(270 days)
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 to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate products are singleuse, non-sterile devices intended for use in hemodialysis therapy for acute and chronic renal failure. Both products consist of electrolytes (chloride salts of sodium, 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 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.
This document is a 510(k) summary for Fresenius Medical Care's Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and providing detailed study results for a new device's performance.
Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth generation for performance studies is not directly available in this document because these liquid acid concentrates are not software, AI, or imaging devices that would typically undergo such evaluations.
However, I can extract the available information regarding performance testing that supports their substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit "acceptance criteria" in the format typically seen for algorithm performance (e.g., sensitivity, specificity thresholds). Instead, performance is assessed through various verification and validation activities to ensure the products are safe and effective and substantially equivalent to existing predicate devices.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Stability (Shelf Life) | Maintain product integrity and efficacy for 24 months. | "Stability evaluations were conducted... 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." (Section 5.8.1) |
| Shipping & Distribution | Withstand the physical stresses of the distribution environment. | "Shipping and distribution verification testing was performed... in accordance with ASTM D4169-16... Results support that the products' packaging is able to withstand the distribution environment." (Section 5.8.2) |
| Biocompatibility | Demonstrate biological safety for direct and indirect blood contact lasting >24 hours to 30 days. Includes chemical characterization, cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity, and hemocompatibility. | "The following endpoints were assessed to support the biological safety... Chemical characterization, Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Material mediated pyrogenicity, Hemocompatibility. A toxicological risk assessment was also performed." (Section 5.8.3) |
| Human Factors/Usability | Ensure safe and effective use of the device. | "The Citrasate Liquid Acid Concentrate and NaturaLyte Liquid 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..." (Section 5.8.4) |
| Substantial Equivalence | The device's technological characteristics (intended use, design, principle of operation, materials, performance) are comparable to predicate devices and raise no new safety/efficacy concerns. | "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... do not raise new concerns..." (Section 5.9) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified in terms of numerical units for each test (e.g., number of stability batches, number of shipping units, or biological samples). The document mentions "real time stability evaluations" and implies a representative number of products were subjected to shipping, biocompatibility, and human factors testing.
- Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The studies appear to be conducted internally by Fresenius Medical Care during the device development and validation process ("Performance testing was conducted"). These are likely prospective studies as part of product validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For biocompatibility, this would typically involve toxicologists and material scientists. For human factors, usability engineers would be involved.
4. Adjudication Method for the Test Set
- No information provided. Adjudication methods are typically relevant for subjective assessments, especially in clinical or image-based studies, which are not applicable here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This type of study is specific to imaging devices, especially those that involve AI assistance for human interpretation. The devices in question are liquid acid concentrates for hemodialysis, which do not involve diagnostic interpretation by human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. These devices do not contain software or algorithms in the context of diagnostic performance. The document explicitly states: "Not applicable. The Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate do not contain software." (Section 5.8.6).
7. The Type of Ground Truth Used
- For Stability: The ground truth is the chemical and physical integrity/composition of the concentrates over time, as measured by analytical methods.
- For Shipping Verification: The ground truth is the intactness of the packaging and product after simulated shipping stresses, determined by visual inspection and potentially functional tests.
- For Biocompatibility: The ground truth involves established biological responses and toxicology principles. This would be based on validated assays and expert toxicological assessment against recognized safety limits.
- For Human Factors/Usability: The ground truth relates to the absence of use errors and the ability of intended users to safely and effectively use the product, assessed through observation and user feedback against pre-defined safety and efficacy goals.
8. The Sample Size for the Training Set
- Not applicable. These products are physical chemical concentrates, not AI/ML algorithms that require a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As these are not AI/ML algorithms, there is no training set or associated ground truth establishment process in that context.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
April 24, 2020
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K192017
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: II Product Code: KPO Dated: March 24, 2020 Received: March 25, 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.
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
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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 medical devices and radiation-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
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Indications for Use
510(k) Number (if known) K192017
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 to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.
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.
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 StreetWaltham, MA 02451-1457 |
| Phone: | (781) 996-9103 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior DirectorRegulatory Affairs – Devices |
| Preparation Date: | 26 July 2019 |
5.2. Device Name
| Trade Name: | Citrasate® Liquid Acid ConcentrateNaturaLyte® Liquid 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 Liquid Acid Concentrate is the Citrasate Dialysate Acid Concentrate Liquid cleared under K000792. The legally marketed predicate device for the NaturaLyte Liquid Acid Concentrate is the Dialysol Acid Concentrate Liquid cleared under K981043.
