(30 days)
The Arrow Cannon™ II Plus is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Cannon™ II Plus 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 Cannon™ II Plus is intended for use in adult patients.
The Arrow Cannon™ II Plus consists of a double lumen catheter with a detached connector assembly. This allows the catheter tip to be precisely positioned 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.
Here's an analysis of the provided 510(k) summary for the Cannon™ II Plus Chronic Hemodialysis Catheter, focused on acceptance criteria and supporting studies:
This 510(k) submission, K040078, provides very limited information regarding specific acceptance criteria and detailed study designs. It is a submission for a Class III Medical Device and claims substantial equivalence to a previously marketed device, the Arrow Cannon Catheter™ (K010399). This type of submission generally relies on demonstrating that the new device is as safe and effective as the predicate device by showing similar technological characteristics and performance in relevant tests, rather than establishing de novo performance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the "acceptance criteria" are implied by the performance tests conducted to demonstrate substantial equivalence to the predicate device. The document does not explicitly state quantitative acceptance limits for these tests.
| Performance Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Flow rate tests | Comparable to predicate device (K010399) | "Tests were performed to demonstrate substantial equivalence" |
| Chemical compatibility | Non-reactive or compatible with relevant medical materials/fluids | "Tests were performed to demonstrate substantial equivalence" |
| Leak tests | No leakage or leakage within acceptable limits | "Tests were performed to demonstrate substantial equivalence" |
| Biocompatibility tests | Biocompatible (e.g., non-toxic, non-irritating) | "Tests were performed to demonstrate substantial equivalence" |
| Tensile tests | Mechanical strength comparable to predicate device | "Tests were performed to demonstrate substantial equivalence" |
Conclusion: The document states, "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices." This implies that the device met the unstated acceptance criteria for each test category by performing comparably to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided documents. The term "test set" in the context of AI/ML models is not directly applicable here as this is a medical device clearance, not an AI/ML algorithm submission. The tests performed are laboratory-based performance tests for a physical device.
- Data Provenance: Not explicitly stated. The tests are described as "laboratory tests," implying they were conducted by Arrow International, Inc. or a contracted lab. There is no mention of country of origin of data or whether it was retrospective or prospective, as these are typically not relevant for bench performance tests of a physical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. For a physical medical device, "ground truth" is typically established through objective measurements against engineering specifications or established standards, not expert consensus in the way it's used for AI/ML.
- Qualifications of Experts: Not applicable. The tests would be performed by trained technicians or engineers, not "experts" in the clinical sense of establishing ground truth for disease detection.
4. Adjudication Method for the Test Set
- Adjudication method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human reviewers when establishing ground truth, typically in image interpretation or clinical diagnosis. This is not relevant for the bench performance tests described for this physical device.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC study was not done, and is not applicable to this type of device clearance. MRMC studies are primarily used for evaluating the effectiveness of diagnostic imaging devices or AI-powered algorithms where human interpretation is involved. This submission is for a physical chronic hemodialysis catheter, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a physical medical instrument, not an algorithm. Therefore, "standalone performance" in the context of AI/ML is not relevant.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "performance tests" listed (flow rate, chemical compatibility, leak, biocompatibility, tensile), the ground truth would be based on:
- Engineering Specifications/Standards: Each test would have defined parameters and acceptable ranges based on recognized standards (e.g., ISO, ASTM) or internal design specifications. For example, a flow rate test would measure the actual flow rate and compare it to the specified design flow rate.
- Predicate Device Performance: Crucially, for a 510(k) substantial equivalence claim, the performance of the new device is compared directly to that of the legally marketed predicate device (K010399). The "ground truth" for acceptable performance is what the predicate device achieved.
- Chemical/Biological Test Results: Biocompatibility would be determined by standard assays (e.g., cytotoxicity, irritation tests) against established pass/fail criteria.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
Summary of the Study and Device Clearance:
The K040078 submission for the Cannon™ II Plus Chronic Hemodialysis Catheter is a traditional 510(k) premarket notification based on substantial equivalence. This means the primary "study" is a set of laboratory performance tests designed to demonstrate that the new device has technological characteristics and performance that are as safe and effective as its predicate device (Arrow Cannon Catheter™, K010399).
The document highlights the following performance tests:
- Flow rate tests
- Chemical compatibility tests
- Leak tests
- Biocompatibility tests
- Tensile tests
The "acceptance criteria" are implicitly met by showing that the Cannon™ II Plus performed comparably to the predicate device in these tests, leading to the conclusion that it is "as safe and effective." This type of submission does not involve clinical trials, AI/ML algorithm validation, or detailed "ground truth" establishment by clinical experts in the way that diagnostic or AI-powered devices might. The focus is on demonstrating equivalent mechanical, material, and functional performance to an already approved 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.