(267 days)
Not Found
No
The device description and intended use clearly define the product as a liquid concentrate for hemodialysis, with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML. The focus is on the chemical composition and physical packaging of the concentrate.
Yes
The device is a component of dialysate used in hemodialysis therapy for patients with renal failure, which is a therapeutic intervention.
No
Explanation: The device is an acid concentrate used to prepare dialysate for hemodialysis, which is a therapeutic treatment. It does not diagnose any condition.
No
The device description clearly states that the device is a liquid concentrate and a bottle with a modified cap, which are physical components, not software.
Based on the provided text, these devices are not In Vitro Diagnostics (IVDs).
Here's why:
- Intended Use: The intended use is for preparing dialysate used in extracorporeal bicarbonate hemodialysis. This process involves filtering blood outside the body, not analyzing samples of human origin in vitro.
- Device Description: The description details the chemical composition of the concentrates and their role in a hemodialysis machine to create dialysate. It focuses on the physical process of solute exchange across a membrane, not on diagnostic testing.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's condition
- Use in a laboratory setting for testing
These devices are components used in a therapeutic process (hemodialysis) to treat renal failure, not to diagnose it or monitor it through in vitro testing.
N/A
Intended Use / Indications for Use
Citrasate® Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate® Liquid Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.
NaturaLyte® Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte® Liquid Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.
Product codes (comma separated list FDA assigned to the subject device)
KPO
Device Description
The Citrasate Liquid Acid Concentrate product line consists of three (3) formulations that differ in concentrations of potassium chloride. Each formulation is offered in two (2) presentations-a 1gallon high density polyethylene bottle and a 55-gallon high density polyethylene drum-for a total of six (6) product codes. Only the bottle presentation is the subject of this 510(k).
The NaturaLyte Liquid Acid Concentrate product line consists of 16 formulations that differ in concentrations of potassium chloride and calcium chloride. All formulations are offered in a 1-gallon high density polyethylene bottle and six (6) formulations are offered in a 55-gallon high density polyethylene drum, for a total of 22 product codes. Only the bottle presentation is the subject of this 510(k).
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate products are single-use, non-sterile devices intended for use in hemodialysis therapy for acute and chronic renal failure. Both products consist of electrolytes (chloride salts of sodium, calcium, magnesium, and potassium), dextrose, and an organic acid source (citric acid in Citrasate and acetic acid in NaturaLyte). Citrasate also contains sodium acetate as a secondary pH adjuster. All formulation components are mixed in a single solution with dialysis quality water and provided to the customer ready for use.
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one (1) component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis. The proposed Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate 1-gallon bottles have a modified cap design with alternate raw materials. The proposed bottle cap is composed of high density polyethylene (HDPE). The tamper-evident cap has a grooved ring pull tab intended to provide a thread lock. Due to the difference in cap design, the bottle threads are modified to match the threads and dimensions of the proposed cap. Dimensional changes are limited to the threads and bottle termination area only and do not affect the main bottle dimensions. There is no change in wall thickness or material used to manufacture the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate 1-gallon bottles.
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
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are used in environments where acute and chronic hemodialysis is performed.
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)
Stability evaluations were conducted for Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate to support the 24-month (2-year) shelf life. Stability is monitored as part of routine production testing.
Shipping and distribution verification testing was performed for the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate products in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems. Results support that the products' packaging is able to withstand the distribution environment.
Biocompatibility testing was conducted in accordance with ISO 10993-1:2018 and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (04 September 2020). The following endpoints were assessed to support the biological safety of the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate bottles: Chemical characterization, Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Material mediated pyrogenicity, Hemocompatibility. A toxicological risk assessment was also performed.
A Human Factors assessment was conducted for the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate to demonstrate their safe and effective use in accordance with FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
No animal studies were performed. No clinical studies were 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.
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
May 10, 2022
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K212620
Trade/Device Name: Citrasate® Liquid Acid Concentrate, NaturaLyte® Liquid Acid Concentrate Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: Class II Product Code: KPO Dated: August 17, 2021 Received: August 18, 2021
Dear Denise Oppermann:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Gema Gonzalez, MS Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212620
Device Name Citrasate® Liquid Acid Concentrate NaturaLyte® Liquid Acid Concentrate
Indications for Use (Describe)
Citrasate® Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate® Liquid Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.
NaturaLyte® Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte® Liquid Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that looks like three chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top and "MEDICAL CARE" on the bottom.
5. 510(K) SUMMARY
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.
