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The Medline Quick Switch Valve with ENFit Connector is a multi-port connector/valve closed system indicated for controlling fluid flow (nutrition, medication and water) between ENFit compatible devices, while reducing the frequency of disconnections between the associated ENFit devices. The Medline Quick Switch Valve with ENFit Connector can be used in pediatric (infants over 10kg, children, and adolescents) and adult patients, for up to 30 days.

The Medline Quick Switch Valve with ENFit Connector is a three-way stopcock valve intended to control fluid flow between ENFit enteral devices (i.e., Gastrostomy tubes, enteral syringes, extension sets, feeding sets) used for different enteral functions (i.e., liquid nutrition, water, or medication administration), reducing the frequency of disconnections between the associated enteral devices.

The provided document describes the Medline Quick Switch Valve with ENFit Connector and its substantial equivalence to a predicate device, the ICU Medical Lopez Valve (K915171), rather than a study proving the device meets specific acceptance criteria with reported device performance. The testing performed is non-clinical verification and primarily focuses on demonstrating that the proposed device performs similarly to the predicate device and meets relevant ISO standards and biocompatibility requirements.

Therefore, many of the requested elements (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone algorithm performance, and specific acceptance criteria with reported device performance values) are not applicable or cannot be extracted from this type of regulatory submission. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence, not on providing detailed clinical study results or AI performance metrics.

However, I can extract information related to the performance characteristics, the type of testing performed, and the general conclusion of equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with numerical values and reported device performance against those criteria in the way envisioned for, for example, an AI diagnostic device. Instead, it refers to compliance with ISO standards and successful completion of various tests to demonstrate safety and performance equivalent to a predicate device.

The performance characteristics cited as being equivalent to the predicate device are:

• Flow rate
• ENFit connectors compliant with ISO 80369-3

The reported performance for these characteristics is stated as "equivalent to the predicate device" and compliance with a specific ISO standard. No specific numerical values for flow rate are provided, nor are specific numerical metrics for ENFit connector compliance beyond the reference to the standard itself.

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

Not applicable. The tests performed are non-clinical bench tests and biocompatibility tests on the device itself, not studies on a "test set" of patient data.

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

Not applicable. This device is a medical accessory, not a diagnostic tool requiring expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. See point 3.

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 accessory (a valve), not an AI algorithm.

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

Not applicable. The device is a physical medical accessory, not an AI algorithm.

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

Not applicable. The "ground truth" for this device's performance is compliance with international standards (e.g., ISO 80369-3 for metrology, leakage, stress cracking, resistance to separation, overriding, disconnection) and biocompatibility standards (e.g., ISO 10993-5, -10) as well as comparison to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. The device is a physical medical accessory, not an AI algorithm.

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

Not applicable. See point 8.

Summary of Testing Performed (Non-Clinical Verification):

The study (non-clinical verification) involved the following tests to demonstrate safety, performance, and functionality of the Medline Quick Switch Valve with ENFit Connector:

• Biocompatibility Testing:
  • E-MEM Elution Cytotoxicity Test (ISO 10993-5: 2009)
  • Intracutaneous Irritation Test (ISO 10993-10: 2010)
  • Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010)
  • Results: Device considered non-cytotoxic, non-sensitizing, and non-irritant.
• Phthalates Testing: Confirmed device is not made with DEHP or BPA.
• Bioburden Testing: Environmental controls and monitoring support safe bioburden levels.
• Performance Testing (Bench) - with predicate device included for comparison:
  • Metrology per ISO 80369-3
  • Positive Pressure Liquid Leakage per ISO 80369-3 § 6.1.3
  • Stress Cracking per ISO 80369-3 § 6.2
  • Resistance to Separation from Axial Load per ISO 80369-3 § 6.3
  • Resistance to Separation from Unscrewing per ISO 80369-3 § 6.4
  • Resistance to Overriding per ISO 80369-3 § 6.5
  • Disconnection by Unscrewing per ISO 80369-3 § 6.6
  • Flow Rate
  • Tensile testing
  • Torque testing

Conclusion from Testing: The results demonstrated the overall safety of the proposed device and supported a substantial equivalence determination to the predicate, ICU Medical Lopez Valve (K915171).

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