(273 days)
The Arrow Diatek TM Cannon Catheter TM is indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. The Cannon Catheter™ is inserted percutaneously and is preferentially placed into the internal jugular vein. Alternately, this catheter may be inserted into subclavian vein, although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Cannon Catheter™ is intended for use in adult patients.
The Arrow Diatek Cannon Catheter consists of a double-lumen catheter with a detached connector assembly. This allows the catheter tip to be precisely placed within the vein, similar to single lumen, dual catheters. After the catheter has been positioned, the proximal end of the catheter is tunneled retrograde to the exit site. The connector assembly is then fastened to the proximal end of the catheter using a compression sleeve and compression cap.
The provided document for K022662 is a 510(k) summary for the Arrow Diatek™ Cannon Catheter™. This document describes a medical device and its intended use, rather than an AI/ML powered device. As such, the specific criteria requested for AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or available in this submission.
The "Testing" section of the document states: "The catheter has been physically tested by both internal and outside laboratories for a wide range of criteria as well as in comparison to the predicate device. Examples include dimensional comparisons, tensile tests, pressure/flow characteristics, ISO luer conformance, ISO 10555-1 conformance, flex tests, and recirculation."
The acceptance criteria for a physical medical device like a catheter would typically involve meeting predefined specifications for these physical and performance characteristics.
Here’s a table summarizing the available information in the context of your request, while acknowledging the limitations due to the device type:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance / Evaluation | Notes on Specific Criteria |
|---|---|---|
| Physical Testing | The catheter undergone physical testing by both internal and external laboratories. | Specific quantitative acceptance values (e.g., "tensile strength > X N", "pressure/flow within Y-Z range") are not provided in this summary. |
| Dimensional Comparisons | Compared to predicate device. | No specific dimensions or comparison results are detailed. |
| Tensile Tests | Performed. | No specific tensile strength values or acceptance thresholds are detailed. |
| Pressure/Flow Characteristics | Performed. | No specific pressure/flow values or acceptance thresholds are detailed. |
| ISO Luer Conformance | Performed. | Indicates conformity to relevant ISO standards, but specific results are not provided. |
| ISO 10555-1 Conformance | Performed. | Indicates conformity to relevant ISO standards for sterile, single-use catheters, but specific results are not provided. |
| Flex Tests | Performed. | No specific flex test results or acceptance thresholds are detailed. |
| Recirculation | Performed. | No specific recirculation rates or acceptance thresholds are detailed. |
| Comparison to Predicate Device | Testing included comparisons to the predicate device. | The nature and outcome of these comparisons (e.g., non-inferiority, equivalence for specific metrics) are not detailed. |
Regarding the other requested information (2-9):
Since this is a submission for a physical medical device (hemodialysis catheter) and not an AI/ML-powered device, the following points are not applicable or not provided in the document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for physical device testing as described. Testing would involve a number of physical units, not a "test set" of data in the AI/ML sense. Data provenance regarding "country of origin" or "retrospective/prospective" is also not relevant here.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for physical device testing is established by engineering specifications, validated test methods, and performance against known standards, not by expert consensus on clinical data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device would be based on engineering specifications, material properties, and performance standards (e.g., ISO standards) for mechanical, fluid dynamics, and biocompatibility properties.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
In summary, the K022662 submission outlines the physical and performance testing conducted for the Arrow Diatek™ Cannon Catheter™, asserting its substantial equivalence to a predicate device based on these engineering-focused evaluations rather than clinical study data or AI/ML performance metrics.
§ 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.