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The MicroTaper™ Needle Introducer Set is used for percutaneous introduction of a guidewire into the peripheral vasculature. The MicroTaper needle incorporates a blunting mechanism to reduce the risk of accidental needle stick injury.

The Summit Access Needle Introducer Set consists of: 1 - 0.018 inch (0.46 mm) / 0.035 inch (0.89 mm) Tapered Guidewire, Angled, Nitinol 1 - 21G (0.9 mm) Tapered Needle, 18G (1.27 mm) Max Outside Diameter, Echogenic The tapered needle consists of a stainless steel cannula with expansion feature and a translucent standard female luer lock hub. Needle is available in lengths of 3. 4. 7. 10. and 15 cm. The needle is used to gain percutaneous access to the vein or artery. The 0.018 inch tapered segment of the guidewire is advanced through the needle allowing confirmation of guidewire placement in the vasculature. The pass-through blunting mechanism is then actuated by twisting hub to needle main body, expanding the needle distal end. An audible confirmation of the actuation and locking confirms the blunting mechanism advances beyond the tip of the needle. The 0.035 inch segment of the guidewire is then advanced through the needle to desired placement. The needle is withdrawn, leaving the guidewire in place.

The provided FDA 510(k) document for the MicroTaper Needle Introducer Set (K151076) does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in a clinical or AI performance context.

This document is a premarket notification for a medical device that demonstrates substantial equivalence to a legally marketed predicate device, rather than a clinical trial report or an evaluation of an AI-powered device. Therefore, most of the requested information (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, training sets) is not applicable to this type of regulatory submission.

However, I can extract information regarding the non-clinical performance tests conducted to support the substantial equivalence claim, which serve as a form of acceptance criteria for the device's functional and safety aspects.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI or clinical performance study, the "acceptance criteria" here refer to the successful completion of various non-clinical performance, packaging/labeling, sterilization, and biocompatibility tests. The "reported device performance" is indicated by the statement of "successful completion" of these tests.

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

• Not applicable. This document describes non-clinical engineering and biological tests, not a clinical study on a patient test set. The tests would likely involve a statistically appropriate number of device units or components, but specific sample sizes for each test are not provided in this summary. Data provenance is not specified as these are internal manufacturer tests based on recognized standards.

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

• Not applicable. Ground truth in the context of expert consensus is not relevant here as it's not a diagnostic AI device or a clinical outcome study. The "ground truth" for these non-clinical tests would be the established scientific and engineering principles, and the pass/fail criteria defined by the relevant standards (e.g., ISO, FDA guidance). The experts involved would be engineers, microbiologists, and other technical specialists conducting the tests.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert labeling or diagnoses, which is not relevant to non-clinical device testing.

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 study was not done. This device is not an AI-powered diagnostic tool, but a medical instrument (needle introducer set).

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

• Not applicable. This is not an AI algorithm. The device performance is standalone (i.e., the physical device itself is tested), but in a non-clinical context.

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

• Non-clinical test standards and specifications. The "ground truth" for these tests are the pre-defined pass/fail criteria established by international standards (e.g., ISO 10993-1 for biocompatibility, ISO 23908 for sharps injury protection) and internal engineering specifications, based on physical and chemical properties and functional requirements of the device.

8. The sample size for the training set:

• Not applicable. This is not an AI device, so there is no training set in this context.

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

• Not applicable. As above, there is no training set.

Summary Statement regarding the study:

The study proving the device meets its "acceptance criteria" is a series of non-clinical performance and biological evaluations. As stated in the "CONCLUSION OF SAFETY AND EFFECTIVENESS" section: "The successful completion of performance tests; compliance to biological standard ISO 10993-1; and comparison of similarities and differences with predicate device; demonstrate that the Summit Access MicroTaper Needle Introducer Set is as safe, as effective, and performs as well as or better than the legally marketed predicate device NMI Coaxial Microintroducer Set."

The document also explicitly states: "No clinical studies were performed to demonstrate substantial equivalence." (Page 7). This confirms that the evidence presented is based entirely on non-clinical testing and comparison to a predicate device, rather than patient data or trials.

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The Safe-T-Peel® Safety Needle Introducer is used to facilitate placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick.

single patient, single use, stainless steel needle introducers with splittable sheaths, intended to facilitate the placement of Peripherally Inserted Catheters (PICs). Additionally the Safe-T-Peel® Safetv Needle/Introducer contains a splittable plastic sheath identical to the one used in the TFX Medical Introducer Assembly (K993191).

The provided text describes a 510(k) summary for the HDC Corporation's Safe-T-Peel® Safety Needle/Introducer. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as would be found in a clinical trial or a specific standalone performance assessment.

Therefore, many of the requested elements (acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone study, ground truth type, training set size, training set ground truth establishment) cannot be directly extracted from the provided text for a performance study as typically understood for AI/algorithm-based devices.

However, based on the principle of substantial equivalence, the "acceptance criteria" here is that the device performs similarly to the predicate devices, particularly regarding safety features. The "study" proving this comes in the form of comparing the device's characteristics and functionality to those of already approved predicate devices.

