(472 days)
Not Found
No
The summary focuses on the mechanical mixing and dispensing of bicarbonate solution and does not mention any AI or ML components.
No
The device is described as a system for mixing and delivering concentrates and sodium bicarbonate solution for hemodialysis, which supports the dialysis process rather than directly treating the patient therapeutically.
No
The device is described as a system for mixing and dispensing sodium bicarbonate solution used in hemodialysis treatment, not for diagnosing medical conditions.
No
The device description clearly indicates a "System" for mixing and dispensing, implying hardware components beyond just software. The intended use also describes physical processes (mixing and delivery of solutions).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for mixing and dispensing solutions for hemodialysis treatment, not for diagnosing a condition or analyzing a sample from the body.
- Device Description: The description focuses on the mechanical process of mixing and delivering a solution.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to prepare a solution used during treatment, not to analyze a sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to be used in a Hemodialysis facility to allow safe and effective delivery of concentrates as well as central mixing and delivery of sodium bicarbonate solution necessary for a hemodialysis treatment.
Product codes (comma separated list FDA assigned to the subject device)
78 FIN
Device Description
The consistent mixing and delivery of bicarbonate solution for use in hemodialysis
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
Hemodialysis facility
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 USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is an existing device actively marketed by USFilter with a long performance record. This submission seeks to obtain approval so as to begin marketing this device as part of a water system for use in hemodialysis.
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.
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.
0
3
AUG 27 2004
510(k) Summary
1
USFilter/lonpure, Inc. in accordance with the requirements of 21 CFR§807.92 is submitting this summary of 510(k)-safety and effectiveness information.
Submitter's Identification USFilter/lonpure, Inc. 725 Wooten Road Colorado Springs, CO 80915 719-570-9600
Date Summary Prepared 26 March 2003 , (Rev.4 - 02 August 2004)
Official Correspondent/Contact 2
Douglas L. Rufenacht 725 Wooten Road Colorado Springs, CO 80915 719-550-2055
Name of the Device 3
USFilter Bicarbonate Mixing and Dispensing (Bicarb) System
Substantial Equivalence 4
MAR COR Services, Inc. MAR COR Services Bicarb System K003560
Device Description 5
The consistent mixing and delivery of bicarbonate solution for use in hemodialysis
6 Intended Use
The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to be used in a Hemodialysis facility to allow safe and effective delivery of concentrates as well as central mixing and delivery of sodium bicarbonate solution necessary for a hemodialysis treatment.
1
Comparison to Substantial Equivalence Devices 7
The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System unit contains the same fundamental scientific technology as the substantial equivalent device. Please reference the following Chart of Comparison:
| Specifications and
Technical Information | USFilter
BICARB50SYS &
BICARB100SYS | | MAR COR
MCB 210-50 & MCB 210-
100 | |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Indications for Use: | The USFilter Bicarbonate Mixing
and Dispensing (Bicarb) System
is intended to be used in a
Hemodialysis facility to allow safe
and effective delivery of
concentrates as well as central
mixing and delivery of sodium
bicarbonate solution necessary
for a hemodialysis treatment. | | The Bicarb Mixing and Distribution
System (Bicarb System) designed
and manufactured by Mar Cor
Services is, safe, reliable and easy
to use. This system will reduce staff
time by providing consistent bicarb
mixing, and through system
cleaning and disinfection. | |
| Utility Requirements | | | | |
| Water Feed: | RO or DI water produced to AAMI
standards for Hemodialysis | | RO or DI water produced to AAMI
standards for Hemodialysis | |
| Electrical
requirements: | 115 VAC, Single Phase, 20 AMP | | 115 VAC, Single Phase, 20 AMP | |
| Drain: | 1" Minimum | | 1" Minimum | |
| Physical Dimensions | 50 | 100 | 50 | 100 |
| Length: | 70" | 83" | 85" | 85" |
| Depth: | 27" | 35" | 32" | 32" |
| Height: | 60" | 60" | 57" | 61" |
| Operating Weight: | 1800 LBS | 2500 LBS | 1300 LBS | 2050 LBS |
| Dimensional/Operating Room | | | | |
| Width: | 6' 10" | | 6' 10" | |
| Depth: | 3' 3" | | 3' 3" | |
| Height: | 6" 0" | | 6" 0" | |
| Installation Piping | | | | |
| Feedwater: | ½" schedule 80 PVC | | ½" schedule 80 PVC | |
| Loop Distribution: | ¾" schedule 80 PVC | | ¾" schedule 80 PVC | |
| Loop Return: | ¾" schedule 80 PVC | | ¾" schedule 80 PVC | |
| Drain: | 1" schedule 80 PVC | | 1" schedule 80 PVC | |
| System Floats | | | | |
| Mix Tank Float: | The mix tank is equipped with a
high level float that will close the
fill valve if the water in the tank
exceeds 100 gallons (50 gallons
for 50 gallon systems). The fill
valve controller will not reactivate
unless the water level is below
the float level. | | The mix tank is equipped with a
high level float that will close the fill
valve if the water in the tank
exceeds 100 gallons (50 gallons for
50 gallon systems). The fill valve
controller will not reactivate unless
the water level is below the float
level. | |
| Distribution Tank
Float: | The distribution tank is equipped
with a low-level float that lights a
warning light if the bicarbonate in
the tank drops below 25 gallons.
