(282 days)
No
The summary describes a standard hemodialysis delivery system with monitoring and display functions, and there are no mentions of AI, ML, or related concepts.
Yes
The device is used to provide hemodialysis treatment, which is a therapeutic intervention for patients with renal failure. It directly treats a medical condition.
No
Explanation: The device description states its purpose is to "provide hemodialysis treatment" and deliver dialysate, and monitor functions during that treatment. This indicates a therapeutic or treatment-delivery device, not one primarily used for diagnosis.
No
The device description clearly outlines a physical hemodialysis delivery system with hardware components like a display monitor, touch screen, and the ability to monitor machine, dialysate, and blood circuit functions. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide hemodialysis treatment to patients with renal failure. This is a therapeutic treatment performed on the patient's body, not a diagnostic test performed on a sample in vitro (outside the body).
- Device Description: The description details a system that prepares and delivers dialysate and monitors machine and circuit functions during dialysis. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, etc.) to diagnose a condition or provide information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to perform a therapeutic procedure.
N/A
Intended Use / Indications for Use
To provide hemodialysis treatment to patients with acute or chronic renal failure.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
K954187 p.1/2.
AUG - 8 1996
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Applicant Information:
ﻟ
Date Prepared: October 18, 1995 Name: Althin Medical, Inc. Address: 13520 Pheasant Court Portland, OR 97222
Contact Person: Alan Lewis Phone Number: (503) 659-3355 Fax Number: (503) 652-0225
Device Information:
AltraTouch™ 1000 Single Patient Hemodialysis Delivery System Trade Name: Common Name: As above. Classification Name: Hemodialysis Delivery System
Equivalent Device:
Drake Willock® System 1000® Single Patient Hemodialysis Delivery System
Device Description:
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.
Intended Use:
To provide hemodialysis treatment to patients with acute or chronic renal failure.
Image /page/0/Picture/17 description: The image shows the logo for "The Althin Group". The logo consists of a large, bold letter "A" above the company name. The letter "A" is stylized with a thick, blocky design, and the company name is written in a simple, serif font.
Althin Medical, Inc. Drake Willock® dialysis equipment 13520 S.E. Pheasant Court Portland, Oregon 97222-1298
Phone 503-659-3355 Telefax 503-652-0225
1
Comparison To Predicate Device:
The AltraTouch™ 1000 Single Patient Hemodialysis Delivery System is a modification of the Drake Willock® System 1000 Single Patient Dialysate Delivery System {510(k) number K910215}, the predicate machine. The modifications consist of: 1.Replacing the 12 inch (diagonal) Cathode Ray Tube display of the predicate machine with a 9 1/2 inch (diagonal) Liquid Crystal Display (which lowers the overall height of the machine by approximately two inches, and reduces its overall weight by approximately 31 pounds).
-
- Reducing the maximum dialysate flow rate by 20%.
-
- Increasing the minimum temperature requirement for the incoming water, and offering some of the features that are standard on the predicate machine as options.
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. Althin Medical, Inc. believes that the design and testing of this modified System1000® machine demonstrates that it is safe and effective.