(71 days)
The Hemocor HPH® Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed.
The Minntech I lemocor HPI 700 Hemoconcentrator is made of glycerin-free, microporous, hollow fiber, polysulfone membrane encased in a polycarbonate chamber meroporous, notiow troot, porty and polycarbonate blood port header caps. The FIPE 700 TS device has attached PVC 1/4" tubing and accessory polycarbonate adapters for blood path connection. The no-rinse device feature provides versatility for inscrtion of the hemococentrator into the extracorporeal circuit.
Here's a breakdown of the acceptance criteria and study information for the Minntech Hemocor HPH® 700 Hemoconcentrator and Tubing Set, based on the provided 510(k) summary:
This device is not an AI/ML device, so many of the requested fields are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the Minntech Hemocor HPH® 700 Hemoconcentrator does not explicitly list "acceptance criteria" in the traditional sense of a pass/fail threshold for a performance metric. Instead, it presents a comparison of technological characteristics with a predicate device and outlines performance testing that was conducted to demonstrate device effectiveness and substantial equivalence.
| Characteristic / Test | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (HPH® 700) |
|---|---|---|
| Technological Characteristics | ||
| Housing | Polycarbonate | Polycarbonate |
| Potting Material | Polyurethane | Polyurethane |
| Membrane | Polysulfone | Polysulfone |
| Membrane Surface Area | (Comparable to predicate, though smaller) | 0.7 m² |
| Max Transmembrane Pressure (mmHg) | 500 mmHg | 500 mmHg |
| Max. Blood Flow Rate (ml/min) | 500 ml/min | 500 ml/min |
| Min. Blood Flow Rate (ml/min) | 100 ml/min | 50 ml/min |
| Priming Volume (ml) | 70 ml | 58 ml |
| Molecular Weight Cut-off (daltons) | 65000 daltons | 65000 daltons |
| Performance Testing | (Demonstrates effectiveness as a hemoconcentrator comparable to predicate) | (Testing conducted to determine effectiveness) |
| Ultrafiltration Rate vs. Transmembrane Pressure | (Sufficient ultrafiltration for intended use) | Testing conducted |
| Pressure Drop vs. Blood Flow Rate | (Acceptable pressure drop for intended use) | Testing conducted |
| Protein Rejection | (Adequate protein rejection) | Testing conducted |
| Minimum Blood Flow Rate & Blood Path Integrity | (Maintains integrity and function at minimum flow) | Testing conducted |
Note on Acceptance Criteria: For legacy medical devices like this, especially for 510(k) submissions, "acceptance criteria" are often implicitly demonstrated by showing substantial equivalence to a legally marketed predicate device. The goal is to show the new device is as safe and effective as the predicate, not necessarily meet pre-defined numerical thresholds beyond what is necessary to support the same indications for use. The technological characteristics table serves as a primary source of this comparison. The performance testing further supports that the device performs as expected for a hemoconcentrator.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify sample sizes for the performance testing conducted. It only states that testing was conducted. This is typical for 510(k) summaries where detailed pre-clinical test results are often kept in the full submission, not in the publicly available summary.
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given this is a device performance test, it likely refers to in vitro or ex vivo lab testing, rather than human clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This question is not applicable as the ground truth for mechanical device performance (like a hemoconcentrator) is established through technical testing and measurement against engineering specifications and industry standards, not expert clinical consensus.
4. Adjudication Method for the Test Set
This question is not applicable as the ground truth for mechanical device performance is established through technical testing and measurement, not consensus among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or clinical interpretation where human readers are involved. This submission is for a medical device (hemoconcentrator) and its physical performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The concept of "standalone performance" for an algorithm or AI is not applicable here. This is a physical medical device, not a software algorithm. The "performance testing" described (Ultrafiltration Rate, Pressure Drop, Protein Rejection, Blood Path Integrity) represents the "standalone" performance of the device in a laboratory setting.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through:
- Bench testing/Laboratory Measurements: Based on established engineering principles, fluid dynamics, membrane science, and medical device performance standards.
- Comparison to Predicate Device: The performance of the new device is compared to the known and accepted performance of the legally marketed predicate device (Hemocor HPH® 1000 Hemoconcentrator). Substantial equivalence means the new device performs at least as safely and effectively.
8. The Sample Size for the Training Set
This question is not applicable. This device is not an AI/ML system, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. As there is no AI/ML component, there is no "training set" or ground truth for such a set.
§ 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.”