FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB

K071387 · Fresenius Medical Care North America · KPO · Jun 15, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071387
• Device Name: FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB
• Applicant: Fresenius Medical Care North America
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Jun 15, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates

Device Story

Naturalyte® Sodium Bicarbonate Liquid Concentrate is a chemical component used in hemodialysis. It functions as a bicarbonate source in a three-stream proportioning system. The concentrate is mixed with water and acid concentrate by the hemodialysis machine to create the final dialysate solution. It is intended for use in clinical settings by trained healthcare professionals. The device ensures proper electrolyte balance during the dialysis process, which is essential for patients with renal failure. Proper calibration of the hemodialysis machine is required to ensure the correct proportioning of the concentrate, as incorrect use may lead to patient injury or death.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by chemical formulation analysis and bench testing demonstrating safety and effectiveness for the intended use.

Technological Characteristics

Liquid sodium bicarbonate concentrate for hemodialysis. Designed for use with three-stream proportioning systems. Requires water meeting ANSI/AAMI RD 62 standards. Not for parenteral use.

Indications for Use

Indicated for use in patients undergoing hemodialysis, specifically formulated for three-stream hemodialysis machines calibrated for acid and bicarbonate concentrates. Not for parenteral use.

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

• Fresenius Biosol Powder Bicarbonate Concentrate (K981043)

Submission Summary (Full Text)

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K071387 Page 1 of 3

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JUN 1 5 2007

# Fresenius Medical Care

# Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate "Special" 510(k) Premarket Notification

# 510(k) Summary

#### A. Submitter's Information: Fresenius Medical Care North America Name: Address: 920 Winter Street Waltham, MA 02451 [phone] Phone: Fax: [phone] Contact Person: Janet C. Kay, Manager Regulatory Affairs Date of Preparation: June 14, 2007

### B. Device Name:

| Trade Name: | Naturalyte® Sodium Bicarbonate Liquid<br>Concentrate |
|----------------------|------------------------------------------------------|
| Common/Usual Name: | Dialysate Concentrate for Hemodialysis (liquid) |
| Classification Name: | Hemodialysis systems and accessories |

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Ko71387 Page 2 of

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# Fresenius Medical Care

# Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate "Special" 510(k) Premarket Notification

## 510(k) Summary

#### C. Predicate Device Name:

The Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate is a modified version of the Fresenius Biosol Powder Bicarbonate Concentrate

- #K981043 (5/26/1998) .
#### D. Device Description/Indications for Use:

The intended use for the modified device is equivalent to that of the unmodified device:

#### Intended Use

This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates

#### E. Substantial Equivalence:

#### Substantial Equivalence Decision Making Process

#### 1. Is the product a device?

YES - The Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate is a device pursuant to 21 CFR §201 [321] (h).

#### 2. Does the new device have the same intended use?

- YES The intended use for the modified device is equivalent to the unmodified device.
#### Fresenius modified Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrates - Intended Use

This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates

#### Fresenius unmodified Biosol Powder Bicarbonate Concentrate -Intended Use

This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates

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K07L387 Page 3 of 3

JUN 15 2007

# Fresenius Medical Care

## Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate "Special" 510(k) Premarket Notification

## 510(k) Summary

#### 3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?

NO -- The Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrates is a modified versions of the Biosol Powder Bicarbonate Concentrates. The technological characteristics of the modified devices are equivalent to those of the unmodified devices and raise no new types of safety or effectiveness questions.

#### 4. Does descriptive or performance information demonstrate equivalence?

YES - Fresenius Medical Care North America believes that the information provided in this submission clearly describes the modified Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate and demonstrates that it is substantially equivalent to the unmodified devices.

#### F. Safety Summary

The Fresenius modified Naturalyte® Sodium Bicarbonate Liquid Concentrate is substantially equivalent in chemical formulation, chemical composition, and intended use to the commercially available Biosol Powder Bicarbonate Concentrates currently distributed as Fresenius Naturalyte® Dry Pack Bicarbonate Concentrates. In addition, testing of the modified device indicates that the formulations are safe and effective for its intended use.

#### G. General Safety and Effectiveness Concerns

The Fresenius modified Naturalyte® Sodium Bicarbonate Liquid Concentrates are to be used with a three-stream proportioning systems when calibrated to specified proportions depending on the series and mixed with water that meet ANSI/AAMI RD 62.. Use with other equipment or without associated bicarbonate concentrate may cause patient injury or death. Not for Parenteral Use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Janet C. Kay Manager of Regulatory Affairs Fresenius Medical Care North America 920 Winter Street WALTHAM MA 02451

**JUN 15 2007**

Re: K071387

Trade/Device Name: Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrates, (4000 Series) Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: May 16, 2007 Received: May 18, 2007

Dear Ms. Kay:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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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Protesting and Promoting Public Health

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please eontact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

> 21 CFR 876.xxxx 21 CFR 884.xxxx 21 CFR 892.xxxxx Other

(Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0115 (Radiology); 240-276-0120 240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

<http://www.fda.gov/oc/industry/support/index.html>

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known):

Device Name:

Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrates, 4000 Series.

Indications for Use:

This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates

Prescription Use 4 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Device

510(k) Number K071387

(Posted November 13, 2003)

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Fresenius Medical Care North America

Corporate Headquarters: 920 Winter Street Waltham, MA 02451 [phone]