2008 HEMODIALYSIS SORBENT SYSTEM

K123835 · Renal Solutions, Inc. · FKT · Feb 15, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K123835
• Device Name: 2008 HEMODIALYSIS SORBENT SYSTEM
• Applicant: Renal Solutions, Inc.
• Product Code: FKT · Gastroenterology, Urology
• Decision Date: Feb 15, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.

Device Story

The 2008 Sorbent System is a hemodialysis device consisting of the 2008 Machine and the SORB Module. It functions by recirculating and chemically regenerating used dialysate into fresh dialysate via a sorbent cartridge, significantly reducing water consumption compared to single-pass systems. The system is used in institutional settings under the supervision of a healthcare practitioner. The device processes dialysate through a multi-layer sorbent cartridge (activated carbon, enzyme, zirconium phosphate, zirconium oxide/carbonate) to remove uremic toxins. The healthcare practitioner monitors the system via machine alarms and functional controls. By regenerating dialysate, the system enables hemodialysis treatment with minimal water requirements, benefiting patients requiring acute or chronic renal replacement therapy.

Clinical Evidence

Bench testing only. Verification activities included software/hardware functional testing (disinfection, infusate delivery, modes of operation, alarms) and performance testing of the reconfigured HISORB+ cartridge (dialysate chemistry comparison, performance, and shipping tests).

Technological Characteristics

Sorbent-regenerated hemodialysis system. Components: 2008 Machine and SORB Module. Sorbent cartridge layers: Activated Carbon, Enzyme/Retention, Activated Carbon, Zirconium Phosphate, Zirconium Oxide/Carbonate. Power: 120V AC, 60Hz, 12.5A max. Treatment duration: 3-4 hours. Software-controlled operation with alarm monitoring.

Indications for Use

Indicated for adult (≥18 years) acute and chronic uremic patients requiring hemodialysis, prescribed by a physician, for use in the presence of a healthcare practitioner.

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

• 2008 Sorbent System (K093362)

Submission Summary (Full Text)

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K123835
PAGE 1 of 4

### Section 6: 510(k) Summary

FEB 1 5 2013

# 510(k) Summary

## Submitter's Information

| Name | Renal Solutions, Inc. |
|------------------|------------------------------------------------------------------------------------------------|
| Address | 770 Commonwealth Drive<br>Warrendale, Pa 15086<br>Phone: [phone]<br>FAX: [phone] |
| Official Contact | David J. Vanella<br>Senior Vice President, Quality Assurance & Regulatory<br>Affairs |
| Date Prepared | 12/12/2012 |

## Device Information

| Name | 2008 Sorbent System |
|-----------------------|-------------------------------------------------|
| Common/Usual Name | Hemodialysis System |
| Product Code | FKT |
| Classification Name | System, Dialysate Delivery, Sorbent Regenerated |
| Regulation Number | 876.5600 |
| Proprietary Name | 2008 Sorbent System |
| Unmodified Device | 2008 Sorbent System (K093362) |
| Reason for Submission | Modification to existing device |

## Device Description

The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.

The 2008 Sorbent System consists of two distinct components:

- the 2008 Machine, and .
- . the SORB™ Module.

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Special 510(k)

## Section 6: 510(k) Summary

The SORB Module is a sorbent dialysate regenerative system that attaches to the 2008 Machine and replaces the machine's existing single-pass dialysate delivery system.

During treatment, used dialysate is chemically reprocessed into fresh, new dialysate and sent back to the dialyzer instead of being sent down a drain. By recirculating and regenerating the dialysate, the 2008 Sorbent System uses less than 15 liters of potable tap water per treatment compared to a standard sinqle-pass system that uses at least 120 liters of purified water during a standard 4-hour dialysis treatment.

## Intended Use

The intended use of the modified 2008 Sorbent System is identical to the unmodified device, 2008 Sorbent System (K093362).

### Indications for Use

The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.

## Substantial Equivalence

The 2008 Sorbent System (K123835) is substantially equivalent to the unmodified device, 2008 Sorbent System (K093362), in terms of its intended use, environment of use, operating principles, and technology.

