(57 days)
The Trio-CT® Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and 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 Trio-CT® Triple Lumen Catheter is a short-term (less than 30 days) dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (purple) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, power injection of contrast media, central venous pressure monitoring, blood draws and infusion of medications. The catheter is available with straight or curved extensions in a variety of lengths to accommodate physician preference and clinical needs. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.
The provided text describes the submission of a medical device, the "Trio-CT® Triple Lumen Catheter w/ Curved Extensions," for FDA 510(k) clearance, asserting its substantial equivalence to a predicate device, the "Trio-CT™ Triple Lumen Catheter." The document focuses on regulatory compliance and does not detail a study proving the device meets specific acceptance criteria in the context of an AI/human-in-the-loop performance study.
Therefore, many of the requested elements for an AI evaluation study, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity, AUC), sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI training sets, are not applicable to this document. This document pertains to the regulatory clearance of a physical medical device, not an AI software component.
However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its substantial equivalence.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the format typically used for performance studies (e.g., sensitivity, specificity thresholds). Instead, it compares the technical specifications and performance characteristics of the subject device to its predicate to demonstrate substantial equivalence. The "acceptance criteria" are implied to be that the subject device's performance is comparable to or better than the predicate device across various technical and performance specifications.
| Characteristic | Acceptance Criteria (Implied: Comparable to Predicate) | Reported Subject Device Performance | Reported Predicate Device Performance |
|---|---|---|---|
| Device Trade Name | Same name with "w/ Curved Extensions" suffix, indicating a minor variant. | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Trio-CT™ Triple Lumen Catheter |
| Indications for Use | Identical | The Trio-CT® Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and 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 Trio-CT® Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and 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. |
| Prescription/Over-the-Counter Use | Identical | Prescription Use | Prescription Use |
| Target Population | Identical | Adult | Adult |
| Duration of Use | Identical | Short Term | Short Term |
| Sterilization Method | Identical | 1x and/or 2x EO Sterilized | 1x and/or 2x EO Sterilized |
| Catheter French Size | Identical | 13.5F | 13.5F |
| Inner Diameters | Identical | Venous - 0.088" nominal | |
| Arterial – 0.088" nominal | |||
| Infusion - 0.042" nominal | Venous - 0.088" nominal | ||
| Arterial - 0.088" nominal | |||
| Infusion - 0.042" nominal | |||
| Number of Lumens | Identical | Three (3) | Three (3) |
| Catheter Lengths | Similar (subject device has one less length option) | 12cm, 15cm, 20cm and 24cm | 12cm, 15cm, 20cm, 24cm and 30cm |
| Priming Volume (cc) | Comparable across shared lengths | 12cm: Center 0.4, Art 1.4, Ven 1.4 | |
| 15cm: Center 0.4, Art 1.5, Ven 1.5 | |||
| 20cm: Center 0.5, Art 1.7, Ven 1.7 | |||
| 24cm: Center 0.5, Art 1.9, Ven 1.9 | 12cm: Center 0.4, Art 1.2, Ven 1.2 | ||
| 15cm: Center 0.4, Art 1.3, Ven 1.3 | |||
| 20cm: Center 0.5, Art 1.5, Ven 1.5 | |||
| 24cm: Center 0.5, Art 1.6, Ven 1.6 | |||
| 30cm: Center 0.6, Art 1.9, Ven 1.9 | |||
| Power Injection Pressure (psi) | Comparable | Max Indicated Power Injection Flow-Rate: 5 ml/sec | |
| Average Max Catheter Pressure: 92 psi | |||
| Average Max Burst Pressure: 314 psi | |||
| Range of Max Burst Pressures: 277-425 psi | Max Indicated Power Injection Flow-Rate: 5 ml/sec | ||
| Average Max Catheter Pressure: 84 psi | |||
| Average Max Burst Pressure: 420 psi | |||
| Range of Max Burst Pressures: 332-446 psi | |||
| Flow Rate (ml/min) vs Pressure (mmHg) | Comparable across various flow rates and lengths | 12CM Venous: 20 (200), 41 (300), 61 (400) | |
| Arterial: -29 (200), -44 (300), -69 (400) | |||
| 15CM Venous: 21 (200), 40 (300), 59 (400) | |||
| Arterial: -30 (200), -45 (300), -70 (400) | |||
| 20CM Venous: 30 (200), 45 (300), 72 (400) | |||
| Arterial: -30 (200), -49 (300), -74 (400) | |||
| 24CM Venous: 30 (200), 46 (300), 71 (400) | |||
| Arterial: -30 (200), -50 (300), -80 (400) | 12CM Venous: 20 (200), 30 (300), 51 (400) | ||
| Arterial: -21 (200), -40 (300), -60 (400) | |||
| 15CM Venous: 20 (200), 40 (300), 63 (400) | |||
| Arterial: -26 (200), -46 (300), -70 (400) | |||
| 20CM Venous: 21 (200), 40 (300), 62 (400) | |||
| Arterial: -30 (200), -50 (300), -70 (400) | |||
| 24CM Venous: 30 (200), 50 (300), 76 (400) | |||
| Arterial: -33 (200), -50 (300), -80 (400) | |||
| 30CM Venous: 30 (200), 51 (300), 84 (400) | |||
| Arterial: -33 (200), -59 (300), -90 (400) | |||
| Insertion Site | Identical | Jugular, femoral or subclavian vein | Jugular, femoral or subclavian vein |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable. The document describes non-clinical testing for a physical medical device, not a test set for an AI algorithm. The performance testing was "Design validation performance testing... leveraged from the predicate device manufactured by Medical Components, Inc." and "Design verification performance testing was completed to confirm performance criteria of the subject device." No specific sample sizes for these tests are mentioned in the provided text, nor is data provenance in the context of patient data described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as this document does not concern an AI/algorithm where human expert ground truth would be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable.
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:
This information is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance comes from adherence to established technical specifications and performance characteristics, and the results of various non-clinical tests. These include:
- Biocompatibility Evaluation: This involved specific tests like ISO Muscle Implantation, USP Rabbit Pyrogen, ASTM Hemolysis, SC5b-9 Complement Activation Assay, ISO Guinea Pig Maximization Sensitization, ISO Intracutaneous, Cytotoxicity Study, ISO Acute Systemic Toxicity, ISO Systemic Toxicity in Rat, Bacterial Reverse Mutation, Genotoxicity: Mouse Lymphoma Assay, Infrared Spectroscopy, Mechanical Hemolysis Testing, and In Vivo GLP 30 Day Thromboresistance Study. These tests provide "ground truth" regarding the material's safety and biological interactions.
- Performance Testing: This refers to design verification tests to confirm the device meets its specified technical characteristics (e.g., Catheter French Size, Inner Diameters, Priming Volume, Power Injection Pressure, Flow Rate vs. Pressure). The "ground truth" here is the direct measurement of these physical properties.
8. The sample size for the training set:
This information is not applicable. The document focuses on regulatory clearance of a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established:
This information is not applicable.
§ 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.