(268 days)
No
The device description and performance studies focus on the chemical composition, packaging, and physical properties of dry acid concentrates used in hemodialysis, with no mention of AI or ML technologies.
Yes.
The device is used in extracorporeal bicarbonate hemodialysis, which is a therapeutic intervention for acute and chronic renal failure.
No
Explanation: The devices (Citrasate and GranuFlo Dry Acid Concentrates) are described as components for preparing dialysate used in hemodialysis machines. Their purpose is therapeutic (to treat renal failure) rather than diagnostic (to identify or characterize a disease).
No
The device is a dry acid concentrate for hemodialysis, which is a physical substance, 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 preparing dialysate for patients undergoing extracorporeal bicarbonate hemodialysis. This is a therapeutic process, not a diagnostic one.
- Device Description: The device is a concentrate of electrolytes and acids used to create dialysate. It is used in a hemodialysis machine to facilitate the exchange of solutes with blood. This is a treatment function, not a diagnostic function.
- Lack of Diagnostic Language: The text does not mention any diagnostic purpose, such as analyzing samples, detecting biomarkers, or providing information for diagnosis.
- Focus on Therapy: The entire description revolves around the use of the product in the process of hemodialysis, which is a treatment for renal failure.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Citrasate® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate® Dry 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.
GranuFlo® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. GranuFlo® Dry Acid Concentrate is intended to be used as one component in the preparation of dialysate in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.
Product codes
KPO
Device Description
Citrasate Dry Acid Concentrate product line consists of eight (8) formulations which differ in potassium chloride and calcium chloride mass. These dry components are packaged in four (4) flexible, laminated, sealed, and low-density polyethylene-based bags. These bags are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611).
GranuFlo Dry Acid Concentrate product line consists of nine (9) formulations which differ in potassium chloride and calcium chloride mass. GranuFlo Dry Acid Concentrate components are packaged in three (3) flexible, laminated, sealed, and low-density polyethylene-based bags. The bags' contents are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611).
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate products are 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; sodium diacetate in GranuFlo). Citrasate also contains sodium acetate as a secondary pH adjuster.
Citrasate Dry Acid Concentrate is a single use, non-sterile, device offered in 8 formulations which differ in potassium chloride and calcium chloride mass. The product components are contained in a four-bag packaging system. These bags are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611).
GranuFlo Dry Acid Concentrate is a single use, non-sterile, device offered in 9 formulations which differ in potassium chloride and calcium chloride mass. The product components are contained in a three-bag packaging system. These bags are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611).
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each 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. 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.
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 Dry Acid Concentrate and GranuFlo Dry 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)
Performance testing was conducted for the Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate products. Results of performance testing support substantial equivalence, safety, and efficacy of the Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate.
Stability Design Verification: Stability evaluations were conducted for Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate to support the 24-month (2-year) shelf life. Stability is monitored as part of routine production testing. The 24-month shelf life is supported by real time stability evaluations.
Shipping Verification: Shipping and distribution verification testing was performed for the Citrasate Dry Acid Concentrate and GranuFlo Dry 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: The following endpoints were assessed to support the biological safety of the Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate:
- Chemical characterization
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Material mediated pyrogenicity
- Hemocompatibility
A toxicological risk assessment was also performed.
Human Factors Validation Testing: The Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate were validated for 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 for Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate.
No clinical studies were performed for Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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May 8, 2020
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K192209
Trade/Device Name: Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: April 7, 2020 Received: April 8, 2020
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.
1
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 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.
Carolyn Y. Neuland, Ph.D. 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) K192209
Device Name Citrasate® Dry Acid Concentrate GranuFlo® Dry Acid Concentrate
Indications for Use (Describe)
Citrasate® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate® Dry 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.
GranuFlo® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. GranuFlo® Dry 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/0 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.
510(K) SUMMARY 5.
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.
