(266 days)
The Pristine™ Hemodialysis Catheter is indicated for acute and chronic hemodialysis, apheresis and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40cm implant length are indicated for femoral placement.
Pristine™ Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables a long-term vascular access for hemodialysis and apheresis. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter junction and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of the catheter's distal tip includes a split, symmetric tip with notches and without side-holes nor slots. The symmetric tip design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Hemodialysis Catheter is packed along with a Tunneler and two sealing caps in a vented blister tray and lid, sealed within a Tyvek pouch. The packed catheter and accessories set is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process.
The provided text describes a 510(k) premarket notification for the Pristine™ Hemodialysis Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria in a clinical study against a defined ground truth.
Therefore, many of the requested points, such as detailed acceptance criteria with reported device performance numbers, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable or not provided in this type of regulatory document.
However, based on the information given, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All tests passed and met the predefined acceptance criteria," but it does not provide the specific numerical acceptance criteria or the quantitative reported performance for most of the tests. It only lists the tests performed.
| Test Type | Acceptance Criteria (Not explicitly stated numerically, but implied as "met predefined acceptance criteria") | Reported Device Performance (Not explicitly stated numerically, but implied as "passed") |
|---|---|---|
| Biocompatibility Testing | Compliance with ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-17, ANSI/AAMI T72:2011/(R)2016 and ASTM F 756 standards. | All tests completed with passing results. |
| Cytotoxicity Study | Compliance with ISO 10993-5: 2009 | Passed |
| Sensitization Test | Compliance with ISO 10993-10: 2010 | Passed |
| Irritation Study | Compliance with ISO 10993-10:2010 | Passed |
| Acute Systemic Injection Study | Compliance with ISO 10993-11: 2010 | Passed |
| Pyrogen Study | Compliance with ISO 10993-11:2010 and ANSI/AAMI T72:2011/(R)2016 | Passed |
| Hemocompatibility | Compliance with ASTM F 756, ISO 10993-12:2012 | Passed |
| Complement Activation | Compliance with ANSI/AAMI/ISO 10993-12 | Passed |
| Thrombogenicity | Compliance with ISO 10993-4 | Passed |
| Implantation (13 weeks) | Compliance with ISO 10993-6 | Passed |
| Extractable/leachable Analysis | Compliance with ISO 10993-17 | Passed |
| Subacute/subchronic toxicity, Genotoxicity, Chronic toxicity and Carcinogenicity | Evaluation by extractable/leachable analysis according to ISO 10993-17 | Passed |
| Tunneler and Caps Biocompatibility | Same applicable ISO standards as above for individual tests with similar nature | All tests completed with passing results. |
| Sterilization, Packaging, Shelf Life | Compliance with ISO 11135 and support of labeled shelf life. | All tests successfully completed. |
| Bench Testing (Per FDA guidance Implanted Blood Access Devices for Hemodialysis, 2016) | Predefined acceptance criteria for: Dimensional Attributes, Distal Tip Visual Inspection, Luer Dimensions, Shaft Radiopacity, Flow vs. Pressure, Nominal Flow vs. Pressure, Air leakage during aspiration, Leak, Chemical resistance (Conditioning), Clamp fatigue (Conditioning), Tensile, Kink resistance, Priming volume, Tip recirculation, Mechanical Hemolysis, Hydration, Accessories compatibility analysis. | All tests passed and met the predefined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "testing" and "performance data" without detailing the number of devices or components tested for each bench or biocompatibility test.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The tests performed are laboratory/bench tests and biocompatibility studies, not clinical studies on human subjects. The data would be generated in a lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable in the context of this document. The "ground truth" for the tests mentioned (biocompatibility, bench testing) is defined by established engineering and biological standards (e.g., ISO, ASTM). These are objective measurements against specified criteria, not subjective expert interpretations that require consensus.
4. Adjudication Method for the Test Set
- Not applicable. As described above, the tests are objective measurements against defined standards, not subjective assessments requiring an adjudication process.
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. This type of study is typically performed for diagnostic devices, especially those involving human interpretation of images, to assess the impact of AI on reader performance. The Pristine Hemodialysis Catheter is a physical medical device, not a diagnostic AI system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone performance assessment (in the context of an algorithm) was not done. This device does not involve an algorithm for performance, but rather physical and biological performance characteristics.
7. The Type of Ground Truth Used
- The "ground truth" for the performance data in this submission is based on adherence to international and national standards (e.g., ISO, ASTM, ANSI/AAMI) for medical device performance and biocompatibility. For bench testing, this means meeting predefined engineering specifications and functional requirements. For biocompatibility, it means demonstrating that the materials are safe for biological contact as per established protocols.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No training set is used for this type of device submission.
§ 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.