(211 days)
The SPpro™ ESP is an anesthesia conduction needle incorporating a needle tip shielding mechanism to aid in the prevention of needle-stick injuries after use to deliver an anesthetic and/or therapeutic agent to provide regional anesthesia. The needle can be used for a single dose administration or in conjunction with a catheter for continuous regional anesthesia.
The SPpro™ ESP anesthesia conduction needle is a single use device for injection of local anesthetics into body cavities other than blood vessels. The device will be packaged as sterile single units or incorporated into kits. The device is designed with a tip shield and sheath mechanism integrated with the introducer hub to aid in the prevention of sharps injuries. After activation the shield covers the introducer tip. The device is disposed of according to institutional procedure in a sharps container.
"The provided document is limited in detail regarding explicit acceptance criteria and a comprehensive study report. However, based on the information available, here's a structured response:
Acceptance Criteria and Device Performance
The document does not provide a table with specific quantitative acceptance criteria (e.g., minimum percentage of successful shield activations) or detailed reported device performance metrics in a tabular format. It broadly states that the device "met all functional requirements and specifications" and that "functional and simulated clinical testing was performed to support that there are no new issues or effectiveness raised by adding the sharps injury protection feature."
The primary performance claim is related to the sharps injury protection feature and its ability to "aid in the prevention of needle-stick injuries after use."
Implied Acceptance Criteria (Derived from text):
- Functional requirements: The sharps injury protection feature must activate and shield the needle tip effectively after use.
- Sharps Injury Prevention: The device design must aid in preventing needle-stick injuries.
- Biocompatibility: Materials must demonstrate biocompatibility for transient external tissue contact.
- Substantial Equivalence: The device must demonstrate substantial equivalence to predicate devices in its therapeutic function and the safety feature's technological equivalence.
Reported Device Performance (Derived from text):
- "The SPpro™ ESP met all functional requirements and specifications." (Section 2: Device Performance/Product Testing)
- "Functional and simulated clinical testing was performed to support that there are no new issues or effectiveness raised by adding the sharps injury protection feature." (Section 2: Device Performance/Product Testing)
- The safety feature is described as "an active shielding system that incorporates a second hub section integrated with the luer portion of the needle that slides up from the needle hub and locks over the needle tip." This describes the mechanism intended to achieve the sharps injury prevention.
Study Information
The document describes functional and simulated clinical testing rather than a formal clinical study with a specified sample size, ground truth, or expert involvement as typically seen in efficacy studies for AI/diagnostic devices.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "functional and simulated clinical testing" but does not quantify the number of devices tested or the number of simulated cases.
- Data Provenance: Not specified. It can be inferred that the testing was conducted in a controlled environment as "simulated clinical testing." There is no mention of country of origin or whether it was retrospective or prospective data from actual patient use.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the testing described is functional and simulated clinical testing, not a study requiring expert-established ground truth for a diagnostic outcome. The "ground truth" here would be the successful activation and shielding of the needle, observable during testing.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable due to the nature of the functional and simulated clinical testing. Adjudication methods are typically used when interpreting subjective findings or reconciling discrepancies in expert opinions for diagnostic assessments.
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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
- No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic or AI-powered devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The SPpro™ ESP is a medical device with a sharps injury prevention feature, not a diagnostic or AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance of the sharps injury protection feature would be objective observation during functional and simulated clinical tests: whether the shield successfully activated and covered the needle tip as designed. The document refers to "functional requirements and specifications," implying that the device was tested against pre-defined performance standards for its mechanical function.
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The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
Additional Context from the Document:
The nature of the submission (K032981) is a 510(k) premarket notification, which establishes "substantial equivalence" to legally marketed predicate devices. The focus of the performance testing for this type of submission is often to demonstrate that the new or modified feature (the sharps injury protection in this case) does not raise new questions of safety or effectiveness and performs comparably to or better than previously cleared devices, especially considering relevant guidance documents. The document explicitly states: "Clinical simulation testing was in accordance with the Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features: Guidance for Industry and FDA issued on December 31, 2002." This indicates adherence to regulatory guidance for this specific type of safety feature.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).