(89 days)
Spire Biomedical, Inc.'s Decathlon™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane catheter designed for percutaneous insertion via cutdown. Catheters longer than 40cm are intended for femoral vein insertion.
The Decathlon™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is constructed of radiopaque medical grade polyurethane. To reduce recirculation during hemodialysis. the arterial lumen of the catheter is shorter than the venous lumen at the catheter's distal end. The catheter has a felt cuff and dual extensions. Each extension has a color coded luer lock adaptor, red for arterial and blue for venous lumen determination. Additionally, each extension has a clamp.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Decathlon™ Kuhle Twin Lumen Chronic Hemodialysis Catheter:
Summary of Device and Context:
The "Decathlon™ Kuhle Twin Lumen Chronic Hemodialysis Catheter with Separated Tips" is a radiopaque polyurethane catheter designed for chronic hemodialysis and apheresis. It is intended for percutaneous insertion. This 510(k) submission seeks to demonstrate substantial equivalence to a predicate device (15.5Fr Decathlon™ Twin Lumen Hemodialysis Catheter with Separated Tips, K032061, K042858). The key difference in the proposed device is a "small angle" divergence of the lumens at the distal end, compared to the predicate's "substantially parallel" lumens.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type/Evidence |
|---|---|---|---|
| Material Composition | Identical polyurethane resin to predicate | Identical polyurethane resin used | Comparison to predicate device specifications |
| Physical Design | Similar hub-lumen-extension tubes, luer connections, kit components, packaging, sterilization, and product labeling to predicate. | Identical hub-lumen-extension tubes design, luer connections, kit components, packaging and sterilization, and product labeling. | Comparison to predicate device specifications |
| Functional Performance (Flow Rates) | Identical flow rates to predicate | Identical flow rates | Comparison to predicate device specifications |
| Functional Performance (Priming Volumes) | Identical priming volumes to predicate | Identical priming volumes | Comparison to predicate device specifications |
| Biocompatibility | Meets standards for medical devices | (Implicit: Predicate device passed, and this subtle change won't affect it) | Reference to predicate device test data |
| Mechanical/Physical Properties | Meets standards for medical devices | (Implicit: Predicate device passed, and this subtle change won't affect it) | Reference to predicate device test data |
Note: The acceptance criteria are largely implied by the claim of substantial equivalence to the predicate device. The core argument is that the single design change (angle of distal lumen divergence) is minor enough not to alter the established safety and effectiveness characteristics of the predicate.
Study Information:
The provided document describes a comparison study to a legally marketed predicate device, rather than a de novo clinical or extensive performance study.
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2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a separate test set. The submission relies on data from the predicate device. If "test set" refers to the new device itself, there's no mention of a specific number of new devices being tested for this submission.
- Data Provenance: The data provenance is from the predicate device (Spire Biomedical, Inc.'s 15.5Fr Decathlon™ Twin Lumen Hemodialysis Catheter with Separated Tips, K032061, K042858). It appears to be retrospective in the sense that existing data from a previously cleared device is being leveraged. The country of origin of the data is not specified, but the submitter is based in the USA.
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3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This was not a study requiring expert-established ground truth in the typical sense (e.g., for diagnostic accuracy). The comparison is against engineering specifications and existing regulatory clearance of a predicate device.
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4. Adjudication Method for the Test Set:
- Not applicable. There was no specific "adjudication" (e.g., expert consensus on clinical cases) for a test set. The review process was a regulatory submission evaluated by the FDA.
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5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This device is a physical medical device, not an AI or diagnostic imaging tool that would typically involve human readers.
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6. Standalone (Algorithm Only) Performance Study:
- No, a standalone performance study in the context of an algorithm or AI was not done. This is not an algorithmic device.
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7. Type of Ground Truth Used:
- The "ground truth" for this submission is the established safety and effectiveness profile of the predicate device, as demonstrated through its mechanical, physical, and biocompatibility tests that led to its previous FDA clearance (K032061, K042858). The manufacturer is asserting that the minor design change in the new device does not alter this established ground truth.
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8. Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device submission.
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9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI/machine learning model. The underlying "ground truth" for the predicate device would have been established through a combination of engineering specifications, material testing, mechanical testing, and biocompatibility studies conducted according to relevant standards at the time of its original clearance.
§ 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.