5.1. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA | |
| 02451-1457 | |
| Phone: | (781) 996-9103 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Preparation Date: | 17 August 2021 |
5.2. Device Name
| Trade Name: | Citrasate® Liquid Acid Concentrate |
|---|---|
| NaturaLyte® Liquid Acid Concentrate | |
| Common Name: | Liquid Acid Concentrates |
| Regulation Name: | Hemodialysis system and accessories |
| Regulatory Class: | Class II per 21 CFR § 876.5820 |
| Product Code: | KPO |
| Product Code Name: | Dialysate Concentrate for Hemodialysis (Liquid or Powder |
| FDA Review Panel: | Gastroenterology/Urology |
5.3. Legally Marketed Predicate Device
The legally marketed predicate devices are the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate cleared under K192017.
These devices are not currently subject to a design-related recall.
5.4. Device Description
5.4.1. Device Identification- Citrasate
The Citrasate Liquid Acid Concentrate product line consists of three (3) formulations that differ in concentrations of potassium chloride. Each formulation is offered in two (2) presentations-a 1gallon high density polyethylene bottle and a 55-gallon high density polyethylene drum-for a total of six (6) product codes. Only the bottle presentation is the subject of this 510(k). Descriptions of the available Citrasate Liquid Acid Concentrate bottle formulations are provided in Table 1.
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Image /page/4/Picture/1 description: The image shows the Fresenius Medical Care logo. On the left is a blue symbol that consists of three chevrons stacked on top of each other, pointing downwards. To the right of the symbol is the text "FRESENIUS MEDICAL CARE", with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line. The text is also in blue.
| Part Number | Part Number Description |
|---|---|
| 08-1251-CA | Citrasate Liquid Acid – 1.0 K, 2.5 Ca, 1.0 Mg – 1-gal bottle |
| 08-2251-CA | Citrasate Liquid Acid – 2.0 K, 2.5 Ca, 1.0 Mg – 1-gal bottle |
| 08-3251-CA | Citrasate Liquid Acid – 3.0 K, 2.5 Ca, 1.0 Mg – 1-gal bottle |
Table 1: Citrasate Liquid Acid Concentrate Products (1-Gallon Bottles)
5.4.2. Device Identification- NaturaLyte
The NaturaLyte Liquid Acid Concentrate product line consists of 16 formulations that differ in concentrations of potassium chloride and calcium chloride. All formulations are offered in a 1-gallon high density polyethylene bottle and six (6) formulations are offered in a 55-gallon high density polyethylene drum, for a total of 22 product codes. Only the bottle presentation is the subject of this 510(k). Descriptions of the available NaturaLyte Liquid Acid Concentrate bottle formulations are provided in Table 2.
| Part Number | Part Number Description |
|---|---|
| 08-0231-4 | NaturaLyte Liquid Acid - 0.0 K, 2.25 Ca, 1.0 Mg - 1-gal bottle |
| 08-1001-0 | NaturaLyte Liquid Acid - 1.0 K, 0.0 Ca, 1.0 Mg - 1- gal bottle |
| 08-1201-8 | NaturaLyte Liquid Acid - 1.0 K, 2.0 Ca, 1.0 Mg - 1- gal bottle |
| 08-1231-3 | NaturaLyte Liquid Acid - 1.0 K, 2.25 Ca, 1.0 Mg - 1-gal bottle |
| 08-1251-1 | NaturaLyte Liquid Acid - 1.0 K, 2.5 Ca, 1.0 Mg - 1-gal bottle |
| 08-1301-4 | NaturaLyte Liquid Acid - 1.0 K, 3.0 Ca, 1.0 Mg - 1-gal bottle |
| 08-2201-5 | NaturaLyte Liquid Acid - 2.0 K, 2.0 Ca, 1.0 Mg - 1-gal bottle |
| 08-2231-2 | NaturaLyte Liquid Acid - 2.0 K, 2.25 Ca, 1.0 Mg - 1-gal bottle |
| 08-2251-0 | NaturaLyte Liquid Acid - 2.0 K, 2.5 Ca, 1.0 Mg - 1-gal bottle |
| 08-2301-3 | NaturaLyte Liquid Acid - 2.0 K, 3.0 Ca, 1.0 Mg - 1-gal bottle |
| 08-2351-8 | NaturaLyte Liquid Acid - 2.0 K, 3.5 Ca, 1.0 Mg - 1-gal bottle |
| 08-3201-4 | NaturaLyte Liquid Acid - 3.0 K, 2.0 Ca, 1.0 Mg - 1-gal bottle |
| 08-3231-1 | NaturaLyte Liquid Acid - 3.0 K, 2.25 Ca, 1.0 Mg - 1-gal bottle |
| 08-3251-9 | NaturaLyte Liquid Acid - 3.0 K, 2.5 Ca, 1.0 Mg - 1-gal bottle |
| 08-3301-2 | NaturaLyte Liquid Acid - 3.0 K, 3.0 Ca, 1.0 Mg - 1-gal bottle |
| 08-4231-0 | NaturaLyte Liquid Acid - 4.0 K, 2.25 Ca, 1.0 Mg - 1-gal bottle |
Table 2: NaturaLyte Liquid Acid Concentrate Products (1-Gallon Bottles)
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Image /page/5/Picture/1 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three chevrons stacked on top of each other, pointing downwards. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top and "MEDICAL CARE" on the bottom.
