(168 days)
The VWING Vascular Needle Guide is indicated for use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or "buttonhole" method of needle insertion.
The VWING vascular needle guide has been designed to facilitate repeated needle access to the vasculature. The VWING vascular needle guide is an accessory for constant site or "buttonhole" method of needle insertion and is indicated for use for patient therapies requiring repeated access to the vascular system. such as hemodialysis. It is a single piece of titanium device that is implanted subcutaneously and attached to the outside of the vasculature, including on arteriovenous fistulae (AVF). The VWING acts as a guide for needles and accommodates currently available 15-17 gage needles to accurately cannulate the targeted vessel.
"The provided text describes the VWING™ Vascular Needle Guide, a medical device designed to facilitate repeated needle access to the vasculature, particularly for hemodialysis patients using the ""buttonhole"" method.
Here's an analysis of the acceptance criteria and the study information as requested:
Acceptance Criteria and Device Performance
The document does not explicitly state a table of quantifiable acceptance criteria with numerical targets. Instead, it describes a series of tests and their successful completion as evidence of the device meeting safety and effectiveness requirements. The primary ""performance"", as implicitly defined for this device, seems to be its ability to safely and effectively facilitate vascular access for hemodialysis via the buttonhole method, particularly in hard-to-cannulate fistulas, while maintaining acceptable safety outcomes.
Based on the text, the following can be inferred as the "reported device performance" and implied acceptance criteria:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (no adverse biological reactions) | Biocompatibility testing according to ISO 10993-1 was performed (Implies successful completion). |
| Sterility & Shelf Life Maintenance | Sterilization validations performed (ISO 11137-2). Packaging validations and ship testing performed (ISO 11607-1, ISO 11607-2, ASTM F1980-07, ASTM F2096-11, ASTM F88-09, and ASTM D4169-09) to ensure sterility is maintained throughout the product's labeled shelf life (Implies successful completion). |
| MR Compatibility | MR compatibility testing performed according to FDA Guidance and ASTM standards (ASTM F2052-06, ASTM F2213-06, ASTM F2119-07, and ASTM F2182-11) (Implies successful completion). |
| Safety in Animal Model (ability to safely facilitate access) | Pre-clinical safety and efficacy testing conducted using an animal model (5 weeks to 6 months duration) and evaluated for its ability to safely facilitate access to a vessel for hemodialysis procedures (Implies safety was demonstrated). |
| Feasibility & Safety in Humans (Pilot) | A first-in-human clinical evaluation conducted in New Zealand demonstrated the feasibility and safety of the VWING as a method of providing dialysis access to patients with difficult-to-access fistulas using the buttonhole technique (Implies successful demonstration of feasibility and safety). |
| Effectiveness in Facilitating Access | 96% of examined patients achieved access through a VWING at the three-month primary endpoint follow-up in the SAVE Trial (prospective, multicenter IDE clinical study). |
| Long-Term Safety Profile (Clinical Study) | No new concerns of safety and effectiveness observed during the SAVE trial. Occurrence rate of safety-related events was within expectation. Rates of sepsis and study-related serious adverse events were very low (0.04 and 0.31, respectively). All serious adverse events were resolved, leaving the fistula intact and functional. No study-related deaths. (Implies acceptable safety profile). |
| Substantial Equivalence to Predicate Devices | The device was determined to be substantially equivalent to predicate devices based on indications for use and technological characteristics, with no new issues of safety or efficacy raised. |
Study Details:
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Sample Size used for the test set and the data provenance:
- Clinical Efficacy/Safety Test Set (SAVE Trial): The text mentions ""examined patients"" for the 96% success rate but does not explicitly state the total number of patients enrolled or evaluated at the 3-month primary endpoint. It is described as a ""prospective, multicenter IDE clinical study.""
- Data Provenance: The crucial SAVE Trial was a ""multicenter IDE clinical study."" A ""first-in-human clinical evaluation"" was conducted in New Zealand. The animal studies are also a form of prospective test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish ground truth. Clinical trials typically involve medical professionals (e.g., nephrologists, vascular surgeons, nurses) to assess outcomes, but their specific roles in establishing a ""ground truth"" for a device like this (which is more about physical access success and adverse events) are not detailed here. The outcome measures (successful access, adverse events) are generally directly observable and documented by the clinical site investigators.
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Adjudication method for the test set:
- The document does not specify an adjudication method like 2+1 or 3+1. For clinical trials, adverse events are typically reported by site investigators and may be reviewed by an independent Data Monitoring Committee (DMC) or a Clinical Events Committee (CEC), but the specific mechanism is not detailed.
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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. This is a physical medical device (a vascular needle guide), not an AI/software device that involves "readers" interpreting images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. Its performance is always ""standalone"" in the sense that it is a physical component guiding a needle, and its function does not involve human interpretation of algorithm output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ""ground truth"" for the clinical studies (SAVE Trial and New Zealand feasibility study) consisted primarily of outcomes data. This includes:
- Successful vascular access: Determined by direct observation during hemodialysis sessions.
- Safety outcomes: Documented adverse events (e.g., sepsis, serious adverse events), their resolution, and impact on fistula integrity, which are direct clinical observations and records.
- For biocompatibility, sterilization, MR compatibility, the ""ground truth"" is established by meeting the specific objective criteria and thresholds defined in the referenced ISO and ASTM standards.
- The ""ground truth"" for the clinical studies (SAVE Trial and New Zealand feasibility study) consisted primarily of outcomes data. This includes:
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The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/machine learning model, so there is no ""training set"" in the computational sense. The device design and verification were based on engineering principles and preclinical testing.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for a physical device. Design and engineering principles, alongside bench testing, animal models, and initial human feasibility studies, inform its development and refinement."
§ 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.