(449 days)
The LifeSite Hemodialysis Access System provides fully implantable blood access for chronic (long term) hemodialysis. It is intended for use in patients who would otherwise be treated with standard cuffed hemodialysis catheters. A 70% isopropyl alcohol solution is used in conjunction with the LifeSite System for the localized cleansing of the access site (buttonhole), valve pocket and LifeSite valve.
The LifeSite Hemodialysis Access System is a dialysis access device comprised of two separate valves and cannulas. One valve/cannula is used as the draw and the other valveleannula is the return. The cannulas are placed in cither the internal or external jugular or subclavian veins. They are manufactured from radiopaque silicone. The cannula ends connect to the valves, which are placed in a subcutancous pocket. The values are manufactured from titanium and stainless steel. When accessed with a 14 gauge, fistula needle the valves internal pinch clamp opens allowing access to the vein via the cannula.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the LifeSite® Hemodialysis Access System:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides acceptance criteria mainly through a simulated use test for device longevity and a clinical study for patient safety and equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Simulated Use Testing: | |
| Device functionality over long-term use (6000 actuations, approximately 38 years) | All valves operated properly for 6000 actuations. |
| Leak-testing after every 100 actuations | No leaks were observed after every 100 actuations. |
| Clinical Study: | |
| Patient safety for chronic (long-term) hemodialysis use | Safe for use in patients who require chronic (long-term) hemodialysis when used with 70% isopropyl alcohol. |
| Substantial equivalence to predicate device (LifeSite Hemodialysis Access System and Medical Components Inc. Tesio®-Cath Catheter) | Found to be substantially equivalent to the predicate device. |
2. Sample Size and Data Provenance
- Test Set (Clinical Study): 67 patients, with 25 of those patients on dialysis using LifeSite for 12 months in the alcohol trial.
- Data Provenance: The document does not explicitly state the country of origin. It is a clinical study, implying prospective data collection.
3. Number of Experts and Qualifications for Ground Truth
- The document does not mention the use of experts to establish a "ground truth" in the traditional sense of image interpretation or diagnostic accuracy for this device. The evaluation is based on direct device performance (simulated use) and clinical outcomes (patient safety and equivalence).
4. Adjudication Method
- Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic accuracy studies where expert consensus is needed to determine the true positive/negative status of a case. This is not applicable to the studies described for the LifeSite system, which focus on device function and clinical safety/equivalence.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of the studies presented for the LifeSite Hemodialysis Access System.
6. Standalone Performance Study
- Yes, a form of standalone performance was done through the "Simulated use testing of the LifeSite Valve." This test evaluated the device's functionality and integrity (leak-testing) independent of human interaction during its long-term simulation. The clinical study also assesses the device's performance in a standalone capacity within patients, albeit with human use involved.
7. Type of Ground Truth Used
- Simulated Use Testing: The "ground truth" was the physical performance and integrity of the device itself (e.g., proper operation, absence of leaks).
- Clinical Study: The "ground truth" was established through patient safety outcomes and a comparison of the device's performance against a predicate device to determine substantial equivalence. This would involve clinical observations, adverse event tracking, and potentially various clinical measurements relevant to hemodialysis access.
8. Sample Size for the Training Set
- The document does not describe a "training set" in the context of an AI/machine learning model. The studies described are for the validation of a medical device, not the development of an algorithm.
9. How Ground Truth for the Training Set Was Established
- Not applicable, as no training set for an AI/machine learning model is described in the provided text.
§ 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.