ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM

K954987 · Althin Medical AB an Affiliate of Baxter Intl · KDI · Aug 8, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K954987
• Device Name: ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM
• Applicant: Althin Medical AB an Affiliate of Baxter Intl
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Aug 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To provide hemodialysis treatment to patients with acute or chronic renal failure.

Device Story

Hemodialysis delivery system; provides dialysate at prescribed temperature/ionic concentration; monitors machine, dialysate, and blood circuit functions. Operator interface via interactive touch screen; treatment parameters displayed on LCD monitor. Used in clinical settings by trained personnel. Device modifies predicate by replacing CRT with LCD, reducing dialysate flow rate by 20%, and adjusting water temperature requirements. Safety systems identical to predicate.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Hemodialysis delivery system; LCD display; interactive touch screen interface. Components largely identical to predicate. Software controls display color palette. Safety monitoring systems for machine, dialysate, and blood circuits.

Indications for Use

Indicated for patients with acute or chronic renal failure requiring hemodialysis treatment.

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® System 1000® Single Patient Hemodialysis Delivery System (K910215)

Submission Summary (Full Text)

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K954987 p.1/2

Althin

Medical, Inc.

AUG - 8 1996

# 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: ________________

## Applicant Information:

Date Prepared: October 18, 1995

Name: Althin Medical, Inc.

Address: 13520 Pheasant Court

Portland, OR 97222

Contact Person: Alan Lewis

Phone Number: [phone]

Fax Number: [phone]

## Device Information:

Trade Name: AltraTouch™ 1000 Single Patient Hemodialysis Delivery System

Common Name: As above.

Classification Name: Hemodialysis Delivery System

## Equivalent Device:

Drake Willock® System 1000® Single Patient Hemodialysis Delivery System

## Device Description:

A hemodialysis delivery system which will provide dialysate at the prescribed temperature and ionic concentration to be used for hemodialysis treatment. It has the ability to monitor machine, dialysate, and blood circuit functions during dialysis. The machine treatment parameters are displayed on a Liquid Crystal Display monitor screen. The operator controls is done through an interactive touch screen.

## Intended Use:

To provide hemodialysis treatment to patients with acute or chronic renal failure.

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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# Comparison To Predicate Device:

The AltraTouch™ 1000 Single Patient Hemodialysis Delivery System is a modification of the Drake Willock® System 1000 Single Patient Dialysate Delivery System {510(k) number K910215}, the predicate machine. The modifications consist of:

1. Replacing the 12 inch (diagonal) Cathode Ray Tube display of the predicate machine with a 9 1/2 inch (diagonal) Liquid Crystal Display (which lowers the overall height of the machine by approximately two inches, and reduces its overall weight by approximately 31 pounds).

2. Reducing the maximum dialysate flow rate by 20%.

3. Increasing the minimum temperature requirement for the incoming water, and offering some of the features that are standard on the predicate machine as options.

Except for the parts associated with the change to the LCD screen, the AltraTouch™ 1000 machine is built from the same parts as the predicate device. The only software changes are those that control the display color pallet. All machine/patient safety systems are identical to the predicate device. Althin Medical, Inc. believes that the design and testing of this modified System 1000® machine demonstrates that it is safe and effective.