropriate connecting devices, ensures dry connections, minimizes exposure to contaminants and drug vapors, and reduces microbial ingress for up to 7 days. It is intended for use by health care professionals in clinical settings for handling hazardous drugs.

The Subject device will be a part of a grouping of currently, twelve (12) cleared component device offerings, to the ProSeal™ CSTD system together with Epic Medical's most recently FDA cleared CSTD devices (K241988).

The provided FDA 510(k) summary (K243976) for the ZeroClear™ Bag Access details the device and its intended use as a component of a Closed System Drug Transfer Device (CSTD). However, it does not contain the specific information requested regarding acceptance criteria and the comprehensive study details as outlined in the prompt (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance, ground truth establishment, training set size).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (ProSeal™ Closed System Bag Access, K241988), primarily through functional performance, biocompatibility, and sterility testing against recognized standards. It highlights that no animal or clinical tests were deemed applicable for this submission.

Therefore, many of the requested fields cannot be directly populated from the provided text. Based on the document, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text for individual tests. The document mentions "testing data" but does not give specific numbers of devices or samples tested.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the tests were retrospective or prospective. The manufacturer is Singapore-based, but testing could occur elsewhere.

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

• This information is not applicable to the types of performance and safety tests conducted for this device (bench testing, biocompatibility, sterility). These tests do not involve expert interpretation or "ground truth" in the diagnostic or AI sense.

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

• Not applicable. Adjudication methods are typically used for studies involving human interpretation or subjective assessment, which is not the case for the physical and biological tests described.

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. The device is a physical medical device (component of a CSTD), not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant here.

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

• Not applicable. The ZeroClear™ Bag Access is a physical component, not an algorithm or software. Its performance is inherent to its design and materials, not a standalone algorithmic output. The performance tests mentioned (e.g., airtightness, microbial ingress) evaluate the device itself.

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

• For the functional, biocompatibility, and sterility tests, the "ground truth" is defined by the pass/fail criteria of the referenced international and national standards (ISO, ANSI AAMI, ASTM, USP, NIOSH). For example, a device either leaks or it doesn't, based on predefined measurable thresholds in the standards.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.

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

• Not applicable. No training set is involved.

Ask a specific question about this device

The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management.
· Routes of administration: intravenous and subcutaneous.

The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery.
· Route of administration: intravenous.

The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.
· Routes of administration: intravenous and intra-arterial.

The SMARTeZ™ Elastomeric Infusion Pump (SMARTeZ™ Pump) is a sterile, single-use, mechanical (non-electric, non-electronic) infusion pump that consists of an elastomeric fluid reservoir as an energy source and an administration line. The constriction of the elastomeric fluid reservoir drives the fluid through the administration tubing and eventually through a flow restrictor, into the patient connection.

The SMARTeZ™ Pump is intended to administer infusion therapies only, and not for fluid storage.

This Special 510(k) Submission is to inform FDA of the addition to the thirty-nine (39) existing SMARTeZ™ Pump offerings, four (4) new models of different nominal volumes, flow rates and time: 498111: 100 ml, 0.5 ml/h, 200 h; 498121: 100 ml, 1 ml/h, 100 h: 498131: 50 ml, 0.5 ml/h, 100 h: 498141: 50 ml. 1 ml/h, 50 h. with KVO (Keep Vein Open) infusion pump labeling.

This document describes the FDA clearance for the SMARTeZ™ Elastomeric Infusion Pump (K242152), which identifies it as substantially equivalent to a previously cleared device (K151650). This submission is a "Special 510(k)" for the addition of new models with different nominal volumes, flow rates, and infusion times, along with a change to a detachable administration tube.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to recognized international standards. The document doesn't provide a direct "table" of acceptance criteria values alongside specific performance metrics for each, but rather states that tests were performed in conformance with these standards.

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

The document does not explicitly state the numerical sample size for each specific test in the "test set". It mentions "bench performance verifications and validations performed on the Subject device (pump and administration tubing connected) and referred-to existing devices (K151650)". The provenance of the data is not specified in terms of country of origin. The studies are described as "bench performance verifications and validations," indicating controlled laboratory testing, and would be considered prospective for the specific tests performed on the Subject device to support this 510(k).

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

This information is not provided in the document. The document describes bench testing and compliance with standards for a medical device. Ground truth, in the context of expert review, is not applicable here as these are performance tests and biocompatibility assessments, not diagnostic or interpretive tasks.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes objective performance testing and compliance with standards, not a case-based review where expert adjudication would be needed.

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. The device is an elastomeric infusion pump, a hardware device for fluid delivery, not a software device or an AI application that assists human readers.

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, an elastomeric infusion pump, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The concept of "ground truth" as derived from expert consensus, pathology, or outcomes data is not applicable here. The ground truth for this device's performance is objective measurements against established engineering and biocompatibility standards (e.g., flow rate accuracy within specifications, confirmation of sterility, absence of cytotoxicity).

8. The Sample Size for the Training Set

This information is not applicable. This document describes the clearance of a physical medical device (an elastomeric infusion pump) based on engineering performance and biocompatibility testing, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable as there is no training set for this device.

Ask a specific question about this device

Mobility+ is intended to deliver liquid nutrition formula, to an enteral access device (feeding tube) in users aged 2 years and over.

The Mobility+ Enteral Feeding System ("Mobility+" or the "System") is a portable, lightweight, nonelectronic, disposable enteral feeding system intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over in the clinical or home care settings. The device is for single patient use, disposable and intended for use over a 24 hour period. The System has three primary components; food pouch, filling set and giving set.

The provided text describes the regulatory submission for the Mobility+ Enteral Feeding System, a medical device. It does not contain information about an AI/ML-driven device or a study involving acceptance criteria for an AI algorithm's performance. The document focuses on demonstrating substantial equivalence to a predicate device using bench testing and non-clinical data, not on the performance of a software algorithm.

Therefore, I cannot extract the information required to populate the fields related to AI/ML device performance, ground truth, expert adjudication, or MRMC studies, as these concepts are not applicable to the descriptions within your input.

The document explicitly states:
"Clinical studies were not deemed necessary for The Mobility+ Enteral Feeding Set as bench testing was sufficient to demonstrate substantial equivalence by way of comparison to a legally marketed predicate device."

This indicates that the study performed was a non-clinical bench testing and design verification/validation study to demonstrate that the physical device performs as intended and is equivalent to existing devices, not a study evaluating an AI algorithm's diagnostic or therapeutic capabilities.

Ask a specific question about this device