Submitter's Information 5.1.
| 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 |
| Regulatory Affairs – Devices | |
| Preparation Date: | 13 August 2019 |
5.2. Device Name
| Trade Name: | Citrasate® Dry Acid Concentrate
GranuFlo® Dry Acid Concentrate |
|-----------------------|-------------------------------------------------------------------|
| 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) |
| Classification Panel: | Gastroenterology/Urology |
5.3. Legally Marketed Predicate Device
The legally marketed predicate device for the Citrasate Dry Acid Concentrate is the DRYalysate Concentrate cleared under K980659. The legally marketed predicate device for the GranuFlo Dry Acid Concentrate is the Naturalyte Granuflo Dry Acid Concentrate cleared under K030497.
GranuFlo Dry Acid Concentrate is currently subject to an open recall (Z-0516-2019, Z-0517-2019, and Z-0518-2019). Destruction of the product is in progress. After destruction, closure of the recall will be requested.
In March 2012, a Class I recall was initiated for FMCRTG acid concentrate products regarding total buffer prescribing information. Concerns arose due to the contribution of acetate in acid concentrates in addition to the prescribed bicarbonate. This contribution was later determined to present a lower patient risk than initially understood. Through a series of Pre-Submission (Q131379) correspondence, FMCRTG and FDA came to an agreement on a final warning statement for acid concentrate labeling in June 2018.
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Image /page/4/Picture/0 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 and is also blue.
5.4. Device Description
5.4.1. Device Identification- Citrasate
Citrasate Dry Acid Concentrate product line consists of eight (8) formulations which differ in potassium chloride and calcium chloride mass. These dry components are packaged in four (4) flexible, laminated, sealed, and low-density polyethylene-based bags. These bags are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611). A list of the available Citrasate Dry Acid Concentrate products is provided in Table 1.
| Part Number | Part Number Description |
|---|---|
| 0FD1231-DA | Citrasate Dry Acid – 1.0 K, 2.25 Ca, 1.0 Mg |
| 0FD1251-DA | Citrasate Dry Acid – 1.0 K, 2.5 Ca, 1.0 Mg |
| 0FD2231-DA | Citrasate Dry Acid – 2.0 K, 2.25 Ca, 1.0 Mg |
| 0FD2251-DA | Citrasate Dry Acid – 2.0 K, 2.5 Ca, 1.0 Mg |
| 0FD2301-DA | Citrasate Dry Acid – 2.0 K, 3.0 Ca, 1.0 Mg |
| 0FD3231-DA | Citrasate Dry Acid – 3.0 K, 2.25 Ca, 1.0 Mg |
| 0FD3251-DA | Citrasate Dry Acid – 3.0 K, 2.5 Ca, 1.0 Mg |
| 0FD3301-DA | Citrasate Dry Acid – 3.0 K, 3.0 Ca, 1.0 Mg |
Table 1: Citrasate Dry Acid Concentrate Products
5.4.2. Device Identification- GranuFlo
GranuFlo Dry Acid Concentrate product line consists of nine (9) formulations which differ in potassium chloride and calcium chloride mass. GranuFlo Dry Acid Concentrate components are packaged in three (3) flexible, laminated, sealed, and low-density polyethylene-based bags. The bags' contents are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611). A list of the available GranuFlo Dry Acid Concentrate products is provided in Table 2.
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Image /page/5/Picture/0 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. 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.
| Part Number | Part Number Description |
|---|---|
| 0FD1251-3B | GranuFlo Dry Acid – 1.0 K, 2.5 Ca, 1.0 Mg |
| 0FD2201-3B | GranuFlo Dry Acid – 2.0 K, 2.0 Ca, 1.0 Mg |
| 0FD2231-3B | GranuFlo Dry Acid – 2.0 K, 2.25 Ca, 1.0 Mg |
| 0FD2251-3B | GranuFlo Dry Acid – 2.0 K, 2.5 Ca, 1.0 Mg |
| 0FD2301-3B | GranuFlo Dry Acid – 2.0 K, 3.0 Ca, 1.0 Mg |
| 0FD3201-3B | GranuFlo Dry Acid – 3.0 K, 2.0 Ca, 1.0 Mg |
| 0FD3231-3B | GranuFlo Dry Acid – 3.0 K, 2.25 Ca, 1.0 Mg |
| 0FD3251-3B | GranuFlo Dry Acid – 3.0 K, 2.5 Ca, 1.0 Mg |
| 0FD3301-3B | GranuFlo Dry Acid – 3.0 K, 3.0 Ca, 1.0 Mg |
Table 2: GranuFlo Dry Acid Concentrate Products
5.4.3. Device Characteristics
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate products are 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; sodium diacetate in GranuFlo). Citrasate also contains sodium acetate as a secondary pH adjuster.
