NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)

K191474 · Fresenius Medical Care Renal Therapies Group, LLC · KPO · Feb 24, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K191474
• Device Name: NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)
• Applicant: Fresenius Medical Care Renal Therapies Group, LLC
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Feb 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NaturaLyte® Dry Bicarbonate Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte® Dry Bicarbonate 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.

Device Story

NaturaLyte Dry Bicarbonate Concentrate consists of USP-grade sodium bicarbonate powder; supplied in bags or cartons. Used as one component in 3-stream proportioning hemodialysis machines; mixed with water to prepare dialysate. Dialysate pumped through dialyzer; creates osmotic gradient across membrane to exchange solutes with blood. Used in clinical environments for acute/chronic renal failure; operated by trained healthcare professionals. Benefits patient by facilitating solute exchange during hemodialysis.

Clinical Evidence

No clinical studies were performed. Evidence consists of bench testing, including stability evaluations (24-month shelf life), shipping verification (ASTM D4169-16), biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, material-mediated pyrogenicity, hemocompatibility), and human factors validation.

Technological Characteristics

Composition: USP-grade sodium bicarbonate. Packaging: 9-layer nylon/polyethylene film (bags) or solid bleached sulfate fiberboard with LDPE coating (cartons). Principle: Chemical concentrate for 3-stream proportioning (1:1.72:42.28 ratio). Non-sterile, single-use. No electrical or software components.

Indications for Use

Indicated for patients with acute or chronic renal failure undergoing extracorporeal bicarbonate hemodialysis.

Regulatory Classification

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.

Predicate Devices

• Biosol Bicarbonate Powder Concentrate (K981043)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 24, 2020

Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451

Re: K191474

> Trade/Device Name: NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag) NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag) NaturaLyte Dry Bicarbonate Concentrate (Carton) Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: KPO Dated: June 3, 2019 Received: June 4, 2019

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.

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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 ([e-mail]) or phone [phone] 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) K191474

### Device Name

NaturaLyte® Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte® Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte® Dry Bicarbonate Concentrate (Carton)

### Indications for Use (Describe)

NaturaLyte® Dry Bicarbonate Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte® Dry Bicarbonate 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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CER 801 Subpart D) </span> </div> | <div> <span> <span>□</span> Over-The-Counter Use (21 CER 801 Subpart C) </span> </div> |

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Image /page/3/Picture/1 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo, there is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol, the words "FRESENIUS" and "MEDICAL CARE" are written in bold, blue letters, with "MEDICAL CARE" on the second line.

### ર. 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 8807.92.

#### 5.1. Submitter's Information

| Name: | Fresenius Medical Care Renal Therapies Group, LLC | |
|-------------------|-------------------------------------------------------------------|--|
| Address: | 920 Winter Street<br>Waltham, MA 02451-1457 | |
| Phone: | [phone] | |
| Fax: | [phone] | |
| Contact Person: | Denise Oppermann, Senior Director<br>Regulatory Affairs – Devices | |
| Preparation Date: | 03 June 2019 | |

#### 5.2. Device Name

| Trade Name: | NaturaLyte® Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte® Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte® Dry Bicarbonate Concentrate (Carton) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 is the Biosol Bicarbonate Powder Concentrate (K981043). This device is not currently subject to a design-related recall.

#### 5.4. Device Description

#### 5.4.1. Device Identification

The NaturaLyte Dry Bicarbonate Concentrate is available in three (3) presentations based on the desired volume of bicarbonate concentrate. The 4879 g presentation yields 15.85 gallons (60 liters) and the 7807 g presentation yields 25.36 gallons (96 liters) and are supplied in bag-style packaging. The 650 g presentation, used for preparation of individual batches, yields 2.1 gallons (8.0 liters) of bicarbonate concentrate and is supplied in carton-style packaging. The available NaturaLyte Dry Bicarbonate Concentrate products are provided in Table 1.

