(616 days)
The CorrectInject™ Safety System is intended for the injection of local or regional anesthetics, narcotics or other medications indicated for neuraxial injection. The system consists of components that have a unique non-Luer taper that allows connection of compatible CorrectInject™ components that, when used together as a system, help reduce the risk of mis-connection that may result in the injection of medications not intended for neuraxial use.
The CorrectInject™ Catheter Connector is intended for use with an epidural anesthesia catheter and CorrectInject™ compatible components for the injection of local or regional anesthetics, narcotics or other medications indicated for injection into the epidural space.
The CorrectInject™ Syringe is intended for use with CorrectInject™ compatible components for the injection of medications.
The CorrectInject™ anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid when used with CorrectInject™ compatible components.
The CorrectInject™ filter needle is intended to draw up medication when using the CorrectInject™ Syringe.
The CorrectInject™ white transport cap is intended to fit the CorrectInject™ syringe.
The CorrectInject™ yellow cap is intended to fit the female side of the CorrectInject™ catheter connector or CorrectInject™ filter.
The CorrectInject™ System specially designed non-Luer taper aids in preventing a standard Luer taper device from connecting or delivering a medication by the wrong route of administration.
The objective of the CorrectInject™ Taper system is to provide a non-Luer style, safety connection system that will help reduce the risk of misconnection.
The CorrectInject™ Taper system is intended to connect and be used solely with the components of the CorrectInject™ Safety System. The CorrectInject™ Safety System is intended to deliver medication to epidural and neuraxial locations.
CorrectInject™ Safety System components are considered not to be effectively connected if any of the following apply:
- Attachment to Luer components that requires the use of excessive force, torque, time or manipulation
- Physical resistance to attachment to Luer components beyond that defined in ISO 594-1, ISO 594-2 and BS EN 1707
- If an attachment is made to a standard Luer component, this attachment is non-functional as indicated by leakage per ISO 594-2, section 4.2 and BS EN 1707 section 4.2
The term "effectively connected" is defined as the ability to assemble linearly with normal clinical assembly force, or securely assemble together CorrectInject™ Safety System components using equivalent force, torque and technique, and resulting in a physically secure and functional assembly as defined by ISO 594 or BS EN 1707. The term "attachment" means to assemble such components that results in an assembly that may, or may not, be physically secure but is not functional as defined by ISO 594-1, ISO 594-2 and BS EN 1707.
The CorrectInject™ Safety System is designed to function in a similar manner as currently available Luer epidural systems. The locking components are attached together with a twisting motion the same as current Luer lock connectors. The difference in this system is that the interconnection taper is not a standard Luer taper (per ISO 594 Parts 1 &2). This CorrectInject™ Safety System is color-coded yellow for a neuraxial system.
The design consists of several unique pieces:
- Epidural Catheter Connector
- CorrectInject™ Syringe
- Filter
- Filter Needle Assembly
- Caps
- CorrectInject™ non-Luer epidural label
The document describes the CorrectInject™ Safety System, a medical device designed to prevent misconnections during the administration of neuraxial medications by using a non-Luer taper system. The system's components are color-coded yellow.
