(387 days)
The Hospal Multiflow 100 and Multiflow 100 Kits A0 (A0/B A0 and A0/0 ) and Multiflow 100 Kits B22 (B22, B22B, & B22/0) can be used whenever continuous arterio-venous or veno-venous hemofiltration, ultrafiltration or hemodialysis is indicated. This can be used for acute hemodialysis, hemofiltration or continuous ultrafiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration, and clotting times should be performed under the direction of a physician
The Hospal Multiflow 100, Multiflow 100 Kit A0, Multiflow 100 Kit B22 are identical in construction in function to other hemofilters currently marketed in the United States. These devices are intended for use in continuous pump assisted veno-venous The membrane used in this device is Acrylonitrile and sodium hemofiltration and. methallyl sulfonate copolymer (AN69) which is identical to the membrane utilized in the Kit Multiflow 60P which have been previously approved for marketing in the United States under a 510K Notification (K884365).
Blood enters a blood inlet port where it is distributed to Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) hollow fibers. Each hollow fiber has an inner diameter of approximately 240 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. There are 6,000 Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) hollow fibers having an effective length of 27 cm. The effective membrane surface area of the Multiflow 100 hemofilter is 0.90 m2. At either end of the device the hollow fibers are potted in polyurethane to isolate the blood compartment from the filtrate compartment. Each end of the hemofilter is sealed using a silicone O-ring and polycarbonate end cap. The housing of this hemofilter is also made of polycarbonate. The fibers used in this device are identical in design and materials to the previously approved Hospal Kit Multiflow 60P. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.
By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) membrane and into the counter current flowing dialysis solution during CVVHD. During CVVH, no dialysis solution is perfused through the filtrate compartment in which case removal of plasma water and uremic toxins is accomplished by means of convection alone. The dialysate exits the devices via a dialysate outlet port. Schematic drawings of the Hospal Multiflow 100, Multiflow 100 Kit A0, and Multiflow 100 Kit B22 are included in this Section.
- The Multiflow 100 Kit A0 (A0, A0/B and A0/0) and Multiflow 100 Kit B22 (B22, ● B22/B, & B22/0) are an extracorporeal blood circuit with the Multiflow 100 , Hemofilter and are intended to be used with a variety of equipment for pump assisted The Multiflow 100 Kit B22 consists of the Multiflow 100 CVVH, and CVVHD. Hemofilter pre-attached to blood tubing. The Multiflow 100 Kits A0 (A0, A0/B and A0/0) and Multiflow 100 Kits B22 (B22/B22/B/B22/0) can be used for continuous veno-venous hemodialysis (CVVHD), continuous veno-venous hemofiltration (CVVH). These kits are designed to operate with pump-assisted blood circulation. An ultrafiltrate / dialysate collection and measurement set is also included with these kits.
- The component parts of the Multiflow Kits 100 B22/B22/0 are: .
- A Multiflow 100 Hemofilter 1.
- A arterial blood line 2.
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- A venous blood line
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- An ultrafiltrate line
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- A ultrafiltrate/dialysate measuring container (not in the B22/0 Kit)
- A 5 liter ultrafiltrate/dialysate collection container (included in only the B22Kit) 6.
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- A priming adaptor
- A reinfusion line 8.
- The component parts of the Multiflow Kits 100 A0. A0/B and A0/0 are:
- A Multiflow 100 Hemofilter 1.
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- An ultrafiltrate line
- A ultrafiltrate/dialysate measuring container (included in only the A0 Kit) 3.
- A 5 liter ultrafiltrate/dialysate collection container (included in only the A0/B Kit) ব:
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- A priming adaptor
The provided text describes a 510(k) premarket notification for the Hospal Multiflow 100, Multiflow 100 Kit A0, and Multiflow 100 Kit B22. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device. Therefore, the information typically requested for acceptance criteria and studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance with metrics like sensitivity/specificity, and specific effect sizes) is not present in this document.
