(162 days)
The Hemo-Stream™ Hemodialysis Catheter Set is designed for chronic hemodialysis and apheresis.
The Rex Medical Hemo-Stream™ Hemodialysis Catheter is a 16F chronic, multilumen, radiopaque, polyurethane catheter with a polyester cuff and two female luer locking adapters. The cuff promotes tissue in-growth for fixation of the catheter in a subcutaneous tunnel. The luer locking adapters, as well as the tubing clamps, are colored to differentiate the arterial and venous lumens. Four arterial intake lumens are located 360º around a central venous lumen. The catheter intended purpose is identical to the predicate device with the exception that the Hemo-Stream™ Catheter does not facilitate the use of a tear-away sheath during the insertion procedure. The catheter will be manufactured in useable lengths, or the length from the distal catheter tip to the hub junction, of 24cm, 28cm, 32cm, 36cm, and 40cm.
This looks like a medical device submission, specifically a 510(k) premarket notification for a hemodialysis catheter. The document describes the device, compares it to a predicate device, and lists non-clinical tests performed.
Crucially, this document explicitly states in section 8: "Discussion of Clinical Tests Performed: Not applicable, as there are no new indications for use which must be supported by clinical data."
Therefore, a study demonstrating the device meets acceptance criteria through clinical performance (like an AI algorithm would require) was not performed, nor was it required for this type of device submission.
However, I can extract the information related to the non-clinical testing and general equivalency which serves as the "proof" for this particular device submission.
Here's the breakdown based on the provided text, with many fields being "Not Applicable" due to the nature of the device and submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Performance comparable to predicate device (Vaxcel Dialysis Catheter) | "Comparative Functional testing to the predicate was performed based on ISO 10555-1 and the FDA's Reviewer Guidance for Long Term and Short Term Intravascular Catheters." |
| Adequate offset distance to reduce arterial/venous blood recirculation | "adequate offset distance on the distal tip between the arterial intake lumen and the venous return lumen to reduce the effects of arterial/venous blood re-circulation." | |
| Color-coded luer adapters for arterial/venous differentiation | "Both Catheters offer a color-coded female luer adapter, red for arterial and blue for venous..." | |
| Luer priming volume ensures proper heparin lock | "The female luers for both catheters offer the corresponding lumen primina volume to insure the catheter receives the proper heparin lock between treatments." | |
| Material Safety | Biocompatibility | "Material Testing also included ISO 10993 Biocompatibility Testing." |
| Structural Integrity | Tissue in-growth facilitation for fixation and infection barrier | "Both catheters offer a fixed polyester felt cuff located on the catheter lumen to stimulate tissue in-growth which will anchor the catheter in place as well as form an infection barrier." |
| Secure integration of hub, catheter tubing, and extension tubing junctions | "Proximal to the catheter lumens for both catheters is an integrated hub that encapsulates the catheter tubing and extension tubing junctions." | |
| Ability to anchor catheter to patient (suture wing) | "On this hub is a rotating suture wing that may be used to anchor the catheter to the patient until the tissue in-growth around the catheter cuff is matured." | |
| Overall Equivalence | No new questions of safety and effectiveness compared to predicate device | "Testing results revealed the subject device to be substantially equivalent to the predicate device." "no differences in their technological characteristics, thereby not raising any new questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set was used because the submission relies on demonstrating substantial equivalence through non-clinical testing and comparison to a legally marketed predicate device.
- Data Provenance: Not applicable for a clinical test set. Non-clinical testing was performed (likely in a controlled laboratory environment).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. No clinical test set with human ground truth was used. Non-clinical tests would be evaluated against established standards by qualified laboratory personnel.
- Qualifications of Experts: Not applicable in the context of clinical ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring human adjudication was performed.
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
- MRMC Study: No, not applicable. This is a medical device, not an AI diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical tests, the "ground truth" would be established engineering specifications, material properties, and performance benchmarks derived from ISO standards (ISO 10555-1 and ISO 10993) and FDA guidance documents. Direct clinical "ground truth" (e.g., pathology, outcomes data) was not used because clinical trials were not conducted.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. As this is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. As this is not an AI/ML algorithm.
§ 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.