(57 days)
The Vaxcel™ Plus Chronic Dialysis Catheter is designed for chronic hemodialysis and apheresis. Catheter lengths of 37 cm and 50 cm are indicated for femoral vein insertion.
The major components of the Vaxcel™ Plus Dialysis Catheter are the dual lumen catheter, dead end cap, introducer sheath/dilator, tunneler and CSR wrap.
The provided document is a 510(k) summary for the Vaxcel™ Plus Chronic Dialysis Catheter, dated May 18, 2004. This type of document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
The document does not contain the kind of detailed information requested about acceptance criteria, specific device performance against those criteria, detailed study designs (sample sizes for test and training sets, data provenance, expert qualifications, etc.), or specific statistical analyses (like MRMC studies or standalone performance metrics). This information is typically found in the full 510(k) submission, not in the publicly available summary.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria/Performance: The document states that "All data gathered demonstrate this device as substantially equivalent." This is the overarching acceptance criterion for a 510(k) submission. However, it does not specify what performance metrics (e.g., flow rates, complication rates, material properties) were used to demonstrate this equivalence, nor does it present a direct comparison of those metrics against specific numerical acceptance thresholds. It only mentions the device "has been tested and compared to the predicate device."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | All data gathered demonstrate substantial equivalence to the Vaxcel™ Plus Chronic Dialysis Catheter, Medcomp Split cath II, and Bard Hickman catheter. |
2. Sample size used for the test set and the data provenance
- Not provided. The document does not specify any sample sizes for tests conducted, nor does it mention the country of origin of the data or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. This type of information is relevant for studies involving human interpretation (e.g., imaging devices). For a physical medical device like a catheter, "ground truth" is typically established through engineering tests, clinical performance, and comparisons to predicate device characteristics, not through expert human review in the same way an AI diagnostic tool would be evaluated. The document does not refer to any experts establishing ground truth.
4. Adjudication method for the test set
- Not applicable/Not provided. As with point 3, adjudication methods like 2+1 or 3+1 are used for human-reviewed data, not typically for evaluating a physical device's performance through engineering or clinical tests in this context.
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. This is not relevant to a chronic dialysis catheter. This type of study applies to diagnostic imaging or AI-assisted interpretation, which is not the device's function.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is also not relevant to a chronic dialysis catheter. This applies to AI algorithms.
7. The type of ground truth used
- Implicitly, "substantial equivalence" to predicate devices. For this type of device, "ground truth" isn't a single definitive external reference like pathology for an image. Instead, it's defined by meeting the performance characteristics (e.g., material properties, flow rates, thrombogenicity, biocompatibility, infection rates, ease of insertion, durability) demonstrated by legally marketed predicate devices, which are considered safe and effective for their intended use. This often involves a combination of bench testing, pre-clinical (animal) studies, and, sometimes, limited clinical data comparing performance parameters. The document states, "The Vaxcel™ Plus Chronic Dialysis Catheter and tunneler have been tested and compared to the predicate device."
8. The sample size for the training set
- Not applicable/Not provided. The concept of a "training set" applies to machine learning algorithms. This document describes a physical medical device, not an AI model.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As explained in point 8, "training set" and "ground truth for training" are not relevant here.
§ 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.