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 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. 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. 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 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.

AI/ML Overview

The provided document describes the "Allient® Sorbent Hemodialysis System" and its substantial equivalence to a predicate device, the REDY 2000. It focuses on the device's specifications and compliance with various domestic and international standards, rather than a clinical study with acceptance criteria in the typical sense of accuracy, sensitivity, or specificity for a diagnostic or AI-driven device.

However, I can extract the relevant information from the document to construct an answer regarding acceptance criteria based on performance specifications and the study that "proves" (or verifies, in this context) the device meets them.

Acceptance Criteria and Device Performance based on provided specifications:

1. Table of Acceptance Criteria and Reported Device Performance

For a medical device like a hemodialysis system, "acceptance criteria" are more about meeting technical specifications and safety standards rather than diagnostic performance metrics (like sensitivity/specificity). The document details various operating parameters, flow rates, and safety features as the de facto acceptance criteria. The "reported device performance" is implicitly stated by saying the system "meets its specifications" and various standards.

Feature / Parameter	Acceptance Criteria (Specification)	Reported Device Performance
Dialysate Flow Rate	0 to 400 +/- 10% mL/min (into 25 psi max back pressure from Sorbent cartridge); Measuring Tolerance: +/- 10% of set point; Increment: 10 mL/min (200-400 mL/min range)	"The Allient System has been tested to verify that it meets its specifications as listed above." (Implicitly, the device performs within these specified tolerances.)
Infusate Flow Rate	0 to 3 mL/hr against +/- psi back pressure; Measuring Tolerance: +/- 10% of set point	"The Allient System has been tested to verify that it meets its specifications as listed above."
Heparin Flow Rate	0 to 3 mL/hr; Measuring Tolerance: +/- 0.1mL/hr (< 1 mL/hr) or +/- 10% (>1 mL/hr); Increment: 0.25 mL/hr; Accuracy: 10% of set point	"The Allient System has been tested to verify that it meets its specifications as listed above."
Blood Flow Rates	Single Needle: 150-200 mL/min; Dual Needle: 150-400 mL/min	"The Allient System has been tested to verify that it meets its specifications as listed above."
Air Detectors	Detection Range: > 1.0 ml bubble or microbubbles > 1.5 ml	"The Allient System has been tested to verify that it meets its specifications as listed above."
Dialysate Temperature	Control Range: 34°C to 37°C	"The Allient System has been tested to verify that it meets its specifications as listed above."
Blood Leak Detector	Leak Detection Range: 0.35 ml/min of 0.25% hematocrit Blood in dialyzer output flow	"The Allient System has been tested to verify that it meets its specifications as listed above."
Saline Flow Rate	Controlled at 200 mL/min; Measuring Tolerance: +/- 10% of set point	"The Allient System has been tested to verify that it meets its specifications as listed above."
Net Ultrafiltration	Min. 20g/hour to 2000 g/hour (based on acceptable Dialyzer); Measuring Tolerance: +/- 20 g/hr or 5% (whichever is greater)	"The Allient System has been tested to verify that it meets its specifications as listed above."
Degassing Flow Rate	750 mL/min (with SORB cartridge bypassed)	"The Allient System has been tested to verify that it meets its specifications as listed above."
Compliance with Standards	ANSI/AAMI RD17, ANSI/AAMI RD5, EN 556, IEC 60529, IEC 60601 series, ISO 10993 series, ISO 11135, ISO 8638	"The Allient System has also been tested and meets the following domestic and international standards."
Substantial Equivalency	To predicate REDY 2000 system	"All testing performed on the Allient Sorbent Hemodialysis System verifies the substantial equivalency of the Allient System to the predicate REDY 2000 system."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "sample size" for a test set in the traditional sense of a clinical trial with patient data. The "testing" referred to is engineering verification and validation against technical specifications and recognized standards. This typically involves testing multiple units of the device and its components in a controlled laboratory environment.

Test Set Sample Size: Not specified as a number of patients or cases. It would refer to the number of devices or components tested.
Data Provenance: The testing is internal (by Renal Solutions Inc.) for verification and validation against engineering specifications and international standards (e.g., IEC, ISO, AAMI). This is a technical validation, not clinical data provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This concept is not applicable to the type of device and study described. For a hemodialysis machine, the "ground truth" is defined by the physical laws of operation and the engineering specifications that ensure safety and effectiveness. Experts (e.g., engineers, quality control personnel) would be involved in designing, measuring, and verifying these specifications against established benchmarks and regulatory requirements. There is no "ground truth" established by clinical experts reading or interpreting output in the way one would for an AI-driven diagnostic device.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials or studies where there is subjective interpretation (e.g., image reading) and a need to resolve disagreements among multiple experts to establish a definitive ground truth. For the Allient System, performance is measured against objective, quantifiable engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done, and the document does not mention any clinical trials comparing human performance with and without AI assistance. This type of study is typically for evaluating diagnostic accuracy or decision support systems, which the Allient System is not.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The Allient System is a physical medical device, not an algorithm or AI system. Its performance is inherent in its electromechanical and chemical operations. Therefore, the concept of "standalone" performance for an algorithm is not applicable here. Its operation is standalone in the sense that it performs its function (dialysis) according to its design.

