(415 days)
Disposable Hemodialysis Access Catheter Sets, including Single-lumen and Dual-lumen, are intended to attain long or short term (less than 30 days) vascular access for hemodialysis via the internal jugular, subclavian or femoral vein.
Disposable Hemodialysis Access Catheter Sets, including Single-lumen and Dual-lumen, are intended to attain long or short term (less than 30 days) vascular access for hemodialysis via the internal jugular, subclavian or femoral vein. It consists of a catheter, a puncture needle, a guide wire and a dilator. The set is provided EO sterilized.
The provided text describes a medical device, a "Disposable Hemodialysis Access Catheter Set," and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity commonly associated with AI/ML devices or diagnostic tools.
The "Test Conclusion" section outlines performance tests conducted, but these are primarily engineering, material, and sterilization validation tests, not clinical performance studies measuring effectiveness in a patient population or against specific clinical endpoints.
Therefore, many of the requested elements for an AI/ML device or diagnostic tool study, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets, are not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria and the "reported device performance" in the context of the engineering and validation tests described.
Here's the information based on the provided text, recognizing the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Per ISO 10993-1:2009 | "The test results were determined to be acceptable" |
| Physical Performance | Per ISO 10555-1:1995/AMD.1:1999/AMD.2:2004(E) and ISO 10555-3:1996/AMD.1:1999, including: |
- Surfaces
- Dimensions
- Mechanical Strength
- Leakage
- Flow Rate
- Fatigue | "The test results demonstrated that the proposed devices comply with the performance standards" |
| Recirculation & Clamping | Recirculation and Repeated Clamp Tests | (Implicitly acceptable as part of overall design specifications met) |
| Sterilization | Per ISO 11135-1:2006 (SAL of 10^-6, acceptable sterilant residual) | "The results demonstrated that the sterilization method and cycle of the proposed device could reach SAL of 10^-6, and the sterilant residual was acceptable" |
| Package Integrity | Seal Strength, Internal Pressure, Dye Penetration | "Performed to evaluate the package integrity of the proposed device to demonstrate that the immediate package could maintain the sterility during its shelf life." (Implicitly acceptable as meeting design specifications) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "laboratory testing" and various ISO standards, which would involve a defined sample size for each test (e.g., number of catheters for mechanical strength, number of samples for biocompatibility), but these specific numbers are not disclosed in this summary.
- Data Provenance: The tests were conducted by Foshan Nanhai Bai He Medical Technology Co., LTD, which is based in Foshan, Guangdong, China. These are laboratory data, not clinical patient data. The nature of these tests is prospective for the device under submission, meaning the tests were performed specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. These are engineering and material validation tests conducted in a laboratory setting against specified standards, not diagnostic or clinical performance studies requiring expert ground truth or assessment of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to resolving discrepancies in expert interpretations for clinical ground truth, which is not relevant to the described laboratory validation tests.
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/ML device or a diagnostic imaging device subject to MRMC studies.
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 set), not an algorithm or AI solution.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the described tests, the "ground truth" refers to the established specifications within the cited ISO standards (e.g., specific tensile strength values, defined biocompatibility parameters, required sterility assurance levels). These are objective, measurable parameters, not clinical ground truth derived from patient data.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 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.