Citrasate Dry Acid Concentrate is a single use, non-sterile, device offered in 8 formulations which differ in potassium chloride and calcium chloride mass. The product components are contained in a four-bag packaging system. These bags are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611).
GranuFlo Dry Acid Concentrate is a single use, non-sterile, device offered in 9 formulations which differ in potassium chloride and calcium chloride mass. The product components are contained in a three-bag packaging system. These bags are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611).
5.4.4. Environment of Use
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are used in environments where acute and chronic hemodialysis is performed.
5.4.5. Brief Written Description of the Device
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each 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. 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
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Image /page/6/Picture/0 description: The image shows 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", with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line. The text is also in blue.
an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
Materials of Use 5.4.6.
Citrasate Dry Acid Concentrate and GranuFlo Dry 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 (16 June 2016). The Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate bag packaging is composed of PVDC-coated PET/LLDPE film.
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are composed of USP grade raw chemicals or equivalent.
5.4.7. Key Performance Specifications/Characteristics
Citrasate Dry Acid Concentrate and GranuFlo Dry 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) using water that meets ISO 13959 or ANSI/AAMI RD62 requirements to generate dialysate.
5.5. Intended Use
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended for use in hemodialysis therapy for acute and chronic renal failure.
5.6. Indications for Use
Citrasate® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate® Dry 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.
GranuFlo® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. GranuFlo® Dry 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.
Comparison of Technological Characteristics with the Predicate 5.7. Device
The Citrasate Dry Acid Concentrate is substantially equivalent to the predicate DRYalysate Concentrate (K980659), and the GranuFlo Dry Acid Concentrate is substantially equivalent to the predicate Naturalyte Granuflo Dry Acid Concentrate (K030497) with regard to the following technological characteristics:
- Intended use ●
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Image /page/7/Picture/0 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. 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.
- Design
- Principle of operation .
- Materials of construction
- Performance specifications ●
Performance Data 5.8.
Performance testing was conducted for the Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate products. Results of performance testing support substantial equivalence, safety, and efficacy of the Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate.
5.8.1. Stability Design Verification
Stability evaluations were conducted for Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate to support the 24-month (2-year) shelf life. Stability is monitored as part of routine production testing. The 24-month shelf life is supported by real time stability evaluations.
Shipping Verification 5.8.2.
Shipping and distribution verification testing was performed for the Citrasate Dry Acid Concentrate and GranuFlo Dry 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
The following endpoints were assessed to support the biological safety of the Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate:
- Chemical characterization ●
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity ●
- Material mediated pyrogenicity ●
- Hemocompatibility ●
A toxicological risk assessment was also performed.
5.8.4. Human Factors Validation Testing
The Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate were validated for their safe and effective use in accordance with FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
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Image /page/8/Picture/0 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. 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.
Electrical Safety and Electromagnetic Compatibility 5.8.5.
Not applicable. The Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are not electrical mechanical devices.
5.8.6. Software Verification and Validation Testing
Not applicable. The Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate do not contain software.
5.8.7. Animal Studies
No animal studies were performed for Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate.
5.8.8. Clinical Studies
No clinical studies were performed for Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate.
5.9. Conclusions
The intended use, design, principle of operation, and materials of construction of the Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are substantially equivalent to those of the predicate devices. Differences between the Citrasate Dry Acid Concentrate and GranuFlo Dry 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 Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are safe and effective for their intended use.