(44 days)
SecureLoc™ Safety Introducer Needles are intended to be used for those patients requiring percutaneous procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures. The SecureLoc™ Safety Introducer Needles are intended to be used as integral safety procedure needles for those patients requiring percutaneous procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures. The SecureLoc™ Safety Introducer Needle's safety engineered integral safety guard is advanced by the clinician. The safety guard automatically senses the end of the needle and reduces the risk of accidental needlestick injuries by locking a safety guard covering the needle tip. The safety guard can be activated over stylettes, obturators, and guidewires. Will be marketed as bulk non-sterile single use devices to procedural kit manufacturers and also as sterile, non-pyrogenic, single use devices to clinical endusers. May be used in any appropriate patient population.
AdvancIntroducer™ Introducer Needles are intended to be used with those patients requiring percutaneous entry procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures. Will be marketed as bulk non-sterile single use devices to procedural kit manufacturers and also as sterile, non-pyrogenic, single use devices to clinical endusers. May be used in any appropriate patient population.
The AdvancIntroducer™ needles consist of a stainless steel needle and a colored translucent standard female Luer lock hub locking connector for rapid (flashback) visualization. The hub has a bevel-up orientation indicator. The hub has been designed to provide the end-user excellent ergonomic tactile balance and stability. The AdvancIntroducer™ needles are available in one-wall with or without a Seldinger shield. The stainless steel needles are available with and without an echogenic feature or a specialty coating to enhance available war and with oneedles are available in a range of wall thicknesses, gauges and lengths to match the end-user need. AdvancIntroducer™ needles will be marketed to the clinical end-user as sterile, nonpyrogenic, and single use devices. Additionally, the device will be marketed as the safety procedure needle in procedure trays. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The AdvancIntroducer™ will be incorporated into the procedure kit, packaged and sterilized.
SecureLoc™ Safety Introducer Needles have all the same components as the AdvancIntroducer™ and in addition, incorporates an intuitive easy to use safety guard which is an integral part of the device. SecureLoc™ Safety Introducer Needles are designed for common Introducer needle lengths and gauges. Obturators and stylettes are appropriately available. Stylette handles have an incorporated key to align to the cutting bevel. The SecureLoc™ Safety Introducer Needle's safety engineered integral safety guard is advanced by the clinician. The safety guard automatically senses the end of the needle and locks a safety guard covering the needle tip. The SecureLoc™ Safety Introducer Needle's easy to use intuitive safety guard reduces the risk of accidental needlestick injuries by shielding the needle tip. A visual, tactile feel, and/or audible confirmation of the locking component over the needle confirms lockout of the safety guard over the needle. The sharps injury prevention guard cannot be deactivated and remains protective through disposal into a sharps container. The safety guard can be activated over stylettes, obturators, and guidewires. SecureLoc™ Safety Introducer Needles will be marketed to the clinical end-user as sterile, non-pyrogenic, single use devices. Additionally, the device will be marketed as the safety procedure needle in procedure trays. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The SecureLoc™ Safety Introducer will be incorporated into the procedure kit, which is then packaged and sterilized.
Here's the breakdown of the acceptance criteria and study information for the SecureLoc™ Safety Introducer Needles, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs in a substantially equivalent manner to predicate devices. | "Test results indicate that the AdvancIntroducer™ and SecureLoc™ Safety Introducer Needles perform in a substantially equivalent manner." (Section: SUMMARY OF PERFORMANCE TESTING) |
| Needlestick Injury Prevention: |
- Safety guard automatically senses the end of the needle and locks over the tip.
- Reduces the risk of accidental needlestick injuries.
- Lock-out can be confirmed visually, tactilely, and/or audibly.
- Safety guard cannot be deactivated and remains protective through disposal.
- Safety guard can be activated over stylettes, obturators, and guidewires. | - "The safety guard automatically senses the end of the needle and locks a safety guard covering the needle tip."
- "Reduces the risk of accidental needlestick injuries by shielding the needle tip."
- "A visual, tactile feel, and/or audible confirmation of the locking component over the needle confirms lockout."
- "The sharps injury prevention guard cannot be deactivated and remains protective through disposal into a sharps container."
- "The safety guard can be activated over stylettes, obturators, and guidewires."
- Simulated Use Study: "No sharps injuries or failures of the integral needlestick prevention guard/safety guard occurred." |
| Sterility & Pyrogenicity: Device to be marketed as sterile, non-pyrogenic. | "SecureLoc™ Safety Introducer Needles will be marketed... as sterile, non-pyrogenic, single use devices." (Implied acceptance by the FDA for this claim and as part of the overall substantial equivalence determination). |
| Material Compatibility: Similar in function, materials and use to predicate devices. | "The AdvancIntroducer™ and SecureLoc™ Safety Introducer Needles are similar in function, materials and use as the predicate Merit Medical Introducer needle devices." (Section: TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 500 SecureLoc™ Safety Introducer Needles were used in the simulated use study.
- Data Provenance: The data is prospective, generated from a "simulated use study" specifically conducted for this submission. The country of origin is not explicitly stated, but it is implied to be generated within the US by Specialized Health Products®, Inc. as part of their 510(k) submission to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document states "clinicians" performed the insertions in the simulated use study.
- Number of Experts: Not explicitly stated as a specific number of individual experts or clinicians. It simply refers to "clinicians" in the plural.
- Qualifications of Experts: The specific qualifications (e.g., years of experience, specialty) of these clinicians are not provided.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the simulated use study. The assessment of "no sharps injuries or failures" appears to have been a direct observation during the study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. This device is a physical medical device (introducer needle) and not an AI/software-as-a-medical-device (SaMD) that would involve human "readers" or AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No standalone algorithm performance study was done. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the simulated use study was the direct observation of events and outcomes during the simulated procedure. Specifically, the ground truth checked for:
- Successful insertion into simulated tissue.
- Activation of the safety mechanism.
- Absence of sharps injuries.
- Absence of failures of the safety guard.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI development. The device design and materials were likely based on general engineering principles and comparison to existing predicate devices.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As noted above, there is no training set for an AI algorithm. The "ground truth" equivalent for the development of this device would be its adherence to design specifications, material properties, and functional requirements, which were likely evaluated through engineering tests (referred to as "Comparative testing" and "material testing").
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).