HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310

K053512 · Baxter Healthcare Corp · FKX · Feb 16, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K053512
• Device Name: HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
• Applicant: Baxter Healthcare Corp
• Product Code: FKX · Gastroenterology, Urology
• Decision Date: Feb 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for 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

HomeChoice Automated Personal Cycler (version 8.9) automates dialysate solution exchanges for peritoneal dialysis; used for pediatric and adult renal failure patients. Device cycles peritoneal dialysis fluid based on clinician-prescribed amounts and timing. Operated in clinical or home settings to manage renal replacement therapy. System ensures precise fluid delivery; replaces manual exchange processes to improve patient convenience and therapy adherence.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including functional testing for delivery integrity and conformance to manufacturing specifications.

Technological Characteristics

Automated peritoneal dialysis cycler; software-controlled fluid exchange system. Design and materials are identical to predicate devices. Operates via automated fluid cycling based on programmed clinician prescriptions.

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 Automated Personal Cycler Peritoneal Dialysis System (K923065)
• HomeChoice Automated Personal Cycler Peritoneal Dialysis System (K012988)

Submission Summary (Full Text)

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## FEB 1 6 2006

## 510(K) SUMMARY

| Submitter's Name: | Michael C. Garcia |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1620 Waukegan Rd. MPGR-AL |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | David E. Curtin<br>[phone] |
| Date Prepared: | 12/09/05 |
| Trade Name: | HomeChoice Automated Personal Cycler |
| Common Name: | APD Cycler |
| Classification Name: | Peritoneal dialysis system and accessories per 21 CFR<br>876.5630 |
| Equivalent Predicate: | HomeChoice Automated Personal Cycler Peritoneal<br>Dialysis System (K923065 and K012988) |
| Device Description: | The HomeChoice Automated Personal Cycler, version 8.9<br>software is used for automatic control of dialysate solution<br>exchanges in the treatment of pediatric and adult renal<br>failure patients undergoing peritoneal dialysis therapy. The<br>HomeChoice Automated Personal Cycler automatically<br>cycles peritoneal dialysis fluid in the amounts and time<br>prescribed by a clinician. |

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| Intended Use: | The HomeChoice Automated Personal Cycler is intended<br>for automatic control of dialysate solution exchanges in the<br>treatment of pediatric and adult renal failure patients<br>undergoing peritoneal dialysis. |
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| Summary of the<br>Technological<br>Characteristics<br>Compared to the<br>Predicate Device: | The general design and material of the HomeChoice<br>Automated Personal Cycler is identical<br>to the HomeChoice Automated Personal Cycler cleared<br>under K923065 & K012988. It does not raise any new<br>types of safety and effectiveness issues when compared<br>to the predicate product |
| Clinical Data: | N/A |
| Conclusions Drawn | Validation and Verification testing was successful in<br>demonstrating that all design requirements have been met.<br>Bench testing was performed on the HomeChoice<br>Automated Personal Cycler to support substantial<br>equivalence to the predicate device, as well as<br>demonstrating that the device operates as intended and is<br>safe and efficacious.<br>Functional testing for delivery integrity and conformance to<br>manufacturing specifications are performed as in-process<br>and/or final inspections prior to product release to ensure a<br>quality product. |
| Additional<br>Information<br>Requested by FDA: | None to date |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 6 2006

David E. Curtin, RAC Associate Director, Global Regulatory Affairs Baxter Healthcare Corporation Renal Division, MPGR-A2E 1620 Waukegan Road MCGAW PARK IL 60085

Re: K053512

K 053312
Trade/Device Name: HomeChoice Automated Personal Cycler, Models 5C4471 and 5C8310 Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FKX Dated: December 15, 2005 Received: December 16, 2005

Dear Mr. Curtin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We have revewed your SCC001 510(K) promation investions for the indications for use stated in above and have decemined the devices marketed in interstate commerce prior to the enclosure) to regally marketed predical Device Amendments, or to devices that have been May 28, 1970, the chacultion date 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 do not require approval of a premiance approvations of the Act. The general controls provisions of the Act device, subject to the general controls provisions 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 device is classince (see ao ro) into can controls. Existing major regulations affecting your Approval), it illay de subject to such address. Title 21, Parts 800 to 898. In addition, FDA device can oc tound in the Coucerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that Please be advised that I DA s 133dailed of a subscanning with other requirements of the Act or any
FDA has made a determination that your device complies with other with all F DA has made a decemination mad your device contines. You must comply with all the Federal statues and regulations administered 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) (ZT CFR Part 801); good manufacturing product radiation control 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 algguner and and the first of a line of a beteratiol aquivalence of your devi This letter will allow you to begin maketing your antile of your device of your device to a legally
premarket notification. The FDA finding of substantial equir device and t premarket notification. The FDA Inding of substantial equivale of 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
r and the many of the following numbers, hased on the regulation numbers, 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 premarket notification" (21 CFR Also, please note the regulation entitled, "Misonalians of tesponsibilities under the Act from the 807.97). You may obtain other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address 056-2011-01-01-01-01-01-2019/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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 STATEMENT

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: HomeChoice Automated Personal Cycler

Indications For Use: HomeChoice Automated Personal Cycler

The HomeChoice Automated Personal Cycler Peritoneal Dialysis System is intended for The TromeChotee Praisition exchanges in the treatment of pediatric and adult renal failure patients undergoing 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 | <div style="text-decoration:underline;">✓</div> |
|------------------|-------------------------------------------------|
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(Per 21 CFR 801.109)

OR Over-The-Counter Use*_*_

Nancy C. Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number