ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000

K043574 · Renal Solutions, Inc. · FKT · Jun 3, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K043574
• Device Name: ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000
• Applicant: Renal Solutions, Inc.
• Product Code: FKT · Gastroenterology, Urology
• Decision Date: Jun 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Allient® Sorbent Hemodialysis System, including the SORB™ series and HISORB™ series of cartridges, is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.

Device Story

Allient Sorbent Hemodialysis System provides hemodialysis for acute/chronic uremic patients. System components: hemodialysis machine, SORB/HISORB sorbent cartridges, disposable blood tubing, dialysate set, infusate chemicals. Operates via batch recirculating dialysate delivery; uses sorbent cartridge to purify dialysate from potable water, enabling recirculation instead of single-pass disposal. Features Pulsar™ dual-chamber pneumatic blood pump. Used in hospitals, acute/chronic-care facilities, or dialysis clinics; operated by clinicians or technicians. GUI touch-screen allows prescription parameter entry, treatment monitoring, and machine control. Safety features include audible/visible alarms for unsafe conditions. Benefits include reduced water consumption (6L vs 120L) compared to traditional systems. Healthcare providers use output to manage patient toxin levels, sodium, and bicarbonate balance.

Clinical Evidence

Bench testing only. The system was tested to verify compliance with specifications and international standards, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993 series), and sterilization validation (ISO 11135).

Technological Characteristics

Sorbent-regenerated dialysate delivery system. Components: Pulsar™ pneumatic dual-chamber blood pump, sorbent cartridges, GUI touch-screen. Power: 115-265 VAC, 50/60 Hz. Connectivity: Standalone. Sterilization: Ethylene Oxide (ISO 11135). Materials: Tested per ISO 10993 for cytotoxicity, sensitization, irritation, systemic toxicity, and genotoxicity. Dimensions: 59.42" x 27.02" x 21.79" (with monitor).

Indications for Use

Indicated for acute and chronic uremic patients requiring hemodialysis as prescribed by a physician.

Regulatory Classification

Identification

A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the means to circulate dialysate through this cartridge and the dialysate compartment of the dialyzer. The device is used with the extracorporeal blood system and the dialyzer of the hemodialysis system and accessories (§ 876.5820). The device includes the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate, and alarms to indicate abnormal dialysate conditions. The sorbent cartridge may include absorbent, ion exchange and catalytic materials.

Predicate Devices

• REDY 2000 (K840743 and K882428)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness 510(k) Summary Allient® Sorbent Hemodialysis System

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## 510(k) K043574

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| Date of<br>Application | April 22 , 2005 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitters<br>Name | Renal Solutions Inc<br>770 Commonwealth Drive<br>Warrendale, PA 15086 |
| Contact<br>Name | Richard G. Confer, Director of Regulatory Affair<br>770 Commonwealth Drive<br>Warrendale, PA 15086<br>Phone: [phone]<br>e-mail: [e-mail] |
| Trade Name | Allient® Sorbent Hemodialysis System |
| Common<br>Name | System, Dialysate Delivery, Sorbent Regenerated |
| Classification | Class II per 21CFR876.5600 code FKT |
| Predicate<br>Device<br>Information | REDY 2000 (K840743 and K882428) |

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#### Overview of the Allient® Sorbent Hemodialysis System Device Description

The Allient Sorbent Hemodialysis System (Allient System) is intended for the treatment of acute or chronic uremic patients where hemodialysis is prescribed by the physician.

The system consists of the Allient hemodialysis machine, SORB™ series of Sorbent cartridges, a single-use, sterile, disposable blood tubing set, a singleuse disposable dialysate set, and various dialysate and infusate chemicals. The system is recommended for use with a variety of dialyzers, access needles or access cannulae, which will be supplied by other manufacturers.

Figure E-1 below is an illustration of the Allient System with major components of the system labeled for clarity.

