(348 days)
Not Found
No
The device description focuses on the chemical composition and manufacturing standards of a hemodialysis concentrate, with no mention of AI or ML technologies.
Yes.
The device is indicated for use in acute and chronic Hemodialysis, which is a therapeutic process.
No
Explanation: This device is an acid concentrate used in hemodialysis and is an accessory to a hemodialysis machine. It is a chemical component for treatment, not a diagnostic tool that identifies or characterizes a disease or condition.
No
The device description clearly states that CitriSol is a physical product (dry powder or liquid) used as an accessory with a hemodialysis machine. It is 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 "acute and chronic Hemodialysis" as an "accessory to be used with the appropriate Hemodialysis machine." This describes a device used in the treatment of a patient, not for testing a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description focuses on the chemical composition and manufacturing of a concentrate used in the hemodialysis process. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic or monitoring information based on sample analysis
The device is a component used in the hemodialysis process itself, which is a treatment, not a diagnostic procedure.
N/A
Intended Use / Indications for Use
CitriSol acid concentrate dry powder or liquid is indicated for use in the acute and chronic Hemodialysis. It is an accessory to be used with the appropriate Hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSE/AAMI/ISO standard water for hemodialysis and Sodium Bicarbonate Mix.
Product codes (comma separated list FDA assigned to the subject device)
KPO
Device Description
CitriSol acid concentrate comes in Iiquid and dry powder form. The product is available in all 3 different proportioning, as shown in the table below:
| 45X LIQUID | 36.83X LIQUID | 35X LIQUID | POWDER |
|---|---|---|---|
| CITRISOL | CITRISOL | CITRISOL | CITRISOL |
| FORMULATIONS | FORMULATIONS | FORMULATIONS | FORMULATIONS |
| 100020-75-DEX100 | 80020-75-DEX100 | 78020-75-DEX100 | |
| 100120-75-DEX100 | 80120-75-DEX100 | 78120-75-DEX100 | |
| 100220-75-DEX100 | 80220-75-DEX100 | 78220-75-DEX100 | |
| 100320-75-DEX100 | 80320-75-DEX100 | 78320-75-DEX100 | |
| 100420-75-DEX100 | 80420-75-DEX100 | 78420-75-DEX100 | ALL |
| 100025-75-DEX100 | 80025-75-DEX100 | 78025-75-DEX100 | FORMULATIONS |
| 100125-75-DEX100 | 80125-75-DEX100 | 78125-75-DEX100 | AVAILABLE |
| 100225-75-DEX100 | 80225-75-DEX100 | 78225-75-DEX100 | IN |
| 100325-75-DEX100 | 80325-75-DEX100 | 78325-75-DEX100 | POWDER FORM |
| 100425-75-DEX100 | 80425-75-DEX100 | 78425-75-DEX100 | ALSO |
| 100030-75-DEX100 | 80030-75-DEX100 | 78030-75-DEX100 | |
| 100130-75-DEX100 | 80130-75-DEX100 | 78130-75-DEX100 | |
| 100230-75-DEX100 | 80230-75-DEX100 | 78230-75-DEX100 | |
| 100330-75-DEX100 | 80330-75-DEX100 | 78330-75-DEX100 | |
| 100430-75-DEX100 | 80430-75-DEX100 | 78430-75-DEX100 | |
| 100035-75-DEX100 | 80035-75-DEX100 | 78035-75-DEX100 | |
| 100135-75-DEX100 | 80135-75-DEX100 | 78135-75-DEX100 | |
| 100235-75-DEX100 | 80235-75-DEX100 | 78235-75-DEX100 | |
| 100335-75-DEX100 | 80335-75-DEX100 | 78335-75-DEX100 | |
| 100435-75-DEX100 | 80435-75-DEX100 | 78435-75-DEX100 |
CitriSol acid concentrate dry powder or liquid is indicated for use in the acute and chronic Hemodialysis. It is an accessory to be used with the appropriate Hemodialysis machine in a 3 stream mix in the exact preserthed proportion with ANSI/AAMI/ISO standard water for hemodialysis and Sodium Bicarbonate Mix.
CitriSol, contains all the same electrolytes as Diasol Concentrate and 2.4mEq of Citric Acid.
CitriSol, when mixed with ANSEAAMI/ISO standard water for hemodialysis, has the same chemical equivalenev as the predicates.
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)
Not Found
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.
Diasol Acid concentrate K854391, Dryasol Concentrate K993212, Citrapure K062399, Citrasate K000792
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
K130211 Page 1 of 2
DIASOL., INC.
510(k) Summary ട്.