7. The Type of Ground Truth Used

The "ground truth" for the Allient System is based on:

Engineering Specifications: Quantifiable parameters and tolerances for flow rates, temperatures, leak detection, etc.
Compliance with Recognized Standards: Adherence to established domestic and international standards for medical devices (e.g., ANSI/AAMI, IEC, ISO) which define safety, electrical, biological, and sterilization requirements.
Predicate Device Performance: The predicate device, REDY 2000, serves as a benchmark for "substantial equivalency," implying its established safety and effectiveness forms part of the "ground truth" or acceptable performance standard.

8. The Sample Size for the Training Set

This concept is not applicable. The Allient System is not an AI/ML algorithm that requires a "training set" of data. Its design and operational parameters are determined through engineering principles, bench testing, and adherence to established medical device standards.

9. How the Ground Truth for the Training Set Was Established

This concept is not applicable as there is no "training set" for this type of medical device. The "ground truth" for its design and verification is established through a combination of engineering design principles, regulatory requirements, and established industry standards for hemodialysis systems.

Summary

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JUN 3 - 2005

Image /page/0/Picture/2 description: The image shows a logo with the word "Renal" in a serif font, with the letters slightly spaced apart. Above the word is a stylized graphic resembling a crescent shape or a curved arrow, with a small, curved element inside the crescent. To the right of the word "Renal" is the trademark symbol "TM" in a small font size.

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

510(k) K043574

Date ofApplication	April 22 , 2005
SubmittersName	Renal Solutions Inc770 Commonwealth DriveWarrendale, PA 15086
ContactName	Richard G. Confer, Director of Regulatory Affair770 Commonwealth DriveWarrendale, PA 15086Phone: 724-772-6900e-mail: rick.confer@renalsolutionsinc.com
Trade Name	Allient® Sorbent Hemodialysis System
CommonName	System, Dialysate Delivery, Sorbent Regenerated
Classification	Class II per 21CFR876.5600 code FKT
PredicateDeviceInformation	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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K043574 Page 3 of 9

"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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Ko43574 Page 4 of 9

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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K043574

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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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K04 3574

page 8 of 9

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 - RequirementsFor Terminally-Sterilized Devices To BeLabeled 'Sterile'
IEC 60529	Degrees Of Protection Provided By Enclosures(IP Code)Note: It is agreed that IXP 1 is the level ofprotection to be afforded by the Allient system.
IEC 60601-1:2003	Medical Electrical Equipment, Part 1- GeneralRequirements for Safety
IEC 60601-1-2:2001	Medical Electrical Equipment - Part 1: 2 Generalrequirements for safety; 4. Collateral Standard:Electomagnetic Compatibility
IEC 60601-2-16:1998	Medical electrical equipment - Part 2: Particularrequirements for the safety of hemodialysis,haemodiafiltration and haemofiltrationequipment
ISO 10993-10	Biological evaluation of medical devices -- Part10: Tests for irritation or intracutaneousReactivity
ISO 10993-1:1993	Biological evaluation of medical devices -Systemic Toxicity- Material MediatedPyrogenicity
Iso 10993-3:1993	Biological evaluation of medical devices -Biological evaluation of medicaldevices, Part 3: Tests forgenotoxicity, carcinogenicity,and reproductive toxicityGenotoxicity- Ames test
ISO 10993-10:2002	Biological evaluation of medical devices -- Part10: Tests for irritation and sensitization
ISO 10993-5:1999	Biological evaluation of medical devices -- Part5: Tests for In Vitro cytotoxicity
ISO 10993-7:1995	Biological Evaluation of Medical Devices - Part7: Ethylene Oxide Sterilization Residuals
ISO 11135:1994	Medical Devices - Validation and RoutineControl of Ethylene Oxide Sterilization
ISO 8638:	Extracorporeal Blood Circuit ForHaemodialysers, Haemofilters andHaemoconcentrators

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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 (800) 638-2041 or (301) 443-6597 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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Ko43754

Indications for Use

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

Allient® Sorbent Hemodialysis System Device Name:

Indications For Use:

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

Regulation Number and Section

§ 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.

(a)
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.(b)
Classification. Class II (performance standards).