(111 days)
Not Found
No
The device description focuses on the chemical composition and packaging of a dry dialysate concentrate, with no mention of software, algorithms, or any form of computational processing that would suggest AI/ML.
Yes
The device, DRYalysate™ Concentrate, is intended for use in hemodialysis, which is a medical treatment for patients with kidney failure. The "Summary of Performance Studies" also states that it is "safe and effective," indicating its therapeutic purpose.
No
The device is a chemical concentrate used to prepare dialysate for hemodialysis, which is a treatment for kidney failure. It does not perform any diagnostic function.
No
The device description clearly states it consists of "packaged dry chemicals" which are mixed to form a liquid concentrate. This is a physical product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for patients undergoing hemodialysis, a treatment for kidney failure. It's used in the hemodialysis machine to create dialysate, which is a fluid that helps remove waste products from the blood. This is a therapeutic process, not a diagnostic one.
- Device Description: The device is a dry chemical concentrate that is mixed to create a liquid concentrate used in hemodialysis machines. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Language: The text does not mention any diagnostic purpose, such as analyzing samples, detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
DRYalysate™ Concentrate is intended for use for patients being treated by hemodialysis. The primary patient population that will use this device are those who suffer from loss of kidney function and who are prescribed acute or chronic hemodialysis. The indications for use of this product are exactly the same as those for currently marketed dialysate concentrates.
DRYalysate™ Concentrate is indicated for use for patients being treated by hemodialysis. The patient population that will use this device are those who suffer from loss of kidney function and who are prescribed acute or chronic hemodialysis. The indications for use of this product are exactly the same as those for currently marketed dialysate concentrates.
Product codes (comma separated list FDA assigned to the subject device)
78 KPO
Device Description
The device consists of packaged dry chemicals which, when mixed and dissolved with AAMI quality water, according to the directions for use, makes an acid concentrate that can be used by current proportioning type hemodialysis machines to make dialysate.
DRYalysate™ Concentrate will be packaged and sold in two convenient boxed sizes; a 'single dose' package designed to make enough dialysate concentrate (5 Liters) for one patient for one treatment and a 'bulk' package which contains enough powder to make 50 liters of dialysate at a time.
Once the package of chemicals is mixed according to the instructions for use, the resulting liquid concentrate is used in the hemodialysis process in proportioning type hemodialysis machines in exactly the same way that existing concentrates are used.
A list of available DRYalysate™ final dialysate formulations was provided.
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)
The three clinical studies and other testing data submitted provide the necessary and sufficient evidence to support that Advanced Renal Technologies DRYalysate™ Concentrate is cafe and effective and substantially equivalent to currently marketed products.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K911459, K922005, K864265, K901471
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Page 1 of 3
510 (k) SUMMARY
The information contained on the following pages is required to be included pursuant to $807.87 (h) of 21 CFR which cross-references to the requirements of $807.92. The information follows the order asked for in §807.92:
SUBMITTER
Submitter:
Advanced Renal Technologies
Address:
2151 N. Northlake Way, Suite #200 Seattle, WA 98103
Phone:
Robin Callan
(206) 545-3570
Date prepared:
Contact person:
" " January 9, 1998
DEVICE NAME
Proprietary Name:
DRYalysate™ Concentrate.
Common/Usual Name:
- Acid Concentrate, 'A' component of bicarbonate dialysate, "A Concentrate" and granulated or powdered dialysate concentrate for hemodialysis.
Classification Name:
Dialysate Concentrate for Hemodialysis.
1
PREDICATE DEVICES
1980659
DRYalysate™ Concentrate is a powdered concentrate substantially equivalent to the powdered dialysate products supplied by Fresenius USA sold as Granuflo™ Dry Acid Concentrate (originally granted FDA marketing approval as Granulyte™ Powder Dialysate Concentrate; 510 (k) #'s K911459 and K922005), Dial Medical's DMF (Dial Medical of Florida, Inc.) Hemodialysis Concentrates; 510 (k) # K864265, and Granite Chemical's GC-1000, GC-2000 and GC-3000 formulas; 510 (k) # K901471, all of which have been determined equivalent to pre-enactment devices.
Available dialysate concentration formulations supplied by these predicate device manufacturers were provided.
DEVICE DESCRIPTION
The device consists of packaged dry chemicals which, when mixed and dissolved with AAMI quality water, according to the directions for use, makes an acid concentrate that can be used by current proportioning type hemodialysis machines to make dialysate.
DRYalysate™ Concentrate will be packaged and sold in two convenient boxed sizes; a 'single dose' package designed to make enough dialysate concentrate (5 Liters) for one patient for one treatment and a 'bulk' package which contains enough powder to make 50 liters of dialysate at a time.
Once the package of chemicals is mixed according to the instructions for use, the resulting liquid concentrate is used in the hemodialysis process in proportioning type hemodialysis machines in exactly the same way that existing concentrates are used.
A list of available DRYalysate™ final dialysate formulations was provided.
STATEMENT OF INTENDED USE
DRYalysate™ Concentrate is intended for use for patients being treated by hemodialysis. The primary patient population that will use this device are those who suffer from loss of kidney function and who are prescribed acute or chronic hemodialysis. The indications for use of this product are exactly the same as those for currently marketed dialysate concentrates.
2
STATEMENT OF EQUIVALENCE
1296 501 3
1980659
The intended use of DRY alysate™ Concentrate is identical with that of currently marketed dialysate concentrates.
A comparison of the technological characteristics (chemical formulation) of DRYalysate™ Concentrate with currently marketed dialysate concentrates demonstrates that the only substantive change is the use of citric acid as the acidifying agent, otherwise the formulations are identical.
The concentration ranges of ART DRYalysate™ Concentrates were provided.
ASSESSMENT OF PERFORMANCE DATA
The three clinical studies and other testing data submitted provide the necessary and sufficient evidence to support that Advanced Renal Technologies DRYalysate™ Concentrate is cafe and effective and substantially equivalent to currently marketed products.
3
Image /page/3/Picture/16 description: The image shows a circular seal or logo. The text around the top of the circle reads "U.S.A.", and the text around the bottom of the circle reads "DEPARTMENT OF HEALTH & HUM.". Inside the circle is a stylized graphic of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1998
Ms. Robin Callan President Advanced Renal Technologies 2151 N. Northlake Way, Suite 200 Seattle, WA 98103
Re: K980659 ART DRYalysate™ Concentrate Dated: May 14, 1998 Received: May 15, 1998 Regulatory Class: II 21 CFR $876.5820/Procode: 78 KPO
Dear Ms. Callan:
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 (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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) 594-4613. 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/cdrb/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510 (k) Number
None asigned at this time.
Device Name
DRYalysate™ Concentrate
Indications for Use
DRYalysate™ Concentrate is indicated for use for patients being treated by hemodialysis. The patient population that will use this device are those who suffer from loss of kidney function and who are prescribed acute or chronic hemodialysis. The indications for use of this product are exactly the same as those for currently marketed dialysate concentrates.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert Sattley/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .
Prescription Use (per 21 CFR 801.109)
Over-the-Counter Use
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