(178 days)
The Fresenius PUNCTUR-GUARD® Fistula Needle Set is indicated for use as a nonimplantable (less than 30 days use) vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit. The set includes a needlestick prevention device using PUNCTUR-GUARD® technology. The features of this device may aid in the prevention of needlestick injury. This device is intended for single use only.
The Fresenius PUNCTUR-GUARD® Fistula Needle Set is a non-implantable vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit. It includes a needlestick prevention device using PUNCTUR-GUARD® technology.
Fresenius PUNCTUR-GUARD® Fistula Needle Set: Acceptance Criteria & Study Summary
This document addresses the acceptance criteria and study proving the Fresenius PUNCTUR-GUARD® Fistula Needle Set meets those criteria, as detailed in the provided 510(k) Premarket Notification.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied as passing specific tests for safety and performance, demonstrating equivalence to predicate devices. The reported device performance indicates that all tested samples for each criterion "passed". The key performance criteria and results are:
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| ISO 10993-1 Biocompatibility | Passed |
| Sheath Removal Force | All samples passed |
| Penetration Testing | All samples passed |
| Tubing Tensile Strength | All samples passed |
| Tubing/Luer Bond Strength | All samples passed |
| Tubing/Third Wing Bond Strength | All samples passed |
| Wing Body/Third Wing Disassembly Force | All samples passed |
| Front Cannula/Wing Body Bond Strength | All samples passed |
| Blunting Member/Third Wing Bond Strength | All samples passed |
| Safety Feature Activation Torque Testing | All samples passed |
| Lock Force - Spring Arm | All samples passed |
| Positive Pressure Leak Testing | All samples passed |
| Negative Pressure Leak Testing | All samples passed |
| Tip to Tip Distance Testing | All samples passed |
| Rate Flow vs. Pressure Drop (for each gauge size) | Maximum recommended flow rate for each gauge size: |
| 17G ≤200 ml/min | |
| 16G ≤300 ml/min | |
| 15G ≤400 ml/min | |
| 14G ≤600 ml/min |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for each test set. It repeatedly mentions "All samples passed," indicating that multiple units were tested for each criterion. The data provenance is internal to Fresenius Medical Care North America and is retrospective, as the tests were conducted as part of design verification prior to the 510(k) submission. No specific country of origin for the data is mentioned beyond the company's location in Lexington, MA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the submitted document. The "ground truth" for the performance tests relies on established engineering and medical device standards (e.g., ISO 10993-1 for biocompatibility) and internal design specifications, not expert consensus on interpretations of medical data. The evaluation of test results would be conducted by qualified internal engineers and quality personnel, whose specific qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, quantitative measurements against predefined specifications. There is no subjective interpretation requiring an adjudication method like 2+1 or 3+1. A "pass" or "fail" is determined based on adherence to the established test limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a medical device (fistula needle set) and not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI assistance evaluation is irrelevant to this submission.
6. 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 or software. Its performance is evaluated through physical and material tests, not standalone algorithm performance.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests are the pre-defined technical specifications and established regulatory standards (e.g., ISO 10993-1, internal limits for bond strength, flow rate, etc.). These are objective benchmarks against which the device's physical and functional properties are measured.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context. The design and manufacturing processes are validated through design verification and process validation, not through training a data model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The specifications for manufacturing and performance are established through engineering design, risk assessment, and adherence to relevant industry standards and regulatory requirements.
§ 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.