Image /page/1/Figure/5 description: The image is a diagram of the Allient Sorbent Hemodialysis System. The diagram labels the different parts of the system, including the monitor, central status LEDs, dialysate bypass, dialysate out flow pump, blood pump, dialyzer, dialysate in flow pump, infusate, ammonia detector, dialysate inflow pump, venous clamp, venous air detector, heparin pump, arterial air detector, arterial clamp, dialysate reservoir, and IV pole. The diagram also shows the dialysate side and the blood side of the system.

The Allient System operates in a similar manner to standard hemodialysis systems currently approved for use. The only significant differences between the Allient System and standard hemodialysis machines are as follows:

The Allient System utilizes a Sorbent cartridge to purify dialysate made from potable water. After passing through the dialyzer, the dialysate is recirculated to the dialyzer instead of being disposed of. This contrasts with traditional

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"single pass" dialysis, which uses purified water, mixes it continuously with dialysate, and passes it across the dialysate side of a dialyzer membrane in a single flow-through system. Wastewater is routed to a drain and not recirculated. By recirculating and refreshing the dialysate, the Allient System uses 6 liters of water per dialysis treatment. A traditional single-pass dialysis system uses at least 120 liters of purified water during the typical 4-hour dialysis session.

The Allient System utilizes the Pulsar™ air-activated pump in contrast to the roller-activated pump commonly employed in traditional hemodialysis systems. The Pulsar blood pump is a dual-chamber pneumatically operated pump.

All other aspects of Renal Solutions' Allient Sorbent Hemodialysis System process are identical to those employed in the standard "single pass" method of dialysis: there are no significant differences in the technology employed in Sorbent dialysis therapy between the Allient System and traditional methods.

The Allient System functions as a traditional recirculating Sorbent hemodialysis system, similar to the REDY 2000 System. Either single-needle or dual-needle access to the patient is permitted.

The patient's blood is pumped from the access through a dialyzer and is returned to the patient. Heparin is administered via a flow-controlled heparin pump capable of delivering rates of 0 to 3 milliliter per hour (mL/hr) in 0.5 mL/hr increments as well as an initial bolus of 0 to 10 mL. Blood-flow rates are settable in 10 milliliter per minute (mL/min) increments in the range of 200 to 400 mL/min in the dual-needle mode and 200 to 300 mL/min in the singleneedle mode.

The dialysate delivery system consists of a container for dialysate. Sorbent regenerative cartridges, chemical infusion system to replace chemicals removed by the Sorbent cartridges, and an ultrafiltrate control system. The dialysate delivery system operates in a batch recirculating mode and continuously recirculates the dialysate through the cartridge. The cartridge removes dialyzed toxins from the dialysate and buffers the sodium and bicarbonate levels in the dialysate to maintain normal levels in the patient.

The Acute mode of operation is intended for use in a hospital, acute or chronic-care facility, or dialysis clinic where the patient is continually monitored. The Acute mode of operation allows the clinician or dialysis technician to enter prescription parameters and machine operating parameters for each patient.

The Allient System incorporates a Graphical User Interface (GUI) comprised of a touch-screen display, which controls the System software. The GUI is

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used to select the mode of operation of the Allient System and enter prescription data and machine control parameters during setup. This information is stored for future reference and verification prior to subsequent treatments. Treatment status and progress, in addition to machine status, is continually collected and displayed on the GUI screen to support treatment. The GUI's touch-screen technology also provides ease of use for Home patients. The Allient System incorporates a control system that contains a number of safety features and audible and visible alert and alarm functions to warn the operator or patient of unsafe conditions.

## Specifications:

#### Physical Dimensions:

System: Height 35.49" Width 27.02" Depth 21.79"

## System with Monitor:

Height: 59.42" Width: 27.02" Depth: 21.79"

#### Monitor (only):

Height (including base):15.4" (391 mm) Width: 15.4" (391 mm): Depth: 8.2" (208 mm)

#### Monitor Arm (only):

Vertical Adjustment Range: 20" (508 mm) Panel Extend/retract: 25" (635 mm) Weight: ----------------------------------------------------------------------------------------------------------------------------------------------------------------------23 lbs: (10.4 kg)

#### System with Cart:

Height: 53.50" Cart (only) Height:18.50" Width: 26.50" Depth: 22.0"

## Weight:

System: 240 pounds 109 kg System (with Cart) 282 pounds 128 kg

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#### Environmental Requirements

#### Operating Conditions:

Operating Temperature

Ambient temperature range: +10°C to +35°C.

