(255 days)
The NexSite HD, Hemodialysis Catheter for long term use is indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein.
The NexSite HD, Hemodialysis Catheter for long term use is a long term catheter intended for use in attaining long term vascular access for hemodialysis and apheresis. The polyurethane NexSite HD, Hemodialysis Catheter for long term use is available in two lengths, 24cm and 28cm, and has a Dacron cuff distal to the bifurcation hub. A Polyurethane/Dacron Dermal Ingrowth Support Collar (DISC) supplied with the Catheter is implanted subcutaneously, and is intended to minimize Catheter movement. The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, Coring Scalpel and Luer Caps) that are used to facilitate catheter placement. The NexSite HD, Hemodialysis Catheter for long term use is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process. The NexSite HD, Hemodialysis Catheter for long term use is a blood contact device with greater than 30 days of exposure.
The provided text describes a medical device, the NexSite™ HD Hemodialysis Catheter, and its 510(k) submission for regulatory clearance. It details the device's intended use, comparison to predicate devices, and the testing performed. However, it does not contain the kind of information typically associated with acceptance criteria and study results for an AI/device performance study as described in your request.
The document pertains to a physical medical device (catheter) and focuses on demonstrating substantial equivalence to already marketed devices through in vitro and in vivo (animal, not human clinical) testing, rather than a study evaluating the performance of an AI algorithm or digital medical device.
Therefore, many of the requested fields cannot be filled. I will fill in what information is available based on the provided text, and explicitly state when information is not present.
Acceptance Criteria and Study for NexSite™ HD Hemodialysis Catheter
The document describes the testing performed for the NexSite™ HD Hemodialysis Catheter to demonstrate its safety and effectiveness for substantial equivalence, rather than setting distinct acceptance criteria for an AI algorithm's performance. The "acceptance criteria" here are implied by meeting the requirements of applicable standards and demonstrating substantial equivalence to predicate devices through various tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| In Vitro Test Requirements (in accordance with ISO 10555-1:2004) | Tests performed: Visual and dimensional, catheter joint strength, catheter pressure, catheter flow rate testing, catheter recirculation testing, radiopacity, and corrosion resistance. |
| Results: "The test results demonstrate that the NexSite™ HD, Hemodialysis Catheter for long-term use meets the requirements in the applicable standards and is substantially equivalent to legally marketed predicate devices." | |
| In Vivo Performance (as intended) | Tests performed: In vivo implantation studies. |
| Results: "In vivo implantation studies were also performed to demonstrate that the device would perform as intended." | |
| Substantial Equivalence to Predicate Devices (K994105 and K110627) | Comparison: "Comparison testing was performed on pre-defined characteristics using finished NexSite™ HD devices and commercial predicate devices (K994105 and K110627)." |
| Results: "The test results support the substantial equivalence of the NexSite™ HD device to the predicate devices." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as numerical sample sizes for each test in the provided text. The document refers to "finished NexSite™ HD devices" and "commercial predicate devices" being tested.
- Data Provenance: The "in vivo implantation studies" suggest animal studies, not human data. The in vitro testing was performed on the device itself. Specific country of origin for the data is not mentioned beyond the manufacturing location (Ireland) and the regulatory submission to the FDA (USA). The studies were conducted specifically for the purpose of this 510(k) submission (prospective, in the context of device development and regulatory clearance).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. This device does not involve expert-established ground truth in the context of diagnostic AI. The "ground truth" for its performance is determined by physical and biological testing against established standards and predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. This concept is not relevant to the type of device testing described.
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:
- Not applicable. This is not an AI or imaging device that would involve human readers.
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. The testing described is "standalone" in the sense that it evaluates the physical performance of the device without human interaction in the performance metrics, but it is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on engineering standards (ISO 10555-1:2004) for in vitro tests, and biological/physiological performance in animal models for in vivo tests, demonstrating the device performs "as intended" and is substantially equivalent to predicate devices.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI model.
§ 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.