(164 days)
The HemoSplit™ long-term hemodialysis catheter is indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion.
HemoSplit Long-Term Dialysis Catheters are dual lumen catheters available in straight and precurved configurations with multiple insertion lengths. HemoSplit catheter bodies are made from a polyurethane material that is radiopaque. The dual lumen shaft has a double-D cross-sectional design with a venous lumen tip opening molded to facilitate over-the-guide wire placement. The arterial and venous lumens are separated a maximum of 8cm proximal to the distal tip of the venous lumen, and are able to float freely in the blood stream. The molded bifurcation has an integral suture wing that is suitable for use with StatLock® securement devices. Each extension leg coming out of the bifurcation has an atraumatic acetal occlusion clamp, which closes to the lumen. The clamps have integral tags with the priming volumes of the individual lumen printed on them. Red and blue colorcoded luer connectors identify the arterial and venous lumens, respectively.
The provided document, K030020, AI Response HemoSplit, describes a 510(k) submission for the HemoSplit Catheter, a long-term hemodialysis catheter. This is a medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices, not on proving effectiveness through clinical trials with human readers or AI.
Therefore, many of the requested categories related to AI performance, expert consensus, and multi-reader multi-case studies are not applicable to this document. The document details non-clinical performance data (bench testing) to show substantial equivalence.
Here's an analysis of the information that is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria and reported device performance in a direct "table" format as requested for AI performance metrics (e.g., sensitivity, specificity). Instead, it states that the device was tested against recognized standards and in-house protocols, and the results met the requirements and demonstrated equivalence.
| Item | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Performance | Conformance to: |
- ISO 594-1:1986 (Luer Taper General Requirements)
- ISO 594-2:1986 (Luer Lock Fittings)
- FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term Intravascular Catheters, dated 3/16/95
- ISO 10555-1:1997 (Sterile, single-use, Part 1 General requirements)
- ISO 10555-3:1997 (Sterile, single-use, Part 3 Central venous catheters) | Bench testing was performed according to the referenced standards and in-house protocols. The test results met the requirements and were compared to the predicate devices. Conclusion: "All test results confirm the modified device to be substantially equivalent to the predicate devices." |
| Biocompatibility | Conformance to: - AAMI/ANSI/ISO-10993-1: 1997 (Biological evaluation of medical devices Part 1: Evaluation and testing)
- FDA Modified ISO 10993 Test Profile | "Results from biocompatibility testing met the requirements of ISO-10993, 'Biological Evaluation of Medical Devices Part-1: Evaluation and Testing' and the FDA Modified ISO 10993 Test Profile for externally communicating blood contacting long term devices." Conclusion: "All test results confirm the modified device to be substantially equivalent to the predicate devices." |
| Sterilization | Conformance to: - AAMI/ANSI/ISO 11135:1994 (Medical devices - Validation and routine control of ethylene oxide sterilization) | (Implied by overall conclusion of substantial equivalence and adherence to standards.) The document states that the sterilization method is equivalent to predicate devices, and adherence to AAMI/ANSI/ISO 11135:1994 indicates validated routine control. Conclusion: "All test results confirm the modified device to be substantially equivalent to the predicate devices." |
| Overall Substantial Equivalence | Demonstration of substantial equivalence to predicate devices (Opti-Flow/HemoGlide and Medcomp Ash Split-Cath II) based on safety and effectiveness. | "Performance data demonstrate that the HemoSplit Long-Term Hemodialysis Catheters are substantially equivalent to the predicate HemoGlide Long-Term Hemodialysis Catheters and Ash Split-Cath II Hemodialysis Catheters." And "The HemoSplit Long-Term Dialysis Catheter met all the performance criteria of the tests performed and, based on FDA's decision tree, is substantially equivalent to the predicate..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for the bench tests. It broadly states "Bench testing was performed" and "design verification testing was conducted." Given this is a 510(k) for a physical medical device, not a diagnostic AI, the "test set" refers to the tested physical units.
- Data Provenance: The testing was non-clinical (bench testing) and conducted internally by Bard Access Systems, Inc. The location of the testing facility is not specified but would likely be within the United States where the company is based. It is prospective testing of manufactured units, not retrospective analysis of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for this device's performance is established by metrological standards and physical measurements as part of bench testing, not by expert interpretation of images or patient data. The experts would be the engineers and quality control personnel performing the tests according to the cited standards.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert opinions or interpretations. The tests are based on objective physical measurements against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a physical medical device (catheter), not an AI-powered diagnostic tool, and did not involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done
Not applicable. This is not an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is derived from recognized international and national standards for medical devices (e.g., ISO, AAMI/ANSI, FDA guidances) and internal design specifications/requirements. This involves quantitative measurements and qualitative assessments (e.g., material compatibility, structural integrity) against predefined criteria.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no AI training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI 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.