Here's an analysis of the provided text for acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Connection Effectiveness | Not effectively connected if: | The CorrectInject™ Safety System is designed to connect and be used solely with its own components. |
| - Attachment to Luer components requires excessive force, torque, time, or manipulation. | "The objective of the Correctingect™ Taper system is to provide a non-Luer style, safety connection system that will help reduce the risk of misconnection." The system is "intentionally designed to be incompatible with Luer tapers." | |
| - Physical resistance to attachment to Luer components beyond that defined in ISO 594-1, ISO 594-2, and BS EN 1707. | Implied to meet this by design and non-clinical testing against these standards. | |
| - If an attachment is made to a standard Luer component, this attachment is non-functional as indicated by leakage per ISO 594-2, section 4.2 and BS EN 1707 section 4.2. | Implied to meet this, as the purpose is to prevent functional Luer connections. | |
| Material/Component Standards | Meets requirements related to: | "The CorrectInject™ Safety System meets the requirements of the stated sections of BS 6196:1989, Sterile Epidural Catheters and Introducer Needles for Single Use, Section D.3.3 Only (Strength of union between catheter and catheter connector); BS EN 1707:1997, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings; ISO 594-1, Conical fittings with a 6% (Luer) taper for syringes needles and certain other medical equipment - Part 1 General Requirements; ISO 594-2., Conical fittings with a 6% (Luer) taper for syringes needles and certain other medical equipment -- Part 2 Lock Fittings and ISO 7886-1:1993(E), Sterile hypodermic syringes for single use - Part 1: Syringes for manual use with a modification for the taper." |
| Biocompatibility | Chemical characterization in accordance with ISO Biological evaluation of medical devices - Part 18: Chemical characterization of materials. | "Chemical characterization has been performed in accordance with ISO Biological evaluation of medical devices - Part 18: Chemical characterization of materials." |
| Drug-Device Stability & Compatibility | Differences between average assay result (triplicate) and corresponding control sample within ± 5.0%. | "The differences between the average assay result of a sample run in triplicate, and the assay result from its corresponding control sample were within ± 5.0% thus meeting the pre-set acceptance criteria." |
| Clinical Acceptability | Clinical studies demonstrate safety and effectiveness, and reduction of misconnections. | "Most of the clinicians (85%) that participated in the study felt that the system is clinically acceptable." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Non-clinical testing" and "Clinical studies."
- Non-clinical testing: No specific sample sizes for components (e.g., number of connectors tested for force, leakage) are provided. The provenance is internal testing by Smiths Medical.
- Clinical studies: No specific sample size is provided for the "clinical studies." The provenance is internal to Smiths Medical. The study is referred to in the past tense ("The clinical studies performed by Smiths Medical show..."). It is not explicitly stated whether the studies were retrospective or prospective, but the phrasing "performed by Smiths Medical" and "participated in the study" suggests prospective data collection for the clinical acceptability assessment. No country of origin is specified for the clinical data beyond "Smiths Medical," which is based in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For the "clinical studies," the document states "Most of the clinicians (85%) that participated in the study felt that the system is clinically acceptable."
- Number of experts: Not explicitly stated, other than "most of the clinicians (85%)". The total number of clinicians is unknown.
- Qualifications of experts: The experts are referred to as "clinicians." No further specific qualifications (e.g., specialty, years of experience) are provided.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method for the clinical studies. The reported performance is based on a collective sentiment ("85%... felt that the system is clinically acceptable"), rather than independent expert adjudication of specific outcomes.
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
- No, an MRMC comparative effectiveness study was not done.
- This device is a physical medical component, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical medical system, not an algorithm. However, the non-clinical testing can be considered "standalone" in the sense that the components' performance (e.g., strength of union, leakage) was evaluated without direct human-in-the-loop clinical use.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Non-clinical testing: The ground truth for effectiveness was based on adherence to international standards (e.g., ISO 594-1, ISO 594-2, BS EN 1707) for connection characteristics, and established physical and chemical testing protocols for biocompatibility and drug-device compatibility.
- Clinical studies: The ground truth appears to be based on clinicians' subjective assessment of "clinical acceptability" and the device's ability to "reduce the risk of misconnections that lead to mis-injections of medication not intended for the epidural space." This is a form of expert opinion/consensus regarding clinical utility and risk reduction.
8. The Sample Size for the Training Set
- This information is not provided. As this is a physical medical device and not an AI/machine learning algorithm, the concept of a "training set" in the context of data-driven model development is not directly applicable. If "training set" refers to samples used for initial design, prototyping, or iterative testing, that information is not detailed.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reasons as in point 8. The "ground truth" for the device's development would likely stem from engineering specifications, regulatory standards, and clinical needs identified during its design process.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).