5.4.3. Device Characteristics
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate products are single-use, non-sterile devices intended for use in hemodialysis therapy for acute and chronic renal failure. Both products consist of electrolytes (chloride salts of sodium, calcium, magnesium, and potassium), dextrose, and an organic acid source (citric acid in Citrasate and acetic acid in NaturaLyte). Citrasate also contains sodium acetate as a secondary pH adjuster.
All formulation components are mixed in a single solution with dialysis quality water and provided to the customer ready for use.
5.4.4. Environment of Use
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are used in environments where acute and chronic hemodialysis is performed.
5.4.5. Brief Written Description of the Device
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one (1) component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
The proposed Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate 1-gallon bottles have a modified cap design with alternate raw materials. The proposed bottle cap is composed of high density polyethylene (HDPE). The tamper-evident cap has a grooved ring pull tab intended to provide a thread lock. Due to the difference in cap design, the bottle threads are modified to match the threads and dimensions of the proposed cap. Dimensional changes are limited to the threads and bottle termination area only and do not affect the main bottle dimensions. There is no change in wall thickness or material used to manufacture the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate 1-gallon bottles.
5.4.6. Materials of Use
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are classified as externally communicating, blood path indirect, prolonged contact (>24 hours to 30 days) duration, Class II (Category B) devices in accordance with FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process" (04 September 2020). Packaging for the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate bottles consists of the following materials:
- 1-gallon bottle - high density polyethylene
- Bottle cap high density polyethylene ●
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Image /page/6/Picture/1 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are composed of USP grade raw chemicals. Purified water meeting the requirements of ISO 13959 is used in the manufacture of Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate.
5.4.7. Key Performance Specifications/Characteristics
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each used as a component of the dialysate for hemodialysis treatments. Both concentrates are intended to be used in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The water used for the final dialysate meets ISO 13959 or ANSI/AAMI RD62 requirements.
5.5. Intended Use
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended for use in hemodialysis therapy for acute and chronic renal failure.
5.6. Indications for Use
Citrasate® Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate® Liquid Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription.
NaturaLyte® Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte® Liquid Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription.
5.7. Comparison of Technological Characteristics with the Predicate Device
The Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are substantially equivalent to the predicate devices (K192017) with regard to the following technological characteristics:
- Intended use
- Design
- Principle of operation
- Materials of construction ●
- . Performance specifications
5.8. Performance Data
Performance testing was conducted for the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate products. Results of performance testing support substantial equivalence, safety, and efficacy of the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate.
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Image /page/7/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons, stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
Stability Design Verification 5.8.1.
Stability evaluations were conducted for Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate to support the 24-month (2-year) shelf life. Stability is monitored as part of routine production testing.
5.8.2. Shipping Verification
Shipping and distribution verification testing was performed for the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate products in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems. Results support that the products' packaging is able to withstand the distribution environment.
5.8.3. Biocompatibility Testing
Biocompatibility testing was conducted in accordance with ISO 10993-1:2018 and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (04 September 2020). The following endpoints were assessed to support the biological safety of the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate bottles:
- Chemical characterization ●
- Cytotoxicity ●
- Sensitization ●
- Irritation
- Systemic toxicity ●
- Material mediated pyrogenicity ●
- Hemocompatibility ●
A toxicological risk assessment was also performed.
Human Factors Validation Testing 5.8.4.
A Human Factors assessment was conducted for the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate to demonstrate their safe and effective use in accordance with FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
5.8.5. Electrical Safety and Electromagnetic Compatibility (EMC)
Not applicable. Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are not electrical mechanical devices.
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Image /page/8/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right, also in blue. The symbol is made up of three downward-pointing chevrons stacked on top of each other.
Software Verification and Validation Testing 5.8.6.
Not applicable. Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate do not contain software.
5.8.7. Animal Studies
No animal studies were performed for Citrasate Liquid Acid Concentrate or NaturaLyte Liquid Acid Concentrate.
5.8.8. Clinical Studies
No clinical studies were performed for Citrasate Liquid Acid Concentrate or NaturaLyte Liquid Acid Concentrate.
5.9. Conclusion
The intended use, design, principle of operation, and materials of construction of the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are substantially equivalent to those of the predicate devices. Differences between the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate and the predicates do not raise new concerns with regard to safety or efficacy. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are safe and effective for their intended use.