(119 days)
The NexSite HD Hemodialysis Step Tip 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. Catheters greater than 40cm are indicated for femoral vein insertion.
The proposed device, the NexSite HD Hemodialysis Step Tip Catheter for long term use is a long term catheter intended for use in attaining long term vascular access for hemodialysis and apheresis. The proposed device is available in the following models below and has a Dacron cuff distal to the bifurcation hub.
Models:
NexSite HD Hemodialysis Step Tip Catheter for long term use (24cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (28cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (32cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (36cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (40cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (55cm)
A Dermal Ingrowth Support Collar (DISC), manufactured from polyurethane and Dacron®. and supplied with the Catheter, is implanted subcutaneously, and is intended to assist with the direction of the catheter. The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, and Luer Caps) that are used to facilitate catheter placement.
The NexSite HD Hemodialysis Step Tip Catheter for long term use is provided as a sterile, singleuse device, and is sterilized using a validated ethylene oxide process. It is a blood contact device with greater than 30 days of exposure.
The provided text describes a 510(k) premarket notification for a medical device, the NexSite™ HD Hemodialysis Step Tip Catheter. It outlines the device, its intended use, comparison to predicate devices, and performance data. However, it does not include detailed acceptance criteria or a study that specifically proves the device meets those acceptance criteria in the format typically used for AI-driven software or diagnostic tests.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a combination of in vitro and in vivo testing. The acceptance criteria mentioned are general, pertaining to the requirements in applicable standards and specifications for the catheter's physical and functional properties, rather than performance metrics related to an algorithm's output.
Here's an attempt to answer your questions based on the provided text, recognizing that it's for a physical device, not an AI or diagnostic tool:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria and reported numerical device performance metrics in the way one might expect for a diagnostic or AI device (e.g., sensitivity, specificity, AUC with associated thresholds). Instead, it states that the device "meets the requirements in the applicable standards and specifications."
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Physical & Functional Properties | |
| Visual and Dimensional conformity | Meets requirements |
| Priming Volume | Meets requirements |
| Catheter Leakage | Meets requirements |
| Catheter Joint Strength | Meets requirements |
| Catheter Pressure | Meets requirements |
| Catheter Flow Rate | Meets requirements |
| Catheter Recirculation | Meets requirements |
| Catheter Clamp Fatigue | Meets requirements |
| Mechanical Hemolysis | Meets requirements |
| Chemical Tolerance to Disinfectants | Meets requirements |
| Radiopacity | Meets requirements |
| Corrosion Resistance | Meets requirements |
| Biocompatibility/Safety (In Vivo) | Performs as intended |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific tests. The document mentions "finished proposed NexSite™ HD Step Tip catheters" were used for comparative performance testing, and "in vivo implantation studies were also performed." The exact number of catheters or animal subjects is not provided.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal testing ("In vitro testing was performed on the NexSite HD Hemodialysis Step Tip Catheter"). The in vivo studies were also performed to demonstrate the device would perform as intended, but details on their nature (e.g., animal or human, retrospective or prospective) are lacking, though the context suggests animal models for a physical device before human use. Given it's a 510(k) for a physical device, no "data provenance" in the clinical data sense is typically required beyond the testing performed to demonstrate substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to the provided document. The "ground truth" for this medical device (a catheter) is based on engineering specifications, material properties, and biological compatibility standards, not on expert interpretations of data like in an AI diagnostic. The safety and effectiveness are evaluated against these standards and through performance testing, not through expert consensus on diagnostic labels.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication method described as would be for a diagnostic or AI system. The tests are objective measurements against defined standards.
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-assisted device for diagnostic interpretation. It is a physical medical device (catheter).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Compliance with ISO 10555-1:2013 (Sterile, single-use intravascular catheters — Part 1: General requirements).
- Adherence to internal specifications derived from the design and intended use of the catheter, and comparison to legally marketed predicate devices.
- Results from in vitro and in vivo studies demonstrating functional performance and biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not a machine learning or AI device.
§ 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.