(360 days)
The Medcomp® Split-Cath® II is indicated for use in attaining chronic (longthe wousehip access for hemodialysis and apheresis. It may be inserted tonni/ vaceusly and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site includes the subclavian vein as required.
The Medcomp Split-Cath II is a polycarbonate/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 document is a 510(k) premarket notification for the Medcomp® Split-Cath® II Hemodialysis Catheter. It seeks to demonstrate substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness. Therefore, the information typically found in a study proving a device meets acceptance criteria for new devices (like detailed performance metrics against specific acceptance criteria, sample sizes for test and training sets, expert qualifications for ground truth, MRMC studies, or standalone algorithm performance) is largely absent.
However, based on the provided text, here's an attempt to answer the questions within the context of a substantial equivalence submission:
Acceptance Criteria and Study to Prove Device Meets Criteria for Medcomp® Split-Cath® II Hemodialysis Catheter
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance metrics against pre-defined acceptance criteria for a new device. The "acceptance criteria" here are implicitly tied to the performance of the predicate device and the general safety/effectiveness standards for such devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| I. Substantial Equivalence to Predicate Devices: | Met: The technological characteristics of the Split-Cath II are stated to be substantially equivalent to the predicate devices (Medcomp Ash Split-Cath II, Medcomp Bio-Flex CS Cath, and Medcomp Split-Stream SC4) in terms of: |
- Intended use
- Insertion method
- Anatomical location
- Design
- Performance
- Labeling
- Manufacturing process
- Method of sterilization |
| II. Physical and Functional Performance (In Vitro): | Met: In Vitro performance data for the Medcomp Split Cath II demonstrated substantial equivalence to the legally marketed Ash Split-Cath II catheter for: - Tensile strength
- Joint strength
- Leakage
- Recirculation
- Flow performance
- Flexural
- Lumen peel |
| III. Biocompatibility: | Met: Biocompatibility testing on the Split-Cath II demonstrates the lumen materials meet the requirements of USP XXII for a permanent contact device. Substantial equivalence for lumen material formulation to the predicate device (polyurethane) is also noted, with the only difference being a second vendor for the material. |
| IV. Regulatory Compliance (e.g., GMP, Labeling, Sterilization): | Met (Implied): The FDA letter instructs the submitter to comply with all Act's requirements, including annual registration, listing of devices, good manufacturing practice (QSR), and labeling, implying these are expected for market entry. The submission likely contained documentation to support compliance with manufacturing and sterilization processes, as these were mentioned in the substantial equivalence comparison. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" sample size in the traditional sense of a clinical trial. The performance data provided is in vitro, focusing on engineering characteristics. The "test set" for demonstrating substantial equivalence primarily refers to the Medcomp Split Cath II samples used in the specified in vitro tests. The document does not specify the number of devices or components tested for each in vitro performance measure.
Data Provenance: The in vitro data was generated specifically for this 510(k) submission, likely at Medcomp's facilities or an accredited testing lab. No country of origin for the data is specified, but the submitter is based in Harleysville, PA, USA. The data is prospective in the sense that it was generated for the purpose of this submission and to evaluate the new device against the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. For a 510(k) submission based on substantial equivalence and in vitro testing, there isn't typically a ground truth established by medical experts in the same way there would be for a diagnostic or AI device that requires expert adjudication. The "ground truth" for in vitro performance tests would be the established engineering and materials science principles and the performance of the legally marketed predicate device.
4. Adjudication Method for the Test Set
Not applicable and not provided. As the primary performance data discussed is in vitro and focused on mechanical and material characteristics, there is no expert adjudication method like "2+1" typically used for clinical endpoints or image interpretation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data was not deemed necessary since substantial equivalence is addressed by way of comparison to a legally marketed device." Therefore, there is no information on human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Not applicable. This device is a medical catheter, not an AI algorithm or an imaging device.
7. The Type of Ground Truth Used
The "ground truth" for this submission is:
- Predicate Device Performance: The established performance characteristics of the legally marketed predicate device(s), particularly the Ash Split-Cath II catheter, as demonstrated through in vitro testing.
- Industry Standards/Regulations: Compliance with relevant standards like USP XXII for biocompatibility.
- Design Specifications: The documented design specifications of the proposed device being identical to the predicate (Ash Split-Cath II) except for the lumen material vendor.
8. The Sample Size for the Training Set
Not applicable. This submission is for a physical medical device (catheter) and does not involve AI algorithms that require training sets in the typical sense.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, no training set for an AI algorithm is involved.
§ 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.