(114 days)
The Liberty Cycler is indicated for acute and chronic peritoneal dialysis.
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 provided document is a 510(k) Premarket Notification for the Fresenius Liberty Cycler and Disposable Cycler Set. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel acceptance criteria or a comprehensive study proving a device meets specific performance metrics against an established ground truth.
Therefore, the document does not contain the information requested in the prompt regarding:
- A table of acceptance criteria and reported device performance: The submission states that "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." However, specific quantitative acceptance criteria or detailed performance data are not provided.
- Sample size used for the test set and data provenance: No information is available about the sample size or the origin of any test data.
- Number of experts used to establish ground truth and qualifications: No ground truth establishment process or experts are mentioned.
- Adjudication method for the test set: Not applicable as no ground truth establishment is described.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This type of study is not mentioned as the device is a medical cycler, not an AI diagnostic tool.
- Standalone (algorithm-only) performance: Not applicable as the device is a physical cycler.
- Type of ground truth used: Not applicable as no ground truth is described.
- Sample size for the training set: Not applicable as the device is not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on establishing substantial equivalence to predicate devices. It states:
- Intended Use: "The intended use for the Liberty Cycler is identical to that for the Fresenius PD* IQcard Cycler" and "The Liberty Cycler is indicated for acute and chronic peritoneal dialysis."
- Technological Characteristics: "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."
- Functional and Software Validation: It mentions that "The Fresenius Liberty Cycler Functional and Software validation and release testing rigorously tested the features of the cycler." and "The results of this testing indicate that the Liberty Cycler is safe and effective for its intended use." However, these are general statements and do not include specific performance data against acceptance criteria.
{0}------------------------------------------------
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 AveLexington, MA 02420 |
| Phone: | 1-781-402-9068 |
| Fax: | (781) 402-9635 |
| Contact Person: | Arthur Eilinsfeld, Director of Regulatory Affairs |
| Date of Preparation: | 3 December 2004 |
B. Device Name:
| Trade Name: | Fresenius Liberty Cycler and Disposable CyclerSet |
|---|---|
| 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).
{1}------------------------------------------------
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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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.
{4}------------------------------------------------
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
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows a sequence of handwritten characters. The characters are 'K043363'. The characters appear to be written in a cursive style.
Image /page/5/Picture/1 description: The image shows a geometric figure that resembles a funnel or a series of stacked, truncated pyramids. The figure is composed of four trapezoidal shapes stacked on top of each other, with the largest trapezoid at the top and the smallest at the bottom. The figure is symmetrical and has a three-dimensional appearance due to the use of shading and perspective.
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(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
| Nancy C Brogdon(Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal,and Radiological Devices | |
| 510(k) Number | K043363 |
Fresenius Medical Care North America
000068Corporate Headquarters: 95 Hayden Avenue Lexington, MA 02420 (781) 402-9000
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
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.
(b)
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.