Storage Temp: -40°C to +70°C with condensing humidity allowable. Relative Humidity:30% to 95% non-condensing. Atmospheric Pressure: 585 mmHg to 795 mmHg.

## Storage Temperature: SORB Cartridges

Long Term: Ambient temperature range: +4°C to +30°C. Short Term (less than 30 days): Relative Humidity: 20% to 80% non-condensing storage.

#### Power

The system operates on fused AC power with the following requirements: Line voltage: 115-265 VAC Line Frequency: 50/60 Hz Power consumption: 12 Amps at 120VAC, 6 Amps at 240 VAC max Fuse: 12Amps 250V time delay Leakage Current: less than 300 uA Electrical Outlet Requirement: Dedicated 15 Amp, three prong, grounded electrical circuit

#### Power Failure:

Indicated by an audible alarm. The system is capable of continuing operation during a power loss or dip of a minimum of 1 second in length.

#### Power Loss Recovery:

If the power loss is longer than 1 second, the system will shut down in a safe mode; no log data or treatment data will be lost.

## Treatment Requirements:

## Water Quality

Six liters of potable water that meets the EPA standard for drinkable water; normally requires no additional water purification.

#### Flow Rates

Dialysate Flow Rate: 0 to 400 +/- 10% mL/min into 25 psi maximum back pressure from the Sorbent cartridge Measuring Tolerance: + / - 10% of set point 10 mL/min within the range of 200 to 400 mL/min Increment:

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Infusate Flow Rate: Measuring Tolerance: + / - 10% of set point

0 to 3 mL/hr against +/- psi back pressure Heparin Flow Rate: Measuring Tolerance: + / - 0.1mL/hr (rates are < 1 mL/hr) + / - 10% (rates are >1 mL/hr) Increment: 0.25 mL/hr increments

## Blood Management System:

Single Needle: 150 mL/min to 200 mL/min Blood Flow Rates: Dual Needle: 150 mL/min to 400 mL/min Vascular Access Range: up to 17 gauge (dependant on patient access and dialyzer)

## Monitoring Systems:

Air Detectors Air Detection Range greater than 1.0 ml bubble or microbubbles greater than 1.5 ml

## Dialysate Temperature Control:

Temperature Range 34o C to 37o C

#### Blood Leak Detector:

Leak Detection Range: 0.35 ml/min of 0.25% hematocrit Blood in the dialyzer output flow

#### Saline:

Controlled at 200 mL/min Flow Rate: Measuring Tolerance: + / - 10% of set point Selectable Bolus volumes:

#### Ultrafiltration:

Min. 20g/hour to 2000 g//hour based on acceptable Dialyzer Net UFR: Measuring Tolerance: + / - 20 g/hr or 5% whichever is greater based on the set UFR:

Maximum UF 6 Liters

#### Heparin:

Flow Rate: 0 mL/hr to 3 mL/hr 10 mL and 30 mL vial of 1,000 u/mL heparin solution Vial sizes: Flow Rate Accuracy: 10% of set point

#### Degassing:

Dialysate flow rate of 750 mL/min with the SORB cartridge Flow Rate:

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bypassed Frequency: 0 - 20 seconds 0 - 60 minutes Duration:

The Allient Sorbent Hemodialysis System, including the SORB series and Intended Use HISORB series cartridges, is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.

