(347 days)
- The Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for Hemodialysis therapy and apheresis.
- It may be inserted percutaneously and is primarily placed in the internal jugular vein of an patient.
- Alternate insertion sites include subclavian vein as required.
- Catheters greater than 40 cm are intended for femoral vein insertion.
- The curved Hemodialysis Catheter is intended for internal jugular vein insertion.
- 8-10Fr Hemodialysis Catheters can be used in pediatric patients.
The Hemodialysis Catheter is indicated for use in attaining vascular access for Hemodialysis and Apheresis therapy. The catheter tubing is made of radiopaque polyurethane with a dual D cross-sectional design, providing independent arterial and venous lumens. The proximal end of the catheter features two luer connectors. The luer connectors are connected to extension legs. The extension legs are made of silicone material. Each extension leg has a catheter clamp, which is durable and can effectively ensure timely closure of the extension leg. The lumen with the red catheter clamp, which is called arterial lumen, is used for blood outflow; The lumen with the blue catheter clamp, which is called venous lumen, is used for blood return. The arterial and venous lumen priming volumes are printed directly on the ID ring of the clamp. Catheters range from approximately 13-55 cm long and are offered in straight or curved catheter configurations with cuff for long-term implantation. The Hemodialysis Catheter is packaged in a tray with legally marketed accessories intended for use during catheter placement. The Hemodialysis Catheter Kit is provided sterile, single use.
The provided FDA 510(k) clearance letter and associated documentation for the Hemodialysis Catheter (K241581) primarily detail the regulatory approval process, comparison to predicate devices, and non-clinical performance testing. It does not contain information about acceptance criteria for device performance based on clinical study data, nor does it describe a study that validates the device performance against such criteria in a clinical setting.
The document specifically states: "Clinical test: Clinical testing is not required." This indicates that the clearance was based on non-clinical performance data and substantial equivalence to legally marketed predicate devices, not on direct clinical evidence of the device's performance in patients.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance from a clinical study.
- Sample sizes used for the test set and data provenance from a clinical study.
- Number of experts used to establish ground truth and their qualifications from a clinical study.
- Adjudication method for a clinical study.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only without human-in-the-loop performance) study.
- Type of ground truth used in a clinical study.
- Sample size for the training set from a clinical study.
- How ground truth for the training set was established in a clinical study.
The provided document focuses on the following types of performance data, which are non-clinical in nature:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical)
While not presented in a table with specific pass/fail metrics, the document implies that the device met the requirements of the following standards and guidance:
- FDA guidance "Implanted Blood Access Devices for Hemodialysis, issued on January 21, 2016"
- ISO 10555-1:2013 (Sterile, single-use intravascular catheters - Part 1: General requirements)
The following non-clinical tests were performed to demonstrate compliance:
| Test/Criteria Category | Reported Device Performance and Compliance |
|---|---|
| Physical and Mechanical Performance | |
| Visual Assessment | Performed according to requirements (implied acceptance) |
| Air and Liquid Leakage Testing | Performed according to requirements (implied acceptance) |
| Catheter Tensile Testing | Performed according to requirements (implied acceptance) |
| Repeated Clamping | Performed according to requirements (implied acceptance) |
| Priming Volumes | Accurate volumes printed on ID ring of clamp (implied acceptance as per standard practice). Measured for compliance. |
| Luer Connector | Conforms to ISO 80369-7:2021 (Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications) |
| Pressure Versus Flow Rates | Performed according to requirements (implied acceptance). Data demonstrates that the difference in O.D. (size range) compared to predicate does not affect safety and effectiveness. |
| Recirculation Rate | Performed according to requirements (implied acceptance) |
| Mechanical Hemolysis Testing | Performed according to requirements (implied acceptance) |
| Chemical Tolerance Testing | Performed according to requirements (implied acceptance) |
| Particulate Contamination Testing | Performed according to requirements (implied acceptance) |
| Dimension Testing | Overall dimensions (length, O.D.) within acceptable ranges. Data demonstrates that the difference in O.D. (broader size range, e.g., 8F~15.5F) compared to predicate (12.5Fr) does not affect safety and effectiveness. Pediatric catheter (8-10Fr) performance test results compared against K202150 (a predicate for pediatric use) and toxicological risk assessment based on children's weight proved non-inferiority. |
| Biocompatibility | The compatibility of patient-contacting materials (PU and Silicone) meets requirements. Evaluation and tests comply with ISO 10993-1: "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process." |
| Sterilization | EO sterile for single use. Complies with ISO 11607-1:2019 (Packaging for terminally sterilized medical devices) and ISO 11135:2014 (Sterilization of health care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices). |
| Shelf Life | Accelerated aging tests confirmed the validity of the 3-year shelf life. |
2. Sample Sized Used for the Test Set and the Data Provenance
- Not Applicable for Clinical Data: The document explicitly states "Clinical testing is not required."
- For Non-Clinical Data: Specific sample sizes for each non-clinical test (e.g., tensile testing, leakage testing) are not detailed in this summary document. Data provenance is implied to be from internal lab testing conducted by Haolang Medical USA Corporation, in compliance with the cited ISO standards and FDA guidance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable as clinical testing with expert-established ground truth was not performed or required for this 510(k) clearance.
4. Adjudication Method for the Test Set
- Not applicable as clinical testing with an adjudication method was not performed or required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Not applicable. This type of study is typically for AI/imaging device performance evaluation, not for a physical device like a hemodialysis catheter, and certainly not for a clearance that states "Clinical testing is not required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not a software/AI device.
7. The Type of Ground Truth Used
- For Non-Clinical Testing: The "ground truth" for the non-clinical tests is adherence to the specified performance requirements as outlined in the referenced ISO standards (e.g., ISO 10555-1) and FDA guidance documents for hemodialysis catheters (e.g., "Implanted Blood Access Devices for Hemodialysis"). This involves objective, measurable physical, mechanical, and biological properties.
8. The Sample Size for the Training Set
- Not applicable. This refers to training data for AI/ML algorithms, which is not relevant to this device's clearance.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
In summary, the FDA 510(k) clearance for the Hemodialysis Catheter (K241581) was granted based on a substantial equivalence determination supported by comprehensive non-clinical performance testing (physical, mechanical, biocompatibility, sterilization, and shelf-life) against recognized industry standards and FDA guidance, rather than a clinical study with patient data and expert-derived ground truth.
§ 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.