Renal Solutions has determined that the differences from the predicate device have no impact on the safety and effectiveness of the device and that the changes to the 2008 Sorbent System do not raise new types of safety or effectiveness questions. The design verification testing demonstrates the device meets the design requirements and supports substantial equivalence. In summary, the 2008 Sorbent Hemodialysis System (K123835) is substantially equivalent to the predicate device (K093362).

| Area | Predicate | Modified Device |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| | 2008 Sorbent System<br>(K093362) | 2008 Sorbent System<br>(K123835) |
| Intended Use /<br>Indications for Use | The 2008 Sorbent System is<br>intended for adult acute and<br>chronic uremic patients in the<br>presence of a healthcare<br>practitioner where hemodialysis is<br>prescribed on the order of a<br>physician. | Same |
| Target Population | Adults ( $≥$ 18 years) | Same |

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K123835
PAGE 3 OF 4

#### 2008 Sorbent System

#### . Special 510(k)

### Section 6: 510(k) Summary

| Area | Predicate | Modified Device |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2008 Sorbent System<br>(K093362) | 2008 Sorbent System<br>(K123835) |
| Environment of Use | Institutional, where competent<br>intervention is present | Same |
| Energy Used and/or<br>Delivered | AC 120 V ± 10%<br>• 60 Hz<br>• 12.5 A max | Same |
| Treatment Duration | 3 - 4 hours | Same |
| Sorbent Regenerative<br>Model | Spent dialysate is passed through<br>a sorbent cartridge and<br>regenerated into fresh dialysate. | Same |
| Sorbent Cartridge Type | HISORB+TM Cartridge | Same |
| Sorbent Cartridge<br>Layers | Layer 1: Activated Carbon<br>Layer 2: Enzyme/Enzyme<br>Retention<br>Layer 3: Zirconium Phosphate<br>Layer 4: Zirconium<br>Oxide/Zirconium Carbonate | Layer 1: Activated Carbon<br>Layer 2: Enzyme/Enzyme<br>Retention<br>Layer 3: Activated Carbon<br>Layer 4: Zirconium Phosphate<br>Layer 5: Zirconium<br>Oxide/Zirconium Carbonate |

## 2008 Sorbent System Verification (non-clinical) Testing Summary

The following list summarizes the 510(k) verification testing activities performed. These activities include performance and software testing, which demonstrates by technical examination that the 2008 Sorbent System meets its performance specifications and is substantially equivalent to the predicate device.

The following tests were conducted for the 2008 Sorbent System (K123835):

#### 1. 2008 System Software/ Hardware

- · 2008 Machine Functional SW Verification Protocol
- · Disinfection testing
- · Infusate Delivery testing
- · Modes of Operation testing
- · Alarms testing

#### 2. HISORB+ Cartridge

- · Comparison of dialysate chemistries between a reconfigured HISORB+ cartridge and the HISORB+ cartridge
- · Modified HISORB+ cartridge performance testing
- Modified HISORB+ cartridge shipping test

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K123835
PAGE 4 OF 4

### 2008 Sorbent System Special 510(k)

### Section 6: 510(k) Summary

## General Safety and Effectiveness

The modified 2008 Sorbent System (K123835) is an updated version of the 2008 Sorbent System (K093362). The performance and technological characteristics of the modified device are equivalent to those of the unmodified device and raise no new types of safety or effectiveness questions.

## Conclusions

The verification (non-clinical) testing information consisting of performance and software testing that was performed verifies that the modified 2008 Sorbent System (K123835) meets its performance specifications and demonstrates that the device is substantially equivalent to the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract human figure or a caduceus, rendered in black.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### February 15, 2013

Renal Solutions, Inc. % Mr. David J. Vanella Senior Vice President Quality Assurance & Regulatory Affairs 770 Commonwealth Drive, Suite 101 WARRENDALE PA 15086

Re: K123835

Trade/Device Name: 2008 Sorbent System Regulation Number: 21 CFR§ 876.5600 Regulation Name: Sorbent regenerated dialysate delivery system for hemodialysis Regulatory Class: II Product Code: FKT Dated: January 18, 2013 Received: January 24, 2013

Dear Mr. Vanella:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device 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 statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. David J. Vanella

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Benjamin Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 2008 Sorbent System

#### Special 510(k)

#### Section 5: Indications for Use Statement

## Indications for Use Statement

123835 510(k) Number (if known): MA K

Device Name: 2008 Sorbent System

#### Indications for Use:

The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a 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)

Benjamir 2013.02.

Renal Solutions, Inc. Division Sign-2008 Sorbent System Special 510(KD)vis inn of R