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The Allient System has been tested to verify that it meets its specifications as Summary of Testing listed above;

> The Allient System has also been tested and meets the following domestic and international standards.

| Standard | Title |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI/AAMI RD17 | Hemodialyzer Blood Tubing |
| ANSI/AAMI RD5 | Hemodialysis Systems |
| EN 556 | Sterilization of Medical Devices - Requirements<br>For Terminally-Sterilized Devices To Be<br>Labeled 'Sterile' |
| IEC 60529 | Degrees Of Protection Provided By Enclosures<br>(IP Code)<br>Note: It is agreed that IXP 1 is the level of<br>protection to be afforded by the Allient system. |
| IEC 60601-1:2003 | Medical Electrical Equipment, Part 1- General<br>Requirements for Safety |
| IEC 60601-1-2:2001 | Medical Electrical Equipment - Part 1: 2 General<br>requirements for safety; 4. Collateral Standard:<br>Electomagnetic Compatibility |
| IEC 60601-2-16:1998 | Medical electrical equipment - Part 2: Particular<br>requirements for the safety of hemodialysis,<br>haemodiafiltration and haemofiltration<br>equipment |
| ISO 10993-10 | Biological evaluation of medical devices -- Part<br>10: Tests for irritation or intracutaneous<br>Reactivity |
| ISO 10993-1:1993 | Biological evaluation of medical devices -<br>Systemic Toxicity- Material Mediated<br>Pyrogenicity |
| Iso 10993-3:1993 | Biological evaluation of medical devices -<br>Biological evaluation of medical<br>devices, Part 3: Tests for<br>genotoxicity, carcinogenicity,<br>and reproductive toxicity<br>Genotoxicity- Ames test |
| ISO 10993-10:2002 | Biological evaluation of medical devices -- Part<br>10: Tests for irritation and sensitization |
| ISO 10993-5:1999 | Biological evaluation of medical devices -- Part<br>5: Tests for In Vitro cytotoxicity |
| ISO 10993-7:1995 | Biological Evaluation of Medical Devices - Part<br>7: Ethylene Oxide Sterilization Residuals |
| ISO 11135:1994 | Medical Devices - Validation and Routine<br>Control of Ethylene Oxide Sterilization |
| ISO 8638: | Extracorporeal Blood Circuit For<br>Haemodialysers, Haemofilters and<br>Haemoconcentrators |

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KOH 3574

- All testing performed on the Allient Sorbent Hemodialysis System verifies Conclusions the substantial equivalency of the Allient System to the predicate REDY 2000 system, when used with the Renal Solutions Sorbent Dialysis (SORB) cartridges for acute and chronic hemodialysis.

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Image /page/9/Picture/1 description: The image shows a logo with a stylized bird in the center. The bird is depicted with three curved lines forming its body and wings, giving it a sense of motion. Encircling the bird is text that reads 'DEPARTMENT OF NATURAL RESOURCES'. The text is arranged in a circular fashion, following the contour of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville*MD 20050

JUN 3 - 2005

Mr. Richard G. Confer Renal Solutions", Inc. 770 Commonwealth Drive Suite 101 WARRENDALE PA 15086

Re: K043574

Trade/Device Name: Allient® Sorbent Hemodialysis System Regulation Number: 21 CFR §876.5600 Regulation Name: Sorbent regenerated dialysate delivery system for hemodialysis Regulatory Class: II Product Code: FKT Dated: April 18, 2005 Received: April 26, 2005

Dear Mr. Confer:

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, listing 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 Approval), it may be subject to such additional controls. Existing major regulations affecting your Apple 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 statues and regulations administered by other Federal agencies. You must comply with all the r carrers states and reguling, but not limited to registration and listing (21 CFR Part 807); labeling All CFR Part 801); good nanufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 800); 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) I his letter will anow you to begin marketing your and equivalence of your device to a legally premarket notification: "The I DA midnig of backation 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 If you desire specific advice for your device on our laboring of
eontact 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, "Wiseration on your responsibilities under the Act from the 807.97). You may obtain other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/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

510(k) Number (if known): N/A

Allient® Sorbent Hemodialysis System Device Name:

Indications For Use:

The Allient® Sorbent Hemodialysis System, including the SORB™ series and HISORB™ series of cartridges, is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.

.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rat A. Phillips

(Division Sign-Off) Division of Reproductiv and Radiological Q 510(k) Number

0010