HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469

K012988 · Baxter Healthcare Corp · FKX · Dec 5, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012988
• Device Name: HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
• Applicant: Baxter Healthcare Corp
• Product Code: FKX · Gastroenterology, Urology
• Decision Date: Dec 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The HomeChoice® Personal Cycler Peritoneal Dialysis System is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

Device Story

The HomeChoice Personal Cycler is an automated peritoneal dialysis system used to control dialysate solution exchanges. It is designed for use by patients undergoing peritoneal dialysis. The device automates the fluid exchange process, providing specific drain logic for both low fill volumes (60-1000 mLs) and standard fill volumes. By managing these exchanges automatically, the system facilitates therapy for patients requiring varying fill volume ranges, supporting both pediatric and adult populations.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison of the modified drain logic.

Technological Characteristics

Automated peritoneal dialysis system; provides software-controlled drain logic for fill volumes ranging from 60 to 1000 mLs. Operates as a cycler for dialysate solution exchanges.

Indications for Use

Indicated for pediatric and adult patients with renal failure requiring 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

• HomeChoice® Personal Cycler Peritoneal Dialysis System (K923065)

Submission Summary (Full Text)

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KOI 2988

DEC 0 5 2001

Renal Division

Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, II 60085-6730

847-473-6030

## BAXTER

# 510(k) SUMMARY

## HomeChoice® Personal Cycler Peritoneal Dialysis System

| Submitter's name, addresss, phone, fax, contact person | Baxter Healthcare Corporation<br>Renal Division<br>1620 Waukegan Road<br>McGaw Park, IL 60085<br>Phone: [phone]<br>Fax: [phone]<br>Contact: David Curtin |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date prepared | September 4, 2001 |
| Trade name of device | HomeChoice® Personal Cycler Peritoneal Dialysis<br>System |
| Common name | Automated Peritoneal Dialysis System |
| Classification name | Peritoneal dialysis system and Accessories<br>(per 21CFR 876.5630) |
| Substantially equivalent devices | HomeChoice® Personal Cycler Peritoneal Dialysis<br>System<br>[510(k) number K923065] |
| Description of the device | The HomeChoice® Personal Cycler Peritoneal Dialysis<br>System provides automatic control of dialysate solution<br>exchanges for low fill volume and standard fill volume<br>therapies with software drain logic designed specific to<br>each fill volume range. |
| Intended use of the device | The HomeChoice® Personal Cycler Peritoneal Dialysis<br>System is intended for automatic control of dialysate<br>solution exchanges in the treatment of pediatric and adult<br>renal failure patients undergoing peritoneal dialysis. |
| Comparison of technological<br>characteristics between new and<br>predicate devices | The HomeChoice® Personal Cycler Peritoneal Dialysis<br>System is exactly the same as the predicate device, with<br>the exception that the modified device provides low fill<br>volume mode drain logic for renal failure patients<br>requiring fill volumes of 60 - 1000 mLs. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design resembling an eagle or bird in flight, composed of three curved lines.

DEC 5 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

David E. Curtin, R.A.C. Associate Director, Regulatory Affairs Baxter Healthcare Corporation Renal Division, MPR-A2E 1620 Waukegan Road MCGAW PARK IL 60085

Re: K012988 Trade/Device Name: HomeChoice® Personal Cycler Peritoneal Dialysis System (Models 5C8310, 5C8302, 5C4471 and 5C4469) Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: 78 FKX Dated: September 6, 2001 Received: September 6, 2001

Dear Mr. Curtin:

We have reviewed your Section 510(k) premarket notification of intent to market the devices in diest We have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) the actessed predicate devices marketed in interstate for use stated in the encrosule, to regally manatiment date of the Medical Device Amendments, or to commerce prior to May 28, 1970, the enaomience with the provisions of the Federal Food, Drug, devices that have been reclassince in access approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval a and Cosment Act (Act) that to not require subject to the general controls provisions of the Act. The You may, mercede, market the device, becycer or use in the most registration, listing of general controls provisions of the rise, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), and If your device is classified (Scc above) into exting major regulations affecting your device can be
it may be subject to additional controls. Existing major readition EDA m It may oe subject to additional condois. Extreming Lington of 898. In addition, FDA may found in the Code of I ederal Regulations) your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised that FDA s issualled of a backed complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirem that FDA has made a decemmanon that Jour as Jour as a ministered by other Federal and listing and listing and listing and listing and listing and listing and listing and list or any Federal Statutes and regulations and limited to: registration and listing comply whil all the Act 3 requirements, medaling on analufacturing practice requirements as set (21 CFR Patt 807), labornig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regarations 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 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy Cbrogdon

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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510(K) Number (if known):

Device Name: HomeChoice Personal Cycler Peritoneal Dialysis System

#### Indications for Use:

### HomeChoice® Personal Cycler Peritoneal Dialysis System

The HomeChoice® Personal Cycler Peritoneal Dialysis System is intended for automatic I he HomeCholce® Felsonal Cycler i effectives by a patients undergoing peritoneal dialysis.

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Concurrence of CDRH, Office Device Evaluation (ODE)

510k) Nur

Prescription Use (Per 21 CFR 801.109 Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1/2/96)

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