(43 days)
The Arrow NextStep Antegrade Chronic Hemodialysis Catheter is intended for use in adult patients. The Arrow NextStep Antegrade catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep Antegrade Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow NextStep Antegrade catheter is intended for use in adult patients.
The Arrow NextStep Antegrade Chronic Hemodialysis Catheter is a one piece, two lumen, 15 Fr., step tipped catheter designed for antegrade placement. The catheter is available in multiple lengths.
This is a 510(k) summary for a medical device modification, not a study evaluating AI performance or diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria for an AI/CADe device, sample sizes for test sets, expert involvement, and MRMC studies is not applicable.
The document describes a device modification for the Arrow® NextStep® Antegrade Chronic Hemodialysis Catheter. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical tests.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Kink Resistance: Met requirements for intended use. | Kink tests were performed. (Specific quantitative criteria and results are not detailed in this summary, but the conclusion states "the catheters met the requirements that are considered adequate for their intended use"). |
| Column Strength: Met requirements for intended use. | Column strength tests were performed. (Specific quantitative criteria and results are not detailed in this summary, but the conclusion states "the catheters met the requirements that are considered adequate for their intended use"). |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria was a non-clinical testing study focused on the physical characteristics of the catheter.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document states "Kink and column strength tests were performed," but does not provide details on the number of catheters tested.
- Data provenance: Not applicable in the context of clinical data. This refers to physical product testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable. The ground truth for physical performance tests (kink, column strength) is based on engineering specifications and direct measurement, not expert opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable. This concept is relevant for reconciling conflicting expert opinions, which did not occur here.
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:
- MRMC study: No, an MRMC comparative effectiveness study was not done. This device is a physical medical catheter, not an AI or CADe system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone performance: No, a standalone performance study was not done. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of ground truth: Engineering specifications and physical measurements for kink resistance and column strength.
8. The sample size for the training set:
- Sample size for training set: Not applicable. As this is not an AI/ML device, there is no training set in the conventional sense. The "training" for the device's design would be iterative engineering and material science development.
9. How the ground truth for the training set was established:
- How ground truth for training set was established: Not applicable. There is no training set. The "ground truth" for the device's design and materials would be based on established engineering principles, material properties, and previous iterations of similar devices.
§ 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.