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The LILY Extension Tube and Needleless Connector is a sterile single patient use device for the administration of fluids from a container into the patient's vascular system through a vascular access device. It is for direct injection, continuous or intermittent infusion, aspiration and needle-free delivery of solutions during IV therapy.

The LILY Extension Tube and Needleless is a closed luer activated device and passively aids in the reduction of needle stick injuries. Fluid flow through the device is activated by the ISO male luer from standard administration set, extension sets and syringes. The LILY Extension Tube and Needleless Connector provide a solid, sealed, surface for effective disinfection in 3 seconds. It is non-hemolytic. The clear housing and open, fluid filled design of the LILY Extension Tube and Needleless Connector enhance flushing particles. There is less volume of interstitial or dead space internal to the device. The LILY Extension Tube and Needleless Connector may be sued with power injection procedures to a maximum pressure of 325 psi at a flow rate of 10 mL per second.

The LILY Extension Tube and Needleless Connector is a sterile single-patient-use device intended for the administration of fluids into a patient's vascular system. It facilitates direct injection, continuous or intermittent infusion, aspiration, and needle-free delivery of solutions during IV therapy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The provided document does not explicitly present a table of "acceptance criteria" for the LILY Extension Tube and Needleless Connector. Instead, it presents a comparison of the subject device's technological characteristics with a predicate device (MaxZero Extension Sets with Needleless Connector, K140831), and then details performance testing results against recognized standards and FDA guidance.

However, based on the provided "Comparison of Technology Characteristics with the Predicate Device" and "Performance Testing" sections, we can infer some of the implicit acceptance criteria and the device's reported performance against them.

Inferred Acceptance Criteria and Reported Device Performance

• CIC-006SN: ≥170 mL/min
• CIC-007NL: ≥100 mL/min
• CET-015S, CET-015SD, CET-SS02L0, CET-SS02S0: ≥100 mL/min
• CET-HS03L0, CET-HS03S0, CET-HT03L0, CET-HT03S0: ≥75 mL/min |
  | | - Priming Volume: Within acceptable limits for intended use (FDA Guidance, ISO 80369-7:2021) | - CIC-005S: 0.25 mL
• CIC-006SN: 0.07 mL
• CIC-007NL: 0.04 mL
• CET-015S, CET-015SD: 0.55 mL
• CET-SS02L0, CET-SS02S0: 0.34 mL
• CET-HS03L0, CET-HS03S0, CET-HT03L0, CET-HT03S0: 0.36 mL |
  | | - Residual Volume: Within acceptable limits for intended use (FDA Guidance, ISO 80369-7:2021) | - CIC-005S: 0.3 mL
• CIC-006SN: 0.07 mL
• CIC-007NL: 0.04 mL
• CET-015S, CET-015SD: 0.60 mL
• CET-SS02L0, CET-SS02S0: 0.34 mL
• CET-HS03L0, CET-HS03S0, CET-HT03L0, CET-HT03S0: 0.36 mL |
  | | - Flush Volume: Meet specified requirements (FDA Guidance, ISO 80369-7:2021) | - CIC-005S, CET-015S, CET-015SD: 5mL
• CIC-006SN, CIC-007NL, CET-SS02L0, CET-SS02S0, CET-HS03L0, CET-HS03S0, CET-HT03L0, CET-HT03S0: 3mL |
  | | - Displacement: Within acceptable limits (FDA Guidance, ISO 80369-7:2021) | - CIC-005S, CET-015S, CET-015SD: ≤0.05 mL
• CIC-006SN, CET-SS02L0, CET-SS02S0, CET-HS03L0: ≤0.003 mL
• CIC-007NL, CET-HS03S0, CET-HT03L0, CET-HT03S0: ≤0.001 mL |
  | | - Power Injection: Capable of 10mL/sec @ 325 PSI (FDA Guidance) | Pass (10mL/sec @325 PSI) |
  | | - Microbial Ingress: Prevent microbial ingress (FDA Guidance) | Pass |
  | | - Tensile Strength: Meet specified requirements for material strength (FDA Guidance) | Pass |
  | | - Particle Contamination: Meet USP requirements | Pass (USP ) |
  | | - Reducing (oxidizable) Matter: Meet specified requirements (FDA Guidance) | Pass |
  | | - Metal Ions: Meet specified requirements (FDA Guidance) | Pass |
  | | - Titration Acidity or Alkalinity: Meet specified requirements (FDA Guidance) | Pass |
  | | - Residue on Evaporation: Meet specified requirements (FDA Guidance) | Pass |
  | | - UV Absorption of Extract Solution: Meet specified requirements (FDA Guidance) | Pass |
  | Device Characteristics (Comparison) | - Indication for use: Administration of fluids from container into patient's vascular system through a vascular access device; for direct injection, continuous or intermittent infusion, aspiration, and needle-free delivery of solutions during IV therapy, similar to predicate device. | Matches predicate device in intended use and indications. |
  | | - Power Infusion Flow Rate: Capable of 10mL/sec @325 PSI, same as predicate. | Same as predicate. |
  | | - Hemolysis: Non-hemolytic, same as predicate. | Same as predicate. |
  | | - Use: Single Patient, same as predicate. | Same as predicate. |
  | | - Method of Disinfection: 70% IPA, same as predicate. | Same as predicate. |
  | | - Provided Sterile: Yes, same as predicate. | Same as predicate. |
  | | - Packaged Quantity: Single Unit Per Package, same as predicate. | Same as predicate. |
  | Differences from Predicate (with Rationale for Equivalence) | - Physical Specification: Different component configuration (needleless connector alone vs. extension set with connector). Acceptance: Performance tests (biocompatibility, bench testing) demonstrated substantial equivalence. Physical specs (tubing length/ID/OD) are in User Manual. | Differences in models and specific dimensions exist, but testing validated safety and effectiveness. |
  | | - Gravity Flow Rate, Priming Volume, Residual Volume, Flush Volume, Displacement: Different values from predicate. Acceptance: Minor differences, performance evaluated per standards, no new safety/effectiveness issues. Values are detailed in User Manual. | Device meets specified flow rates (per model), and priming/residual/flush/displacement volumes are documented and deemed safe. |
  | | - Number of Activations: Subject device has higher activation capacity for some models (600 vs. 200 for predicate). Acceptance: Microbial ingress testing demonstrated safety for expanded activation counts. Details are in User Manual. | Some models pass 600 activations, others 200, which is higher or equal to the predicate's 200. |
  | | - Sterilization Method: Ethylene Oxide vs. E-beam (Radiation) for predicate. Acceptance: Both are widely used, FDA recognized methods; functional evaluation post-sterilization showed no issues. | ETO sterilization is validated and found safe and effective. |
  | | - Sterile Barrier Packaging: Medical-Grade Papers vs. Tyvek Polyethylene for predicate. Acceptance: Both materials are suitable, and seal strength, dye penetration, burst, and creep tests demonstrated no issues. | Packaging materials and integrity tests (Seal Strength, Dye Penetration, Burst Test & Creep Test) passed. |

The Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed in the "Performance Testing" section of the 510(k) Summary. It consists of two main types of testing:

• Biocompatibility Testing: Conducted in accordance with ISO 10993-1 and FDA guidance for an External Communicating Device, Blood Path Direct Contact (Infusion Only), Prolonged Duration.
• Bench Testing (Functional Testing): Conducted against specific FDA guidance and recognized ISO/ASTM standards relevant to intravascular administration sets and luer activated valves.

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

The document does not specify the exact sample sizes (number of units tested) for each individual biocompatibility or bench test. It reports the results of these tests as "Pass."

The data provenance is from non-clinical data provided by LILY Medical Corporation, a manufacturer based in Taoyuan, Taiwan. The tests were likely conducted in laboratories associated with the manufacturer or certified testing facilities. The tests are "bench tests," making the concept of "country of origin of the data" less relevant in a clinical context; rather, it refers to the location where the physical tests were performed. These are non-clinical (pre-clinical) studies, not human subject studies.

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 as the document describes non-clinical performance testing (biocompatibility and functional bench testing), not a clinical study involving human readers or expert panels establishing ground truth for diagnostic or AI performance. The "ground truth" for these tests is defined by the acceptance limits of the scientific standards and FDA guidance used.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3. Adjudication methods like "2+1" or "3+1" are used in clinical studies, particularly for diagnostic imaging, where expert consensus is needed to establish a definitive diagnosis (ground truth). The tests described here have objective pass/fail criteria based on physical properties and known biological responses.

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 a physical medical device (extension tube and needleless connector), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant to this submission.

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

This information is not applicable as the device is not an algorithm or AI product.

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

The "ground truth" for the performance testing described is established by:

• International Standards: e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterilization, ISO 11607-1 for packaging, ISO 8536-4 for infusion equipment, ISO 80369 series for small-bore connectors.
• National Standards: e.g., ASTM F1980-16 for accelerated aging, ASTM F756-17 for hemolysis, AAMI ANSI CN27:2021 for Luer activated valves.
• Pharmacopoeia Standards: e.g., USP , for pyrogenicity, USP for endotoxin, USP for particulate contamination.
• FDA Guidance Documents: Specifically, "Use of International Standard ISO 10993-1," "Intravascular Administration Sets Premarket Notification Submissions [510(k)]," which define acceptable performance and safety profiles for this class of device.

These standards and guidances provide the objective criteria and methodologies against which the device's performance is measured, effectively serving as the "ground truth."

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of physical medical device performance testing as described. Training sets are relevant for machine learning models.

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

This information is not applicable for the same reason as point 8.

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