(163 days)
Not Found
No
The description focuses on mechanical and fluidic control for hemodialysis, with no mention of AI/ML terms or functions. The "auto start option" is a simple timer function, not indicative of AI/ML.
Yes
The device is described as a "Dialysate Delivery System for hemodialysis" and is intended "to provide hemodialysis treatments," functioning "as a total artificial kidney." These functions directly treat a medical condition (kidney failure), thus classifying it as a therapeutic device.
No
The device is described as a hemodialysis system that delivers dialysate and removes liquid from a patient's blood, functioning as an artificial kidney. This is a treatment device, not a diagnostic one.
No
The device description clearly outlines a hardware system (dialysate proportioning system) that mixes concentrates, delivers dialysate, and removes liquid from the patient's blood. The modification described is an "auto start option" which is a software feature added to this existing hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide hemodialysis treatments, which is a therapeutic procedure performed directly on the patient to filter their blood. IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a "dialysate proportioning system for hemodialysis" that mixes fluids, delivers dialysate, removes liquid from the patient's blood, and acts as an artificial kidney. These are all functions related to the hemodialysis treatment itself, not the analysis of patient specimens.
- No Mention of Specimen Analysis: There is no mention of the device analyzing blood, urine, or any other biological specimen. Its function is to prepare and deliver the dialysate and manage fluid removal from the patient.
Therefore, the Drake Willock® System 1000® Single Patient Dialysate Delivery System is a therapeutic device used for hemodialysis treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use of the device are to provide hemodialysis treatments in the acute and chronic setting including high flux hemodialysis.
- The device is intended to be used by trained operators when prescribed by a physician.
- The device is intended to be used in conjunction with a hollow fiber or parallel plate dialyzer.
- The auto start option is intended to allow up to a three day delayed start of the fluid path heat clean or rinse cycle.
Product codes
78KDI
Device Description
The Drake Willock® System 1000® Single Patient Dialysate Delivery System is a dialysate proportioning system for hemodialysis. The system fulfills the following functions:
- Mixes concentrate with water in the appropriate proportions to produce dialysate.
- Delivers dialysate at the appropriate temperature and ionic concentration to the dialyzer,
- Removes the appropriate amount of liquid from the patient's blood.
- Along with the dialyzer and blood pump acts as a total artificial kidney.
The following option is the subject of this submission that will be implemented with FDA approval.
The fundamental modification is to provide the patient care provider with a means to delay the start of fluid path rinse or heat clean up to 3 calendar days.
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
Acute and chronic setting. Intended to be used by trained operators when prescribed by a physician.
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
MAY 2 | 1997
1/2
510(k) SUMMARY
Date:
December 4, 1996
Name:
Althin Medical Inc.
Drake Willock® dialysis equipment
Address:
| 13520 S.E. Pheasant Court
| Portland, Oregon 97222-1298 | |
|---|---|
| Phone Number: | 503-659-3355 |
| Fax Number: | 503-652-0225 |
| Contact person: | Thomas D. Kelly |
Trade Names:
Drake Willock® System 1000® Dialysate Delivery System with AutoStart Disinfection Option
AltraTouch™ 1000 Dialysate Delivery System with AutoStart Disinfection Option
Common Name:
Dialysate Delivery System
Classification Name:
Hemodialysis System and accessories, Class III Device.
Product code:
78KDI
Equivalence Information / Comparison to Predicate Device:
The AutoStart feature is a modification to predicate System 1000® and AltraTouch™ 1000 Dialysate Delivery Systems [510(k) numbers K910215 and K954987.] The System 10000 and AltraTouch™ 1000 single patient hemodialysis delivery systems with the Auto Start option are built with the same fluid path and hardware components as the predicate System 1000@ and AltraTouch™ 1000 single patient hemodialysis delivery systems. The only difference is a software change to delay the start of heat clean or fluid path rinse. The machine and patient safety systems are the same as the predicate devices.
Althin Medical. Inc. believes that the design and testing of this modified System 1000@ AltraTouch™1000 Dialysate Delivery System demonstrates that it is safe and effective.
Pages of this 510(k) that refer to the new AutoStart option are marked with a star (*) in the right hand margin.
1
Device Description:
The Drake Willock® System 1000® Single Patient Dialysate Delivery System is a dialysate proportioning system for hemodialysis. The system fulfills the following functions:
- Mixes concentrate with water in the appropriate proportions to produce dialysate .
- Delivers dialysate at the appropriate temperature and ionic concentration to the . dialyzer,
- Removes the appropriate amount of liquid from the patient's blood .
- Along with the dialyzer and blood pump acts as a total artificial kidney. .
The following option is the subject of this submission that will be implemented with FDA approval.
The fundamental modification is to provide the patient care provider with a means to delay the start of fluid path rinse or heat clean up to 3 calendar days.
Intended Use:
Intended use of the System 1000® and AltraTouch™ 1000 single patient hemodialysis delivery systems
The intended use of the device is to provide hemodialysis treatments in the acute and chronic setting including high flux hemodialysis.
- The device is intended to be used by trained operators when prescribed by a . physician.
- . The device is intended to be used in conjunction with a hollow fiber or parallel plate dialyzer.
Intended use System 1000® and AltraTouch™ 1000 single patient hemodialysis delivery systems with the Auto Start option *
The intended use of the device is to provide hemodialysis reatments in the acute and chronic setting including high flux hemodialysis.
- The device is intended to be used by trained operators when prescribed by a . physician.
- The device is intended to be used in conjunction with a hollow fiber or parallel plate . dialyzer.
Technological Characteristics:
The System 10000 and AltraTouch™ 1000 single patient hemodialysis delivery systems with the Auto Start * option are built with the same fluid path and hardware components as the predicate System 10000 and AltraTouch™ 1000 single patient hemodialysis delivery systems. The only difference is a software change to delay the start of heat clean or fluid path rinse. The machine and patient safety systems are the same as the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes that resemble a stylized caduceus or a symbol representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas D. Kelly Senior Manager of Marketing and Regulatory Affairs ...........................................................................................................................................................
Althin Medical, Inc. 13520 S.E. Pheasant Court Portland, Oregon 97222-1298 MAY 2 1 1997
Re: K964922
Auto Start Disinfection Option - modification of the Altra Touch™ and Drake Wiltock® System 1000® ----------------Dialysate Delivery Machines Dated: March 21, 1997 Received: March 24, 1997 Regulatory class: III 21 CFR §876.5860/Product code: 78 KDI
Dear Mr. Kelly:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Yi
Lillian Yin, Pr.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number K964922
Page 1 of 1
ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤ
Drake Willock® System 1000® Dialysis Delivery Device Name: System with Auto Start Disinfection Option
AltraTouch™ 1000® Dialysis Delivery System with Auto Start Disinfection Option -------------
Indications For Use:
Indications for use of the Drake Willock® System 1000® Dialysis Delivery System with Auto Start Disinfection Option and AltraTouch™ 1000® Dialysis Delivery System with Auto Start Disinfection Option:
The indications for use of the device are to provide hemodialysis treatments in the acute and chronic setting including high flux hemodialysis.
- The device is intended to be used by trained operators when . prescribed by a physician.
- The device is intended to be used in conjunction with a hollow fiber or parallel plate dialyzer.
- The auto start option is intended to allow up to a three day . delayed start of the fluid path heat clean or rinse cycle.
(Please do not write below this line continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dater R. Settling
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
ರಾ
510(k) Number K964922
Prescription Use __ (Per 21 CFR 801.109)
Over the Counter Use _________