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The TERUMO® Surshield® Safety I.V. Catheter (18G × 51mm and 20G × 51mm catheter sizes) is inserted into the patient's vascular system for short term (

The TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length) are devices consisting of an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque, plastic catheter with a hub that is inserted into the patient's vascular system for short term (

The provided text describes a Special 510(k) submission for a medical device, the TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics against a medical condition.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth generation is not applicable to this document because it describes a 510(k) submission for a modified device, which focuses on demonstrating substantial equivalence to a predicate device rather than on novel performance validation.

Here's a breakdown based on the provided text, indicating why certain information is not present:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence)

This submission relies on demonstrating substantial equivalence to a predicate device (K082362 TERUMO® Surshield® SAFETY I.V. CATHETER). The "performance" section states: "All performance testing conducted on the TERUMO® Surshield® SAFETY IV CATHETER (51mm sizes length) manufactured by Terumo Corporation determined that the modified device was substantially equivalent to the predicate."

Therefore, there are no explicit acceptance criteria or direct performance metrics against a disease condition as would be found in a study for a novel device. The criteria for acceptance are that the new device performs equivalently to the predicate.

Study Details (Not Applicable - Substantial Equivalence)

The filing for a Special 510(k) for a modified device doesn't typically involve new clinical studies that establish de novo performance against a medical condition. The focus is on ensuring the changes to the device do not raise new issues of safety or effectiveness compared to the predicate.

Therefore, the following information is not available in the provided text:

• Sample size used for the test set and the data provenance: No new test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a new test set with expert-established ground truth is not part of this type of submission.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this device does not involve an algorithm.
• Type of ground truth used: Not applicable.

Training Set Information (Not Applicable - Substantial Equivalence)

• Sample size for the training set: Not applicable, as this device is not an AI/ML algorithm requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Summary of Device Information from Text:

The provided document is a 510(k) summary for a TERUMO® Surshield® SAFETY I.V. CATHETER (51mm catheter length).

• Proprietary Name: TERUMO® Surshield® SAFETY I.V. CATHETER (51mm catheter)
• Classification Name: Intravascular Catheter (880.5200)
• Product Code: FOZ
• Classification: Class II
• Predicate Device: K082362 TERUMO® Surshield® SAFETY I.V. CATHETER
• Intended Use: Inserted into the patient's vascular system for short term (

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The TERUMO® Surshield® SAFETY I.V. CATHETER is inserted into the patient's vascular system for short term use (

The TERUMO® Surshield® Safety I.V. Catheter are devices consisting of an over-the needle, peripheral catheter made of an a slender, flexible, radio-opaque, plastic catheter with a hub that is inserted into the patient's vascular system for short term (

The provided text describes the TERUMO® Surshield® SAFETY I.V. CATHETER. The performance section indicates that several tests were performed on the device. However, the document does not explicitly state acceptance criteria for these tests, nor does it provide a detailed study that proves the device meets specific acceptance criteria with quantifiable results. The information mainly lists the types of tests conducted and specifies the materials and sterilization methods used.

Therefore, for aspects like "reported device performance" against "acceptance criteria," "sample size," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone study," "ground truth type," "training set size," and "ground truth establishment for training set," the information is not available in the provided document.

Here's an attempt to structure the answer based on the available information, indicating where data 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 for Test Set: Not specified.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.

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

• This type of information is not relevant or applicable for the device described, as it is a physical medical device and not an AI/diagnostic software. No ground truth was established by experts in this context.

4. Adjudication method for the test set

• Not applicable as no expert adjudication for ground truth was involved.

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, not an AI/diagnostic system.

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 AI/diagnostic system.

7. The type of ground truth used

• Not applicable. For this type of physical medical device, "ground truth" would be objective measurements and functional tests according to established standards (e.g., force measurements, flow rate, biocompatibility tests). The document indicates such tests were performed but does not detail the "ground truth" methodology beyond listing the test types.

8. The sample size for the training set

• Not applicable. This is a physical medical device and does not involve AI training sets.

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

• Not applicable. This is a physical medical device and does not involve AI training sets or ground truth establishment in that context.

Summary of available performance claims related to acceptance:

The document states that the listed tests (Reactive force to close shutter, Force to detach safety cover, Initial sliding friction, Tensile strength, Force to needle breaking safety cover, Flow rate) were performed. It also specifies material equivalence to predicate devices and validated sterilization methods (ISO 11135-2007 to a SAL of 10-6, and EtO residual limits per ISO 10993-7). These aspects imply compliance with relevant standards and safety requirements, which effectively serve as "acceptance criteria" for regulatory clearance, even if explicit performance results against those criteria are not detailed in this specific summary. The 510(k) clearance itself (K082362) indicates that the FDA found the device "substantially equivalent" to predicate devices based on the submitted information, which would have included data demonstrating safety and effectiveness.

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