(107 days)
The HemoCath Hemodialysis/Apheresis Catheter is indicated for use in attaining long term vascular access for hemodialysis or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.
The HemoCath is a radiopaque silicone, double lumen catheter used to remove and return blood through two segregated circular lumen passages. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed Dacron cuff allows for tissue ingrowth for long-term placement.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document is a 510(k) summary for a medical device (HemoCath Hemodialysis/Apheresis Catheter) seeking clearance from the FDA. It does not describe an "AI device" or a study in the typical sense of evaluating software performance with AI. Instead, it describes a medical device undergoing a regulatory review process for substantial equivalence to existing legally marketed devices. Therefore, many of the requested fields related to AI, software performance, expert reviews, ground truth, and training sets are explicitly not applicable.
Here's the information extracted and contextualized:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria/Performance Goal: To demonstrate substantial equivalence to legally marketed predicate devices in terms of performance. The specific performance criteria for central venous catheters (like flow rate and tensile strength) are implied to be met.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|---|
| Flow Rate | Substantially equivalent to predicate devices | Substantially equivalent to predicate devices | The document states, "Information submitted... includes in vitro performance data for the HemoCath including flow rate... that is substantially equivalent to the legally marketed devices." Detailed quantitative values are not provided in this summary. The expectation is that the HemoCath's flow rate performance is comparable to or within acceptable ranges of the predicate devices. |
| Tensile Strength | Substantially equivalent to predicate devices | Substantially equivalent to predicate devices | Similar to flow rate, the document confirms that "tensile strength that is substantially equivalent to the legally marketed devices" was demonstrated. This refers to the catheter's ability to resist breaking under tension, a critical safety and durability aspect. |
| Other Performance Characteristics | Substantially equivalent to predicate devices | Not explicitly detailed, but implied as "substantially equivalent" | The summary indicates that substantial equivalence was shown for "design, material type, performance, and method of sterilization." This implies other relevant performance characteristics for a long-term intravascular catheter (e.g., biocompatibility, resistance to kinking, radiopacity) were also addressed and found to be equivalent, even if not itemized with specific data. |
Study that Proves the Device Meets the Acceptance Criteria:
The document explicitly states that "Clinical data was not deemed necessary since in vitro testing was sufficient to demonstrate safety and efficacy by way of comparison to legally marketed predicate device intended for hemodialysis and apheresis treatments."
Therefore, the "study" was an in vitro performance study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the 510(k) summary. For in vitro testing of a physical device like a catheter, the sample size would typically refer to the number of catheters tested for each metric (e.g., X number of catheters for flow rate, Y for tensile strength). This level of detail is usually found in the full 510(k) submission, not the summary.
- Data Provenance: The data is from in vitro testing. It does not involve human subjects or retrospective/prospective collection of patient data. Therefore, country of origin is not applicable in the patient data sense; the testing would have been conducted by the manufacturer or a contract lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This was an in vitro engineering/performance test, not a study requiring expert clinical review or interpretation of patient data to establish ground truth. The "ground truth" here would be objective physical measurements of the catheter's performance against established engineering standards or predicate device performance.
4. Adjudication Method for the Test Set
- Not applicable. There was no human interpretation or subjective assessment of the test set data that would require an adjudication method. The results were objective measurements (e.g., flow rate in ml/min, tensile strength in N).
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
- No, an MRMC comparative effectiveness study was not done. This is a physical medical device (catheter), not an AI algorithm, and therefore this type of study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Objective physical measurements and engineering standards.
- For flow rate: Measurements of fluid volume over time.
- For tensile strength: Measurements of force at which the catheter breaks.
- Comparison was made against the performance of legally marketed predicate devices (DermaPort™ Access Device and RetrO™ Catheter) and likely against relevant international or industry standards for such devices.
8. The Sample Size for the Training Set
- Not applicable. This pertains to a physical medical device developed through engineering and manufacturing processes, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set was used for an AI algorithm. The "ground truth" in the context of developing this catheter would involve engineering specifications, materials science data, and performance characteristics derived from predicate devices and industry standards.
§ 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.