(55 days)
The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheters are indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein as required. Catheters greater than 40cm in length are intended for femoral vein insertion.
The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheter is manufactured from soft radiopaque polyurethane material which provides increased patient comfort while providing excellent biocompatibility. The Hemodialysis Catheter can be connected to an extracorporeal tubing system via a connecting tube equipped with a Luer-Lock connector. The proximal lumen (red clamp) provides "arterial" blood outflow from the patient, the distal lumen (blue clamp) provides "venous" blood return to the patient. Important information such as priming volume and catheter length is printed on both sides of the clamp. The catheter comes in a variety of sizes and lengths with straight or curved extensions.
The provided text describes a medical device called the "NovoFlo Catheter LT Dual Lumen Long Term Hemodialysis Catheter" and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance metrics, or a study that uses statistical analysis with human readers or standalone algorithm performance.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data as might be found in a PMA (Premarket Approval) submission or detailed clinical trial reports.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance thresholds (e.g., sensitivity, specificity, accuracy). The acceptance criteria were based on demonstrating substantial equivalence to the predicate device in terms of design, materials, performance, biocompatibility, safety, and product effectiveness.
- Reported Device Performance: No specific quantitative performance metrics (e.g., flow rates, complication rates, longevity) are reported for the NovoFlo™ Catheter itself. The document states there are "no major differences in design, materials, performance, biocompatibility, safety and product effectiveness" compared to the predicate device.
2. Sample size used for the test set and the data provenance:
- Not applicable. This device is not an AI/diagnostic device that uses a "test set" of patient data in the computational sense. The "tests" mentioned are engineering studies and biocompatibility tests. No human patient data test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" establishment by experts on a test set is described.
4. Adjudication method for the test set:
- Not applicable. No test set adjudication is described.
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 not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Not applicable in the context of diagnostic/AI performance studies. The "ground truth" for the device's substantial equivalence likely refers to established industry standards (ISO, FDA guidances) and the performance characteristics of the predicate device.
8. The sample size for the training set:
- Not applicable. This is not an AI device.
9. How the ground truth for the training set was established:
- Not applicable.
Summary based on provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Design | Substantial equivalence to predicate device (Medcomp Hemo-Flow Catheter) | "no major differences in design" compared to predicate. |
| Materials | Substantial equivalence to predicate device in material composition and properties (soft radiopaque polyurethane) | "no major differences in materials" compared to predicate. |
| Performance | Met engineering standards (FDA Guidances, ISO 10555), substantial equivalence to predicate device in functional performance. | "no major differences in performance" compared to predicate. Engineering studies performed to FDA's "Guidance on Premarket Notification 510(k) Submissions for Short Term and Long Term Intravascular Catheters", "Coronary and Cerebrovascular Guidewire Guidance", and ISO 10555. |
| Biocompatibility | Met ISO 10993 standards and substantial equivalence to predicate device regarding biological safety. | "no major differences in biocompatibility" compared to predicate. Tested according to ISO 10993 - "Biological Evaluation of Medical Devices". |
| Safety | Substantial equivalence to predicate device in terms of patient safety profile and design features (e.g., radiopaque, dual lumen function). | "no major differences in safety" compared to predicate. Device is made from "soft radiopaque polyurethane material", has a "proximal lumen (red clamp)" for "arterial" blood outflow and a "distal lumen (blue clamp)" for "venous" blood return. Priming volume and catheter length are printed on the clamp. |
| Effectiveness | Substantial equivalence to predicate device in achieving long-term vascular access for hemodialysis and apheresis. | "no major differences in product effectiveness" compared to predicate. Indicated for "Long Term vascular access for hemodialysis and apheresis," and can be inserted percutaneously in internal jugular, subclavian, or femoral veins (for >40cm catheters), consistent with the indicated use. "The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheter was demonstrated to be substantially equivalent to the predicate device based on its design, test results, and indications for use." |
2. Sample size used for the test set and the data provenance:
- Not applicable. The provided document details a 510(k) submission for a physical medical device, not a diagnostic algorithm. The "tests" were engineering studies and biocompatibility evaluations, not clinical studies with patient data test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" involving expert consensus on patient data is mentioned.
4. Adjudication method for the test set:
- Not applicable.
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 not an AI device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used:
- For the purpose of the 510(k) submission, the "ground truth" was the established characteristics and performance of the legally marketed predicate device (Medcomp Hemo-Flow Catheter), as well as adherence to recognized industry standards (ISO 10555, ISO 10993) and FDA guidance documents.
8. The sample size for the training set:
- Not applicable. This is not an AI device.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.