DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION

K955384 · Althin Medical AB an Affiliate of Baxter Intl · KDI · Jan 10, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K955384
• Device Name: DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION
• Applicant: Althin Medical AB an Affiliate of Baxter Intl
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Jan 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Single Needle Single Lumen Dialysis is indicated for use when a single venipuncture is chosen for use in chronic or acute hemodialysis treatments.

Device Story

System 1000 Dialysate Delivery System modified to support Single Needle Single Lumen (SNSL) hemodialysis. Device operates cyclically: arterial phase (blood aspiration) and venous phase (blood return). Arterial phase: venous line clamped; blood pumped into holding chamber until volume threshold reached. Venous phase: arterial line clamped; venous line opened; blood returned to patient via pump or pressure differential until low-pressure trip point reached. Supports one or two peristaltic pumps and one or two line clamps. Used in clinical settings by trained personnel. Provides alternative to standard two-needle access, reducing venipuncture requirements for patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design/testing of hardware and functional safety systems.

Technological Characteristics

Hemodialysis system utilizing cyclic arterial/venous operation. Features include peristaltic blood pumps, line clamps, and holding chambers. Hardware modifications support single needle/lumen access. Safety systems include pressure monitoring (venous pressure trip points).

Indications for Use

Indicated for patients requiring chronic or acute hemodialysis treatment where a single venipuncture access is chosen.

Regulatory Classification

Identification

A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.). (3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).

Special Controls

*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ” (2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,” (3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,” (4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and (5) “Guidance for Hemodialyzer Reuse Labeling.”

Predicate Devices

• Drake Willock 8810 Single Needle Device (K873279)
• Drake Willock 8806 Single Needle Device
• Fresenius A 2008 D Single Needle Device
• Hospal BSM 22

Submission Summary (Full Text)

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Althin
Medical, Inc.
K955384
JAN 10 1997

# 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K955384

## Applicant Information:

Date Prepared: November 21, 1995
Name: Althin Medical, Inc.
Address: 13520 Pheasant Court
Portland, OR 97222-1298

Contact Person: Alan Lewis
Phone Number: [phone]
Fax Number: [phone]

## Device Information:

Trade Name: Drake Willock® System 1000® Dialysate
Delivery System with Single Needle Single Lumen option
Common Name: As above.
Classification Name: Hemodialysis System and Accessories.

## Devices to Which Substantial Equivalence is Being Claimed:

The Single Needle Single Lumen option for the System 1000 Hemodialysis Machine is substantially equivalent to the following products, which are currently legally marketed medical devices.

1. Drake Willock 8810 Single Needle Device
Althin Medical, Inc. (K873279)

2. Drake Willock 8806 Single Needle Device
Althin Medical, Inc.

3. Fresenius A 2008 D Single Needle Device
Fresenius, USA

4. Hospal BSM 22
Hospal, France

The Althin Group

Althin Medical, Inc.
Drake Willock® dialysis equipment
13520 S.E. Pheasant Court
Portland, Oregon 97222-1298
Phone
503-659-3355
Telefax
503-652-0225

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## Device Description:

This application is for adding the option of Single Needle Single Lumen dialysis treatment to the current System 1000® Hemodialysis Machine. Single Needle Single Lumen dialysis is performed by controlling blood flow into and out of the patient with a single needle single lumen blood access, as opposed to dialysis blood access with two needle punctures. Because of the single lumen access, the hemodialysis machine operates cyclically, i.e. part of the time blood is aspirated from the patient (arterial phase), and part of the time blood is infused to the patient (venous phase).

Arterial Phase: During the arterial phase, the venous blood line is clamped, and blood is pumped via the peristaltic blood pump from the patient into the machine's extracorporeal circuit, and into (a) holding chamber(s) until a predetermined volume of blood has been accumulated. When the specified volume has been reached, the blood pump is stopped. The arterial phase is now complete.

Venous Phase: During the venous phase, the venous blood line is unclamped, the arterial blood line is clamped, and the blood in the holding chamber(s) and extracorporeal circuit is returned to the patient. When the venous pressure reaches a predetermined Low Pressure Trip Point, the venous blood line is clamped. At this point, the system returns to the arterial phase, and the cycle starts again.

Single Needle Single Lumen dialysis can be performed using either one peristaltic blood pump or two. (The Arterial and Venous phases described above apply to either system configuration). In systems using two pumps, the second pump returns the blood to the patient (Venous Phase). In systems using one pump, the pressure difference between the venous drip chamber and the patient causes the blood to return to the patient.

Single Needle Single Lumen dialysis (with systems using either one peristaltic pump or two) can be performed using either one line clamp or two. (The Arterial and Venous phases described above apply to either system configuration.) The second (arterial) clamp is required only when a blood line with an arterial drip chamber is used.

## Intended Use:

Single Needle Single Lumen Dialysis is indicated for use when a single venipuncture is chosen for use in chronic or acute hemodialysis treatments.

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# Comparison to Predict Devices:

The System 1000® Single Needle Single Lumen option and the Predicate Devices identified above all have the following technological characteristics in common:

1. Single needle, single lumen blood access.
2. One or two peristaltic blood pumps.
3. One or two line clamps.
4. Cyclic operation: Arterial phase and Venous phase.

All existing safety systems in the System 1000® machine are still in place. Additional safety systems have been added to accommodate the hardware and functional changes and additions required for the Single Needle Single Lumen option. Althin Medical, Inc. believes that the design and testing of this device demonstrates that it is safe and effective.

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