(63 days)
The Zenysis™ Short-Term Dialysis Catheter, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required.
Zenysis™ Short-Term Dialysis Catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into two separate lumens permitting continuous blood flow. Both the venous (blue) and the arterial (red) lumens may be used for hemodialysis, hemoperfusion, and apheresis treatments. The Attachable Suture Wing and Attachable Suture Wing Fastener will be used to support the Zenysis™ Short-Term Dialysis Catheter, as securement devices to fixate the exposed portion of the catheter shaft to the patient's skin. The subject device included in this submission will be offered in varying French size and catheter configuration types, as summarized in the table below: Straight Extension Legs with Insertion Lengths of 15 cm, 20 cm, 24 cm and Precurved Extension Legs with Insertion Lengths of 12.5 cm, 15 cm, 20 cm, 24 cm. The subject catheters will be packaged with legally marketed components used in the placement procedure.
The provided document is a 510(k) premarket notification for the Zenysis™ Short-Term Dialysis Catheter. It does not describe a study involving an AI/algorithmic device or human readers. Instead, it focuses on demonstrating substantial equivalence to a predicate device through technological characteristic comparisons and performance testing to ensure safety and effectiveness.
Therefore, most of the information requested in your prompt (acceptance criteria tables, sample sizes for test/training sets for AI, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, type of ground truth used for AI) is not applicable to this document.
However, I can extract the acceptance criteria and performance related to the device itself from the safety and performance testing section.
Here's the relevant information that can be extracted from the provided document:
Study Type: This is a medical device substantial equivalence submission (510(k)), not a study on an AI/algorithmic medical device. It involves bench testing of the physical catheter, not evaluation of a diagnostic algorithm's performance with human readers.
Acceptance Criteria and Device Performance for Zenysis™ Short-Term Dialysis Catheter
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Priming Volumes | Device met predetermined acceptance criteria based on listed industry standards and in-house protocols. |
| Assembly Leak Resistance | Device met predetermined acceptance criteria based on listed industry standards and in-house protocols. |
| Hemolysis | Device met predetermined acceptance criteria based on listed industry standards (ASTM F756, ASTM F1841). |
| Tip Tensile Strength | Device met predetermined acceptance criteria based on listed industry standards and in-house protocols. |
| Recirculation | Device met predetermined acceptance criteria based on listed industry standards and in-house protocols. |
| Dialysis Flow Testing and Collapse | Device met predetermined acceptance criteria based on listed industry standards and in-house protocols. |
| Shaft to Bifurcation Tensile Strength | Device met predetermined acceptance criteria based on listed industry standards and in-house protocols. |
| Radiopacity | Device met predetermined acceptance criteria based on listed industry standard (ASTM F640). |
| Shaft Stiffness | Device met predetermined acceptance criteria based on listed industry standards and in-house protocols. |
| Catheter Shaft Outer Dimensions | Device met predetermined acceptance criteria based on listed industry standards and in-house protocols. |
| Extension Leg to Bifurcation Tensile Strength | Device met predetermined acceptance criteria based on listed industry standards and in-house protocols. |
| Assembly Burst Strength | Device met predetermined acceptance criteria based on listed industry standards and in-house protocols. |
| Axial Restraint | Device met predetermined acceptance criteria based on listed industry standards and in-house protocols. |
| Overall Safety & Performance | The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device. |
Details from the document that are not applicable to the AI prompt but are included for context:
- Sample size used for the test set and the data provenance: Not applicable to an AI device. The testing here refers to physical product testing (bench tests) on the Zenysis™ catheter. The document does not specify the number of catheters tested for each metric, but mentions "Verification tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI and expert consensus are not relevant here.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI device. For this physical medical device, "ground truth" would be established by physical measurements, material properties, and functional performance testing against established engineering and medical standards.
- The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Relevant Guidance Documents and Standards Used for Testing:
- Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
- Draft Guidance for Industry and Food and Drug Administration Staff: Implanted Blood Access Devices for Hemodialysis, June 28, 2013
- ISO 10555-1:2013, Sterile, single-use intravascular catheters – Part 1: General requirements
- ISO 10555-3:2013, Sterile, single-use intravascular catheters – Part 3: Central Venous catheters
- ASTM F640:2012, Standard Test Methods for Determining Radiopacity for Medical Use
- ASTM F756:2013, Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F1841:1997 (R2013), Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
- ISO 10993-1 CORR1:2010. Biological Evaluation of Medical Devices: Part 1 - Evaluation and Testing
- ISO 14971:2012, Medical Devices - Risk Management for Medical Devices (for Risk Management/FMEA)
§ 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.