(217 days)
The A.V. Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device is intended for single use only.
A.V. Fistula Needle Set is a single-use fistula needle which is inserted for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device consists of a needle that is attached to wings, a flexible tube and a luer lock connector.
The provided text is a 510(k) summary for a medical device called the "A.V. Fistula Needle Set for Single Use." This type of document focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials with acceptance criteria for a novel AI or diagnostic device.
Therefore, the information required to populate the fields regarding acceptance criteria, study design details, ground truth establishment, sample sizes, and expert qualifications for a diagnostic device is not present in this document.
The document describes performance data for the A.V. Fistula Needle Set, but these are related to biocompatibility and sterilization tests for a physical medical device, not performance metrics for an AI/diagnostic algorithm.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ASTM F750-87: Standard practice for evaluating material extracts by systemic injection in the mouse | Completed |
| ISO 10993-1: Biological evaluation of medical devices, Part 11. Tests for System Toxicity | Completed |
| ISO 10993-4: Biological evaluation of medical devices, Part 1. Evaluation and testing with a risk management process | Completed |
| ISO 10993-5: Biological evaluation of medical devices, Part 5. Tests for in vitro cytotoxicity | Completed |
| ISO 10993-7: Biological evaluation of medical devices, Part 7. Ethylene oxide sterilization residuals | Completed |
| ISO 10993-10: Biological evaluation of medical devices, Part 10. Tests for Irritation & sensitization | Completed |
| ISO 10993-11: Biological evaluation of medical devices, Part 11. Tests for System Toxicity | Completed |
| Sterilization: | |
| ISO 11135-1: Sterilization of health care Ethylene oxide, Part 1. validation and routine control of a sterilization process | Completed |
| Mechanical Performance: | |
| Tensile Force Test | Completed and compared to the predicate device. |
Note: The document states these tests were "completed" but does not provide specific quantitative results or defined acceptance thresholds for these tests beyond general compliance with the standards.
Missing Information (Not Applicable to this type of device and submission):
- Sample sizes used for the test set and the data provenance: Not applicable. This document refers to physical device testing, not a test set for an AI algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. There is no AI training set.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" for this device consists of a series of standard performance tests and biocompatibility evaluations required for medical devices. The document implies that the device successfully passed these tests, thereby demonstrating its safety and effectiveness for its intended use and substantial equivalence to the predicate device. The tests, as listed above, cover:
- Biocompatibility: Evaluating the material extracts, system toxicity, cytotoxicity, irritation, sensitization, and residuals from ethylene oxide sterilization. These tests ensure the device materials are safe for contact with the human body during temporary cannulation.
- Sterilization: Validation and routine control of the ethylene oxide sterilization process to ensure the device is sterile for single use.
- Mechanical Performance: A "Tensile Force Test" was conducted, and its results were compared to the predicate device to ensure similar mechanical properties.
The document states that a "claim of substantial equivalence is made to JMS North America Corp. A.V. Fistula Needle Set for Single Use (K990470)" and that "Bench testing was conducted to verify that the APLAN A.V. Fistula Needle Set for Single Use performs as well as the predicate device, thus concluding they are substantially equivalent." This indicates that the predicate device serves as the benchmark for acceptable performance, and the tests performed aimed to demonstrate that the new device performs equivalently.
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.