(242 days)
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.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).