HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q

K031676 · Baxter Healthcare Corp · KDJ · Nov 20, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031676
• Device Name: HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
• Applicant: Baxter Healthcare Corp
• Product Code: KDJ · Gastroenterology, Urology
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The HomeChoice APD Set with Lineo Connector is intended for use with the HomeChoice Automated Personal Cycler. The HomeChoice Integrated APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the HomeChoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set. The HomeChoice Low Recirculation Volume APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy in pediatric and adult renal failure patients requiring fill volumes of 60 - 1000 ml, using only the HomeChoice Automated Personal Cycler with Low Fill Mode Drain Logic. The Lineo OptiCap is for protection of the Lineo Connector (patient line) of APD Disposable Sets with Lineo Connector that are intended for delivery of peritoneal dialysis therapy.

Device Story

Disposable tubing administration set for automated peritoneal dialysis (APD). Connects patient and dialysis solutions to HomeChoice automated cycler. Incorporates disinfectant feature into patient connector via Lineo Connector/OptiCap. Used in clinical or home settings by patients or caregivers. Facilitates fluid delivery for renal failure therapy. Replaces standard connectors with integrated disinfectant protection to reduce contamination risk.

Clinical Evidence

No clinical data. Bench testing performed including biological evaluation per ISO 10993-1 and functional/physical testing prior to release. Sterilization validated to SAL of 10^-6.

Technological Characteristics

Disposable tubing administration set. Materials meet ISO 10993-1 biological requirements. Features integrated disinfectant patient connector. Sterilized to SAL ≥ 10^-6.

Indications for Use

Indicated for pediatric and adult patients with renal failure requiring peritoneal dialysis therapy. Compatible with HomeChoice Automated PD Systems. Specific sets indicated for fill volumes 60-1000 ml.

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 APD Set (K923065)
• HomeChoice Low Recirculation Volume APD Set (K012988)
• High Dose Disconnect Cap and MiniCap with Povidone Iodine (K972579)
• Disconnect Caps with Povidone Iodine (K895631)

Submission Summary (Full Text)

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K031676

Page 1/2

NOV 2 0 2003

## 510(K) SUMMARY

| Submitter's Name: | David E. Curtin, RAC |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1620 Waukegan Rd. MPGR-A2E |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | David E. Curtin |
| Date Prepared: | May 30, 2003 |
| Trade Name: | HomeChoice APD Set with Lineo Connector |
| Common Name: | Sets, Administration, for Peritoneal Dialysis, Disposable |
| Classification Name: | Peritoneal Dialysis System and Accessories 21 CFR 876.5630 |
| Equivalent Predicate: | HomeChoice APD Set (Baxter Healthcare Corp., K923065),<br>HomeChoice Low Recirculation Volume APD Set (Baxter Healthcare Corp., K012988), High Dose Disconnect Cap and<br>MiniCap with Povidone Iodine (Baxter Healthcare Corp., K972579) and Disconnect Caps with Povidone Iodine (Baxter Healthcare Corp., K895631) |
| Device Description: | HomeChoice APD Set with Lineo Connector is a disposable<br>tubing administration set used in automated peritoneal dialysis<br>therapies. It provides for connection of the patient and the<br>peritoneal dialysis solutions to the automated cycler. |
| Intended Use: | The HomeChoice APD Set with Lineo Connector is intended<br>for use with the HomeChoice Automated Personal Cycler |

:

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.

| Summary of the<br>Technological<br>Characteristics<br>Compared to the | The general design and material of the HomeChoice APD Set<br>with Lineo Connector is to the HomeChoice APD Set<br>(K923065 and K012988) and High Dose Disconnect<br>Cap/MiniCap (K972579 and K895631) in that it incorporates<br>the disinfectant feature of the Disconnect Cap/MiniCap into the<br>patient connector of the set. The technological characteristics<br>of the HomeChoice APD Set with Lineo Connector do not<br>raise any new types of safety and effectiveness issues, when<br>compared to the predicate product. |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device: | HomeChoice APD Set (Baxter Healthcare Corp), HomeChoice<br>Low Recirculation Volume APD Set (Baxter Healthcare<br>Corp.), High Dose Disconnect Cap and MiniCap with<br>Povidone Iodine (Baxter Healthcare Corp.) and Disconnect<br>Caps with Povidone Iodine (Baxter Healthcare Corp) |
| Clinical Data: | N/A |
| Conclusions Drawn | Components of the subject HomeChoice APD Set with Lineo<br>Connector have met the biological requirements of ISO 10993-<br>1: Biological Evaluation of Medical devices - Part: Guidance<br>on selection of tests.<br><br>Sterilization of the HomeChoice APD Set with Lineo<br>Connector is by a method determined and validated to ensure<br>an SAL of ≥ 106. Functional and physical testing is performed<br>prior to product release |

Additional
Information Requested by FDA:

None to date

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The bird is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

Public Health Service

NOV 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031676

Trade/Device Name: HomeChoice Automated PD Set with Lineo Connector; #5C4469Q, 5C4468Q HomeChoice Integrated APD Set with Lineo Connector; #5C4531Q HomeChoice Low Recirculation Volume APD Set with Lineo Connector; #5C8302Q and Lineo Opticap; #5C4599Q

Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal Dialysis System and Accessories Regulatory Class: II Product Code: 78 KDJ Dated: August 29, 2003 Received: September 2, 2003

Dear Mr. Curtin:

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. Iisting 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 (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); 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,

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This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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 C. Brogdon

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

Enclosure

Page 2

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510(k) Number (if known): K031676

Device Name: HomeChoice Integrated APD Set with Lineo Connector

Indications For Use:

The HomeChoice Integrated APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the HomeChoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set.

(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)

22

Division of Reproduct and Radiological Devices 510(k) Number

G:\510k\Lineo\response!\Indications for Use Statement

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510(k) Number (if known):________________________________________________________________________________________________________________

Device Name: HomeChoice Low Recirculation Volume APD Set with Lineo Connector

Indications For Use:

The HomeChoice Low Recirculation Volume APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy in pediatric and adult renal failure patients requiring fill volumes of 60 - 1000 ml, using only the HomeChoice Automated Personal Cycler with Low Fill Mode Drain Logic.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive, Abdomi nd Radiological Dev

G:\510k\Lineo\response 1\Indications for Use Statement

23

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K031676 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Lineo OptiCap

Indications For Use:

The Lineo OptiCap is for protection of the Lineo Connector (patient line) of APD Disposable Sets with Lineo Connector that are intended for delivery of peritoneal dialysis therapy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

Nancy C Brogdon
Division Sign Off

Reproductive, Abdom and Radiological D 510(k) Number

24

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510(k) Number (if known): K031676

Device Name: HomeChoice Automated PD Set with Lineo Connector

Indications For Use:

The HomeChoice Automated PD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the HomeChoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set.

(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 Brogdon
(Division Sign-Off)

vision of Reproductive, Abdo and Radiological De 510(k) Number

G:\510k\Lineo\response 1\Indications for Use Statement