(264 days)
The Omni System, which consists of the Omni-DL™ Control Unit, Omni-DL™ CVVHDF Kit, and 5 Liter Effluent Bag, is intended for use in renal replacement therapies in a hospital or clinical setting where CRRT is administered. Four different solute and fluid management therapies are available:
- SCUF (Slow Continuous Ultrafiltration)
- CVVH (Continuous Veno-venous Hemofiltration)
- CVVHD (Continuous Veno-venous Hemodialysis)
- CVVHDF (Continuous Veno-venous Hemodiafiltration)
The Omni-DLTM System (Omni System) provides continuous renal replacement therapies (hemodialysis, hemofiltration, hemodiafiltration, and ultrafiltration) in an intensive care setting for patients with acute renal failure and/or fluid overload. The Omni System consists of the Omni-DLTM Control Unit (Control Unit), the Omni-DLTM CVVHDF Kit (Omni Kit); a dedicated disposable tubing set which does not incorporate a hemofilter, and a separately packaged 5 Liter Effluent Bag.
The Omni System is a continuous renal replacement therapy (CRRT) system intended for patients with acute renal failure and/or fluid overload. The Omni is indicated for continuous solute and or fluid removal in patients with acute renal failure and/or fluid overload. Blood access for therapy with the Omni System is via established methods of vascular access. The Omni System is designed for use on patients in a hospital setting to provide the following treatments: SCUF (Slow Continuous Ultrafiltration), CVVH (Continuous Veno-Venous Hemofiltration), CVVHD (Continuous Veno-Venous Hemodialysis), and CVVHDF (Continuous Veno-Venous Hemodiafiltration).
The provided document, K080650, describes the Transvivo Omni-DL™ system, a high permeability hemodialysis system. The submission focuses on substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria met by specific performance metrics. Therefore, explicit "acceptance criteria" and "reported device performance" in a quantitative sense, as typically seen for novelAI-driven diagnostic tools, are not provided.
Instead, the document asserts that the device met its functional and performance specifications through "extensive safety, software, and performance testing." The conclusion is based on the device having the "same intended use, with similar technological characteristics" as the predicate device (Prisma CFM System [K946279]).
Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:
Acceptance Criteria and Study for Transvivo Omni-DL™ System
The provided 510(k) summary for the Transvivo Omni-DL™ device focuses on demonstrating substantial equivalence to a predicate device. It does not present specific quantitative acceptance criteria or a detailed clinical study report proving the device meets such criteria as would be expected for a novel AI-driven diagnostic system. Instead, it relies on non-clinical testing to demonstrate functional and performance specifications.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Inferred from "Spec. Compliance") | Reported Device Performance (Inferred from "Extensive Testing") |
|---|---|
| Functional Specifications | Met |
| Performance Specifications | Met |
| Safety | Extensive safety testing performed; deemed equivalent to predicate |
| Software Functionality | Extensive software testing performed; deemed equivalent to predicate |
| Technological Characteristics | Similar to predicate device |
| Intended Use | Same as predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or patient samples for performance evaluation. The testing described is "non-clinical testing" for functional and performance specifications, likely involving laboratory or bench testing of the device hardware and software. No patient-specific data, country of origin, or retrospective/prospective nature is mentioned as this was likely not a clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This was a non-clinical evaluation of a medical device's functional and performance specifications, not an AI model requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. No "test set" requiring adjudication by experts is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not performed. The device is a high permeability hemodialysis system, not an AI-assisted diagnostic tool that would typically involve human reader performance evaluation.
6. Standalone (Algorithm Only) Performance Study
No. Since this device is a physical system for renal replacement therapies and not an AI algorithm, a standalone algorithm performance study is not applicable. The "software" referred to in the document relates to the control unit's operation, not a diagnostic algorithm.
7. Type of Ground Truth Used
Not applicable. The evaluation was based on functional and performance specifications for a medical device, which would involve engineering and physical measurements against predefined requirements, rather than clinical ground truth (e.g., pathology, outcomes data, or expert consensus).
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as the device is not an AI/ML model that undergoes a training phase.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reasons as above.
§ 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.”