(92 days)
The Hemo-Stream™ True Over the Wire Dialysis Catheter is designed for chronic hemodialysis and apheresis.
The Rex Medical Hemo-Stream™ True Over the Wire Dialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures. The Hemo-Stream™ True Over the Wire Dialysis Catheter will be available in lengths of 24, 28, 32, 36 and 40cm. The device is used in exactly the same manner as the predicate devices and other substantially equivalent 510(k) cleared devices.
The provided text describes a Special 510(k): Device Modification for the Hemo-Stream Hemodialysis Catheter. This type of submission is for modifications to a previously cleared device, asserting substantial equivalence to predicate devices, rather than establishing de novo performance criteria against a disease or condition. Therefore, the traditional concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" as it would apply to a diagnostic or AI-driven device with performance metrics (like sensitivity, specificity, etc.) is not directly applicable here.
Instead, the acceptance criteria for this type of submission are based on demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. The "study" in this context is a series of non-clinical (bench) tests and material testing to show that the modified device performs comparably to its predicates and does not raise new questions of safety or effectiveness.
Here's how the information aligns with your request:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally that the modified device's performance in relevant non-clinical tests is comparable to or better than that of the predicate devices, and that its technological characteristics do not introduce new safety or effectiveness concerns.
| Attribute Tested | Acceptance Criteria (Implicit) | Reported Device Performance (Hemo-Stream™ True Over the Wire Dialysis Catheter) |
|---|---|---|
| Functional Testing | Performance comparable to or better than predicate devices according to ISO 10555-1 and FDA's Reviewer Guidance for Long Term and Short Term Intravascular Catheters. | "Testing results revealed the subject device to be substantially equivalent to the predicate devices." |
| Material Testing (Biocompatibility) | Meeting standards outlined in ISO 10993 for biocompatibility. | "Material testing also included ISO 10993 Biocompatibility Testing." (Implies satisfactory results) |
| Intended Use | Same as predicate devices. | "The Hemo-Stream™ True Over the Wire Dialysis Catheter is designed for chronic hemodialysis and apheresis." (Same as predicates) |
| Technological Characteristics | No significant differences from predicate devices that raise new questions of safety or effectiveness. | Bench testing and non-clinical testing demonstrate no new questions of safety and effectiveness. |
| Safety and Effectiveness | Equivalent to predicate devices. | Determined to be substantially equivalent with no new questions of safety or effectiveness. |
Details Regarding the "Study" (Non-Clinical Testing)
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not explicitly state the sample sizes for the non-clinical tests. Non-clinical tests typically involve a defined number of device units tested according to standardized methods, but these numbers are not disclosed here.
- The data provenance is from non-clinical (bench) testing performed by the manufacturer, Rex Medical, LP, in the United States (Conshohocken, PA). This is implicitly prospective testing, as it was performed to support the 510(k) submission for the device modification.
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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. As this is a non-clinical (bench) study, "experts" in the context of clinical ground truth (like radiologists) are not involved in the test execution or data interpretation. The ground truth for such tests is typically established by engineering specifications, validated test methods, and comparison against established predicate device performance or industry standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of medical data by multiple experts. For non-clinical bench testing, results are objective measurements against defined standards.
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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. This is a medical device modification involving a physical catheter, not an AI or diagnostic imaging device. Therefore, MRMC studies are not relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This relates to AI/software performance, which is not applicable to a physical hemodialysis catheter.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is based on engineering specifications, performance against established industry standards (ISO 10555-1, ISO 10993), and direct comparison to the performance of the legally marketed predicate devices in non-clinical tests.
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The sample size for the training set:
- Not applicable. There is no AI algorithm being "trained" in this context. The "training" for a physical device involves its design, manufacturing processes, and testing against known performance benchmarks.
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How the ground truth for the training set was established:
- Not applicable. There is no training set as this is not an AI/machine learning 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.