(173 days)
The 15.5Fr. Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.
The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter is a product line extension of Spire Biomedical, Inc.'s Pourchez XpressO™ flexible radiopaque silicone catheters and supplements our Pourchez XpressO catheter line by offering a polyurethane catheter with similar tip-to-hub length catheters of 24cm, 28cm, 32cm, 36cm & 40cm. The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter's split tip design (with the exception of the polyurethane catheter body, clear urethane tubing, urethane hub and cross-sectional profile) are identical to our silicone Pourchez XpressO™ catheters listed within our 510(K) Premarket Notification Submission (K013160). The round outer profile with semi-circular cross-sectional lumens is similar to the MedComp Ash Split Cath™. The polyurethane catheter body material is identical to that used in the Kendall Healthcare Maxid™ catheter, as verified by an IR Scan analysis (Appendix (Appendix (G). Optional use of polyvinyl chloride luer adapters has also been qualified.
The provided document (K032061) describes a 510(k) premarket notification for a medical device, specifically a 15.5Fr Polyurethane "Decathlon" Twin Lumen Chronic Hemodialysis Catheter. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study that establishes acceptance criteria and then proves the device meets those criteria in the context of an AI/human performance study.
Therefore, much of the requested information regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment cannot be found in this document because the document describes a traditional medical device (a catheter) and not an AI/ML-driven device.
However, I can extract the information related to the device's performance based on the provided text.
Here's an attempt to answer the questions based only on the provided text, noting where information is unavailable.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by comparison to predicate devices and/or conformance to established ISO standards for hemodialysis catheters. The document states the device met these criteria. Specific numerical values for criteria are not detailed in this summary.
| Performance Metric Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Results of selected biocompatibility testing for the catheter and carbothane resin. (Criteria implicitly met if documented in Appendix B, which is not provided). | "Selected biocompatibility testing was conducted on the catheter and carbothane resin. Results are provided in Appendix B." (Assumed to meet criteria). |
| Flow Rates | Similar product performance flow rates as predicate devices (Spire Biomedical, Inc.'s Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheters with Separated Tips). | "15.5Fr Decathlon catheters have similar product performance flow rates as compared to our silicone Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheters with Separated Tips." |
| Priming Volumes | Similar priming volumes as predicate devices (Spire Biomedical, Inc.'s Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheters with Separated Tips). | "15.5Fr Decathlon catheters have similar product performance... priming volumes as compared to our silicone Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheters with Separated Tips." |
| Mechanical & Physical Tests | Equivalent to predicate devices (Spire Biomedical, Inc.'s Pourchez XpressO™, MedComp Ash Split Cath™, Kendall Healthcare Maxid™) or conformation to established ISO standards for hemodialysis catheters. Exceed minimum acceptance criteria established by appropriate standard. | "A series of mechanical and physical tests were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters. In all cases, the 15.5Fr "Decathlon" catheter demonstrated equivalent or better performance to the predicate devices and/or exceeded the minimum acceptance criteria established by the appropriate standard." |
| Material Composition | Identical polyurethane material to Kendall Healthcare Maxid™ catheter. | "The polyurethane catheter body material is identical to that used in the Kendall Healthcare Maxid™ catheter, as verified by an IR Scan analysis (Appendix G)." |
| Luer Adapters | Qualified for optional use of polyvinyl chloride luer adapters. | "Optional use of polyvinyl chloride luer adapters has also been qualified." |
2. Sample size used for the test set and the data provenance
This document describes a physical medical device (catheter), not an AI algorithm. Therefore, the concept of a "test set" in the context of AI performance data (e.g., images for classification, clinical data for prediction) does not apply here. The document describes tests performed on the physical catheter rather than a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is for a physical medical device, not an AI algorithm requiring expert ground truth for a test set.
4. Adjudication method for the test set
Not applicable. This is for a physical medical device, not an AI algorithm with a test set requiring adjudication.
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
Not applicable. This document pertains to a physical medical device. It does not involve AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document pertains to a physical medical device, not an AI algorithm.
7. The type of ground truth used
For the performance data described, the "ground truth" is established through:
- Comparison to predicate devices: Performance characteristics (flow rates, priming volumes) were deemed acceptable if they were "similar" to the legally marketed predicate devices.
- Conformance to established ISO standards: Mechanical and physical tests were evaluated against relevant ISO standards for hemodialysis catheters.
- Analytical verification: Material composition was verified through an "IR Scan analysis."
8. The sample size for the training set
Not applicable. This document is for a physical medical device, not an AI algorithm with a training set.
9. How the ground truth for the training set was established
Not applicable. This document is for a physical medical device, not an AI algorithm.
§ 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.