FRESENIUS LIBERTY CYCLER

K043363 · Fresenius Medical Care North America · FKX · Mar 31, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K043363
• Device Name: FRESENIUS LIBERTY CYCLER
• Applicant: Fresenius Medical Care North America
• Product Code: FKX · Gastroenterology, Urology
• Decision Date: Mar 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Liberty Cycler is indicated for acute and chronic peritoneal dialysis.

Device Story

The Fresenius Liberty Cycler is an automated peritoneal dialysis (APD) system used for acute and chronic dialysis. It utilizes a disposable cycler set with a cassette-based fluid delivery system to manage dialysis solution exchange. The device automates the delivery and drainage of dialysate to and from the patient's peritoneal cavity. It is intended for use in clinical or home settings, with patients receiving extensive training for operation. The system incorporates features from previous Fresenius cyclers and a cassette design similar to the Baxter HomeChoice Pro. Healthcare providers use the device to manage patient fluid and solute removal; the automated process aims to improve the efficiency and safety of peritoneal dialysis therapy compared to manual methods.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including functional validation of the cycler, software validation, and biocompatibility testing of the disposable cycler sets.

Technological Characteristics

Automated peritoneal dialysis system; cassette-based fluid delivery; disposable cycler set. Materials underwent biocompatibility testing. System incorporates features from previous Fresenius cyclers and cassette design similar to Baxter HomeChoice Pro. Software-controlled fluid management.

Indications for Use

Indicated for patients requiring acute or chronic peritoneal dialysis.

Regulatory Classification

Identification

(1) A peritoneal dialysis 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 a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments. (3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles. (4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.

Special Controls

*Classification.* Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.

Predicate Devices

• Fresenius 90/2 Cycler (K902149)
• Baxter HomeChoice Pro (K012988)
• Baxter HomeChoice Pro (K923065)
• Fresenius PD* IQcard Cycler (K002892)

Submission Summary (Full Text)

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### MAR 3 1 2005

KC43363
Page 1 of 3

## Fresenius Liberty Cycler and Disposable Cycler Set 510(k) Premarket Notification

## Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

#### A. Submitter's Information:

| Name: | Fresenius Medical Care North America |
|----------------------|---------------------------------------------------|
| Address: | 95 Hayden Ave<br>Lexington, MA 02420 |
| Phone: | 1-781-402-9068 |
| Fax: | [phone] |
| Contact Person: | Arthur Eilinsfeld, Director of Regulatory Affairs |
| Date of Preparation: | 3 December 2004 |

#### B. Device Name:

| Trade Name: | Fresenius Liberty Cycler and Disposable Cycler<br>Set |
|----------------------|-------------------------------------------------------|
| Common/Usual Name: | Peritoneal Dialysis Cycler |
| Classification Name: | System, Peritoneal, Automatic Delivery |

#### C. Predicate Device Name:

The predicate devices for the Fresenius Liberty Cycler are the following:

- Fresenius 90/2 Cycler #K902149 (10/30/90); .
- Baxter HomeChoice Pro -- #K012988 (12/5/01) and #K923065 (3/4/94); .
- . Fresenius PD* IQcard Cycler - #K002892 (4/5/01).

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## Fresenius Liberty Cycler and Disposable Cycler Set 510(k) Premarket Notification

KC43363
Page 2 of 3

## Summary of Safety and Effectiveness

#### D. Device Description/Indications for Use:

The intended use for the Liberty Cycler is identical to that for the Fresenius PD* IQcard Cycler and is as follows:

#### Intended Use

The Liberty Cycler is indicated for acute and chronic peritoneal dialysis.

#### E. Substantial Equivalence:

#### 510(k) Substantial Equivalence Decision Making Process

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

YES - The Fresenius Liberty Cycler 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 Liberty Cycler is identical to that for the Fresenius PD* IQcard Cycler and is as follows:

### Intended Use

The Liberty Cycler is indicated for acute and chronic peritoneal dialysis.

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

NO -The Liberty Cycler is the first model in the next generation of Fresenius peritoneal dialysis cyclers. It incorporates features found on other Fresenius cvclers and also utilizes a cassette design similar to the cassette for Baxter HomeChoice Pro. The features included in the Liberty Cycler are equivalent to those present on other commercially available peritoneal dialysis cyclers and raise no new types of safety or effectiveness questions.

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K043363
Page 3 of 3

# Summary of Safety and Effectiveness

#### 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 Liberty Cycler and demonstrates that it is substantially equivalent to other commercially available cyclers.

#### F. Safety Summary

The Fresenius Liberty Cycler Functional and Software validation and release testing rigorously tested the features of the cycler. The results of this testing indicate that the Liberty Cycler is safe and effective for its intended use. In addition, functional testing and biocompatibility testing of the Liberty Cycler Set indicate that the cycler sets are safe and effective for their intended use.

#### G. General Safety and Effectiveness Concerns

The device labeling contains an Operator's Manual, which includes indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the device. In addition, extensive training is provided to patients that use the Liberty Cycler. This information promotes safe and effective use of the device.

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Image /page/3/Picture/2 description: The image shows a circular logo with a stylized bird in the center. The bird is composed of three curved lines that suggest movement or flight. Encircling the bird is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES'.

MAR 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MO 20850

Ms. Nichole Riek Regulatory Affairs Supervisor Fresenius Medical Care North America 95 Hayden Avenue LEXINGTON MA 02420

Re: K043363

KU43303
Trade/Device Name: Fresenius Liberty Cycler and Disposable Cycler Set Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FKX Dated: March 15, 2005 Received: March 16, 2005

Dear Ms. Riek:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave reviewed your bootion by equivalent (for the indications for use stated in above and have deceminerarketed predicate devices marketed in interstate commerce prior to the cherosate) to regarly mantone of the Medical Device Amendments, or to devices that have been May 20, 1770, the onlinediations of the Federal Food, Drug, and Cosmetic Act (Act) that reclassince in accordatios and of a proval application (PMA). You may, therefore, market the do not require approval or a promations 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 If your devise is elective (st to such additional controls. Existing major regulations affecting your Apploval), It they of below to earling the Regulations, Title 21, Parts 800 to 898. In addition, FDA device can of round mouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I Rase oc advisor that i Dr. I on 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 I carrates and regulation but not limited to registration and listing (21 CFR Part 807); labeling AOS requirements, moracing bactive practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
10 leggly This letter will allow you to begin marketing your antines of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of y premarket notification. The FDA Inding of substantial equilter 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 If you desire specific advice for your device on our labeling regarities.
contact 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 | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to prematic notification" (21 CFR Also, please note the regulation entined, "Firsonalisms on your responsibilities under the Act from the 180 807.97). You may obtain other general mionnal and Consumer Assistance at its toll-free number (800) Drvision of Small Manufacturers, Internet address http://www.fda.gov/cdrb/dsmaldsmamain.html

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

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# Fresenius Medical Care

# Indications for Use Statement

#### Device Name:

Fresenius Liberty Cycler and Disposable Cycler Set

#### Indications for Use:

The Fresenius Liberty Cycler is intended for acute and chronic peritoneal dialysis.

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

| | Nancy C Brogdon<br>(Division Sign-Off) |
|---------------|------------------------------------------------------------------|
| | Division of Reproductive, Abdominal,<br>and Radiological Devices |
| 510(k) Number | K043363 |

Fresenius Medical Care North America

000068Corporate Headquarters: 95 Hayden Avenue Lexington, MA 02420 [phone]