NaturaLyte Liquid Acid Concentrate is currently subject to an open recall (Z-2110-2018). Closure of this recall was requested to FDA on March 14, 2019.
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 Fresenius Medical Care logo. 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.
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 1-gallon high density polyethylene bottle and a 55-gallon high density polyethylene drum-for a total of six (6) product codes. Descriptions of the available Citrasate Liquid Acid Concentrate products are provided in Table 1.
| 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 |
| 13-1251-CA | Citrasate Liquid Acid – 1.0 K, 2.5 Ca, 1.0 Mg – 55-gal drum |
| 13-2251-CA | Citrasate Liquid Acid – 2.0 K, 2.5 Ca, 1.0 Mg – 55-gal drum |
| 13-3251-CA | Citrasate Liquid Acid – 3.0 K, 2.5 Ca, 1.0 Mg – 55-gal drum |
Table 1: Citrasate Liquid Acid Concentrate Products
Device Identification- NaturaLyte 5.4.2.
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 onegallon high density polyethylene bottle and six (6) formulations are offered in a 55-gallon high density polyethylene drum, for a total of twenty-two (22) product codes. Descriptions of the available NaturaLyte Liquid Acid Concentrate products 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 |
Table 2: NaturaLyte Liquid Acid Concentrate Products
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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 |
|---|---|
| 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 |
| 13-1251-1 | NaturaLyte Liquid Acid – 1.0 K, 2.5 Ca, 1.0 Mg – 55-gal drum |
| 13-2201-5 | NaturaLyte Liquid Acid – 2.0 K, 2.0 Ca, 1.0 Mg – 55-gal drum |
| 13-2231-2 | NaturaLyte Liquid Acid – 2.0 K, 2.25 Ca, 1.0 Mg – 55-gal drum |
| 13-2251-0 | NaturaLyte Liquid Acid – 2.0 K, 2.5 Ca, 1.0 Mg – 55-gal drum |
| 13-3231-1 | NaturaLyte Liquid Acid – 3.0 K, 2.25 Ca, 1.0 Mg – 55-gal drum |
| 13-3251-9 | NaturaLyte Liquid Acid – 3.0 K, 2.5 Ca, 1.0 Mg – 55-gal drum |
Table 2: NaturaLyte Liquid Acid Concentrate Products (Continued)
5.4.3. Device Characteristics
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate products are singleuse, non-sterile devices intended for use in hemodialysis therapy for acute and chronic renal failure. Both products consist of electrolytes (chloride salts of sodium, 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 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
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Image /page/6/Picture/0 description: The image shows the Fresenius Medical Care logo. 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.
dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
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" (16 June 2016). Packaging for the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate consists of the following materials:
- 1-gallon bottle- high density polyethylene ●
- 55-gallon drum- high density polyethylene
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.
Intended Use 5.5.
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.
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Image /page/7/Picture/0 description: The image shows the Fresenius Medical Care logo. 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.
Comparison of Technological Characteristics with the Predicate 5.7. Device
The Citrasate Liquid Acid Concentrate is substantially equivalent to the predicate Citrasate Dialysate Acid Concentrate Liquid (K000792), and the NaturaLyte Liquid Acid Concentrate is substantially equivalent to the predicate Dialysol Acid Concentrate Liquid (K981043) 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.
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. The 24-month shelf life is supported by real time stability evaluations.
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
The following endpoints were assessed to support the biological safety of the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate (bottles and drums):
- Chemical characterization
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
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Image /page/8/Picture/0 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 arrows 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.
- Material mediated pyrogenicity
- . Hemocompatibility
A toxicological risk assessment was also performed.
Human Factors Validation Testing 5.8.4.
The Citrasate Liquid Acid Concentrate and NaturaLyte Liquid 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).
5.8.5. Electrical Safety and Electromagnetic Compatibility
Not applicable. The Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are not electrical mechanical devices.
Software Verification and Validation Testing 5.8.6.
Not applicable. The Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate do not contain software.
Animal Studies 5.8.7.
No animal studies were performed for Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate.
Clinical Studies 5.8.8.
No clinical studies were performed for Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate.
5.9. Conclusions
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.
§ 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.