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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

• 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").

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• The LiftLoc™ Safety Infusion Set device is a safety intravascular administration set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports.
• The integral LiftLoc™ Safety Infusion Set safety mechanism is manually activated during the removal of the LiftLoc™ Safety Infusion Set needle from a surgically implanted vascular port. The safety mechanism reduces the risk of accidental needlestick injuries by shielding the needle.
• The LiftLoc™ Safety Infusion Set is intended for use in the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.
• The LiftLoc™ Safety Infusion Set will be marketed as a sterile, non-pyrogenic, single use device.
• The LiftLoc™ Safety Infusion Set may be used in any appropriate patient population.

The LiftLoc™ Safety Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needlestick prevention feature. The LiftLoc™ Safety Infusion Set is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling. The LiftLoc™ Safety Infusion Set is supplied sterile and non-pyrogenic, for single use only.

Following conventional placement of the LiftLoc™ Safety Infusion Set's Huber needle into the implanted port and completion of either the prescribed infusion of fluids or blood sample withdrawal, the LiftLoc™ Safety Infusion Set may then be removed from the patient.

Conventional clinical practice is used to remove the LiftLoc™ Safety Infusion Set from the implanted port. Fingers of the non-dominant hand are placed on top of the LiftLoc™ safety disc to stabilize the port. A one-handed (dominant hand) technique is then used to grasp the integral wings and pull upward to remove the Huber needle from the port. When the clinician's hands are positioned correctly over the LiftLoc™ safety disc and the needle is removed, the integral safety mechanism is activated and locks a safety shield covering the needle. An audible click or visual confirmation confirms the lockout of the safety shield over the needle. The LiftLoc™ Safety Infusion Set, now with a protected needle, is discarded in a sharps container.

The product has two configurations: one with an adaptable Y-injection site and one without. A Patient Comfort Pad will also be available as an accessory.

Here's a breakdown of the acceptance criteria and study information for the LiftLoc™ Safety Infusion Set, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Note: The 510(k) summary provided does not explicitly list numerical "acceptance criteria" for performance. Instead, it states that the device was deemed "substantially equivalent" to predicate devices based on comparative testing and a simulated use study. The performance described is the successful meeting of the intended function and safety features.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 500 LiftLoc™ Safety Infusion Sets.
   • Data Provenance: The study was a "simulated use study," implying it was conducted in a controlled environment, likely in the US, rather than a clinical setting with patient data from a specific country. It is a prospective test specifically for this device.

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

   • The document states, "A total of 500 LiftLoc™ Safety Infusion Sets were successfully inserted by clinicians..."
   • Number of Experts: The number of clinicians is not specified, only that "clinicians" performed the insertions.
   • Qualifications of Experts: Their specific qualifications (e.g., number of years of experience, specialty) are not detailed beyond being identified as "clinicians."

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The document does not describe a formal adjudication method for the simulated use study. The success of insertion, activation, and absence of sharps injuries were likely directly observed and recorded.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical medical device (infusion set), not an AI-assisted diagnostic tool, so such a study would not be applicable.

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

   • No, a standalone algorithm-only performance study was not done. This device is a physical medical instrument, not a software algorithm. Its performance is intrinsically linked to human interaction (clinician use).

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

   • The "ground truth" for the simulated use study was direct observation of the device's function and safety features during simulated use by clinicians. It aligns most closely with expert observation/direct functional assessment against predetermined success criteria (e.g., successful insertion, proper safety mechanism activation, absence of injury).

7. The sample size for the training set:

   • There is no mention of a "training set." This typically refers to data used to train AI/machine learning algorithms. As this is a mechanical device, a training set in that context is not relevant. The device itself was likely developed and refined through engineering and iterative testing, but not "trained" on a dataset.

8. How the ground truth for the training set was established:

   • Not applicable, as there was no "training set" in the context of an AI/machine learning algorithm.

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The ExtreSafe™ Phlebotomy device is intended to be used in phlebotomy procedures using vacuum blood collection tubes. A powered needle retraction feature provided a shield for the necure f 11 following use.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding the Extresafe™ Phlebotomy device. This document does not describe any acceptance criteria or a study proving the device meets acceptance criteria. It primarily states that the device is substantially equivalent to legally marketed predicate devices and can proceed to market.

Therefore, I cannot provide the requested information from the given document as it is not present.

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For storage and disposal of used sharps devices

The device is a molded plastic container with various features designed to allow the admission of used sharps while preventing the user from coming in contact with the contents of the container. It has provisions for both temporary and permanent closure of the container. When closed permanently, the container is disposed of in accordance with medical waste procedures. The Safety Cradle sharps container utilizes a unique two part design that provides the following features: 1. Unique automatic closure means for the disposal of sharps utilizing a biased flap referred to as the Safety Cradle, a living hinge and a depressable cover that is linked to the biased flap and living hinge. 2. A secondary temporary closure with temporary lock and a handle for safe transport. In between uses, the biased flap and cover provide two barriers of protection against exposure to sharps within the container. 3. Permanent closure when container is full. 4. Highly absorbent pad with gelling compound for fluid control. 5. Left handed and right handed phlebotomy needle extractors. 6. Multiple uses in applications that include a wall mounted container, table mount use and as a free standing container. 7. Safety Cradle feature provides a unique means for a horizontal drop of a sharp.

The document provided is a 510(k) Premarket Notification for a "Safety Cradle® sharps container." This type of document is for a medical device that needs to demonstrate substantial equivalence to a legally marketed predicate device. The information requested in your prompt regarding acceptance criteria, study details, ground truth, and expert involvement is typically found in performance studies for diagnostic or AI-driven medical devices.

The provided text does not contain the detailed performance study information you are asking for because this is a submission for a sharps container, not a diagnostic device that outputs numerical performance metrics against a defined ground truth.

Here's a breakdown based on the information provided and what is missing:

1. Table of acceptance criteria and the reported device performance:

The document focuses on comparing features for substantial equivalence, not quantitative performance against acceptance criteria in the way you might see for an AI algorithm or a diagnostic test. The "performance" here relates to functional characteristics and safety standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. For a sharps container, testing would likely involve simulated usage scenarios, material testing, and physical characteristic evaluations, rather than a "test set" of data in the way a diagnostic algorithm would have. The document references ASTM standards for puncture resistance, implying that such tests were conducted to those standards, but details of sample size and provenance are absent.

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

This information is not provided and is not applicable in the context of this device. The "ground truth" for a sharps container would be its physical conformance to specifications and safety standards, not a clinical judgment by experts on a dataset.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided and is not applicable.

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:

This information is not provided and is not applicable. This is for a physical medical device, not an AI or imaging-based diagnostic tool.

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

This information is not provided and is not applicable. This is for a physical medical device.

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

The "ground truth" for this device would be its adherence to established safety standards (like ASTM for puncture resistance) and functional specifications (e.g., leak-proof in upright position, stable in free-standing position). There's no clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set:

This information is not provided and is not applicable as there is no "training set" for a physical device like this.

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

This information is not provided and is not applicable.

Summary:

The provided text is a 510(k) Premarket Notification for a physical medical device (sharps container). It focuses on demonstrating "substantial equivalence" to a predicate device by comparing features and adherence to a general safety standard (ASTM for puncture resistance) and functional design elements. It does not include the detailed performance study data, expert involvement, or algorithm-specific metrics that would be found in submissions for diagnostic or AI-powered devices. Such information is not typically required or relevant for this type of device submission.

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