(307 days)
GamCath® High Flow Dolphin® catheters are indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein. GamCath® High Flow Dolphin® Catheter is not intended for use in pediatric patients.
The GamCath® High Flow Dolphin® Catheters are single use medical devices for short term use to obtain vascular access in patients with acute or chronic renal failure. The GamCath® High Flow Dolphin® Catheter combines the GamCath® High Flow Catheter with an additional coating based on a block copolymer. The polymer layer results in a surface structure that locks in barium sulfate particles. The coated catheter is free of heparin, therefore the use of the catheter is not contraindicated in patients with HIT syndrome. Catheters made of Polyurethane are equipped with small rotatable Polypropylene suture rings, still allowing rotation of catheter when sutured to skin. Polyurethane Extension lines, present on each lumen, are equipped with PVC luer-lock connectors according to ISO 594-1 with Polyethylene protection caps and are provided with clamps which may be color coded to indicate the venous (blue), arterial (red). Clamp inserts bear easily legible and permanently fixed imprints indicating usable catheter length and outer diameter of catheter shaft (in French calibration) as well as priming volumes. The Catheter is available in 13 French and 11.5 French straight and curved extension line configuration. An inner dilator made of FEP is provided in the venous lumen for insertion. The insertion length is available in range from 150 mm (5.906") up to 250 mm (9.843"). The Dolphin coating is a co-polymer film which is applied over the catheter surface to form a continuous surface that has a smoother surface morphology than an untreated catheter. The copolymer film is formed by providing a hydrophobic polymer block, such as polydimethylsiloxan (PDMS) with functional -OH end groups.
The GamCath® High Flow Dolphin® Catheter is a short-term hemodialysis catheter. The study provided does not describe a clinical trial with human subjects or a comparison to human performance or AI. Instead, the "study" is a series of non-clinical, benchtop tests designed to demonstrate substantial equivalence to predicate devices and ensure the device meets recognized safety and performance standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 | Successfully passed (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute Systemic toxicity, Genotoxicity, and Hemolysis) |
| Sterilization | Validation as per ISO 11135-1 and 10993-7 | Ethylene Oxide sterilization validated |
| Package Integrity | Integrity maintained | Successfully passed |
| Catheter Integrity | No air or liquid leakage (as per ISO 10555-1) | Demonstrated by testing for air and liquid leakage |
| Clamping | Absence of visible delamination or detachable particles after 300 cycles | Showed absence of visible delamination or detachable particles |
| Pressure Drop | Pressure within acceptable range over flow rates | Measured over the range of flow rates |
| Tensile Strength | Compliance with ISO 10555-1 for various connection points | Verified for Connector to extension line, Extension line to hub, Hub to catheter shaft, and Catheter shaft to tip |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample sizes for each non-clinical test.
- Data Provenance: Not applicable. These were non-clinical, benchtop tests conducted to verify compliance with standards, not a clinical study involving human patients or real-world data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. The ground truth for these non-clinical tests is based on established engineering and biocompatibility standards (e.g., ISO 10993-1, ISO 11135-1, ISO 10555-1) and the successful execution of validated test protocols by qualified personnel in a laboratory setting. There is no mention of expert consensus for interpreting test results in the way it would be established for clinical image analysis or diagnostics.
4. Adjudication Method for the Test Set
- Not applicable. As these are non-clinical, objective tests against established standards, an adjudication method for a "test set" (in the sense of a clinical or image-based evaluation) is not required. Test results are compared directly to the specified criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance testing of a medical device, not an AI or diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device (catheter), not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical tests is a combination of recognized industry standards (e.g., ISO 10993-1, ISO 11135-1, ISO 10555-1) and predefined engineering specifications for the device's performance characteristics (e.g., specific tensile strength values, acceptable pressure ranges, absence of leakage).
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI context, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI model, the method of establishing its ground truth is irrelevant 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.