(378 days)
The Cook Turbo-Flo® HD Acute Hemodialysis Catheter is intended for acute hemodialysis, apheresis and hemofiltration. It is intended for percutaneous insertion into the subclavian, jugular or femoral veins. The device is a short-term use catheter (less than 30 days).
The Cook Turbo-Flo® HD Hemodialysis Catheters are short-term, 12 Fr., hydrophilically coated, radiopaque polyurethane central venous catheters with two independent, non-communicating lumens. Lengths of 15, 20 and 25 cm are available based on the anatomical needs of the patient. Various components may be included that are associated with placement of the device.
Here's a breakdown of the requested information based on the provided document:
The provided document is a 510(k) summary for the Cook Turbo-Flo® HD Acute Hemodialysis Catheter. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information (especially points 2-9 related to AI/algorithm studies) is not applicable or not found in this type of regulatory submission.
However, I can extract the relevant information from the document that aligns with your request for device performance and the study that proves it meets criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of "acceptance criteria" with quantitative targets and corresponding "reported device performance" in the way one might see for an AI diagnostic device. Instead, it lists various tests conducted to ensure reliable design and performance, concluding that the results support substantial equivalence to the predicate. The implicit acceptance criterion for each test is that the device performs comparably to or within acceptable limits for a hemodialysis catheter.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Tensile Strength | Test results support safety and effectiveness. |
| Flow Rate | Test results support safety and effectiveness. |
| Burst Pressures | Test results support safety and effectiveness. |
| Liquid/Air Leakage | Test results support safety and effectiveness. |
| Collapsibility | Test results support safety and effectiveness. |
| Cyclic Bending | Test results support safety and effectiveness. |
| Leakage following Clamp Cycling | Test results support safety and effectiveness. |
| Recirculation Rate | Design elements (dual lumens, different termination points) support flow and minimize recirculation; test results support safety and effectiveness. |
| Biocompatibility | Test results support safety and effectiveness. |
| Sterilization | Test results support safety and effectiveness. |
| Performance following Aging | Test results support safety and effectiveness. |
Study Details:
The "study" described here is a series of bench and possibly non-clinical (e.g., in vitro, animal) tests conducted on the Cook Turbo-Flo® HD Acute Hemodialysis Catheter to demonstrate its safety and effectiveness relative to a legally marketed predicate device (K993933, Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg+ard Blue).
- Type of Study: This is not a clinical trial or an AI algorithm performance study. It is a design verification and validation study comprised of various engineering and biological tests typical for medical device clearance via the 510(k) pathway.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided summary. These would typically be a statistical sample of devices for the bench tests.
- Data Provenance: Not specified, but generally refers to in-house laboratory testing (Cook Incorporated, USA).
- Retrospective or Prospective: These are prospective tests performed on newly manufactured devices.
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)
- Not Applicable. This type of information is irrelevant for bench testing of a physical medical device. Ground truth for these tests is established by objective physical and chemical measurements against design specifications and industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in diagnostic studies. For physical device performance, results are typically objective 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
- No. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the tests listed (tensile, flow rate, burst pressure, etc.) are objective physical and chemical properties and measurements against established engineering specifications, industry standards, and biocompatibility criteria.
8. The sample size for the training set
- Not Applicable. This is not an AI device. There is no "training set" in the context of this 510(k) submission.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.
§ 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.