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The BIOTEQ® Arterial-Venous Fistula (A.V.F) Needle Set with Safety Flex is used for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The Safety Feature(Safety Flex) aids in prevention of needle-sticks injuries when removing and discarding needles after dialysis session.

The BIOTEQ® A. V. FISTULA NEDDLE SET WITH SAFETY FLEX consists of the following major components: ① Protection Cap ② Needle Cannula ③ Butterfly Wing ④ Needle Hub ⑤ Safety Flex ⑥ Small Pinch Clamp ⑦ PVC Tubing ⑧ Female Luer ⑨ Cap for Female Luer These components assembled together as BIOTEQ® Arterial-Venous Fistula (A.V.F) Needle Set with Safety Flex for use during hemodialysis procedures. The Safety Feature(Safety Flex) aids in prevention of needle-sticks injuries when removing and discarding needles after dialysis session. Various models of needle size manufactured such as 14 gauge, 15 gauge, 16 gauge, 17 gauge.

The provided document is a 510(k) summary for a medical device called the BIOTEQ® A. V. FISTULA NEEDLE SET WITH SAFETY FLEX. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria related to device performance in a clinical setting.

Therefore, the document does not contain detailed information about acceptance criteria or a study proving the device meets them in the way clinical performance studies typically do. Instead, it focuses on demonstrating that the device meets safety and effectiveness requirements by conforming to applicable standards and showing equivalence to a legally marketed predicate device.

Here's a breakdown of the information that is and is not available based on your request:

1. A table of acceptance criteria and the reported device performance

• Not Applicable in the traditional sense. This 510(k) summary does not present specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy for an AI device) or reported performance metrics against such criteria.
• What is reported: The document states, "In terms of Physical specification, Chemical specification, Biological specification & Sterilization Specification, the device conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards". This is the closest equivalent to "acceptance criteria" here, indicating that the device meets established industry standards for these categories.

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

• Not Provided. This information is not typically included in a 510(k) summary focused on substantial equivalence through bench testing. The "test set" here refers to "bench testing" rather than a clinical dataset.
• The document mentions "bench testing contained in this submission," but does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. For a device like an A.V. Fistula Needle Set, "ground truth" is not established by human experts in the same way it would be for an AI diagnostic device evaluating images. Device performance is assessed against engineering and biological standards.

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

• Not Applicable. Adjudication methods are relevant for studies where human interpretation or consensus is needed to establish ground truth, which is not the case for the type of testing described (physical, chemical, biological, sterilization specifications).

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 type of study is relevant for AI-powered diagnostic devices, not for a physical medical device like a needle set.

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

• Not Applicable. This device is a physical medical instrument, not an algorithm, so "standalone performance" in the context of AI is not relevant. The device itself is "standalone" in its function.

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

• Ground truth for this device type is based on established engineering, biological, and sterilization standards. For example, "Physical specification" would refer to tensile strength, needle sharpness, flow rates; "Chemical specification" to material composition and biocompatibility; "Biological specification" to absence of certain toxins, and "Sterilization Specification" to sterility assurance levels.

8. The sample size for the training set

• Not Applicable. There is no "training set" for this type of device. The document describes a manufactured product, not an AI/ML algorithm that requires training.

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

• Not Applicable. As there is no training set for this device type, the establishment of ground truth for it is irrelevant.

Summary of the Study (as described in the 510(k)):

The study described is bench testing to demonstrate substantial equivalence to a predicate device (JMS A.V. FISTULA NEEDLE WingEater, K 010406).

• Purpose: To show that any differences in technological characteristics between the BIOTEQ® A. V. FISTULA NEDDLE SET WITH SAFETY FLEX and the predicate device "do not raise any new questions of safety or effectiveness."
• Methods: The device was tested "in terms of Physical specification, Chemical specification, Biological specification & Sterilization Specification." It "conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards."
• Conclusion: Based on this bench testing and comparison of intended use and technological characteristics, the device was deemed "substantially equivalent to the predicate devices."

In essence, this 510(k) summary provides evidence of compliance with established standards and equivalence to a predicate, rather than reporting on a clinical trial with specific performance metrics against defined acceptance criteria.

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Bioteque A.V. Fistula Needle is used during hemodialysis. It's a part of accessory of extracorporeal system for treatment of renal failure. A.V. Fistula Needle applied on the access site of patient's vessel to obtain blood flow adequate to pass through the dialyses, and the reinfusion of dialysed blood back to patient via the fistula needle during hemodialysis.

Bioteque A.V. Fistula Needle Set consist of the following 6 major components: the stainless needle, protector cap for needle, the plastic butterfly wing, the PVC tubing, the female luer, the cap for female luer. These 6 major components assembled together as A.V. Fistula Needle Set for use during hemodialysis procedures. Various models of needle size manufactured such as 14 gauge, 15 gauge, 16 gauge.

The provided document is a 510(k) summary for the BIOTEQUE A.V. FISTULA NEEDLE SET. This submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and testing results as would be typical for more complex devices or novel technologies.

Here's an analysis based on the provided text, addressing the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria or specific performance metrics in a table format with numerical results. Instead, it states that the device "conforms to applicable standards." The acceptance criteria are implicitly tied to compliance with these standards and demonstrating similar technological characteristics to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "bench testing contained in this submission" but does not specify the sample size for any test sets used. The nature of the device (a medical needle for hemodialysis) suggests bench testing primarily, not clinical trials with patient data. Therefore, questions of retrospective/prospective data or country of origin for a clinical test set are not applicable here. The testing would have been conducted in a laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided for this type of device and submission. The "ground truth" for mechanical and biological safety of an A.V. fistula needle is established by adherence to recognized international and national standards (e.g., ISO, USP) and engineering principles, not through expert consensus on diagnostic images or clinical outcomes in the same way as, for example, an AI diagnostic tool.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving subjective human interpretation (e.g., image reading) to establish a consensus ground truth. The tests mentioned (physical, chemical, biological, sterilization, performance) are objective laboratory/bench tests, not requiring human adjudication in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human readers interpret medical images or data. The BIOTEQUE A.V. FISTULA NEEDLE SET is a physical medical device (a needle), and its effectiveness is determined by its functional performance and safety according to engineering and biological standards, not by human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This question is not applicable as the device is a physical medical needle, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance and safety is established through adherence to recognized industry standards and laboratory testing protocols. These standards (e.g., ISO 10993 series for biocompatibility, ISO 11607-1 for packaging, ISO 11135 for sterilization, USP Pyrogenic standards) define the acceptable limits and methods for evaluating the physical, chemical, biological, and performance characteristics of such devices. Therefore, the ground truth is based on objective measurements against established standards, not expert consensus, pathology, or outcomes data in the sense typically understood for diagnostic or interventional devices.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of device.

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