(90 days)
Spire Biomedical Inc's Alta Gold, Coated Twin Lumen Chronic Indications for Use: Hemodialysis Catheter with fixed tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane with a heparin coating, designed for percutaneous insertion or insertion via cutdown. The ability of the Carmeda End point Bonded Heparin Coating to reduce clotting is supported by in-vitro testing. Catheters longer than 40cm are intended for femoral vein insertion.
Spire Biomedical, Inc.'s 15.5Fr Alta Gold, Twin Lumen Fixed Tip Coated Chronic Hemodialysis Catheter is processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the device. The coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Alta Gold, Heparin Coated Catheter is fully coated with CBAS® on the internal surface and on the external surface of the catheter body (from 2cm distal to the ends of the distal tips; the cuff is not coated).
The coating is essentially non-leaching. Additionally, the maximum amount of heparin on the surface is only 1mg. Therefore; the effects of the entire coating on a patient's coagulation status would be insignificant.
Acceptance Criteria and Study for K063441: 15.5Fr Alta Gold, Twin Lumen Fixed Tip Coated Chronic Hemodialysis Catheter
This document describes the acceptance criteria and the study that proves the Spire Biomedical, Inc.'s 15.5Fr Alta Gold, Twin Lumen Fixed Tip Coated Chronic Hemodialysis Catheter meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Coating Performance | Heparin bioactivity maintained for a minimum of 90 days. | Heparin bioactivity remained essentially constant throughout the 90-day test period. | In-vitro durability test |
| Reduction in total thrombus accumulation. | 91% reduction in total thrombus accumulation compared to uncoated catheters. | In-vitro thromboresistance study | |
| Effective in mitigating disturbed flow-mediated thrombosis (at catheter tip). | Demonstrated effectiveness in mitigating disturbed flow-mediated thrombosis. | In-vitro thromboresistance study | |
| Effective in mitigating fibrin sheath propagation (on catheter shaft). | Demonstrated effectiveness in mitigating fibrin sheath propagation. | In-vitro thromboresistance study | |
| Coating is essentially non-leaching. | The coating is essentially non-leaching. | Stability testing | |
| Maximum amount of heparin on the surface is 1mg. | Maximum amount of heparin on the surface is only 1mg. | (Implied by design, not a direct performance measure in studies) | |
| Physical/Mechanical Properties | Catheter flows | Met established performance (specific values not provided but implied by passing). | Bench testing |
| Tensile strength (Catheter to hub, Extension to hub, Luer adapter to extensions, Cuff to catheter) | Met established performance (specific values not provided but implied by passing). | Mechanical testing | |
| Catheter extrusion | Met established performance (specific values not provided but implied by passing). | Mechanical testing | |
| Biocompatibility | Meets requirements for a permanent contact device. | Met the requirements for a permanent contact device per ISO 10993. | Biocompatibility testing |
2. Sample Size Used for the Test Set and Data Provenance
The primary performance studies for the Alta Gold catheter leveraged data from previously cleared devices, particularly the 15.5Fr Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter (K060155), due to identical material, outside dimensions, and coating.
- In-vitro durability test (90-day bioactivity): Not explicitly stated, but performed on "coated catheters in saline."
- In-vitro thromboresistance study (2-hour blood loop): Involved "circulation of bovine blood" through an outer loop with "coated or uncoated catheter." The number of catheters tested is not specified but it's a comparative study. This study was performed on the Alta Gold catheters, while other tests were performed on the predicate Decathlon Gold catheters.
- Biocompatibility Testing: Conducted on the 15.5Fr Decathlon coated catheter. Number of samples not explicitly stated but implied to be sufficient for ISO 10993 compliance.
Data Provenance:
All studies mentioned are in-vitro laboratory studies, and thus the concept of "country of origin of the data" or "retrospective/prospective" does not apply in the same way as for clinical trials with human subjects. The studies were conducted by Spire Biomedical, Inc. (or their contractors) in support of regulatory submission in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This submission does not involve a standard clinical study with expert interpretation of cases. The "ground truth" for the performance claims is established through objective, quantitative, in-vitro scientific measurements and validated international standards (e.g., ISO 10993). Therefore, there were no "experts" in the traditional sense establishing a diagnostic ground truth for a test set of medical images or patient data. The scientists and technicians conducting the laboratory tests provided the data.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) was used as this was not a study involving human interpretation of medical data requiring consensus or arbitration. The performance data was derived from laboratory measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This device is a medical device (catheter) and not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a chronic hemodialysis catheter, not an algorithm or AI system. Its performance is inherent to the device's material properties and coating, not dependent on an algorithm.
7. Type of Ground Truth Used
The ground truth used for performance validation was based on:
- Quantitative In-vitro Measurements: Direct measurements of heparin bioactivity (pmol/cm²), thrombus accumulation (radiolabeled measurements), pressure increase, and visual evaluation in controlled laboratory settings.
- Adherence to Standards: Compliance with established physical and mechanical test methods, and international biocompatibility standards (ISO 10993).
8. Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI, and therefore no "training set" was used. The device's design and performance are based on engineering principles and established biological interactions, not data training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
§ 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.