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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.

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