(219 days)
The Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray is intended for acute hemodialysis, apheresis and hemofiltration via 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 Acute Hemodialysis Catheter Set/Tray is a short-term, 12 Fr, radiopaque polyurethane central venous catheter with two independent, noncommunicating lumens. Lengths of 15, 20, and 25 cm are available based on the anatomical needs of the patient.
This FDA 510(k) summary describes a medical device, a hemodialysis catheter, and its substantial equivalence to a predicate device. It does not contain information about an AI/ML-based device or a study proving its performance against specific acceptance criteria in the manner requested.
However, I can extract the information provided about the Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray and frame it as if it were describing a device's performance against acceptance criteria, using the available data. It's important to note that this is an analogy and not a direct fit for explaining an AI/ML device's validation.
Here's an interpretation based on the provided text, modified to fit the requested format for a device validation, specifically focusing on the "Validation testing" mentioned.
The document describes the Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray and its validation testing, which ensures reliable design and performance. The primary change from the predicate device (K122091) is the removal of a hydrophilic coating, and the validation tests were conducted to demonstrate that this modification does not impact safety or effectiveness.
1. Acceptance Criteria and Reported Device Performance
The device underwent "Validation testing" to ensure reliable design and performance. The acceptance criteria and reported performance for specific parameters were as follows:
| Performance Parameter | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Preparation | Rating scale should be "adequate" or "good" in a three-point scale. | Pre-determined acceptance criterion was met. |
| Introduction | Rating scale should be "adequate" or "good" in a three-point scale. | Pre-determined acceptance criterion was met. |
| Pushability | Rating scale should be "adequate" or "good" in a three-point scale. | Pre-determined acceptance criterion was met. |
| Trackability | Rating scale should be "adequate" or "good" in a three-point scale. | Pre-determined acceptance criterion was met. |
| Flexibility | Rating scale should be "adequate" or "good" in a three-point scale. | Pre-determined acceptance criterion was met. |
| Radiopacity | Rating scale should be "adequate" or "good" in a three-point scale. | Pre-determined acceptance criterion was met. |
| Blood Draw | Rating scale should be "adequate" or "good" in a three-point scale. | Pre-determined acceptance criterion was met. |
| Infusion | Rating scale should be "adequate" or "good" in a three-point scale. | Pre-determined acceptance criterion was met. |
| Interaction | Rating scale should be "adequate" or "good" in a three-point scale. | Pre-determined acceptance criterion was met. |
| Withdrawal | Rating scale should be "adequate" or "good" in a three-point scale. | Pre-determined acceptance criterion was met. |
| Inspection | Rating scale should be "adequate" or "good" in a three-point scale. | Pre-determined acceptance criterion was met. |
| Biocompatibility | No impact on biocompatibility from the modification. | Testing results indicate the modification does not impact biocompatibility. |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: The document states "When tested in an animal model that simulates clinical use." It does not specify the exact number of animals used for the validation testing.
- Data Provenance: The study was conducted retrospectively or prospectively cannot be determined from the document. The country of origin for the animal model data is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes a physical medical device and its performance in an animal model, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. Therefore, the concept of "experts" to establish ground truth in this context is not directly applicable as it would be for an AI/ML study. The evaluation likely involved veterinary or technical personnel assessing the catheter's performance based on predefined objective criteria in the animal model.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication methods like 2+1 or 3+1 are typical for human-in-the-loop or expert consensus studies for AI/ML. For a physical device animal study, the method of assessing the "adequate" or "good" rating is not detailed but would likely involve direct observation and measurement, potentially with a single or small team of trained evaluators. No specific adjudication method is mentioned.
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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 study is for a physical medical device and does not involve AI assistance, human readers, or an MRMC study design.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This study pertains to the physical performance of a medical catheter in an animal model, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance was established through direct observation and qualitative assessment ("rating scale... 'adequate' or 'good'") within an animal model simulating clinical use. This is a functional performance assessment rather than a diagnostic accuracy assessment.
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The sample size for the training set:
- This concept is not applicable for a physical medical device's validation testing described here. No "training set" for an algorithm is mentioned or implied. Design control activities and pre-clinical testing would have informed the device's design, but not in the sense of an algorithm training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an algorithm in this context. The "ground truth" for the device's design would have been established through engineering specifications, previous predicate device performance, and clinical requirements for hemodialysis catheters.
Summary of Limitations based on the Document:
The provided text is a 510(k) summary for a physical medical device, not an AI/ML algorithm. Therefore, many of the requested details about AI/ML study design (e.g., algorithm performance, human reader studies, training sets, expert consensus for ground truth) are not present or directly applicable. The document confirms that "appropriate design control activities" and "appropriate validation test" were performed, and the device met its pre-determined acceptance criterion regarding functional performance in an animal model and biocompatibility.
§ 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.