(168 days)
The Symetrex™ Long Term Hemodialysis Catheter with Sideholes is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.
Long term, greater than 30 days, vascular access for Hemodialysis and Apheresis treatments.
The Symetrex™ Long Term Hemodialysis Catheter with Sideholes is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to anchor the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.
Here's a breakdown of the acceptance criteria and study information for the Symetrex™ Long Term Hemodialysis Catheter with Sideholes, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily demonstrated through equivalence to the predicate device and compliance with various ISO and ASTM standards. The document doesn't explicitly state quantitative acceptance criteria in all cases, but rather reports the device performance against established standards through "performance testing."
Key performance aspects are outlined in the comparison to the predicate device and in the performance standards section.
| Performance Aspect | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Recirculation | Less than 1% recirculation in forward and reverse flow (implied by predicate's performance) | Symetrex™ Long Term Hemodialysis Catheter with Sideholes has less than 1% recirculation in forward and reverse flow when tested in vitro. |
| Priming Volumes | Match predicate device for various tip-to-cuff lengths (e.g., 2.1cc for 19cm, 2.3cc for 23cm, etc.) | Matches predicate device: |
| 19cm: 2.1cc | ||
| 23cm: 2.3cc | ||
| 28cm: 2.5cc | ||
| 33cm: 2.6cc | ||
| 37cm: 2.8cc | ||
| 42cm: 3.2cc | ||
| Physical/Mechanical | Compliance with ISO 10555-1 (e.g., Air Leak, Catheter Leak, Extension-Hub, Extrusion-Hub, Gravity Flow) | "Performance testing was performed in accordance with... ISO 10555-1" for Air Leak, Catheter Leak, Extension-Hub, Extrusion-Hub, Gravity Flow. (Implies compliance, but no specific values are given.) |
| Packaging | Compliance with ISO 11607-1 and ISO 11607-2 (e.g., Shipping and Shelf Life testing) | "Performance testing was performed in accordance with... ISO 11607-1" and "ISO 11607-2" for Shipping and Shelf Life testing. (Implies compliance.) |
| Luer Fittings | Compliance with ISO 594-1 (Gauging) and ISO 594-2 (Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking) | "Performance testing was performed in accordance with... ISO 594-1" for Gauging, and "ISO 594-2" for Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking. (Implies compliance.) |
| Biocompatibility | Compliance with various ISO 10993 series and ASTM standards for blood-contacting implants with permanent exposure (> 30 days) | "Biocompatibility was performed... per ISO 10993-1 for a blood implant device with permanent exposure (i.e. > 30 days). Biocompatibility was performed on the final, finished device." Specific tests listed (Hemocompatibility, Genotoxicity, Cytotoxicity, Irritation/Intracutaneous, Acute Systemic Toxicity, Implantation, Additional Testing) were conducted. (Implies satisfactory results based on these standards.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the performance testing (test set) for the device. It also does not provide information on data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are primarily in vitro (Recirculation) or bench/laboratory testing (physical, mechanical, packaging, luer fittings, biocompatibility).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The studies described are non-clinical, benchtop, and in vitro tests governed by engineering and scientific standards, rather than clinical trials requiring expert-established ground truth in the medical diagnostic sense.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable and therefore not provided in the document. The studies are non-clinical hardware tests.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document pertains to a physical medical device (catheter), not an AI-powered diagnostic system. Therefore, the concept of "human readers improve with AI" is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical catheter, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the non-clinical performance testing and biocompatibility studies, the "ground truth" is established by:
- Engineering and Scientific Standards: Compliance with relevant ISO and ASTM standards (e.g., ISO 10555-1 for intravascular catheters, ISO 11607-1 for packaging, ISO 594-1/2 for luer fittings, and various ISO 10993 parts for biocompatibility).
- Measurement and Comparison: Direct measurement of physical properties (e.g., priming volumes) and comparison to the predicate device.
- Established Test Methods: In vitro testing for recirculation rates.
8. The Sample Size for the Training Set
This information is not applicable as there is no "training set" in the context of this physical medical device. The device is not learning-based.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this physical medical device.
§ 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.