ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493

K961825 · Baxter Healthcare Corp · KDJ · Aug 6, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961825
• Device Name: ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
• Applicant: Baxter Healthcare Corp
• Product Code: KDJ · Gastroenterology, Urology
• Decision Date: Aug 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ultra Sets are designed for drainage and infusion of PD solution during a peritoneal dialysis exchange.

Device Story

Y-shaped tubing set for peritoneal dialysis (PD) exchanges; enables drainage of spent dialysate into attached bag and infusion of fresh solution from container. Components: patient connector (luer lock), spike connector for solution container, drain bag, and occlusion clamps. Used by patients in home or clinical settings for manual PD exchanges. Facilitates fluid management; reduces risk of contamination during connection/disconnection. 3L Ultra Set includes 5L drain bag for larger effluent volumes.

Clinical Evidence

No clinical data. Bench testing only. Materials meet USP XXII Class VI biological requirements. Sterilization validated via ANSI/AAMI guidelines for radiation sterilization (14.3-25 kGy). Pyrogen testing performed per FDA LAL guidelines (limit 0.5 EU/mL).

Technological Characteristics

Y-shaped plastic tubing configuration. Materials meet USP XXII Class VI standards. Gamma sterilized per ANSI/AAMI guidelines (14.3-25 kGy). Includes luer lock patient connector, spike connector, and occlusion clamps. 3L model features 5L drain bag.

Indications for Use

Indicated for patients undergoing peritoneal dialysis requiring drainage and infusion of dialysis solution during an exchange.

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

• Baxter CAPD Disposable Disconnect Y-Set (K902526)
• UV-III Disposable Disconnect Y-Set (K883239)

Submission Summary (Full Text)

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K961825

# 510(k) SUMMARY

| Submitter's name and Address: | David C. Ross, Pharm.D., RAC
Baxter Healthcare Corporation, Renal Division
1620 Waukegan Road
McGaw Park, IL 60085 |
| --- | --- |
| Telephone Number:
Fax Number: | [phone]
[phone] |
| Contact: | David Ross |
| Trade Name: | Ultra Set CAPD Disposable Disconnect Y-Set and 3L Ultra Set CAPD Disposable Disconnect Y-Set |
| Common Name: | Disconnect Y-Sets with solution drainage bag for Peritoneal Dialysis (PD) |
| Classification Name: | Peritoneal dialysis system and accessories per 21 CFR 876.5630 |
| Equivalent Predicate: | Baxter CAPD Disposable Disconnect Y-Set (K902526) and UV-III Disposable Disconnect Y-Set (K883239). |
| Device Description: | The Y-shaped design of the set enables patients to initially drain the dialysis solution from the peritoneum into the attached drain bag and then to fill new dialysis solution from a solution container into the patient's peritoneum. The plastic Y-shaped configuration serves as a junction for three lengths of tubing. The first length of tubing is the patient connector and connects to the patient's transfer set via a luer lock connection. The second length of tubing has a spike connector for connection to the new solution container and an occlusion clamp which is utilized during the solution exchange. The third length of tubing has a empty drain bag and an occlusion clamp for collection of spent dialysate during the dialysis exchange. |
| Intended Use: | The Ultra Sets are designed for drainage and infusion of PD solution during a peritoneal dialysis exchange. |

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Summary of the technological characteristics compared to the predicate device:

In general, the design and materials of the subject disposable disconnect Y-sets are the same as the Baxter predicate devices. Differences in the subject Y-sets compared to the Baxter predicate devices consist of minor differences in the solution container and patient connections. Additionally, the drain bag on the 3L Ultra Set is five liters to accommodate larger effluent volumes.

Clinical Data:

Not applicable

Conclusions drawn from tests:

Components of the Ultra Set CAPD Disposable Disconnect Y-set and 3L Ultra Set CAPD Disposable Disconnect Y-set have previously met the USP XXII Class VI biological requirements and guidelines for safety screening of materials. The sets are gamma sterilized at the minimum sterilizing dose (msd) by a method determined and verified using Method 1 of the American National Standard Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) Guideline for radiation sterilization. The msd is between 14.3 and 25 kilogray (1.43-2.50 Mrad). The msd is audited quarterly.

The testing specification for pyrogen evaluation detail the FDA guideline for the Limulus Amebocyte Lysate (LAL) Test. The sets are tested to an endotoxin limit of $0.5\mathrm{EU/mL}$ in accordance with the established limit for medical devices and as validated under FDA's "Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices", December 1987.

Functional and physical testing are performed as in process and/or final inspections prior to release of product release ensuring a quality product.

Additional information requested by FDA:

None to date.

David C. Ross, Pharm.D., RAC
Manager, Regulatory Affairs

5/8/96
Date

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