(101 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical design of a sodium bicarbonate column for hemodialysis, with no mention of AI or ML technologies.
No
The device is a column containing sodium bicarbonate intended for preparing hemodialysis solutions. It is an accessory used with a hemodialysis machine, rather than directly performing a therapeutic function itself.
No
The device is indicated for the preparation of hemodialysis solutions, not for diagnosis of a medical condition.
No
The device description clearly describes a physical column containing sodium bicarbonate and associated hardware components (holder, connecting system, spike, membrane, O-ring, mesh filter). It is not solely software.
Based on the provided information, the Althin Medical AB Altracart II is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the preparation of hemodialysis solutions, which are then used in the patient during hemodialysis. IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a column containing sodium bicarbonate for mixing with water and acid concentrate. It's a component in the process of creating the dialysis fluid, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on patient specimens.
The Altracart II is a component used in the process of hemodialysis, which is a treatment for kidney failure. It's a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Althin Medical AB Altracart II is indicated for the preparation of sodium bicarbonate containing hemodialysis solutions for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and acid concentrate solutions.
Product codes (comma separated list FDA assigned to the subject device)
78 KPO
Device Description
The Althin Medical AB Altracart II is a column, which contains sodium bicarbonate formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and acid concentrate solution. It is designed to fit into a holder with a connecting system where a spike punctures a membrane at the top and bottom of the cartridge/column which then permits water to flow through the column and mix with the sodium bicarbonate. The connections to the column are sealed by a standard 0-ring, which allows an internal positive or negative pressure to be created in the column. The Altracart II is fitted with a mesh filter to prevent the sodium bicarbonate powder from entering the dialysis machine before it is dissolved or placed in solution with water. The Altracart is supplied in the following 2 configurations:
Altracart II Number: 500-750 A, Weigh of Sodium Bicarbonate (grams): 750
Altracart II Number: 500-000 A, Weigh of Sodium Bicarbonate (grams): 1000
The different weights of sodium bicarbonate, 750 and 1000 grams are provided in the Altracart II to accommodate dialysis treatment sessions of shorter and longer durations. This sodium bicarbonate powder when proportioned/ mixed with pre-treated or purified water meeting or exceeding AAMI Standards, may be used in conventional and commercially available hemodialysis machines or monitors to include the Althin System 1000, Tina, Altra Touch machines, and the Cobe Centry 3 hemodialysis machines as a hemodialysis solution.
The Altracart II can be used with all of these machines which have a cartridge holder installed for use with another manufacturer's sodium bicarbonate columns (ie. Gambro BiCart column). Included in this 510(k) is also information and a description of the Altracart II holder retrofit kits designed for installation on the Althin System 1000, Tina and Altra Touch hemodialysis machines.
The hemodialysis sodium bicarbonate powder presented in this 510K Notification is intended to be used in three stream hemodialysis machines in which an aciditied concentrate is proportioned into one stream, a sodium bicarbonate, concentrate solution which has been prepared by mixing the powder with a specified volume of water is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third stream. The Altracart II columns are designed to be used with commercially available acid concentrate solutions containing 3 mmol of H (hydrogen) and between 100-103 mmol Na' (sodium). The final dialysis solution prepared using the Altracart II will have between 135 and 140 mmol of sodium and 32 to 42 mmol of bicarbonate per liter depending on the acid concentrate and sodium profiling system used with and depending on the particular hemodialysis machine. These three streams are then mixed to prepare a final proportioned hemodialysis solution. These types of a 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 cut-off 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 and non-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 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 Altracart II which is a column containing sodium bicarbonate and presented in this 510K Notification is designed or formulated to be used with hemodialysis machines that proportion at different ratios.
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)
Study Type: In vitro testing
Key Results: 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 substantially equivalent to the proposed device for these parameters. Clinical testing was not performed.
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
§ 876.5820 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.