However, based on the provided text, we can extract details about the non-clinical tests performed to demonstrate substantial equivalence to the predicate device.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets in the way one might expect for a new device's performance study. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" is implicitly deemed acceptable if it is "substantially equivalent" to the predicate.
| Parameter Tested (Non-Clinical) | Reported Device Performance (Hospal Multiflow 100) | Acceptance Criteria Implied |
|---|---|---|
| Blood Side Priming Volume | Results confirmed substantial equivalence | Performance "substantially equivalent" to predicate device (Hospal Kit Multiflow 60P) |
| Dialysate Side Priming Volume | Results confirmed substantial equivalence | Performance "substantially equivalent" to predicate device (Hospal Kit Multiflow 60P) |
| Dialysate Flow Resistance | Results confirmed substantial equivalence | Performance "substantially equivalent" to predicate device (Hospal Kit Multiflow 60P) |
| Blood Flow Resistance | Results confirmed substantial equivalence | Performance "substantially equivalent" to predicate device (Hospal Kit Multiflow 60P) |
| Ultrafiltration Coefficient | Results confirmed substantial equivalence | Performance "substantially equivalent" to predicate device (Hospal Kit Multiflow 60P) |
| Urea Sieving Coefficient | Results confirmed substantial equivalence | Performance "substantially equivalent" to predicate device (Hospal Kit Multiflow 60P) |
| Creatinine Sieving Coefficient | Results confirmed substantial equivalence | Performance "substantially equivalent" to predicate device (Hospal Kit Multiflow 60P) |
| Phosphate Sieving Coefficient | Results confirmed substantial equivalence | Performance "substantially equivalent" to predicate device (Hospal Kit Multiflow 60P) |
| Vitamin B12 Sieving Coefficient | Results confirmed substantial equivalence | Performance "substantially equivalent" to predicate device (Hospal Kit Multiflow 60P) |
| Inulin Sieving Coefficient | Results confirmed substantial equivalence | Performance "substantially equivalent" to predicate device (Hospal Kit Multiflow 60P) |
| Myoglobin Sieving Coefficient | Results confirmed substantial equivalence | Performance "substantially equivalent" to predicate device (Hospal Kit Multiflow 60P) |
| Albumin Sieving Coefficient | Results confirmed substantial equivalence | Performance "substantially equivalent" to predicate device (Hospal Kit Multiflow 60P) |
Note on "Acceptance Criteria": For a 510(k) submission, the primary acceptance criterion is substantial equivalence to a predicate device. The in vitro tests were designed to demonstrate this equivalence across key performance parameters. The specific numerical thresholds for "substantial equivalence" are not detailed in this summary but would have been defined by comparison to the predicate device's known performance.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "In vitro testing was performed on the Multiflow 100 to determine the following..." It does not specify the sample size for these in vitro tests (e.g., number of devices tested, number of replicates).
- Sample Size for Test Set: Not specified.
- Data Provenance: In vitro laboratory testing. The country of origin of the data is not explicitly stated, but it would presumably be the testing facilities associated with Gambro Healthcare (formerly Cobe Renal Care, Inc.) in Lakewood, CO, USA, or the manufacturer Hospal Industrie. The data is retrospective in the sense that it's generated for a submission of a device already developed, not from an ongoing prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the type of testing described. The "ground truth" for in vitro performance tests is typically established through validated analytical methods and measurements, not expert consensus. These are objective physical and chemical measurements.
4. Adjudication Method for the Test Set
This is not applicable as the tests are in vitro measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document explicitly states: "Clinical testing was not performed." Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted. This is not an AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical device (hemofilter), not an AI algorithm. Its performance is intrinsic to its physical design and materials, not an algorithm's output.
7. The Type of Ground Truth Used
For the in vitro tests, the ground truth was based on objective physical and chemical measurements of device parameters (e.g., priming volumes, flow resistances, sieving coefficients) using established laboratory methods.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI device, there is no training set or associated ground truth establishment method.
§ 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.”