(207 days)
Spire Biomedical Inc.'s RetrO Silver™ and XpressO Silver™ Coated Twin Lumen Chronic Hemodialysis Catheters with Separated Tips are designed for chronic hemodialysis and apheresis. They are radiopaque silicone catheters designed for percutaneous insertion or insertion via a cutdown. Catheters longer than 40cm are intended for femoral vein insertion. The silver coating on the catheter may reduce bacterial surface colonization for up to two months. This performance was supported by literature citing clinical testing.
Spire Biomedical, Inc.'s RetrO Silver™ and XpressO Silver™ are radiopaque silicone catheters that have been coated with silver using a physical vapor deposition process. The silver is applied to the distal end of the catheter from approximately 2-5mm below the cuff to the tips, and is on the exterior surfaces of the catheter only. Aside from the silver coating, the catheters have identical physical characteristics to the non-coated RetrO and XpressO catheters, both of which have 510(k) Premarket Approval. The catheter configurations (available lengths and insertion kit components) are also identical. The silver coating is applied by a vacuum-based physical vapor deposition process called ion beam assisted deposition (IBAD). IBAD combines evaporation with concurrent ion beam bombardment. The process is performed under a high vacuum environment. A silver vapor is formed via electron beam evaporation and deposited onto the catheter. Simultaneously, energetic ions bombard the catheter surface and coating as it is deposited. The coating consists of three layers: titanium, palladium, and silver. The film layers are deposited sequentially with the titanium and palladium layers being completely covered by the silver.
This document, K060288, describes the Spire Biomedical, Inc.'s RetrO Silver™ and XpressO Silver™ Coated Twin Lumen Chronic Hemodialysis Catheters with Separated Tips. The key performance claim for these devices is the silver coating's ability to reduce bacterial surface colonization for up to two months.
Here's an analysis of the acceptance criteria and the study that supports it:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reduction of Bacterial Surface Colonization for up to two months | "The silver coating on the catheter may reduce bacterial surface colonization for up to two months. This performance was supported by literature citing clinical testing." (Specifically references Bambauer et al., 2001) |
| Frictional Resistance (Facilitating Insertion) | "On average, the coated catheter provided a 65% reduction in friction against the sheath." (Compared to uncoated catheters) |
| Low Silver Elution Rates | "After 60 days, approximately 0.2% of the total silver on the catheter segment had been released into solution." (Based on saline immersion studies, showing "essentially linear behavior" after the first day's initial rise in concentration.) |
| Equivalent Flows and Mechanical Properties | "The RetrO Silver™ and XpressO Silver™ catheters have demonstrated equivalent flows and mechanical properties compared to the predicate devices." (Predicate devices: Pourchez RetrO and XpressO catheters, which are non-coated versions with 510(k) Premarket Approval.) |
| Biocompatibility | "Biocompatibility testing has been performed on the coated catheters." |
2. Sample Size Used for the Test Set and Data Provenance
For the reduction of bacterial surface colonization, the document refers to a published clinical study by Bambauer et al. (2001). The sample size and specific details of the test set for this study are not provided in the submission itself, but would be found in the referenced publication. The data provenance is implied to be clinical, but the country of origin is not specified in this document. It is a retrospective reference to existing literature.
For frictional resistance, silver coated catheters and uncoated catheters were compared. The document doesn't specify the exact number of catheters in the test set, but states "Tests were conducted at several different normal load conditions" and "All measurements were conducted in the dry state." This was a prospective in-vitro bench test.
For silver elution rates, "segments were cut from the shafts of silver coated catheters" and "Tests were performed in triplicate for periods ranging from 1 day to 8 weeks." This was a prospective in-vitro bench test with a sample size of at least three per time point.
For equivalent flows and mechanical properties, these were compared to predicate devices. The document does not specify the sample size but implies an in-vitro equivalence study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
For the reduction of bacterial surface colonization, the information is based on a referenced clinical study. The number and qualifications of experts involved in establishing the ground truth (e.g., diagnosing infections, culturing bacteria) for that study are not provided in this 510(k) submission.
For the in-vitro tests (frictional resistance, silver elution rates, flows, mechanical properties), "experts" in the traditional sense of medical diagnoses were not involved. The ground truth was established through laboratory measurement protocols and analyses by qualified technical personnel within Spire Biomedical or a contract lab.
4. Adjudication Method for the Test Set
Given the nature of the evidence provided (reference to a clinical study for bacterial colonization, and in-vitro bench testing for other characteristics), there is no mention of an adjudication method (like 2+1 or 3+1 consensus) in this submission. This type of adjudication is typically relevant for studies involving human interpretation of medical images or symptoms, which is not the primary focus of the performance data presented here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported in this submission. The device is a physical medical device (catheter), and its performance data focuses on material properties, bacterial colonization rates, and mechanical equivalence, rather than human interpretation or diagnostic aid. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" does not apply.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
This question is not applicable to this device. The RetrO Silver™ and XpressO Silver™ catheters are physical medical devices, not AI algorithms. Their performance is described in a standalone manner, entirely independent of human-in-the-loop performance in the context of interpretation or decision-making.
7. Type of Ground Truth Used
- Reduction of Bacterial Surface Colonization: The ground truth for this claim is based on clinical testing from referenced literature. This would typically involve microbiological culture results or clinical infection rates.
- Frictional Resistance: The ground truth was established through direct physical measurement using a test rig platform.
- Silver Elution Rates: The ground truth was established through chemical analysis (measuring silver concentration in solution) in laboratory immersion studies.
- Equivalent Flows and Mechanical Properties: The ground truth was established through physical measurements and engineering tests to compare the coated catheters to their non-coated predicate devices.
8. Sample Size for the Training Set
This device does not involve a "training set" in the context of machine learning or AI models. Therefore, this question is not applicable. The performance data is derived from direct testing of the physical device or references to clinical studies, not from a model trained on data.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this physical medical device, this question is not applicable.
§ 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.