FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures. The device is used in the same manner as the predicate device and other substantially equivalent 510(k) cleared devices.

AI/ML Overview

This document describes a Special 510(k) submission for a device modification, the UltraStream Chronic Hemodialysis Catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the Hemo-Stream™ True Over the Wire Dialysis Catheter (K071422).

Here's the analysis based on your request, but please note that this document is for a medical device modification and not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested criteria related to AI/SaMD studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of submission. The provided document details a comparison of physical and functional characteristics of the new catheter with its predicate, supported by non-clinical testing.

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for a Special 510(k) of this nature is demonstrating substantial equivalence to a previously cleared predicate device, meaning the new device is as safe and effective as the predicate. This is achieved by showing that the new device has similar technological characteristics and the non-clinical testing supports that there are no new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a device modification, the "acceptance criteria" is essentially the successful demonstration of substantial equivalence to the predicate device, based on the non-clinical tests performed. The "reported device performance" is that these tests revealed the subject device to be substantially equivalent to the predicate device.

Attribute/Test Category	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Functional Testing	Must demonstrate comparable performance to predicate based on ISO 10555-1 and FDA Guidance for Intravascular Catheters.	"Testing results revealed the subject device to be substantially equivalent to the predicate device."
Material Testing	Must meet biocompatibility standards (e.g., ISO 10993).	"Material testing also included ISO 10993 Biocompatibility Testing." (Implied successful completion and comparability).
Technological Characteristics	No significant differences that raise new questions of safety or effectiveness compared to the predicate.	"Bench testing and non-clinical testing supplied within our submission demonstrates that there are not any differences in their technological characteristics thereby not raising any new questions of safety and effectiveness."
Intended Use	Same as the predicate device.	"The subject device... has the same intended use as the predicate device."

2. Sample size used for the test set and the data provenance:

Not applicable for this type of medical device modification. The submission relies on non-clinical comparative functional and material testing, performed in a lab setting, not on patient data or clinical datasets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No expert ground truth establishment for a test set in the context of an AI/SaMD product. The ground truth for device performance is established via standardized engineering and material testing protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There is no "test set" in the sense of a dataset requiring expert adjudication for ground truth. Performance is determined by engineering measurements and observations.

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 a physical medical device (catheter), not an AI/SaMD product. MRMC studies are used for evaluating AI-assisted diagnostic tools.

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 (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device modification is the established performance and safety profiles of the predicate device, as determined by previous clearances and regulatory standards (e.g., ISO standards, FDA guidance documents). The new device is evaluated against these benchmarks through bench testing and material testing.

8. The sample size for the training set:

Not applicable. No training set exists as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable. No training set exists.

Summary of what was done (based on the provided text):

Type of Study: Non-clinical comparative functional testing and material testing.
Purpose: To demonstrate substantial equivalence of the modified UltraStream Chronic Hemodialysis Catheter to its predicate, the Hemo-Stream™ True Over the Wire Dialysis Catheter (K071422).
Methods:
- Functional Testing: Performed based on ISO 10555-1 and the FDA's Reviewer Guidance for Long Term and Short Term Intravascular Catheters. This would involve specific tests to measure flow rates, pressure resistance, strength, durability, etc., in a lab setting.
- Material Testing: Included ISO 10993 Biocompatibility Testing to ensure the materials used are safe for human contact.
- Bench Testing: A general term for laboratory testing of the device's physical and mechanical properties.
Results/Conclusion: "Testing results revealed the subject device to be substantially equivalent to the predicate device." The submission concluded that there were "not any differences in their technological characteristics thereby not raising any new questions of safety and effectiveness."
Clinical Studies: "Not applicable as there are no new indications for use which must be supported by clinical data." This confirms that no human clinical trials were performed or required for this particular modification.

Summary

Regulation Number and Section

§ 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.