0
| K990010 | Page 1 of | |
|---|---|---|
| 510K Notification | ||
| Althin Medical AB Altracart II | ||
| April 6, 1999 | ||
| APR 15 | ||
| SECTION XV. | ||
| 510(K) Summary | ||
| Submitter: | Althin Medical AB | |
| Box 39 | ||
| S-372 21 RONNEBY, Sweden | ||
| Phone: 46-457 759 00 | ||
| Date prepared: | 6 April, 1999 | |
| Device name: | Althin Medical AB Altracart II | |
| Classification name: | Hemodialysis Accessories | |
| Hemodialysis Concentrate Solutions & Powders | ||
| Predicate device: | Gambro BiCart Columns |
Device Description:
The Althin Medical AB Altracart II is a column, which contains sodium bicarbonate formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and acid concentrate solution. It is designed to fit into a holder with a connecting system where a spike punctures a membrane at the top and bottom of the cartridge/column which then permits water to flow through the column and mix with the sodium bicarbonate. The connections to the column are sealed by a standard 0-ring, which allows an internal positive or negative pressure to be created in the column. The Altracart II is fitted with a mesh filter to prevent the sodium bicarbonate powder from entering the dialysis machine before it is dissolved or placed in solution with water. The Altracart is supplied in the following 2 configurations:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A the successful and the same of the contract and the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the cont
Altracart II Number
and and the country of the country of the continued and the first of | ----------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | LA MALE LE MERICA A A MI-LA A A . LE . LA A
Weigh of Sodium - Contains a Valve - Contains a Valve |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| and state works of the consisted on the country | Canadian Canada Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Car
The Call Property of Children | The Call Property of Children
Concession and Concession Company of Children Company of Children
The Real Property of Children of Children of Children
Concession of the consistent of the contributed to
Bicarbonate (grams) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
and the control of the control of the control of the contribution of the county of |
| 500-750 A | | |
| 500-000 A | 1000 | |
The different weights of sodium bicarbonate, 750 and 1000 grams are provided in the Altracart II to accommodate dialysis treatment sessions of shorter and longer durations.
This sodium bicarbonate powder when proportioned/ mixed with pre-treated or purified water meeting or exceeding AAMI Standards, may be used in conventional and commercially available hemodialysis machines or monitors to include the Althin System 1000, Tina, Altra Touch machines, and the Cobe Centry 3 hemodialysis machines as a hemodialysis solution.
1
510K Notification
Althin Medical AB Altracart II
April 6, 1999
The Altracart II can be used with all of these machines which have a cartridge holder installed for use with another manufacturer's sodium bicarbonate columns (ie. Gambro BiCart column). Information is provided in 510(k) Notification which demonstrates that the Althin Medical AB Altracart II can be used with these machines and column holders. Included in this 510(k) is also information and a description of the Altracart II holder retrofit kits designed for installation on the Althin System 1000, Tina and Altra Touch hemodialysis machines.
The hemodialysis sodium bicarbonate powder presented in this 510K Notification is intended to be used in three stream hemodialysis machines in which an aciditied concentrate is proportioned into one stream, a sodium bicarbonate, concentrate solution which has been prepared by mixing the powder with a specified volume of water is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third stream. The Altracart II columns are designed to be used with commercially available acid concentrate solutions containing 3 mmol of H (hydrogen) and between 100-103 mmol Na' (sodium). The final dialysis solution prepared using the Altracart II will have between 135 and 140 mmol of sodium and 32 to 42 mmol of bicarbonate per liter depending on the acid concentrate and sodium profiling system used with and depending on the particular hemodialysis machine. These three streams are then mixed to prepare a final proportioned hemodialysis solution. These types of a 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 cut-off 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 and non-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 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 Altracart II which is a column containing sodium bicarbonate and presented in this 510K Notification is designed or formulated to be used with hemodialysis machines that proportion at different ratios.
2
Page 3 of 4
510K Notification
Althin Medical AB Altracart II
April 6, 1999
Predicate Devices:
The Althin Medical AB Altracart II sodium bicarbonate containing columns for hemodialysis are identical in design and construction to the currently marketed Gambro BiCart Columns which has been approved for marketing / sale in the United States under a 510K Notifications (K873155 and K940601). Both the predicate and the proposed devices, incorporate an identical compound, sodium bicarbonate and other dialysis fluid contact materials and have the same intended use, preparation of a hemodialysis solution containing sodium bicarbonate,
Intended Use:
The Althin Medical AB Altracart II is indicated for the preparation of sodium bicarbonate containing hemodialysis solutions for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and acid concentrate solutions.
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 substantially equivalent to the proposed device for these parameters.
3
Page 4 of 4
510K Notification
Althin Medical AB Altracart II
April 6, 1999
Clinical Test Results:
Clinical testing was not performed
Conclusions:
Testing performed on the Althin Medical AB Altracart II indicates that they are safe, effective, and perform as well as the predicate device, when used in accordance with the instructions for use.
4
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 1999
Mr. Ulf Lundgren Director of Quality Assurance Althin Medical AB Box 39 (Fridhemsv. 15) 372 21 Ronneby SWEDEN
Re: K990010
Althin Medical AB Altracart II Dated: March 30, 1999 Received: April 8, 1999 Regulatory Class: II 21 CFR 876.5820/Procode: 78 KPO
Dear Mr. Lundgren:
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 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). 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 III (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 requlatory 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) 594-4613. 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 requlation 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510K Notification Althin Medical AB Altracart II December 22, 1998
SECTION XVIII.
Indications for use Statement
Indications for Use: Althin Medical AB Altracart II
The Althin Medical AB Altracart II is indicated for the preparation of sodium bicarbonate containing hemodialysis solutions for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine / monitor and acid concentrate solutions.
Prescription
Over-the-Counter __
Jarint h. Seymon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number