(364 days)
- The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.
- The dual lumen ultrafiltration catheter [A1537] is indicated for use in attaining short-term (less than 30 days) percutaneous vascular access of the central circulatory system for ultrafiltration with the System 100.
- The catheter extension [A1513] mav also be used to connect commercially available CVC of the appropriate flow rate to the System 100 UF500 blood filter circuits.
- The System 100 S-100 console [A1100] may be used when either peripheral or central venous access is employed.
- The UF 500 circuit [A1500 and A1550] may be used when either peripheral or central venous access is employed.
The System 100 Ultrafiltration Catheters are part of the fluid pathway and intended for blood withdrawal and infusion when repeat venous access over a period of ≤ 30 days is medically desired. Common medical practice is to exchange the catheter every seven days to minimize infection. The CVC catheter is percutaneously introduced into the subclavian vein or the internal jugular vein with the distal tip ending in the mid to lower superior vena cava. The proximal end with the proprietary connectors resides outside the body connecting to the withdrawal and infusion blood lines of the UF500 blood circuits which engages the System 100 pump console for ultrafiltration in patients with fluid overloaded. The catheter extension (A1513) may also be used to connect other commercially available CVC of the appropriate flow rate to the System 100 UF500 blood filter circuits.
The provided text describes the System 100 Ultrafiltration Catheter and System 100 device. However, it is a 510(k) summary for a medical device and not a study report on device performance or an AI/software device. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria for an AI or software product.
Based on the provided document, I can only extract limited information about "acceptance criteria" and "device performance" as it pertains to substantial equivalence for a physical medical device (catheter and ultrafiltration system). The document focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria with detailed study data.
Here's an attempt to answer your request based only on the provided text, highlighting where information is missing due to the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Similar materials of construction to predicate device | UF catheter and primary predicate device are similar in materials of construction. |
| Identical packaging to predicate device | UF catheter and primary predicate device are identical for packaging. |
| Identical sterilization to predicate device | UF catheter and primary predicate device are identical for sterilization. |
| Provided sterile | The UF catheter is provided sterile. |
| Provided nonpyrogenic | The UF catheter is provided nonpyrogenic. |
| Compatible with the System 100 console/system | Bench tests demonstrate the UF catheter is compatible with the System 100. |
| Acceptable flow rate (for CVCs used with System 100) | Other CVC with an acceptable flow rate would also be compatible with the System 100. |
| Safe and effective for intended use | Catheter has been shown to be safe and effective for its intended use (via substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "Bench tests," but does not provide details on the number of samples or tests performed.
- Data Provenance: Not specified. It's likely laboratory bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. This document describes bench testing for a physical device, not an AI or software device that would require expert-established ground truth for a test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This document describes bench testing for a physical device, not an AI or software device that would require an adjudication method for a test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No. This document describes a 510(k) submission for a physical medical device (catheter and ultrafiltration system), not an AI or software device. Therefore, an MRMC comparative effectiveness study is not relevant or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This document is for a physical medical device. There is no "algorithm only" performance component to evaluate.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "bench tests," the ground truth would be established by the physical measurements and specifications of the device and its compatibility with the System 100. This is based on engineering and manufacturing standards, not expert consensus, pathology, or outcomes data in the context of an AI study.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI or software device, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. This is not an AI or software device, so there is no training set or associated ground truth.
Summary of Device Safety and Performance from the Document:
The safety and performance of the System 100 Ultrafiltration Catheter are primarily established through substantial equivalence to its predicate device (System 100, K013733, K023224, K024124) and other commercially available catheters. The document states:
- The UF catheter and primary predicate device are similar in materials of construction and identical for packaging and sterilization.
- The UF catheter is provided sterile and nonpyrogenic.
- Bench tests demonstrate the UF catheter is compatible with the System 100.
- The use of CVCs (Central Venous Catheters) is expected to be performed in hospital environments where CVC use is common, implying standard medical practice and known risks.
The conclusion is that "Based on the similar intended use, patient population, technology characteristics including well understood CVC medical risks, and performance as access with bench testing the catheter has been shown to be safe and effective for its intended use." This indicates that simple bench testing for compatibility and adherence to material/sterilization similarities to predicate devices were sufficient for demonstrating substantial equivalence for this type of physical medical device.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”