(109 days)
Spire Biomedical Inc.'s Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic Hemodialysis and apheresis. It is a radiopaque polyurethane catheter with a heparin coating, designed for percutaneous insertion or insertion via a cutdown.
The ability of the Carmeda® End-Point Bonded heparin coating to reduce clotting is supported by in-vitro and animal testing.
The catheters are offered in 24cm, 28cm, 32cm, 36cm, 40cm and 55cm lengths.
Catheters longer than 40cm are intended for femoral vein insertion.
Spire Biomedical, Inc.'s 15.5Fr Decathlon Coated catheters are 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 Decathlon Coated catheters are fully coated with CBAS® on the internal surface and on external surface of the catheter body (from 2cm distal to the cuff to the ends of the distal tips; the cuff is not coated).
The coating is essentially non-leaching. Additionally, maximum amount of heparin on the surface is only 1mg. Therefore, even the effect on a patient's coagulation status would be totally insignificant.
Acceptance Criteria and Study for 15.5Fr Decathlon Coated Catheters (K060155)
The provided documentation describes the acceptance criteria and supporting studies for the 15.5Fr Decathlon Coated Catheters, which incorporate a Carmeda® BioActive Surface (CBAS®) coating to reduce thrombus formation.
The "device performance" in this context refers to the coating's ability to maintain bioactivity and reduce thrombus. The acceptance criteria are implicitly derived from the product claims and the results of the performed in-vitro and animal studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Coating Durability/Bioactivity | Heparin's bioactive properties maintained for a minimum of 90 days. | Heparin bioactivity remained essentially constant throughout the 90-day test period in saline. |
| Thrombus Reduction (In-vitro) | Significant reduction in total thrombus accumulation compared to uncoated catheters. | 96% reduction in thrombus accumulation in a two-hour in-vitro thromboresistance study (radiolabeled measurements). |
| Thrombus Reduction (In-vivo/Animal) | Significant reduction in total thrombus accumulation compared to uncoated catheters. | 94% reduction in total thrombus accumulation in an ovine model (thrombus weight measurements). |
| Qualitative Thrombus Reduction | Improved thromboresistance based on visual evaluation and mitigation of disturbed flow-mediated thrombosis and fibrin sheath propagation. | Visual evaluation of catheters showed improved thromboresistance. The coating was effective in mitigating both disturbed flow-mediated thrombosis (at the catheter tip) and fibrin sheath propagation (on the catheter shaft). Optical and scanning electron microscopy showed differences in thrombus accumulation. |
| Catheter Functionality | No adverse impact on blood flow through the catheter. | Pressure increase in the arterial lumen was used as a criterion to determine coating effects, implying that acceptable flow dynamics were maintained. |
| Biocompatibility | Meets requirements for a permanent contact device. | Biocompatibility testing demonstrated that the device meets the requirements for a permanent contact device per ISO 10993. |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- In-vitro Thromboresistance Study: Not explicitly stated, but implies multiple coated and uncoated catheters were tested as part of the "circulation of bovine blood through an outer loop."
- Animal (Ovine) Studies: 3 animals were used for evaluation. Within each animal, one coated and one uncoated catheter were evaluated.
- 90-day Durability Tests: Not explicitly stated how many catheters were tested, but "coated catheters" were used.
- Data Provenance: The studies were conducted by Spire Biomedical, Inc. (submitter). The country of origin for the studies is not explicitly stated but is implied to be in the USA where the company is located. The studies are prospective in nature as they are specifically designed to test the performance of the new coated catheter.
3. Number of Experts and Qualifications for Ground Truth
- No information provided regarding the number or qualifications of experts involved in establishing ground truth for the provided studies.
- For the animal studies, examination "using optical and scanning electron microscopy" would likely involve trained histologists or pathologists, but their specific qualifications are not detailed.
- Visual evaluations in the in-vitro study and interpretation of mechanical/biological data would also involve expert judgment, but again, details are absent.
4. Adjudication Method for the Test Set
- No information provided regarding a specific adjudication method (e.g., 2+1, 3+1). The studies appear to be quantitative (e.g., radiolabeled measurements, thrombus weight) and qualitative (visual evaluation, microscopy) assessments. Expert consensus or arbitration related to the interpretation of results is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was performed. The described studies are focused on the device's inherent biological and physical performance attributes, not on human reader performance with or without AI assistance. The device is a physical catheter, not an AI-powered diagnostic tool.
6. Standalone Performance Study
- Yes, standalone performance studies were done. All described studies (in-vitro, animal, durability, biocompatibility, mechanical properties) evaluate the performance of the catheter itself, without human intervention as part of the primary performance metric. The "algorithm" in this context is the CBAS® coating technology applied to the catheter, and its performance is evaluated directly.
7. Type of Ground Truth Used
- Experimental/Objective Measurements:
- In-vitro Thrombus Reduction: Radiolabeled measurements (objective quantitative data) and visual evaluation (qualitative observation).
- In-vivo Thrombus Reduction (Animal Study): Thrombus weight measurements (objective quantitative data), optical microscopy, and scanning electron microscopy (qualitative and semi-quantitative analysis).
- Coating Durability: Surface-bound heparin bioactivity (pmol/cm2) measurements over time (objective quantitative data).
- Biocompatibility: Conformance to ISO 10993 requirements.
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical device (catheter) with a bioactive coating, not a machine learning or AI algorithm that requires a "training set" in the traditional sense. The coating technology itself is the "algorithm" and its performance is characterized through direct experimentation.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As explained in point 8, there is no "training set" for this device. The ground truth for the device's performance claims is established through the specific experimental methodologies and measurements described in the in-vitro and animal studies.
§ 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.