HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R

K102936 · Baxter Healthcare Corp · FKX · Mar 30, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K102936
• Device Name: HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
• Applicant: Baxter Healthcare Corp
• Product Code: FKX · Gastroenterology, Urology
• Decision Date: Mar 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The HomeChoice Automated Personal Cycler 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/HomeChoice PRO Automated Personal Cycler is an electromechanical device used to automate peritoneal dialysis therapy. It functions by heating dialysate solution, pumping the solution to and from the patient, managing dwell times, and tracking fluid volumes based on a physician-prescribed therapy. The device records the ultrafiltration volume produced during treatment. It is intended for use in the treatment of renal failure. The system automates the exchange process, which helps ensure adherence to prescribed therapy parameters and provides data for clinical review. The device is designed for use in both pediatric and adult populations.

Clinical Evidence

No clinical data. The device was evaluated through non-clinical bench testing, including software validation and verification, electromagnetic compatibility (IEC 60601-1-2), electrical safety (IEC 60601-1), and human factors testing.

Technological Characteristics

Automated peritoneal dialysis cycler. Features fluid heating, pumping, and measurement controls. Software version 10.4. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for pediatric and adult patients with renal failure undergoing peritoneal dialysis therapy.

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/HomeChoice PRO Automated Personal Cycler (K053512)
• HomeChoice/HomeChoice PRO Automated Personal Cycler (K012988)
• HomeChoice/HomeChoice PRO Automated Personal Cycler (K923065)

Submission Summary (Full Text)

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K102936
Page 1 of 3

MAR 3 0 2011

## 5. 510(K) SUMMARY

## DATE PREPARED

September 30, 2010 .

## OWNER

Baxter Healthcare Corporation

## CONTACT PERSON

| Name: | David E. Curtin |
|----------------------------------|-------------------------------------|
| Address (street, suite #): | 1620 Waukegan Road |
| Address (City, state, zip code): | McGaw Park, IL 60085 |
| Title: | Director, Global Regulatory Affairs |
| Telephone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |

## DEVICE NAME

HomeChoice/HomeChoice PRO Automated Personal Cycler

#### COMMON NAME

Automated Peritoneal Dialysis (APD) Cycler

# CLASSIFICATION NAME

: ·

Peritoneal dialysis system and accessories per 21 CFR 876.5630

## PREDICATE DEVICE

| K053512 | HomeChoice/HomeChoice PRO Automated Personal Cycler |
|---------|-----------------------------------------------------|
| K012988 | HomeChoice/HomeChoice PRO Automated Personal Cycler |
| K923065 | HomeChoice/HomeChoice PRO Automated Personal Cycler |

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## DEVICE DESCRIPTION

The HomeChoice/HomeChoice PRO Automated Personal Cycler is used for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis therapy. The HomeChoice/HomeChoice PRO cycler automates peritoneal dialysis by heating the dialysis solution, pumping the solution to and from the patient, controlling dwell times, accounting for volumes of the solution according to a physician prescribed therapy and recording the ultrafiltration volume produced by the therapy.

### STATEMENT OF INTENDED USE

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

### TECHNOLOGICAL CHARACTERISTICS

The HomeChoice/HomeChoice PRO Automated Personal Cycler with Version 10.4 software intended use and general technological characteristics remain the same as the HomeChoice Automated Personal Cycler predicate device cleared under K053512. K012988 and K923065. It has the same fluid heating, pumping and measurement controls as the predicate device as well as the same safety and effectiveness features, design and materials of construction.

The HomeChoice/HomeChoice PRO Automated Personal Cycler with Version 10.4 software is substantially equivalent to the predicate device.

### ASSESSMENT OF NON-CLINICAL DATA

The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. It is further verified for system compatibility with the devices with which it communicates. Device hardware is certified to applicable safety standards.

Full system validation and software verification testing was performed to ensure that the modifications to the HomeChoice/HomeChoice PRO Automated Personal Cycler function as intended and that the modifications did not negatively impact the overall system. Testing included:

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K102936
Page 3 of

- · Software validation and verification testing
- · Electromagnetic compatibility (EMC) testing
- · Electrical safety testing
- · Human Factors Testing

The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria.

Electromagnetic compatibility testing (EMC) was conducted according to the IEC 60601-1-2. The modified HomeChoice/HomeChoice PRO device, outlined in this submission, meets the requirements of IEC 60601-1-2.

Electrical safety testing was conducted according to IEC 60601-1. The modified HomeChoice/HomeChoice PRO device, outlined in this submission, meets the requirements of IEC 60601-1.

### ASSESSMENT OF CLINICAL DATA

Not Applicable

### CONCLUSION

Based upon the results of non-clinical testing, the modified HomeChoice/HomeChoice PRO device is safe and effective, and performs equivalently to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Baxter Healthcare Corporation c/o Lisa Skeens, Ph.D Vice President, Global Regulatory Affairs 1620 Waukegan Road MCGAW PARK, IL 60085

MAR 3 0 2011

Re: K102936

Trade/Device Name: HomeChoice / HomeChoice PRO Automated Personal Cycler Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FKX Dated: 'September 30, 2010 Received: October 4, 2010

Dear Dr. Skeens:

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. 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.

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

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#### Page 2

adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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## 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: HomeChoice/HomeChoice Pro Automated Personal Cycler

Indication(s) for Use:

The HomeChoice/HomeChoice Pro Automated 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.

| Prescription Use: | Over-the-Counter Use: |
|----------------------|-----------------------|
| 21 CFR 801 Subpart D | 21 CFR Subpart C |

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