(194 days)
The SH14 hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemiconcentrator depends on the protocol being used and required filtration rate. The device is intended to be used for six hours of less.
The SH14 Hemoconcentrator is a hollow fiber type hemoconcentrator available for adult patients consisting of an external transparent housing with two filtrate ports on the cylindrical body and a fiber bundle. These fibers are bonded within the housing with polyurethane. A transparent blood header cap with a male Pos-Lock port is bonded to each end of the housing. Diluted blood is drawn, from the patient, inside the fibers of the plasma water is removed across the semi-permeable hollow fibers from the blood pathway to the filtrate side. The SH hemoconcentrator is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only.
Here's an analysis of the acceptance criteria and supporting study for the SH14 Hemoconcentrator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for each performance metric in a pass/fail format. Instead, it indicates that the results of the tests "met established specifications" or "met established specifications." For comparative purposes, it also states that data collected show that functional and biocompatibility parameters exhibited by the currently marketed predicate devices (Sorin Group USA HC1400 Maxi and DHF 0.6) apply to the SH14.
Therefore, the table below will list the tests performed and the general outcome as reported. The implication is that the performance of the SH14 was either equivalent to or within the established specifications of the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Hemocompatibility (ISO 10993-1.1995 & FDA May 1, 1995 Memorandum) | Met established specifications and applied to SH14 |
| Cytotoxicity (ISO 10993-1.1995 & FDA May 1, 1995 Memorandum) | Met established specifications and applied to SH14 |
| Irritation (ISO 10993-1.1995 & FDA May 1, 1995 Memorandum) | Met established specifications and applied to SH14 |
| Acute Systemic Toxicity (ISO 10993-1.1995 & FDA May 1, 1995 Memorandum) | Met established specifications and applied to SH14 |
| Mutagenicity (ISO 10993-1.1995 & FDA May 1, 1995 Memorandum) | Met established specifications and applied to SH14 |
| Sterility & Safety: | |
| Sterility | Met established specifications and demonstrated effective production techniques |
| Pyrogenicity | Met established specifications and demonstrated effective production techniques |
| ETO residuals | Met established specifications |
| Package integrity | Met established specifications |
| In Vitro Functional Performance: | |
| Mechanical integrity (Guidance for "conventional and high permeability hemodyalizers, August 7, 1990") | Met established specifications |
| Priming Volume (Guidance for "conventional and high permeability hemodyalizers, August 7, 1990") | Met established specifications |
| Pressure Drop (Guidance for "conventional and high permeability hemodyalizers, August 7, 1990") | Met established specifications |
| Ultrafiltration rate (Guidance for "conventional and high permeability hemodyalizers, August 7, 1990") | Met established specifications |
| Sieving coefficient (Guidance for "conventional and high permeability hemodyalizers, August 7, 1990") | Met established specifications |
| Hemolysis (Guidance for "conventional and high permeability hemodyalizers, August 7, 1990") | Met established specifications |
| Shipping carton protection | Passed basic testing, capable of adequate protection |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" for the in vitro tests (e.g., number of SH14 devices tested for priming volume). It generally states "a complete battery of tests were carried out" and "in vitro testing were carried out."
Regarding data provenance:
- Country of Origin: Not explicitly stated for each test, but the submitter is Sorin Group Italia S.r.I. (Italy).
- Retrospective or Prospective: These were laboratory "in vitro" tests, implying they were prospective tests conducted specifically for this submission. The biocompatibility tests were performed on the SH14, aged up to three years ("accelerated aging").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and is not provided. The "ground truth" for device performance in this context is based on objective, measurable physical, chemical, and biological properties evaluated through standardized laboratory tests, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation by multiple readers) to establish a consensus ground truth. Here, the "truth" is derived directly from quantitative measurements in laboratory settings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, and the AI's impact on their performance is being evaluated. This device is a medical device for hemoconcentration, not a diagnostic AI.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, the studies described are standalone performance studies of the device itself (not an algorithm in the typical AI sense). The "in vitro test results" and "biocompatibility test results" sections detail these standalone performance evaluations against established specifications and comparison with predicate devices.
7. The Type of Ground Truth Used
The "ground truth" in this context is the objective performance of the device as measured by established scientific and engineering methods, guided by:
- Standardized Test Methods: ISO 10993-1.1995 for biocompatibility and "Guidance for the content of premarket notifications for conventional and high permeability hemodyalizers, August 7, 1990" for in vitro functional performance.
- Predicate Device Performance: The functional and biocompatibility parameters of the Sorin Group USA HC1400 Maxi and DHF 0.6 served as a comparative benchmark, implying that the SH14's performance should be substantially equivalent to these legally marketed devices.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for a physical medical device like the SH14 Hemoconcentrator in the context of AI.
§ 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.”