(104 days)
THE MEDCOMP EXCELL™ SPLIT-TIP CATHETER IS 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. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.
The Medcomp Excell™ Split-Tip Catheter is a 15F polyurethane, double lumen catheter used to remove and return blood through two, segregated furnen passages. Both lumens are "D" shaped, open at the distal tip, with two side holes. The distal venous lumen is tapered and extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long-term placement. The arterial and venous lumens now are designed to be split, or peeled apart, prior to insertion to provide two free-floating lumens within the vessel. The lumens are connected to the extensions via a soft pliable hub with suture wing. The arterial and venous extensions are identified by red and blue luer connectors and clamps. Priming volume information is printed on the I.D. rings for ease in identification.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medcomp Excell™ Split-Tip Catheter:
Acceptance Criteria and Device Performance
The provided document describes the modification of a legally marketed device and asserts its substantial equivalence to predicate devices. The "acceptance criteria" are implied by the performance data demonstrating "substantial equivalence." However, explicit, quantifiable acceptance criteria with pass/fail thresholds are not stated in the document.
The performance data focuses on demonstrating that the modified device performs similarly to existing, legally marketed devices for hemodialysis and apheresis treatments.
Here's a table based on the provided information:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to legally marketed predicate devices | Demonstrated through in vitro testing. |
| Performance in recirculation (similar to predicate devices) | Data indicates performance is "substantially equivalent." |
| Performance in gravity flow (similar to predicate devices) | Data indicates performance is "substantially equivalent." |
| Performance in flow vs. pressure (similar to predicate devices) | Data indicates performance is "substantially equivalent." |
| Lumen peel strength/integrity (similar to predicate devices) | Data indicates performance is "substantially equivalent." |
| Safety (similar to predicate devices) | Clinical studies were not deemed necessary as in vitro testing was sufficient to demonstrate safety by way of comparison to legally marketed predicate devices. |
| Effectiveness (similar to predicate devices) | Clinical studies were not deemed necessary as in vitro testing was sufficient to demonstrate effectiveness by way of comparison to legally marketed predicate devices. |
| Specific quantified criteria (e.g., recirculation Y ml/min) | Not explicitly stated in the provided document. The criteria are implicitly tied to the performance characteristics of the predicate devices. |
Note regarding "Acceptance Criteria": The document does not explicitly list quantified acceptance criteria (e.g., "recirculation must be less than 5%"). Instead, it states that the device was tested to demonstrate "substantial equivalence" to predicate devices for specific performance characteristics. This implies that the acceptance criteria were met if the device's performance in these tests was comparable to that of the predicate devices, falling within an acceptable range for the intended use.
Study Details (Based on the provided text)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The study involved "in vitro performance data," which typically refers to laboratory testing and might involve multiple samples of the device, but the exact number is not provided.
- Data Provenance: The study was an in vitro performance test, meaning it was conducted in a laboratory setting, not on human subjects. The country of origin for the data is not explicitly mentioned, but the submitter is a U.S. company (Harleysville, PA). It is by definition a prospective study in that the testing was performed on the device designed for submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This was an in vitro performance study comparing the device to predicate devices. There was no "ground truth" established by human experts in the context of clinical observations or diagnoses. Instead, the performance parameters of the device were measured and compared.
- Qualifications of Experts: Not applicable for establishing ground truth.
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Adjudication method for the test set:
- Adjudication Method: Not applicable. As an in vitro performance study, there was no need for expert adjudication of results in the way it would be required for clinical image analysis or diagnostic studies. The results were likely derived from standardized test protocols and measurements.
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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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a medical catheter, not an AI software intended for interpretation by human readers.
- Effect Size of AI assistance: Not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm. Therefore, "standalone" performance for an algorithm doesn't apply. The in vitro testing represents the "standalone" performance of the physical device in a controlled environment.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable in the traditional sense of clinical "ground truth." For in vitro performance studies, the "ground truth" is typically defined by standardized physical measurements, engineering specifications, and the established performance characteristics of the predicate devices. The "truth" is that the device should perform comparably to its predicates under controlled test conditions.
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The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" for the device itself.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable for the reasons stated above (physical device, no machine learning 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.