(136 days)
The NIPRO SafeTouch TULIP™ Safety Fistula Needle is intended for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood. Secondly, it is designed with an active sharp safety feature requiring physical action by the clinician to aid in the prevention of accidental needlesticks. The compatibility of available configurations is the responsibility of the physician in charge.
The NIPRO SafeTouch TULIP™ Safety Fistula Needle is a sterile, single use, safety AVF needle. It consists of an arterial and venous adaptor, flexible tube and needle with an active sharps safety feature (non-implanted blood access device) as described in 21 CFR 876.5540.
The NIPRO SafeTouch TULIP™ Safety Fistula Needle includes 2 basic types of designs; fixed wing type (stationary) and turnable wing type (rotating). These two designs are offered in 64 configurations with options that include needle gauge, needle length, type of needle (with or without backeye), and tubing length.
The integrated sharps injury prevention feature requires physical action by the clinician to activate and is designed to cover the cannula after treatment. Correct uses of this anti-stick feature will eliminate accidental needlesticks.
These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.
The provided text is a 510(k) summary for the NIPRO SafeTouch TULIP™ Safety Fistula Needle, which is a medical device. This type of document focuses on establishing substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of characteristics, rather than extensive clinical studies with acceptance criteria, human readers, and ground truth as would be typical for an AI/CADe device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device and submission.
However, I can extract the acceptance criteria (inferred from performance testing) and the study that proves the device meets these criteria based on the provided information.
Here's a summary tailored to the provided document:
Acceptance Criteria and Device Performance for NIPRO SafeTouch TULIP™ Safety Fistula Needle
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Performance Testing) | Reported Device Performance |
|---|---|
| Biocompatibility (Sterility, Bacterial Endotoxin, Systemic Injection, Intracutaneous Reactivity, Hemolysis, Implantation) | Results of biocompatibility data support equivalence to the predicate device. |
| Tensile, Flexural, and Elongation Strength of Materials | Performance testing was conducted to verify these properties. (Specific values not provided in summary) |
| Force to Attach and Detach Connections | Performance testing was conducted to verify these properties. (Specific values not provided in summary) |
| Rate of Fluid Flow Simulating Extremes of Pressure | Performance testing was conducted to verify these properties. (Specific values not provided in summary) |
| Force to Activate and Deactivate the Safety Feature | Performance testing was conducted to verify these properties. (Specific values not provided in summary) |
| Strength of Joints, Bonds, Connections, Hinges, Valves, Locking Mechanisms | Performance testing was conducted to verify these properties. (Specific values not provided in summary) |
| Operational Characteristics | Compared favorably to the predicate device (Medisystems Masterguard™ AVF Needle). |
| Labeling | Compared favorably to the predicate device (Medisystems Masterguard™ AVF Needle). |
| Overall Performance Characteristics | Compared favorably to the predicate device (Medisystems Masterguard™ AVF Needle). (Specific details not provided) |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a non-clinical performance testing and substantial equivalence comparison study as described in the 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated for performance tests. As this is a non-clinical device, "test set" typically refers to the samples of the device components/materials subjected to engineering and material strength tests rather than patient data.
- Data Provenance: Not applicable in terms of country of origin of patient data, as the tests are non-clinical material and component tests performed by the manufacturer. The tests evaluate the physical properties and functionality of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not Applicable. For a medical device 510(k) submission, "ground truth" typically refers to the clinical diagnosis or outcome in patient studies. Here, the "ground truth" for the performance tests would be the accepted engineering standards, material specifications, and functional requirements for the device. These are established by engineering and quality control professionals, but specific numbers and qualifications of "experts" are not detailed in this type of summary.
4. Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods like "2+1" or "3+1" are specific to clinical studies involving human interpretation of medical images or data. The performance testing conducted for this device would follow standard engineering and quality control protocols for verifying physical and functional parameters.
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 AI/CADe devices where human readers interpret medical images or data, with or without AI assistance. This device is a physical medical instrument (needle).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This concept applies to AI algorithms. This device is a physical medical instrument.
7. The Type of Ground Truth Used:
- The "ground truth" for the performance tests mentioned (biocompatibility, material strength, connection force, fluid flow rate, safety feature activation force, bond strength) is based on established engineering standards, material specifications, and functional requirements for similar medical devices. The predicate device (Medisystems Masterguard™ AVF Needle and Nipro AVF Needle) also served as a benchmark for comparison.
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" in the context of this device's submission. Training sets are used to develop AI algorithms.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set.
§ 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.