If the distribution tank is allowed
to go empty an audible alarm will
sound. | | The distribution tank is equipped
with a low-level float that lights a
warning light if the bicarbonate in
the tank drops below 25 gallons. If
the distribution tank is allowed to go
empty an audible alarm will sound. | |
| Pumps | | | | |
| Mix Pump: | ½ hp Totally Enclosed Fan
Cooled (TEFC) motor | | ½ hp Totally Enclosed Fan Cooled
(TEFC) motor | |
| Distribution Pump: | 1/9 hp TEFC motor | | 1/8 hp TEFC motor | |
| Tank Material: | Polyethylene | | Polyethylene | |
2
Image /page/2/Picture/0 description: The image shows the text "KC3: 542 PAGE 3 OF 3". The text appears to be handwritten. The text is black and the background is white.
Discussion of Non-Clinical Test Performed for Determination of Substantial 8 Equivalence is as follows:
The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is an existing device actively marketed by USFilter with a long performance record. This submission seeks to obtain approval so as to begin marketing this device as part of a water system for use in hemodialysis.
Discussion of Clinical Test Performed: 9
N/A
Biocompatibility Testing: 10
USFilter certifies that all materials utilized in the design, manufacture, and operation of the USFilter Bicarbonate Mixing and Dispensing (Bicarb) System are utilized in the predicate device as well as used in other registered devices and systems currently sold by USFilter and registered with the Food and Drug Administration. The tables in appendix D provide the detailed break down of these materials as well as a documented review in accordance with Appendix C of FDA document G95-1. It is the contention of USFilter that as per the results of the review documented in appendix D no further testing is required.
11 Conclusions:
As was true for the MAR COR Services Bicarb System, the USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to provide consistent bicarbonate mixing and distribution for Hemodialysis applications.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes extending from its head, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2004
Mr. Douglas Rufenacht Validation Manager and Regulatory Compliance USFilter Process Water Systems High Purity Systems 725 Wooten Road COLORADO SPRINGS CO 80915
Re: K031502
KU31302
Trade/Device Name: USFilter Bicarbonate Mixing and Dispensing (Bicarb) System Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FIN Dated: August 20, 2004 Received: August 23, 2004
Dear Mr. Rufenacht:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally interest date of the Medical Device Amendments, or to commerce prior to May 20, 1970, are eccordance with the provisions of the Federal Food, Drug, devices that have been roomstilled in quire approval of a premarket approval application (PMA). and Costhere 710 (110) that to nevice, subject to the general controls provisions of the Act. The 1 ou may, uicierore, market the act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (500 a00 regulations affecting your device can be it may be subject to adultions, 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 Ficase be advised that I Drive issuation that your device complies with other requirements of the Act that I DA has made a active regulations administered by other Federal agencies. You must of any I ederal statutes and roginements, including, but not limited to: registration and listing comply with an the riot 5 requirements, as and 801); good manufacturing practice requirements as set (21 CFR Part 607), labornig (21 OF Reason), government (20); and if applicable, the clectronic forth in the quality bysteins (QD) rog to the Act); 21 CFR 1000-1050.
4
l'are 2
This letter will allow you to begin marketing your device as described in your Section 10(k).
The station and the market of alling of edicantial equivalence of your device to This letter will allow you to begin marketing your device of your device of your device to a le;sally
premarket notification. The FDA finding of substanted of your device an premarket notification. The FDA inding of substantal Quivation or 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), phease
s on the secure of the comments of the following numbers, based on the reg If you desire specific advice for your device on our labourig region in and on the regulation
contact the Office of Compliance at one of the following numbers, based on the r 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 advectising of your device, please contact the Additionally, for questions on the promotion and are mote the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, planse note the regulation of t Office of Compliance at (301) Syland St. Also, production oveganization Other general
by reference to premarket notification" (21CFR Part 807.97) you may obtain. Division o by reference to premarket notification (21CFA i are oo 1779 yoed firon the Division of Small
information on your responsibilities under the Act may be obtained from the (800) information on your responsibilities under Asstance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its today, main html. Manufacturers, International and Collishiner Fisistance a the re-ri-
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
5
Indication for Use
The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to be used in a Hemodialysis facility to allow safe and effective delivery of concentrates as well as central mixing and delivery of sodium bicarbonate solution necessary for a hemodialysis treatment.
Prescription Use
Daniel A. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________