(99 days)
THE MEDCOMP ASH SPLIT-CATH II IS INDICATED FOR USE IN ATTAINING LONG-TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED. CATHETERS GREATER THAN 40cm ARE INTENDED FOR FEMORAL VEIN INSERTION.
The Medcomp Ash Split-Cath II is a polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, tapered at the distal tip, with eight side holes. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement. The arterial and venous lumens are designed to be split, or peeled apart, prior to insertion to provide two free-floating lumens within the vessel. The side holes are orientated to allow 360-degree arterial uptake and venous return. The lumens are connected to the extensions via a soft pliable hub with suture wing. Red and blue luer connectors and clamps identify the arterial and venous extensions. Priming volume information is printed an identification ring housed within the extension line clamp.
The provided text describes a 510(k) premarket notification for the Medcomp Ash Split-Cath II Hemodialysis Catheter. This is a medical device, not an AI/ML-driven solution or a diagnostic tool that would typically involve acceptance criteria based on metrics like sensitivity, specificity, or reader performance. Therefore, many of the requested points are not applicable.
The "acceptance criteria" for this type of medical device submission are typically met by demonstrating substantial equivalence to a previously legally marketed predicate device. This is achieved through performance data showing that the new device is as safe and effective as the predicate.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Material Formulation & Compatibility | The new lumen materials meet the requirements of ISO 10993 for a permanent contact device through Biocompatibility testing. Performance is "substantially equivalent" to predicate. |
| Tensile Strength | In Vitro performance data demonstrates substantial equivalence to the legally marketed Ash Split-Cath I catheter. |
| Joint Strength | In Vitro performance data demonstrates substantial equivalence to the legally marketed Ash Split-Cath I catheter. |
| Leakage | In Vitro performance data demonstrates substantial equivalence to the legally marketed Ash Split-Cath I catheter. |
| Recirculation | In Vitro performance data demonstrates substantial equivalence to the legally marketed Ash Split-Cath I catheter. |
| Flow Performance | In Vitro performance data demonstrates substantial equivalence to the legally marketed Ash Split-Cath I catheter. |
| Flexural Properties | In Vitro performance data demonstrates substantial equivalence to the legally marketed Ash Split-Cath I catheter. |
| Lumen Peel | In Vitro performance data demonstrates substantial equivalence to the legally marketed Ash Split-Cath I catheter. |
| Intended Use | Expanded to include femoral vein insertion (previously internal jugular and subclavian). Still deemed substantially equivalent to predicate device's intended use. |
| Design Specifications | Identical to the predicate device. |
| Insertion Method, Anatomical Location, Labeling, Manufacturing Process, Sterilization | Substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the context of this 510(k) submission. The "test set" primarily refers to in vitro performance data of the device itself, comparing its physical and functional properties to the predicate. There is no mention of a "test set" in the sense of clinical data or patient data. The provenance of the in vitro test data is not specified (e.g., country of origin), but it would have been generated in a lab setting. It is not retrospective or prospective patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for a physical device's performance (e.g., tensile strength, flow rate) is established through standardized engineering and laboratory testing protocols, not human expert consensus.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical assessments or image interpretations involving human readers. The performance data here is based on objective laboratory measurements.
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 device is a catheter, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance relies on objective physical and mechanical testing standards (e.g., tensile strength, flow rate measurements as per ISO 10993 for biocompatibility) compared to the performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML model.
§ 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.