(232 days)
The Medcomp® T3 T catheter is a triple lumen catheter indicated for use in attaining short-term vascular access for hemodialysis, apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.
The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.
The T3 CT is a triple lumen catheter with a designated lumen for power injection, infusion or pressure monitoring. Each catheter lumen terminates through an extension to a female luer- lock connector. Each extension has an in-line clamp to control fluid flow and the clamp I.D. Ring is marked with the priming volume plus power injection rate is printed on the center clamp. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size, lumen length and both the company and catheter design name. The outer extensions are clear and marked with "Do Not Power Inject" and the center extension is a translucent purple pigment printed with "Power Injectable". The catheter is available with either straight or curved out extensions.
The catheter lumen is composed of a soft, thermo-sensitive, polyurethane material with barium sulfate for radiopacity. At bodv temperature the catherer lumen becomes softer to reduce the risk of vessel trauma.
The catheter hub and extensions are molded from soft pliable polyurethane to increase patient comfort. The suture wing is flexible with suture holes for catheter securement.
The provided document does not contain a study demonstrating acceptance criteria or device performance in the way typically expected for a medical device efficacy or performance study. This document is a 510(k) summary for a hemodialysis catheter (T3 CT).
Instead of a clinical study or performance data against specific acceptance criteria, the submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that instead of proving the device meets certain performance metrics through a new study, the applicant argues that the new device is as safe and effective as devices already on the market because it has the same intended use, materials, anatomical location, basic design, performance, labeling, manufacturing process, and method of sterilization.
Here's an analysis based on the information provided, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, there is no explicit table of acceptance criteria and reported device performance from a specific study presented in this 510(k) summary. The submission asserts that the device "meets the performance criteria of design verification as specified by ISO standards, guidance documents and test protocols." However, the details of these criteria or the test results are not included.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new clinical or performance test set (as in a study to evaluate efficacy or performance against specific metrics) is described. The submission relies on equivalence to predicate devices and adherence to design verification standards (ISO, guidance documents, test protocols), but details of these tests are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. No ground truth establishment for a test set is described as part of this 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring an adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device 510(k) summary for a catheter, not an AI software or imaging device that would typically undergo an MRMC study.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable. This is a medical device 510(k) summary for a catheter, not an algorithm or AI system.
7. Type of Ground Truth Used
Not applicable in the context of a new efficacy/performance study. The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the identified predicate devices, based on their prior clearance and market history.
8. Sample Size for the Training Set
Not applicable. This is a medical device 510(k) summary for a catheter. The concept of a "training set" is relevant for machine learning algorithms, which is not what this submission is about.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
Summary of the Acceptance Criteria and "Study":
The "acceptance criteria" for the Medcomp® T3 CT catheter, as presented in this 510(k) summary, are primarily based on:
- Substantial Equivalence: The device is considered substantially equivalent to legally marketed predicate devices (K033570, K083675, K102605 as primary, and several others as secondary). This is the core "study" or justification for its market clearance. The argument is that "there are no differences that raise new issues of safety and effectiveness."
- Design Verification: The submission states that the "proposed device meets the performance criteria of design verification as specified by ISO standards, guidance documents and test protocols." While the specific tests and their results are not detailed, this implies that the device underwent engineering and materials testing to ensure it meets established specifications for medical catheters (e.g., strength, flow rates, material compatibility, etc.).
- Biocompatibility: The materials used meet the requirements of ISO 10993, and all materials have been cleared under past approved 510(k)s. This demonstrates the materials are biologically safe.
Conclusion:
The Medcomp® T3 CT 510(k) submission (K123292) for a hemodialysis catheter does not describe a clinical study to prove device performance against specific efficacy or performance acceptance criteria. Instead, it relies on demonstrating substantial equivalence to existing predicate devices and adherence to established design verification standards and biocompatibility requirements. This is a common pathway for medical device clearance, especially for devices that are modifications or improvements upon existing technologies rather than entirely novel ones.
§ 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.