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510(k) Data Aggregation
(246 days)
The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20kg and ≤ 40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing ≤ 40 kg. The 2008T BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.
The 2008T BlueStar Hemodialysis Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms.
The 2008T BlueStar Hemodialysis Machine provides hemodialysis treatment by controlling and monitoring both the dialysate circuit and the extracorporeal blood circuit. The machine pumps blood from the patient's body through an extracorporeal circuit, one component of which is the dialyzer. The dialyzer contains a semi-permeable membrane that uses diffusion to transfer toxins and ultrafiltration to transport excess water from the blood into the dialysate circuit. In this separate dialysate circuit, the dialysate concentrates are mixed with purified water, heated, degassed, and delivered to the dialyzer. Balancing chambers control the incoming flow and outgoing flow of the dialysate fluid during ultrafiltration. During hemodialysis, the extracorporeal blood circuit is monitored for venous and arterial blood pressures as well as for the presence of air and blood.
The 2008T BlueStar Hemodialysis Machine has automation features (independent internal conductivity testing, auto priming, auto start, CDX auto on, assisted reinfusion) to minimize user workload and improve user experience. The 2008T BlueStar Hemodialysis Machine includes SLED (Sustained Low Efficiency Dialysis), Low Volume, and Isolated Ultrafiltration therapy options. The 2008T BlueStar Hemodialysis Machine also accommodates the use of the Patient Card system, a dialysis treatment information system.
Based on the provided FDA 510(k) Clearance Letter, the device in question is the 2008T BlueStar Hemodialysis Machine. This document is a Class II Medical Device submission, which means it relies on substantial equivalence to a predicate device, rather than a clinical trial proving new efficacy. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing new clinical effectiveness benchmarks through a de novo study.
The primary study type proving the device meets the "acceptance criteria" for 510(k) clearance is a comparison to a predicate device and supporting non-clinical performance and safety testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a 510(k) submission are typically related to demonstrating that the new device meets the same performance specifications as the predicate and does not raise new questions of safety or effectiveness. The reported device performance is presented as its features and specifications.
| Feature / Acceptance Criteria (Derived from Predicate) | Reported Device Performance (2008T BlueStar Hemodialysis Machine) |
|---|---|
| Intended Use Equivalence | Identical to predicate (K231125): "The 2008T Machine is intended for use in acute and chronic hemodialysis therapy." |
| Indications for Use Equivalence | Identical to predicate. Includes acute and chronic dialysis therapy in a healthcare facility, with options for Isolated Ultrafiltration, SLED, and low volume hemodialysis (patients ≥20kg and ≤40kg). Accommodates low/high flux dialyzers. Restrictions: not for SLED on patients ≤40kg, plasma replacement, patients <20kg, or renal therapies using substitution fluid. |
| Design Specifications Equivalence | "Design Specifications" are listed as equivalent to the predicate. |
| Technological Characteristics Equivalence | "Technological Characteristics" are listed as equivalent to the predicate. |
| Principle of Operation Equivalence | "Principle of Operation" is listed as equivalent to the predicate. |
| Performance Requirements Equivalence | "Performance Requirements" are listed as equivalent to the predicate. |
| Biocompatibility | Tested per ISO 10993-1:2018 and FDA guidance. Evaluated for Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Hemocompatibility, Chemical Characterization, Toxicological Risk Assessment. (Specific pass/fail criteria are implicit in compliance with standards). |
| Electrical Safety and EMC | Tested per IEC 60601-1-2 (2020). (Specific pass/fail criteria are implicit in compliance with standards). |
| Software V&V (if changes) | "No changes to the 2008T BlueStar Hemodialysis Machine's software." Therefore, software V&V was not required. (Implicit acceptance criteria: software stability/no new risks). |