SUBMITTER:
FEB 1 0 2014
7
CONTACT:
DATE SUMMARY WAS PREPARED:
CLASSIFICATION:
REGULATION NUMBER:
CLASSIFICATION PRODUCT CODE:
NAME OF DEVICE:
COMMON NAME:
CLASSIFICATION NAME:
PREDICATE DEVICE:
DIASOL. INC 1110 Arroyo St San Fernando, CA 91340 Tel: 818-838-7077 Fax: 818-838-7007 MONICA ABELES
December 6. 2012
GASTROENTEROLOGY/UROLOGY
21 CFR 876.5820 Hemodialysis system and accessories KPO
CITRISOL ACID CONCENTRATE
ACID CONCENTRATE FOR HEMODIALYSIS USE 21 CFR 876.5820 Hemodialysis system and accessories CLASS II
ACID CONCENTRATE FOR HEMODIALYSIS USE 21 CFR 876.5820 Hemodialysis system and accessories CLASS II
Diasol Acid concentrate K854391 Dryasol Concentrate K993212 Citrapure K062399 Citrasate K000792
SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL --EQUIVALENCE DETERMINATION
1
CitriSol is manufactured following strict cGMP's and in accordance with the AAMI/ANSI/ISO 13958:2009 concentrates for hemodialysis and AAMI/ISCHANSI 13959:2009 Water for Hemodialysis.
Our product codes are casy to understand. The electrolytes present in each solution. Preceded by CS representing the Citric Acid part.
In the 45x proportioning formulations the first three numbers -100 stand for the Na. followed by K (ex 2). Ca (25). -Mg (75)
This example stands for CS 100225-75 a 2K 2.5 Ca product.
CitriSol acid concentrate comes in Iiquid and dry powder form. The product is available in all 3 different proportioning, as shown in the table below:
| 45X LIQUID | 36.83X LIQUID | 35X LIQUID | POWDER |
|---|---|---|---|
| CITRISOL | CITRISOL | CITRISOL | CITRISOL |
| FORMULATIONS | FORMULATIONS | FORMULATIONS | FORMULATIONS |
| 100020-75-DEX100 | 80020-75-DEX100 | 78020-75-DEX100 | |
| 100120-75-DEX100 | 80120-75-DEX100 | 78120-75-DEX100 | |
| 100220-75-DEX100 | 80220-75-DEX100 | 78220-75-DEX100 | |
| 100320-75-DEX100 | 80320-75-DEX100 | 78320-75-DEX100 | |
| 100420-75-DEX100 | 80420-75-DEX100 | 78420-75-DEX100 | ALL |
| 100025-75-DEX100 | 80025-75-DEX100 | 78025-75-DEX100 | FORMULATIONS |
| 100125-75-DEX100 | 80125-75-DEX100 | 78125-75-DEX100 | AVAILABLE |
| 100225-75-DEX100 | 80225-75-DEX100 | 78225-75-DEX100 | IN |
| 100325-75-DEX100 | 80325-75-DEX100 | 78325-75-DEX100 | POWDER FORM |
| 100425-75-DEX100 | 80425-75-DEX100 | 78425-75-DEX100 | ALSO |
| 100030-75-DEX100 | 80030-75-DEX100 | 78030-75-DEX100 | |
| 100130-75-DEX100 | 80130-75-DEX100 | 78130-75-DEX100 | |
| 100230-75-DEX100 | 80230-75-DEX100 | 78230-75-DEX100 | |
| 100330-75-DEX100 | 80330-75-DEX100 | 78330-75-DEX100 | |
| 100430-75-DEX100 | 80430-75-DEX100 | 78430-75-DEX100 | |
| 100035-75-DEX100 | 80035-75-DEX100 | 78035-75-DEX100 | |
| 100135-75-DEX100 | 80135-75-DEX100 | 78135-75-DEX100 | |
| 100235-75-DEX100 | 80235-75-DEX100 | 78235-75-DEX100 | |
| 100335-75-DEX100 | 80335-75-DEX100 | 78335-75-DEX100 | |
| 100435-75-DEX100 | 80435-75-DEX100 | 78435-75-DEX100 |
CitriSol acid concentrate dry powder or liquid is indicated for use in the acute and chronic Hemodialysis. It is an accessory to be used with the appropriate Hemodialysis machine in a 3 stream mis in the exact preserthed proportion with ANSI/AAMI/ISO standard water for hemodialysis and Sodium Bicarbonate Mix.
CitriSol, contains all the same electrolytes as Diasol Concentrate and 2.4mEq of Citric Acid.
CitriSol, when mixed with ANSEAAMI/ISO standard water for hemodialysis, has the same chemical equivalenev as the predicates.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2014
Diasol, Inc. Monica Abeles President 1110 Arroyo Street San Fernando, CA 91340
Re: K130211
Trade/Device Name: CitriSol acid concentrate Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: December 9, 2013 Received: December 11, 2013
Dear Monica Abeles,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Monica Abeles
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin DBA Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510tk) Number (if known): k1305 // Device Name: Citrisol Acid Concentrate
Indications For Use:
CitriSol acid concentrate dry powder or liquid is indicated for use in the acute and chronic Hemodialysis. It is an accessory to be used with the appropriate Hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSE/AAMI/ISO standard water for hemodialysis and Sodium Bicarbonate Mix.
Preseription Use (Part 21 CFR 801 Subpart 1))
AND:OK
()ver-The-Counter I Isc (2) CFR 807 Subpart C)