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K191474

| Product Line | Part Number | Part Number Description |
|-----------------------------------------------|-------------|------------------------------------------------|
| NaturaLyte Dry<br>Bicarbonate<br>Concentrates | 08-4110-6 | NaturaLyte Dry Bicarbonate, 4879 g (Rx-10 bag) |
| | 08-4112-2 | NaturaLyte Dry Bicarbonate, 7807 g (Rx-12 bag) |
| | 08-4400-1 | NaturaLyte Dry Bicarbonate, 650 g (carton) |

#### Table 1: NaturaLyte Dry Bicarbonate Concentrate Products

#### Device Characteristics 5.4.2.

NaturaLyte Dry Bicarbonate Concentrate is a non-sterile, single use device composed of United States Pharmacopeia (USP) grade sodium bicarbonate. NaturaLyte Dry Bicarbonate Concentrate products are packaged in either bags or cartons. The two (2) bag configurations are constructed from identical materials and only differ in the mass of dry bicarbonate powder contained within. The cartons are used for preparation of individual batches of bicarbonate concentrate.

#### 5.4.3. Environment of Use

NaturaLyte Dry Bicarbonate Concentrate is used in environments where acute and chronic hemodialysis is performed.

#### 5.4.4. Brief Written Description of the Device

NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription. NaturaLyte Dry Bicarbonate Concentrate is 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.

#### 5.4.5. Materials of Use

NaturaLyte Dry Bicarbonate Concentrate is classified as an externally communicating, blood path indirect, prolonged contact (>24 hours to 30 days) duration. Class II (Category B) device 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 NaturaLyte Dry Bicarbonate Concentrate packaging is composed of the following materials:

- Bag (4879 g or 7807 g)- 9-layer nylon/polyethylene (PE) coextruded film ●
- Carton- solid bleached sulfate (SBS) 100% virgin fiberboard substrate, coated on both sides with low-density polyethylene (LDPE)

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Image /page/5/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue abstract symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The abstract symbol is made up of three downward-pointing chevron shapes stacked on top of each other.

#### Key Performance Specifications/Characteristics 5.4.6.

NaturaLyte Dry Bicarbonate Concentrate is packaged dry sodium bicarbonate which is used as a component of the dialysate for hemodialysis treatments. The dry sodium bicarbonate is intended to be mixed with water that meets ISO 13959 or ANSI/AAMI RD62 requirements. Once mixed with water according to the instructions for use, NaturaLyte Dry Bicarbonate Concentrate is 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.

#### ર.ડ. Intended Use

NaturaLyte Dry Bicarbonate Concentrate is intended for use in hemodialysis therapy for acute and chronic renal failure.

#### 5.6. Indications for Use

NaturaLyte® Dry Bicarbonate Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLvte® Dry Bicarbonate 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 NaturaLyte Dry Bicarbonate Concentrate is substantially equivalent to the predicate Biosol Bicarbonate Powder Concentrate (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 NaturaLyte Dry Bicarbonate Concentrate products. Results of performance testing support substantial equivalence, safety, and efficacy of the NaturaLyte Dry Bicarbonate Concentrate.

#### 5.8.1. Stability Design Verification

Stability evaluations were conducted for NaturaLyte Dry Bicarbonate Concentrate in support of 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.

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K191474

#### Shipping Verification 5.8.2.

Shipping and distribution verification testing was performed for the NaturaLyte Dry Bicarbonate Concentrate product in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems. Results support that the product's 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 NaturaLyte Dry Bicarbonate Concentrate (bags and cartons):

- 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 NaturaLyte Dry Bicarbonate Concentrate was validated for its 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 NaturaLyte Dry Bicarbonate Concentrate is not an electrical mechanical device.

#### 5.8.6. Software Verification and Validation Testing

Not applicable. The NaturaLyte Dry Bicarbonate Concentrate does not contain software.

#### 5.8.7. Animal Studies

No animal studies were performed for NaturaLyte Dry Bicarbonate Concentrate.

#### Clinical Studies 5.8.8.

No clinical studies were performed for NaturaLyte Dry Bicarbonate Concentrate.

#### 5.9. Conclusions

The intended use, design, principle of operation, and materials of construction of the NaturaLyte Dry Bicarbonate Concentrate are substantially equivalent to that of the predicate device.

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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 words "FRESENIUS MEDICAL CARE" in blue on the right. The symbol is made up of three downward-pointing chevrons.

K191474

Differences between the NaturaLyte Dry Bicarbonate Concentrate and the predicate 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, NaturaLyte Dry Bicarbonate Concentrate is safe and effective for its intended use.