| Key Performance Specifications (Specifics compared) | Blood Flow Rates: - 8 mm: 20–600 mL/min* (*Not available with Low Volume)- 6.35 mm: 20–465 mL/min- 4.8 mm: 10–274 mL/min- 2.6 mm: 6–86 mL/min- Accuracy: ±10% at -200 mmHg |
| Maximum Dialysate Flow Rate: - Selectable: (0)/100†‡/150†‡/200†‡/300†/400/500/600/700/800 mL/min- Auto Flow (based on Qb): Ranges from 300 mL/min (for Qb 0-165 mL/min) up to 800 mL/min (for Qb 481+ mL/min)- Dialysate flow adjusts if blood pump adjusted ~15-20 mL/min. | |
| Net Fluid Removal: 0–4000 mL/hr- Accuracy: ± (1% UF rate + 18 mL/hr) at 100 mL/min Qd- Accuracy: ± (1% UF rate + 30 mL/hr) at 500 mL/min Qd- Accuracy: ± (1% UF rate + 48 mL/hr) at 800 mL/min Qd | |
| Dialysis Time: - Hemodialysis: 0–9:59 hours (adjustable)- SLED: Fixed at 12 hours- Accuracy: + 1 second per hour | |
| Dialysis Fluid Composition: - Volumetric, selectable- Acid adjustment: 130–155 mEq/L Na+- Bicarbonate adjustment: 20–40 mEq/L Bicarbonate- Monitoring conductivity average accuracy: ±1.5% | |
| Dialysis Fluid Temperature: - Range: 35°C–39°C (alarm window ±2°C)- Accuracy: ±0.3°C | |
| Heparin Delivery Rate: - 0–9.9 mL/hr- Accuracy: ±5% | |
| Human Factors Impact | "Changes do not impact the usability of the device. Human Factors Validation Testing is not required." |
2. Sample Size Used for the Test Set and Data Provenance
For a 510(k) of this nature (a hemodialysis machine), the "test set" does not refer to a clinical data set in the same way it would for an AI/ML algorithm. Instead, it refers to the units of the device that underwent various engineering and biocompatibility tests.
- Sample size for test set: Not explicitly stated as a number of specific units in a formal statistical sense, but implies a sufficient number of devices were tested to demonstrate compliance with standards and specifications for various non-clinical tests (e.g., electrical safety, EMC, performance specifications). For biocompatibility, representative materials were tested.
- Data provenance: Not directly applicable in the sense of patient data. The provenance of the testing is internal company testing (Fresenius Medical Care Renal Therapies Group, LLC). All testing is prospective in the sense that the tests were conducted specifically for this submission. The origin of the testing would be within the manufacturer's facilities or accredited testing labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this type of 510(k) submission. This clearance is for a hardware device (hemodialysis machine) with embedded software, not an AI/ML diagnostic or prognostic device that relies on expert interpretation of medical images or patient data to establish ground truth for a test set. The "ground truth" for the device's performance is established by engineering specifications, validated sensors, and calibrated measurement systems.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" of patient cases requiring adjudication by multiple experts for a hemodialysis machine clearance. Engineering tests are pass/fail based on predefined thresholds and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI/ML diagnostic or imaging device. There were no human readers or AI assistance studies conducted or required for this clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device contains software, it is an electromechanical device, not a standalone algorithm. Its performance is intrinsically linked to the physical machine. Therefore, a "standalone algorithm performance" study is not relevant or applicable. The software controls the machine's functions, and its performance is evaluated as part of the total system.
7. The Type of Ground Truth Used
The "ground truth" for the 2008T BlueStar Hemodialysis Machine's performance is established by:
- Engineering Specifications: The design and expected performance metrics (e.g., flow rates, temperatures, accuracies) are the primary ground truth for the device's functional integrity.
- International and Industry Standards: Compliance with standards like IEC 60601-1-2 for EMC and ISO 10993-1 for biocompatibility serves as the ground truth for safety and foundational performance aspects.
- Predicate Device Performance: The underlying assumption for a 510(k) is that the predicate device's performance is the established "ground truth" for safe and effective hemodialysis delivery. The new device demonstrates equivalence to this established standard.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model.
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