Here's an attempt to address the prompt based on the available information, highlighting what can and cannot be provided:

Acceptance Criteria and Study for HDC Corporation's Safe-T-Peel® Safety Needle/Introducer

The provided 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with explicit acceptance criteria and quantitative results for device performance against a predefined metric. For a 510(k) submission of this nature, the "acceptance criteria" revolve around demonstrating that the new device has the same intended use, similar technological characteristics, and comparable safety/performance to the predicate devices. The "study" involves a comparative analysis of these attributes.

1. Table of Acceptance Criteria and Reported Device Performance

As a 510(k) submission seeking substantial equivalence for a medical device rather than a software algorithm, explicit "acceptance criteria" in terms of sensitivity, specificity, or similar statistical metrics are not provided in this document. Instead, the acceptance criteria relate to structural and functional similarity to predicate devices, particularly for safety features.

2. Sample size used for the test set and the data provenance

Not applicable/provided. This device is a physical medical device, not an AI/algorithm. The "test set" for substantial equivalence is the comparison against the characteristics and performance of the predicate devices. The data provenance would be the design specifications and testing data of the device itself and of the predicate devices, which are not detailed in this summary.

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

Not applicable/provided. The concept of "ground truth" established by experts for a test set (as typically used for AI/algorithm evaluation) does not apply directly to this 510(k) summary for a physical medical device. The "truth" here is established by regulatory approval of the predicate devices and the demonstration of equivalence through design and performance testing (not detailed in this summary).

4. Adjudication method for the test set

Not applicable/provided. See explanation for point 3.

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 safety needle/introducer, not an AI/algorithm-assisted diagnostic tool.

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

Not applicable. This is a physical safety needle/introducer.

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

Not applicable. For this device submission, the "ground truth" is effectively the established safety and efficacy of the predicate devices, against which the new device is compared to demonstrate substantial equivalence, based on design features, materials, and functional testing.

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no "training set" in the context of an algorithm.

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

Not applicable. See explanation for point 8.

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The Modified TFX Medical Safety Needle with Introducer is intended to be used for guidewire introduction during gastrointestinal procedures such as PEG (Percutaneous Endoscopic Gastrostomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.

This device, with the exception of length, is identical to the TFX Medical Safety Needle with Introducer cleared by the FDA in K000665. The working length of the needle has been increased, due to the intended gastrointestinal use, and will be available in 2F - 6F sizes with lengths ranging between 2.50″ - 4.0″. The Modified TFX Medical Safety Needle with Introducer will allow placement of guidewires ranging from 0.015″ - 0.052″. The variance in sizes and lengths is due to specific procedure, physician preference and patient body type.

This product consists of two components:

• Safety Needle (Needle with Passive Sharps Protection)
• Peelable Splitable Introducer

The provided text is a 510(k) summary for a medical device (Modified TFX Medical Safety Needle with Introducer) and a determination letter from the FDA. It does not contain information about acceptance criteria, study methodologies, or test performance data for this device.

The document states that the device is "substantially equivalent in design and materials" to previously cleared devices and mentions the use of a "guidance document, 'Supplementary Guidance on the Content of Premarket Notification Submissions for Medical Devices with Sharps (510 (k) | Injury Protection Features)', was used in the design and verification of the function of the Safety Needle." However, it does not detail the specific acceptance criteria or the results of any testing done to prove the device meets them.

Therefore, I cannot provide the requested information from the given input. The requested details would typically be found in a more comprehensive study report or a different section of a 510(k) submission that elaborates on design verification and validation testing.

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The Modified TFX Medical Safety Needle with Introducer is intended to be used for guidewire introduction during gastrointestinal procedures such as PEG (Percutaneous Endoscopic Gastrostomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.

This device, with the exception of length, is identical to the TFX Medical Safety Needle with Introducer cleared by the FDA in K000665. The working length of the needle has been increased, due to the intended gastrointestinal use, and will be available in 2F - 6F sizes with lengths ranging between 2.50″ - 4.0″. The Modified TFX Medical Safety Needle with Introducer will allow placement of guidewires ranging from 0.015″ - 0.052″. The variance in sizes and lengths is due to specific procedure, physician preference and patient body type. This product consists of two components: 1. Safety Needle (Needle with Passive Sharps Protection) - The Safety Needle, which has the same blunter technology as the Bio-Plexus, Punctur-Guard® Blood Collection needle, is manufactured under the QSR Design Control requirements. The guidance document, "Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Protection Features", was used in the design and verification of the function of the Safety Needle. 2. Peelable Splitable Introducer - This introducer is identical to the existing introducer sold by TFX Medical, which was cleared under K920908.

This 510(k) summary describes a medical device, the "Modified TFX Medical Safety Needle with Introducer," and claims substantial equivalence to other legally marketed devices. However, it does not include any acceptance criteria or a study proving the device meets specific performance criteria.

The document focuses on:

• Device Description: Highlighting that the new device is almost identical to a previously cleared device (K000665) but with an increased working length for gastrointestinal use and the addition of a safety feature to prevent needle sticks.
• Intended Use: Specifying its application in guidewire introduction during gastrointestinal procedures.
• Technological Characteristics: Emphasizing the added anti-stick safety feature as the primary reason for the submission.
• Substantial Equivalence: Listing several predicate devices to which the new device is claimed to be substantially equivalent.
• FDA Clearance Letter: Confirming that the FDA has reviewed the submission and determined the device to be substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than presenting detailed performance study data against specific acceptance criteria.

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