(233 days)
The Symetrex Long Term Hemodialysis Catheter 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.
The Symetrex Long Term Hemodialysis Catheter 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.
This document is a 510(k) Summary for the Symetrex Long Term Hemodialysis Catheter. It focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner typically associated with clinical trial outcomes or AI/algorithm performance.
Therefore, many of the requested sections (2-6, 8-9) are not applicable or cannot be extracted from this document as it does not describe a study involving an algorithm or human readers.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable way for the device's functional performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparative functional testing and material testing. The performance is reported as meeting these equivalence standards.
| Acceptance Criteria Category (Implied by equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence | The Symetrex Long Term Hemodialysis Catheter has the same intended use (chronic hemodialysis and apheresis) as the predicate devices. |
| Technological Characteristics Equivalence | Catheter Type: Implanted Vascular Access (Same as predicates) |
| Intended Use: Hemodialysis and Apheresis (Same as predicates) | |
| Lumen Configuration: 2 Kidney Shaped Lumens (Different from one predicate with 2 Kidney Shaped Arterial and 1 Round Venous, but deemed equivalent) | |
| Catheter O.D.: 15.5 Fr. (Same as one predicate, different from another) | |
| Arterial/Venous Access Lumens: Yes (Same as predicates) | |
| Color Coded Female Luers: No (Different from predicates, but indicates interchangeability, implying equivalent safety/functionality) | |
| Color Coded Clamp on Extensions: Yes (Different from predicates) | |
| Suture Wing on Cath. Hub: Yes (Same as predicates) | |
| Catheter Cuff for Tissue In-Growth: Yes (Same as predicates) | |
| Radiopaque Catheter Lumen: 20% Barium Sulfate (Same as predicates) | |
| Offset Tip for Arterial / Venous Separation: Symmetrical Tip (Same as one predicate, different from another with Stepped Tip, but deemed equivalent) | |
| Hub junction for catheter lumen / extension tubing: Injection Molded, One Piece Hub (Same as predicates) | |
| Dilator Provided for Catheter Insertion: 10-12 Fr. Dilator, 12-14 Fr. Dilator (Different sizes from predicates, but dilators are provided) | |
| Tunneling Tool provided for Catheter Insertion: Yes (Same as predicates) | |
| Injection Sites supplied with Catheter: Yes : Qty 2 Latex Free Injection Sites (Same as predicates) | |
| Priming Volume Printed on Female Luers: Yes: Priming Volume Printed on I.D. Tag (Different location/method than one predicate, but still provided) | |
| Catheter Identification and Reference size printed on Catheter Hub: Yes: Name of Catheter Printed on Hub (Different location than one predicate, but still provided) | |
| Safety and Effectiveness Equivalence (Non-Clinical) | Comparative functional testing to predicate devices performed based on ISO 10555-1 and FDA's Draft Guidance. Material testing included ISO 10993 Biocompatibility Testing. The device conforms to special controls mandated by 21 CFR 876.5540. Testing results revealed the subject device to be substantially equivalent to the predicate device, raising no new questions of safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "comparative functional testing" and "material testing" but does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as this document does not describe a study involving expert-established ground truth for a diagnostic or AI device. The ground truth for device performance is established through engineering and material testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as this document does not describe a study involving human readers or adjudication.
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
This information is not applicable. This document describes a medical device (hemodialysis catheter), not an AI system or diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document describes a medical device (hemodialysis catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" is established by:
- ISO 10555-1 standards: These international standards define requirements for sterile, single-use intravascular catheters. Meeting these standards serves as the "ground truth" for functional performance.
- FDA's Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration Staff: This guidance provides the "ground truth" for regulatory expectations and acceptable performance characteristics for such devices.
- ISO 10993 Biocompatibility Testing: These standards establish the "ground truth" for material safety and biological compatibility.
- 21 CFR 876.5540 (Special Controls): This regulation specifies the "ground truth" for mandatory controls for blood access devices.
8. The sample size for the training set
This information is not applicable as this document describes a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this document describes a physical medical device, not an AI model.
§ 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.