(90 days)
The Diatek Connector Assembly Replacement Kit is to be used for replacing the original connector assembly on a Diatek Cannon-Cath Dialysis Catheter if the connector assembly becomes damaged or dysfunctional. This prevents the patient from requiring additional surgery for catheter removal and replacement.
The Connector Assembly Replacement Kit is intended for use in any patient who has a previously implanted Diatek Cannon-Cath implanted.
The Diatek Connector Assembly Replacement Kit consists of a Cannon-Cath connector assembly and components needed to remove the previously implanted connector assembly and attach the new connector assembly to the previously implanted dialysis catheter.
The provided 510(k) summary for the Diatek Connector Assembly Replacement Kit (K020430) is not a study of device performance in the typical sense of measuring efficacy or safety in a clinical trial. Instead, it describes a component replacement kit for an existing, already cleared device (Diatek Cannon-Cath Dialysis Catheter).
The "study" cited here is not a clinical study but rather a statement of equivalence based on the components being identical to those already tested and found acceptable for the predicate device. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable in this context.
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (or rationale for acceptance) |
|---|---|
| Functional Equivalence | The Diatek Connector Assembly Replacement Kit components are identical to the components in the Diatek Cannon-Cath product. |
| Prior Testing and Acceptance | The identical components have been tested by both internal and outside laboratories for a range of criteria and found acceptable as submitted in 510(k) 010399 for the predicate device. (This implies the original acceptance criteria for the Cannon-Cath apply and were met.) |
| Intended Use | Replacing damaged/dysfunctional original connector assembly to prevent additional surgery. |
| Compatibility | Intended for use with previously implanted Diatek Cannon-Cath Dialysis Catheter. |
Since this is a component replacement kit, the acceptance criteria are primarily focused on maintaining the safety and effectiveness profile of the original device. The "performance" is the fact that the components are the same as those already proven acceptable.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This information is not provided in the summary. The summary refers to previous testing performed on the predicate device's components.
- Data Provenance: The original testing on the predicate device's components was conducted by "both internal and outside laboratories." The country of origin and whether it was retrospective or prospective data are not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This type of information is pertinent to studies involving diagnostic accuracy or interpretation, often with imaging or clinical data. Since this is a hardware component replacement kit, "ground truth" established by experts in this manner is not relevant to the testing described. The "ground truth" would be the successful function and safety of the original components as determined by engineering and biocompatibility testing.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to resolve discrepancies in diagnosis or assessment. This is not reported for the engineering and material testing referenced.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is typically for evaluating diagnostic imaging systems or decision support tools where human readers are interpreting cases. This device is a mechanical component, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This refers to the performance of an AI algorithm without human involvement. This device is not an AI algorithm. The performance of the components themselves (e.g., strength, biocompatibility, fluid dynamics) was likely evaluated in a standalone manner without human intervention during the specific tests, but this isn't in the context of an AI algorithm.
7. The Type of Ground Truth Used
- For the original predicate device components, the "ground truth" would have been established through bench testing results, material specifications, biocompatibility studies, and potentially animal or clinical performance data validating the functional integrity and safety of the components. The exact types are not specified beyond "a range of criteria."
8. The Sample Size for the Training Set
- Not Applicable. A "training set" refers to data used to train machine learning models. This device is a mechanical component, not an AI system.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, there is no training set for a mechanical device.
Summary of the "Study" Proving Acceptance Criteria:
The "study" cited for the Diatek Connector Assembly Replacement Kit is a bridging argument based on identity to a predicate device's components, rather than new, independent testing or a clinical trial for the kit itself. The critical information provided is:
- The components in the replacement kit are identical to those in the predicate Diatek Cannon-Cath product.
- These identical components were previously tested (via 510(k) 010399) by internal and external laboratories against "a range of criteria" and found acceptable.
This approach is common for component-level changes or replacement kits that do not introduce new technology or alter the fundamental operating principles of an already cleared device. The focus is on demonstrating that the replacement kit maintains the same safety and effectiveness profile as the original, proven components.
§ 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.