(88 days)
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No
The device description focuses on the chemical composition and physical process of hemodialysis, with no mention of AI or ML technologies.
Yes
The device is a concentrate used to prepare a hemodialysis solution, which is then used in hemodialysis to remove waste products and toxins from a patient's blood, thereby treating renal failure. Devices used to treat or mitigate disease are considered therapeutic devices.
No
The device is a concentrate for bicarbonate dialysis, used for hemodialysis treatment to remove waste products from the blood, not to diagnose a condition.
No
The device description clearly states the device is a chemical concentrate solution containing water, salt, dextrose, and non-sugar electrolytes, which are physical components, not software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "acute and chronic hemodialysis," which is a treatment for kidney failure. This is a therapeutic procedure performed on a patient, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The device is a concentrate solution that is mixed with water and another concentrate to create a "hemodialysis solution." This solution is then used in a hemodialysis machine to remove waste products from a patient's blood. This process is a form of blood purification, not a diagnostic test.
- Mechanism of Action: The description explains how the hemodialysis solution creates a concentration gradient across a semi-permeable membrane to remove waste products from the blood. This is a physical and chemical process for therapeutic purposes, not a method for diagnosing a condition.
- Lack of Diagnostic Language: The text does not mention analyzing patient samples (like blood, urine, or tissue) to diagnose a disease or condition. The focus is entirely on the preparation and use of the solution for the hemodialysis treatment.
In summary, the device is a component used in a therapeutic procedure (hemodialysis) and does not perform any diagnostic function on patient samples. Therefore, it is not an IVD.
N/A
Intended Use / Indications for Use
The Rockwell Medical Technologies, Inc., Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and bicarbonate concentrate
Product codes (comma separated list FDA assigned to the subject device)
78 KPO
Device Description
The Rockwell Medical Technologies, Inc. Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acctate contain, water, salt, dextrose, and non-sugar electrolytes formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate solution. These concentrate solutions, when proportioned/ mixed in a threestream dialysis machine with pre-treated or purified water meeting AAMI Standards and a bicarbonate concentrate solution, may be used in conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. The Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate presented in this 510K Notification are intended to be used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate, chloride and sodium concentrate solution is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution. These types of final hemodialysis solutions are commonly referred to as "Bicarbonate Hemodialysis Solutions." These proportioned hemodialysis solutions are then heated to body temperature and then perfused through the dialysis fluid compartment of artificial kidneys or hemodialyzers. These bicarbonate hemodialysis solutions are separated from the patient's blood by means of a semi-permeable cellulosic or non-cellulosic membrane which serves as a molecular weight selective barrier to the passage of molecules beyond a certain molecular weight. The molecular weigh cutoff of each type of membrane may vary depending on the membrane type, manufacturing process, etc. The semi-permeable membrane in a hemodialyzer permits the passage of smaller molecular weight (less than 5,000 Daltons for conventional cellulosic membranes), ionized molecules, waste products and toxins (i.e. blood urea nitrogen, creatinine, potassium, etc.) contained in the patient's blood circulating through the dialyzer, to pass through the semi-permeable membrane into the bicarbonate hemodialysis solutions, exit the hemodialyzer, enter the hemodialysis monitor and exit the monitor and are ultimately discarded. The ionic and molecular composition of the hemodialysis solution establishes the concentration gradient between the blood and the hemodialysis solution passing through the hemodialyzer which permits the effective removal of waste products and toxins found in excess in the patient's blood during acute and end-stage renal failure.
Since different patients have different requirements for the removal rates and quantities of various molecules and toxins (i.e. blood urea nitrogen, creatinine, potassium, phosphate, magnesium, chloride, sodium calcium water, etc.) in acute and chronic renal failure, it necessitates having a variety of different bicarbonate containing hemodialysis solutions to satisfy the needs of all acute and end-stage renal failure patients. In addition, there a number of different types of hemodialysis machines which have different proportioning rates. The concentrate mixes and solutions presented in this 510K Notification are designed or formulated to be used with hemodialysis machines that proportion according to the following dilution ratios:
Stream 1: Water
Stream 2: Acidified Concentrate Proportioning Ratios 1:35.83 or 1:44.00 or 1:34.00
Stream 3: Bicarbonate Concentrate Proportioning Ratios 1:19.13 or 1:27.57 or 1:25.16
It is for these reasons that a manufacturer of these hemodialysis concentrate solutions and must provide a number of different formulations to contain varying concentrations of the various molecular weight The concentrations of these various molecular components are varied in the final components. hemodialysis solution within physiological and non-physiological ranges to permit the efficient removal of lack thereof from the patient's blood during hemodialysis.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
Non-Clinical Tests: In vitro testing was performed to determine the chemical composition and range of composition. The results of these tests confirmed that the proposed device is equivalent to the proposed device for these parameters.
Clinical Test Results: Clinical testing was not performed
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.
