(282 days)
To provide hemodialysis treatment to patients with acute or chronic renal failure.
A hemodialysis delivery system which will provide dialysate at the prescribed temperature and ionic concentration to be used for hemodialysis treatment. It has the ability to monitor machine, dialysate, and blood circuit functions during dialysis. The machine treatment parameters are displayed on a Liquid Crystal Display monitor screen. The operator controls is done through a interactive touch screen.
This 510(k) summary does not contain the level of detail required to fulfill all aspects of your request. It's a summary for clearance, not a comprehensive study report. Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided text. The document states that the AltraTouch™ 1000 is a modification of a predicate device and that "Althin Medical, Inc. believes that the design and testing of this modified System1000® machine demonstrates that it is safe and effective." However, it does not specify any quantitative acceptance criteria or present performance data against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. No details about specific testing or data are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided text. No mention of experts or ground truth establishment is made.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. No mention of adjudication or test methods is made.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not available in the provided text. The device described is a hemodialysis delivery system, not an AI diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not available in the provided text. The device is a physical medical device, not an algorithm, so "standalone performance" in the context of AI is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided text. No ground truth is mentioned.
8. The sample size for the training set
This information is not available in the provided text. No mention of a training set is made.
9. How the ground truth for the training set was established
This information is not available in the provided text. No mention of a training set or its ground truth establishment is made.
Summary of available information regarding the device and its compliance:
The document describes the AltraTouch™ 1000 Single Patient Hemodialysis Delivery System as a modification of the Drake Willock® System 1000. The key modifications are:
- Replacing a 12-inch CRT with a 9.5-inch LCD, reducing height and weight.
- Reducing maximum dialysate flow rate by 20%.
- Increasing the minimum temperature requirement for incoming water.
- Making some standard features from the predicate optional.
The document emphasizes that "Except for the parts associated with the change to the LCD screen, the AltraTouch™1000 machine is built from the same parts as the predicate device. The only software changes are those that control the display color pallet. All machine/patient safety systems are identical to the predicate device."
This reliance on the predicate device's established safety and effectiveness, along with the assertion that "All machine/patient safety systems are identical to the predicate device," is the primary argument for the device meeting safety and effectiveness criteria in this 510(k) summary. It suggests that the "study" proving the device meets criteria is largely a comparison to and demonstration of equivalence with the previously cleared predicate device, rather than a de novo clinical trial or extensive independent performance study reported here.
§ 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.”