Not Found
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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510K Notification Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate November 25th, 2002
510(k) SUMMARY
FFB 2 & 2003
SUBMITTER:
DATE PREPARED:
DEVICE NAME:
CLASSIFICATION NAMES:
PREDICATE DEVICE:
Rockwell Medical, Technologies, Inc. 30142 Wixom Road Wixom. MI 48393 Phone: 248-960-9009
November 25th, 2002
Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate
Concentrate Solutions for Hemodialysis Accessories to Hemodialysis
Rockwell Medical Dri-Sate Acid Concentrate Solutions and Powders
Fresenius USA, Inc. Granuflo Dialysate Concentrate
Device Description:
The Rockwell Medical Technologies, Inc. Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acctate contain, water, salt, dextrose, and non-sugar electrolytes formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate solution. These concentrate solutions, when proportioned/ mixed in a threestream dialysis machine with pre-treated or purified water meeting AAMI Standards and a bicarbonate concentrate solution, may be used in conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. The Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate presented in this 510K Notification are intended to be used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate, chloride and sodium concentrate solution is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution. These types of final hemodialysis solutions are commonly referred to as "Bicarbonate Hemodialysis Solutions." These proportioned hemodialysis solutions are then heated to body temperature and then perfused through the dialysis fluid compartment of artificial kidneys or hemodialyzers. These bicarbonate hemodialysis solutions are separated from the patient's blood by means of a semi-permeable cellulosic or non-cellulosic membrane which serves as a molecular weight selective barrier to the passage of molecules beyond a certain molecular weight. The molecular weigh cutoff of each type of membrane may vary depending on the membrane type, manufacturing process, etc. The semi-permeable membrane in a hemodialyzer permits the passage of smaller molecular weight (less than 5,000 Daltons for conventional cellulosic membranes), ionized molecules, waste products and toxins (i.e. blood urea nitrogen, creatinine, potassium, etc.) contained in the patient's blood circulating through the dialyzer, to pass through the semi-permeable membrane into the bicarbonate hemodialysis solutions, exit the hemodialyzer, enter the hemodialysis monitor and exit the monitor and are ultimately discarded. The ionic and molecular composition of the hemodialysis solution establishes the concentration gradient between the blood and the hemodialysis solution passing through the hemodialyzer which permits the effective removal of waste products and toxins found in excess in the patient's blood during acute and end-stage renal failure.
Since different patients have different requirements for the removal rates and quantities of various molecules and toxins (i.e. blood urea nitrogen, creatinine, potassium, phosphate, magnesium, chloride, sodium calcium water, etc.) in acute and chronic renal failure, it necessitates having a variety of different bicarbonate containing hemodialysis solutions to satisfy the needs of all acute and end-stage renal failure patients. In addition, there a number of different types of hemodialysis machines which have different proportioning rates. The concentrate mixes and solutions presented in this 510K Notification are designed
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510K Notification Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate November 25th, 2002
or formulated to be used with hemodialysis machines that proportion according to the following dilution ratios:
| TABLE I | ||
|---|---|---|
| Stream 1 | Stream 2: Acidified Concentrate Proportioning Ratios | Stream 3: Bicarbonate Concentrate Proportioning Ratios |
| Water | 1:35.83 or 1:44.00 or 1:34.00 | 1:19.13 or 1:27.57 or 1:25.16 |
It is for these reasons that a manufacturer of these hemodialysis concentrate solutions and must provide a number of different formulations to contain varying concentrations of the various molecular weight The concentrations of these various molecular components are varied in the final components. hemodialysis solution within physiological and non-physiological ranges to permit the efficient removal of lack thereof from the patient's blood during hemodialysis.
Predicate Devices:
The Rockwell Medical Technologies, Inc. Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate are substantially equivalent to the Rockwell Medical Acid concentrate solutions for bicarbonate hemodialysis as well as the Fresenius USA, Inc., Granuflo/Granulate Powder Dialysate Concentrates.
Intended Use:
Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate Indications:
The Rockwell Medical Technologies, Inc., Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and bicarbonate concentrate
This indication statement is essentially the same as the indication statement for the predicate device.
Technological Characteristics:
Comparing the proposed device to the predicate devices utilize the same range of chemical compositions, packaging and formulations. There are no significant differences.
Summary of Non-Clinical Tests:
In vitro testing was performed to determine the chemical composition and range of composition.. The results of these tests confirmed that the proposed device is equivalent to the proposed device for these parameters.
Clinical Test Results:
Clinical testing was not performed
Conclusions:
Testing performed on the Rockwell Medical Technologies, Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate Inc. indicates that they are safe, effective, and performs as well as the predicate device, when used in accordance with the instructions for use.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2003
Mr. Gerry Fritz Director of Quality Assurance & Operations Rockwell Medical Technologies, Inc. 30142 Wixom Road WIXOM MI 48393
Re: K023985
Trade/Device Name: Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: November 25, 2002 Received: December 2, 2002
Dear Mr. Fritz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
Page / of /
510 (k) NUMBER (IF KNOWN):
DEVICE NAME: Rockwell Medical Technologies, Inc., Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate
INDICATIONS FOR USE:
Indications for Use Statement
The Rockwell Medical Technologies, Inc., Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and bicarbonate concentrate
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
David A. Lynn
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number _